Medicines Regulations 1984
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Version as at 1 February 2026
Medicines Regulations 1984
(SR 1984/143)
David Beattie, Governor-General
Order in Council
At the Government House at Wellington this 5th day of June 1984
Present:
His Excellency the Governor-General in Council
Note
The Parliamentary Counsel Office has made editorial and format changes to this version using the powers under subpart 2 of Part 3 of the Legislation Act 2019.
Note 4 at the end of this version provides a list of the amendments included in it.
These regulations are administered by the Ministry of Health.
Pursuant to section 105 of the Medicines Act 1981, and, in the case of Part 3 of the regulations, to section 62 of that Act, His Excellency the Governor-General, acting on the advice of the Minister of Health tendered after consultation with the organisations and bodies that appeared to the Minister to be representatives of persons likely to be substantially affected, and by and with the advice and consent of the Executive Council, hereby makes the following regulations.
Contents
Regulations
1 Title and commencement
(1)
These regulations may be cited as the Medicines Regulations 1984.
(2)
These regulations shall come into force on 1 August 1984.
2 Interpretation
(1)
In these regulations, unless the context otherwise requires,—
Act means the Medicines Act 1981
appropriate designation, in relation to a medicine, or an ingredient of a medicine, or a related product, or an active ingredient of a related product, has the following meaning in each of the cases specified:
(a)
where the medicine, related product, or ingredient is named or described in a monograph contained in the current edition of a specified publication, the term means the name or one of the synonyms used in that specified publication for that medicine, related product, or ingredient:
(b)
where the medicine, related product, or ingredient—
(i)
is not named or described in a monograph contained in the current edition of any specified publication but was named or described in a monograph contained in an earlier edition; and
(ii)
is not sold under any name or description except the name or one of the synonyms used in that earlier edition for that medicine, related product, or ingredient,—
the term means the name or one of the synonyms so used in that earlier edition followed immediately by a reference to that earlier edition:
(c)
where neither paragraph (a) nor paragraph (b) applies, the term means—
(i)
the international non-proprietary name of the medicine, related product, or ingredient; or
(ii)
if it has no international non-proprietary name, the name appearing in a list published in the United Kingdom on the recommendation of the Medicines Commission pursuant to section 100 of the Medicines Act 1968 (UK); or
(iii)
if the medicine, related product, or ingredient has neither an international non-proprietary name nor a name appearing in a list referred to in subparagraph (ii), its accepted scientific name or some other name descriptive of the true nature of the medicine, related product, or ingredient
appropriate quantitative particulars, in relation to any active ingredients of a medicine or of a related product,—
(a)
where the medicine or related product consists of or comprises tablets, capsules, or other separate portions, means the quantity (expressed by weight or volume) of each of the ingredients contained in each portion; or
(b)
in any other case, means the percentage of each of those ingredients contained in the medicine or related product, or the quantity of each of those ingredients contained in a stated quantity of the medicine or related product
approved immunisation programme means a vaccination programme—
(a)
pursuant to the National Immunisation Schedule administered by Pharmac; or
(b)
approved by the Director-General or a Medical Officer of Health
biochemical preparation includes—
(a)
an antigen; and
(b)
an antitoxin; and
(c)
a toxin; and
(d)
a blood fractionation preparation; and
(e)
an insulin; and
(f)
a preparation from a mammalian gland; and
(g)
a serum; and
(h)
a vaccine; and
(i)
any other substance or preparation that is similar in nature to any of those specified in paragraphs (a) to (h),—
whether natural or synthetic, that is intended for diagnostic, prophylactic, or therapeutic purposes
consent to distribute, in relation to any medicine or related product, means a consent to the distribution of that medicine or related product given by the Minister under section 20 of the Act; and includes a provisional consent given under section 23 of the Act
controlled drug has the same meaning as in the Misuse of Drugs Act 1975
described, in relation to any medicine, related product, or medical device, means represented or held out (whether in writing or otherwise) by the manufacturer, seller, or supplier of the medicine, related product, or medical device
dispensary technician means a person who holds a certificate issued by the Pharmaceutical Society of New Zealand before 18 September 2004 that—
(a)
classifies the holder as a dispensary assistant; or
(b)
records that the person has completed the requirements of the Pharmacy Technicians Certificate
for external use, in relation to any medicine or related product, means for application to the anal canal, ear, eye, mucosa of the mouth, nose, skin, teeth, throat, or vagina, where local action only is required and where extensive systemic absorption will not occur; but nothing in these regulations relating to medicines or related products intended for external use shall apply to nasal drops, nasal inhalations, nasal sprays, teething applications, throat lozenges, throat pastilles, throat sprays, or throat tablets
general sale medicine has the meaning given to it by section 99(2) of the Act
Pharmac means the Pharmaceutical Management Agency continued by section 67 of the Pae Ora (Healthy Futures) Act 2022
Pharmacy Council means the Pharmacy Council established by section 114(5) of the Health Practitioners Competence Assurance Act 2003
pharmacy graduate means a person who is not a pharmacist, but who—
(a)
has 1 or more of the qualifications prescribed by the Pharmacy Council under section 12(1) of the Health Practitioners Competence Assurance Act 2003 for registration as a pharmacist; and
(b)
is actively taking steps towards registration as a pharmacist
pharmacy student means a person who is undertaking, but has not yet completed, the course and examinations leading to a qualification of a kind prescribed by the Pharmacy Council under section 12(1) of the Health Practitioners Competence Assurance Act 2003
pharmacy technician means any person who has a National Certificate in Pharmacy (Technician)
pharmacy technician student means a person who is undertaking, but who has not yet completed, training and examinations leading to a National Certificate in Pharmacy (Technician)
poison bottle means a container that is made of glass, plastic, or other like material, and that either—
(a)
has embossed on at least one-third of its outer surface narrow flutings, ribs, nettings, or points, or other similar surface impressions readily recognisable by touch; or
(b)
has clearly embossed on 2 opposite sides of the shoulder of the container the word “POISON”
in capital letters, the height of the letters being not less than half the width of that shoulder
principal display panel means the part of a label that is most likely to be displayed, presented, shown, or examined under ordinary or customary conditions of display; and, if such likelihood is equal in respect of 2 or more panels, means every such panel
printed includes written, typewritten, engraved, lithographed, or otherwise traced or copied
registered midwife means a health practitioner who is, or is deemed to be, registered with the Midwifery Council established by section 114(3) of the Health Practitioners Competence Assurance Act 2003 as a practitioner of the profession of midwifery
safety container means a container, whether or not part of a strip of containers, that—
(a)
encloses a single tablet or other single item of a medicine that is a solid or a class of medicines that are solids (including a medicine or class of medicines in powder form); and
(b)
is made of aluminium foil or laminated plastic, or such other material as may be approved by the Director-General in relation to the packaging of any solid medicine to which regulation 37 applies, either by notice in the Gazette or in writing addressed to a particular manufacturer, packer, importer, or seller of medicines; and
(c)
is reasonably resistant to attempts by young children to open it
specified publication means a publication named in section 108(1) of the Act
student means a pharmacy student or a pharmacy technician student.
(2)
In these regulations, unless the context otherwise requires, all references to proportions in a medicine (whether as percentages, parts per million, or otherwise) shall be references to—
(a)
proportions by weight, where the medicine is a solid; or
(b)
proportions by volume, where the medicine is a liquid at ambient temperatures.
Regulation 2(1) approved immunisation programme: inserted, on 17 April 1992, by regulation 2 of the Medicines Regulations 1984, Amendment No 5 (SR 1992/43).
Regulation 2(1) approved immunisation programme paragraph (a): amended, on 29 November 2012, by regulation 4(1) of the Medicines Amendment Regulations 2012 (SR 2012/329).
Regulation 2(1) approved school: revoked, on 1 August 2011, by regulation 4(1) of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 2(1) colouring substance: revoked, on 1 August 2011, by regulation 4(1) of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 2(1) designated prescriber nurse: revoked, on 1 October 2005, by regulation 3 of the Medicines Amendment Regulations 2005 (SR 2005/255).
Regulation 2(1) Dispensary Assistant’s Certificate: revoked, on 1 August 2011, by regulation 4(1) of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 2(1) dispensary technician: substituted, on 1 August 2011, by regulation 4(2) of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 2(1) general sale medicine: inserted, on 1 August 2011, by regulation 4(3) of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 2(1) Pharmac: inserted, on 29 November 2012, by regulation 4(2) of the Medicines Amendment Regulations 2012 (SR 2012/329).
Regulation 2(1) Pharmac: amended, on 1 July 2022, by section 104 of the Pae Ora (Healthy Futures) Act 2022 (2022 No 30).
Regulation 2(1) Pharmacy Council: inserted, on 1 August 2011, by regulation 4(4) of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 2(1) pharmacy graduate: substituted, on 1 August 2011, by regulation 4(5) of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 2(1) pharmacy student: substituted, on 1 August 2011, by regulation 4(5) of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 2(1) pharmacy technician: substituted, on 1 August 2011, by regulation 4(5) of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 2(1) pharmacy technician student: inserted, on 19 December 2002, by regulation 3(3) of the Medicines Amendment Regulations (No 2) 2002 (SR 2002/374).
Regulation 2(1) registered midwife: substituted, on 18 September 2004, by section 175(3) of the Health Practitioners Competence Assurance Act 2003 (2003 No 48).
Regulation 2(1) safety container paragraph (b): amended, on 1 January 1995, by regulation 2 of the Medicines Regulations 1984, Amendment No 6 (SR 1994/299).
Regulation 2(1) student: added, on 19 December 2002, by regulation 3(4) of the Medicines Amendment Regulations (No 2) 2002 (SR 2002/374).
2A Transitional, savings, and related provisions
The transitional, savings, and related provisions set out in Schedule 1AA have effect according to their terms.
Regulation 2A: inserted, on 16 June 2023, by regulation 4 of the Medicines Amendment Regulations 2023 (SL 2023/130).
Part 1 Classification of medicines
3 Classification of medicines
(1)
All medicines and classes of medicines specified in Part 1 of Schedule 1 are hereby declared to be prescription medicines.
(1A)
[Revoked](1B)
[Revoked](2)
All medicines and classes of medicines specified in Part 2 of Schedule 1 are hereby declared to be restricted medicines.
(3)
Subject to subclause (4), all medicines and classes of medicines specified in Part 3 of Schedule 1 are hereby declared to be pharmacy-only medicines.
(4)
Nothing in subclause (3) shall apply to a remedy that is, and is described as, homoeopathic.
Regulation 3(1A): revoked, on 1 November 2005, by regulation 12(2)(a) of the Medicines (Designated Prescriber: Nurse Practitioners) Regulations 2005 (SR 2005/266).
Regulation 3(1B): revoked, on 1 November 2005, by regulation 12(2)(a) of the Medicines (Designated Prescriber: Nurse Practitioners) Regulations 2005 (SR 2005/266).
Part 2 Standards
4 Standards for medicines, related products, medical devices, cosmetics, and surgical dressings
(1)
Any medicine or related product, other than a medicine or related product for which a standard is otherwise prescribed in these regulations, shall, where it is described as conforming to a monograph in a specified publication, conform to the description and tests set out in that publication for that medicine or related product.
(2)
Every medicine, related product, or cosmetic used or represented as suitable for application into the eye shall conform to the tests for sterility set out in a specified publication.
(3)
Every medicine, related product, or cosmetic that is a dusting powder for use on the skin of a baby, or on any inflamed, abraded, or broken skin, shall be free of pathogenic organisms.
(4)
No medicine, related product, cosmetic, or dentifrice intended for sale shall contain or have attached to it or enclosed with it any extraneous thing that is harmful, dangerous, or offensive.
(5)
A surgical dressing that is described as conforming to a monograph in a specified publication shall conform to the description and tests set out in that publication for that surgical dressing.
(6)
A medical device that is described as conforming to a particular description shall conform to that description.
4A Standard for CBD products
(1)
The minimum quality standard imposed by Part 1 of the Misuse of Drugs (Medicinal Cannabis) Regulations 2019 applies to a CBD product as if it were both a cannabis-based ingredient and a medicinal cannabis product under those regulations.
(2)
However, the minimum quality standard does not apply to a CBD product that is imported by—
(a)
a medical practitioner whose purpose is to prescribe, supply, or administer it for the treatment of a particular patient under their care; or
(b)
a pharmacist for a prescription to which paragraph (a) applies.
(3)
Subclause (4) applies to a CBD product of a type that, at the commencement of this regulation, has been imported into New Zealand by the holder of a licence issued under the Medicines Act 1981.
(4)
The minimum quality standard does not apply to any of that product of the licence holder until 1 October 2021.
(4A)
The minimum quality standard does not apply to a CBD product if—
(a)
it is carried by a traveller when they enter or leave New Zealand; or
(b)
it is supplied for a clinical trial under section 30 of the Medicines Act 1981; or
(c)
it is used for veterinary medicine; or
(d)
it is used for research, testing, analysis, or product development that is not for, or does not relate to, a therapeutic purpose; or
(e)
its ingredients are not derived from a cannabis plant; or
(f)
it has consent for distribution under the Medicines Act 1981.
(5)
In this regulation, CBD product has the meaning given by section 2A of the Misuse of Drugs Act 1975.
Regulation 4A: inserted, on 1 April 2020, by regulation 84 of the Misuse of Drugs (Medicinal Cannabis) Regulations 2019 (LI 2019/321).
Regulation 4A(4): amended, on 30 March 2021, by regulation 4 of the Medicines Amendment Regulations 2021 (LI 2021/44).
Regulation 4A(4): amended, on 30 September 2020, by regulation 4 of the Medicines Amendment Regulations 2020 (LI 2020/262).
Regulation 4A(4A): inserted, on 5 July 2024, by regulation 49 of the Misuse of Drugs (Medicinal Cannabis) Amendment Regulations 2024 (SL 2024/129).
5 Pharmacist may dilute medicine in particular case
Where any liquid medicine in respect of which a standard is prescribed by any of the provisions of these regulations is to be supplied by a pharmacist pursuant to a prescription issued for a particular patient, the pharmacist may add a compatible diluent to the medicine if he is satisfied that—
(a)
such dilution is necessary to adjust the dose to a quantity easily measurable by the patient or by any other person on behalf of the patient; and
(b)
the addition of that diluent will not affect injuriously the composition of the medicine.
6 Colouring substances
[Revoked]Regulation 6: revoked, on 1 August 2011, by regulation 5 of the Medicines Amendment Regulations 2011 (SR 2011/245).
Part 3 Advertisements
7 Advertisements not to claim official approval
No advertisement relating to any medicine, related product, or medical device shall contain a statement to the effect that an advisory or technical committee established under section 8 of the Act, or any member of such a committee, or any officer in the service of the Government, has approved, or has refrained from disapproving, the advertisement or any of the claims or statements made in it.
8 Advertisements for medicines
(1)
Every advertisement for a prescription medicine must include—
(a)
the words “Prescription medicine”
or words of a similar meaning; and
(b)
the name of each active ingredient; and
(c)
the appropriate quantitative particulars of each active ingredient; and
(d)
a statement of the purpose for which the medicine is intended to be used; and
(e)
a statement that the medicine has risks and benefits; and
(f)
a statement about how to find further information on the risks and benefits of the medicine.
(2)
Every advertisement for a restricted medicine must include—
(a)
the following statements, or statements with a similar meaning:
(i)
“Available only from your pharmacist.”
; and
(ii)
“If symptoms persist, see your doctor or health professional.”
; and
(iii)
“Use only as directed.”
; and
(b)
the name of each active ingredient, or the following statement, or a statement with a similar meaning:
“Always read the label.”
; and
(c)
a statement of the purpose for which the medicine is intended to be used; and
(d)
any warning statement that may be required by guidelines issued from time to time by the Ministry of Health.
(3)
Every advertisement for a pharmacy-only medicine or a general sale medicine must include—
(a)
the following statements, or statements with a similar meaning:
(i)
“If symptoms persist, see your doctor or health professional.”
; and
(ii)
“Use only as directed.”
; and
(b)
the name of each active ingredient, or the following statement, or a statement with a similar meaning:
“Always read the label.”
; and
(c)
a statement of the purpose for which the medicine is intended to be used; and
(d)
any warning statement that may be required by guidelines issued from time to time by the Ministry of Health.
(4)
Every advertisement for a medicine to be supplied by mail order, direct marketing, or via the Internet must—
(a)
include the name of each active ingredient; and
(b)
include the appropriate quantitative particulars of each active ingredient; and
(c)
comply with the following, to the extent they are applicable:
(i)
subclause (1)(a), and (d) to (f):
(ii)
subclause (2)(a), (c), and (d):
(iii)
subclause (3)(a), (c), and (d).
(5)
A statement required by this regulation must be—
(a)
clearly printed; or
(b)
clearly spoken.
(6)
A statement that is required by this regulation may be both clearly printed and clearly spoken.
(7)
This regulation does not apply to—
(a)
an advertisement for a medicine that does not refer to a therapeutic purpose:
(b)
an advertisement (not being an advertisement of the kind described in subclause (4)) that is—
(i)
located at the point of sale; and
(ii)
positioned immediately above, below, or next to the medicine to which it relates:
(c)
labels:
(d)
price lists.
(8)
An advertisement for a prescription, restricted, pharmacy-only, or general sale medicine that is subsequently reclassified must be treated as compliant with this regulation if—
(a)
the advertisement was compliant with every applicable requirement in this regulation immediately before the medicine was reclassified; and
(b)
not more than 3 months have elapsed since the medicine was reclassified.
(9)
In any proceedings for an offence against section 57 of the Act, it is for the defendant to prove that subclause (8) applies.
Regulation 8: substituted, on 1 August 2011, by regulation 6 of the Medicines Amendment Regulations 2011 (SR 2011/245).
9 Advertisements for related products
(1)
Every advertisement for a related product, other than a label or a price list, shall include a statement of the uses of the related product.
(2)
Every advertisement that refers to an active ingredient of a related product by name shall state the appropriate designation of the ingredient.
10 Advertisements for medical devices
Every advertisement for a medical device, other than a label or a price list, shall include, where appropriate, the following:
(a)
an accurate description of the medical device:
(b)
a statement of the uses of the medical device:
(c)
a statement of the appropriate precautions to be taken in the use of the medical device:
(d)
a statement of any contraindications to the use of the medical device.
11 Advertisements intended for health professions
(1)
This regulation applies—
(a)
to advertisements intended for members of the medical, dental, pharmaceutical, and related professions; and
(b)
in addition to the requirements in regulations 7, 9, and 10 (but not regulation 8).
(2)
Every advertisement for a medicine must—
(a)
include—
(i)
the classification of the medicine; and
(ii)
the name of each active ingredient; and
(iii)
the appropriate quantitative particulars of each active ingredient; and
(iv)
a statement of the purpose for which the medicine is intended to be used; and
(v)
a statement of the appropriate precautions to be taken in the use of the medicine; and
(vi)
information on the effectiveness and limitations of the medicine; and
(vii)
a statement of any restriction imposed on distribution; and
(viii)
the dosage regime and mode of administration, or method of use, of the medicine; and
(ix)
a statement of any contraindications to the use of the medicine; and
(x)
information on the likely potentiating effects and interactions with other substances, medicines, or environmental influences; and
(xi)
a statement of the known or likely poisonous effects of, or adverse reactions to, the medicine; but
(b)
not include—
(i)
a statement (based on the citation of a report) relating to the effectiveness or safety of the medicine that omits relevant parts of the report, or quotes from the report in such a way that another meaning to that intended by the report is conveyed; or
(ii)
an unsubstantiated comparison with other medicines; or
(iii)
data, previously considered valid, but made obsolete or false by subsequent findings; or
(iv)
a statement of the use of the medicine, or the dosage of the medicine, that contravenes any condition of a consent given under section 20, 23, or 24 of the Act.
(3)
Nothing in subclause (2)(a)(iii) or (vi) to (xi) applies to an advertisement that—
(a)
is intended to provide a practitioner with details of—
(i)
a major therapeutic indication of a medicine; or
(ii)
the listing of a medicine in the pharmaceutical schedule (within the meaning of section 4 of the Pae Ora (Healthy Futures) Act 2022); or
(iii)
a new or changed strength of a medicine; and
(b)
does not enable the practitioner to reach a prescribing decision.
(4)
Every advertisement for a related product or medical device must include—
(a)
a statement of any restriction imposed on distribution; and
(b)
the dosage regime and mode of administration, or method of use, of the related product or medical device; and
(c)
information on the effectiveness and limitations of the related product or medical device.
Regulation 11: substituted, on 1 August 2011, by regulation 7 of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 11(3)(a)(ii): amended, on 1 July 2022, by section 104 of the Pae Ora (Healthy Futures) Act 2022 (2022 No 30).
Part 4 Labelling
12 Medicines, related products, and medical devices not to be sold unless properly labelled
(1)
No person shall sell any medicine or related product in a container if the container—
(a)
does not bear a label containing all the particulars required by these regulations to be on a label relating to such a container; or
(b)
bears a label containing anything that is prohibited by these regulations from appearing on a label relating to such a container; or
(c)
bears a label containing any particulars that are not in the position, manner, and style required by these regulations in respect of a label relating to such a container.
(2)
No person shall sell a package containing a single container of any medicine or related product unless that package is labelled in a manner similar to that in which the container is labelled.
(3)
No person shall sell any medicine in a poison bottle bearing any label that obscures any flutings, ribs, nettings, points, embossed words, or similar markings on the bottle.
(4)
No person shall sell any medical device that does not bear the name of the manufacturer of the medical device or the name of the manufacturer’s distributor in New Zealand.
(5)
Notwithstanding anything in the foregoing provisions of this regulation, the Director-General may, by notice in writing to the manufacturer or importer of any medicine, exempt from the labelling requirements of these regulations the sale of that medicine in a container of a specified type.
13 Labelling of medicines
(1)
Every container of a medicine must, unless otherwise provided by these regulations, bear a label containing the following information:
(a)
the trade name of the medicine or, if there is no trade name, the appropriate designation of the medicine:
(b)
the name of each active ingredient:
(c)
the appropriate quantitative particulars of each active ingredient:
(d)
a description of the medicine, including dose form, or presentation, that indicates the true nature of the medicine:
(e)
a statement of the net weight or volume or number of the contents of the container, as the case may require:
(f)
in the case of a prescription medicine,—
(i)
the words “PRESCRIPTION MEDICINE”
or words of a similar meaning; or
(ii)
the words “PRESCRIPTION-ONLY MEDICINE”
or words of a similar meaning; or
(iii)
the acronym “POM”
:
(g)
in the case of a restricted medicine,—
(i)
the words “RESTRICTED MEDICINE”
; or
(ii)
the words “PHARMACIST-ONLY MEDICINE”
:
(h)
in the case of a pharmacy-only medicine,—
(i)
the words “PHARMACY-ONLY MEDICINE”
or words of a similar meaning; or
(ii)
the words “PHARMACY MEDICINE”
or words of a similar meaning:
(i)
any warning statement required by these regulations for the medicine:
(j)
in the case of a medicine other than a prescription medicine, a statement of the purpose for which the medicine is intended to be used:
(k)
in the case of a medicine sold, or intended for sale, for external use,—
(i)
a statement of directions for use and frequency of use; and
(ii)
the words “Caution: not to be taken”
, or “For external use only”
, or words of a similar meaning:
(l)
in the case of a medicine sold, or intended for sale, for internal use,—
(i)
the dose recommended; and
(ii)
the frequency of that dose:
(m)
the words “Batch Number”
or “Lot Number”
, or the word “Batch”
or “Lot”
, or the letter “B”
(either alone or inside a circle) followed by the batch or lot number of the medicine:
(n)
the words “Use by”
or “Use before”
, or words of a similar meaning, followed by the expiry date (being in no case later than 5 years after the date of manufacture of the medicine) appropriate to the stability of the medicine:
(o)
where appropriate, a statement of the recommended storage conditions:
(p)
the name and address of—
(i)
the manufacturer or seller of the medicine; or
(ii)
the owner of the rights of manufacture; or
(iii)
the agent of any person who comes within subparagraph (i) or (ii).
(2)
For the purposes of subclause (1)(p),—
(a)
an address at a post office is not sufficient:
(b)
the name and address of a person not ordinarily resident in New Zealand are not sufficient unless the medicine is wholly manufactured and packed outside New Zealand:
(c)
in the case of a body corporate registered in New Zealand, the name of the town in which the body corporate has its registered office is sufficient.
(3)
In the case of a medicine intended for administration only in accordance with the directions of a practitioner, it is sufficient compliance with subclause (1)(l) to indicate the dose by a range if the container is accompanied by a more specific statement relating to each usage.
(4)
In the case of a prescription medicine, compliance with the requirements of subclause (1)(k) or (l) is required only at the time at which that medicine—
(a)
is sold by retail; or
(b)
is supplied in circumstances corresponding to retail sale; or
(c)
is supplied by way of gift or sample for the purpose of promoting a sale.
(5)
Subclause (1)(l) does not apply in the case of a medicine intended to be administered by or under the supervision of a practitioner, in circumstances where the dosage is to be dependent on concurrent skilled observation.
(6)
Every container of a medicine that is prepared for injection into the human body and that contains an antiseptic or preservative must be labelled with a statement of the nature and amount of the antiseptic or preservative.
(7)
Every container of a medicine that is a biochemical preparation must, in addition to the other requirements in this regulation, bear a label containing the following:
(a)
a statement of the potency of the preparation; and
(b)
a statement of the nature and amount of every antiseptic or preservative (if any) used in the medicine.
(8)
Where it is impractical to put all of the information required by this regulation on a label because the container is too small, it is sufficient compliance with this regulation to print the information required by subclause (1)(i), (j), and (o) on a separate information sheet, in the same manner as that information would be required by these regulations to be printed on a label, and to supply that sheet to the customer with the medicine.
(9)
This regulation is subject to regulations 15 and 23.
Regulation 13: substituted, on 1 August 2011, by regulation 8 of the Medicines Amendment Regulations 2011 (SR 2011/245).
14 Labelling of related products
(1)
Every container of a related product must, unless otherwise provided by these regulations, bear a label containing the following information:
(a)
the trade name of the related product or, if there is no trade name, the appropriate designation of the related product:
(b)
the name of each active ingredient:
(c)
the appropriate quantitative particulars of each active ingredient:
(d)
a description of the related product that indicates the true nature of the related product:
(e)
a statement of the net weight or volume or number of the contents of the container, as the case may require:
(f)
any warning statement required by these regulations for the related product:
(g)
in the case of a related product sold, or intended for sale, for external use,—
(i)
a statement of directions for use and frequency of use; and
(ii)
the words “Caution: not to be taken”
, or “For external use only”
, or words of a similar meaning:
(h)
in the case of a related product sold, or intended for sale, for internal use,—
(i)
the dose recommended; and
(ii)
the frequency of that dose:
(i)
the words “Batch Number”
or “Lot Number”
, or the word “Batch”
or “Lot”
, or the letter “B”
(either alone or inside a circle) followed by the batch or lot number of the related product:
(j)
where appropriate, an expiry date:
(k)
the name and address of—
(i)
the manufacturer or seller of the related product; or
(ii)
the owner of the rights of manufacture; or
(iii)
the agent of any person who comes within subparagraph (i) or (ii).
(2)
For the purposes of subclause (1)(k),—
(a)
an address at a post office is not sufficient:
(b)
the name and address of a person not ordinarily resident in New Zealand are not sufficient unless the related product is wholly manufactured and packed outside New Zealand:
(c)
in the case of a body corporate registered in New Zealand, the name of the town in which the body corporate has its registered office is sufficient.
Regulation 14: substituted, on 1 August 2011, by regulation 8 of the Medicines Amendment Regulations 2011 (SR 2011/245).
15 Exemptions from regulations 13 and 14
(1)
Nothing in regulation 13 (except subclause (1)(a), (b), (c), (m), and (n)) and nothing in regulation 14 (except subclause (1)(a), (b), (c), (i), and (j)) applies to—
(a)
a container that—
(i)
contains a single dose of a medicine or related product; and
(ii)
is made of sheet material; and
(iii)
is not attached to another container; and
(iv)
is contained in a package that complies with regulation 13 or 14 (as the case requires); and
(v)
is not intended for sale other than in that package:
(b)
a container that—
(i)
contains a single dose of a medicine or related product; and
(ii)
is not made of sheet material; and
(iii)
has a volume of 20 millilitres or less; and
(iv)
is contained in a package that complies with regulation 13 or 14 (as the case requires); and
(v)
is not intended for sale other than in that package:
(c)
a container (other than an aerosol container) that—
(i)
contains a medicine or related product that is a gas; and
(ii)
is of a kind commonly used for storing or transporting gases in compressed, liquefied, or dissolved form; and
(iii)
has a capacity not exceeding 250 litres water capacity:
(d)
a container of a remedy that is, or is described as, homeopathic.
(2)
Nothing in regulation 13 or 14 applies to a strip of containers that—
(a)
is made of sheet material; and
(b)
bears the information required by—
(i)
regulation 13(1)(m) and (n) or regulation 14(1)(i) and (j) (as the case requires) at least once on the strip; and
(ii)
regulation 13(1)(a), (b), and (c) or regulation 14(1)(a), (b), and (c) (as the case requires)—
(A)
at least once in relation to every 2 containers, if the containers are easily detached from the strip; and
(B)
at least once on the strip in any other case; and
(c)
is contained in a package that complies with regulation 13 or 14 (as the case requires); and
(d)
is not intended for sale other than in that package.
(3)
In this regulation, strip of containers means a series of containers that each contain a single dose of a medicine or related product and that together form a strip.
(4)
Nothing in regulation 13(1)(f), (g), or (h) applies to a prescription medicine, restricted medicine, or pharmacy-only medicine, held for sale by a manufacturer or wholesaler, for the period of 3 months immediately following the date on which it becomes a prescription medicine, restricted medicine, or pharmacy-only medicine (as the case may be) if, at that date, the medicine was part of the existing stock-in-trade in New Zealand of the manufacturer or wholesaler.
(5)
Nothing in regulation 13(1)(f), (g), or (h) applies to a prescription medicine, restricted medicine, or pharmacy-only medicine, held for sale by a retailer, for the period of 6 months immediately following the date on which it becomes a prescription medicine, restricted medicine, or pharmacy-only medicine (as the case may be) if, at that date, the medicine was part of the existing stock-in-trade in New Zealand of the retailer.
(6)
For the purposes of subclauses (4) and (5), any goods purchased before the date on which a substance becomes a prescription medicine, restricted medicine, or pharmacy-only medicine (as the case may be) for importation into New Zealand are deemed to be part of the purchaser’s stock-in-trade in New Zealand.
(7)
In any proceedings for an offence against section 44 of the Act in respect of any container that does not comply with regulation 13(1)(f), (g), or (h), the onus is on the defendant to prove that the relevant paragraph does not apply by virtue of subclause (4) or (5) of this regulation.
Regulation 15: substituted, on 1 August 2011, by regulation 8 of the Medicines Amendment Regulations 2011 (SR 2011/245).
16 Principal display panel
(1)
The principal display panel of the label of a medicine must contain—
(a)
the information required by regulation 13(1)(a), (d), and (e); and
(b)
the information required by regulation 13(1)(b) and (c), but only if the medicine contains 3 or fewer active ingredients.
(2)
Subclause (1) is subject to regulation 23.
(3)
The principal display panel of the label of a related product must contain—
(a)
the information required by regulation 14(1)(a), (d), and (e); and
(b)
the information required by regulation 14(1)(b) and (c), but only if the related product contains 3 or fewer active ingredients.
(4)
Nothing in subclause (1) or (3) prevents the inclusion in the principal display panel of any other matters required by these regulations to appear on a label of any medicine or related product.
(5)
Subclause (4) is subject to regulation 19.
Regulation 16: substituted, on 1 August 2011, by regulation 8 of the Medicines Amendment Regulations 2011 (SR 2011/245).
17 Form and manner of labelling
(1)
Subject to subclause (4), every label that is required by these regulations to be borne on a container shall—
(a)
be conspicuously written in English and, for each statement separately required, be in a colour or colours contrasting strongly with the statement’s background; and
(b)
be legibly and durably marked either on the material of the container or on material firmly and securely attached to the container; and
(c)
be of such nature and material that it will not fade to the extent of becoming illegible, or become detached, by the influence of—
(i)
light; or
(ii)
atmospheric humidity or dryness; or
(iii)
normal atmospheric temperatures; or
(iv)
recommended storage temperatures; or
(v)
the contents of the container; and
(d)
be of such a nature and in such a position that it will not readily be defaced in the course of normal handling and use; and
(e)
be in such a position that it is not damaged, defaced, destroyed, or removed when the container is opened; and
(f)
not be obscured by any other label, folder, or pamphlet.
(g)
[Revoked](2)
The lettering of the words required by these regulations shall be clear, distinct, and legible, with no decoration, embellishment, or distortion that could interfere with the legibility of the words.
(3)
Every label that is required by these regulations to appear on a container shall, if the medicine or related product is sold otherwise than in a container, appear on the medicine or related product.
(4)
It shall be sufficient compliance with subclause (1) if the particulars required by paragraphs (d) and (e) of regulation 13(1) are embossed conspicuously on the container of the medicine.
Regulation 17(1)(a): amended, on 30 November 2000, by regulation 7(1) of the Medicines Amendment Regulations 2000 (SR 2000/220).
Regulation 17(1)(g): revoked, on 30 November 2000, by regulation 7(2) of the Medicines Amendment Regulations 2000 (SR 2000/220).
18 Size of letters
(1)
A minimum size of lettering used on labels that is prescribed by these regulations refers to the height of capital letters, or lower case letters with an ascender or descender, in the typeface used.
(2)
[Revoked](3)
[Revoked](4)
[Revoked](5)
Subject to subclause (6) and except as otherwise expressly permitted by any of the provisions of these regulations, the lettering of words required by these regulations to appear on labels shall be not less than 1.5 millimetres in height.
(6)
Where words are required by these regulations to appear on labels in letters of a specified size, and the container to be labelled is so small as to prevent the use of letters of that size, letters of a smaller size may be used if they are of the largest size practicable in the circumstances and are in any event no smaller than 0.75 millimetres.
(7)
[Revoked]Regulation 18(1): substituted, on 30 November 2000, by regulation 8(1) of the Medicines Amendment Regulations 2000 (SR 2000/220).
Regulation 18(2): revoked, on 30 November 2000, by regulation 8(2) of the Medicines Amendment Regulations 2000 (SR 2000/220).
Regulation 18(3): revoked, on 30 November 2000, by regulation 8(2) of the Medicines Amendment Regulations 2000 (SR 2000/220).
Regulation 18(4): revoked, on 30 November 2000, by regulation 8(2) of the Medicines Amendment Regulations 2000 (SR 2000/220).
Regulation 18(7): revoked, on 30 November 2000, by regulation 8(2) of the Medicines Amendment Regulations 2000 (SR 2000/220).
19 Labelling of prescription medicines, restricted medicines, and pharmacy-only medicines
Where a label on a container is required by these regulations to bear—
(a)
the words “PRESCRIPTION MEDICINE”
or words of a similar meaning; or
(b)
the words “PRESCRIPTION ONLY MEDICINE”
or words of a similar meaning; or
(c)
the acronym “POM”
; or
(d)
the words “RESTRICTED MEDICINE”
; or
(e)
the words “PHARMACIST ONLY MEDICINE”
; or
(f)
the words “PHARMACY-ONLY MEDICINE”
or words of a similar meaning; or
(g)
the words “PHARMACY MEDICINE”
or words of a similar meaning,—
the words or acronym, as the case may require, shall be placed prominently and legibly on the label.
Regulation 19: substituted, on 1 January 1995, by regulation 5 of the Medicines Regulations 1984, Amendment No 6 (SR 1994/299).
Regulation 19: amended, on 1 August 2011, by regulation 9 of the Medicines Amendment Regulations 2011 (SR 2011/245).
20 Consumer information panel
[Revoked]Regulation 20: revoked, on 1 August 2011, by regulation 10 of the Medicines Amendment Regulations 2011 (SR 2011/245).
21 Labels on containers of medicines or related products containing vitamins
The quantitative declaration of every vitamin in any medicine or related product shall be expressed in milligrams or micrograms.
22 Warning statements for medicines and related products
(1)
Every container of a medicine or related product must include on its label any warning statement that may be required by guidelines issued from time to time by the Ministry of Health.
(2)
A warning statement is additional to any other statement or information that is required by these regulations to be shown on a label.
(3)
Subclause (1) is subject to regulation 23.
Regulation 22: substituted, on 1 August 2011, by regulation 11 of the Medicines Amendment Regulations 2011 (SR 2011/245).
23 Labels on containers of medicines sold by authorised prescribers or pharmacists
It shall not be necessary to comply with the requirements of regulation 13 or regulation 16(1) or regulation 22 in respect of any label on a container of a medicine that is packed, supplied, or sold by an authorised prescriber or a pharmacist with reference to the needs of a particular patient or (as the case may be) a particular customer, if the label contains the following:
(a)
the name of, or a description of the nature of, the contents; and
(b)
the name of the patient; and
(c)
the name and address of the seller; and
(d)
in the case of a medicine for internal use, the dose and frequency of dose; and
(e)
in the case of a medicine for external use, a statement of the directions for use and frequency of use, and one or other of the following statements, or words of similar meaning:
“Caution: Not To Be Taken”
, or “For External Use Only”
; and
(f)
a unique identifying number or code for the prescription or record of supply; and
(g)
the date on which the medicine was packed, sold, or supplied.
Regulation 23 heading: substituted, on 11 October 2001, by regulation 7(1) of the Medicines Amendment Regulations 2001 (SR 2001/232).
Regulation 23 heading: amended, on 1 October 2005, by regulation 5(1) of the Medicines Amendment Regulations 2005 (SR 2005/255).
Regulation 23: amended, on 1 August 2011, by regulation 12(1) of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 23: amended, on 1 October 2005, by regulation 5(2) of the Medicines Amendment Regulations 2005 (SR 2005/255).
Regulation 23(a): substituted, on 1 August 2011, by regulation 12(2) of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 23(e): amended, on 1 August 2011, by regulation 12(3) of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 23(f): added, on 1 August 2011, by regulation 12(3) of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 23(g): added, on 1 August 2011, by regulation 12(3) of the Medicines Amendment Regulations 2011 (SR 2011/245).
24 Labels on containers of hair dyes
(1)
This regulation applies to labels on containers of related products and cosmetics that are intended for dyeing hair and consist of or contain—
(a)
phenylenediamine, or its salts; or
(b)
toluenediamine, or its salts; or
(c)
other aromatic amines intended for dyeing hair, or their salts; or
(d)
any derivative of any substance to which paragraph (a) or paragraph (b) or paragraph (c) applies.
(2)
Every label to which this regulation applies shall include the following:
(a)
the name or description of the dye substance:
(b)
the name and address of the manufacturer or (as the case may be) the packer or seller of the related product or cosmetic:
(c)
directions for the use of the related product or cosmetic:
(d)
one or other of the following statements, or words of similar meaning:
“Not To Be Taken”
, or “For External Use Only”
:
(e)
the following statement, or words of similar meaning:
“May cause serious inflammation of the skin. Do not use on eyelashes”
.
25 Misleading statements
(1)
No written, pictorial, or other descriptive matter appearing on or attached to or supplied or displayed with any medicine or medical device shall include any comment on, reference to, or explanation of any statement or label required by these regulations to be borne on any medicine or medical device if that comment, reference, or explanation either directly or by implication contradicts, qualifies, or modifies that statement or the contents of that label.
(2)
No written, pictorial, or other descriptive matter supplied or displayed with any medicine or medical device shall include any false or misleading statement, word, brand, picture, or mark purporting to indicate the nature, suitability, quantity, quality, strength, purity, composition, weight, origin, age, effects, or proportion of the medicine or medical device or any ingredients of the medicine or components of the medical device.
Part 5 Manufacture, packing, storage, and handling
26 Persons handling medicines, related products, and cosmetics
(1)
Every person who—
(a)
is engaged or employed in the manufacture, packing, labelling, storage, or supply of any medicine, related product, or cosmetic for sale; and
(b)
in the course of his engagement or employment in that activity comes into direct contact with—
(i)
any medicine, related product, or cosmetic; or
(ii)
the interior part of any container containing any medicine, related product, or cosmetic; or
(iii)
a wrapper for any medicine, related product, or cosmetic—
shall, at all times while so engaged or employed, maintain his clothing and his person in a state of cleanliness.
(2)
No person who is engaged or employed in the sale of any medicine, related product, or cosmetic, or in the manufacture, packing, labelling, storage, or supply of any medicine, related product, or cosmetic for sale, shall do any act or make any default or omission whereby that medicine, related product, or cosmetic becomes or is liable to become contaminated, polluted, or tainted.
27 Infected persons
No person who is suffering from a communicable disease (within the meaning of the Health Act 1956), or is a carrier (within the meaning of that Act), or is suffering from a condition causing a discharge of pus or exudate, shall engage or be employed in the sale, or the manufacture, packing, labelling, storage, or supply, for sale, of—
(a)
any medicine, related product, or cosmetic; or
(b)
any material or article used or likely to be used as a wrapper or container for any medicine, related product, or cosmetic.
28 Persons in contact with infected persons
(1)
The Medical Officer of Health may, by notice in writing served on a person who has been in recent contact with any person to whom regulation 27 applies, prohibit the person so served from engaging or being employed in the sale of any medicine, related product, or cosmetic, or the manufacture, packing, labelling, storage, or supply of any medicine, related product, or cosmetic for sale.
(2)
Where, in the opinion of the Medical Officer of Health, there is no longer any risk of any medicine, related product, or cosmetic becoming infected by a person on whom any such notice has been served, the Medical Officer of Health shall revoke the notice, and shall notify the person in writing of the revocation.
(3)
No person shall—
(a)
engage or undertake employment in any activity in contravention of a notice served on him under this regulation; or
(b)
knowingly employ any other person in contravention of a notice served on that other person under this regulation.
29 Places of manufacture, storage, and sale
No person shall use any place or permit any place to be used for or in connection with the sale of any medicine, related product, or cosmetic, or the manufacture, storage, or packing of any medicine, related product, or cosmetic for sale, unless the place complies with the following requirements:
(a)
the place shall be kept adequately lighted by daylight or artificial light, as the circumstances require, at all times when any work is being carried out there:
(b)
the place shall be kept appropriately ventilated at all times while any medicine, related product, or cosmetic, or any container or material for the packing of any medicine, related product, or cosmetic, is present there:
(c)
if a waste liquid is produced there, the place shall be provided with a means of drainage that is sufficient for the removal of the waste liquid, and that is kept in good, clean, working order and condition:
(d)
the place shall be kept, so far as is practicable, clean and free from foul odours and free from dust and creatures likely to contaminate the medicine, related product, or cosmetic:
(e)
the walls, floors, ceilings, and roofs shall be properly constructed and kept in good repair, and shall be easy to clean:
(f)
the place shall not be used for any purpose (other than the sale of any medicine, related product, or cosmetic, or the manufacture, storage, or packing of any medicine, related product, or cosmetic for sale) that might affect the quality of the medicine, related product, or cosmetic:
(g)
the place shall be provided with sinks and other sanitary fittings reasonably necessary for cleansing appliances used there, and all such sinks and other sanitary fittings shall be maintained in good, clean working order and condition:
(h)
the place shall be provided with an adequate supply of hot and cold water, and soap or other detergent:
(i)
the place shall be provided adequately with wash basins and toilets for the use of persons engaged or employed in or about the premises, and all such wash basins and toilets shall be maintained in good, clean working order and condition, and shall be provided with an adequate supply of hot and cold water, soap or other detergent, nail brushes, and towels or other drying equipment.
30 Dwellinghouses prohibited for manufacture and packing
No person shall use any dwellinghouse, or permit any dwellinghouse to be used, for or in connection with the manufacture or packing of any medicine, related product, or cosmetic for sale if the use of the dwellinghouse is likely to result in the contamination of the medicine, related product, or cosmetic, or to affect injuriously its cleanliness.
31 Powers of Medical Officer of Health in respect of premises
(1)
This regulation shall apply to premises that are, in the opinion of the Medical Officer of Health, by reason of their construction or disrepair, or by reason of the use or character of any neighbouring premises, in such a condition that any medicine, related product, or cosmetic in the first premises may be exposed to contamination or taint, or may deteriorate or become dirty.
(2)
Subject to subclause (6), the Medical Officer of Health may serve a notice in writing on any owner or occupier of any premises to which this regulation applies, prohibiting the use of the premises for or in connection with the manufacture, storage, or packing of any medicine, related product, or cosmetic for sale.
(3)
Every such notice shall—
(a)
specify the premises to which it relates:
(b)
state the reason for the prohibition:
(c)
specify a date on which the prohibition is to come into force.
(4)
Subject to subclause (6), where in the opinion of the Medical Officer of Health the reason for which any such notice was served has ceased to exist, he shall revoke the notice, and shall notify in writing the owner or occupier of the premises concerned, and every other person on whom a copy of the notice has been served, of the revocation.
(5)
While any such notice remains in force,—
(a)
no person on whom it has been served shall use or permit the use of the premises specified in the notice for or in connection with the manufacture, storage, or packing of any medicine, related product, or cosmetic for sale; and
(b)
no person on whom a copy of the notice has been served or who knows the contents of the notice shall use those premises for any such purpose.
(6)
No notice shall be served by a Medical Officer of Health pursuant to subclause (2) or subclause (4) unless approval to serve the notice has first been obtained from the Director-General.
32 Storage of medicines, etc
(1)
Every person in possession or control of any medicine, related product, or cosmetic for sale, or of any container or appliance used for or in connection with the sale of any medicine, related product, or cosmetic, or the manufacture, storage, or packing of any medicine, related product, or cosmetic for sale, shall at all times—
(a)
keep the medicine, related product, cosmetic, container, or appliance clean and free from contamination by moisture, foul odours, or dust; and
(b)
protect the medicine, related product, cosmetic, container, or appliance from access by creatures likely to contaminate it.
(2)
Every person in possession of any medicine, related product, or cosmetic for sale shall at all times store and keep it packed in such manner as to minimise its deterioration, and shall comply with all requirements for storage stated on the label or contained in a specified publication in respect of that medicine, related product, or cosmetic.
33 Construction and use of containers, etc
(1)
No person shall use, or permit to be used, any container, appliance, or vehicle for or in connection with the manufacture, storage, packing, or supply of any medicine, related product, or cosmetic for sale unless that container, appliance, or vehicle is constructed of such material and in such manner as to allow for easy cleaning, and is kept clean.
(2)
No person shall use, or permit to be used, in the supply of any medicine, related product, or cosmetic for sale any container, appliance, or vehicle that is also used for the carriage of any matter that endangers or could endanger the cleanliness or freedom from contamination of the medicine, related product, or cosmetic.
(3)
No person shall use, or permit to be used, for the manufacture, storage, or packing of any medicine, related product, or cosmetic for sale, any container that has been used for any purpose that may contaminate or taint the medicine, related product, or cosmetic, unless the container has been thoroughly cleaned.
34 Exposure to toxic substances prohibited
Except as otherwise provided in these regulations, no person shall, in the course of the manufacture, storage, packing, or supply of any medicine, related product, or cosmetic for sale, keep, carry, spread, or use, or permit to be kept, carried, spread, or used, any toxic or noxious substance so as to expose the medicine, related product, or cosmetic to the risk of contamination by that substance at any time.
35 Containers for medicines, related products, and cosmetics
(1)
A person must not pack, store, or sell a prescription medicine, restricted medicine, or pharmacy-only medicine in a container made of paper; but nothing in this subclause prevents the person from packing, storing, or selling the medicine in a container made of cardboard.
(2)
[Revoked](3)
No person shall use, or permit to be used, in the storage, packing, or supply of any medicine, related product, or cosmetic for sale, a container that yields, or could yield, to its contents a toxic, injurious, or tainting substance.
(4)
Every container used in the packing of a medicine and made of glass or plastic shall comply with the tests for that type of container (if any) specified in the United States Pharmacopeia.
(5)
Every container used in the packing of a medicine and made of metal shall be impermeable to moisture.
(6)
Every container used in the packing of a medicine and made of metal or plastic shall be made of a material that will not adversely react with the contents of the container.
(7)
Except as provided in subclause (8), no person shall store, pack, or sell in a container of a capacity of not less than 15 millilitres and not more than 2.5 litres any medicine, related product, or cosmetic that—
(a)
is in liquid form; and
(b)
is intended for external use; and
(c)
has poisonous properties,—
unless the container is a poison bottle.
(8)
It shall not be necessary to pack in a poison bottle any medicine, related product, or cosmetic to which subclause (7) applies if that medicine, related product, or cosmetic is—
(a)
supplied to or held for use in educational establishments, or in scientific or industrial laboratories; or
(b)
supplied to or held by analysts, pharmacists, authorised prescribers, or veterinary surgeons; or
(c)
supplied to or held by persons engaged as suppliers to any of the establishments, laboratories, or classes of persons mentioned in paragraphs (a) and (b); or
(d)
a hair dye to which regulation 24 applies.
(9)
No person shall have in his possession or charge (whether for the purposes of sale or otherwise) in an open container, any medicine, related product, or cosmetic that has poisonous properties, except while the container is being filled or the medicine, related product, or cosmetic in the container is being used.
(10)
No person in possession or charge of any medicine, related product, or cosmetic shall keep it, whether temporarily or permanently, in any bottle, jar, can, tinplate container, culinary utensil, or other container of a type that—
(a)
bears any brand, mark, statement, or picture that indicates the presence in the container of any food, drink, or condiment; or
(b)
is of a distinctive type in which any food, drink, or condiment, has been commonly or is being currently sold, whether or not the container bears any brand, mark, statement, or picture.
Regulation 35(1): substituted, on 24 July 2006, by regulation 6 of the Medicines Amendment Regulations 2006 (SR 2006/158).
Regulation 35(2): revoked, on 24 July 2006, by regulation 6 of the Medicines Amendment Regulations 2006 (SR 2006/158).
Regulation 35(8)(b): amended, on 1 October 2005, by regulation 6 of the Medicines Amendment Regulations 2005 (SR 2005/255).
36 Storage to be separate
No person shall store or keep for ready use any medicine, related product, or cosmetic in such manner that a food or drink may be contaminated by the escape or leakage of the medicine, related product, or cosmetic, or by the release of vapours from the medicine, related product, or cosmetic.
37 Safety containers
(1)
No person shall sell any tablet, or other single item in solid form that is intended to be taken orally, being or comprising a medicine or belonging to a class of medicines to which this regulation applies, unless the tablet or item is enclosed in a safety container.
(2)
Subclause (1) shall not apply—
(a)
where an authorised prescriber directs, either on the prescription or otherwise,—
(i)
that a medicine is not to be sold enclosed in a safety container; or
(ii)
that he or she does not wish the name of the medicine to appear on the label; or
(b)
where a pharmacist is of the opinion that, because of the age or infirmity of a particular person, a medicine to be used by that person should not be enclosed in a safety container; or
(c)
in the case of capsules, pills, powder, or other solid dose forms, prepared in a pharmacy with reference to the particular needs of a patient.
(3)
[Revoked](4)
This regulation applies to the following medicines:
aspirin, and its salts; and medicines containing aspirin or its salts:
iron, in medicines for human use containing more than 24 milligrams of elemental iron per dose:
paracetamol; and medicines containing paracetamol.
(5)
This regulation applies to the following classes of medicines:
barbiturates:
phenothiazine, and derivatives of phenothiazine and their salts, except dimethothiazine, methdilazine, promethazine, and trimeprazine, and their salts and molecular compounds:
tricyclic, tetracyclic, and analogous antidepressants.
Regulation 37(2)(a): amended, on 1 October 2005, by regulation 7 of the Medicines Amendment Regulations 2005 (SR 2005/255).
Regulation 37(2)(a)(ii): amended, on 11 October 2001, by regulation 9(b) of the Medicines Amendment Regulations 2001 (SR 2001/232).
Regulation 37(3): revoked, on 1 August 2011, by regulation 13 of the Medicines Amendment Regulations 2011 (SR 2011/245).
Part 6 Importation and transport
38 Containers
(1)
Every medicine imported into, or packed or consigned for transport in, New Zealand shall be securely packed in a container that is sufficiently strong to withstand, and to protect the contents from damage arising in, the ordinary course of transport.
(2)
No person shall import into, or transport or cause to be transported in, New Zealand any medicine that is not packed in compliance with subclause (1).
(3)
Every related product packed or consigned for transport in New Zealand shall be securely packed in a container that is sufficiently strong to withstand, and to protect the contents from damage arising in, the ordinary course of transport.
(4)
No person shall transport or cause to be transported in New Zealand any related product that is not packed in compliance with subclause (3).
38A Prohibition relating to personal importation of CBD products
A person must not import into New Zealand any CBD product (regardless of whether the ingredients are made from cannabis) for their personal use by any method of import (such as overseas courier or post), except by physically carrying it on the person when entering New Zealand.
Regulation 38A: inserted, on 5 July 2024, by regulation 50 of the Misuse of Drugs (Medicinal Cannabis) Amendment Regulations 2024 (SL 2024/129).
Part 7 Prescriptions
39 Conditions under which authorised prescribers and veterinarians may prescribe prescription medicines
(1)
An authorised prescriber (including a designated prescriber) may only prescribe a prescription medicine if the authorised prescriber—
(a)
is prescribing the prescription medicine—
(i)
for the treatment of a patient under the authorised prescriber’s care; and
(ii)
within, and in accordance with all conditions (if any) stated in, the authorised prescriber’s scope of practice, as determined by an authorisation granted under section 21 of the Health Practitioners Competence Assurance Act 2003 by the authority responsible for the registration of the authorised prescriber; and
(b)
is not prohibited by a notice under section 48(1) of the Act from prescribing that prescription medicine or any prescription medicines of a class or description that includes that prescription medicine.
(2)
An authorised prescriber who is a designated prescriber may only prescribe a prescription medicine if—
(a)
the prescription medicine is of a class or description that the designated prescriber is authorised to prescribe by regulations made under the Act; and
(b)
the requirements specified in or imposed under those regulations are satisfied.
(3)
A veterinarian may only prescribe a prescription medicine that is for the treatment of an animal under the veterinarian’s care.
(4)
Subclause (1) does not apply to an authorised prescriber who is acting in the course of his or her employment by the Crown.
Regulation 39: substituted, on 1 December 2011, by regulation 14 of the Medicines Amendment Regulations 2011 (SR 2011/245).
39A Limit on period of supply of prescription medicines
(1)
An authorised prescriber may not on any occasion prescribe for any patient a quantity of any prescription medicine that exceeds 12 months’ supply.
(2)
However, the Director-General may, at his or her discretion, authorise—
(a)
an authorised prescriber to prescribe for any patient, or any specified class or classes of patients, a quantity of a prescription medicine exceeding 12 months’ supply:
(b)
a class of authorised prescribers to prescribe for any patient, or any specified class or classes of patients, a quantity of a prescription medicine exceeding 12 months’ supply.
Regulation 39A: inserted, on 1 December 2011, by regulation 15 of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 39A(1): replaced, on 1 February 2026, by regulation 4(1) of the Medicines (Increasing the Period of Supply) Amendment Regulations 2025 (SL 2025/203).
Regulation 39A(2)(a): amended, on 1 February 2026, by regulation 4(2) of the Medicines (Increasing the Period of Supply) Amendment Regulations 2025 (SL 2025/203).
Regulation 39A(2)(b): amended, on 1 February 2026, by regulation 4(2) of the Medicines (Increasing the Period of Supply) Amendment Regulations 2025 (SL 2025/203).
40 Prescriptions to comply with regulations
(1)
Except as provided in regulation 40A, every authorised prescriber or veterinarian who issues a prescription to a person must comply with regulation 41.
(2)
Subclause (1) applies to a prescription for any medicine (whether a prescription medicine or not).
(3)
Subclause (2) does not prevent the sale by retail, or the supply in circumstances corresponding to retail sale, or the dispensing, of a medicine (other than a prescription medicine) without a prescription.
Regulation 40: substituted, on 11 October 2001, by regulation 11 of the Medicines Amendment Regulations 2001 (SR 2001/232).
Regulation 40(1): amended, on 1 August 2011, by regulation 16 of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 40(1): amended, on 1 October 2005, by regulation 9 of the Medicines Amendment Regulations 2005 (SR 2005/255).
40A Urgently required prescriptions of prescription medicines may be communicated orally if later confirmed
(1)
Where an authorised prescriber or veterinarian finds it necessary to do so, he or she may communicate orally to a pharmacist to whom he or she is known personally (whether in the pharmacist’s presence or by speaking to the pharmacist on the telephone) a prescription relating to a prescription medicine that the authorised prescriber or veterinarian requires urgently.
(2)
Within 7 days after a communication made by an authorised prescriber or veterinarian to a pharmacist under subclause (1), the authorised prescriber or veterinarian must issue a prescription in paper or electronic form that confirms the oral communication and forward or transmit the prescription to the pharmacist.
Regulation 40A: inserted, on 11 October 2001, by regulation 11 of the Medicines Amendment Regulations 2001 (SR 2001/232).
Regulation 40A heading: amended, on 22 December 2022, by regulation 4(1) of the Medicines Amendment Regulations (No 2) 2022 (SL 2022/304).
Regulation 40A(1): amended, on 1 August 2011, by regulation 17 of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 40A(1): amended, on 1 October 2005, by regulation 10(1) of the Medicines Amendment Regulations 2005 (SR 2005/255).
Regulation 40A(1): amended, on 1 October 2005, by regulation 10(2) of the Medicines Amendment Regulations 2005 (SR 2005/255).
Regulation 40A(2): amended, on 22 December 2022, by regulation 4(2) of the Medicines Amendment Regulations (No 2) 2022 (SL 2022/304).
Regulation 40A(2): amended, on 1 August 2011, by regulation 17 of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 40A(2): amended, on 1 October 2005, by regulation 10(3) of the Medicines Amendment Regulations 2005 (SR 2005/255).
Regulation 40A(2): amended, on 1 October 2005, by regulation 10(4) of the Medicines Amendment Regulations 2005 (SR 2005/255).
41 Form of prescription
(1)
A prescription issued or given under these regulations must be in paper or electronic form.
(2)
Every prescription must—
(a)
[Revoked](b)
be dated with the date on which it was issued; and
(c)
set out the following information in relation to the prescriber:
(i)
the prescriber’s full name; and
(ii)
the full street address of the prescriber’s place of work or, in the absence of the prescriber having a place of work, the postal address of the prescriber; and
(iii)
the prescriber’s telephone number; and
(d)
set out—
(i)
the surname, each given name, and the address of the person for whose use the prescription is given; and
(ii)
in the case of a child under the age of 13 years, the date of birth of the child; and
(e)
indicate by name the medicine and, where appropriate, the strength that is required to be dispensed; and
(f)
indicate the total amount of medicine that may be sold or dispensed, or the total period of supply; and
(g)
if the medicine is to be administered by injection, or by insertion into any cavity of the body, or by swallowing, indicate the dose and frequency of dose; and
(h)
if the medicine is for application externally, indicate the method and frequency of use; and
(i)
[Revoked](j)
in the case of a prescription relating to the treatment of an animal,—
(i)
set out the surname, each given name, and the address of the owner of the animal; and
(ii)
contain the following statement, or words of similar meaning:
“Not for human use”
.
(3)
A paper prescription must—
(a)
be legible and indelible; and
(b)
be signed physically by the prescriber in their own handwriting.
(4)
An electronic prescription must be completed using, and transmitted through, an approved system.
(5)
Any reference in these regulations that relates to including or recording anything in or on a prescription means, for an electronic prescription, including or recording it in the electronic records for the electronic prescription.
(6)
In this regulation, approved system means a system approved by the Director-General by notice in the Gazette.
Regulation 41(1): inserted, on 22 December 2022, by regulation 5(1) of the Medicines Amendment Regulations (No 2) 2022 (SL 2022/304).
Regulation 41(2): amended, on 22 December 2022, by regulation 5(2) of the Medicines Amendment Regulations (No 2) 2022 (SL 2022/304).
Regulation 41(2)(a): revoked, on 22 December 2022, by regulation 5(3) of the Medicines Amendment Regulations (No 2) 2022 (SL 2022/304).
Regulation 41(2)(b): replaced, on 22 December 2022, by regulation 5(3) of the Medicines Amendment Regulations (No 2) 2022 (SL 2022/304).
Regulation 41(2)(c): substituted, on 1 December 2011, by regulation 18(1) of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 41(2)(d)(i): substituted, on 1 December 2011, by regulation 18(2) of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 41(2)(f): substituted, on 1 December 2011, by regulation 18(3) of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 41(2)(i): revoked, on 1 December 2011, by regulation 18(4) of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 41(2)(j)(i): substituted, on 1 December 2011, by regulation 18(5) of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 41(3): inserted, on 22 December 2022, by regulation 5(4) of the Medicines Amendment Regulations (No 2) 2022 (SL 2022/304).
Regulation 41(4): inserted, on 22 December 2022, by regulation 5(4) of the Medicines Amendment Regulations (No 2) 2022 (SL 2022/304).
Regulation 41(5): inserted, on 22 December 2022, by regulation 5(4) of the Medicines Amendment Regulations (No 2) 2022 (SL 2022/304).
Regulation 41(6): inserted, on 22 December 2022, by regulation 5(4) of the Medicines Amendment Regulations (No 2) 2022 (SL 2022/304).
42 Dispensing of prescription medicines
(1)
Except as provided in subclause (2), no person other than an authorised prescriber, veterinarian, pharmacist, pharmacy graduate, a pharmacy technician, a student, or dispensary technician may dispense a prescription medicine.
(1A)
The following persons may not dispense prescription medicines unless under the direct personal supervision of a pharmacist:
(a)
dispensary technicians:
(b)
pharmacy graduates:
(c)
pharmacy technicians:
(d)
students.
(2)
An agent or employee of a veterinarian may, in any particular case, dispense any prescription medicine at the direction of the veterinarian for use in the treatment of any animal under the care of the veterinarian.
(3)
Every person dispensing a prescription relating to a prescription medicine must comply with the following requirements:
(a)
if the prescription has been communicated orally under regulation 40A(1), the prescription must not be dispensed on more than 1 occasion before the pharmacist has received the confirmation of the prescription, as required by regulation 40A(2):
(b)
the following information must be recorded on the prescription:
(i)
the name and address of the proprietor of the business at which the prescription is dispensed; and
(ii)
the date on which the prescription is dispensed; and
(iii)
the quantity of medicine dispensed; and
(iv)
a unique identifying number or code for the prescription:
(c)
a prescription for a medicine must not be dispensed for the first time after 3 months have elapsed from the date on which the prescription was issued or, if given under regulation 40A(1), communicated orally:
(d)
a prescription for a medicine must not be dispensed on any occasion after 12 months have elapsed from the date on which the prescription was issued or, if given under regulation 40A(1), communicated orally:
(da)
a prescription for a medicine must not, unless requested in accordance with authorisation under regulation 43(1)(c), be dispensed on any occasion in a quantity that exceeds—
(i)
6 months’ supply in the case of an oral contraceptive; or
(ii)
3 months’ supply in any other case:
(e)
every paper prescription must be retained for a period of 3 years by the pharmacist on the premises on which it was dispensed or at a place approved by the Medical Officer of Health and must be kept in an orderly and consecutive manner so as to be readily available for inspection.
(4)
If an authorised prescriber or a veterinarian refers in a prescription to a medicine by its trade mark or trade name, or by reference to the name of its manufacturer, a pharmacist may supply an alternative brand of medicine, provided that—
(a)
the authorised prescriber or veterinarian has not marked the prescription “No brand substitution permitted”
or with words of similar meaning; and
(b)
the substituted brand contains the same active ingredient or active ingredients, and no other active ingredients; and
(c)
the substituted brand is in the same dose form and strength as the prescribed brand; and
(d)
there is no clinical reason why the substituted brand should not be supplied; and
(e)
the pharmacist records the brand substitution on the prescription; and
(f)
the pharmacist dates the prescription; and
(fa)
for a paper prescription, the pharmacist signs the prescription; and
(g)
the pharmacist informs the patient of the brand substitution.
(5)
This regulation is subject to regulation 43.
Regulation 42(1): substituted, on 11 October 2001, by regulation 12(1) of the Medicines Amendment Regulations 2001 (SR 2001/232).
Regulation 42(1): amended, on 1 August 2011, by regulation 19(1) of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 42(1): amended, on 1 October 2005, by regulation 11(1) of the Medicines Amendment Regulations 2005 (SR 2005/255).
Regulation 42(1): amended, on 19 December 2002, by regulation 4(1) of the Medicines Amendment Regulations (No 2) 2002 (SR 2002/374).
Regulation 42(1A): inserted, on 19 December 2002, by regulation 4(2) of the Medicines Amendment Regulations (No 2) 2002 (SR 2002/374).
Regulation 42(2): amended, on 1 August 2011, by regulation 19(1) of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 42(3): substituted, on 1 August 2011, by regulation 19(2) of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 42(3)(a): amended, on 22 December 2022, by regulation 6(1) of the Medicines Amendment Regulations (No 2) 2022 (SL 2022/304).
Regulation 42(3)(c): replaced, on 1 February 2026, by regulation 5 of the Medicines (Increasing the Period of Supply) Amendment Regulations 2025 (SL 2025/203).
Regulation 42(3)(d): replaced, on 1 February 2026, by regulation 5 of the Medicines (Increasing the Period of Supply) Amendment Regulations 2025 (SL 2025/203).
Regulation 42(3)(da): inserted, on 1 February 2026, by regulation 5 of the Medicines (Increasing the Period of Supply) Amendment Regulations 2025 (SL 2025/203).
Regulation 42(3)(e): amended, on 22 December 2022, by regulation 6(3) of the Medicines Amendment Regulations (No 2) 2022 (SL 2022/304).
Regulation 42(4): substituted, on 1 August 2011, by regulation 19(2) of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 42(4)(f): amended, on 22 December 2022, by regulation 6(4) of the Medicines Amendment Regulations (No 2) 2022 (SL 2022/304).
Regulation 42(4)(fa): inserted, on 22 December 2022, by regulation 6(5) of the Medicines Amendment Regulations (No 2) 2022 (SL 2022/304).
Regulation 42(5): added, on 1 August 2011, by regulation 19(2) of the Medicines Amendment Regulations 2011 (SR 2011/245).
43 Director-General may waive certain requirements
(1)
Despite the requirements in regulations 41 and 42, the Director-General may, at his or her discretion,—
(a)
authorise a form of prescription that does not comply with all or any of the requirements in regulation 41, but that is subject to any other requirements that he or she thinks fit; and
(b)
authorise the dispensing of prescription medicines in a manner that does not comply with all or any of the requirements in regulation 42, but that is subject to any other requirements that he or she thinks fit; and
(c)
authorise—
(i)
an authorised prescriber to request dispensing for any patient, or any specified class or classes of patients, a quantity of a prescription medicine exceeding the period of supply in regulation 42(3)(da)(i) or (ii):
(ii)
a class of authorised prescribers to request dispensing for any patient, or any specified class or classes of patients, a quantity of a prescription medicine exceeding the period of supply in regulation 42(3)(da)(i) or (ii).
(2)
A form of prescription that may be authorised under subclause (1)(a) includes, but is not limited to, an electronic form of prescription.
Regulation 43: substituted, on 1 August 2011, by regulation 20 of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 43(1)(c): inserted, on 1 February 2026, by regulation 6 of the Medicines (Increasing the Period of Supply) Amendment Regulations 2025 (SL 2025/203).
44 Prescriptions for prescription medicines not required in certain cases
A prescription medicine may be sold or dispensed otherwise than under a prescription given by a practitioner, registered midwife, veterinarian, or designated prescriber if it is sold to or dispensed for—
(a)
a person licensed to sell the prescription medicine by wholesale; or
(b)
a person obtaining the prescription medicine for use in any process of manufacture or trade not involving the resale of the medicine; or
(c)
an analyst under the Act, or a person approved by the Director-General and in charge of a laboratory maintained for the purposes of research, study, or analysis; or
(d)
a hospital care operator within the meaning of section 58(4) of the Health and Disability Services (Safety) Act 2001; or
(e)
a pharmacist in control of any pharmacy, or any dispensary in a hospital care institution within the meaning of section 58(4) of the Health and Disability Services (Safety) Act 2001; or
(f)
an authorised prescriber or veterinarian; or
(fa)
[Revoked](fb)
[Revoked](g)
a patient under his or her care by an authorised prescriber; or
(ga)
[Revoked](gb)
[Revoked](h)
a patient under the care of an authorised prescriber, provided that—
(i)
the medicine is administered by a person who has been instructed by the authorised prescriber (either verbally or in writing) to do so; and
(ii)
the person administering the medicine records the administration in the patient’s medical record; and
(iii)
the authorised prescriber records the instruction under subparagraph (i) in the patient’s medical record; or
(ha)
[Revoked](hb)
[Revoked](i)
the master of a New Zealand ship within the meaning of the Maritime Transport Act 1994,—
(i)
if the medicine is prescribed by rules under section 36(1)(e) of that Act; or
(ii)
at a time before the commencement of the first rules made under section 36(1)(e) of that Act, if the medicine is authorised or required by scales issued under section 138 or section 239 of the Shipping and Seamen Act 1952; or
(ia)
the master of a foreign ship within the meaning of the Maritime Transport Act 1994, if the law of the State whose flag the ship is entitled to fly requires the master to carry the medicine; or
(j)
a person for inclusion in an emergency medical kit kept or to be kept for use in any vessel to which paragraph (i) does not apply, and is so sold or dispensed pursuant to an order signed by a Medical Officer of Health; or
(k)
the person in charge of an aircraft if the medicine is required to be carried on the aircraft as a condition of the issue of a certificate of airworthiness; or
(l)
a person for inclusion in an emergency medical kit pursuant to an order signed by a Medical Officer of Health for use in a place of a class approved by the Director-General; or
(m)
a person who has previously been supplied with the medicine on the prescription of an authorised prescriber for a particular condition, and is so sold or dispensed—
(i)
by a pharmacist who is satisfied that the person requires an emergency supply of the medicine for that condition; and
(ii)
in an amount not exceeding the quantity reasonably required by that person for a period of 72 hours, or a minimum pack of a special container from which it is not practicable to dispense a lesser amount; or
(n)
any person by a veterinarian for the treatment of an animal under the care of the veterinarian; or
(o)
a person or body authorised to distribute, or a person authorised to administer, the prescription medicine in an approved immunisation programme.
Regulation 44 heading: amended, on 11 October 2001, by regulation 13(1) of the Medicines Amendment Regulations 2001 (SR 2001/232).
Regulation 44: amended, on 30 November 2000, by regulation 10(1) of the Medicines Amendment Regulations 2000 (SR 2000/220).
Regulation 44(d): substituted, on 1 October 2002, by section 58(3) of the Health and Disability Services (Safety) Act 2001 (2001 No 93).
Regulation 44(e): substituted, on 1 October 2002, by section 58(3) of the Health and Disability Services (Safety) Act 2001 (2001 No 93).
Regulation 44(f): substituted, on 1 October 2005, by regulation 12(1) of the Medicines Amendment Regulations 2005 (SR 2005/255).
Regulation 44(f): amended, on 1 August 2011, by regulation 21(1) of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 44(fa): revoked, on 1 October 2005, by regulation 12(1) of the Medicines Amendment Regulations 2005 (SR 2005/255).
Regulation 44(fb): revoked, on 1 October 2005, by regulation 12(1) of the Medicines Amendment Regulations 2005 (SR 2005/255).
Regulation 44(g): substituted, on 1 October 2005, by regulation 12(1) of the Medicines Amendment Regulations 2005 (SR 2005/255).
Regulation 44(ga): revoked, on 1 October 2005, by regulation 12(1) of the Medicines Amendment Regulations 2005 (SR 2005/255).
Regulation 44(gb): revoked, on 1 October 2005, by regulation 12(1) of the Medicines Amendment Regulations 2005 (SR 2005/255).
Regulation 44(h): substituted, on 1 August 2011, by regulation 21(2) of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 44(ha): revoked, on 1 October 2005, by regulation 12(1) of the Medicines Amendment Regulations 2005 (SR 2005/255).
Regulation 44(hb): revoked, on 1 October 2005, by regulation 12(1) of the Medicines Amendment Regulations 2005 (SR 2005/255).
Regulation 44(i): substituted, on 30 November 2000, by regulation 10(2) of the Medicines Amendment Regulations 2000 (SR 2000/220).
Regulation 44(ia): inserted, on 30 November 2000, by regulation 10(2) of the Medicines Amendment Regulations 2000 (SR 2000/220).
Regulation 44(m): amended, on 1 August 2011, by regulation 21(3) of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 44(m): amended, on 1 October 2005, by regulation 12(2) of the Medicines Amendment Regulations 2005 (SR 2005/255).
Regulation 44(n): amended, on 1 August 2011, by regulation 21(4) of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 44(n): amended, on 17 April 1992, by regulation 3(2) of the Medicines Regulations 1984, Amendment No 5 (SR 1992/43).
Regulation 44(o): added, on 17 April 1992, by regulation 3(1) of the Medicines Regulations 1984, Amendment No 5 (SR 1992/43).
44A Administration and supply of vaccines and other medicines in approved immunisation programmes
(1)
Any medical practitioner or other person who is authorised by the Director-General or a Medical Officer of Health in accordance with this regulation to administer or supply, for the purposes of an approved immunisation programme, a vaccine or other prescription medicine may, in carrying out that immunisation programme, administer or supply that prescription medicine otherwise than pursuant to a prescription.
(1A)
Any medical practitioner or other person who is authorised by the Director-General or a Medical Officer of Health in accordance with this regulation to administer or supply a restricted or pharmacy-only medicine for the purposes of an approved immunisation programme may supply or administer that medicine for those purposes without complying with section 18(1) of the Act.
(2)
The Director-General or a Medical Officer of Health may authorise any person for the purposes of subclause (1) or (1A) if that person, following written application, provides documentary evidence satisfying the Director-General or the Medical Officer of Health, as the case may be, that that person—
(a)
can carry out basic emergency techniques including resuscitation and the treatment of anaphylaxis; and
(b)
has knowledge of the safe and effective handling of immunisation products and equipment; and
(c)
can demonstrate clinical interpersonal skills; and
(d)
has knowledge of the relevant diseases and vaccines in order to be able to explain the vaccination to the patient, or to the parent or guardian of the patient who is to consent to the vaccination on behalf of the patient, to ensure that the patient or the parent or guardian of the patient can give informed consent to the vaccination.
(3)
Subject to subclause (4), any authorisation given by the Director-General or a Medical Officer of Health under subclause (2) shall be valid for a period of 2 years and shall be subject to such conditions as the Director-General or the Medical Officer of Health, as the case may be, thinks fit.
(4)
An authorisation given to any person under subclause (2) may be withdrawn at any time before its expiry if the Director-General or a Medical Officer of Health is satisfied that the authorised person has failed to comply with any condition specified by the Director-General or the Medical Officer of Health under subclause (3).
Regulation 44A: inserted, on 17 April 1992, by regulation 4 of the Medicines Regulations 1984, Amendment No 5 (SR 1992/43).
Regulation 44A heading: replaced, on 19 December 2025, by regulation 4(1) of the Medicines (Administration and Supply of Medicines in Approved Immunisation Programmes) Amendment Regulations 2025 (SL 2025/318).
Regulation 44A(1): amended, on 19 December 2025, by regulation 4(2) of the Medicines (Administration and Supply of Medicines in Approved Immunisation Programmes) Amendment Regulations 2025 (SL 2025/318).
Regulation 44A(1): amended, on 19 December 2025, by regulation 4(3) of the Medicines (Administration and Supply of Medicines in Approved Immunisation Programmes) Amendment Regulations 2025 (SL 2025/318).
Regulation 44A(1A): inserted, on 19 December 2025, by regulation 4(4) of the Medicines (Administration and Supply of Medicines in Approved Immunisation Programmes) Amendment Regulations 2025 (SL 2025/318).
Regulation 44A(2): amended, on 19 December 2025, by regulation 4(5) of the Medicines (Administration and Supply of Medicines in Approved Immunisation Programmes) Amendment Regulations 2025 (SL 2025/318).
Regulation 44A(2)(a): amended, on 11 October 2001, by regulation 14 of the Medicines Amendment Regulations 2001 (SR 2001/232).
44AA Alternative authorisation of vaccinators
(1)
The Director-General or a Medical Officer of Health may authorise a person who meets the requirements of this regulation to—
(a)
prepare a vaccine:
(b)
administer a vaccine without a prescription.
(2)
An authorised person must, at all times while performing the tasks authorised under these regulations, work under the clinical supervision and direction of a suitably qualified health practitioner.
Application for authorisation
(3)
In applying for authorisation, a person must provide evidence to satisfy the Director-General or the Medical Officer of Health, as the case may be,—
(a)
that the person has successfully completed training as approved by the Director-General for either or both of the following:
(i)
preparing for administration the 1 or more vaccines for which the person has applied for authorisation:
(ii)
administering those vaccines; and
(b)
that the person also has the following competencies:
(i)
the person can carry out basic emergency techniques, including resuscitation and the treatment of anaphylaxis; and
(ii)
the person has knowledge of the safe and effective handling of immunisation products and equipment.
Conditions, etc, of authorisation
(4)
The Director-General or the Medical Officer of Health, as the case may be,—
(a)
must specify in the authorisation the 1 or more vaccines that the authorised person may prepare or administer (or both):
(b)
may, on application by the authorised person, amend the authorisation by adding or removing any vaccine.
(5)
An application to add a vaccine must be made in accordance with subclause (3)(a).
(6)
The Director-General or the Medical Officer of Health, as the case may be, may—
(a)
impose conditions on an authorisation as they think fit:
(b)
amend or revoke any condition by written notice to the authorised person.
(7)
An authorisation is valid for a period of 2 years, unless it is revoked earlier under subclause (8).
(8)
The Director-General or the Medical Officer of Health, as the case may be, may revoke an authorisation by written notice to the authorised person if satisfied that the authorised person has failed to comply with any condition on their authorisation.
Regulation 44AA: inserted, on 19 May 2022, by regulation 4 of the Medicines Amendment Regulations 2022 (SL 2022/116).
44AB Authorisation of COVID-19 vaccinators
[Revoked]Regulation 44AB: revoked, on 1 June 2023, by regulation 44AB(5).
44B Duty to supply information
(1)
The Medical Officer of Health may require any authorised prescriber to supply information relating to the prescribing, administering, or supplying of any prescription medicines if the Medical Officer of Health has reason to suspect that prescription medicines may have been improperly prescribed, administered, or supplied by the authorised prescriber.
(2)
Every requirement to supply information must be in writing, stating the reasons for the Medical Officer of Health’s suspicion.
(3)
The information that must be supplied is information justifying the prescription, administering, or supply of the prescription medicines as follows:
(a)
the age of the patient:
(b)
the diagnosis of the patient’s condition:
(c)
the prognosis of the patient’s condition:
(d)
details of any specialist referral:
(e)
any alternative treatments considered or tried.
(4)
An authorised prescriber to whom any such notice is sent must supply the required information in writing to the Medical Officer of Health within 30 days.
Regulation 44B: inserted, on 18 September 1997, by regulation 2(1) of the Medicines Amendment Regulations 1997 (SR 1997/165).
Regulation 44B(1): amended, on 1 October 2005, by regulation 13(1) of the Medicines Amendment Regulations 2005 (SR 2005/255).
Regulation 44B(4): amended, on 1 October 2005, by regulation 13(2) of the Medicines Amendment Regulations 2005 (SR 2005/255).
44BA Restriction on prescribing gonadotropin-releasing hormone analogues
(1)
An authorised prescriber must not prescribe a prescription medicine that is a gonadotropin-releasing hormone analogue for the purpose of puberty suppression in a person who is a child or adolescent with—
(a)
gender incongruence; or
(b)
gender dysphoria.
(2)
See Part 2 of Schedule 1AA for a transitional provision in respect of this regulation.
Regulation 44BA: inserted, on 19 December 2025, by regulation 4 of the Medicines (Restriction on Prescribing Gonadotropin-releasing Hormone Analogues) Amendment Regulations 2025 (SL 2025/256).
Regulation 44BA(1): amended, on 19 December 2025, by regulation 4 of the Medicines (Restriction on Prescribing Gonadotropin-releasing Hormone Analogues) Amendment Regulations (No 2) 2025 (SL 2025/302).
Part 7A Export of prescription medicines
Part 7A: inserted, on 3 November 2000, by regulation 11 of the Medicines Amendment Regulations 2000 (SR 2000/220).
44C No export of prescription medicines for retail sale without New Zealand prescription
(1)
No person may export a prescription medicine in the course or for the purpose of retail sale, otherwise than under a prescription given by a practitioner, a registered midwife, or a designated prescriber.
(2)
The meaning of retail sale in subclause (1) must be determined by reference to section 5(2) of the Act.
(3)
Subclause (1) is intended to limit the sale and supply of prescription medicines pursuant to section 33(b) of the Act.
Regulation 44C: inserted, on 3 November 2000, by regulation 11 of the Medicines Amendment Regulations 2000 (SR 2000/220).
Part 7B Supply of restricted medicine and pharmacy-only medicine
Part 7B: inserted, on 18 September 2004, by regulation 3 of the Medicines Amendment Regulations 2004 (SR 2004/300).
44D Supply of restricted medicine and pharmacy-only medicine
(1)
A person may, in the course of any business carried on by that person, supply a restricted medicine or pharmacy-only medicine if he or she—
(a)
is authorised to supply the medicine in accordance with a standing order; and
(b)
supplies that medicine in accordance with that standing order.
(2)
The circumstances in which a person may supply a restricted medicine or pharmacy-only medicine under subclause (1) are in addition to the circumstances in which a person may supply a restricted medicine or pharmacy-only medicine under section 18(1)(b) or (c) of the Medicines Act 1981.
Regulation 44D: inserted, on 18 September 2004, by regulation 3 of the Medicines Amendment Regulations 2004 (SR 2004/300).
Part 8 Licences
45 Application for licence to manufacture, hawk, sell, or pack medicine
(1)
Every application for a licence to manufacture, hawk, sell, or pack medicine must—
(a)
be made in form 1 of Schedule 2:
(b)
be accompanied by the appropriate fee:
(c)
specify—
(i)
the premises the applicant intends to use for the activity to which the application relates; or
(ii)
in the case of an application for a licence to hawk medicines, the area in which the applicant intends to operate:
(d)
specify the medicines, or the descriptions or classes of medicines, that the applicant proposes to manufacture, hawk, sell, or pack:
(e)
specify—
(i)
the applicant’s qualifications; or
(ii)
if the applicant is a body corporate, the qualifications of every person who will, if the application is successful, be a responsible person for the purposes of the licence to which the application relates:
(f)
in the case of an application for a licence to sell any medicine by retail or to hawk any medicine, be accompanied by a certificate of character that states that the applicant—
(i)
is well known to the person giving the certificate; and
(ii)
is of good character; and
(iii)
is considered by the person giving the certificate to be a fit and proper person to be licensed to sell or hawk medicine.
(2)
A licence to undertake an activity referred to in subclause (1) may only be granted in respect of 1 place of business.
(3)
Despite subclause (2), the licensing authority may grant a licence that allows for the manufacture of medicine, or a description or class of medicines, at more than 1 place of business if—
(a)
the application to which the licence relates is made by a body corporate; and
(b)
the licensing authority is satisfied that the body corporate has taken steps to ensure appropriate supervision of the manufacture of the product at each of the places of business.
(4)
Every applicant for a licence under this regulation must provide the licensing authority with the following things if required by the licensing authority under section 51 of the Act:
(a)
further information:
(b)
an opportunity to inspect the applicant’s premises and equipment.
(5)
The licensing authority may, in order to determine if a person to whom section 51(1)(d) of the Act applies has a sufficient knowledge of the obligations of a licensee and of the hazards associated with the medicines to which a licence to manufacture, hawk, sell, or pack medicine relates, require that person to undertake and pass any oral, written, or practical tests that the licensing authority considers reasonably necessary in the particular case.
Regulation 45: substituted, on 18 September 2004, by regulation 4 of the Medicines Amendment Regulations 2004 (SR 2004/300).
45A Application for licence to operate pharmacy
(1)
Every application for a licence to operate a pharmacy must—
(a)
(b)
be accompanied by—
(i)
the appropriate fee prescribed in Schedule 5A; and
(ii)
a completed statutory declaration (as set out in the relevant form).
(2)
A licence to operate a pharmacy may only be granted in respect of 1 place of business.
(3)
Every applicant for a licence under this regulation must provide the licensing authority with the following things if required by the licensing authority under section 51 of the Act:
(a)
further information:
(b)
an opportunity to inspect the applicant’s premises and equipment.
(4)
The licensing authority may, in order to determine if a person to whom section 51(1)(d) of the Act applies has a sufficient knowledge of the obligations of a licensee and of the hazards associated with the medicines to which a licence to operate a pharmacy relates, require that person to undertake and pass any oral, written, or practical tests that the licensing authority considers reasonably necessary in the particular case.
Regulation 45A: inserted, on 18 September 2004, by regulation 4 of the Medicines Amendment Regulations 2004 (SR 2004/300).
Regulation 45A(1)(b)(i): substituted, on 21 August 2006, by regulation 4 of the Medicines (Fees) Amendment Regulations 2006 (SR 2006/188).
45B Licences that relate to CBD products
(1)
A licence to manufacture medicines, to sell medicines by wholesale, to pack medicines, or to operate a pharmacy that is issued under these regulations does not apply to a CBD product (as defined by section 2A of the Misuse of Drugs Act 1975) unless expressly authorised by the licence.
(2)
The licence must not be issued, or amended, to expressly authorise its application to the supply of a CBD product unless—
(a)
the product has been assessed as complying with the minimum quality standard under the Misuse of Drugs (Medicinal Cannabis) Regulations 2019; or
(b)
the product is being manufactured and supplied for export only and the exporter provides evidence to the Director-General that the ingredients and products are accepted by the importing country; or
(c)
the product has consent for distribution under the Medicines Act 1981; or
(d)
the product is not intended for therapeutic use in a human; or
(e)
the active ingredients and cannabinoids in the product are not made from cannabis; or
(f)
the product is being imported and supplied by a pharmacist under regulation 4A(2); or
(g)
the product is being supplied for a clinical trial under section 30 of the Medicines Act 1981.
(3)
A product is assessed as complying with the minimum quality standard under those regulations if—
(a)
an application is made under those regulations to assess the CBD product, in which case those regulations (including the requirement to pay fees) apply for that purpose as if the product were being assessed as a medicinal cannabis product; and
(b)
the Director-General assesses the evidence in the application and is satisfied that a representative sample of at least 10% of each of 3 batches of the product complied with the minimum quality standard.
Regulation 45B: inserted, on 1 April 2020, by regulation 85 of the Misuse of Drugs (Medicinal Cannabis) Regulations 2019 (LI 2019/321).
Regulation 45B(2): replaced, on 5 July 2024, by regulation 51 of the Misuse of Drugs (Medicinal Cannabis) Amendment Regulations 2024 (SL 2024/129).
46 Form and conditions of licence
(1)
The following licences must be in the following forms:
(a)
a licence to manufacture medicines must be in form 2 of Schedule 2:
(b)
a licence to hawk medicines must be in form 3 of Schedule 2:
(c)
a licence to sell medicines by wholesale must be in form 4 of Schedule 2:
(d)
a licence to sell medicines by retail must be in form 5 of Schedule 2:
(e)
a licence to pack medicines must be in form 6 of Schedule 2:
(f)
a licence to operate a pharmacy must be in form 7 of Schedule 2.
(2)
On granting a licence under the Act, the licensing authority may impose such conditions as he thinks fit.
Regulation 46(1): substituted, on 18 September 2004, by regulation 5 of the Medicines Amendment Regulations 2004 (SR 2004/300).
47 Licence to manufacture medicines
(1)
Every application for a licence to manufacture any medicine shall specify which of the following descriptions or classes the medicine comes within or belongs to:
(a)
antibiotics and preparations of antibiotics:
(b)
vaccines and sera:
(c)
sterile preparations:
(d)
hormones and steroid preparations:
(e)
preparations, other than vitamins, that have a dose of 5 milligrams or less per unit dose:
(f)
antineoplastic agents and immunosuppressant agents, other than steroid preparations:
(g)
other medicines.
(2)
Where an application to manufacture medicines applies to 1 or more medicines or descriptions or classes of medicines, the licensing authority may grant a licence for all the medicines or descriptions or classes of medicines to which the application relates, or for such of the medicines or descriptions or classes of medicines to which the application relates as the licensing authority is satisfied the applicant is qualified to manufacture and capable of manufacturing.
48 Licence to hawk certain medicines
(1)
Subject to subclause (2), and without affecting the generality of regulation 46(2), every licence to hawk any prescription medicine, restricted medicine, or pharmacy-only medicine shall be granted subject to the following conditions:
(a)
the licence shall apply only to those medicines or descriptions or classes of medicine specified in the licence:
(b)
the licensee shall keep the stocks of medicines in a place approved by the licensing authority:
(c)
where the licensing authority imposes a limit on the quantity of medicines that may be carried by the licensee when hawking, the licensee shall not carry medicines in excess of that quantity:
(d)
the licensee shall hawk medicines only to those persons or classes of persons specified in the licence.
(2)
No person shall be granted a licence to hawk any prescription medicines, restricted medicines, or pharmacy-only medicines by retail.
48A Licensing authority to be advised of change in particulars relating to operating pharmacy
(1)
A company or person who is granted a licence to operate a pharmacy must advise the licensing authority as soon as practicable of any change in the details that relate to the application for that licence (including, without limitation, changes in the details of any additional information required by the licensing authority).
(2)
A company that is granted a licence to operate a pharmacy under section 55D(2)(a) of the Act must immediately advise the licensing authority if there is a change or are changes in the ownership of the share capital of the company that means that more than 50% of the share capital is no longer owned by a pharmacist or pharmacists.
(3)
The requirement imposed by subclause (2) is in addition to the requirement imposed by subclause (1).
Regulation 48A: inserted, on 18 September 2004, by regulation 6 of the Medicines Amendment Regulations 2004 (SR 2004/300).
49 Surrender of licence
(1)
Subclause (1A) applies if a licensee ceases to—
(a)
manufacture, hawk, sell, or pack any medicine; or
(b)
operate a pharmacy.
(1A)
If this subclause applies, the licensee must, within 7 days of ceasing to undertake the activity to which the licence relates, surrender that licence to the licensing authority.
(2)
The licensing authority, on receiving a licence pursuant to subclause (1A), shall retain the licence for the remainder of the current licence period.
(3)
Nothing in this regulation shall prevent a licensee who has surrendered his licence pursuant to subclause (1A) from applying to the licensing authority for restoration of the licence to the licensee at any time during the current licence period.
(4)
In any such case, but subject to subclause (5), the licensing authority, on being satisfied that the licensee complies with the requirements of the Act and these regulations relating to the granting of licences, shall restore the licence to the licensee.
(5)
Notwithstanding anything in these regulations, it shall not be necessary for any licensee who surrenders his licence to pay a further licence fee on application for restoration of that licence.
Regulation 49(1): substituted, on 18 September 2004, by regulation 7(1) of the Medicines Amendment Regulations 2004 (SR 2004/300).
Regulation 49(1A): inserted, on 18 September 2004, by regulation 7(1) of the Medicines Amendment Regulations 2004 (SR 2004/300).
Regulation 49(2): amended, on 18 September 2004, by regulation 7(2) of the Medicines Amendment Regulations 2004 (SR 2004/300).
Regulation 49(3): amended, on 18 September 2004, by regulation 7(3) of the Medicines Amendment Regulations 2004 (SR 2004/300).
Part 9 Withdrawal of medicines, etc
50 Withdrawal of medicines, etc
(1)
The Director-General may issue to any importer, manufacturer, or seller of any medicine, related product, or medical device an order—
(a)
directing the withdrawal from sale of any medicine, related product, or medical device in respect of which there is in force a notice given by the Minister under section 35 or section 37 of the Act, or of any portion of the produced quantity of any such medicine, related product, or medical device, if the Director-General believes on reasonable grounds that such withdrawal is necessary to protect the public; or
(b)
directing the withdrawal from sale of any medicine, related product, or medical device, or any portion of the produced quantity of any medicine, related product, or medical device, that does not conform to the specifications claimed for that medicine, related product, or medical device; or
(c)
requiring the disposal of any medicine or related product, or any specific quantity of a medicine or related product, that has been directed to be withdrawn under paragraph (a) or paragraph (b); or
(d)
requiring the disposal or destruction of any medical device, or any specific quantity of any medical device, that has been directed to be withdrawn under paragraph (a) or paragraph (b).
(2)
The importer, manufacturer, or seller shall, on receipt of an order made under subclause (1), advise the Director-General of the manner and time in which he proposes to comply with the order, and shall give written notice to the Director-General when the order has been complied with.
(3)
Notwithstanding anything in subclause (2), the Director-General may issue directions to the recipient of an order made under subclause (1) as to the manner and time in which the order is to be complied with.
Part 10 Data sheets
51 Interpretation
In this Part, unless the context otherwise requires, data sheet, in relation to a medicine, means a document containing information relating to the safe and effective use of the medicine.
Regulation 51: substituted, on 1 August 2011, by regulation 22 of the Medicines Amendment Regulations 2011 (SR 2011/245).
52 Approval of data sheets for new medicines
(1)
A person who applies under section 20 or 23 of the Act for the consent of the Minister to the distribution of a prescription medicine or restricted medicine (an applicant) must include with his or her application a proposed data sheet for the medicine in such form as may be required by guidelines issued from time to time by the Ministry of Health.
(2)
On receipt of the proposed data sheet, the Minister may—
(a)
approve the data sheet; or
(b)
require the data sheet to be resubmitted for approval after such changes have been made to it as the Minister considers appropriate.
(3)
Within 10 days after the Minister’s consent to the distribution of a prescription medicine or restricted medicine has been notified in the Gazette, the applicant must send to the Director-General for publication an electronic copy of the approved data sheet for that medicine.
Regulation 52: substituted, on 1 August 2011, by regulation 22 of the Medicines Amendment Regulations 2011 (SR 2011/245).
53 Approval of data sheets for changed medicines
(1)
An importer or manufacturer who gives to the Director-General a notice under section 24(1) of the Act describing a material change to a prescription medicine or restricted medicine must include with the notice a proposed revised data sheet for the medicine in such form as may be required by guidelines issued from time to time by the Ministry of Health if a revision of the data sheet is necessary or desirable because of the material change.
(2)
On receipt of the proposed revised data sheet, the Director-General may—
(a)
approve the revised data sheet; or
(b)
require the revised data sheet to be resubmitted for approval after such changes have been made to it as the Director-General considers appropriate.
(3)
After the Director-General has approved a revised data sheet, the Director-General must give written notice of the approval to the importer or manufacturer.
(4)
Within 10 days after receiving a notice of approval under subclause (3), the importer or manufacturer must send to the Director-General for publication an electronic copy of the approved revised data sheet.
Regulation 53: substituted, on 1 August 2011, by regulation 22 of the Medicines Amendment Regulations 2011 (SR 2011/245).
54 Particulars in data sheets
[Revoked]Regulation 54: revoked, on 1 August 2011, by regulation 22 of the Medicines Amendment Regulations 2011 (SR 2011/245).
Part 11 Records
54A Sale of Medicines Registers
(1)
This regulation applies to the sale of a medicine if it is—
(a)
a restricted medicine sold by retail otherwise than under a prescription; or
(b)
a prescription medicine, restricted medicine, or pharmacy-only medicine, sold by wholesale.
(2)
A person who makes sales to which subclause (1) applies must—
(a)
maintain a Sale of Medicines Register for recording and keeping the information stated in subclause (4); and
(b)
ensure that the information kept in it is arranged in such a way that the information about each particular sale can be conveniently inspected, or retrieved and inspected.
(3)
The register must be in 1 or more of the following forms:
(a)
a system for recording and keeping the information electronically:
(b)
a book for recording and keeping the information in writing:
(c)
some other system for recording and keeping the information, approved by the Director-General (either generally or in any particular case) for the purposes of this regulation.
(4)
The information to be recorded and kept in relation to each sale is—
(a)
the date of the sale:
(b)
the buyer’s name:
(c)
the address of the buyer’s place of business or residence:
(d)
the name of the medicine sold:
(e)
the quantity of the medicine sold:
(f)
the name of the person making the sale.
Regulation 54A: inserted, on 30 November 2000, by regulation 12 of the Medicines Amendment Regulations 2000 (SR 2000/220).
55 Records of sales by retail or wholesale
(1)
Before giving to the buyer a medicine to whose sale regulation 54A(1) applies, the person making the sale must record in the Sale of Medicines Register maintained under regulation 54A(2) the information stated in regulation 54A(4).
(2)
It is not necessary to comply with subclause (1) in relation to a sale by wholesale if the information stated in regulation 54A(4) can be discovered from the seller’s books and records.
Regulation 55: substituted, on 30 November 2000, by regulation 12 of the Medicines Amendment Regulations 2000 (SR 2000/220).
56 Record of hawker’s sales
(1)
Every person who hawks any prescription medicine, restricted medicine, or pharmacy-only medicine shall keep and maintain a “Hawker’s Medicines”
book that records the medicines that he hawks or has in his possession.
(2)
Each page of the Hawker’s Medicines book shall—
(a)
be in the form set out in Schedule 4:
(b)
relate to only 1 form and 1 strength of 1 medicine.
(3)
The particulars in the Hawker’s Medicines book shall be legibly and indelibly entered not later than the ordinary business day next following the day on which the medicine concerned was sold.
(4)
Every person to whom subclause (1) applies shall—
(a)
satisfy himself that the purchaser is entitled to the medicine; and
(b)
before selling the medicine to the purchaser, obtain from the purchaser a printed request for the medicine, signed and dated by the purchaser, that contains the following particulars:
(i)
the date of each transaction:
(ii)
the name of the purchaser:
(iii)
the address of the place of business or residence of the purchaser:
(iv)
the name of the medicine sold:
(v)
the quantity of the medicine sold.
57 Record of supplies pursuant to prescriptions
(1)
Every person who dispenses or supplies any prescription medicine or restricted medicine pursuant to a prescription shall, not later than the ordinary business day next following the day on which the medicine was dispensed or supplied, record that dispensing or supply of the medicine in a “Prescriptions”
register, or in such other form, or within such other period of time, as the Director-General may from time to time approve.
(a)
the date of each transaction:
(b)
the name of the patient or (as the case may require) the owner of the animal:
(c)
the address of the patient or (as the case may require) the owner of the animal:
(d)
the name of the medicine supplied:
(e)
the quantity of the medicine supplied:
(f)
the name of the prescriber:
(g)
in the case of a prescription medicine, the unique identifying number or code of the prescription.
58 Records to be kept
(1)
The person responsible for a record to which this Part applies must keep it for at least 3 years after it was made (or, if it is kept together with other records, for at least 3 years after the most recent of them was made).
(2)
The person must keep the record—
(a)
in a secure place at his or her place of business; or
(b)
in some other place authorised by the licensing authority.
Regulation 58: substituted, on 30 November 2000, by regulation 13 of the Medicines Amendment Regulations 2000 (SR 2000/220).
Part 12 Miscellaneous
58A Substances that are not medicines or related products for purposes of Act
(1)
The following classes of substances are not medicines or related products for the purposes of the Act:
(a)
dentifrice products, provided that—
(i)
the dentifrice product does not contain a medicine specified in Schedule 1; and
(ii)
the dentifrice product is not claimed to be for use in relation to any therapeutic purpose other than one or both of the following:
(A)
preventing dental decay:
(B)
improving oral hygiene:
(b)
anti-dandruff hair products, provided that—
(i)
the hair product does not contain a medicine specified in Schedule 1; and
(ii)
the hair product is not claimed to be for use in relation to any therapeutic purpose except controlling dandruff; and
(iii)
the hair product is claimed to be effective through cleansing, moisturising, exfoliating, or drying the scalp and not through any other process:
(c)
anti-acne skin care products, provided that—
(i)
the skin care product does not contain a medicine specified in Schedule 1; and
(ii)
the skin care product is not claimed to be for use in relation to any therapeutic purpose except preventing acne; and
(iii)
the skin care product is claimed to be effective through cleansing, moisturising, exfoliating, or drying the skin and not through any other process:
(d)
barrier cream products, provided that—
(i)
the barrier cream product does not contain a medicine specified in Schedule 1; and
(ii)
the barrier cream product is not claimed to be for use in relation to any therapeutic purpose except preventing nappy rash; and
(iii)
the barrier cream product is claimed to be effective through providing a barrier to the transmission of moisture and not through any other process:
(e)
anti-bacterial skin products, provided that—
(i)
the product does not contain a medicine specified in Schedule 1; and
(ii)
the product is not claimed to be for use in relation to any therapeutic purpose except preventing the spread of bacteria (but not a named bacterium); and
(iii)
the product is not presented as being for use in connection with—
(A)
any procedure associated with the risk of transmission of disease from contact with blood or other bodily fluids; or
(B)
either of the procedures specified in subclause (2); and
(iv)
the product is not recommended for use in connection with the provision of health services (as defined in section 2 of the Health and Disability Commissioner Act 1994).
(2)
The procedures referred to in subclause (1)(e)(iii)(B) are—
(a)
piercing the skin or mucous membrane for any purpose; and
(b)
venipuncture, or the delivery of an injection.
Regulation 58A: inserted, on 1 August 2011, by regulation 23 of the Medicines Amendment Regulations 2011 (SR 2011/245).
58B Fluoridating agents and fluoridated water not medicines or related products
(1)
This regulation applies in relation to drinking water in a drinking water supply.
(2)
Fluoridating agents for use in fluoridating drinking water are not medicines or related products for the purposes of the Act.
(3)
The addition of 1 or more fluoridating agents to drinking water does not make the drinking water a medicine or related product for the purposes of the Act.
(4)
In this regulation,—
drinking water has the same meaning as in section 6 of the Water Services Act 2021
drinking water supply has the same meaning as in section 9 of the Water Services Act 2021
fluoridating agent means—
(a)
hydrofluorosilicic acid:
(b)
sodium fluoride:
(c)
sodium silicofluoride:
(d)
any other substance that releases fluoride when added to water.
Regulation 58B: inserted, on 30 January 2015, by regulation 4 of the Medicines Amendment Regulations 2015 (LI 2015/7).
Regulation 58B(1): amended, on 15 November 2021, by section 206(2) of the Water Services Act 2021 (2021 No 36).
Regulation 58B(4) drinking water: replaced, on 15 November 2021, by section 206(2) of the Water Services Act 2021 (2021 No 36).
Regulation 58B(4) drinking water supply: replaced, on 15 November 2021, by section 206(2) of the Water Services Act 2021 (2021 No 36).
58C Substances used to terminate pregnancy are medicines
Substances used to terminate a pregnancy are medicines for the purposes of the Act.
Regulation 58C: inserted, on 24 March 2020, by section 18(2) of the Abortion Legislation Act 2020 (2020 No 6).
58D Non-oral products containing nicotine are medicines
(1)
Products containing nicotine that are not for oral use are medicines for the purposes of the Act.
(2)
To avoid doubt, oral use includes (without limitation) inhalation.
Regulation 58D: inserted, on 11 November 2020, by section 30 of the Smokefree Environments and Regulated Products (Vaping) Amendment Act 2020 (2020 No 62).
58E Medications used for assisted dying are medicines
Medications, when used for assisted dying under the End of Life Choice Act 2019, are medicines for the purposes of the Act.
Regulation 58E: inserted, on 7 November 2021, by regulation 4 of the Medicines (Assisted Dying Medications) Amendment Regulations 2021 (LI 2021/266).
59 General sale medicines may be sold by vending machine
(1)
The Director-General may, by notice in the Gazette,—
(a)
approve the sale of a general sale medicine by means of a vending machine:
(b)
specify any conditions to which an approval under paragraph (a) is subject:
(c)
withdraw an approval given under paragraph (a):
(d)
vary or revoke any conditions specified under paragraph (b), or specify additional conditions, to which an approval under paragraph (a) is subject.
(2)
A notice given under subclause (1) takes effect on the day after the date of notification.
Regulation 59: substituted, on 1 August 2011, by regulation 24 of the Medicines Amendment Regulations 2011 (SR 2011/245).
60 Certificate of analyst
The certificate of an analyst given for the purposes of section 70 of the Act shall be in the form set out in Schedule 5.
61 Fees
(1)
The licence fees set out in Schedule 5A are payable for the licences to which they relate.
(2)
The amount to be deposited with the Medicines Review Committee pursuant to section 13(2) of the Act shall be $9,000.
(3)
The fee to accompany an application made under section 21 of the Act for the Minister’s consent under section 20 of the Act shall be $122,625 where any active ingredient of the medicine that is the subject of the application is not generally available as at the date of that application.
(4)
The fee to accompany any other application made under section 21 of the Act for the Minister’s consent under section 20 of the Act shall be $79,877.
(5)
The fee to accompany an application made under section 21 of the Act (as applied by section 96(1) of the Act) for the Minister’s consent under section 20 of the Act in relation to a related product shall be $5,731.
(6)
The fee to accompany an application made under section 23 of the Act for the Minister’s provisional consent shall be $85,202.
(7)
The fee to accompany a notice deposited with the Director-General under section 24 of the Act shall be $79,877.
(8)
The fee to accompany an application made under section 30 of the Act for the approval of a clinical trial, and of the persons (in that section called investigators) who will conduct that trial, shall be $9,843.
(9)
For the purposes of section 70(4) of the Act, the fee for a copy of a certificate of an analyst, or (as the case may be) a copy of a report made by an analyst in respect of a sample, shall be $60.
(10)
For the purposes of section 97(1) of the Act, the fee for procuring a sample of any medicine and submitting it for analysis shall be $600.
Regulation 61: substituted, on 29 August 1991, by regulation 2 of the Medicines Regulations 1984, Amendment No 4 (SR 1991/134).
Regulation 61(1): substituted, on 21 August 2006, by regulation 5(1) of the Medicines (Fees) Amendment Regulations 2006 (SR 2006/188).
Regulation 61(3): amended, on 21 August 2006, by regulation 5(2) of the Medicines (Fees) Amendment Regulations 2006 (SR 2006/188).
Regulation 61(4): amended, on 1 July 2022, by regulation 6(1) of the Medicines Amendment Regulations 2022 (SL 2022/116).
Regulation 61(5): amended, on 1 July 2022, by regulation 6(2) of the Medicines Amendment Regulations 2022 (SL 2022/116).
Regulation 61(6): amended, on 1 July 2022, by regulation 6(3) of the Medicines Amendment Regulations 2022 (SL 2022/116).
Regulation 61(7): amended, on 1 July 2022, by regulation 6(4) of the Medicines Amendment Regulations 2022 (SL 2022/116).
Regulation 61(8): amended, on 21 August 2006, by regulation 5(6) of the Medicines (Fees) Amendment Regulations 2006 (SR 2006/188).
61A Waiver and refund of fees
(1)
The Director-General may, in a particular case or class of cases, waive or refund, in whole or in part, any fee otherwise payable under regulation 61.
(2)
In exercising his or her powers under subclause (1), the Director-General shall have regard to—
(a)
the time reasonably required to consider any application made or notice given under the Act:
(b)
the degree of complexity involved in considering any such application or notice:
(c)
the interests of public health in New Zealand.
Regulation 61A: inserted, on 29 August 1991, by regulation 2 of the Medicines Regulations 1984, Amendment No 4 (SR 1991/134).
61B Fees inclusive of goods and services tax
The fees fixed by these regulations are inclusive of goods and services tax under the Goods and Services Tax Act 1985.
Regulation 61B: inserted, on 29 August 1991, by regulation 2 of the Medicines Regulations 1984, Amendment No 4 (SR 1991/134).
62 Medical devices
No person shall sell any medical device that is claimed to operate by inducing, concentrating, directing, or producing, or counteracting, screening, or giving protection from, any magnetic, galvanic, electric, electronic, radiation, or vibratory forces or effects unless—
(a)
such properties are, before or at the time of sale, quantitatively described to the purchaser in writing in terms that can be measured by scientific physical means; and
(b)
the medical device demonstrably has the properties claimed and described.
63 Restriction on, and supervision of, compounding medicine
(1)
A dispensary technician must not undertake any process of compounding a medicine.
(2)
The following persons may compound a medicine, but only if under the direct personal supervision of a pharmacist:
(a)
pharmacy graduates:
(b)
pharmacy technicians:
(c)
students:
(d)
despite subclause (1), dispensary technicians who have served an apprenticeship in pharmacy under the Pharmacy Act 1939.
Regulation 63: substituted, on 19 December 2002, by regulation 6 of the Medicines Amendment Regulations (No 2) 2002 (SR 2002/374).
64 Offences
(1)
Every person commits an offence against these regulations who—
(a)
(b)
fails to comply with any order made by the Director-General under regulation 50(1); or
(2)
Every person who commits an offence against these regulations is liable on conviction to a fine not exceeding $500.
Regulation 64(1)(a): amended, on 19 December 2025, by regulation 5 of the Medicines (Restriction on Prescribing Gonadotropin-releasing Hormone Analogues) Amendment Regulations 2025 (SL 2025/256).
Regulation 64(1)(a): amended, on 1 August 2011, by regulation 25(1) of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 64(1)(a): amended, on 11 October 2001, by regulation 16 of the Medicines Amendment Regulations 2001 (SR 2001/232).
Regulation 64(1)(a): amended, on 18 September 1997, by regulation 2(2) of the Medicines Amendment Regulations 1997 (SR 1997/165).
Regulation 64(1)(c): amended, on 5 July 2024, by regulation 52 of the Misuse of Drugs (Medicinal Cannabis) Amendment Regulations 2024 (SL 2024/129).
Regulation 64(1)(c): amended, on 1 August 2011, by regulation 25(2) of the Medicines Amendment Regulations 2011 (SR 2011/245).
Regulation 64(2): amended, on 1 July 2013, by section 413 of the Criminal Procedure Act 2011 (2011 No 81).
65 Appeals to District Court
(1)
Any occupier of premises in respect of which any decision has been made under regulation 31 by a Medical Officer of Health, may appeal against that decision to a District Court within 14 days after being notified in writing of the decision.
(2)
An appeal under this regulation shall be made by way of originating application in accordance with the District Courts Rules 2014, and shall be filed in the office of the court nearest to the place of business or employment of the appellant.
(3)
On hearing an appeal brought under this regulation, the court may confirm, reverse, or modify the decision made by the Medical Officer of Health, and the decision of the court on the appeal shall be final.
Regulation 65(2): amended, on 1 July 2014, by regulation 4 of the Medicines Amendment Regulations 2014 (LI 2014/165).
65A Transitional provision arising from enactment of Medicines Amendment Regulations 2011
[Revoked]Regulation 65A: revoked, on 16 June 2023, by regulation 5 of the Medicines Amendment Regulations 2023 (SL 2023/130).
66 Revocations
(1)
The regulations specified in Schedule 6 are hereby revoked.
(2)
Amendment(s) incorporated in the Drug Tariff 1981 (SR 1981/171).
Schedule 1AA Transitional, savings, and related provisions
Schedule 1AA: inserted, on 16 June 2023, by regulation 6 of the Medicines Amendment Regulations 2023 (SL 2023/130).
Part 1 Provisions relating to Medicines Amendment Regulations 2023
Schedule 1AA Part 1: inserted, on 16 June 2023, by regulation 6 of the Medicines Amendment Regulations 2023 (SL 2023/130).
1 Exemption from requirement in regulation 13(1)(f) for zopiclone and zolpidem supplied before 1 July 2023
The requirement in regulation 13(1)(f) does not apply in respect of zopiclone or zolpidem supplied by a retailer, manufacturer, or wholesaler before 1 July 2023.
Schedule 1AA clause 1: inserted, on 16 June 2023, by regulation 6 of the Medicines Amendment Regulations 2023 (SL 2023/130).
2 Exemption from requirement in regulation 13(1)(f) for tramadol supplied before 1 October 2023
The requirement in regulation 13(1)(f) does not apply in respect of tramadol supplied by a retailer, manufacturer, or wholesaler before 1 October 2023.
Schedule 1AA clause 2: inserted, on 16 June 2023, by regulation 6 of the Medicines Amendment Regulations 2023 (SL 2023/130).
Part 2 Provision relating to Medicines (Restriction on Prescribing Gonadotropin-releasing Hormone Analogues) Amendment Regulations 2025
Schedule 1AA Part 2: inserted, on 19 December 2025, by regulation 6(a) of the Medicines (Restriction on Prescribing Gonadotropin-releasing Hormone Analogues) Amendment Regulations 2025 (SL 2025/256).
3 Application of restriction in regulation 44BA
The restriction in regulation 44BA does not apply in respect of a person who has been prescribed a prescription medicine that is a gonadotropin-releasing hormone analogue for a purpose described in regulation 44BA before 19 December 2025.
Schedule 1AA clause 3: inserted, on 19 December 2025, by regulation 6(a) of the Medicines (Restriction on Prescribing Gonadotropin-releasing Hormone Analogues) Amendment Regulations 2025 (SL 2025/256).
Part 3 Provisions relating to Medicines (Administration and Supply of Medicines in Approved Immunisation Programmes) Amendment Regulations 2025
Schedule 1AA Part 3: inserted, on 19 December 2025, by regulation 5(b) of the Medicines (Administration and Supply of Medicines in Approved Immunisation Programmes) Amendment Regulations 2025 (SL 2025/318).
4 Interpretation
In this Part,—
commencement date means the date on which the Medicines (Administration and Supply of Medicines in Approved Immunisation Programmes) Amendment Regulations 2025 come into force
existing authorisation means an authorisation given before the commencement date under regulation 44A to administer, for the purposes of an approved immunisation programme, a vaccine otherwise than pursuant to a prescription.
Schedule 1AA clause 4: inserted, on 19 December 2025, by regulation 5(b) of the Medicines (Administration and Supply of Medicines in Approved Immunisation Programmes) Amendment Regulations 2025 (SL 2025/318).
5 Existing authorisations
A medical practitioner or other person who has an existing authorisation is treated as having been authorised to administer or supply, for the purposes of an approved immunisation programme,—
(a)
a vaccine or other prescription medicine otherwise than pursuant to a prescription; and
(b)
a restricted or pharmacy-only medicine without complying with section 18(1) of the Act.
Schedule 1AA clause 5: inserted, on 19 December 2025, by regulation 5(b) of the Medicines (Administration and Supply of Medicines in Approved Immunisation Programmes) Amendment Regulations 2025 (SL 2025/318).
Schedule 1 Prescription, restricted, and pharmacy-only medicines
Schedule 1: replaced, on 1 September 2021, by regulation 4 of the Medicines Amendment Regulations (No 2) 2021 (LI 2021/228).
Every reference to a medicine in this schedule applies whether the medicine is synthetic in origin or is from biological or mineral sources.
Unless specific reference is made otherwise, every reference applies also to medicines that are—
•
preparations and admixtures containing any proportion of any substance listed in this schedule:
•
salts and esters of any substance listed in this schedule:
•
preparations or extracts of biological materials listed in this schedule:
•
salts or oxides of elements listed in this schedule.
Unless specific reference is made otherwise, every reference to a medicine in this schedule applies,—
•
if the medicine is an injection or eye preparation, to any concentration of that medicine; and
•
if the medicine is not an injection or eye preparation, only if the concentration of the medicine is greater than 10 milligrams per litre or per kilogram.
Where any reference is modified by a statement of the strength of the medicine, the strength is calculated using the free acid, base, alcohol, or element unless specifically stated otherwise.
Part 1 Prescription medicines
Amending or replacing this Part may affect designated prescriber regulations under section 105(1)(q) of the Act.
1
19-norandrostenedione
2
2,4-dinitrochlorobenzene
3
4-aminopyridine
4
4-chloromethandienone
5
4-chlorotestosterone
6
5-aminolevulinic acid
7
Abacavir
8
Abatacept
9
Abciximab
10
Abemaciclib
11
Abiraterone
12
Abrus precatorius; at all strengths
13
Acamprosate
14
Acarbose
15
Acebutolol
16
Acepromazine
17
Acetanilides
18
Acetarsol
19
Acetazolamide
20
Acetohexamide
21
Acetylcarbromal
22
Acetylcholine; except in medicines containing 1 milligram or less per litre or per kilogram
23
Acetylcysteine; for injection or inhalation
24
Acetyldigitoxin
25
Acetylmethyldimethyloximidophenylhydrazine
26
Acetylstrophanthidin
27
Aciclovir; except when specified elsewhere in this schedule
28
Acipimox
29
Acitretin
30
Aclidinium bromide
31
Acokanthera ouabaio
32
Acokanthera schimperi
33
Aconitum spp; except when specified elsewhere in this schedule
34
Acrivastine
35
Adalimumab
36
Adapalene; except in medicines containing 1 milligram or less per millilitre or gram and when supplied by a pharmacist in a pack containing not more than 30 grams for the treatment of comedo, popular, and pustular acne (acne vulgaris) of the face, chest, or back
37
Adefovir
38
Adenosine; for injection
39
Adinazolam
40
Adiphenine
41
Adonis vernalis
42
Adrafinil
43
Adrenal extract; except for dermal use in medicines containing 0.02% or less of ketosteroids
44
Adrenaline; in medicines containing more than 1%
45
Adrenocortical hormones; except adrenal extract for dermal use containing 0.02% or less of ketosteroids
46
Afamelanotide
47
Afatinib
48
Aflibercept
49
Agalsidase
50
Agomelatine
51
Alatrofloxacin
52
Albendazole
53
Albumin; except human albumin
54
Alclofenac
55
Alclometasone; except when specified elsewhere in this schedule
56
Alcohol; for injection in medicines containing more than 20%
57
Alcuronium
58
Aldesleukin
59
Aldosterone; except in medicines containing 10 micrograms or less per litre or per kilogram
60
Alectinib
61
Alefacept
62
Alemtuzumab
63
Alendronic acid
64
Alfacalcidol
65
Alfentanil
66
Alfuzosin
67
Alglucerase
68
Alglucosidase
69
Alirocumab
70
Aliskiren
71
Alitretinoin
72
Alkyl nitrites
73
Alkyl sulfonals
74
Allergens
75
Allopurinol
76
Allylisopropylacetylurea; at all strengths
77
Allyloestrenol
78
Alogliptin
79
Aloracetam
80
Alosetron
81
Alpelisib
82
Alpha1-proteinase inhibitor
83
Alphadolone
84
Alphaxalone
85
Alprazolam
86
Alprenolol
87
Alprostadil
88
Alseroxylon
89
Alteplase
90
Altretamine
91
Amantadine
92
Ambenonium
93
Ambrisentan
94
Ambucetamide
95
Ambutonium
96
Amcinonide
97
Amethocaine; except when specified elsewhere in this schedule; for ophthalmic use except when used in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board
98
Amfebutamone
99
Amfepramone
100
Amidopyrine
101
Amifampridine
102
Amifostine
103
Amikacin
104
Amiloride
105
Aminocaproic acid
106
Aminoglutethimide
107
Aminometradine
108
Aminophenazone; at all strengths
109
Aminophylline; except when specified elsewhere in this schedule
110
Aminopterin
111
Aminorex
112
Aminosalicylic acid
113
Amiodarone
114
Amiphenazole
115
Amisometradine
116
Amisulpride
117
Amitriptyline
118
Amlodipine
119
Ammi visnaga
120
Ammonium bromide
121
Amobarbital
122
Amodiaquine
123
Amorolfine; except when specified elsewhere in this schedule; except in preparations for the treatment of tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
124
Amoxapine
125
Amoxycillin
126
Amphomycin
127
Amphotericin
128
Ampicillin
129
Amprenavir
130
Amrinone
131
Amsacrine
132
Amygdalin; at all strengths
133
Amyl nitrite; except when sold to a person who is appropriately authorised under the Health and Safety at Work Act 2015
134
Amylocaine
135
Anabolic steroids
136
Anagrelide
137
Anakinra
138
Anastrozole
139
Ancestim
140
Anchusa officinalis; at all strengths
141
Ancrod and its immunoglobulin antidote
142
Androgenic and anabolic steroidal agents
143
Androgens
144
Androisoxazole
145
Androstanolone
146
Androstenediol
147
Androstenedione
148
Anecortave
149
Angiotensinamide
150
Anidulafungin
151
Aniracetam
152
Anistreplase
153
Antazoline; except for ophthalmic use
154
Antibiotic substances; except when specified elsewhere in this schedule
155
Antigens
156
Antihistamines; except when specified elsewhere in this schedule
157
Antimony; except in medicines containing 1 milligram or less per litre or per kilogram
158
Antisera; for injection
159
AOD-9604
160
Apalutamide
161
Apixaban
162
Apocynum spp
163
Apomorphine; except in medicines containing 1 milligram or less per litre or per kilogram
164
Apraclonidine
165
Apremilast
166
Aprepitant
167
Apronal
168
Aprotinin
169
Arecoline
170
Aripiprazole
171
Aristolochia spp; at all strengths
172
Aristolochic acid; at all strengths
173
Armodafinil
174
Arsenic; except in medicines containing 1 milligram or less per litre or per kilogram
175
Artemether
176
Artemisia annua extract
177
Artesunate
178
Articaine; except when used as a local anaesthetic in practice by a dental therapist or oral health therapist registered with the Dental Council
179
Asenapine
180
Asfotase alfa
181
Asparaginase
182
Aspirin; except when specified elsewhere in this schedule; for injection; when combined with caffeine, paracetamol, or salicylamide
183
Astemizole
184
Asunaprevir
185
Atamestane
186
Atazanavir
187
Atenolol
188
Atezolizumab
189
Atomoxetine
190
Atorvastatin
191
Atosiban
192
Atovaquone
193
Atracurium
194
Atropa belladonna; except when specified elsewhere in this schedule; except in medicines containing 300 micrograms or less of total solanaceous alkaloids per litre or per kilogram
195
Atropine; except when specified elsewhere in this schedule; except when used as an antidote in a device designed for self-injection; except in medicines containing 300 micrograms or less per litre or per kilogram
196
Atropine methonitrate
197
Auranofin
198
Aurothiomalate sodium
199
Avanafil
200
Avelumab
201
Avibactam
202
Aviptadil
203
Axitinib
204
Azacitidine
205
Azacyclonol
206
Azapropazone
207
Azaribine
208
Azatadine; except when specified elsewhere in this schedule
209
Azathioprine
210
Azelaic acid; except when specified elsewhere in this schedule
211
Azelastine; except when specified elsewhere in this schedule
212
Azithromycin
213
Azlocillin
214
Aztreonam
215
Bacampicillin
216
Bacitracin
217
Baclofen
218
Baloxavir marboxil
219
Balsalazide
220
Bambuterol
221
Bamethan
222
Bamipine
223
Bamlanivimab
224
Barbital
225
Barbiturates
226
Baricitinib
227
Basiliximab
228
Bazedoxifene
229
Becaplermin
230
Beclamide
231
Beclomethasone; except when specified elsewhere in this schedule
232
Bedaquiline
233
Belatacept
234
Belimumab
235
Bemegride
236
Benactyzine
237
Benazepril
238
Bendamustine
239
Bendrofluazide
240
Benethamine penicillin
241
Benorylate
242
Benoxaprofen
243
Benperidol
244
Benralizumab
245
Benserazide
246
Benzathine penicillin
247
Benzatropine
248
Benzbromarone
249
Benzhexol
250
Benzilonium
251
Benzocaine; except when specified elsewhere in this schedule
252
Benzodiazepine derivatives; except when specified elsewhere in this schedule
253
Benzodiazepines; except when specified elsewhere in this schedule
254
Benzoyl metronidazole
255
Benzoyl peroxide; except when specified elsewhere in this schedule
256
Benzthiazide
257
Benzydamine; except when specified elsewhere in this schedule
258
Benzylpenicillin
259
Bepridil
260
Beractant
261
Besifloxacin
262
Beta carotene; in medicines containing more than 18 milligrams per recommended daily dose
263
Betahistine
264
Betaine; for the treatment of homocystinuria
265
Betamethasone
266
Betaxolol
267
Bethanechol
268
Bethanidine
269
Bevacizumab
270
Bevantolol
271
Bexarotene
272
Bezafibrate
273
Bezlotoxumab
274
Bicalutamide
275
Bictegravir
276
Bifonazole; except when specified elsewhere in this schedule
277
Bilastine; except when specified elsewhere in this schedule
278
Bimatoprost
279
Binimetinib
280
Biperiden
281
Bismuth; except for external use in medicines containing 3% or less
282
Bisoprolol
283
Bithionol; at all strengths
284
Bivalirudin
285
Bleomycin
286
Blinatumomab
287
Boceprevir
288
Bolandiol
289
Bolasterone
290
Bolazine
291
Boldenone
292
Bolenol
293
Bolmantalate
294
Boron, including borax and boric acid; except in medicines for internal use containing 6 milligrams or less per recommended daily dose; except in medicines for dermal use other than paediatric use containing 0.35% or less; except when present as an excipient
295
Bortezomib
296
Bosentan
297
Bosutinib
298
Botulinum toxins
299
Brentuximab vedotin
300
Bretylium
301
Brexpiprazole
302
Brigatinib
303
Brimonidine
304
Brinzolamide
305
Brivaracetam (and its stereoisomers)
306
Brolucizumab
307
Bromazepam
308
Bromocriptine
309
Bromoform
310
Brompheniramine; except when specified elsewhere in this schedule
311
Bromvaletone
312
Brotizolam
313
Brugmansia spp
314
Buclizine; except for oral use
315
Budesonide; except when specified elsewhere in this schedule
316
Bufexamac; except in suppositories; except for dermal use in medicines containing 5% or less
317
Bumetanide
318
Buniodyl sodium; at all strengths
319
Buphenine
320
Bupivacaine
321
Buprenorphine
322
Bupropion
323
Buserelin
324
Buspirone
325
Busulphan
326
Butacaine
327
Butobarbital
328
Butoconazole; except for vaginal use
329
Butorphanol
330
Butyl aminobenzoate; except in medicines for dermal use containing 2% or less
331
Butyl nitrite
332
Butylchloral hydrate
333
Cabazitaxel
334
Cabergoline
335
Cabotegravir
336
Cabozantinib
337
Cacalia spp; at all strengths
338
Cadmium
339
Calcipotriol; except in medicines containing not more than 50 micrograms per gram or per millilitre and when sold in a pack of not more than 30 grams or 30 millilitres by a pharmacist to an adult with mild to moderate psoriasis previously diagnosed by a doctor
340
Calcitonin
341
Calcitriol
342
Calcium carbimide
343
Calcium polystyrene sulphonate
344
Calotropis gigantea
345
Calotropis procera
346
Calusterone
347
Camazepam
348
Camphorated oil
349
Camphotamide
350
Canagliflozin
351
Canakinumab
352
Candesartan
353
Candicidin
354
Cannabidiol
355
Capecitabine
356
Capreomycin
357
Captodiame
358
Captopril
359
Capuride
360
Caramiphen
361
Carbachol
362
Carbamazepine
363
Carbaryl; except for external use in medicines containing 2% or less
364
Carbazochrome
365
Carbenicillin
366
Carbenoxolone; except for external use
367
Carbetocin
368
Carbidopa
369
Carbimazole
370
Carbocromen
371
Carboplatin
372
Carboprost
373
Carbromal
374
Carbutamide
375
Carbuterol
376
Carfilzomib
377
Carglumic acid
378
Carindacillin
379
Carisoprodol
380
Carmustine
381
Carprofen
382
Carvedilol
383
Caspofungin
384
Catumaxomab
385
Cebaracetam (and its stereoisomers)
386
Cedazuridine
387
Cefacetrile
388
Cefaclor
389
Cefaloridine
390
Cefamandole
391
Cefapirin
392
Cefazolin
393
Cefepime
394
Cefetamet
395
Cefixime
396
Cefodizime
397
Cefonicid
398
Cefoperazone
399
Cefotaxime
400
Cefotetan
401
Cefotiam
402
Cefoxitin
403
Cefpirome
404
Cefpodoxime
405
Cefsulodin
406
Ceftaroline fosamil
407
Ceftazidime
408
Ceftibuten
409
Ceftolozane
410
Ceftriaxone
411
Cefuroxime
412
Celecoxib
413
Celiprolol
414
Cenegermin
415
Cephaelis acuminata; except in medicines containing less than 0.2% of emetine
416
Cephaelis ipecacuanha; except in medicines containing less than 0.2% of emetine
417
Cephalexin
418
Cephalothin
419
Cephradine
420
Ceritinib
421
Cerivastatin
422
Cerliponase alfa
423
Certolizumab pegol
424
Ceruletide
425
Cetirizine; except when specified elsewhere in this schedule
426
Cetrorelix
427
Cetuximab
428
Chenodeoxycholic acid
429
Chloral hydrate; except for dermal use in medicines containing 2% or less
430
Chloralformamide
431
Chloralose
432
Chlorambucil
433
Chloramphenicol; except when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board; except when specified elsewhere in this schedule
434
Chlorandrostenolone
435
Chlorazanil
436
Chlorcyclizine
437
Chlordiazepoxide
438
Chlormerodrin
439
Chlormethiazole
440
Chlormezanone
441
Chloroform; for anaesthesia; except when specified elsewhere in this schedule
442
Chloroquine
443
Chlorothiazide
444
Chlorotrianisene
445
Chloroxydienone
446
Chloroxymesterone
447
Chlorpheniramine; except when specified elsewhere in this schedule
448
Chlorphentermine
449
Chlorpromazine
450
Chlorpropamide
451
Chlorprothixene
452
Chlorquinaldol
453
Chlortetracycline
454
Chlorthalidone
455
Chlorzoxazone
456
Cholera vaccine; except in the form of an oral liquid containing vibrio cholerae when sold in a pharmacy by a registered pharmacist
457
Cholic acid
458
Choline salicylate; except in medicines containing 10% or less and in pack sizes of 15 grams or less
459
Chorionic gonadotrophin; except in pregnancy test kits
460
Chymopapain
461
Ciclacillin
462
Ciclesonide
463
Ciclopirox; except when specified elsewhere in this schedule
464
Cidofovir
465
Cilastatin
466
Cilazapril
467
Cilnidipine
468
Cilostazol
469
Cimetidine; except when specified elsewhere in this schedule
470
Cinacalcet
471
Cinchocaine; for injection; for ophthalmic use; for external use in medicines containing more than 0.5%
472
Cinchophen
473
Cinnarizine
474
Cinoxacin
475
Ciprofloxacin
476
Cisapride
477
Cisatracurium
478
Cisplatin
479
Citalopram
480
CJC-1295
481
Cladribine
482
Clarithromycin
483
Clavulanic acid
484
Clemastine; except for oral use
485
Clemizole
486
Clenbuterol
487
Clevidipine
488
Clidinium
489
Clindamycin
490
Clioquinol; at all strengths
491
Clobazam
492
Clobetasol
493
Clobetasone; except when specified elsewhere in this schedule
494
Clocortolone
495
Clodronic acid
496
Clofarabine
497
Clofazimine
498
Clofenamide
499
Clofibrate
500
Clomiphene
501
Clomipramine
502
Clomocycline
503
Clonazepam
504
Clonidine
505
Clopamide
506
Clopidogrel
507
Clorazepic acid
508
Clorexolone
509
Clorprenaline
510
Clostebol
511
Clotiazepam
512
Clotrimazole; except when specified elsewhere in this schedule
513
Cloxacillin
514
Cloxazolam
515
Clozapine
516
Cobalt
517
Cobicistat
518
Cobimetinib
519
Cocaine; except when specified elsewhere in this schedule
520
Codeine
521
Co-dergocrine
522
Colaspase
523
Colchicine
524
Colchicum
525
Colecalciferol; except in medicines containing 25 micrograms or less per recommended daily dose; except in parenteral nutrition replacement preparations
526
Colestipol
527
Colestyramine
528
Colfosceril
529
Colistin
530
Collagen; in injections or implants for tissue augmentation or cosmetic use
531
Collagenase clostridium histolyticum
532
Coluracetam
533
Conium maculatum; at all strengths
534
Convallaria keiski
535
Convallaria majalis
536
Corifollitropin alfa
537
Coronilla spp
538
Corticosterone
539
Corticotrophin
540
Cortisone and other steroidal hormones of the adrenal cortex; except when specified elsewhere in this schedule; except adrenal extract for dermal use in medicines containing 0.02% or less of ketosteroids
541
Cotarnine; at all strengths
542
Co-trimoxazole
543
Coumarin
544
COVID-19 vaccines; except when administered by vaccinators, registered pharmacists, or registered intern pharmacists who have successfully completed the COVID-19 Vaccinator Education Course (or any equivalent training course on COVID-19 vaccination approved by the Ministry of Health) and who comply with the immunisation standards of the Ministry of Health (but excluding vaccinators who have completed the Provisional Vaccinator Foundation Course or the COVID-19 Vaccinator - Working under Supervision Course)
545
Crisaborole
546
Crizotinib
547
Crofelemer
548
Crotalaria spp; at all strengths
549
Croton tiglium; except in medicines containing 1 milligram or less per litre or per kilogram
550
Crystal violet
551
Curare
552
Cyclandelate
553
Cyclizine; except when specified elsewhere in this schedule
554
Cyclobenzaprine
555
Cyclofenil
556
Cycloheximide
557
Cyclopenthiazide
558
Cyclopentolate; except when used in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board
559
Cyclophosphamide
560
Cyclopropane
561
Cycloserine
562
Cyclosporin
563
Cyclothiazide
564
Cycrimine
565
Cymarin
566
Cynoglossum spp; at all strengths
567
Cyproheptadine; except for oral use
568
Cyproterone
569
Cysteamine
570
Cytarabine
571
Dabigatran
572
Dabrafenib mesilate
573
Dacarbazine
574
Daclatasvir
575
Daclizumab
576
Dactinomycin
577
Dalfopristin
578
Dalteparin
579
Danaparoid
580
Danazol
581
Danthron
582
Dantrolene
583
Dapagliflozin
584
Dapoxetine
585
Dapsone
586
Daptomycin
587
Daratumumab
588
Darbepoetin
589
Darifenacin
590
Darolutamide
591
Darunavir
592
Dasabuvir
593
Dasatinib
594
Datura spp; except for oral use when specified elsewhere in this schedule; except datura stramonium or datura tatula for smoking or burning
595
Daunorubicin
596
Deanol
597
Debrisoquine
598
Decamethonium
599
Decitabine
600
Deferasirox
601
Deferiprone
602
Defibrotide
603
Deflazacort
604
Degarelix
605
Dehydrochloromethyltestosterone
606
Dehydrocorticosterone
607
Delavirdine
608
Delorazepam
609
Demecarium
610
Demeclocycline
611
Denosumab
612
Deoxycortone
613
Deoxycholic acid; for injection; except for oral use
614
Deoxyribonuclease; except for external use
615
Dermatophagoides farina allergen extract
616
Dermatophagoides pteronyssinus allergen extract
617
Desferrioxamine
618
Desflurane
619
Desipramine
620
Desirudin
621
Deslanoside
622
Desloratadine; except for oral use
623
Deslorelin
624
Desmopressin
625
Desogestrel; except when supplied for oral contraception to women who meet the clinical and eligbility criteria of the Pharmacy Council and the Pharmaceutical Society of New Zealand Incorporated approved training programme on oral contraception, when sold in the manufacturer’s original pack that has received the consent of the Minister or Director-General to their distribution as medicines, containing not more than 6 months’ supply by a registered pharmacist who has successfully completed the approved training programme
626
Desonide
627
Desoximetasone
628
Desvenlafaxine
629
Dexamethasone
630
Dexamfetamine
631
Dexchlorpheniramine; except when specified elsewhere in this schedule
632
Dexfenfluramine
633
Dexmedetomidine
634
Dextromethorphan; except when specified elsewhere in this schedule
635
Dextromoramide
636
Dextropropoxyphene
637
Dextrorphan
638
Di-iodohydroxy quinoline; except when specified elsewhere in this schedule
639
Di-isopropylamine dichloroacetate
640
Diazepam
641
Diazoxide
642
Dibenzepin
643
Dibotermin
644
Dibrompropamidine; except for ophthalmic use
645
Dichloralphenazone
646
Dichlorophen
647
Dichlorphenamide
648
Diclofenac; in preparations for the treatment of solar keratosis; except when specified elsewhere in this schedule; except in preparations for topical use other than for the treatment of solar keratosis
649
Dicloxacillin
650
Dicyclomine
651
Didanosine
652
Dienoestrol
653
Dienogest
654
Diethazine
655
Diethylcarbamazine
656
Diethylstilbestrol
657
Diflorasone
658
Diflucortolone
659
Diflunisal
660
Digitalis lanata
661
Digitalis purpurea
662
Digitoxin
663
Digoxin
664
Digoxin-specific antibody fragment
665
Dihydralazine
666
Dihydrocodeine
667
Dihydroergotoxine
668
Dihydrolone
669
Dihydrotachysterol
670
Diltiazem
671
Dimenhydrinate; except when specified elsewhere in this schedule
672
Dimercaprol
673
Dimethandrostanolone
674
Dimethazine
675
Dimethindene; except for oral use
676
Dimethothiazine
677
Dimethoxanate
678
Dimethyl fumarate
679
Dimethyl sulphoxide
680
Dimiracetam (and its stereoisomers)
681
Dinitrocresols
682
Dinitronaphthols
683
Dinitrophenols
684
Dinitrothymols
685
Dinoprost
686
Dinoprostone
687
Diperodon
688
Diphemanil; except for dermal use
689
Diphenhydramine; except when specified elsewhere in this schedule
690
Diphenidol
691
Diphenoxylate; except when specified elsewhere in this schedule
692
Diphenylpyraline
693
Diphtheria, tetanus, and pertussis (acellular, component) vaccine; except when administered in a single dose to a person 18 years of age or over or to a pregnant woman aged 13 years or over by a registered pharmacist who has successfully completed the Vaccinator Foundation Course (or any equivalent training course approved by the Ministry of Health) and who complies with the immunisation standards of the Ministry of Health (but excluding a vaccinator who has completed the Provisional Vaccinator Foundation Course)
694
Diphtheria toxoid
695
Diphtheria vaccine
696
Dipivefrin
697
Dipyridamole
698
Dirithromycin
699
Disopyramide
700
Distigmine
701
Disulfiram
702
Disulphamide
703
Ditiocarb
704
DMHA, including the isomers 2-amino-6-methylheptane (also known as 1,5-dimethylhexylamine, and octodrine) and 2-amino-5-methylheptane (also known as 1,4-dimethylhexylamine)
705
Dobutamine
706
Docetaxel
707
Dofetilide
708
Dolasetron
709
Doliracetam (and its stereoisomers)
710
Dolutegravir
711
Domperidone
712
Donepezil
713
Dopamine
714
Dopexamine
715
Doravirine
716
Doripenem
717
Dornase
718
Dorzolamide
719
Dothiepin
720
Doxantrazole
721
Doxapram
722
Doxazosin
723
Doxepin
724
Doxorubicin
725
Doxycycline
726
Doxylamine; except when specified elsewhere in this schedule
727
Dronedarone
728
Droperidol
729
Drospirenone
730
Drostanolone
731
Drotrecogin
732
Duboisia leichhardtii; except when specified elsewhere in this schedule
733
Duboisia myoporides; except when specified elsewhere in this schedule
734
Dulaglutide
735
Dulcin; at all strengths
736
Duloxetine
737
Dupilumab
738
Dupracetam
739
Durvalumab
740
Dutasteride
741
Dydrogesterone
742
Econazole; except when specified elsewhere in this schedule
743
Ecothiopate
744
Ectylurea
745
Eculizumab
746
Edetic acid; except in medicines containing 0.25% or less; except in contact lens preparations; except dicobalt edetate for the treatment of cyanide poisoning
747
Edoxudine
748
Edrophonium
749
Efalizumab
750
Efavirenz
751
Eflornithine
752
Elbasvir
753
Eletriptan
754
Elosulfase alfa
755
Elotuzumab
756
Eltrombopag olamine
757
Eluxadoline
758
Elvitegravir
759
Emepronium
760
Emetine; except in medicines containing 0.2% or less
761
Emicizumab
762
Empagliflozin
763
Emtricitabine
764
Enalapril
765
Enasidenib
766
Encorafenib
767
Enestebol
768
Enflurane
769
Enfuvirtide
770
Enobosarm
771
Enoxacin
772
Enoxaparin
773
Enoximone
774
Enprostil
775
Entacapone
776
Entecavir
777
Entrectinib
778
Enzalutamide
779
Ephedrine
780
Epicillin
781
Epinastine
782
Epirubicin
783
Epitiostanol
784
Eplerenone
785
Epoetins
786
Epoprostenol
787
Eprosartan
788
Eptifibatide
789
Erenumab
790
Ergocalciferol; except in medicines containing 25 micrograms or less per recommended daily dose
791
Ergometrine
792
Ergot
793
Ergotamine
794
Ergotoxine
795
Eribulin
796
Erlotinib
797
Ertapenem
798
Ertugliflozin
799
Erysimum spp; except in medicines containing 1 milligram or less per litre or per kilogram
800
Erythromycin
801
Erythropoietin
802
Escitalopram
803
Esketamine
804
Esmolol
805
Esomeprazole; except when specified elsewhere in this schedule
806
Estazolam
807
Estramustine
808
Estropipate
809
Etanercept
810
Ethacrynic acid
811
Ethambutol
812
Ethamivan
813
Ethanolamine; for injection
814
Ethchlorvynol
815
Ether; for anaesthesia; except when specified elsewhere in this schedule
816
Ethinamate
817
Ethinyloestradiol; except when supplied at a strength of 35 micrograms or less in combination with either levonorgestrel or norethisterone for oral contraception to women who meet the clinical and eligibility criteria of the Pharmacy Council and the Pharmaceutical Society of New Zealand Incorporated approved training programme on oral contraception, when sold in the manufacturer’s original pack that has received the consent of the Minister or Director-General to their distribution as medicines, containing not more than 6 months’ supply by a registered pharmacist who has successfully completed the approved training programme
818
Ethionamide
819
Ethisterone
820
Ethoglucid
821
Ethoheptazine
822
Ethopropazine
823
Ethosuximide
824
Ethotoin
825
Ethoxzolamide
826
Ethyl chloride; for inhalation
827
Ethyl loflazepate
828
Ethyldienolone
829
Ethylhexanediol; at all strengths
830
Ethyloestrenol
831
Ethynodiol
832
Etidocaine
833
Etidronic acid; except in medicines for external use containing 1% or less
834
Etilefrine
835
Etiracetam
836
Etodolac
837
Etofenamate; except for external use
838
Etomidate
839
Etonogestrel
840
Etoposide
841
Etoricoxib
842
Etravirine
843
Etretinate
844
Everolimus
845
Evolocumab
846
Exemestane
847
Exenatide
848
Ezetimibe
849
Factor VIII inhibitor bypassing fraction
850
Famciclovir; except when specified elsewhere in this schedule
851
Famotidine; except when specified elsewhere in this schedule
852
Fampridine
853
Farfugium japonicum; at all strengths
854
Fasoracetam (and its stereoisomers)
855
Febuxostat
856
Felbamate
857
Felbinac; except for external use
858
Felodipine
859
Felypressin; except when combined with a local anaesthetic and used in practice by a dental therapist or oral health therapist registered with the Dental Council
860
Fenbufen
861
Fenclofenac
862
Fenfluramine
863
Fenofibrate
864
Fenoldopam
865
Fenoprofen
866
Fenoterol
867
Fenpipramide
868
Fenpiprane
869
Fentanyl
870
Ferric carboxymaltose
871
Ferric derisomaltose
872
Fexofenadine; except when specified elsewhere in this schedule
873
Fibrin
874
Fibrinolysin; except for external use
875
Fibroblast growth factor
876
Fidaxomicin
877
Filgrastim
878
Finasteride
879
Fingolimod
880
Flecainide
881
Fleroxacin
882
Floctafenine
883
Fluanisone
884
Flubromazolam
885
Fluclorolone
886
Flucloxacillin
887
Fluconazole; except when specified elsewhere in this schedule
888
Flucytosine
889
Fludarabine
890
Fludiazepam
891
Fludrocortisone
892
Flufenamic acid
893
Flumazenil
894
Flumethasone
895
Flumethiazide
896
Flunarizine
897
Flunisolide
898
Flunitrazepam
899
Fluocinolone
900
Fluocinonide
901
Fluocortin
902
Fluocortolone
903
Fluorescein; for injection
904
Fluorides; for internal use in medicines containing more than 0.5 milligrams per dose unit except in medicines containing 15 milligrams or less per litre or per kilogram; except in parenteral nutrition replacement preparations; for external use in medicines containing more than 5.5 grams per litre or per kilogram except when supplied to a dental professional registered with the Dental Council
905
Fluorometholone
906
Fluorouracil
907
Fluoxetine
908
Fluoxymesterone
909
Flupenthixol
910
Fluphenazine
911
Flurandrenolone
912
Flurazepam
913
Flurbiprofen; except when specified elsewhere in this schedule
914
Fluroxene
915
Fluspirilene
916
Flutamide
917
Fluticasone; except when specified elsewhere in this schedule
918
Fluvastatin
919
Fluvoxamine
920
Folic acid; except when specified elsewhere in this schedule
921
Folinic acid; except when specified elsewhere in this schedule
922
Follicle-stimulating hormone; except in medicines containing 100 micrograms or less per litre or per kilogram
923
Follistatin
924
Follitropin
925
Follitropin delta
926
Fomepizole
927
Fomivirsen
928
Fondaparinux
929
Fonturacetam (and its stereoisomers)
930
Formebolone
931
Formestane
932
Formoterol
933
Fosamprenavir
934
Fosaprepitant
935
Foscarnet
936
Fosfestrol
937
Fosfomycin
938
Fosinopril
939
Fosnetupitant
940
Fosphenytoin
941
Fotemustine
942
Framycetin
943
Fremanezumab
944
Fulvestrant
945
Furaltadone
946
Furazabol
947
Furazolidone
948
Furosemide
949
Fusidic acid
950
Gabapentin
951
Galantamine
952
Galanthus spp
953
Galcanezumab
954
Gallamine
955
Galsulfase
956
Ganciclovir
957
Ganirelix
958
Gatifloxacin
959
Gefitinib
960
Gemcitabine
961
Gemeprost
962
Gemfibrozil
963
Gemifloxacin
964
Gemtuzumab ozogamicin
965
Gentamicin
966
Gestodene
967
Gestonorone
968
Gestrinone
969
Ghrelin
970
Gilteritinib
971
Gitalin
972
Glatiramer acetate
973
Glecaprevir
974
Glibenclamide
975
Glibornuride
976
Gliclazide
977
Glimepiride
978
Glipizide
979
Glisoxepide
980
Glutathione; for injection
981
Glyceryl trinitrate; for injection; for transdermal use; except in medicines containing 100 micrograms or less per litre or per kilogram
982
Glycopyrronium
983
Glymidine
984
Golimumab
985
Gonadorelin
986
Gonadotrophic hormones; except when specified elsewhere in this schedule
987
Goserelin
988
Gramicidin
989
Granisetron
990
Grazoprevir
991
Grepafloxacin
992
Griseofulvin
993
Growth hormone releasing hormones
994
Growth hormone releasing peptide-6
995
Growth hormone releasing peptides
996
Guaifenesin; except when specified elsewhere in this schedule
997
Guanabenz
998
Guanethidine
999
Guanfacine
1000
Guanidine
1001
Guselkumab
1002
Hachimycin
1003
Haematin
1004
Haemophilus influenzae vaccine; except in oral vaccines for the prophylaxis of bacterial complications of colds
1005
Halazepam
1006
Halcinonide
1007
Halofantrine
1008
Halofenate
1009
Haloperidol; except in medicines containing 1 milligram or less per litre or per kilogram
1010
Halothane
1011
Haloxazolam
1012
Halquinol; except for external use
1013
Heliotropium spp; at all strengths
1014
Hemerocallis
1015
Heparins; except when present as an excipient; except for external use
1016
Hepatitis A vaccine
1017
Hepatitis B vaccine
1018
Hetacillin
1019
Hexachlorophane; in medicines containing more than 3%; except when specified elsewhere in this schedule
1020
Hexamethonium
1021
Hexarelin
1022
Hexetidine; except for external use
1023
Hexobendine
1024
Hexocyclium
1025
Hexoprenaline
1026
Hexaminolevulinate
1027
Histamine; except in medicines containing 0.5% or less
1028
Homatropine
1029
Human chorionic gonadotrophin; except in pregnancy test kits
1030
Human growth hormone secretagogues
1031
Human papillomavirus vaccine; except when administered by a registered pharmacist or registered intern pharmacist who has successfully completed the Vaccinator Foundation Course (or any equivalent training course approved by the Ministry of Health) and who complies with the immunisation standards of the Ministry of Health (but excluding a vaccinator who has completed the Provisional Vaccinator Foundation Course)
1032
Human protein C
1033
Hyaluronic acid; in injections or implants for tissue augmentation or cosmetic use
1034
Hydralazine
1035
Hydrargaphen
1036
Hydrochlorothiazide
1037
Hydrocortisone; except when specified elsewhere in this schedule
1038
Hydrocyanic acid; except when specified elsewhere in this schedule
1039
Hydroflumethiazide
1040
Hydromorphone
1041
Hydroquinone; except when specified elsewhere in this schedule
1042
Hydroxychloroquine
1043
Hydroxyephedrine
1044
Hydroxyphenamate
1045
Hydroxyprogesterone
1046
Hydroxystenozol
1047
Hydroxyurea
1048
Hydroxyzine
1049
Hylan polymer; in injections or implants for tissue augmentation or cosmetic use
1050
Hyoscine; except when specified elsewhere in this schedule; except in medicines containing 300 micrograms or less per litre or per kilogram
1051
Hyoscine butylbromide; except when specified elsewhere in this schedule
1052
Hyoscyamine; except when specified elsewhere in this schedule; except in medicines containing 300 micrograms or less per litre or per kilogram
1053
Hyoscyamus niger; except when specified elsewhere in this schedule
1054
Hypothalamic releasing factors
1055
Hypromellose; for injection; except in intraocular viscoelastic products
1056
Ibandronic acid
1057
Ibogaine
1058
Ibritumomab tiuxetan
1059
Ibrutinib
1060
Ibufenac
1061
Ibuprofen; except when specified elsewhere in this schedule
1062
Ibutamoren
1063
Ibuterol
1064
Ibutilide
1065
Icatibant
1066
Idarubicin
1067
Idarucizumab
1068
Idebenone
1069
Idelalisib
1070
Idoxuridine; except for dermal use in medicines containing 0.5% or less
1071
Idursulfase
1072
Ifosfamide
1073
Iloprost
1074
Imatinib
1075
Imiglucerase
1076
Imipenem
1077
Imipramine
1078
Imiquimod
1079
Immunoglobulins
1080
Imuracetam
1081
Indacaterol
1082
Indapamide
1083
Indinavir
1084
Indocyanine green
1085
Indomethacin; except when specified elsewhere in this schedule
1086
Indoprofen
1087
Indoramin
1088
Infliximab
1089
Influenza and coryza vaccines; for injection; for nasal use
1090
Influenza vaccine; except when administered by vaccinators, registered pharmacists, or registered intern pharmacists who have successfully completed the Vaccinator Foundation Course (or any equivalent training course approved by the Ministry of Health) and who comply with the immunisation standards of the Ministry of Health (but excluding vaccinators who have completed the Provisional Vaccinator Foundation Course)
1091
Ingenol mebutate
1092
Inotuzumab ozogamicin
1093
Insulin degludec
1094
Insulin-like growth factors; except when specified elsewhere in this schedule
1095
Insulins
1096
Interferons
1097
Interleukins
1098
Iodothiouracil
1099
Ipamorelin
1100
Ipecacuanha; except when specified elsewhere in this schedule
1101
Ipilimumab
1102
Ipratropium; except for nasal use
1103
Ipriflavone
1104
Iprindole
1105
Iproniazid
1106
Irbesartan
1107
Irinotecan
1108
Iron; except when specified elsewhere in this schedule
1109
Isatuximab
1110
Isavuconazole
1111
Isoaminile
1112
Isoamyl nitrite
1113
Isobutyl nitrite
1114
Isocarboxazid
1115
Isoconazole; except when specified elsewhere in this schedule
1116
Isoetarine
1117
Isoflurane
1118
Isometheptene
1119
Isoniazid
1120
Isoprenaline
1121
Isoprinosine
1122
Isopropamide; except when specified elsewhere in this schedule
1123
Isosorbide dinitrate
1124
Isosorbide mononitrate
1125
Isotretinoin
1126
Isoxicam
1127
Isoxsuprine
1128
Isradipine
1129
Itraconazole
1130
Ivabradine
1131
Ivacaftor
1132
Ivermectin
1133
Ixabepilone
1134
Ixazomib
1135
Ixekizumab
1136
Japanese encephalitis vaccine
1137
Juniperus sabina; at all strengths
1138
Kanamycin
1139
Ketamine
1140
Ketanserin
1141
Ketazolam
1142
Ketoconazole; except when specified elsewhere in this schedule
1143
Ketoprofen; except when specified elsewhere in this schedule
1144
Ketorolac
1145
Ketotifen; except for ophthalmic use in medicines containing 0.025% or less
1146
Khellin
1147
Labetalol
1148
Lacidipine
1149
Lacosamide
1150
Lamivudine
1151
Lamotrigine
1152
Lanadelumab
1153
Lanatosides
1154
Lanreotide
1155
Lansoprazole; except when specified elsewhere in this schedule
1156
Lanthanum
1157
Lapatinib
1158
Laronidase-rch
1159
Laropiprant
1160
Larotrectinib
1161
Latamoxef
1162
Latanoprost
1163
Laudexium
1164
Lauromacrogols; for injection
1165
Lead
1166
Ledipasvir
1167
Lefetamine
1168
Leflunomide
1169
Lenalidomide
1170
Lenograstim
1171
Lenvatinib
1172
Lepirudin
1173
Leptazol
1174
Lercanidipine
1175
Lesinurad
1176
Letermovir
1177
Letrozole
1178
Leucovorin; for injection
1179
Leuprorelin
1180
Levallorphan
1181
Levamisole
1182
Levetiracetam
1183
Levobunolol
1184
Levobupivacaine
1185
Levocabastine; except for nasal or ophthalmic use
1186
Levocetirizine; except for oral use
1187
Levodopa
1188
Levomepromazine
1189
Levomilnacipran
1190
Levonorgestrel; except when specified elsewhere in this schedule; except in medicines for use as emergency post-coital contraception when sold by nurses recognised by their professional body as having competency in the field of sexual and reproductive health; except when sold by nurses recognised by their professional body as having competency in the field of sexual and reproductive health; except when supplied for oral contraception to women who meet the clinical and eligibility criteria of the Pharmacy Council and the Pharmaceutical Society of New Zealand Incorporated approved training programme on oral contraception, when sold in the manufacturer’s original pack that has received the consent of the Minister or Director-General to their distribution as medicines, containing not more than 6 months’ supply by a registered pharmacist who has successfully completed the approved training programme
1191
Levosimendan
1192
Lidoflazine
1193
Lidocaine; for injection except when used as a local anaesthetic in practice by a nurse whose scope of practice permits the performance of general nursing functions or by a podiatrist registered with the Podiatrists Board or by a dental therapist or an oral health therapist registered with the Dental Council; for ophthalmic use except when used in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board; for oral use except in throat lozenges containing 30 milligrams or less per dose form; for external use in medicines containing more than 10%; except in throat sprays in medicines containing 2% or less; except when specified elsewhere in this schedule
1194
Lifitegrast
1195
Ligularia dentata; at all strengths
1196
Linaclotide
1197
Linagliptin
1198
Lincomycin
1199
Lindane; except for external use in medicines containing 2% or less
1200
Linezolid
1201
Liothyronine
1202
Lipegfilgrastim
1203
Liraglutide
1204
Lisdexamfetamine
1205
Lisinopril
1206
Lisuride
1207
Lithium; except when specified elsewhere in this schedule; except when present as an excipient in dermal medicines containing 0.25% or less
1208
Lixisenatide
1209
Lodoxamide; except in medicines for ophthalmic use
1210
Lofexidine
1211
Lomefloxacin
1212
Lomustine
1213
Loperamide; except when specified elsewhere in this schedule
1214
Lopinavir
1215
Loprazolam
1216
Loracarbef
1217
Loratadine; except when specified elsewhere in this schedule
1218
Lorazepam
1219
Lorlatinib
1220
Lormetazepam
1221
Losartan
1222
Loteprednol
1223
Lovastatin; except when present as an unmodified, naturally occurring substance in a food that has not been subject to a manufacturing process other than heating, freezing, drying, preserving, bottling, canning, or packaging in retort pouches
1224
Loxapine
1225
Lumacaftor
1226
Lumefantrine
1227
Lumiracoxib
1228
Lurasidone
1229
Luteinising hormone
1230
Lymecycline
1231
Macitentan
1232
Mafenide
1233
Mannomustine
1234
Maprotiline
1235
Maraviroc
1236
Mazindol
1237
Measles vaccine; except when administered, in combination with mumps and rubella vaccines in a combination product the supply of which the Minister of Health has consented to, by vaccinators, registered pharmacists, or registered intern pharmacists who have successfully completed the Vaccinator Foundation Course (or any equivalent training course approved by the Ministry of Health) and who comply with the immunisation standards of the Ministry of Health (but excluding vaccinators who have completed the Provisional Vaccinator Foundation Course)
1238
Mebanazine
1239
Mebeverine
1240
Mebhydrolin
1241
Mebolazine
1242
Mebutamate
1243
Mecamylamine
1244
Mecasermin
1245
Mecillinam
1246
Meclocycline
1247
Meclofenamate
1248
Meclofenoxate
1249
Meclozine; except when specified elsewhere in this schedule
1250
Medazepam
1251
Medigoxin
1252
Medroxyprogesterone
1253
Medrysone
1254
Mefenamic acid; except when specified elsewhere in this schedule
1255
Mefloquine
1256
Mefruside
1257
Megestrol
1258
Melagatran
1259
Melanocyte stimulating compounds
1260
Melatonin; except when supplied in medicines for oral use containing 3 milligrams or less per immediate release dose unit, or 2 milligrams or less per modified release dose unit, when sold in the manufacturer’s original pack that has received consent from the Minister of Health or the Director General for the treatment of primary insomnia for adults aged 55 years or older for up to 13 weeks by a registered pharmacist
1261
Meldonium
1262
Melengestrol
1263
Melia azedarach; at all strengths
1264
Meloxicam
1265
Melphalan
1266
Memantine
1267
Meningococcal vaccine; except when administered to a person 16 years of age or over by a registered pharmacist who has successfully completed the Vaccinator Foundation Course (or any equivalent training course approved by the Ministry of Health) and who complies with the immunisation standards of the Ministry of Health (but excluding a vaccinator who has completed the Provisional Vaccinator Foundation Course)
1268
Menotrophin
1269
Mepacrine
1270
Mepenzolate
1271
Mephenesin
1272
Mephentermine
1273
Mepindolol
1274
Mepitiostane
1275
Mepivacaine
1276
Mepolizumab
1277
Meprobamate
1278
Meptazinol
1279
Mepyramine; except when specified elsewhere in this schedule
1280
Mequitazine
1281
Mercaptomerin
1282
Mercaptopurine
1283
Mercurochrome; except when specified elsewhere in this schedule
1284
Mercury; except when specified elsewhere in this schedule
1285
Meropenem
1286
Mersalyl
1287
Mesabolone
1288
Mesalazine
1289
Mesna
1290
Mestanolone
1291
Mesterolone
1292
Mestranol
1293
Metamfetamine
1294
Metamizole
1295
Metandienone
1296
Metaraminol
1297
Metenolone
1298
Metergoline
1299
Metformin
1300
Methacholine
1301
Methacycline
1302
Methadone
1303
Methallenoestril
1304
Methandriol
1305
Methanthelinium
1306
Methazolamide
1307
Methdilazine; except for oral use
1308
Methicillin
1309
Methimazole
1310
Methisazone
1311
Methixene
1312
Methocarbamol
1313
Methohexitone
1314
Methoin
1315
Methotrexate
1316
Methoxamine; except when specified elsewhere in this schedule
1317
Methoxsalen
1318
Methoxyflurane
1319
Methsuximide
1320
Methyclothiazide
1321
Methyl aminolevulinate
1322
Methyl androstanolone
1323
Methyl clostebol
1324
Methyl mercury; except in medicines containing 300 micrograms or less per litre or per kilogram
1325
Methyl salicylate; except for external use; except for internal use when present as an excipient in medicines containing 1.04% or less per dose form
1326
Methyl trienolone
1327
Methyldopa
1328
Methylene blue; for injection
1329
Methylergometrine
1330
Methylhexanamine (1,3-dimethylamylamine (DMAA)); except when present as an unmodified, naturally occurring substance
1331
Methylnaltrexone
1332
Methylpentynol
1333
Methylphenidate
1334
Methylphenobarbital
1335
Methylphenylpiracetam
1336
Methylprednisolone
1337
Methyltestosterone
1338
Methylthiouracil
1339
Methyprylon
1340
Methysergide
1341
Metoclopramide; except when specified elsewhere in this schedule
1342
Metolazone
1343
Metoprolol
1344
Metribolone
1345
Metrifonate
1346
Metronidazole
1347
Metyrapone
1348
Mexiletine
1349
Mezlocillin
1350
Mianserin
1351
Mibefradil
1352
Mibolerone
1353
Micafungin
1354
Miconazole; except when specified elsewhere in this schedule
1355
Midazolam
1356
Midodrine
1357
Midostaurin
1358
Mifepristone
1359
Migalastat
1360
Miglitol
1361
Miglustat
1362
Milnacipran
1363
Milrinone
1364
Minocycline
1365
Minoxidil; except for dermal use in medicines containing 5% or less
1366
Mirabegron
1367
Mirtazapine
1368
Misoprostol
1369
Mitobronitol
1370
Mitomycin
1371
Mitoxantrone
1372
Mitragyna speciosa
1373
Mitragynine
1374
Mivacurium
1375
Moclobemide
1376
Modafinil
1377
Molgramostim
1378
Molindone
1379
Molracetam
1380
Mometasone; except when specified elsewhere in this schedule
1381
Monobenzone
1382
Monoclonal antibodies; except in pregnancy test kits
1383
Montelukast
1384
Moperone
1385
Morazone
1386
Moricizine
1387
Morphine; except when specified elsewhere in this schedule
1388
Motrazepam
1389
Motretinide
1390
Moxifloxacin
1391
Mumps vaccine; except when administered, in combination with measles and rubella vaccines in a combination product the supply of which the Minister of Health has consented to, by vaccinators, registered pharmacists, or registered intern pharmacists who have successfully completed the Vaccinator Foundation Course (or any equivalent training course approved by the Ministry of Health) and who comply with the immunisation standards of the Ministry of Health (but excluding vaccinators who have completed the Provisional Vaccinator Foundation Course)
1392
Mupirocin
1393
Muraglitazar
1394
Muromonab
1395
Mustine
1396
Mycophenolic acid
1397
Nabilone
1398
Nabumetone
1399
Nadolol
1400
Nadroparin
1401
Nafarelin
1402
Naftidrofuryl
1403
Nalbuphine
1404
Nalidixic acid
1405
Nalmefene
1406
Nalorphine
1407
Naloxegol
1408
Naloxone; except when provided as part of an approved emergency kit for the treatment of opioid overdose
1409
Naltrexone
1410
Nandrolone
1411
Naproxen; except when specified elsewhere in this schedule
1412
Naratriptan
1413
Natalizumab
1414
Natamycin
1415
Nateglinide
1416
Nebacumab
1417
Nebivolol
1418
Nebracetam (and its stereoisomers)
1419
Nedocromil
1420
Nefazodone
1421
Nefiracetam
1422
Nefopam
1423
Nelfinavir
1424
Neomycin
1425
Neostigmine
1426
Nepafenac
1427
Nepidermin
1428
Neratinib
1429
Nerium oleander
1430
Nesiritide
1431
Netilmicin
1432
Netupitant
1433
Nevirapine
1434
Nialamide
1435
Nicardipine
1436
Nicergoline
1437
Nicofuranose
1438
Nicoracetam
1439
Nicorandil
1440
Nicotine; except when specified elsewhere in this schedule; except in preparations for oromucosal or transdermal absorption; for nasal use except when sold from a smoking cessation clinic run under the auspices of a registered medical practitioner; in medicines other than for smoking cessation
1441
Nicotinic acid except nicotinamide; except when specified elsewhere in this schedule
1442
Nicoumalone
1443
Nifedipine
1444
Nifenazone
1445
Nikethamide
1446
Nilotinib
1447
Nilutamide
1448
Nimesulide
1449
Nimetazepam
1450
Nimodipine
1451
Nimorazole
1452
Nintedanib
1453
Niraparib
1454
Niridazole
1455
Nisoldipine
1456
Nitazoxanide
1457
Nitisinone
1458
Nitrazepam
1459
Nitrendipine
1460
Nitric oxide
1461
Nitrofurantoin
1462
Nitrofurazone
1463
Nitrous oxide; when supplied for inhalation
1464
Nitroxoline
1465
Nivolumab
1466
Nizatidine; except when specified elsewhere in this schedule
1467
Nomegestrol
1468
Nomifensine
1469
Noopept (and its stereoisomers)
1470
Noradrenaline
1471
Norandrostenolone
1472
Norbolethone
1473
Norclostebol
1474
Nordazepam
1475
Norelgestromin
1476
Norethandrolone
1477
Norethisterone; except when supplied for oral contraception to women who meet the clinical and eligibility criteria of the Pharmacy Council and the Pharmaceutical Society of New Zealand Incorporated approved training programme on oral contraception, when sold in the manufacturer’s original pack that has received the consent of the Minister or Director-General to their distribution as medicines, containing not more than 6 months’ supply by a registered pharmacist who has successfully completed the approved training programme
1478
Norfloxacin
1479
Norgestrel
1480
Noribogaine
1481
Normethandrone
1482
Nortriptyline
1483
Noxiptyline
1484
Nusinersen
1485
Nux vomica; except in medicines containing 1 milligram or less per litre or per kilogram of strychnine
1486
Nystatin; except when specified elsewhere in this schedule
1487
Obeticholic acid
1488
Obinutuzumab
1489
Ocrelizumab
1490
Ocriplasmin
1491
Octamylamine
1492
Octatropine
1493
Octreotide
1494
Octyl nitrite
1495
Oestradiol; except in medicines containing 10 micrograms or less per litre or per kilogram
1496
Oestriol
1497
Oestrogens
1498
Oestrone; except in medicines containing 1 milligram or less per litre or per kilogram
1499
Ofatumumab
1500
Ofloxacin
1501
Olanzapine
1502
Olaparib
1503
Olaratumab
1504
Oleandomycin
1505
Oleandrin
1506
Olmesartan
1507
Olodaterol
1508
Olopatadine
1509
Olsalazine
1510
Omalizumab
1511
Omberacetam
1512
Ombitasvir
1513
Omeprazole; except when specified elsewhere in this schedule
1514
Ondansetron
1515
Opipramol
1516
Opium
1517
Orciprenaline
1518
Orlistat; except in medicines for weight control containing 120 milligrams or less per dose form
1519
Ornidazole
1520
Ornipressin
1521
Orphenadrine
1522
Orthopterin
1523
Oseltamivir; except when specified elsewhere in this schedule
1524
Osimertinib
1525
Otilonium bromide
1526
Ouabain
1527
Ovandrotone
1528
Oxabolone
1529
Oxacillin
1530
Oxaliplatin
1531
Oxandrolone
1532
Oxaprozin
1533
Oxazepam
1534
Oxazolam
1535
Oxcarbazepine
1536
Oxedrine; except in medicines containing 30 milligrams or less per recommended daily dose
1537
Oxetacaine; except for internal use
1538
Oxiconazole; except when specified elsewhere in this schedule
1539
Oxiracetam (and its stereoisomers)
1540
Oxitropium
1541
Oxolamine
1542
Oxolinic acid
1543
Oxpentifylline
1544
Oxprenolol
1545
Oxybuprocaine; except when used in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board
1546
Oxybutynin
1547
Oxycodone
1548
Oxymesterone
1549
Oxymetholone
1550
Oxyphenbutazone
1551
Oxyphencyclimine
1552
Oxyphenisatin; at all strengths
1553
Oxyphenonium
1554
Oxytetracycline
1555
Oxytocin; except in medicines containing 1 microgram or less per litre or per kilogram
1556
Ozanimod
1557
Paclitaxel
1558
Palbociclib
1559
Palifermin
1560
Paliperidone
1561
Palivizumab
1562
Palonosetron
1563
Pamaquin
1564
Pamidronic acid
1565
Pancreatic enzymes; except in medicines containing 20 000 BP units or less of lipase activity
1566
Pancuronium
1567
Panitumumab
1568
Panobinostat
1569
Pantoprazole; except when specified elsewhere in this schedule
1570
Papaveretum
1571
Papaverine; for injection
1572
Paracetamol; except when specified elsewhere in this schedule
1573
Paraldehyde
1574
Paramethadione
1575
Paramethasone
1576
Parecoxib
1577
Paricalcitol
1578
Paritabprevir
1579
Paromomycin
1580
Paroxetine
1581
Pasireotide
1582
Patent blue V; for injection when used in diagnostic procedures
1583
Patiromer sorbitex calcium
1584
Pazopanib
1585
Pecazine
1586
Pefloxacin
1587
Pegaptanib
1588
Pegaspargase
1589
Pegfilgrastim
1590
Peginterferon
1591
Peginterferon beta-1a
1592
Pegvisomant
1593
Pembrolizumab
1594
Pemetrexed
1595
Pemoline
1596
Pempidine
1597
Penbutolol
1598
Penciclovir; except when specified elsewhere in this schedule
1599
Penicillamine
1600
Pentaerythrityl tetranitrate
1601
Pentagastrin
1602
Pentamethonium
1603
Pentamidine
1604
Pentazocine
1605
Penthienate
1606
Pentolinium
1607
Pentosan polysulfate sodium
1608
Pentostatin
1609
Pentoxifylline
1610
Peramivir
1611
Perampanel
1612
Pergolide
1613
Perhexiline
1614
Pericyazine
1615
Perindopril
1616
Permethrin; except in medicines containing 5% or less
1617
Perphenazine
1618
Pertussis antigen
1619
Pertussis (whooping cough) vaccine
1620
Pertuzumab
1621
Pethidine
1622
Phenacemide
1623
Phenacetin; except when present as an excipient
1624
Phenaglycodol
1625
Phenazone; except for external use
1626
Phenazopyridine
1627
Phenelzine
1628
Pheneticillin
1629
Phenformin
1630
Phenglutarimide
1631
Phenibut
1632
Phenindione
1633
Pheniramine; except when specified elsewhere in this schedule
1634
Phenisatin
1635
Phenobarbital
1636
Phenol; for injection
1637
Phenolphthalein
1638
Phenoperidine
1639
Phenoxybenzamine
1640
Phenoxymethylpenicillin
1641
Phensuximide
1642
Phentermine
1643
Phenthimentonium
1644
Phentolamine
1645
Phenylbutazone
1646
Phenylephrine; except when specified elsewhere in this schedule
1647
Phenylpiracetam
1648
Phenylpropanolamine
1649
Phenyltoloxamine
1650
Phenytoin
1651
Phleum pratense extract
1652
Pholcodine; except when specified elsewhere in this schedule
1653
Phosphodiesterase type 5 inhibitors; except when present as an unmodified, naturally occurring substance; except when specified elsewhere in this schedule
1654
Phthalylsulfathiazole
1655
Physostigmine
1656
Pibrentasvir
1657
Picibanil
1658
Picric acid
1659
Picrotoxin
1660
Pilocarpine; except in medicines containing 0.025% or less
1661
Pimecrolimus
1662
Pimozide
1663
Pinacidil
1664
Pinazepam
1665
Pindolol
1666
Pioglitazone
1667
Pipecuronium
1668
Pipemidic acid
1669
Pipenzolate
1670
Piperacetam
1671
Piperacillin
1672
Piperidine
1673
Piperidolate
1674
Pipobroman
1675
Pipothiazine
1676
Pipradrol
1677
Piracetam
1678
Pirbuterol
1679
Pirenoxine
1680
Pirenzepine
1681
Piretanide
1682
Pirfenidone
1683
Piroxicam; except for external use
1684
Pirprofen
1685
Pitavastatin
1686
Pituitary hormones
1687
Pivampicillin
1688
Pizotifen
1689
Plerixafor
1690
Plicamycin
1691
Plitidepsin
1692
Pneumococcal vaccine; except in oral vaccines for the prophylaxis of bacterial complications of colds
1693
Podophyllotoxin; for internal use; for external use for the treatment of anogenital warts; for other external use in medicines containing more than 1%; except in medicines containing 1 milligram or less of podophyllin per litre or per kilogram
1694
Podophyllum emodi; for internal use; for external use for the treatment of anogenital warts; for other external use in medicines containing more than 20% of podophyllin; except in medicines containing 1 milligram or less of podophyllin per litre or per kilogram
1695
Podophyllum peltatum; for internal use; for external use for the treatment of anogenital warts; for other external use in medicines containing more than 20% of podophyllin; except in medicines containing 1 milligram or less of podophyllin per litre or per kilogram
1696
Polatuzumab vedotin
1697
Polidexide
1698
Poliomyelitis vaccine
1699
Polyacrylamide; in injections or implants for tissue augmentation or cosmetic use
1700
Polyestradiol
1701
Polylactic acid; in injections or implants for tissue augmentation or cosmetic use
1702
Polymyxin
1703
Polysulfated glycosaminoglycans; for injection except in intraocular viscoelastic products
1704
Polythiazide
1705
Pomalidomide
1706
Ponatinib
1707
Poractant alfa
1708
Posaconazole
1709
Potassium bromide
1710
Potassium perchlorate
1711
Practolol
1712
Pradofloxacin
1713
Pralatrexate
1714
Pralidoxime
1715
Pralmorelin
1716
Pramipexole
1717
Pramiracetam
1718
Pramocaine
1719
Prampine
1720
Prasterone
1721
Prasugrel
1722
Pravastatin
1723
Prazepam
1724
Praziquantel
1725
Prazosin
1726
Prednisolone
1727
Prednisone
1728
Pregabalin
1729
Pregnenolone
1730
Prenalterol
1731
Prenylamine
1732
Prilocaine; for injection except when used as a local anaesthetic in practice by a dental therapist or an oral therapist registered with the Dental Council; except when specified elsewhere in this schedule
1733
Primaquine
1734
Primidone
1735
Probenecid
1736
Probucol
1737
Procainamide
1738
Procaine
1739
Procaine penicillin
1740
Procarbazine
1741
Prochlorperazine; except when specified elsewhere in this schedule; except when sold for the treatment of nausea associated with emergency contraception by pharmacists or nurses accredited to sell levonorgestrel for emergency contraception
1742
Procyclidine; except for dermal use in medicines containing 5% or less
1743
Progesterone; except in medicines containing 1 milligram or less per litre or per kilogram
1744
Progestogens
1745
Proglumide
1746
Proguanil
1747
Prolintane
1748
Promazine
1749
Promethazine; except when specified elsewhere in this schedule
1750
Promoxolane
1751
Propafenone
1752
Propamidine; except for ophthalmic use
1753
Propanidid
1754
Propantheline
1755
Propetandrol
1756
Propionibacterium acnes
1757
Propofol
1758
Propranolol; except in medicines containing 1 milligram or less per litre or per kilogram
1759
Propylthiouracil
1760
Propyphenazone
1761
Proquazone
1762
Proscillaridin
1763
Prostaglandins
1764
Protamine
1765
Prothionamide
1766
Prothipendyl
1767
Protirelin
1768
Protoveratrines
1760
Protriptyline
1770
Proxymetacaine; except when used in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board
1771
Prucalopride
1772
Pseudoephedrine; except when specified elsewhere in this schedule
1773
Pulmonaria spp; at all strengths
1774
Pyrazinamide
1775
Pyridinolcarbamate
1776
Pyridostigmine
1777
Pyridoxal; except in medicines containing 200 milligrams or less per recommended daily dose
1778
Pyridoxamine; except in medicines containing 200 milligrams or less per recommended daily dose
1779
Pyridoxine; except in medicines containing 200 milligrams or less per recommended daily dose
1780
Pyrimethamine
1781
Pyrvinium
1782
Quazepam
1783
Quetiapine
1784
Quinagolide
1785
Quinapril
1786
Quinbolone
1787
Quinethazone
1788
Quinidine
1789
Quinine; except in medicines containing 50 milligrams or less per recommended daily dose
1790
Quinisocaine
1791
Quinupristin
1792
Rabeprazole
1793
Rabies vaccine
1794
Racetams; except when specified elsewhere in this schedule
1795
Raloxifene
1796
Raltegravir
1797
Raltitrexed
1798
Ramipril
1799
Ramucirumab
1800
Ranibizumab
1801
Ranitidine; except when specified elsewhere in this schedule
1802
Ranolazine
1803
Rapacuronium
1804
Rasagiline
1805
Rasburicase
1806
Rauwolfia serpentina
1807
Rauwolfia vomitoria
1808
Razoxane
1809
Reboxetine
1810
Recombinant human epidermal growth factor
1811
Recombinant varicella zoster virus glycoprotein E antigen
1812
Regorafenib
1813
Remdesivir
1814
Remestemcel-L
1815
Remifentanil
1816
Remoxipride
1817
Repaglinide
1818
Reserpine
1819
Reslizumab
1820
Retapamulin
1821
Reteplase
1822
Retigabine
1823
Ribavirin
1824
Ribociclib
1825
Ridaforolimus
1826
Rifabutin
1827
Rifampicin
1828
Rifamycin
1829
Rifapentine
1830
Rifaximin
1831
Rilmazafone
1832
Rilpivirine
1833
Riluzole
1834
Rimexolone
1835
Rimiterol
1836
Rimonabant
1837
Riociguat
1838
Ripretinib
1839
Risankizumab
1840
Risedronic acid
1841
Risperidone
1842
Ritodrine
1843
Ritonavir
1844
Rituximab
1845
Rivaroxaban
1846
Rivastigmine
1847
Rizatriptan; except when specified elsewhere in this schedule
1848
Rocuronium
1849
Rofecoxib
1850
Roflumilast
1851
Rolipram (and its stereoisomers)
1852
Rolitetracycline
1853
Rolziracetam
1854
Romidepsin
1855
Romiplostim
1856
Romosozumab
1857
Ropinirole
1858
Ropivacaine
1859
Rosiglitazone
1860
Rosoxacin
1861
Rosuvastatin
1862
Rotavirus vaccine
1863
Rotigotine
1864
Roxibolone
1865
Roxithromycin
1866
Rubella vaccine; except when administered, in combination with measles and mumps vaccines in a combination product the supply of which the Minister of Health has consented to, by vaccinators, registered pharmacists, or registered intern pharmacists who have successfully completed the Vaccinator Foundation Course (or any equivalent training course approved by the Ministry of Health) and who complies with the immunisation standards of the Ministry of Health (but excluding vaccinators who have completed the Provisional Vaccinator Foundation Course)
1867
Ruboxistaurin
1868
Rufinamide
1869
Rupatadine
1870
Ruxolitnib
1871
Sabadilla; except in preparations containing 10 milligrams or less of total alkaloids of schoenocaulon officinale per litre or per kilogram
1872
Sacubitril
1873
Safinamide
1874
Safrole; for internal use except in medicines containing 0.1% or less
1875
Salbutamol
1876
Salcatonin
1877
Salmeterol
1878
Sapropterin
1879
Saquinavir
1880
Sargramostim
1881
Sarilumab
1882
Saxagliptin
1883
Schoenocaulon officinale; except in preparations containing 10 milligrams or less of total alkaloids of schoenocaulon officinale per litre or per kilogram
1884
Scopolia carniolica
1885
Sebelipase alfa
1886
Secbutabarbital
1887
Secobarbital
1888
Secukinumab
1889
Selective androgen receptor modulators
1890
Seletracetam (and its stereoisomers)
1891
Selegiline
1892
Selenium; except when specified elsewhere in this schedule; except for oral use in medicines containing 150 micrograms or less per recommended daily dose
1893
Selexipag
1894
Semaglutide
1895
Serelaxin
1896
Sermorelin
1897
Sertindole
1898
Sertraline
1899
Serum, dried human
1900
Sevelamer
1901
Sevoflurane
1902
Sex hormones and all substances having sex hormone activity
1903
Sialoepoetin
1904
Sibutramine
1905
Silandrone
1906
Sildenafil and its structural analogues; except sildenafil in medicines for oral use containing 100 milligrams or less per dose unit when sold in the manufacturer’s original pack containing not more than 12 solid dosage units for the treatment of erectile dysfunction in males aged 35–70 years by a registered pharmacist who has successfully completed a training programme endorsed by the Pharmaceutical Society of New Zealand Incorporated
1907
Silicones; for injection
1908
Silodosin
1909
Siltuximab
1910
Silver sulfadiazine; except for external use in packs containing 50 grams or less
1911
Simeprevir
1912
Simvastatin
1913
Siponimod
1914
Sirolimus
1915
Sisomicin
1916
Sitagliptin
1917
Sitaxentan
1918
Sodium bromide
1919
Sodium cellulose phosphate; for internal use
1920
Sodium cromoglycate; except for nasal and ophthalmic use
1921
Sodium morrhuate; for injection
1922
Sodium nitroprusside
1923
Sodium phenylbutyrate
1924
Sodium phosphate; in oral laxative preparations
1925
Sodium polystyrene sulphonate
1926
Sodium tetradecyl sulphate; for injection
1927
Sodium zirconium cyclosilicate
1928
Sofosbuvir
1929
Solasadine
1930
Solifenacin
1931
Somatostatin
1932
Somatropin
1933
Sonidegib
1934
Sontoquine
1935
Sorafenib
1936
Sotalol
1937
Sparfloxacin
1938
Sparteine
1939
Spectinomycin
1940
Spiramycin
1941
Spirapril
1942
Spironolactone
1943
Squill
1944
Stanolone
1945
Stanozolol
1946
Staphylococcus aureus vaccine; except in oral vaccines for the prophylaxis of bacterial complications of colds
1947
Stavudine
1948
Stenabolic (SR9009) and other synthetic REV-ERB agonists
1949
Stenbolone
1950
Steroid hormones
1951
Stilboestrol
1952
Stiripentol
1953
Stramonium; except for oral use when specified elsewhere in this schedule; except datura stramonium or datura tatula for smoking or burning
1954
Streptococcus beta-haemolyticus vaccine; except in oral vaccines for the prophylaxis of bacterial complications of colds
1955
Streptodornase
1956
Streptokinase
1957
Streptomycin
1958
Streptozocin
1959
Strontium ranelate
1960
Strophanthins
1961
Strophanthus spp
1962
Strychnos spp; except in medicines containing 1 milligram or less per litre or per kilogram of strychnine
1963
Styramate
1964
Succimer
1965
Sufentanil
1966
Sugammadex
1967
Sulbactam
1968
Sulconazole; except for dermal use
1969
Sulfacetamide; except for ophthalmic use in medicines containing 10% or less
1970
Sulfadiazine; except silver sulfadiazine for external use in pack sizes of 50 grams or less
1971
Sulfadimethoxine
1972
Sulfadimidine
1973
Sulfadoxine
1974
Sulfafurazole
1975
Sulfaguanidine
1976
Sulfamerazine
1977
Sulfamethizole
1978
Sulfamethoxazole
1979
Sulfamethoxydiazine
1980
Sulfamethoxypyridazine
1981
Sulfametrole
1982
Sulfamonomethoxine
1983
Sulfamoxole
1984
Sulfaphenazole
1985
Sulfapyridine
1986
Sulfasalazine
1987
Sulfathiazole
1988
Sulfatroxazole
1989
Sulfinpyrazone
1990
Sulfomyxin
1991
Sulfonmethane
1992
Sulindac
1993
Sultamicillin
1994
Sulthiame
1995
Sumatriptan; except when specified elsewhere in this schedule
1996
Sunifiram
1997
Sunitinib
1998
Suprofen
1999
Suvorexant
2000
Sutilains
2001
Suxamethonium
2002
Suxethonium
2003
T cell receptor antibody
2004
Tacrine
2005
Tacrolimus
2006
Tadalafil and its structural analogues
2007
Tafamidis
2008
Tafenoquine succinate
2009
Tafluprost
2010
Talazoparib
2011
Taliglucerase alfa
2012
Talimogene laherparepvec
2013
Tamoxifen
2014
Tamsulosin
2015
Tanacetum vulgare; except in medicines containing 0.8% or less of oil of tansy
2016
Tapentadol
2017
Tasonermin
2018
Tazarotene
2019
Tazobactam
2020
Teduglutide
2021
Tegafur
2022
Tegaserod
2023
Teicoplanin
2024
Telaprevir
2025
Telbivudine
2026
Telithromycin
2027
Telmisartan
2028
Telotristat ethyl
2029
Temazepam
2030
Temozolomide
2031
Temsirolimus
2032
Tenecteplase
2033
Teniposide
2034
Tenofovir
2035
Tenoxicam
2036
Terazosin
2037
Terbinafine; except when specified elsewhere in this schedule
2038
Terbutaline
2039
Terfenadine
2040
Teriflunomide
2041
Teriparatide
2042
Terlipressin
2043
Terodiline
2044
Teropterin
2045
Tesamorelin
2046
Testolactone
2047
Testosterone; except in medicines containing 1 milligram or less per litre or per kilogram
2048
Tetanus antitoxin
2049
Tetanus toxoid
2050
Tetanus vaccine
2051
Tetrabenazine
2052
Tetracosactrin
2053
Tetracycline
2054
Tetraethylammonium
2055
Tetrahydrocannabinol
2056
Tetrazepam
2057
Tetroxoprim
2058
Thalidomide
2059
Thenyldiamine
2060
Theophylline; except when specified elsewhere in this schedule
2061
Thevetia peruviana
2062
Thevetin
2063
Thiambutosine
2064
Thiazosulfone
2065
Thiethylperazine
2066
Thioacetazone
2067
Thiocarlide
2068
Thioguanine
2069
Thiomesterone
2070
Thiopentone
2071
Thiopropazate
2072
Thioproperazine
2073
Thioridazine
2074
Thiotepa
2075
Thiothixene
2076
Thiouracil
2077
Thiourea; except in medicines containing 0.1% or less
2078
Thymosin beta-4
2079
Thymoxamine
2080
Thyroid
2081
Thyrotrophin
2082
Thyrotrophin-releasing factor
2083
Thyroxine; except in medicines containing 10 micrograms or less per litre or per kilogram
2084
Tiagabine
2085
Tianeptine
2086
Tiaprofenic acid
2087
Tiaramide
2088
Tibolone
2089
Ticagrelor
2090
Ticarcillin
2091
Ticlopidine
2092
Tiemonium
2093
Tienilic acid
2094
Tigecycline
2095
Tigloidine
2096
Tiletamine
2097
Tilidine
2098
Tilmanocept
2099
Tiludronic acid
2100
Timbetasin
2101
Timolol
2102
Tinidazole
2103
Tinzaparin
2104
Tioconazole; except when specified elsewhere in this schedule
2105
Tiotropium
2106
Tipepidine
2107
Tipiracil
2108
Tiprinavir
2109
Tirilazad
2110
Tirofiban
2111
Tivozanib
2112
Tizanidine
2113
Tobramycin
2114
Tocainide
2115
Tocilizumab
2116
Tofacitinib
2117
Tolazamide
2118
Tolazoline
2119
Tolbutamide
2120
Tolcapone
2121
Tolfenamic acid
2122
Tolmetin
2123
Tolonium
2124
Tolpropamine
2125
Tolrestat
2126
Tolterodine
2127
Tolvaptan
2128
Topiramate
2129
Topotecan
2130
Torasemide
2131
Toremifene
2132
Toxoids; for injection
2133
Tramadol
2134
Trametinib dimethyl sulfoxide
2135
Trandolapril
2136
Tranexamic acid
2137
Tranylcypromine
2138
Trastuzumab
2139
Trastuzumab emtansine
2140
Travoprost
2141
Trazodone
2142
Trenbolone
2143
Treosulphan
2144
Treprostinil
2145
Trestolone
2146
Tretamine
2147
Tretinoin
2148
Triacetyloleandomycin
2149
Triamcinolone; except when specified elsewhere in this schedule
2150
Triamterene
2151
Triaziquone
2152
Triazolam
2153
Trichlormethiazide
2154
Trichloroacetic acid; except for external use in medicines containing 12.5% or less for the treatment of warts other than anogenital warts
2155
Trichloroethylene
2156
Trichodesma africana; at all strengths
2157
Triclofos
2158
Tricyclamol
2159
Tridihexethyl
2160
Trientine
2161
Trifluoperazine
2162
Trifluperidol
2163
Triflupromazine
2164
Trifluridine
2165
Trimeprazine; except when specified elsewhere in this schedule
2166
Trimetaphan
2167
Trimethoprim; except in medicines for oral use containing 300 milligrams or less per dose unit when sold in a pack of 3 solid dosage units to a woman aged 16–65 years for the treatment of an uncomplicated urinary tract infection by a registered pharmacist who has successfully completed the New Zealand College of Pharmacists’ training in the treatment of urinary tract infections
2168
Trimipramine
2169
Trimustine
2170
Trinitrophenol
2171
Trioxysalen
2172
Triparanol; at all strengths
2173
Triple antigen vaccine
2174
Triprolidine; except when specified elsewhere in this schedule
2175
Triptorelin
2176
Troglitazone
2177
Trometamol; for injection in medicines containing more than 3%
2178
Tropicamide; except when used in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board
2179
Tropisetron
2180
Trovafloxacin
2181
Troxidone
2182
Tryptophan; except in medicines containing 100 milligrams or less per recommended daily dose; except in parenteral nutrition replacement preparations
2183
Tuberculin
2184
Tuberculosis vaccine
2185
Tubocurarine
2186
Tucatinib
2187
Tulobuterol
2188
Typhoid vaccine
2189
Ulipristal
2190
Umeclidinium bromide
2191
Unifiram
2192
Unoprostone
2193
Upadacitinib
2194
Uracil
2195
Urapidil
2196
Urethane
2197
Urofollitropin
2198
Urokinase
2199
Ursodeoxycholic acid
2200
Ustekinumab
2201
Vaccines; except when specified elsewhere in this schedule
2202
Vaccinia virus vaccine
2203
Valaciclovir
2204
Valdecoxib
2205
Valganciclovir
2206
Valnoctamide
2207
Valproic acid
2208
Valsartan
2209
Vancomycin
2210
Vandetanib
2211
Vardenafil and its structural analogues
2212
Varenicline
2213
Varicella vaccine; except when administered for the prevention of herpes zoster (shingles) to a person 50 years of age or over by a registered pharmacist who has successfully completed the Vaccinator Foundation Course (or any equivalent training course approved by the Ministry of Health) and who complies with the immunisation standards of the Ministry of Health (but excluding a vaccinator who has completed the Provisional Vaccinator Foundation Course)
2214
Vasopressin
2215
Vecuronium
2216
Vedolizumab
2217
Velaglucerase alfa
2218
Velpatasvir
2219
Vemurafenib
2220
Venetoclax
2221
Venlafaxine
2222
Verapamil
2223
Veratrum spp
2224
Vernakalant
2225
Verteporfin
2226
Veruprevir
2227
Vidarabine
2228
Vigabatrin
2229
Vilanterol
2230
Vildagliptin
2231
Viloxazine
2232
Vinblastine
2233
Vincamine
2234
Vincristine
2235
Vindesine
2236
Vinflunine
2237
Vinorelbine
2238
Vinyl ether
2239
Virginiamycin
2240
Vismodegib
2241
Visnadine
2242
Vitamin A; except for internal use in medicines containing 3 milligrams or less of retinol equivalents per recommended daily dose; except in parenteral nutrition replacement preparations; except for external use in medicines containing 1% or less
2243
Vitamin D; except for external use; except for internal use in medicines containing 25 micrograms or less per recommended daily dose; except in parenteral nutrition replacement preparations
2244
Voglibose
2245
Vorapaxar
2246
Voretigene neparvovec
2247
Voriconazole
2248
Vorinostat
2249
Vortioxetine
2250
Voxilaprevir
2251
Warfarin
2252
Xamoterol
2253
Xanthinol nicotinate
2254
Ximelagatran
2255
Xipamide
2256
Yellow fever vaccine
2257
Yohimbine
2258
Zafirlukast
2259
Zalcitabine
2260
Zaleplon
2261
Zanamivir
2262
Zidovudine
2263
Zimeldine
2264
Zinc; except for internal use in medicines containing 25 milligrams or less per recommended daily dose; except for internal use in medicines containing 50 milligrams or less and more than 25 milligrams per recommended daily dose in packs that have received the consent of the Minister or the Director-General to their distribution as general sale medicines, when sold in the manufacturer’s original pack and when labelled with a statement that the product may be dangerous if taken in large amounts or for long periods; except for external use when in medicines containing 5% or less; except in parenteral nutrition replacement preparations
2265
Ziprasidone
2266
Zoledronic acid
2267
Zolmitriptan; except when specified elsewhere in this schedule
2268
Zolpidem
2269
Zonisamide
2270
Zopiclone
2271
Zoster immunoglobulin, human
2272
Zoxazolamine
2273
Zuclopenthixol
Schedule 1 Part 1 item 1090: amended, on 19 May 2022, by regulation 7 of the Medicines Amendment Regulations 2022 (SL 2022/116).
Schedule 1 Part 1 item 1772: amended, on 21 March 2024, by regulation 4(1) of the Medicines (Pseudoephedrine) Amendment Regulations 2024 (SL 2024/4).
Part 2 Restricted medicines
1
Adrenaline; in medicines containing 1% or less except in medicines for injection containing 0.02% or less
2
Alclometasone; for dermal use in medicines containing 0.05% or less and in packs containing not more than 30 grams that have received the consent of the Minister or the Director-General to their distribution as restricted medicines, when sold in the manufacturer’s original pack
3
Aminophylline; for oral use in liquid form in medicines containing 2% or less
4
Amorolfine; for external use in medicines containing more than 0.25%
5
Aspirin; in slow-release forms; in enteric coated forms containing more than 300 milligrams per dose form
6
Azatadine; for oral use in adults and children over 2 years of age
7
Azelastine; in medicines for ophthalmic use containing 0.05% or less
8
Brompheniramine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for the treatment of insomnia; for oral use for the treatment of insomnia when sold in the manufacturer’s original pack containing not more than 10 dosage units
9
Buclizine; for oral use
10
Butoconazole; for vaginal use
11
Chloramphenicol; for ophthalmic use; except when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board
12
Chlorbutol; except when specified elsewhere in this schedule
13
Chlorpheniramine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for the treatment of insomnia; for oral use for the treatment of insomnia when sold in the manufacturer’s original pack containing not more than 10 dosage units
14
Ciclopirox; for external use in medicines containing more than 2%; in preparations for application to the nails containing more than 8%
15
Cimetidine; in medicines for the symptomatic relief of heartburn, dyspepsia, and hyperacidity or to be used on the recommendation of a registered medical practitioner, when sold in the manufacturer’s original pack containing not more than 14 days’ supply
16
Clemastine; for oral use
17
Clobetasone; for dermal use in medicines containing 0.05% or less and in packs containing not more than 30 grams that have received the consent of the Minister or the Director-General to their distribution as restricted medicines, when sold in the manufacturer’s original pack
18
Clotrimazole; for vaginal use
19
Cyclizine; for oral use other than in medicines used for the treatment of insomnia when sold in the manufacturer’s original pack containing not more than 6 dosage units; for oral use in medicines used for the treatment of insomnia when sold in the manufacturer’s original pack containing not more than 10 dosage units
20
Cyproheptadine; for oral use
21
Dexchlorpheniramine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for the treatment of insomnia; for oral use for the treatment of insomnia when sold in the manufacturer’s original pack containing not more than 10 dosage units
22
Dextromethorphan; in liquid form when in packs containing not more than 600 milligrams and with a recommended daily dose of not more than 120 milligrams; in medicines for the treatment of symptoms of cough and cold in adults and children aged six years and over
23
Di-iodohydroxy quinoline; for vaginal use
24
Diclofenac; in solid dose form in medicines containing 25 milligrams or less and more than 12.5 milligrams per dose form in packs containing not more than 30 tablets or capsules
25
Dimenhydrinate; for oral use in medicines for adults and children over 2 years of age; except when specified elsewhere in this schedule
26
Dimethindene; for oral use
27
Diphenhydramine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for the treatment of insomnia; for oral use for the treatment of insomnia when sold in the manufacturer’s original pack containing not more than 10 dosage units
28
Dithranol
29
Doxylamine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for the treatment of insomnia; for oral use for the treatment of insomnia when sold in the manufacturer’s original pack containing not more than 10 dosage units
30
Econazole; for vaginal use
31
Erythrityl tetranitrate
32
Famciclovir; in divided solid dosage forms for oral use containing 500 milligrams or less for the treatment of recurrent herpes labialis when sold in the manufacturer’s original pack containing up to 3 dosage units
33
Flavoxate
34
Fluconazole; for oral use in medicines that have received the consent of the Minister or the Director-General to their distribution as restricted medicines, when sold in the manufacturer’s original pack containing 150 milligrams or less as a single dose for the treatment of vaginal candidiasis
35
Fluorides; for external use in liquid form in medicines containing 5.5 grams or less and more than 1 gram per litre or per kilogram and when sold in packs approved by the Minister or the Director-General for distribution as restricted medicines; for external use in non-liquid form in medicines containing 5.5 grams or less and more than 1 gram per litre or per kilogram, except in medicines containing 1.5 grams or less and more than 1 gram per litre or per kilogram; except when supplied to a dental professional registered with the Dental Council
36
Glucagon; except in medicines containing 100 micrograms or less per litre or per kilogram
37
Glyceryl trinitrate; for oral or sublingual use; for rectal use
38
Guaifenesin; for oral use in modified release form with a maximum recommended daily dose of not more than 2.4 grams when sold in the manufacturer’s original pack containing more than 10 days’ supply but not more than 30 days’ supply; except for oral use in modified release form with a maximum recommended daily dose of not more than 2.4 grams when sold in the manufacturer’s original pack containing not more than 10 days’ supply; except for oral use in medicines containing 2% or less or 200 milligrams or less per dose form
39
Haemophilus influenzae vaccine; in oral vaccines for the prophylaxis of bacterial complications of colds
40
Hydrocortisone and hydrocortisone acetate but no other esters of hydrocortisone; for dermal use in medicines containing 1% or less but more than 0.5% by weight of hydrocortisone base with no other active ingredient except an antifungal and in a quantity of 30 grams or less or 30 millilitres or less per container; for dermal use in medicines containing 1% or less but more than 0.5% by weight of hydrocortisone base with no other active ingredient except 5% or less by weight of aciclovir and in a quantity of 2 grams or less or 2 millilitres or less per container in adults and children 12 years of age and older; in rectal medicines containing 1% or less but more than 0.5% by weight of hydrocortisone base and in combination with a local anaesthetic and in a quantity of 35 grams or less per container or up to 12 suppositories per pack
41
Hyoscine butylbromide; for oral use in medicines containing not more than 20 milligrams per dose form and in packs containing not more than 10 tablets or capsules for the relief of muscle spasm of the gastrointestinal tract
42
Ibuprofen; for oral use in tablets or capsules containing up to 400 milligrams per dose form and in packs containing not more than 50 dose units and that have received the consent of the Minister or the Director-General to their distribution as restricted medicines, when sold in the manufacturer’s original pack labelled for use by adults or children over 12 years of age
43
Inositol nicotinate
44
Isoconazole; for vaginal use
45
Ketoprofen; in solid dose form containing 25 milligrams or less per dose form in packs of not more than 30 capsules or tablets
46
Lansoprazole; in divided solid dosage forms for oral use containing 15 milligrams or less with a maximum daily dose of 15 milligrams for the short-term symptomatic relief of gastric reflux-like symptoms in sufferers aged 18 years and over for the relief of heartburn when sold in the manufacturer’s original pack containing not more than 14 dosage units
47
Levonorgestrel; in medicines for use as emergency post-coital contraception when in packs containing not more than 1.5 milligrams
48
Macrogols; in oral preparations for bowel cleansing prior to diagnostic, medical, or surgical procedures
49
Malathion; except for external use in medicines containing 2% or less
50
Mannityl hexanitrate
51
Meclozine; in a pack size of up to 10 dosage units for the treatment of insomnia
52
Mepyramine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for the treatment of insomnia; for oral use for the treatment of insomnia when sold in the manufacturer’s original pack containing not more than 10 dosage units
53
Methdilazine; for oral use
54
Metoclopramide; when compounded with paracetamol in packs of not more than 10 tablets or capsules for the treatment of nausea associated with migraine
55
Miconazole; for the treatment of oral candidiasis; for vaginal use
56
Nicotinic acid except nicotinamide; in medicines containing 250 milligrams or less but more than 100 milligrams per dose form; except in medicines containing 100 milligrams or less per dose form
57
Nicotinyl alcohol; except in medicines containing 100 milligrams or less per dose form
58
Nystatin; for the treatment of oral candidiasis; for vaginal use
59
Orlistat; in medicines for weight control containing 120 milligrams or less per dose form
60
Oseltamivir; in solid dosage forms for oral use containing 75 milligrams in a pack size of up to 10 dosage units for the treatment or prophylaxis of influenza in adults and children aged 13 years and older who have been exposed to the influenza virus
61
Oxiconazole; for vaginal use
62
Paracetamol; in modified-release forms containing 665 milligrams or less
63
Pheniramine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for the treatment of insomnia; for oral use for the treatment of insomnia when sold in the manufacturer’s original pack containing not more than 10 dosage units
64
Pneumococcal vaccine; in oral vaccines for the prophylaxis of bacterial complications of colds
65
Podophyllotoxin; for external use for the treatment of warts other than anogenital warts in medicines containing 1% or less and more than 0.5%; except in medicines containing 1 milligram or less of podophyllin per litre or per kilogram
66
Podophyllum emodi; for external use for the treatment of warts other than anogenital warts in medicines containing 20% or less and more than 10% of podophyllin; except in medicines containing 1 milligram or less of podophyllin per litre or per kilogram
67
Podophyllum peltatum; for external use for the treatment of warts other than anogenital warts in medicines containing 20% or less and more than 10% of podophyllin; except in medicines containing 1 milligram or less of podophyllin per litre or per kilogram
68
Prochlorperazine; in packs containing not more than 10 tablets or capsules for the treatment of nausea associated with migraine
69
Promethazine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for the treatment of insomnia; for oral use for the treatment of insomnia when sold in the manufacturer’s original pack containing not more than 10 dosage units
69A
Pseudoephedrine; in solid-dose cough or decongestant medicines containing not more than 60 milligrams per recommended dose and not more than 240 milligrams per recommended daily dose, in a pack size of 720 milligrams or less; in liquid-dose cough or decongestant medicines containing not more than 60 milligrams per recommended dose and not more than 240 milligrams per recommended daily dose, in a pack size of 800 milligrams or less
70
Rizatriptan; for oral use in medicines for the acute relief of migraine attacks with or without aura in patients who have a stable, well-established pattern of symptoms, when in wafers containing 5 milligrams or less per wafer and when sold in a pack containing not more than 2 wafers approved by the Minister or the Director-General for distribution as a restricted medicine
71
Salicylic acid; except in medicines for dermal use containing 40% or less
72
Santonin
73
Sodium phosphate; in oral preparations for bowel cleansing prior to diagnostic, medical, or surgical procedures
74
Sodium picosulphate; in oral preparations for bowel cleansing prior to diagnostic, medical, or surgical procedures
75
Staphyloccocus aureus vaccine; in oral vaccines for the prophylaxis of bacterial complications of colds
76
Stramonium; for oral use in liquid form; in solid dose form in medicines containing more than 0.3 milligrams per dose or more than 1.2 milligrams per recommended daily dose
77
Streptococcus beta-haemolyticus vaccine; in oral vaccines for the prophylaxis of bacterial complications of colds
78
Sulfacetamide; for ophthalmic use in medicines containing 10% or less
79
Sumatriptan; for oral use in medicines for the acute relief of migraine attacks with or without aura in patients who have a stable, well-established pattern of symptoms when in tablets containing 50 milligrams or less per tablet and when sold in a pack containing not more than 2 tablets that has received the consent of the Minister or the Director-General to its sale as a restricted medicine
80
Theophylline; in liquid form for oral use in medicines containing 2% or less
81
Tioconazole; for vaginal use
82
Triamcinolone; for buccal use in medicines containing 0.1% or less of triamcinolone acetonide and in pack sizes of 5 grams or less
83
Trimeprazine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for the treatment of insomnia; for oral use for the treatment of insomnia when sold in the manufacturer’s original pack containing not more than 10 dosage units
84
Triprolidine; for oral use in medicines for adults and children over 2 years of age; except when specified elsewhere in this schedule
85
Zolmitriptan; in a pre-filled nasal spray device containing not more than 5 milligrams of zolmitriptan, for the acute relief of migraine attacks with or without aura in patients who have a stable, well-established pattern of symptoms and when sold in a pack of not more than 2 devices approved by the Minister or the Director-General for distribution as a restricted medicine
Schedule 1 Part 2 item 69A: inserted, on 21 March 2024, by regulation 4(2) of the Medicines (Pseudoephedrine) Amendment Regulations 2024 (SL 2024/4).
Part 3 Pharmacy-only medicines
1
8-hydroxyquinoline and its non-halogenated derivatives; in medicines containing more than 1% of such substances; except for hydroxyquinoline sulphate for external use
2
Acetic acid and preparations containing more than 80% of acetic acid (CH3COOH); excluding its salts and derivatives
3
Acetylcysteine; for oral use in medicines containing more than 1 gram per recommended daily dose
4
Aciclovir; for external use for the treatment of herpes labialis except in medicines containing 5% or less and in tubes containing 10 grams or less
5
Aconitum spp; for oral use in packs containing 0.2 milligrams or less and more than 0.02 milligrams of total alkaloids; for dermal use in concentrations of 0.02% or less and in packs containing 0.2 milligrams or less and more than 0.02 milligrams of total alkaloids
6
Aloes; for internal use; except when obtained solely from the mucilaginous gel of the leaf
7
Aloin
8
Aloxiprin
9
Amethocaine; for external use in medicines containing 10% or less and more than 2%; except in medicines for external use containing 2% or less
10
Amorolfine; in preparations for topical use; except in preparations for the treatment of tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
11
Antazoline; for ophthalmic use except when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board
12
Atropa belladonna; for external use in medicines containing 0.03% or less of the alkaloids of belladonna; for oral use in liquid form in medicines containing 0.03% or less and 0.3 milligrams or less per dose and not more than 1.2 milligrams per recommended daily dose of the alkaloids of belladonna or in solid dose form in medicines containing 0.3 milligrams or less per dose form and not more than 1.2 milligrams per recommended daily dose of the alkaloids of belladonna
13
Atropine; for oral use in liquid form in medicines containing 0.03% or less and 0.3 milligrams or less per dose and not more than 1.2 milligrams per recommended daily dose or in solid dose form in medicines containing 0.3 milligrams or less per dose form and not more than 1.2 milligrams per recommended daily dose; in medicines containing atropine sulphate for the treatment of organophosphorus poisoning either in packs of not more than 20 dose units containing 0.6 milligrams or less per dose unit or in injections in packs of not more than 5 vials containing 0.6 milligrams per millilitre; except when sold as an antidote in a device designed for self-injection from outlets licensed to sell organophosphorus poisons; except in medicines containing 300 micrograms or less per litre or per kilogram
14
Azelaic acid; for dermal use
15
Azelastine; in preparations for nasal use containing 0.15% azelastine hydrochloride or less; in topical eye preparations containing 0.05% or less
16
Beclomethasone; for the treatment or prophylaxis of allergic rhinitis in adults and children over 12 years of age in aqueous nasal sprays delivering up to 50 micrograms per actuation when the maximum recommended daily dose is no greater than 400 micrograms (200 micrograms per nostril) in a pack containing 200 actuations or less
17
Benzocaine; in preparations for topical use, other than eye drops, containing 10% or less of total anaesthetic substances except in dermal preparations containing 2% or less of total anaesthetic substances; in divided preparations containing 200 milligrams or less of total anaesthetic substances per dosage unit except in lozenges containing 30 milligrams or less of total anaesthetic substances per dosage unit
18
Benzoyl peroxide; for external use in medicines containing more than 5% and not more than 10%; except for medicines for external use containing 5% or less
19
Benzydamine; for external use except for oromucosal or topical use
20
Bephenium
21
Bifonazole; except when specified elsewhere in this schedule; except for dermal use in medicines for tinea pedis only or in shampoos containing 1% or less or when sold in practice by a podiatrist registered with the Podiatrists Board
22
Bilastine; in divided solid dosage forms for oral use containing 20 milligrams or less for the treatment of the symptoms of allergic rhinoconjunctivitis (seasonal and perennial)
23
Bisacodyl
24
Bromhexine
25
Brompheniramine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with 1 or more other therapeutically active ingredients either when in the bedtime dose of a day/night pack containing brompheniramine or when at least 1 of the other active ingredients is a sympathomimetic decongestant
26
Budesonide; for the treatment or prophylaxis of allergic rhinitis in adults and children over 12 years of age in aqueous nasal sprays delivering up to 64 micrograms per actuation and when the maximum recommended daily dose is no greater than 400 micrograms (200 micrograms per nostril)
27
Carbetapentane; except in medicines containing 0.5% or less
28
Carbocisteine
29
Cetirizine; for oral use except in divided solid dosage forms for oral use containing 10 milligrams or less of cetirizine hydrochloride per dose form for the treatment of seasonal allergic rhinitis when sold in the manufacturer’s original pack containing not more than 5 days’ supply
30
Chlophedianol
31
Chlorbutol; in medicines containing 5% or less and more than 0.5%; except in medicines containing 0.5% or less
32
Chloroform; in medicines other than for anaesthesia containing more than 0.5%; except in medicines containing 0.5% or less
33
Chlorpheniramine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with 1 or more other therapeutically active ingredients either when in the bedtime dose of a day/night pack containing chlorpheniramine or when at least 1 of the other active ingredients is a sympathomimetic decongestant
34
Ciclopirox; for external use in medicines containing 2% or less except when for the treatment of tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board; in preparations for application to the nails containing 8% or less
35
Cinchocaine; for external use in medicines containing 0.5% or less
36
Cinnamedrine
37
Clotrimazole; for external use except in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
38
Cocaine; in medicines for oral use, containing not more than 0.1% of cocaine, when combined with 1 or more active ingredients in such a way that the substance cannot be recovered by readily applicable means or in a yield that would constitute a risk to health, and when sold in a pack approved by the Minister or the Director-General for distribution as a pharmacy-only medicine
39
Colocynth
40
Creosote; except in medicines containing 10% or less
41
Cresols; except in medicines containing 3% or less
42
Datura spp; for oral use in liquid form in medicines containing 0.03% or less and 0.3 milligrams or less per dose and not more than 1.2 milligrams per recommended daily dose of total solanaceous alkaloids; in solid dose form in medicines containing 0.3 milligrams or less per dose form and not more than 1.2 milligrams per recommended daily dose of total solanaceous alkaloids
43
Delphinium staphisagria; except in medicines containing 0.2% or less
44
Desloratadine; for oral use
45
Dexchlorpheniramine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with 1 or more other therapeutically active ingredients either when in the bedtime dose of a day/night pack containing dexchlorpheniramine or when at least 1 of the other active ingredients is a sympathomimetic decongestant
46
Dextromethorphan; in liquid form containing more than 0.25% or in solid dose form containing more than 15 milligrams per dose form when in packs containing not more than 600 milligrams and with a recommended daily dose of not more than 120 milligrams; in medicines for the treatment of the symptoms of cough and cold in children aged 6–12 years; except in liquid form containing 0.25% or less in solid dose form containing 15 milligrams or less per dose form when in packs containing not more than 600 milligrams and with a recommended daily dose of not more than 120 milligrams
47
Dibrompropamidine; for ophthalmic use except when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board
48
Diclofenac; in solid dose form in medicines containing 12.5 milligrams or less per dose form in packs containing not more than 30 tablets or capsules and with a recommended daily dose of not more than 75 milligrams
49
Diphenoxylate; in liquid form containing in each millilitre not more than 0.5 milligrams of diphenoxylate calculated as base and not less than 5 micrograms of atropine sulphate; in solid dose form containing not more than 2.5 milligrams of diphenoxylate calculated as base and not less than 5 micrograms of atropine sulphate
50
Dimenhydrinate; for oral use in a sealed container of not more than 10 tablets or capsules for the prevention or treatment of motion sickness in adults or children over 2 years of age except when sold at a transport terminal or aboard a ship or an aircraft
51
Diphenhydramine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with 1 or more other therapeutically active ingredients either when in the bedtime dose of a day/night pack containing diphenhydramine or when at least 1 of the other active ingredients is a sympathomimetic decongestant; for oral use in a sealed container of not more than 10 tablets or capsules for the prevention or treatment of motion sickness in adults and children over 2 years of age except when sold at a transport terminal or aboard a ship or an aircraft
52
Doxylamine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with 1 or more other therapeutically active ingredients either when in the bedtime dose of a day/night pack containing doxylamine or when at least 1 of the other active ingredients is a sympathomimetic decongestant
53
Duboisia leichhardtii; for oral use in liquid form in medicines containing 0.03% or less and 0.3 milligrams or less per dose and not more than 1.2 milligrams per recommended daily dose of total solanaceous alkaloids; in solid dose form in medicines containing 0.3 milligrams or less per dose form and not more than 1.2 milligrams per recommended daily dose of total solanaceous alkaloids
54
Duboisia myoporides; for oral use in liquid form in medicines containing 0.03% or less and 0.3 milligrams or less per dose and not more than 1.2 milligrams per recommended daily dose of total solanaceous alkaloids; in solid dose form in medicines containing 0.3 milligrams or less per dose form and not more than 1.2 milligrams per recommended daily dose of total solanaceous alkaloids
55
Econazole; for dermal use except in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
56
Esomeprazole; in oral preparations containing 20 milligrams or less per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days’ supply
57
Etafedrine
58
Ether; in medicines containing more than 10%; except in medicines containing 10% or less
59
Etofenamate; for external use
60
Famotidine; for the symptomatic relief of heartburn, dyspepsia, and hyperacidity or to be used on the recommendation of a registered medical practitioner, when sold in the manufacturer’s original pack containing not more than 14 days’ supply
61
Felbinac; for external use
62
Fexofenadine; for oral use except for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when in capsules containing 60 milligrams or less of fexofenadine hydrochloride or in tablets containing 120 milligrams or less of fexofenadine hydrochloride with a maximum daily dose of 120 milligrams when sold in the manufacturer’s original pack containing 20 dosage units or less and not more than 10 days’ supply; for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when in tablets containing 180 milligrams or less of fexofenadine hydrochloride with a maximum daily dose of 180 milligrams when sold in the manufacturer’s original pack containing 5 dosage units or less and not more than 5 days’ supply
63
Fluorides; for internal use in medicines containing 0.5 milligrams or less per dose unit; except in parenteral nutrition replacement preparations; for external use in liquid form in medicines containing 1 gram or less per litre or per kilogram and when sold in packs approved by the Minister or the Director-General for distribution as pharmacy-only medicines except in medicines containing 220 milligrams or less per litre or per kilogram and in packs containing not more than 120 milligrams of total fluoride; except when supplied to any dental professional registered with the Dental Council; except in medicines containing 15 milligrams or less per litre or per kilogram
64
Flurbiprofen; in locally acting oromucosal preparations containing 10 milligrams or less per dosage unit
65
Fluticasone; for the treatment or prophylaxis of allergic rhinitis in adults and children over 12 years of age when in aqueous nasal sprays delivering up to 50 micrograms per actuation with a maximum recommended daily dose of 200 micrograms (as a single dose)
66
Folic acid; for oral use in medicines containing more than 500 micrograms per recommended daily dose; except for oral use in medicines containing 500 micrograms or less per recommended daily dose; except in parenteral nutrition replacement preparations
67
Folinic acid; for oral use in medicines containing more than 500 micrograms per recommended daily dose; except for oral use in medicines containing 500 micrograms or less per recommended daily dose
68
Formaldehyde; except in medicines containing 5% or less
69
Gelsemium sempervirens; except in medicines containing 1 milligram or less per litre or per kilogram
70
Glutaraldehyde
71
Hexachlorophane; in medicines containing 3% or less but more than 0.75%; except in medicines containing 0.75% or less
72
Hydrocortisone and hydrocortisone acetate but no other esters of hydrocortisone; for dermal use in medicines containing 0.5% or less by weight of hydrocortisone base with no other active ingredient except an antifungal and in a quantity of 30 grams or less or 30 millilitres or less per container; in rectal medicines containing 0.5% or less by weight of hydrocortisone base and in combination with a local anaesthetic and in a quantity of 35 grams or less per container or 12 suppositories or fewer per pack
73
Hydrocyanic acid; for oral use in packs containing 5 milligrams or less and more than 0.5 milligrams; except in medicines containing 1 microgram or less per litre or per kilogram; except for oral use in packs containing 0.5 milligrams or less
74
Hydroquinone; for external use in medicines containing 2% or less except in hair preparations containing 1% or less
75
Hyoscine; for transdermal use in medicines containing 2 milligrams or less of total solanaceous alkaloids per dose unit; for oral use in liquid form in medicines containing 0.03% or less and 0.3 milligrams or less per dose and not more than 1.2 milligrams per recommended daily dose of total solanaceous alkaloids; in solid dose form in medicines containing 0.3 milligrams or less per dose form and not more than 1.2 milligrams per recommended daily dose of total solanaceous alkaloids
76
Hyoscyamine; for external use in medicines containing 0.03% or less of total solanaceous alkaloids; for oral use in liquid form in medicines containing 0.03% or less and 0.3 milligrams or less per dose and not more than 1.2 milligrams per recommended daily dose of total solanaceous alkaloids; in solid dose form in medicines containing 0.3 milligrams or less per dose form and not more than 1.2 milligrams per recommended daily dose of total solanaceous alkaloids
77
Hyoscyamus niger; for oral use in liquid form in medicines containing 0.03% or less (300 micrograms or less of total solanaceous alkaloids per litre or per kilogram) and 0.3 milligrams or less per dose and not more than 1.2 milligrams per recommended daily dose of total solanaceous alkaloids or in solid dose form in medicines containing 0.3 milligrams or less per dose form and not more than 1.2 milligrams per recommended daily dose except in packs containing 30 micrograms or less of total solanaceous alkaloids
78
Ibuprofen; for oral use in liquid form with a recommended daily dose of not more than 1.2 grams for the relief of pain and reduction of fever or inflammation when sold in the manufacturer’s original pack containing not more than 8 grams; for oral use in solid dose form containing not more than 200 milligrams per dose form and with a recommended daily dose of not more than 1.2 grams when sold in the manufacturer’s original pack containing not more than 100 dose units; except in divided solid dosage forms for oral use containing 200 milligrams or less per dose form with a recommended daily dose of not more than 1.2 grams and when sold in the manufacturer’s original pack containing not more than 25 dose units; except for external use
79
Indanazoline
80
Indomethacin; for external use in medicines containing 1% or less; except in medicines containing 1 milligram or less per litre or per kilogram
81
Iodine; except for external use in medicines containing 2.5% or less; for internal use in medicines containing less than 300 micrograms per recommended daily dose
82
Ipecacuanha; in medicines containing 0.2% or less of emetine and 40 micrograms or more of ipecacuanha alkaloids per recommended dose for the treatment of the symptoms of cough and cold in children aged 6–12 years; except in medicines containing less than 40 micrograms of ipecacuanha alkaloids per recommended dose for the treatment of the symptoms of cough and cold in children aged 6–12 years
83
Ipomoea spp; except ipomoea batatas
84
Ipratropium; for nasal use
85
Iron; for oral use either in medicines containing more than 24 milligrams per recommended daily dose or in medicines containing more than 5 milligrams per dose unit and more than 750 milligrams of iron per pack; except in parenteral nutrition replacement preparations; except for oral use in medicines containing 24 milligrams or less per recommended daily dose in medicines containing not more than 5 milligrams per dose unit; except for oral use in medicines containing 24 milligrams or less per recommended daily dose in medicines containing more than 5 milligrams per dose unit in packs containing not more than 750 milligrams of iron
86
Isoconazole; for dermal use except when sold in practice by a podiatrist registered with the Podiatrists Board
87
Isopropamide; for dermal use in preparations containing 2% or less
88
Jalap resin
89
Ketoconazole; for dermal use except in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board; except in medicines for treatment of the scalp containing 1% or less
90
Ketotifen; for ophthalmic use in medicines containing 0.025% or less except when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board
91
Leucovorin; in medicines containing more than 500 micrograms per recommended daily dose
92
Levocabastine; for nasal use; for ophthalmic use except when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board
93
Levocetirizine; for oral use
94
Lignocaine; for urethral use; for external use in medicines containing 10% or less and more than 2%
95
Lindane; for external use in medicines containing 2% or less
96
Lithium; for dermal use in medicines containing 1% or less but more than 0.01%; except for dermal use in medicines containing 0.01% or less
97
Lobelia inflata; except in medicines for smoking or burning
98
Lobeline; except when in medicines for smoking or burning
99
Lodoxamide; for ophthalmic use except when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board
100
Loperamide; in packs containing not more than 20 tablets or capsules; except in divided solid dosage forms for oral use containing 2 milligrams or less of loperamide per dosage form when sold in a pack containing not more than 8 dosage forms approved by the Minister or the Director-General for distribution as a general sales medicine for the symptomatic treatment of acute non-specific diarrhoea
101
Loratadine; for oral use; except in divided solid dosage forms for oral use containing 10 milligrams or less per dose form for the treatment of seasonal allergic rhinitis when sold in the manufacturer’s original pack containing not more than 10 days’ supply
102
Macrogols; in preparations for oral use as a liquid concentrate for laxative use
103
Mebendazole
104
Meclozine; in a sealed container of not more than 12 tablets or capsules for the prevention or treatment of travel sickness except when sold at a transport terminal or aboard a ship or aircraft
105
Mefenamic acid; in solid dose form in packs containing not more than 30 tablets or capsules for the treatment of dysmenorrhoea
106
Mepyramine; for dermal use; except for external use in medicines containing 2% or less in packs not exceeding 25 grams
107
Mercuric oxide; for ophthalmic use
108
Mercurochrome; in preparations for external use containing 2% or less
109
Mercury; for external use in medicines containing 0.5% or less; except in medicines containing 1 milligram or less per litre or per kilogram
110
Methoxamine; for external use in medicines containing more than 1%; except for external use in medicines containing 1% or less
111
Methoxyphenamine
112
Methylephedrine
113
Miconazole; for external use except in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
114
Minoxidil; for dermal use in medicines containing 5% or less
115
Mometasone; for the treatment or prophylaxis of allergic rhinitis in adults and children over 12 years of age in aqueous nasal sprays delivering up to 50 micrograms per actuation when the maximum recommended daily dose is no greater than 200 micrograms (as a single dose) in a pack containing 200 actuations or less
116
Morphine; in medicines for oral use containing not more than 0.2% of morphine, when combined with 1 or more active ingredients in such a way that the substance cannot be recovered by readily applicable means or in a yield that would constitute a risk to health, when sold in a pack approved by the Minister or the Director-General for distribution as a pharmacy-only medicine
117
Naphazoline; except for ophthalmic use when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board
118
Naproxen; in solid dose form containing 250 milligrams or less per dose form in packs of not more than 30 tablets or capsules
119
Niclosamide
120
Nicotine; for inhalation except when sold from a smoking cessation clinic run under the auspices of a registered medical practitioner, nurse, pharmacist, or psychologist
121
Nizatidine; in medicines for the symptomatic relief of heartburn, dyspepsia, and hyperacidity or to be used on the recommendation of a registered medical practitioner, when sold in the manufacturer’s original pack containing not more than 14 days’ supply
122
Noscapine
123
Nystatin; for dermal use except when sold in practice by a podiatrist registered with the Podiatrists Board; except in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
124
Omeprazole; in divided solid dosage forms for oral use containing 20 milligrams or less with a maximum daily dose of 20 milligrams for the short-term symptomatic relief of gastric reflux-like symptoms in sufferers aged 18 years and over when sold in the manufacturer’s original pack containing not more than 28 dosage units
125
Opium; in medicines for oral use containing not more than 0.2% of morphine, when combined with 1 or more active ingredients in such a way that the substance cannot be recovered by readily applicable means, or in a yield that would constitute a risk to health, when sold in a pack approved by the Minister or the Director-General for distribution as a pharmacy-only medicine
126
Oxetacaine; for internal use
127
Oxiconazole; for dermal use except in medicines for tinea pedis only
128
Oxymetazoline; except for nasal use when sold at an airport; except for ophthalmic use when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board; except for nasal use in medicines containing 0.05% or less when sold in the manufacturer’s original pack with a pack size of 20 millilitres or less
129
Pantoprazole; in divided solid dosage forms for oral use containing 20 milligrams or less with a maximum daily dose of 20 milligrams for the short-term symptomatic relief of gastric reflux-like symptoms in sufferers aged 18 years and over when sold in the manufacturer’s original pack containing not more than 28 dosage units
130
Papaverine; except for injection
131
Paracetamol; in liquid form; in suppositories; in tablets or capsules containing 500 milligrams or less and in packs containing more than 10 grams and not more than 50 grams; in powder form containing not more than 1 gram per sachet and more than 10 grams per pack; except in tablets or capsules containing 500 milligrams or less and in packs containing not more than 10 grams; except in powder form in sachets containing 1 gram or less and in packs of not more than 10 grams
132
Paraformaldehyde; except in medicines containing 5% or less
133
Penciclovir; for external use for the treatment of herpes labialis; except in medicines for external use containing 1% or less in a pack containing 10 grams or less for the treatment of herpes labialis
134
Phedrazine
135
Phenazone; for external use
136
Pheniramine; for ophthalmic use except when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board; for oral use in medicines for adults and children over 6 years of age when combined in the same container with 1 or more other therapeutically active ingredients either when in the bedtime dose of a day/night pack containing pheniramine or when at least 1 of the other active ingredients is a sympathomimetic decongestant
137
Phenol; except in medicines other than for injection containing 3% or less
138
Phenylephrine; for nasal use in medicines containing more than 1%; for ophthalmic use in medicines containing 5% or less and more than 1%; for oral use in medicines containing more than 50 milligrams per recommended daily dose or in packs containing more than 250 milligrams of phenylephrine per pack; in medicines for the treatment of the symptoms of cough and cold in children aged 6–12 years; except for nasal or ophthalmic use in medicines containing 1% or less; except for oral use in medicines containing 50 milligrams or less per recommended daily dose and in packs containing 250 milligrams or less of phenylephrine per pack
139
Pholcodine; in medicines for oral use containing not more than 15 milligrams of pholcodine per solid dosage unit or per dose of liquid with a maximum daily dose not exceeding 100 milligrams of pholcodine, when combined with 1 or more active ingredients in such a way that the substance cannot be recovered by readily applicable means, or in a yield that would constitute a risk to health, when sold in a pack approved by the Minister or the Director-General for distribution as a pharmacy-only medicine
140
Piperazine
141
Podophyllotoxin; for external use for the treatment of warts other than anogenital warts in medicines containing 0.5% or less; except in medicines containing 1 milligram or less of podophyllin per litre or per kilogram
142
Podophyllum emodi; for external use for the treatment of warts other than anogenital warts in medicines containing 10% or less of podophyllin; except in medicines containing 1 milligram or less of podophyllin per litre or per kilogram
143
Podophyllum peltatum; for external use for the treatment of warts other than anogenital warts in medicines containing 10% or less of podophyllin; except in medicines containing 1 milligram or less of podophyllin per litre or per kilogram
144
Potassium; for internal use: in slow-release or enteric coated forms; except for internal use: in medicines containing 100 milligrams or less per recommended dose; in medicines containing more than 100 milligrams per recommended dose except in medicines for oral rehydration therapy, parenteral nutrition replacement, or dialysis; except in glucosamine sulphate complexed products containing 600 milligrams or less of potassium chloride per recommended dose; except for external use
145
Potassium chlorate; except in medicines containing 10% or less
146
Prilocaine; for dermal use in medicines containing 10% or less of local anaesthetic substances
147
Procyclidine; for dermal use in medicines containing 5% or less
148
Promethazine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with 1 or more other therapeutically active ingredients either when in the bedtime dose of a day/night pack containing promethazine or when at least 1 of the other active ingredients is a sympathomimetic decongestant; for oral use in a sealed container of not more than 10 tablets or capsules for the prevention or treatment of motion sickness in adults and children over 2 years of age except when sold at a transport terminal or aboard a ship or aircraft
149
Propamidine; for ophthalmic use except when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board
150
Pyrantel
151
Pyrethrins; except in medicines containing 10% or less
152
Pyrithione zinc; except in medicines for treatment of the scalp containing 2% or less
153
Ranitidine; in medicines for the symptomatic relief of heartburn, dyspepsia, and hyperacidity or to be used on the recommendation of a registered medical practitioner when sold in the manufacturer’s original pack containing not more than 14 days’ supply; except in medicines containing 300 milligrams or less per dose unit when sold in the manufacturer’s original pack containing not more than 7 days’ supply
154
Salicylamide
155
Selenium; for oral use in medicines containing 300 micrograms or less and more than 150 micrograms per recommended daily dose; for external use except in medicines containing 3.5% or less of selenium sulphide
156
Sennosides
157
Silver; except in oral solutions containing 0.3% or less or other medicines containing 1% or less
158
Silver sulfadiazine; for external use in pack sizes of 50 grams or less
159
Sodium cromoglycate; for nasal use; for ophthalmic use except when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board
160
Sodium nitrite; except for use as an excipient
161
Sodium picosulphate; in oral laxative preparations
162
Squill; except in medicines containing 1% or less
163
Stramonium; for oral use in liquid form in medicines containing 0.03% or less and 0.3 milligrams or less per dose and not more than 1.2 milligrams per recommended daily dose of total solanaceous alkaloids; in solid dose form in medicines containing 0.3 milligrams or less per dose form and not more than 1.2 milligrams per recommended daily dose of total solanaceous alkaloids
164
Sulconazole; for dermal use
165
Sulfadiazine, silver; for external use in pack sizes of 50 grams or less
166
Terbinafine; for dermal use except in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
167
Tetrachloroethylene
168
Tetrahydrozoline; except for ophthalmic use when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board
169
Thiabendazole
170
Tioconazole; for dermal use except in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
171
Tramazoline
172
Triamcinolone; for the treatment or prophylaxis of allergic rhinitis in adults and children over 12 years of age and when in aqueous nasal sprays delivering up to 55 micrograms per actuation when the maximum recommended daily dose is no greater than 220 micrograms and the medicine has received the consent of the Minister or the Director-General to its distribution as a pharmacy-only medicine
173
Trimeprazine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with 1 or more other therapeutically active ingredients either when in the bedtime dose of a day/night pack containing trimeprazine or when at least 1 of the other therapeutically active ingredients is a sympathomimetic decongestant
174
Triprolidine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with 1 or more other therapeutically active ingredients either when in the bedtime dose of a day/night pack containing triprolidine or when at least 1 of the other active ingredients is a sympathomimetic decongestant
175
Tuaminoheptane
176
Tymazoline
177
Xylenols; except in medicines containing 3% or less
178
Xylometazoline; except for nasal use when sold at an airport; except for ophthalmic use when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board
179
Zinc chloride; for dermal use in medicines containing more than 5%
Schedule 2
Form 1 Application for licence to manufacture, hawk, sell, or pack medicine
[Before completing this form you should make yourself familiar with the provisions of the Medicines Act 1981 and the Medicines Regulations 1984, especially those parts that deal with licences.
This form may be used to apply for licences to manufacture, pack, sell, or hawk medicines. It is divided into 7 parts. Every applicant must complete either Part 1 or Part 2, and must also complete at least one of Parts 3, 4, 5, 6, and 7.
Every application must be accompanied by the prescribed fee for each licence applied for (viz, regulation 61, Medicines Regulations 1984).]
The form must be completed in type, or in block capitals.
Part 1
[To be completed where the applicant is an individual applying for a licence on his own behalf.]
Name of applicant: [surname] [first names]
I am a New Zealand resident: Yes/No
Date of birth: [day/month/year]
Address (home):
Name of business:
Street address of business premises:
Postal address:
General nature of business:
Position of applicant (for example, “owner”
, “manager”
etc):
Have you previously held a licence to manufacture, pack, sell, or hawk medicines? Yes/No
If yes give details:
Have you ever been declined, or had revoked, a licence to manufacture, pack, sell, or hawk medicines? Yes/No
If yes give details:
Part 2
[To be completed where the applicant is an officer of a body corporate applying for a licence on behalf of the body corporate.]
Name of body corporate:
The body corporate is incorporated in New Zealand Yes/No
Street address of body corporate:
Postal address:
General nature of business of body corporate:
Name of person completing this form: [surname] [first names]
Position in body corporate of person completing form:
Details of persons nominated to be responsible persons under the Medicines Act 1981:
| Name | Date of birth | Position in body corporate |
Have any of the above nominees ever been declined, or had revoked, a licence to manufacture, pack, sell, or hawk medicines? Yes/No
If yes give details:
Have any of the above nominees ever been a licensee or responsible person under the Restricted Drugs Act 1960 or the Medicines Act 1981? Yes/No
If yes give details:
Part 3
Application to manufacture medicines
I hereby make application for a licence to manufacture the medicines listed below (attach extra list if insufficient space provided here). Indicate (by reference to one of the following paragraphs) which of the following classes the medicines come within:
(a)
antibiotics, or preparations of antibiotics:
(b)
vaccines and sera:
(c)
sterile preparations:
(d)
hormones and steroid preparations:
(e)
preparations, other than vitamins, having a dose of 5 milligrams or less per unit dose:
(f)
antineoplastic agents and immunosuppressant agents other than steroid preparations:
(g)
other medicines not included in paragraphs (a) to (f), above.
| Appropriate designation | Trade name of medicine | Class |
Premises where manufacture (including packing and labelling) of the medicines will be carried out:
I enclose the fee of:
Signature of applicant (or Common Seal where applicant is a body corporate):
Date:
Part 4
Application to pack medicines
I hereby make application for a licence to pack the medicines listed below (attach extra list if insufficient space provided here). Indicate in the third column whether the medicine is a prescription medicine, restricted medicine, or pharmacy-only medicine.
| Appropriate designation | Trade name of medicine | Class | |
|---|---|---|---|
Premises where packing and labelling will be carried out:
I enclose the fee of:
Signature of applicant (or Common Seal where applicant is a body corporate):
Date:
Part 5
Application to sell medicines by wholesale
I hereby make application to sell by wholesale the following medicines (attach extra list if insufficient space provided here):
Premises from where medicines are to be sold:
I enclose the fee of:
Signature of applicant (or Common Seal where applicant is a body corporate):
Date:
Part 6
Application to sell medicines by retail
I hereby make application to sell by retail the following medicines (attach extra list if insufficient space provided here):
Premises from where medicines are to be sold:
I declare the above premises are more than 10 kilometres by road from the nearest pharmacy.
The reasons for this application are:
I enclose the fee of:
Signature of applicant (or Common Seal where applicant is a body corporate):
Date:
Part 7
Application to hawk medicines
I hereby make application for a licence to hawk medicines.
Premises where stock of medicines will be kept:
Place where records of sale of medicines will be kept:
Geographical area in which it is proposed to hawk medicines:
Persons or classes of persons to whom it is proposed to hawk medicines:
Name and maximum quantity of medicines intended to be transported when hawking:
I enclose the fee of:
Signature of applicant (or Common Seal where applicant is a body corporate):
Date:
Schedule 2 form 1 heading: substituted, on 18 September 2004, by regulation 9(1)(a) of the Medicines Amendment Regulations 2004 (SR 2004/300).
Schedule 2 form 1 Part 1: amended, on 18 September 2004, by regulation 9(1)(b) of the Medicines Amendment Regulations 2004 (SR 2004/300).
Schedule 2 form 1 Part 2: amended, on 18 September 2004, by regulation 9(1)(c) of the Medicines Amendment Regulations 2004 (SR 2004/300).
Form 1A Application for licence to operate pharmacy made (by employee or agent) on behalf of company
Important information
Before filling out this application please note the following important information:
this form may be used by an employee or agent who is making an application on behalf of a company:
you must make yourself familiar with the provisions of the Medicines Act 1981 and the Medicines Regulations 1984, in particular those provisions relating to licensing and operating pharmacies:
the following must accompany this application:
the prescribed fee:
a completed statutory declaration:
it is an offence to make a false statutory declaration:
the licensing authority may require you to supply additional information at a later date (see section 55B of the Medicines Act 1981). If you do not supply that information within 30 days of the request, this application will lapse.
Please complete the following:
Applicant and company
I, [full name of employee or agent of company], [position in company], make this application for a licence to operate a pharmacy on behalf of [name of company], which—
(a)
was incorporated in New Zealand on [date of incorporation]; and
(b)
has the following board members:
[full names of all board members]. |
The address of the company is [address].
The following persons are nominated to be responsible persons for the purposes of the licence under the Medicines Act 1981:
[full names, dates of birth, and positions held].
Street address and description of pharmacy
The street address of the pharmacy to which this application relates is [street address].
The pharmacy will comprise the following part or parts of that street address: [specify the part or parts of the street address that are to be a pharmacy or attach a line drawing showing the part or parts].
Interests held in pharmacy
Note: Before filling out this part of the form please read section 5A of the Medicines Act 1981, which sets out the meaning of holding an interest in a pharmacy.
The following person(s) or company (or companies) hold an interest in the pharmacy (as defined in section 5A of the Medicines Act 1981) to which this application relates: [name(s) of person(s) or company (or companies), their address(es), and the particulars of the interest held (or “none”
if applicable)].
The following person(s) who hold an interest in the pharmacy to which this applicaton relates is a (or are) practioner(s) (or registered midwife (midwives)) (or designated prescriber(s)): [name of the interest holder(s) and his or her relevant position (or “none”
if applicable)].
Eligibility to hold licence
*The share capital of the company is more than 50% owned by [full name of pharmacist] who is a pharmacist† (or [full names of pharmacists] who are pharmacists) and effective control of the company is vested in the above-named pharmacist (or pharmacists).
| †In this context, a pharmacist— | ||
| (a) | means a health practitioner who is, or is deemed to be, registered with the Pharmacy Council established by the Health Practitioners Competence Assurance Act 2003 as a practitioner of the profession of pharmacy; and |
|
| (b) | includes an administrator of the estate of a deceased pharmacist, and an assignee within the meaning of the Insolvency Act 1967 of the estate of a pharmacist, until— |
|
| (i) | the expiry of the period of 1 year after the date of the death of the deceased pharmacist, or the date on which the pharmacist was adjudicated bankrupt; or |
|
or |
||
| (ii) | subject to any conditions that the licensing authority proposes, the extended period or periods permitted by the licensing authority. |
|
or
*The pharmacy to which this application relates is in a hospital owned or operated by the company. [Specify details.]
or
*[Specify other ground in section 55D(2) of the Medicines Act 1981 that makes the company eligible to hold a licence.]
*Delete if inapplicable. |
Practices and procedures for pharmacists working in pharmacy
The following practices and procedures will be in place to ensure that any pharmacist* who is employed or engaged in duties in the pharmacy to which this application relates is not requested or required to act in a way that is inconsistent with the applicable professional or ethical standards of the pharmacy practice: [specify relevant practices and procedures].
*In this context, a pharmacist means a health practitioner who is, or is deemed to be, registered with the Pharmacy Council established by the Health Practitioners Competence Assurance Act 2003 as a practitioner of the profession of pharmacy. |
Other pharmacies
The company operates the following pharmacy (or pharmacies): [name(s) and address(es) of pharmacy (or pharmacies) (or "none" if applicable)].
[Specify number, or “none”
if applicable] of those pharmacies are (or is) currently for sale.
*Mortgagee in possession
The company is a mortgagee in possession† of the pharmacy to which this application relates.
*Delete if inapplicable. |
†For the purposes of this application a mortgagee in possession has the same meaning as in section 4 of the Property Law Act 2007. |
Signature of applicant:
Declaration
I, [full name of agent or employee of the company], of [place], [occupation], solemnly and sincerely declare that the statements made in the above application are true and correct.
I make this solemn declaration conscientiously believing the same to be true and by virtue of the Oaths and Declarations Act 1957.
Declared at [place, date] before me:
[Signature]
Justice of the Peace
(or other person authorised to take a statutory declaration)
Schedule 2 form 1A: inserted, on 18 September 2004, by regulation 10 of the Medicines Amendment Regulations 2004 (SR 2004/300).
Schedule 2 form 1A: amended, on 1 January 2008, by regulation 4 of the Medicines (Property Law Act 2007) Amendment Regulations 2007 (SR 2007/382).
Form 1B Application for licence to operate pharmacy made by person who is individual (or employee or agent of body corporate that is not company)
Important information
Before filling out this application please note the following important information:
this form may be used by—
an individual who is applying for a licence to operate a pharmacy; or
an employee or agent of a body corporate (other than a company) who is applying for a licence to operate a pharmacy on behalf of that body corporate (for example, an application made on behalf of a partnership or friendly society):
you must make yourself familiar with the provisions of the Medicines Act 1981 and the Medicines Regulations 1984, in particular those provisions relating to licensing and operating pharmacies:
the following must accompany this application:
the prescribed fee:
a completed statutory declaration:
it is an offence to make a false statutory declaration:
the licensing authority may require you to supply additional information at a later date (see section 55B of the Medicines Act 1981). If you do not supply that information within 30 days of the request, this application will lapse.
Please complete the following:
Application (and body corporate)
I, [full name], of [address], being a resident of New Zealand, apply for a licence to operate a pharmacy on—
*my own behalf.
*on behalf of the body corporate called [name of body corporate], which—
(a)
is not a company, but is a [specify the type of body corporate]; and
(b)
was incorporated in New Zealand on [date]; and
(c)
has the following board members (or trustees) (or partners): [full names of board members (or trustees) (or partners)].
| *Delete if inapplicable. |
My address (or The address of the body corporate) is [address].
*I was born on [date].
or
*I hold the office of [specify office held] within the above-named body corporate. The following persons are nominated to be responsible persons under the Medicines Act 1981:
[full names, dates of birth, and positions held].
| *Delete if inapplicable. |
Street address and description of pharmacy
The street address of the pharmacy to which this application relates is [street address].
The pharmacy will comprise the following part or parts of that street address: [specify the part or parts of the street address that are to be a pharmacy or attach a line drawing showing the part or parts].
Interests held in pharmacy
Note: Before filling out this part of the form please read section 5A of the Medicines Act 1981, which sets out the meaning of holding an interest in a pharmacy.
The following person(s) or company (or companies) hold an interest in the pharmacy (as defined in section 5A of the Medicines Act 1981) to which this application relates: [name(s) of person(s) or company (or companies), their address(es), and the particulars of the interest held (or “none”
if applicable)].
The following person(s) who hold an interest in the pharmacy to which this applicaton relates is a (or are) practioner(s) (or registered midwife (midwives)) (or designated prescriber(s)): [name of the interest holder(s) and his or her relevant position (or “none”
if applicable)].
Eligibility to hold licence
*I am (or [Name of person in body corporate who has the majority interest] is) a pharmacist for the purposes of this application because I am (or he or she is) a health practitioner who is, or is deemed to be, registered with the Pharmacy Council established by the Health Practitioners Competence Assurance Act 2003 as a practitioner of the profession of pharmacy.
or
*I am (or The body corporate is) a pharmacist because [specify part of the definition of pharmacist in section 55E(3) of the Medicines Act 1981] applies.
or
*The pharmacy I am (or The body corporate is) applying to operate is in a hospital owned or operated by me (or the body corporate).
[Specify details.]
or
*I am (or The body corporate is) eligible to operate a pharmacy because [specify other ground in section 55E(1) of the Medicines Act 1981 that makes person or body corporate eligible to hold a licence].
*Delete if inapplicable. |
Practices and procedure for pharmacists working in pharmacy
The following practices and procedures will be in place to ensure that any pharmacist* who is employed or engaged in duties in the pharmacy to which this application relates is not requested or required to act in a way that is inconsistent with the applicable professional or ethical standards of the pharmacy practice: [specify practices and procedures].
*In this context, a pharmacist means a health practitioner who is, or is deemed to be, registered with the Pharmacy Council established by the Health Practitioners Competence Assurance Act 2003 as a practitioner of the profession of pharmacy. |
Other pharmacies
I operate (or have a majority interest in) (or The body corporate operates) the following pharmacy (or pharmacies): [name(s) and address(es) of the pharmacy (or pharmacies) (or “none”
if applicable).]
[Specify number, or “none”
if applicable] of those pharmacies are (or is) currently for sale.
*Mortgagee in possession
I am (or The body corporate is) the mortgagee in possession† of the pharmacy to which this application relates.
*Delete if inapplicable. |
†For the purposes of this application a mortgagee in possession has the same meaning as in section 4 of the Property Law Act 2007. |
Signature of applicant:
Declaration
I [full name of applicant], of [place], [occupation], solemnly and sincerely declare that the statements made in the above application are true and correct.
I make this solemn declaration conscientiously believing the same to be true and by virtue of the Oaths and Declarations Act 1957.
Declared at [place, date] before me:
[Signature]
Justice of the Peace
(or other person authorised to take a statutory declaration)
Schedule 2 form 1B: inserted, on 18 September 2004, by regulation 10 of the Medicines Amendment Regulations 2004 (SR 2004/300).
Schedule 2 form 1B: amended, on 1 August 2011, by regulation 28 of the Medicines Amendment Regulations 2011 (SR 2011/245).
Form 2 Licence to manufacture medicines
Licence No:
Name of licensee:
Address of licensee:
Name of responsible persons:
The *licensee or every responsible person named above is hereby authorised pursuant to section 51 of the Medicines Act 1981 to manufacture, pack, label, and sell by wholesale the following medicines or classes of medicines:
*Delete whichever does not apply. | |||
The authority granted by this licence is subject to the following conditions:
(1)
The manufacture, packing, labelling, or sale of the medicines shall be carried out in accordance with the Medicines Act 1981 and the Medicines Regulations 1984.
(2)
[Further conditions imposed by the licensing authority]:
This licence shall expire on [date].
[Signature]
(Licensing authority)
Schedule 2 form 2: amended, on 18 September 2004, by regulation 9(2)(a) of the Medicines Amendment Regulations 2004 (SR 2004/300).
Schedule 2 form 2: amended, on 18 September 2004, by regulation 9(2)(b) of the Medicines Amendment Regulations 2004 (SR 2004/300).
Form 3 Licence to hawk medicines
Licence No:
Name of licensee:
Address of licensee:
Names of responsible persons:
The *licensee or every responsible person named above is hereby authorised pursuant to section 51 of the Medicines Act 1981 to hawk the following medicines:
*Delete whichever does not apply. | |
The authority granted by this licence is subject to the following conditions:
(1)
All sales shall be made in accordance with the Medicines Act 1981 and the Medicines Regulations 1984.
(2)
The stock of medicines held by the licensee or responsible person shall be stored only at the following place or places:
(3)
The records of sale shall be kept at the following premises:
(4)
Sales shall only be made within the following geographical area:
(5)
Sales shall only be made to the following persons or classes of persons:
(6)
[Further conditions imposed by the licensing authority]:
This licence shall expire on [date].
[Signature]
(Licensing authority)
Schedule 2 form 3: amended, on 18 September 2004, by regulation 9(3)(a) of the Medicines Amendment Regulations 2004 (SR 2004/300).
Schedule 2 form 3: amended, on 18 September 2004, by regulation 9(3)(b) of the Medicines Amendment Regulations 2004 (SR 2004/300).
Form 4 Licence to sell medicines by wholesale
Licence No:
Name of licensee:
Address of licensee:
Name of responsible persons:
Address of business premises:
The *licensee or every responsible person named above is hereby authorised pursuant to section 51 of the Medicines Act 1981 to sell by wholesale the following medicines:
| *Delete whichever does not apply. |
The authority granted by this licence is subject to the following conditions:
(1)
The sale of the above medicines shall not take place other than at the business premises set out above.
(2)
All sales shall be made in accordance with the Medicines Act 1981 and the Medicines Regulations 1984.
(3)
[Further conditions imposed by the licensing authority]:
This licence shall expire on [date].
[Signature]
(Licensing authority)
Schedule 2 form 4: amended, on 18 September 2004, by regulation 9(3)(a) of the Medicines Amendment Regulations 2004 (SR 2004/300).
Schedule 2 form 4: amended, on 18 September 2004, by regulation 9(3)(b) of the Medicines Amendment Regulations 2004 (SR 2004/300).
Form 5 Licence to sell medicines by retail
Licence No:
Name of licensee:
Address of licensee:
Name of responsible persons:
Address of business premises:
The *licensee or every responsible person named above is hereby authorised pursuant to section 51 of the Medicines Act 1981 to sell by retail, and supply in circumstances corresponding to retail sale, the following medicines:
| *Delete whichever does not apply. |
The authority granted by this licence is subject to the following conditions:
(1)
The sale of the above medicines shall not take place other than at the business premises set out above.
(2)
All sales shall be made in accordance with the Medicines Act 1981 and the Medicines Regulations 1984.
(3)
[Further conditions imposed by the licensing authority]:
This licence shall expire on [date].
[Signature]
(Licensing authority)
Schedule 2 form 5: amended, on 18 September 2004, by regulation 9(3)(a) of the Medicines Amendment Regulations 2004 (SR 2004/300).
Schedule 2 form 5: amended, on 18 September 2004, by regulation 9(3)(b) of the Medicines Amendment Regulations 2004 (SR 2004/300).
Form 6 Licence to pack medicines
Licence No:
Name of licensee:
Address of licensee:
Names of responsible persons:
Address of business premises:
The *licensee or every responsible person named above is hereby authorised pursuant to section 51 of the Medicines Act 1981 to pack or label for the purpose of sale, and sell by wholesale the following medicines:
| *Delete whichever does not apply. | |
The authority granted by this licence is subject to the following conditions:
(1)
The packing, labelling, or sale of the medicines shall be carried out in accordance with the Medicines Act 1981 and the Medicines Regulations 1984.
(2)
[Further conditions imposed by the licensing authority]:
This licence shall expire on [date].
[Signature]
(Licensing authority)
Schedule 2 form 6: amended, on 18 September 2004, by regulation 9(3)(a) of the Medicines Amendment Regulations 2004 (SR 2004/300).
Schedule 2 form 6: amended, on 18 September 2004, by regulation 9(3)(b) of the Medicines Amendment Regulations 2004 (SR 2004/300).
Form 7 Licence to operate pharmacy
Licence No:
This licence to operate a pharmacy is granted to [full name of person or body corporate] of [address] and authorises—
the establishment of a pharmacy at [location] (or in the following part or parts of [location]: [specify relevant part or parts]); and
the carrying on of pharmacy practice in that pharmacy.
*Names of responsible persons for body corporate:
| *Delete if inapplicable. | |
The pharmacy must be operated in accordance with the duties and obligations in the Medicines Act 1981.
This licence is subject to the following conditions:
(a)
the holder of this licence must not request or require any pharmacist who is employed or engaged in duties at the above-named pharmacy to act in a way that is inconsistent with the applicable professional or ethical standards of pharmacy practice:
(b)
[specify any other conditions].
This licence expires on [date].
[Signature]
(Licensing authority)
Schedule 2 form 7: added, on 18 September 2004, by regulation 11 of the Medicines Amendment Regulations 2004 (SR 2004/300).
Schedule 3 Loose sheet data sheet requirements
[Revoked]Schedule 3: revoked, on 1 August 2011, by regulation 29 of the Medicines Amendment Regulations 2011 (SR 2011/245).
Schedule 4 Hawker’s Medicines book
| Name of medicine | Form | Strength | Page |
|---|---|---|---|
| Date |
Name and address of supplier of medicine or Name and address of person to whom medicine sold |
Order No | In | Out | Balance |
Schedule 5 Analyst’s certificate under the Medicines Act 1981
I, [name], an analyst under the Medicines Act 1981, certify that on [date] there was submitted to me by [name and address of the officer from whom the sample was received] an officer within the meaning of that Act, a sample of [name or description of sample] for analysis in a [nature of the package in which the sample was enclosed, and how it was labelled, marked, and sealed] and that the same has been analysed and that the result of the analysis is as follows [analysis and observations]:
Date:
[Signature]
Analyst
Schedule 5A Licence fees
Schedule 5A: inserted, on 21 August 2006, by regulation 6 of the Medicines (Fees) Amendment Regulations 2006 (SR 2006/188).
| $ | ||
|---|---|---|
| 1 | An application for a licence to manufacture medicines | 14,328 |
| 2 | An application for a licence to pack medicines | 880 |
| 3 | An application for a licence to sell medicines by retail | 880 |
| 4 | An application for a licence to sell medicines by wholesale | 1,123 |
| 5 | An application for a licence to hawk medicines | 880 |
| 6 | An application for a combined licence to pack, and to sell by retail, medicines | 313 |
| 7 | An application for a licence to operate a pharmacy | 1,097 |
Schedule 5A: amended, on 1 July 2022, by regulation 8 of the Medicines Amendment Regulations 2022 (SL 2022/116).
Schedule 6 Regulations revoked
Part ARestricted drugs
Restricted Drugs Regulations 1964 (SR 1964/64)
Restricted Drugs Regulations 1964, Amendment No 1 (SR 1966/84)
Restricted Drugs Regulations 1964, Amendment No 2 (SR 1967/250)
Restricted Drugs Regulations 1964, Amendment No 3 (SR 1969/95)
Restricted Drugs Regulations 1964, Amendment No 4 (SR 1969/193)
Restricted Drugs Regulations 1964, Amendment No 5 (SR 1971/55)
Restricted Drugs Regulations 1964, Amendment No 6 (SR 1972/53)
Restricted Drugs Regulations 1964, Amendment No 7 (SR 1972/163)
Restricted Drugs Regulations 1964, Amendment No 8 (SR 1973/111)
Restricted Drugs Regulations 1964, Amendment No 9 (SR 1974/93)
Restricted Drugs Regulations 1964, Amendment No 10 (SR 1974/133)
Restricted Drugs Regulations 1964, Amendment No 11 (SR 1975/25)
Restricted Drugs Regulations 1964, Amendment No 12 (SR 1977/130)
Restricted Drugs Regulations 1964, Amendment No 13 (SR 1978/52)
Restricted Drugs Regulations 1964, Amendment No 14 (SR 1979/37)
Restricted Drugs Regulations 1964, Amendment No 15 (SR 1979/273)
Restricted Drugs Regulations 1964, Amendment No 16 (SR 1981/120)
Restricted Drugs Regulations 1964, Amendment No 17 (SR 1982/32)
Restricted Drugs Regulations 1964, Amendment No 18 (SR 1982/248)
Restricted Drugs Regulations 1964, Amendment No 19 (SR 1983/132)
Restricted Drugs Regulations 1964, Amendment No 20 (SR 1983/289)
Restricted Drugs Regulations 1964, Amendment No 21 (SR 1984/78)
Part BRestricted drugs licences
Restricted Drug Licences Regulations 1961 (SR 1961/39)
Restricted Drug Licences Regulations 1961, Amendment No 1 (SR 1963/123)
Restricted Drug Licences Regulations 1961, Amendment No 2 (SR 1983/133)
Part CTherapeutic drugs (permitted sales)
Therapeutic Drugs (Permitted Sales) Regulations 1978 (SR 1978/34)
Therapeutic Drugs (Permitted Sales) Regulations 1978, Amendment No 1 (SR 1978/230)
Therapeutic Drugs (Permitted Sales) Regulations 1978, Amendment No 2 (SR 1979/168)
Therapeutic Drugs (Permitted Sales) Regulations 1978, Amendment No 3 (SR 1980/114)
Therapeutic Drugs (Permitted Sales) Regulations 1978, Amendment No 4 (SR 1980/264)
Therapeutic Drugs (Permitted Sales) Regulations 1978, Amendment No 5 (SR 1981/119)
Therapeutic Drugs (Permitted Sales) Regulations 1978, Amendment No 6 (SR 1981/324)
Therapeutic Drugs (Permitted Sales) Regulations 1978, Amendment No 7 (SR 1982/189)
Therapeutic Drugs (Permitted Sales) Regulations 1978, Amendment No 8 (SR 1983/20)
Therapeutic Drugs (Permitted Sales) Regulations 1978, Amendment No 9 (SR 1983/73)
Therapeutic Drugs (Permitted Sales) Regulations 1978, Amendment No 10 (SR 1983/147)
Therapeutic Drugs (Permitted Sales) Regulations 1978, Amendment No 11 (SR 1983/205)
Therapeutic Drugs (Permitted Sales) Regulations 1978, Amendment No 12 (SR 1984/41)
P G Millen,
Clerk of the Executive Council.
Date of notification in Gazette: 7 June 1984.
Notes
1 General
This is a consolidation of the Medicines Regulations 1984 that incorporates the amendments made to the legislation so that it shows the law as at its stated date.
2 Legal status
A consolidation is taken to correctly state, as at its stated date, the law enacted or made by the legislation consolidated and by the amendments. This presumption applies unless the contrary is shown.
Section 78 of the Legislation Act 2019 provides that this consolidation, published as an electronic version, is an official version. A printed version of legislation that is produced directly from this official electronic version is also an official version.
3 Editorial and format changes
The Parliamentary Counsel Office makes editorial and format changes to consolidations using the powers under subpart 2 of Part 3 of the Legislation Act 2019. See also PCO editorial conventions for consolidations.
4 Amendments incorporated in this consolidation
Medicines (Administration and Supply of Medicines in Approved Immunisation Programmes) Amendment Regulations 2025 (SL 2025/318)
Medicines (Restriction on Prescribing Gonadotropin-releasing Hormone Analogues) Amendment Regulations (No 2) 2025 (SL 2025/302)
Medicines (Restriction on Prescribing Gonadotropin-releasing Hormone Analogues) Amendment Regulations 2025 (SL 2025/256)
Medicines (Increasing the Period of Supply) Amendment Regulations 2025 (SL 2025/203)
Misuse of Drugs (Medicinal Cannabis) Amendment Regulations 2024 (SL 2024/129): regulations 49–52
Medicines (Pseudoephedrine) Amendment Regulations 2024 (SL 2024/4)
Medicines Amendment Regulations 2023 (SL 2023/130)
Medicines Amendment Regulations (No 2) 2022 (SL 2022/304)
Pae Ora (Healthy Futures) Act 2022 (2022 No 30): section 104
Medicines Amendment Regulations 2022 (SL 2022/116)
Water Services Act 2021 (2021 No 36): section 206(2)
Medicines (Assisted Dying Medications) Amendment Regulations 2021 (LI 2021/266)
Medicines Amendment Regulations (No 2) 2021 (LI 2021/228)
Medicines Amendment Regulations 2021 (LI 2021/44)
Medicines Amendment Regulations 2020 (LI 2020/262)
Smokefree Environments and Regulated Products (Vaping) Amendment Act 2020 (2020 No 62): section 30
Abortion Legislation Act 2020 (2020 No 6): section 18(2)
Misuse of Drugs (Medicinal Cannabis) Regulations 2019 (LI 2019/321): regulations 84, 85
Medicines Amendment Regulations 2015 (LI 2015/7)
Medicines Amendment Regulations 2014 (LI 2014/165)
Medicines Amendment Regulations 2012 (SR 2012/329)
Criminal Procedure Act 2011 (2011 No 81): section 413
Medicines Amendment Regulations 2011 (SR 2011/245)
Medicines (Property Law Act 2007) Amendment Regulations 2007 (SR 2007/382)
Medicines (Fees) Amendment Regulations 2006 (SR 2006/188)
Medicines Amendment Regulations 2006 (SR 2006/158)
Medicines (Designated Prescriber: Nurse Practitioners) Regulations 2005 (SR 2005/266): regulation 12(2)(a)
Medicines Amendment Regulations 2005 (SR 2005/255)
Medicines Amendment Regulations 2004 (SR 2004/300)
Health Practitioners Competence Assurance Act 2003 (2003 No 48): section 175(3)
Medicines Amendment Regulations (No 2) 2002 (SR 2002/374)
Health and Disability Services (Safety) Act 2001 (2001 No 93): section 58(3)
Medicines Amendment Regulations 2001 (SR 2001/232)
Medicines Amendment Regulations 2000 (SR 2000/220)
Medicines Amendment Regulations 1997 (SR 1997/165)
Medicines Regulations 1984, Amendment No 6 (SR 1994/299)
Medicines Regulations 1984, Amendment No 5 (SR 1992/43)
Medicines Regulations 1984, Amendment No 4 (SR 1991/134)
Medicines Regulations 1984 (SR 1984/143): regulation 44AB(5)
Versions
Medicines Regulations 1984
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