Medicines Regulations 1984

  • This version was replaced on 7 November 2018 to make corrections to Schedule 1 Part 1 item 787 under section 25(1)(j)(ii) of the Legislation Act 2012.

Reprint as at 25 October 2018

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
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
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
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
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.

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).

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).

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).

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 25 October 2018, by regulation 4 of the Medicines Amendment Regulations 2018 (LI 2018/179).

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

Abiraterone

11

Abrus precatorius; at all strengths

12

Acamprosate

13

Acarbose

14

Acebutolol

15

Acepromazine

16

Acetanilides

17

Acetarsol

18

Acetazolamide

19

Acetohexamide

20

Acetylcarbromal

21

Acetylcholine; except in medicines containing 1 milligram or less per litre or per kilogram

22

Acetylcysteine; for injection or inhalation

23

Acetyldigitoxin

24

Acetylmethyldimethyloximidophenylhydrazine

25

Acetylstrophanthidin

26

Aciclovir; except when specified elsewhere in this schedule

27

Acipimox

28

Acitretin

29

Aclidinium bromide

30

Acokanthera ouabaio

31

Acokanthera schimperi

32

Aconitum spp; except when specified elsewhere in this schedule

33

Acrivastine

34

Adalimumab

35

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

36

Adefovir

37

Adenosine; for injection

38

Adinazolam

39

Adiphenine

40

Adonis vernalis

41

Adrafinil

42

Adrenal extract; except for dermal use in medicines containing 0.02% or less of ketosteroids

43

Adrenaline; in medicines containing more than 1%

44

Adrenocortical hormones; except adrenal extract for dermal use containing 0.02% or less of ketosteroids

45

Afamelanotide

46

Afatinib

47

Aflibercept

48

Agalsidase

49

Agomelatine

50

Alatrofloxacin

51

Albendazole

52

Albumin; except human albumin

53

Alclofenac

54

Alclometasone; except when specified elsewhere in this schedule

55

Alcohol; for injection in medicines containing more than 20%

56

Alcuronium

57

Aldesleukin

58

Aldosterone; except in medicines containing 10 micrograms or less per litre or per kilogram

59

Alectinib

60

Alefacept

61

Alemtuzumab

62

Alendronic acid

63

Alfacalcidol

64

Alfentanil

65

Alfuzosin

66

Alglucerase

67

Alglucosidase

68

Alirocumab

69

Aliskiren

70

Alkyl sulfonals

71

Allergens

72

Allopurinol

73

Allylisopropylacetylurea; at all strengths

74

Allyloestrenol

75

Alogliptin

76

Aloracetam

77

Alosetron

78

Alpha1-proteinase inhibitor

79

Alphadolone

80

Alphaxalone

81

Alprazolam

82

Alprenolol

83

Alprostadil

84

Alseroxylon

85

Alteplase

86

Altretamine

87

Amantadine

88

Ambenonium

89

Ambrisentan

90

Ambucetamide

91

Ambutonium

92

Amcinonide

93

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

94

Amfebutamone

95

Amfepramone

96

Amidopyrine

97

Amifampridine

98

Amifostine

99

Amikacin

100

Amiloride

101

Aminocaproic acid

102

Aminoglutethimide

103

Aminometradine

104

Aminophenazone; at all strengths

105

Aminophylline; except when specified elsewhere in this schedule

106

Aminopterin

107

Aminorex

108

Aminosalicylic acid

109

Amiodarone

110

Amiphenazole

111

Amisometradine

112

Amisulpride

113

Amitriptyline

114

Amlodipine

115

Ammi visnaga

116

Ammonium bromide

117

Amobarbital

118

Amodiaquine

119

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

120

Amoxapine

121

Amoxycillin

122

Amphomycin

123

Amphotericin

124

Ampicillin

125

Amprenavir

126

Amrinone

127

Amsacrine

128

Amygdalin; at all strengths

129

Amyl nitrite; except when sold to a person who is appropriately authorised under the Health and Safety at Work Act 2015

130

Amylocaine

131

Anabolic steroids

132

Anagrelide

133

Anakinra

134

Anastrozole

135

Ancestim

136

Anchusa officinalis; at all strengths

137

Ancrod and its immunoglobulin antidote

138

Androgenic and anabolic steroidal agents

139

Androgens

140

Androisoxazole

141

Androstanolone

142

Androstenediol

143

Androstenedione

144

Anecortave

145

Angiotensinamide

146

Anidulafungin

147

Aniracetam

148

Anistreplase

149

Antazoline; except for ophthalmic use

150

Antibiotic substances; except when specified elsewhere in this schedule

151

Antigens

152

Antihistamines; except when specified elsewhere in this schedule

153

Antimony; except in medicines containing 1 milligram or less per litre or per kilogram

154

Antisera; for injection

155

AOD-9604

156

Apalutamide

157

Apixaban

158

Apocynum spp

159

Apomorphine; except in medicines containing 1 milligram or less per litre or per kilogram

160

Apraclonidine

161

Apremilast

162

Aprepitant

163

Apronal

164

Aprotinin

165

Arecoline

166

Aripiprazole

167

Aristolochia spp; at all strengths

168

Aristolochic acid; at all strengths

169

Armodafinil

170

Arsenic; except in medicines containing 1 milligram or less per litre or per kilogram

171

Artemether

172

Artesunate

173

Articaine; except when used as a local anaesthetic in practice by a dental therapist or oral health therapist registered with the Dental Council

174

Asenapine

175

Asfotase alfa

176

Asparaginase

177

Aspirin; except when specified elsewhere in this schedule; for injection; when combined with caffeine, paracetamol, or salicylamide

178

Astemizole

179

Asunaprevir

180

Atamestane

181

Atazanavir

182

Atenolol

183

Atezolizumab

184

Atomoxetine

185

Atorvastatin

186

Atosiban

187

Atovaquone

188

Atracurium

189

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

190

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

191

Atropine methonitrate

192

Auranofin

193

Aurothiomalate sodium

194

Avanafil

195

Aviptadil

196

Axitinib

197

Azacitidine

198

Azacyclonol

199

Azapropazone

200

Azaribine

201

Azatadine; except when specified elsewhere in this schedule

202

Azathioprine

203

Azelaic acid; except when specified elsewhere in this schedule

204

Azelastine; except when specified elsewhere in this schedule

205

Azithromycin

206

Azlocillin

207

Aztreonam

208

Bacampicillin

209

Bacitracin

210

Baclofen

211

Balsalazide

212

Bambuterol

213

Bamethan

214

Bamipine

215

Barbital

216

Barbiturates

217

Basiliximab

218

Bazedoxifene

219

Becaplermin

220

Beclamide

221

Beclomethasone; except when specified elsewhere in this schedule

222

Bedaquiline

223

Belatacept

224

Belimumab

225

Bemegride

226

Benactyzine

227

Benazepril

228

Bendamustine

229

Bendrofluazide

230

Benethamine penicillin

231

Benorylate

232

Benoxaprofen

233

Benperidol

234

Benserazide

235

Benzathine penicillin

236

Benzatropine

237

Benzbromarone

238

Benzhexol

239

Benzilonium

240

Benzocaine; except when specified elsewhere in this schedule

241

Benzodiazepine derivatives; except when specified elsewhere in this schedule

242

Benzodiazepines; except when specified elsewhere in this schedule

243

Benzoyl metronidazole

244

Benzoyl peroxide; except when specified elsewhere in this schedule

245

Benzthiazide

246

Benzydamine; except when specified elsewhere in this schedule

247

Benzylpenicillin

248

Bepridil

249

Beractant

250

Besifloxacin

251

Beta carotene; in medicines containing more than 18 milligrams per recommended daily dose

252

Betahistine

253

Betaine; for the treatment of homocystinuria

254

Betamethasone

255

Betaxolol

256

Bethanechol

257

Bethanidine

258

Bevacizumab

259

Bevantolol

260

Bexarotene

261

Bezafibrate

262

Bezlotoxumab

263

Bicalutamide

264

Bictegravir

265

Bifonazole; except when specified elsewhere in this schedule

266

Bilastine; except when specified elsewhere in this schedule

267

Bimatoprost

268

Binimetinib

269

Biperiden

270

Bismuth; except for external use in medicines containing 3% or less

271

Bisoprolol

272

Bithionol; at all strengths

273

Bivalirudin

274

Bleomycin

275

Boceprevir

276

Bolandiol

277

Bolasterone

278

Bolazine

279

Boldenone

280

Bolenol

281

Bolmantalate

282

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

283

Bortezomib

284

Bosentan

285

Bosutinib

286

Botulinum toxins

287

Brentuximab vedotin

288

Bretylium

289

Brexpiprazole

290

Brimonidine

291

Brinzolamide

292

Brivaracetam (and its stereoisomers)

293

Bromazepam

294

Bromocriptine

295

Bromoform

296

Brompheniramine; except when specified elsewhere in this schedule

297

Bromvaletone

298

Brotizolam

299

Brugmansia spp

300

Buclizine; except for oral use

301

Budesonide; except when specified elsewhere in this schedule

302

Bufexamac; except in suppositories; except for dermal use in medicines containing 5% or less

303

Bumetanide

304

Buniodyl sodium; at all strengths

305

Buphenine

306

Bupivacaine

307

Buprenorphine

308

Bupropion

309

Buserelin

310

Buspirone

311

Busulphan

312

Butacaine

313

Butobarbital

314

Butoconazole; except for vaginal use

315

Butorphanol

316

Butyl aminobenzoate; except in medicines for dermal use containing 2% or less

317

Butyl nitrite

318

Butylchloral hydrate

319

Cabazitaxel

320

Cabergoline

321

Cabozantinib

322

Cacalia spp; at all strengths

323

Cadmium

324

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

325

Calcitonin

326

Calcitriol

327

Calcium carbimide

328

Calcium polystyrene sulphonate

329

Calotropis gigantea

330

Calotropis procera

331

Calusterone

332

Camazepam

333

Camphorated oil

334

Camphotamide

335

Canagliflozin

336

Canakinumab

337

Candesartan

338

Candicidin

339

Cannabidiol

340

Capecitabine

341

Capreomycin

342

Captodiame

343

Captopril

344

Capuride

345

Caramiphen

346

Carbachol

347

Carbamazepine

348

Carbaryl; except for external use in medicines containing 2% or less

349

Carbazochrome

350

Carbenicillin

351

Carbenoxolone; except for external use

352

Carbetocin

353

Carbidopa

354

Carbimazole

355

Carbocromen

356

Carboplatin

357

Carboprost

358

Carbromal

359

Carbutamide

360

Carbuterol

361

Carfilzomib

362

Carglumic acid

363

Carindacillin

364

Carisoprodol

365

Carmustine

366

Carprofen

367

Carvedilol

368

Caspofungin

369

Catumaxomab

370

Cebaracetam (and its stereoisomers)

371

Cefacetrile

372

Cefaclor

373

Cefaloridine

374

Cefamandole

375

Cefapirin

376

Cefazolin

377

Cefepime

378

Cefetamet

379

Cefixime

380

Cefodizime

381

Cefonicid

382

Cefoperazone

383

Cefotaxime

384

Cefotetan

385

Cefotiam

386

Cefoxitin

387

Cefpirome

388

Cefpodoxime

389

Cefsulodin

390

Ceftaroline fosamil

391

Ceftazidime

392

Ceftibuten

393

Ceftolozane

394

Ceftriaxone

395

Cefuroxime

396

Celecoxib

397

Celiprolol

398

Cephaelis acuminata; except in medicines containing less than 0.2% of emetine

399

Cephaelis ipecacuanha; except in medicines containing less than 0.2% of emetine

400

Cephalexin

401

Cephalothin

402

Cephradine

403

Ceritinib

404

Cerivastatin

405

Certolizumab pegol

406

Ceruletide

407

Cetirizine; except when specified elsewhere in this schedule

408

Cetrorelix

409

Cetuximab

410

Chenodeoxycholic acid

411

Chloral hydrate; except for dermal use in medicines containing 2% or less

412

Chloralformamide

413

Chloralose

414

Chlorambucil

415

Chloramphenicol; except when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board; except when specified elsewhere in this schedule

416

Chlorandrostenolone

417

Chlorazanil

418

Chlorcyclizine

419

Chlordiazepoxide

420

Chlormerodrin

421

Chlormethiazole

422

Chlormezanone

423

Chloroform; for anaesthesia; except when specified elsewhere in this schedule

424

Chloroquine

425

Chlorothiazide

426

Chlorotrianisene

427

Chloroxydienone

428

Chloroxymesterone

429

Chlorpheniramine; except when specified elsewhere in this schedule

430

Chlorphentermine

431

Chlorpromazine

432

Chlorpropamide

433

Chlorprothixene

434

Chlorquinaldol

435

Chlortetracycline

436

Chlorthalidone

437

Chlorzoxazone

438

Cholera vaccine; except in the form of an oral liquid containing vibrio cholerae when sold in a pharmacy by a registered pharmacist

439

Cholic acid

440

Choline salicylate; except in medicines containing 10% or less and in pack sizes of 15 grams or less

441

Chorionic gonadotrophin; except in pregnancy test kits

442

Chymopapain

443

Ciclacillin

444

Ciclesonide

445

Ciclopirox; except when specified elsewhere in this schedule

446

Cidofovir

447

Cilastatin

448

Cilazapril

449

Cilostazol

450

Cimetidine; except when specified elsewhere in this schedule

451

Cinacalcet

452

Cinchocaine; for injection; for ophthalmic use; for external use in medicines containing more than 0.5%

453

Cinchophen

454

Cinnarizine

455

Cinoxacin

456

Ciprofloxacin

457

Cisapride

458

Cisatracurium

459

Cisplatin

460

Citalopram

461

CJC-1295

462

Cladribine

463

Clarithromycin

464

Clavulanic acid

465

Clemastine; except for oral use

466

Clemizole

467

Clenbuterol

468

Clevidipine

469

Clidinium

470

Clindamycin

471

Clioquinol; at all strengths

472

Clobazam

473

Clobetasol

474

Clobetasone; except when specified elsewhere in this schedule

475

Clocortolone

476

Clodronic acid

477

Clofarabine

478

Clofazimine

479

Clofenamide

480

Clofibrate

481

Clomiphene

482

Clomipramine

483

Clomocycline

484

Clonazepam

485

Clonidine

486

Clopamide

487

Clopidogrel

488

Clorazepic acid

489

Clorexolone

490

Clorprenaline

491

Clostebol

492

Clotiazepam

493

Clotrimazole; except when specified elsewhere in this schedule

494

Cloxacillin

495

Cloxazolam

496

Clozapine

497

Cobalt

498

Cobicistat

499

Cobimetinib

500

Cocaine; except when specified elsewhere in this schedule

501

Codeine; except when specified elsewhere in this schedule

502

Co-dergocrine

503

Colaspase

504

Colchicine

505

Colchicum

506

Colecalciferol; except in medicines containing 25 micrograms or less per recommended daily dose; except in parenteral nutrition replacement preparations

507

Colestipol

508

Colestyramine

509

Colfosceril

510

Colistin

511

Collagen; in injections or implants for tissue augmentation or cosmetic use

512

Collagenase clostridium histolyticum

513

Coluracetam

514

Conium maculatum; at all strengths

515

Convallaria keiski

516

Convallaria majalis

517

Corifollitropin alfa

518

Coronilla spp

519

Corticosterone

520

Corticotrophin

521

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

522

Cotarnine; at all strengths

523

Co-trimoxazole

524

Coumarin

525

Crizotinib

526

Crofelemer

527

Crotalaria spp; at all strengths

528

Croton tiglium; except in medicines containing 1 milligram or less per litre or per kilogram

529

Crystal violet

530

Curare

531

Cyclandelate

532

Cyclizine; except when specified elsewhere in this schedule

533

Cyclobenzaprine

534

Cyclofenil

535

Cycloheximide

536

Cyclopenthiazide

537

Cyclopentolate; except when used in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board

538

Cyclophosphamide

539

Cyclopropane

540

Cycloserine

541

Cyclosporin

542

Cyclothiazide

543

Cycrimine

544

Cymarin

545

Cynoglossum spp; at all strengths

546

Cyproheptadine; except for oral use

547

Cyproterone

548

Cysteamine

549

Cytarabine

550

Dabigatran

551

Dabrafenib mesilate

552

Dacarbazine

553

Daclatasvir

554

Daclizumab

555

Dactinomycin

556

Dalfopristin

557

Dalteparin

558

Danaparoid

559

Danazol

560

Danthron

561

Dantrolene

562

Dapagliflozin

563

Dapoxetine

564

Dapsone

565

Daptomycin

566

Daratumumab

567

Darbepoetin

568

Darifenacin

569

Darunavir

570

Dasabuvir

571

Dasatinib

572

Datura spp; except for oral use when specified elsewhere in this schedule; except datura stramonium or datura tatula for smoking or burning

573

Daunorubicin

574

Deanol

575

Debrisoquine

576

Decamethonium

577

Deferasirox

578

Deferiprone

579

Defibrotide

580

Deflazacort

581

Degarelix

582

Dehydrochloromethyltestosterone

583

Dehydrocorticosterone

584

Delavirdine

585

Delorazepam

586

Demecarium

587

Demeclocycline

588

Denosumab

589

Deoxycortone

590

Deoxycholic acid; for injection; except for oral use

591

Deoxyribonuclease; except for external use

592

Dermatophagoides farina allergen extract

593

Dermatophagoides pteronyssinus allergen extract

594

Desferrioxamine

595

Desflurane

596

Desipramine

597

Desirudin

598

Deslanoside

599

Desloratadine; except for oral use

600

Deslorelin

601

Desmopressin

602

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

603

Desonide

604

Desoximetasone

605

Desvenlafaxine

606

Dexamethasone

607

Dexamfetamine

608

Dexchlorpheniramine; except when specified elsewhere in this schedule

609

Dexfenfluramine

610

Dexmedetomidine

611

Dextromethorphan; except when specified elsewhere in this schedule

612

Dextromoramide

613

Dextropropoxyphene

614

Dextrorphan

615

Di-iodohydroxy quinoline; except when specified elsewhere in this schedule

616

Di-isopropylamine dichloroacetate

617

Diazepam

618

Diazoxide

619

Dibenzepin

620

Dibotermin

621

Dibrompropamidine; except for ophthalmic use

622

Dichloralphenazone

623

Dichlorophen

624

Dichlorphenamide

625

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

626

Dicloxacillin

627

Dicyclomine

628

Didanosine

629

Dienoestrol

630

Dienogest

631

Diethazine

632

Diethylcarbamazine

633

Diethylstilbestrol

634

Diflorasone

635

Diflucortolone

636

Diflunisal

637

Digitalis lanata

638

Digitalis purpurea

639

Digitoxin

640

Digoxin

641

Digoxin-specific antibody fragment

642

Dihydralazine

643

Dihydrocodeine

644

Dihydroergotoxine

645

Dihydrolone

646

Dihydrotachysterol

647

Diltiazem

648

Dimenhydrinate; except when specified elsewhere in this schedule

649

Dimercaprol

650

Dimethandrostanolone

651

Dimethazine

652

Dimethindene; except for oral use

653

Dimethothiazine

654

Dimethoxanate

655

Dimethyl fumarate

656

Dimethyl sulphoxide

657

Dimiracetam (and its stereoisomers)

658

Dinitrocresols

659

Dinitronaphthols

660

Dinitrophenols

661

Dinitrothymols

662

Dinoprost

663

Dinoprostone

664

Diperodon

665

Diphemanil; except for dermal use

666

Diphenhydramine; except when specified elsewhere in this schedule

667

Diphenidol

668

Diphenoxylate; except when specified elsewhere in this schedule

669

Diphenylpyraline

670

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 a vaccinator training course approved by the Ministry of Health and who is complying with the immunisation standards of the Ministry of Health

671

Diphtheria toxoid

672

Diphtheria vaccine

673

Dipivefrin

674

Dipyridamole

675

Dirithromycin

676

Disopyramide

677

Distigmine

678

Disulfiram

679

Disulphamide

680

Ditiocarb

681

Dobutamine

682

Docetaxel

683

Dofetilide

684

Dolasetron

685

Doliracetam (and its stereoisomers)

686

Dolutegravir

687

Domperidone

688

Donepezil

689

Dopamine

690

Dopexamine

691

Doripenem

692

Dornase

693

Dorzolamide

694

Dothiepin

695

Doxantrazole

696

Doxapram

697

Doxazosin

698

Doxepin

699

Doxorubicin

700

Doxycycline

701

Doxylamine; except when specified elsewhere in this schedule

702

Dronedarone

703

Droperidol

704

Drospirenone

705

Drostanolone

706

Drotrecogin

707

Duboisia leichhardtii; except when specified elsewhere in this schedule

708

Duboisia myoporides; except when specified elsewhere in this schedule

709

Dulcin; at all strengths

710

Duloxetine

711

Dupilumab

712

Dupracetam

713

Dutasteride

714

Dydrogesterone

715

Econazole; except when specified elsewhere in this schedule

716

Ecothiopate

717

Ectylurea

718

Eculizumab

719

Edetic acid; except in medicines containing 0.25% or less; except in contact lens preparations; except dicobalt edetate for the treatment of cyanide poisoning

720

Edoxudine

721

Edrophonium

722

Efalizumab

723

Efavirenz

724

Eflornithine

725

Elbasvir

726

Eletriptan

727

Elosulfase alfa

728

Elotuzumab

729

Eltrombopag olamine

730

Eluxadoline

731

Elvitegravir

732

Emepronium

733

Emetine; except in medicines containing 0.2% or less

734

Emicizumab

735

Empagliflozin

736

Emtricitabine

737

Enalapril

738

Encorafenib

739

Enestebol

740

Enflurane

741

Enfuvirtide

742

Enobosarm

743

Enoxacin

744

Enoxaparin

745

Enoximone

746

Enprostil

747

Entacapone

748

Entecavir

749

Enzalutamide

750

Ephedrine

751

Epicillin

752

Epinastine

753

Epirubicin

754

Epitiostanol

755

Eplerenone

756

Epoetins

757

Epoprostenol

758

Eprosartan

759

Eptifibatide

760

Erenumab

761

Ergocalciferol; except in medicines containing 25 micrograms or less per recommended daily dose

762

Ergometrine

763

Ergot

764

Ergotamine

765

Ergotoxine

766

Eribulin

767

Erlotinib

768

Ertapenem

769

Ertugliflozin

770

Erysimum spp; except in medicines containing 1 milligram or less per litre or per kilogram

771

Erythromycin

772

Erythropoietin

773

Escitalopram

774

Esmolol

775

Esomeprazole; except when specified elsewhere in this schedule

776

Estazolam

777

Estramustine

778

Estropipate

779

Etanercept

780

Ethacrynic acid

781

Ethambutol

782

Ethamivan

783

Ethanolamine; for injection

784

Ethchlorvynol

785

Ether; for anaesthesia; except when specified elsewhere in this schedule

786

Ethinamate

787

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

788

Ethionamide

789

Ethisterone

790

Ethoglucid

791

Ethoheptazine

792

Ethopropazine

793

Ethosuximide

794

Ethotoin

795

Ethoxzolamide

796

Ethyl chloride; for inhalation

797

Ethyl loflazepate

798

Ethyldienolone

799

Ethylhexanediol; at all strengths

800

Ethyloestrenol

801

Ethynodiol

802

Etidocaine

803

Etidronic acid; except in medicines for external use containing 1% or less

804

Etilefrine

805

Etiracetam

806

Etodolac

807

Etofenamate; except for external use

808

Etomidate

809

Etonogestrel

810

Etoposide

811

Etoricoxib

812

Etravirine

813

Etretinate

814

Everolimus

815

Evolocumab

816

Exemestane

817

Exenatide

818

Ezetimibe

819

Factor VIII inhibitor bypassing fraction

820

Famciclovir; except when specified elsewhere in this schedule

821

Famotidine; except when specified elsewhere in this schedule

822

Fampridine

823

Farfugium japonicum; at all strengths

824

Fasoracetam (and its stereoisomers)

825

Febuxostat

826

Felbamate

827

Felbinac; except for external use

828

Felodipine

829

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

830

Fenbufen

831

Fenclofenac

832

Fenfluramine

833

Fenofibrate

834

Fenoldopam

835

Fenoprofen

836

Fenoterol

837

Fenpipramide

838

Fenpiprane

839

Fentanyl

840

Ferric carboxymaltose

841

Ferric derisomaltose

842

Fexofenadine; except when specified elsewhere in this schedule

843

Fibrin

844

Fibrinolysin; except for external use

845

Fibroblast growth factor

846

Fidaxomicin

847

Filgrastim

848

Finasteride

849

Fingolimod

850

Flecainide

851

Fleroxacin

852

Floctafenine

853

Fluanisone

854

Flubromazolam

855

Fluclorolone

856

Flucloxacillin

857

Fluconazole; except when specified elsewhere in this schedule

858

Flucytosine

859

Fludarabine

860

Fludiazepam

861

Fludrocortisone

862

Flufenamic acid

863

Flumazenil

864

Flumethasone

865

Flumethiazide

866

Flunarizine

867

Flunisolide

868

Flunitrazepam

869

Fluocinolone

870

Fluocinonide

871

Fluocortin

872

Fluocortolone

873

Fluorescein; for injection

874

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

875

Fluorometholone

876

Fluorouracil

877

Fluoxetine

878

Fluoxymesterone

879

Flupenthixol

880

Fluphenazine

881

Flurandrenolone

882

Flurazepam

883

Flurbiprofen; except when specified elsewhere in this schedule

884

Fluroxene

885

Fluspirilene

886

Flutamide

887

Fluticasone; except when specified elsewhere in this schedule

888

Fluvastatin

889

Fluvoxamine

890

Folic acid; except when specified elsewhere in this schedule

891

Folinic acid; except when specified elsewhere in this schedule

892

Follicle-stimulating hormone; except in medicines containing 100 micrograms or less per litre or per kilogram

893

Follistatin

894

Follitropin

895

Follitropin delta

896

Fomepizole

897

Fomivirsen

898

Fondaparinux

899

Fonturacetam (and its stereoisomers)

900

Formebolone

901

Formestane

902

Formoterol

903

Fosamprenavir

904

Fosaprepitant

905

Foscarnet

906

Fosfestrol

907

Fosfomycin

908

Fosinopril

909

Fosphenytoin

910

Fotemustine

911

Framycetin

912

Fulvestrant

913

Furaltadone

914

Furazabol

915

Furazolidone

916

Furosemide

917

Fusidic acid

918

Gabapentin

919

Galantamine

920

Galanthus spp

921

Gallamine

922

Galsulfase

923

Ganciclovir

924

Ganirelix

925

Gatifloxacin

926

Gefitinib

927

Gemcitabine

928

Gemeprost

929

Gemfibrozil

930

Gemifloxacin

931

Gemtuzumab ozogamicin

932

Gentamicin

933

Gestodene

934

Gestonorone

935

Gestrinone

936

Ghrelin

937

Gitalin

938

Glatiramer acetate

939

Glecaprevir

940

Glibenclamide

941

Glibornuride

942

Gliclazide

943

Glimepiride

944

Glipizide

945

Glisoxepide

946

Glutathione; for injection

947

Glyceryl trinitrate; for injection; for transdermal use; except in medicines containing 100 micrograms or less per litre or per kilogram

948

Glycopyrronium

949

Glymidine

950

Golimumab

951

Gonadorelin

952

Gonadotrophic hormones; except when specified elsewhere in this schedule

953

Goserelin

954

Gramicidin

955

Granisetron

956

Grazoprevir

957

Grepafloxacin

958

Griseofulvin

959

Growth hormone releasing hormones

960

Growth hormone releasing peptide-6

961

Growth hormone releasing peptides

962

Guaifenesin; except when specified elsewhere in this schedule

963

Guanabenz

964

Guanethidine

965

Guanfacine

966

Guanidine

967

Guselkumab

968

Hachimycin

969

Haematin

970

Haemophilus influenzae vaccine; except in oral vaccines for the prophylaxis of bacterial complications of colds

971

Halazepam

972

Halcinonide

973

Halofantrine

974

Halofenate

975

Haloperidol; except in medicines containing 1 milligram or less per litre or per kilogram

976

Halothane

977

Haloxazolam

978

Halquinol; except for external use

979

Heliotropium spp; at all strengths

980

Hemerocallis

981

Heparins; except when present as an excipient; except for external use

982

Hepatitis A vaccine

983

Hepatitis B vaccine

984

Hetacillin

985

Hexachlorophane; in medicines containing more than 3%; except when specified elsewhere in this schedule

986

Hexamethonium

987

Hexarelin

988

Hexetidine; except for external use

989

Hexobendine

990

Hexocyclium

991

Hexoprenaline

992

Hexaminolevulinate

993

Histamine; except in medicines containing 0.5% or less

994

Homatropine

995

Human chorionic gonadotrophin; except in pregnancy test kits

996

Human growth hormone secretagogues

997

Human papillomavirus vaccine

998

Human protein C

999

Hyaluronic acid; in injections or implants for tissue augmentation or cosmetic use

1000

Hydralazine

1001

Hydrargaphen

1002

Hydrochlorothiazide

1003

Hydrocortisone; except when specified elsewhere in this schedule

1004

Hydrocyanic acid; except when specified elsewhere in this schedule

1005

Hydroflumethiazide

1006

Hydromorphone

1007

Hydroquinone; except when specified elsewhere in this schedule

1008

Hydroxychloroquine

1009

Hydroxyephedrine

1010

Hydroxyphenamate

1011

Hydroxyprogesterone

1012

Hydroxystenozol

1013

Hydroxyurea

1014

Hydroxyzine

1015

Hylan polymer; in injections or implants for tissue augmentation or cosmetic use

1016

Hyoscine; except when specified elsewhere in this schedule; except in medicines containing 300 micrograms or less per litre or per kilogram

1017

Hyoscine butylbromide; except when specified elsewhere in this schedule

1018

Hyoscyamine; except when specified elsewhere in this schedule; except in medicines containing 300 micrograms or less per litre or per kilogram

1019

Hyoscyamus niger; except when specified elsewhere in this schedule

1020

Hypothalamic releasing factors

1021

Hypromellose; for injection; except in intraocular viscoelastic products

1022

Ibandronic acid

1023

Ibogaine

1024

Ibritumomab tiuxetan

1025

Ibrutinib

1026

Ibufenac

1027

Ibuprofen; except when specified elsewhere in this schedule

1028

Ibuterol

1029

Ibutilide

1030

Icatibant

1031

Idarubicin

1032

Idarucizumab

1033

Idebenone

1034

Idelalisib

1035

Idoxuridine; except for dermal use in medicines containing 0.5% or less

1036

Idursulfase

1037

Ifosfamide

1038

Iloprost

1039

Imatinib

1040

Imiglucerase

1041

Imipenem

1042

Imipramine

1043

Imiquimod

1044

Immunoglobulins

1045

Imuracetam

1046

Indacaterol

1047

Indapamide

1048

Indinavir

1049

Indomethacin; except when specified elsewhere in this schedule

1050

Indoprofen

1051

Indoramin

1052

Infliximab

1053

Influenza and coryza vaccines; for injection; for nasal use

1054

Influenza vaccine; except when administered to a person 13 years of age or over by a registered pharmacist who has successfully completed a vaccinator training course approved by the Ministry of Health and who is complying with the immunisation standards of the Ministry of Health

1055

Ingenol mebutate

1056

Insulin degludec

1057

Insulin-like growth factors; except when specified elsewhere in this schedule

1058

Insulins

1059

Interferons

1060

Interleukins

1061

Iodothiouracil

1062

Ipamorelin

1063

Ipecacuanha; except when specified elsewhere in this schedule

1064

Ipilimumab

1065

Ipratropium; except for nasal use

1066

Ipriflavone

1067

Iprindole

1068

Iproniazid

1069

Irbesartan

1070

Irinotecan

1071

Iron; except when specified elsewhere in this schedule

1072

Isoaminile

1073

Isoamyl nitrite

1074

Isobutyl nitrite

1075

Isocarboxazid

1076

Isoconazole; except when specified elsewhere in this schedule

1077

Isoetarine

1078

Isoflurane

1079

Isometheptene

1080

Isoniazid

1081

Isoprenaline

1082

Isoprinosine

1083

Isopropamide; except when specified elsewhere in this schedule

1084

Isosorbide dinitrate

1085

Isosorbide mononitrate

1086

Isotretinoin

1087

Isoxicam

1088

Isoxsuprine

1089

Isradipine

1090

Itraconazole

1091

Ivabradine

1092

Ivacaftor

1093

Ivermectin

1094

Ixabepilone

1095

Ixazomib

1096

Ixekizumab

1097

Japanese encephalitis vaccine

1098

Juniperus sabina; at all strengths

1099

Kanamycin

1100

Ketamine

1101

Ketanserin

1102

Ketazolam

1103

Ketoconazole; except when specified elsewhere in this schedule

1104

Ketoprofen; except when specified elsewhere in this schedule

1105

Ketorolac

1106

Ketotifen; except for ophthalmic use in medicines containing 0.025% or less

1107

Khellin

1108

Labetalol

1109

Lacidipine

1110

Lacosamide

1111

Lamivudine

1112

Lamotrigine

1113

Lanatosides

1114

Lanreotide

1115

Lansoprazole; except when specified elsewhere in this schedule

1116

Lanthanum

1117

Lapatinib

1118

Laronidase-rch

1119

Laropiprant

1120

Latamoxef

1121

Latanoprost

1122

Laudexium

1123

Lauromacrogols; for injection

1124

Lead

1125

Ledipasvir

1126

Lefetamine

1127

Leflunomide

1128

Lenalidomide

1129

Lenograstim

1130

Lenvatinib

1131

Lepirudin

1132

Leptazol

1133

Lercanidipine

1134

Lesinurad

1135

Letermovir

1136

Letrozole

1137

Leucovorin; for injection

1138

Leuprorelin

1139

Levallorphan

1140

Levamisole

1141

Levetiracetam

1142

Levobunolol

1143

Levobupivacaine

1144

Levocabastine; except for nasal or ophthalmic use

1145

Levocetirizine; except for oral use

1146

Levodopa

1147

Levomepromazine

1148

Levomilnacipran

1149

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

1150

Levosimendan

1151

Lidoflazine

1152

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

1153

Ligularia dentata; at all strengths

1154

Linagliptin

1155

Lincomycin

1156

Lindane; except for external use in medicines containing 2% or less

1157

Linezolid

1158

Liothyronine

1159

Lipegfilgrastim

1160

Liraglutide

1161

Lisdexamfetamine

1162

Lisinopril

1163

Lisuride

1164

Lithium; except when specified elsewhere in this schedule; except when present as an excipient in dermal medicines containing 0.25% or less

1165

Lixisenatide

1166

Lodoxamide; except in medicines for ophthalmic use

1167

Lofexidine

1168

Lomefloxacin

1169

Lomustine

1170

Loperamide; except when specified elsewhere in this schedule

1171

Lopinavir

1172

Loprazolam

1173

Loracarbef

1174

Loratadine; except when specified elsewhere in this schedule

1175

Lorazepam

1176

Lormetazepam

1177

Losartan

1178

Loteprednol

1179

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

1180

Loxapine

1181

Lumacaftor

1182

Lumefantrine

1183

Lumiracoxib

1184

Lurasidone

1185

Luteinising hormone

1186

Lymecycline

1187

Macitentan

1188

Mafenide

1189

Mannomustine

1190

Maprotiline

1191

Maraviroc

1192

Mazindol

1193

Measles vaccine

1194

Mebanazine

1195

Mebeverine

1196

Mebhydrolin

1197

Mebolazine

1198

Mebutamate

1199

Mecamylamine

1200

Mecasermin

1201

Mecillinam

1202

Meclocycline

1203

Meclofenamate

1204

Meclofenoxate

1205

Meclozine; except when specified elsewhere in this schedule

1206

Medazepam

1207

Medigoxin

1208

Medroxyprogesterone

1209

Medrysone

1210

Mefenamic acid; except when specified elsewhere in this schedule

1211

Mefloquine

1212

Mefruside

1213

Megestrol

1214

Melagatran

1215

Melanocyte stimulating compounds

1216

Melatonin

1217

Melengestrol

1218

Melia azedarach; at all strengths

1219

Meloxicam

1220

Melphalan

1221

Memantine

1222

Meningococcal vaccine; except when administered to a person 16 years of age or over by a registered pharmacist who has successfully completed a vaccinator training course approved by the Ministry of Health and who is complying with the immunisation standards of the Ministry of Health

1223

Menotrophin

1224

Mepacrine

1225

Mepenzolate

1226

Mephenesin

1227

Mephentermine

1228

Mepindolol

1229

Mepitiostane

1230

Mepivacaine

1231

Mepolizumab

1232

Meprobamate

1233

Meptazinol

1234

Mepyramine; except when specified elsewhere in this schedule

1235

Mequitazine

1236

Mercaptomerin

1237

Mercaptopurine

1238

Mercurochrome; except when specified elsewhere in this schedule

1239

Mercury; except when specified elsewhere in this schedule

1240

Meropenem

1241

Mersalyl

1242

Mesabolone

1243

Mesalazine

1244

Mesna

1245

Mestanolone

1246

Mesterolone

1247

Mestranol

1248

Metamfetamine

1249

Metandienone

1250

Metaraminol

1251

Metenolone

1252

Metergoline

1253

Metformin

1254

Methacholine

1255

Methacycline

1256

Methadone

1257

Methallenoestril

1258

Methandriol

1259

Methanthelinium

1260

Methazolamide

1261

Methdilazine; except for oral use

1262

Methicillin

1263

Methimazole

1264

Methisazone

1265

Methixene

1266

Methocarbamol

1267

Methohexitone

1268

Methoin

1269

Methotrexate

1270

Methoxamine; except when specified elsewhere in this schedule

1271

Methoxsalen

1272

Methoxyflurane

1273

Methsuximide

1274

Methyclothiazide

1275

Methyl aminolevulinate

1276

Methyl androstanolone

1277

Methyl clostebol

1278

Methyl mercury; except in medicines containing 300 micrograms or less per litre or per kilogram

1279

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

1280

Methyl trienolone

1281

Methyldopa

1282

Methylene blue; for injection

1283

Methylergometrine

1284

Methylhexanamine (1,3-dimethylamylamine (DMAA)); except when present as an unmodified, naturally occurring substance

1285

Methylnaltrexone

1286

Methylpentynol

1287

Methylphenidate

1288

Methylphenobarbital

1289

Methylprednisolone

1290

Methyltestosterone

1291

Methylthiouracil

1292

Methyprylon

1293

Methysergide

1294

Metoclopramide; except when specified elsewhere in this schedule

1295

Metolazone

1296

Metoprolol

1297

Metribolone

1298

Metrifonate

1299

Metronidazole

1300

Metyrapone

1301

Mexiletine

1302

Mezlocillin

1303

Mianserin

1304

Mibefradil

1305

Mibolerone

1306

Micafungin

1307

Miconazole; except when specified elsewhere in this schedule

1308

Midazolam

1309

Midodrine

1310

Mifepristone

1311

Migalastat

1312

Miglitol

1313

Miglustat

1314

Milnacipran

1315

Milrinone

1316

Minocycline

1317

Minoxidil; except for dermal use in medicines containing 5% or less

1318

Mirabegron

1319

Mirtazapine

1320

Misoprostol

1321

Mitobronitol

1322

Mitomycin

1323

Mitoxantrone

1324

Mitragyna speciosa

1325

Mitragynine

1326

Mivacurium

1327

Moclobemide

1328

Modafinil

1329

Molgramostim

1330

Molindone

1331

Molracetam

1332

Mometasone; except when specified elsewhere in this schedule

1333

Monobenzone

1334

Monoclonal antibodies; except in pregnancy test kits

1335

Montelukast

1336

Moperone

1337

Morazone

1338

Moricizine

1339

Morphine; except when specified elsewhere in this schedule

1340

Motrazepam

1341

Motretinide

1342

Moxifloxacin

1343

Mumps vaccine

1344

Mupirocin

1345

Muraglitazar

1346

Muromonab

1347

Mustine

1348

Mycophenolic acid

1349

Nabilone

1350

Nabumetone

1351

Nadolol

1352

Nadroparin

1353

Nafarelin

1354

Naftidrofuryl

1355

Nalbuphine

1356

Nalidixic acid

1357

Nalmefene

1358

Nalorphine

1359

Naloxegol

1360

Naloxone; except when provided as part of an approved emergency kit for the treatment of opioid overdose

1361

Naltrexone

1362

Nandrolone

1363

Naproxen; except when specified elsewhere in this schedule

1364

Naratriptan

1365

Natalizumab

1366

Natamycin

1367

Nateglinide

1368

Nebacumab

1369

Nebivolol

1370

Nebracetam (and its stereoisomers)

1371

Nedocromil

1372

Nefazodone

1373

Nefiracetam

1374

Nefopam

1375

Nelfinavir

1376

Neomycin

1377

Neostigmine

1378

Nepafenac

1379

Nepidermin

1380

Nerium oleander

1381

Nesiritide

1382

Netilmicin

1383

Netupitant

1384

Nevirapine

1385

Nialamide

1386

Nicardipine

1387

Nicergoline

1388

Nicofuranose

1389

Nicoracetam

1390

Nicorandil

1391

Nicotine; except when specified elsewhere in the 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

1392

Nicotinic acid except nicotinamide; except when specified elsewhere in this schedule

1393

Nicoumalone

1394

Nifedipine

1395

Nifenazone

1396

Nikethamide

1397

Nilotinib

1398

Nilutamide

1399

Nimesulide

1400

Nimetazepam

1401

Nimodipine

1402

Nimorazole

1403

Nintedanib

1404

Niridazole

1405

Nisoldipine

1406

Nitazoxanide

1407

Nitisinone

1408

Nitrazepam

1409

Nitrendipine

1410

Nitric oxide

1411

Nitrofurantoin

1412

Nitrofurazone

1413

Nitrous oxide; when supplied for inhalation

1414

Nitroxoline

1415

Nivolumab

1416

Nizatidine; except when specified elsewhere in this schedule

1417

Nomegestrol

1418

Nomifensine

1419

Noopept (and its stereoisomers)

1420

Noradrenaline

1421

Norandrostenolone

1422

Norbolethone

1423

Norclostebol

1424

Nordazepam

1425

Norelgestromin

1426

Norethandrolone

1427

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

1428

Norfloxacin

1429

Norgestrel

1430

Noribogaine

1431

Normethandrone

1432

Nortriptyline

1433

Noxiptyline

1434

Nusinersen

1435

Nux vomica; except in medicines containing 1 milligram or less per litre or per kilogram of strychnine

1436

Nystatin; except when specified elsewhere in this schedule

1437

Obinutuzumab

1438

Ocrelizumab

1439

Ocriplasmin

1440

Octamylamine

1441

Octatropine

1442

Octreotide

1443

Octyl nitrite

1444

Oestradiol; except in medicines containing 10 micrograms or less per litre or per kilogram

1445

Oestriol

1446

Oestrogens

1447

Oestrone; except in medicines containing 1 milligram or less per litre or per kilogram

1448

Ofatumumab

1449

Ofloxacin

1450

Olanzapine

1451

Olaparib

1452

Oleandomycin

1453

Oleandrin

1454

Olmesartan

1455

Olodaterol

1456

Olopatadine

1457

Olsalazine

1458

Omalizumab

1459

Ombitasvir

1460

Omeprazole; except when specified elsewhere in this schedule

1461

Ondansetron

1462

Opipramol

1463

Opium; except when specified elsewhere in this schedule

1464

Orciprenaline

1465

Orlistat; except in medicines for weight control containing 120 milligrams or less per dose form

1466

Ornidazole

1467

Ornipressin

1468

Orphenadrine

1469

Orthopterin

1470

Oseltamivir; except when specified elsewhere in this schedule

1471

Osimertinib

1472

Otilonium bromide

1473

Ouabain

1474

Ovandrotone

1475

Oxabolone

1476

Oxacillin

1477

Oxaliplatin

1478

Oxandrolone

1479

Oxaprozin

1480

Oxazepam

1481

Oxazolam

1482

Oxcarbazepine

1483

Oxedrine; except in medicines containing 30 milligrams or less per recommended daily dose

1484

Oxetacaine; except for internal use

1485

Oxiconazole; except when specified elsewhere in this schedule

1486

Oxiracetam (and its stereoisomers)

1487

Oxitropium

1488

Oxolamine

1489

Oxolinic acid

1490

Oxpentifylline

1491

Oxprenolol

1492

Oxybuprocaine; except when used in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board

1493

Oxybutynin

1494

Oxycodone

1495

Oxymesterone

1496

Oxymetholone

1497

Oxyphenbutazone

1498

Oxyphencyclimine

1499

Oxyphenisatin; at all strengths

1500

Oxyphenonium

1501

Oxytetracycline

1502

Oxytocin; except in medicines containing 1 microgram or less per litre or per kilogram

1503

Paclitaxel

1504

Palbociclib

1505

Palifermin

1506

Paliperidone

1507

Palivizumab

1508

Palonosetron

1509

Pamaquin

1510

Pamidronic acid

1511

Pancreatic enzymes; except in medicines containing 20 000 BP units or less of lipase activity

1512

Pancuronium

1513

Panitumumab

1514

Panobinostat

1515

Pantoprazole; except when specified elsewhere in this schedule

1516

Papaveretum

1517

Papaverine; for injection

1518

Paracetamol; except when specified elsewhere in this schedule

1519

Paraldehyde

1520

Paramethadione

1521

Paramethasone

1522

Parecoxib

1523

Paricalcitol

1524

Paritabprevir

1525

Paromomycin

1526

Paroxetine

1527

Pasireotide

1528

Patent blue V; for injection when used in diagnostic procedures

1529

Patiromer sorbitex calcium

1530

Pazopanib

1531

Pecazine

1532

Pefloxacin

1533

Pegaptanib

1534

Pegaspargase

1535

Pegfilgrastim

1536

Peginterferon

1537

Peginterferon beta-1a

1538

Pegvisomant

1539

Pembrolizumab

1540

Pemetrexed

1541

Pemoline

1542

Pempidine

1543

Penbutolol

1544

Penciclovir; except when specified elsewhere in this schedule

1545

Penicillamine

1546

Pentaerythrityl tetranitrate

1547

Pentagastrin

1548

Pentamethonium

1549

Pentamidine

1550

Pentazocine

1551

Penthienate

1552

Pentolinium

1553

Pentosan polysulfate sodium

1554

Pentostatin

1555

Pentoxifylline

1556

Peramivir

1557

Perampanel

1558

Pergolide

1559

Perhexiline

1560

Pericyazine

1561

Perindopril

1562

Permethrin; except in medicines containing 5% or less

1563

Perphenazine

1564

Pertussis antigen

1565

Pertussis (whooping cough) vaccine

1566

Pertuzumab

1567

Pethidine

1568

Phenacemide

1569

Phenacetin; except when present as an excipient

1570

Phenaglycodol

1571

Phenazone; except for external use

1572

Phenazopyridine

1573

Phenelzine

1574

Pheneticillin

1575

Phenformin

1576

Phenglutarimide

1577

Phenibut

1578

Phenindione

1579

Pheniramine; except when specified elsewhere in this schedule

1580

Phenisatin

1581

Phenobarbital

1582

Phenol; for injection

1583

Phenolphthalein

1584

Phenoperidine

1585

Phenoxybenzamine

1586

Phenoxymethylpenicillin

1587

Phensuximide

1588

Phentermine

1589

Phenthimentonium

1590

Phentolamine

1591

Phenylbutazone

1592

Phenylephrine; except when specified elsewhere in this schedule

1593

Phenylpropanolamine

1594

Phenyltoloxamine

1595

Phenytoin

1596

Phleum pratense extract

1597

Pholcodine; except when specified elsewhere in this schedule

1598

Phosphodiesterase type 5 inhibitors; except when present as an unmodified, naturally occurring substance; except when specified elsewhere in this schedule

1599

Phthalylsulfathiazole

1600

Physostigmine

1601

Pibrentasvir

1602

Picibanil

1603

Picric acid

1604

Picrotoxin

1605

Pilocarpine; except in medicines containing 0.025% or less

1606

Pimecrolimus

1607

Pimozide

1608

Pinacidil

1609

Pinazepam

1610

Pindolol

1611

Pioglitazone

1612

Pipecuronium

1613

Pipemidic acid

1614

Pipenzolate

1615

Piperacetam

1616

Piperacillin

1617

Piperidine

1618

Piperidolate

1619

Pipobroman

1620

Pipothiazine

1621

Pipradrol

1622

Piracetam

1623

Pirbuterol

1624

Pirenoxine

1625

Pirenzepine

1626

Piretanide

1627

Pirfenidone

1628

Piroxicam; except for external use

1629

Pirprofen

1630

Pitavastatin

1631

Pituitary hormones

1632

Pivampicillin

1633

Pizotifen

1634

Plerixafor

1635

Plicamycin

1636

Pneumococcal vaccine; except in oral vaccines for the prophylaxis of bacterial complications of colds

1637

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

1638

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

1639

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

1640

Polidexide

1641

Poliomyelitis vaccine

1642

Polyacrylamide; in injections or implants for tissue augmentation or cosmetic use

1643

Polyestradiol

1644

Polylactic acid; in injections or implants for tissue augmentation or cosmetic use

1645

Polymyxin

1646

Polysulfated glycosaminoglycans; for injection except in intraocular viscoelastic products

1647

Polythiazide

1648

Pomalidomide

1649

Ponatinib

1650

Poractant alfa

1651

Posaconazole

1652

Potassium bromide

1653

Potassium perchlorate

1654

Practolol

1655

Pradofloxacin

1656

Pralatrexate

1657

Pralidoxime

1658

Pralmorelin

1659

Pramipexole

1660

Pramiracetam

1661

Pramocaine

1662

Prampine

1663

Prasterone

1664

Prasugrel

1665

Pravastatin

1666

Prazepam

1667

Praziquantel

1668

Prazosin

1669

Prednisolone

1670

Prednisone

1671

Pregabalin

1672

Pregnenolone

1673

Prenalterol

1674

Prenylamine

1675

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

1676

Primaquine

1677

Primidone

1678

Probenecid

1679

Probucol

1680

Procainamide

1681

Procaine

1682

Procaine penicillin

1683

Procarbazine

1684

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

1685

Procyclidine; except for dermal use in medicines containing 5% or less

1686

Progesterone; except in medicines containing 1 milligram or less per litre or per kilogram

1687

Progestogens

1688

Proglumide

1689

Proguanil

1690

Prolintane

1691

Promazine

1692

Promethazine; except when specified elsewhere in this schedule

1693

Promoxolane

1694

Propafenone

1695

Propamidine; except for ophthalmic use

1696

Propanidid

1697

Propantheline

1698

Propetandrol

1699

Propionibacterium acnes

1700

Propofol

1701

Propranolol; except in medicines containing 1 milligram or less per litre or per kilogram

1702

Propylthiouracil

1703

Propyphenazone

1704

Proquazone

1705

Proscillaridin

1706

Prostaglandins

1707

Protamine

1708

Prothionamide

1709

Prothipendyl

1710

Protirelin

1711

Protoveratrines

1712

Protriptyline

1713

Proxymetacaine; except when used in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board

1714

Prucalopride

1715

Pseudoephedrine

1716

Pulmonaria spp; at all strengths

1717

Pyrazinamide

1718

Pyridinolcarbamate

1719

Pyridostigmine

1720

Pyridoxal; except in medicines containing 200 milligrams or less per recommended daily dose

1721

Pyridoxamine; except in medicines containing 200 milligrams or less per recommended daily dose

1722

Pyridoxine; except in medicines containing 200 milligrams or less per recommended daily dose

1723

Pyrimethamine

1724

Pyrvinium

1725

Quazepam

1726

Quetiapine

1727

Quinagolide

1728

Quinapril

1729

Quinbolone

1730

Quinethazone

1731

Quinidine

1732

Quinine; except in medicines containing 50 milligrams or less per recommended daily dose

1733

Quinisocaine

1734

Quinupristin

1735

Rabeprazole

1736

Rabies vaccine

1737

Raloxifene

1738

Raltegravir

1739

Raltitrexed

1740

Ramipril

1741

Ramucirumab

1742

Ranibizumab

1743

Ranitidine; except when specified elsewhere in this schedule

1744

Ranolazine

1745

Rapacuronium

1746

Rasagiline

1747

Rasburicase

1748

Rauwolfia serpentina

1749

Rauwolfia vomitoria

1750

Razoxane

1751

Reboxetine

1752

Recombinant human epidermal growth factor

1753

Recombinant varicella zoster virus glycoprotein E antigen

1754

Regorafenib

1755

Remestemcel-L

1756

Remifentanil

1757

Remoxipride

1758

Repaglinide

1759

Reserpine

1760

Reslizumab

1761

Retapamulin

1762

Reteplase

1763

Retigabine

1764

Ribavirin

1765

Ribociclib

1766

Ridaforolimus

1767

Rifabutin

1768

Rifampicin

1769

Rifamycin

1770

Rifapentine

1771

Rifaximin

1772

Rilmazafone

1773

Rilpivirine

1774

Riluzole

1775

Rimexolone

1776

Rimiterol

1777

Rimonabant

1778

Riociguat

1779

Risedronic acid

1780

Risperidone

1781

Ritodrine

1782

Ritonavir

1783

Rituximab

1784

Rivaroxaban

1785

Rivastigmine

1786

Rizatriptan; except when specified elsewhere in this schedule

1787

Rocuronium

1788

Rofecoxib

1789

Roflumilast

1790

Rolipram (and its stereoisomers)

1791

Rolitetracycline

1792

Rolziracetam

1793

Romidepsin

1794

Romiplostim

1795

Ropinirole

1796

Ropivacaine

1797

Rosiglitazone

1798

Rosoxacin

1799

Rosuvastatin

1800

Rotavirus vaccine

1801

Rotigotine

1802

Roxibolone

1803

Roxithromycin

1804

Rubella vaccine

1805

Ruboxistaurin

1806

Rufinamide

1807

Rupatadine

1808

Ruxolitnib

1809

Sabadilla; except in preparations containing 10 milligrams or less of total alkaloids of schoenocaulon officinale per litre or per kilogram

1810

Sacubitril

1811

Safrole; for internal use except in medicines containing 0.1% or less

1812

Salbutamol

1813

Salcatonin

1814

Salmeterol

1815

Sapropterin

1816

Saquinavir

1817

Sargramostim

1818

Sarilumab

1819

Saxagliptin

1820

Schoenocaulon officinale; except in preparations containing 10 milligrams or less of total alkaloids of schoenocaulon officinale per litre or per kilogram

1821

Scopolia carniolica

1822

Sebelipase alfa

1823

Secbutabarbital

1824

Secobarbital

1825

Secukinumab

1826

Selective androgen receptor modulators

1827

Seletracetam (and its stereoisomers)

1828

Selegiline

1829

Selenium; except when specified elsewhere in this schedule; except for oral use in medicines containing 150 micrograms or less per recommended daily dose

1830

Selexipag

1831

Serelaxin

1832

Sermorelin

1833

Sertindole

1834

Sertraline

1835

Serum, dried human

1836

Sevelamer

1837

Sevoflurane

1838

Sex hormones and all substances having sex hormone activity

1839

Sialoepoetin

1840

Sibutramine

1841

Silandrone

1842

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

1843

Silicones; for injection

1844

Silodosin

1845

Siltuximab

1846

Silver sulfadiazine; except for external use in packs containing 50 grams or less

1847

Simeprevir

1848

Simvastatin

1849

Sirolimus

1850

Sisomicin

1851

Sitagliptin

1852

Sitaxentan

1853

Sodium bromide

1854

Sodium cellulose phosphate; for internal use

1855

Sodium cromoglycate; except for nasal and ophthalmic use

1856

Sodium morrhuate; for injection

1857

Sodium nitroprusside

1858

Sodium phenylbutyrate

1859

Sodium phosphate; in oral laxative preparations

1860

Sodium polystyrene sulphonate

1861

Sodium tetradecyl sulphate; for injection

1862

Sodium zirconium cyclosilicate

1863

Sofosbuvir

1864

Solasadine

1865

Solifenacin

1866

Somatostatin

1867

Somatropin

1868

Sonidegib

1869

Sontoquine

1870

Sorafenib

1871

Sotalol

1872

Sparfloxacin

1873

Sparteine

1874

Spectinomycin

1875

Spiramycin

1876

Spirapril

1877

Spironolactone

1878

Stanolone

1879

Stanozolol

1880

Staphylococcus aureus vaccine; except in oral vaccines for the prophylaxis of bacterial complications of colds

1881

Stavudine

1882

Stenbolone

1883

Steroid hormones

1884

Stilboestrol

1885

Stiripentol

1886

Stramonium; except for oral use when specified elsewhere in this schedule; except datura stramonium or datura tatula for smoking or burning

1887

Streptococcus beta-haemolyticus vaccine; except in oral vaccines for the prophylaxis of bacterial complications of colds

1888

Streptodornase

1889

Streptokinase

1890

Streptomycin

1891

Streptozocin

1892

Strontium ranelate

1893

Strophanthins

1894

Strophanthus spp

1895

Strychnos spp; except in medicines containing 1 milligram or less per litre or per kilogram of strychnine

1896

Styramate

1897

Succimer

1898

Sufentanil

1899

Sugammadex

1900

Sulbactam

1901

Sulconazole; except for dermal use

1902

Sulfacetamide; except for ophthalmic use in medicines containing 10% or less

1903

Sulfadiazine; except silver sulfadiazine for external use in pack sizes of 50 grams or less

1904

Sulfadimethoxine

1905

Sulfadimidine

1906

Sulfadoxine

1907

Sulfafurazole

1908

Sulfaguanidine

1909

Sulfamerazine

1910

Sulfamethizole

1911

Sulfamethoxazole

1912

Sulfamethoxydiazine

1913

Sulfamethoxypyridazine

1914

Sulfametrole

1915

Sulfamonomethoxine

1916

Sulfamoxole

1917

Sulfaphenazole

1918

Sulfapyridine

1919

Sulfasalazine

1920

Sulfathiazole

1921

Sulfatroxazole

1922

Sulfinpyrazone

1923

Sulfomyxin

1924

Sulfonmethane

1925

Sulindac

1926

Sultamicillin

1927

Sulthiame

1928

Sumatriptan; except when specified elsewhere in this schedule

1929

Sunifiram

1930

Sunitinib

1931

Suprofen

1932

Suvorexant

1933

Sutilains

1934

Suxamethonium

1935

Suxethonium

1936

T cell receptor antibody

1937

Tacrine

1938

Tacrolimus

1939

Tadalafil and its structural analogues

1940

Tafenoquine succinate

1941

Tafluprost

1942

Taliglucerase alfa

1943

Talimogene laherparepvec

1944

Tamoxifen

1945

Tamsulosin

1946

Tanacetum vulgare; except in medicines containing 0.8% or less of oil of tansy

1947

Tapentadol

1948

Tasonermin

1949

Tazarotene

1950

Tazobactam

1951

Teduglutide

1952

Tegafur

1953

Tegaserod

1954

Teicoplanin

1955

Telaprevir

1956

Telbivudine

1957

Telithromycin

1958

Telmisartan

1959

Telotristat ethyl

1960

Temazepam

1961

Temozolomide

1962

Temsirolimus

1963

Tenecteplase

1964

Teniposide

1965

Tenofovir

1966

Tenoxicam

1967

Terazosin

1968

Terbinafine; except when specified elsewhere in this schedule

1969

Terbutaline

1970

Terfenadine

1971

Teriflunomide

1972

Teriparatide

1973

Terlipressin

1974

Terodiline

1975

Teropterin

1976

Tesamorelin

1977

Testolactone

1978

Testosterone; except in medicines containing 1 milligram or less per litre or per kilogram

1979

Tetanus antitoxin

1980

Tetanus toxoid

1981

Tetanus vaccine

1982

Tetrabenazine

1983

Tetracosactrin

1984

Tetracycline

1985

Tetraethylammonium

1986

Tetrahydrocannabinol

1987

Tetrazepam

1988

Tetroxoprim

1989

Thalidomide

1990

Thenyldiamine

1991

Theophylline; except when specified elsewhere in this schedule

1992

Thevetia peruviana

1993

Thevetin

1994

Thiambutosine

1995

Thiazosulfone

1996

Thiethylperazine

1997

Thioacetazone

1998

Thiocarlide

1999

Thioguanine

2000

Thiomesterone

2001

Thiopentone

2002

Thiopropazate

2003

Thioproperazine

2004

Thioridazine

2005

Thiotepa

2006

Thiothixene

2007

Thiouracil

2008

Thiourea; except in medicines containing 0.1% or less

2009

Thymosin beta-4

2010

Thymoxamine

2011

Thyroid

2012

Thyrotrophin

2013

Thyrotrophin-releasing factor

2014

Thyroxine; except in medicines containing 10 micrograms or less per litre or per kilogram

2015

Tiagabine

2016

Tianeptine

2017

Tiaprofenic acid

2018

Tiaramide

2019

Tibolone

2020

Ticagrelor

2021

Ticarcillin

2022

Ticlopidine

2023

Tiemonium

2024

Tienilic acid

2025

Tigecycline

2026

Tigloidine

2027

Tiletamine

2028

Tilidine

2029

Tiludronic acid

2030

Timbetasin

2031

Timolol

2032

Tinidazole

2033

Tinzaparin

2034

Tioconazole; except when specified elsewhere in this schedule

2035

Tiotropium

2036

Tipepidine

2037

Tipiracil

2038

Tiprinavir

2039

Tirilazad

2040

Tirofiban

2041

Tizanidine

2042

Tobramycin

2043

Tocainide

2044

Tocilizumab

2045

Tofacitinib

2046

Tolazamide

2047

Tolazoline

2048

Tolbutamide

2049

Tolcapone

2050

Tolfenamic acid

2051

Tolmetin

2052

Tolonium

2053

Tolpropamine

2054

Tolrestat

2055

Tolterodine

2056

Tolvaptan

2057

Topiramate

2058

Topotecan

2059

Torasemide

2060

Toremifene

2061

Toxoids; for injection

2062

Tramadol

2063

Trametinib dimethyl sulfoxide

2064

Trandolapril

2065

Tranexamic acid

2066

Tranylcypromine

2067

Trastuzumab

2068

Trastuzumab emtansine

2069

Travoprost

2070

Trazodone

2071

Trenbolone

2072

Treosulphan

2073

Treprostinil

2074

Trestolone

2075

Tretamine

2076

Tretinoin

2077

Triacetyloleandomycin

2078

Triamcinolone; except when specified elsewhere in this schedule

2079

Triamterene

2080

Triaziquone

2081

Triazolam

2082

Trichlormethiazide

2083

Trichloroacetic acid; except for external use in medicines containing 12.5% or less for the treatment of warts other than anogenital warts

2084

Trichloroethylene

2085

Trichodesma africana; at all strengths

2086

Triclofos

2087

Tricyclamol

2088

Tridihexethyl

2089

Trientine

2090

Trifluoperazine

2091

Trifluperidol

2092

Triflupromazine

2093

Trifluridine

2094

Trimeprazine; except when specified elsewhere in this schedule

2095

Trimetaphan

2096

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

2097

Trimipramine

2098

Trimustine

2099

Trinitrophenol

2100

Trioxysalen

2101

Triparanol; at all strengths

2102

Triple antigen vaccine

2103

Triprolidine; except when specified elsewhere in this schedule

2104

Triptorelin

2105

Troglitazone

2106

Trometamol; for injection in medicines containing more than 3%

2107

Tropicamide; except when used in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board

2108

Tropisetron

2109

Trovafloxacin

2110

Troxidone

2111

Tryptophan; except in medicines containing 100 milligrams or less per recommended daily dose; except in parenteral nutrition replacement preparations

2112

Tuberculin

2113

Tuberculosis vaccine

2114

Tubocurarine

2115

Tulobuterol

2116

Typhoid vaccine

2117

Ulipristal

2118

Umeclidinium bromide

2119

Unoprostone

2120

Uracil

2121

Urapidil

2122

Urethane

2123

Urofollitropin

2124

Urokinase

2125

Ursodeoxycholic acid

2126

Ustekinumab

2127

Vaccines; except when specified elsewhere in this schedule

2128

Vaccinia virus vaccine

2129

Valaciclovir

2130

Valdecoxib

2131

Valganciclovir

2132

Valnoctamide

2133

Valproic acid

2134

Valsartan

2135

Vancomycin

2136

Vandetanib

2137

Vardenafil and its structural analogues

2138

Varenicline

2139

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 a vaccinator training course approved by the Ministry of Health and who is complying with the immunisation standards of the Ministry of Health

2140

Vasopressin

2141

Vecuronium

2142

Vedolizumab

2143

Velaglucerase alfa

2144

Velpatasvir

2145

Vemurafenib

2146

Venetoclax

2147

Venlafaxine

2148

Verapamil

2149

Veratrum spp

2150

Vernakalant

2151

Verteporfin

2152

Veruprevir

2153

Vidarabine

2154

Vigabatrin

2155

Vilanterol

2156

Vildagliptin

2157

Viloxazine

2158

Vinblastine

2159

Vincamine

2160

Vincristine

2161

Vindesine

2162

Vinflunine

2163

Vinorelbine

2164

Vinyl ether

2165

Virginiamycin

2166

Vismodegib

2167

Visnadine

2168

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

2169

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

2170

Vorapaxar

2171

Voriconazole

2172

Vorinostat

2173

Vortioxetine

2174

Warfarin

2175

Xamoterol

2176

Xanthinol nicotinate

2177

Ximelagatran

2178

Xipamide

2179

Yellow fever vaccine

2180

Yohimbine

2181

Zafirlukast

2182

Zalcitabine

2183

Zaleplon

2184

Zanamivir

2185

Zidovudine

2186

Zimeldine

2187

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

2188

Ziprasidone

2189

Zoledronic acid

2190

Zolmitriptan; except when specified elsewhere in this schedule

2191

Zolpidem

2192

Zonisamide

2193

Zopiclone

2194

Zoster immunoglobulin, human

2195

Zoxazolamine

2196

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

Codeine; in medicines for oral use containing not more than 15 milligrams of codeine per solid dosage unit or per dose of liquid with a maximum daily dose not exceeding 100 milligrams of codeine, 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, for use as an analgesic and when sold in a pack of not more than 5 days’ supply, approved by the Minister or the Director-General for distribution as a restricted medicine

20

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

21

Cyproheptadine; for oral use

22

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

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

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

63

Pneumococcal vaccine; in oral vaccines for the prophylaxis of bacterial complications of colds

64

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

65

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

66

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

67

Prochlorperazine; in packs containing not more than 10 tablets or capsules for the treatment of nausea associated with migraine

68

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

69

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

70

Salicylic acid; except in medicines for dermal use containing 40% or less

71

Santonin

72

Sodium phosphate; in oral preparations for bowel cleansing prior to diagnostic, medical, or surgical procedures

73

Sodium picosulphate; in oral preparations for bowel cleansing prior to diagnostic, medical, or surgical procedures

74

Staphyloccocus aureus vaccine; in oral vaccines for the prophylaxis of bacterial complications of colds

75

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

76

Streptococcus beta-haemolyticus vaccine; in oral vaccines for the prophylaxis of bacterial complications of colds

77

Sulfacetamide; for ophthalmic use in medicines containing 10% or less

78

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

79

Theophylline; in liquid form for oral use in medicines containing 2% or less

80

Tioconazole; for vaginal use

81

Triamcinolone; for buccal use in medicines containing 0.1% or less of triamcinolone acetonide and in pack sizes of 5 grams or less

82

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

83

Triprolidine; for oral use in medicines for adults and children over 2 years of age; except when specified elsewhere in this schedule

84

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) and urticaria when sold in a pack containing not more than 30 dosage units

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 50 micrograms per actuation and when the maximum recommended daily dose is no greater than 400 micrograms (200 micrograms per nostril) in a pack containing 200 actuations or less

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

Codeine; in medicines for oral use, containing not more than 15 milligrams of codeine per solid dosage unit or per dose of liquid with a maximum daily dose not exceeding 100 milligrams of codeine, 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, for the treatment of the symptoms of cough and cold and when sold in a pack of not more than 6 days’ supply, approved by the Minister or the Director-General for distribution as a pharmacy-only medicine

40

Colocynth

41

Creosote; except in medicines containing 10% or less

42

Cresols; except in medicines containing 3% or less

43

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

44

Delphinium staphisagria; except in medicines containing 0.2% or less

45

Desloratadine; for oral use

46

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

47

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

48

Dibrompropamidine; for ophthalmic use except when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board

49

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

50

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

51

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

52

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

53

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

54

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

55

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

56

Econazole; for dermal use except in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board

57

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

58

Etafedrine

59

Ether; in medicines containing more than 10%; except in medicines containing 10% or less

60

Etofenamate; for external use

61

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

62

Felbinac; for external use

63

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 10 dosage units or less and not more than 5 days’ supply

64

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

65

Flurbiprofen; in locally acting oromucosal preparations containing 10 milligrams or less per dosage unit

66

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) in a pack containing 200 actuations or less

67

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

68

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

69

Formaldehyde; except in medicines containing 5% or less

70

Gelsemium sempervirens; except in medicines containing 1 milligram or less per litre or per kilogram

71

Glutaraldehyde

72

Hexachlorophane; in medicines containing 3% or less but more than 0.75%; except in medicines containing 0.75% or less

73

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

74

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

75

Hydroquinone; for external use in medicines containing 2% or less except in hair preparations containing 1% or less

76

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

77

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

78

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

79

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

80

Indanazoline

81

Indomethacin; for external use in medicines containing 1% or less; except in medicines containing 1 milligram or less per litre or per kilogram

82

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

83

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

84

Ipomoea spp; except ipomoea batatas

85

Ipratropium; for nasal use

86

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

87

Isoconazole; for dermal use except when sold in practice by a podiatrist registered with the Podiatrists Board

88

Isopropamide; for dermal use in preparations containing 2% or less

89

Jalap resin

90

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

91

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

92

Leucovorin; in medicines containing more than 500 micrograms per recommended daily dose

93

Levocabastine; for nasal use; for ophthalmic use except when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board

94

Levocetirizine; for oral use

95

Lignocaine; for urethral use; for external use in medicines containing 10% or less and more than 2%

96

Lindane; for external use in medicines containing 2% or less

97

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

98

Lobelia inflata; except in medicines for smoking or burning

99

Lobeline; except when in medicines for smoking or burning

100

Lodoxamide; for ophthalmic use except when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board

101

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

102

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

103

Macrogols; in preparations for oral use as a liquid concentrate for laxative use

104

Mebendazole

105

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

106

Mefenamic acid; in solid dose form in packs containing not more than 30 tablets or capsules for the treatment of dysmenorrhoea

107

Mepyramine; for dermal use; except for external use in medicines containing 2% or less in packs not exceeding 25 grams

108

Mercuric oxide; for ophthalmic use

109

Mercurochrome; in preparations for external use containing 2% or less

110

Mercury; for external use in medicines containing 0.5% or less; except in medicines containing 1 milligram or less per litre or per kilogram

111

Methoxamine; for external use in medicines containing more than 1%; except for external use in medicines containing 1% or less

112

Methoxyphenamine

113

Methylephedrine

114

Miconazole; for external use except in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board

115

Minoxidil; for dermal use in medicines containing 5% or less

116

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

117

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

118

Naphazoline; except for ophthalmic use when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board

119

Naproxen; in solid dose form containing 250 milligrams or less per dose form in packs of not more than 30 tablets or capsules

120

Niclosamide

121

Nicotine; for inhalation except when sold from a smoking cessation clinic run under the auspices of a registered medical practitioner, nurse, pharmacist, or psychologist

122

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

123

Noscapine

124

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

125

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

126

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

127

Oxetacaine; for internal use

128

Oxiconazole; for dermal use except in medicines for tinea pedis only

129

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

130

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

131

Papaverine; except for injection

132

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 slow-release forms containing 665 milligrams or less and more than 500 milligrams; 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

133

Paraformaldehyde; except in medicines containing 5% or less

134

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

135

Phedrazine

136

Phenazone; for external use

137

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

138

Phenol; except in medicines other than for injection containing 3% or less

139

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

140

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

141

Piperazine

142

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

143

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

144

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

145

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

146

Potassium chlorate; except in medicines containing 10% or less

147

Prilocaine; for dermal use in medicines containing 10% or less of local anaesthetic substances

148

Procyclidine; for dermal use in medicines containing 5% or less

149

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

150

Propamidine; for ophthalmic use except when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board

151

Pyrantel

152

Pyrethrins; except in medicines containing 10% or less

153

Pyrithione zinc; except in medicines for treatment of the scalp containing 2% or less

154

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

155

Salicylamide

156

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

157

Sennosides

158

Silver; except in oral solutions containing 0.3% or less or other medicines containing 1% or less

159

Silver sulfadiazine; for external use in pack sizes of 50 grams or less

160

Sodium cromoglycate; for nasal use; for ophthalmic use except when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board

161

Sodium nitrite; except for use as an excipient

162

Sodium picosulphate; in oral laxative preparations

163

Squill; except in medicines containing 1% or less

164

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

165

Sulconazole; for dermal use

166

Sulfadiazine, silver; for external use in pack sizes of 50 grams or less

167

Terbinafine; for dermal use except in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board

168

Tetrachloroethylene

169

Tetrahydrozoline; except for ophthalmic use when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board

170

Thiabendazole

171

Tioconazole; for dermal use except in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board

172

Tramazoline

173

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

174

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

175

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

176

Tuaminoheptane

177

Tymazoline

178

Xylenols; except in medicines containing 3% or less

179

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

180

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 2018 (LI 2018/179)

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)