Medicines Regulations 1984

Reprint as at 1 September 2021

Coat of Arms of New Zealand

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

Changes authorised by subpart 2 of Part 2 of the Legislation Act 2012 have been made in this official reprint.

Note 4 at the end of this reprint provides a list of the amendments incorporated.

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

1Title and commencement
2Interpretation
3Classification of medicines
4Standards for medicines, related products, medical devices, cosmetics, and surgical dressings
4AStandard for CBD products
5Pharmacist may dilute medicine in particular case
6Colouring substances [Revoked]
7Advertisements not to claim official approval
8Advertisements for medicines
9Advertisements for related products
10Advertisements for medical devices
11Advertisements intended for health professions
12Medicines, related products, and medical devices not to be sold unless properly labelled
13Labelling of medicines
14Labelling of related products
15Exemptions from regulations 13 and 14
16Principal display panel
17Form and manner of labelling
18Size of letters
19Labelling of prescription medicines, restricted medicines, and pharmacy-only medicines
20Consumer information panel [Revoked]
21Labels on containers of medicines or related products containing vitamins
22Warning statements for medicines and related products
23Labels on containers of medicines sold by authorised prescribers or pharmacists
24Labels on containers of hair dyes
25Misleading statements
26Persons handling medicines, related products, and cosmetics
27Infected persons
28Persons in contact with infected persons
29Places of manufacture, storage, and sale
30Dwellinghouses prohibited for manufacture and packing
31Powers of Medical Officer of Health in respect of premises
32Storage of medicines, etc
33Construction and use of containers, etc
34Exposure to toxic substances prohibited
35Containers for medicines, related products, and cosmetics
36Storage to be separate
37Safety containers
38Containers
39Conditions under which authorised prescribers and veterinarians may prescribe prescription medicines
39ALimit on period of supply of prescription medicines
40Prescriptions to comply with regulations
40AUrgently required prescriptions of prescription medicines may be communicated orally if later confirmed in writing
41Form of prescription
42Dispensing of prescription medicines
43Director-General may waive certain requirements
44Prescriptions for prescription medicines not required in certain cases
44AAdministration of vaccines in approved immunisation programmes
44ABAuthorisation of vaccinators
44BDuty to supply information
44CNo export of prescription medicines for retail sale without New Zealand prescription
44DSupply of restricted medicine and pharmacy-only medicine
45Application for licence to manufacture, hawk, sell, or pack medicine
45AApplication for licence to operate pharmacy
45BLicences that relate to CBD products
46Form and conditions of licence
47Licence to manufacture medicines
48Licence to hawk certain medicines
48ALicensing authority to be advised of change in particulars relating to operating pharmacy
49Surrender of licence
50Withdrawal of medicines, etc
51Interpretation
52Approval of data sheets for new medicines
53Approval of data sheets for changed medicines
54Particulars in data sheets [Revoked]
54ASale of Medicines Registers
55Records of sales by retail or wholesale
56Record of hawker’s sales
57Record of supplies pursuant to prescriptions
58Records to be kept
58ASubstances that are not medicines or related products for purposes of Act
58BFluoridating agents and fluoridated water not medicines or related products
58CSubstances used to terminate pregnancy are medicines
58DNon-oral products containing nicotine are medicines
59General sale medicines may be sold by vending machine
60Certificate of analyst
61Fees
61AWaiver and refund of fees
61BFees inclusive of goods and services tax
62Medical devices
63Restriction on, and supervision of, compounding medicine
64Offences
65Appeals to District Court
65ATransitional provision arising from enactment of Medicines Amendment Regulations 2011
66Revocations
[Revoked]
Gazette Information
Reprint notes

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 established by section 46 of the New Zealand Public Health and Disability Act 2000

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) 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).

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.

(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).

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 6(1) of the New Zealand Public Health and Disability Act 2000); 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).

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).

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—

(a)

6 months’ supply in the case of an oral contraceptive; or

(b)

3 months’ supply in any other case.

(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 the period of supply in subclause (1)(a) or (b):

(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 the period of supply in subclause (1)(a) or (b).

Regulation 39A: inserted, on 1 December 2011, by regulation 15 of the Medicines Amendment Regulations 2011 (SR 2011/245).

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 in writing

(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 forward to the pharmacist a written prescription confirming the oral communication.

Regulation 40A: inserted, on 11 October 2001, by regulation 11 of the Medicines Amendment Regulations 2001 (SR 2001/232).

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 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

Every prescription given under these regulations shall—

(a)

be legibly and indelibly printed; and

(b)

be signed personally by the prescriber with his usual signature (not being a facsimile or other stamp), and dated; 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”.

Regulation 41(c): substituted, on 1 December 2011, by regulation 18(1) of the Medicines Amendment Regulations 2011 (SR 2011/245).

Regulation 41(d)(i): substituted, on 1 December 2011, by regulation 18(2) of the Medicines Amendment Regulations 2011 (SR 2011/245).

Regulation 41(f): substituted, on 1 December 2011, by regulation 18(3) of the Medicines Amendment Regulations 2011 (SR 2011/245).

Regulation 41(i): revoked, on 1 December 2011, by regulation 18(4) of the Medicines Amendment Regulations 2011 (SR 2011/245).

Regulation 41(j)(i): substituted, on 1 December 2011, by regulation 18(5) of the Medicines Amendment Regulations 2011 (SR 2011/245).

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 written 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 other than an oral contraceptive must not be dispensed on any occasion after 6 months have elapsed from the date on which it was printed or, if given under regulation 40A(1), communicated orally:

(d)

a prescription for a medicine that is an oral contraceptive must not be dispensed on any occasion after 9 months have elapsed from the date on which it was printed or, if given under regulation 40A(1), communicated orally:

(e)

every 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 signs and dates 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(4): substituted, on 1 August 2011, by regulation 19(2) of the Medicines Amendment Regulations 2011 (SR 2011/245).

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.

(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).

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 Medicine 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 of vaccines 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, for the purposes of an approved immunisation programme, a vaccine that is a prescription medicine, may, in carrying out that immunisation programme, administer that prescription medicine otherwise than pursuant to a prescription.

(2)

The Director-General or a Medical Officer of Health may authorise any person to administer a vaccine for the purposes of an approved immunisation programme 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(2)(a): amended, on 11 October 2001, by regulation 14 of the Medicines Amendment Regulations 2001 (SR 2001/232).

44AB 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 be a COVID-19 vaccinator—

(a)

to prepare the COVID-19 vaccine:

(b)

to administer the COVID-19 vaccine without a prescription.

(2)

In applying for authorisation as a COVID-19 vaccinator, a person must provide evidence to satisfy the Director-General or 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)

the preparation of the COVID-19 vaccine for administration:

(ii)

the administration of the COVID-19 vaccine; 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.

(3)

A person authorised as a COVID-19 vaccinator 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.

Regulation 44AB: inserted, on 28 May 2021, by regulation 5 of the Medicines (COVID-19 Vaccinators) Amendment Regulations 2021 (LI 2021/123).

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).

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)

be made,—

(i)

in the case of a company, in form 1A of Schedule 2; and

(ii)

in the case of a person (including a body corporate that is not a company), in form 1B of Schedule 2; and

(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 a CBD product unless the product has been assessed as complying with the minimum quality standard under the Misuse of Drugs (Medicinal Cannabis) Regulations 2019.

(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).

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 and drinking-water supply have the same meanings as in section 69G of the Health Act 1956

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).

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).

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 $43,875.

(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 $5,500.

(6)

The fee to accompany an application made under section 23 of the Act for the Minister’s provisional consent shall be $8,437.

(7)

The fee to accompany a notice deposited with the Director-General under section 24 of the Act shall be $3,200.

(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.

(11)

For the purposes of subclause (3), not generally available means not legally available other than pursuant to an exemption granted under any or all of sections 25, 26, 27, 28, 29, 30, 31, 32, 32A, or 33 of the Act.

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 21 August 2006, by regulation 5(3) of the Medicines (Fees) Amendment Regulations 2006 (SR 2006/188).

Regulation 61(6): amended, on 21 August 2006, by regulation 5(4) of the Medicines (Fees) Amendment Regulations 2006 (SR 2006/188).

Regulation 61(7): amended, on 21 August 2006, by regulation 5(5) of the Medicines (Fees) Amendment Regulations 2006 (SR 2006/188).

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)

contravenes or fails to comply with any of the provisions of regulations 26(1), 26(2), 27, 28(3), 29, 30, 31(5), 32(1), 32(2), 33(1), 33(2), 33(3), 34, 35(1), 35(3), 35(7), 35(9), 35(10), 36, 37(1), 39, 39A(1), 40(1), 40A(2), 42(1), 42(3), 42(4), 44B(4), and 49(1); or

(b)

fails to comply with any order made by the Director-General under regulation 50(1); or

(c)

contravenes or fails to comply with any of the provisions of regulations 50(2), 52(3), 53(4), 55(1), 56(1), 56(3), 56(4), 57(1), 58, 62, and 63.

(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 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 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

(1)

Until 1 February 2012, it is sufficient compliance with the advertising requirements of regulations 8 and 11 to comply with regulations 8 and 11 as in force immediately before 1 August 2011.

(2)

For medicines and related products manufactured or imported before 1 September 2012, it is sufficient compliance with the labelling requirements of regulations 13 to 16, 19, 22, 23, and 37 to comply with regulations 13 to 16, 19, 20, 22, 23, and 37 as in force immediately before 1 August 2011.

Regulation 65A: inserted, on 1 August 2011, by regulation 26 of the Medicines Amendment Regulations 2011 (SR 2011/245).

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 1 Prescription, restricted, and pharmacy-only medicines

r 3

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 to a person 13 years of age or over 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

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

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

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

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:

NameDate of birthPosition 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 designationTrade name of medicineClass
 
 
 
 
 
 

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 designationTrade name of medicineClass
 
 
 
 
 
 

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

r 45A(1)(a)(i)

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)

r 45A(1)(a)(ii)

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

(Issued pursuant to the Medicines Act 1981)

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

(Issued pursuant to the Medicines Act 1981)

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

(Issued pursuant to the Medicines Act 1981)

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

(Issued pursuant to the Medicines Act 1981)

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

(Issued pursuant to the Medicines Act 1981)

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

r 46(1)(f)

Section 51, Medicines Act 1981

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]

r 53(2)

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

r 56(2)(a)

Name of medicineFormStrengthPage
 
 
 
 
Date

Name and address of supplier of medicine

or

Name and address of person to whom medicine sold

Order NoInOutBalance
 
 
 
 
 
 
 
 
 

Schedule 5 Analyst’s certificate under the Medicines Act 1981

r 60

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

rr 45A(1)(b)(i), 61(1)

Schedule 5A: inserted, on 21 August 2006, by regulation 6 of the Medicines (Fees) Amendment Regulations 2006 (SR 2006/188).

$
1An application for a licence to manufacture medicines13,750
2An application for a licence to pack medicines845
3An application for a licence to sell medicines by retail845
4An application for a licence to sell medicines by wholesale1,054
5An application for a licence to hawk medicines845
6An application for a combined licence to pack, and to sell by retail, medicines300
7An application for a licence to operate a pharmacy1,030

Schedule 6 Regulations revoked

r 62

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.

Issued under the authority of the Legislation Act 2012.

Date of notification in Gazette: 7 June 1984.

Reprints notes
1 General

This is a reprint of the Medicines Regulations 1984 that incorporates all the amendments to those regulations as at the date of the last amendment to them.

2 Legal status

Reprints are presumed to correctly state, as at the date of the reprint, the law enacted by the principal enactment and by any amendments to that enactment. Section 18 of the Legislation Act 2012 provides that this reprint, published in electronic form, has the status of an official version under section 17 of that Act. A printed version of the reprint produced directly from this official electronic version also has official status.

3 Editorial and format changes

Editorial and format changes to reprints are made using the powers under sections 24 to 26 of the Legislation Act 2012. See also http://www.pco.parliament.govt.nz/editorial-conventions/.

4 Amendments incorporated in this reprint

Medicines Amendment Regulations (No 2) 2021 (LI 2021/228)

Medicines (COVID-19 Vaccinators) Amendment Regulations 2021 (LI 2021/123)

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)