Medicines Regulations 1984

Reprint as at 6 August 2015

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 6 August 2015, by regulation 4 of the Medicines Amendment Regulations (No 2) 2015 (LI 2015/180).

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 for external use for the treatment of herpes labialis

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

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

Alefacept

60

Alemtuzumab

61

Alendronic acid

62

Alfacalcidol

63

Alfentanil

64

Alfuzosin

65

Alglucerase

66

Alglucosidase

67

Aliskiren

68

Alkyl sulfonals

69

Allergens

70

Allopurinol

71

Allylisopropylacetylurea; at all strengths

72

Allyloestrenol

73

Alogliptin

74

Alosetron

75

Alpha1-proteinase inhibitor

76

Alphadolone

77

Alphaxalone

78

Alprazolam

79

Alprenolol

80

Alprostadil

81

Alseroxylon

82

Alteplase

83

Altretamine

84

Amantadine

85

Ambenonium

86

Ambrisentan

87

Ambucetamide

88

Ambutonium

89

Amcinonide

90

Amethocaine; for internal use; for external use in medicines containing more than 10%; for ophthalmic use except when used in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board

91

Amfebutamone

92

Amfepramone

93

Amidopyrine

94

Amifostine

95

Amikacin

96

Amiloride

97

Aminocaproic acid

98

Aminoglutethimide

99

Aminometradine

100

Aminophenazone; at all strengths

101

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

102

Aminopterin

103

Aminorex

104

Aminosalicylic acid

105

Amiodarone

106

Amiphenazole

107

Amisometradine

108

Amisulpride

109

Amitriptyline

110

Amlodipine

111

Ammi visnaga

112

Ammonium bromide

113

Amobarbital

114

Amodiaquine

115

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

116

Amoxapine

117

Amoxycillin

118

Amphomycin

119

Amphotericin

120

Ampicillin

121

Amprenavir

122

Amrinone

123

Amsacrine

124

Amygdalin; at all strengths

125

Amyl nitrite; except when sold to a person who holds a controlled substances licence (issued under section 95B of the Hazardous Substances and New Organisms Act 1996) authorising the person to possess cyanide; except when sold to an exempt laboratory covered by a Hazardous Substances and New Organisms Act 1996 approved code of practice

126

Amylocaine

127

Anabolic steroids

128

Anagrelide

129

Anakinra

130

Anastrozole

131

Ancestim

132

Anchusa officinalis; at all strengths

133

Ancrod and its immunoglobulin antidote

134

Androgenic and anabolic steroidal agents

135

Androgens

136

Androisoxazole

137

Androstanolone

138

Androstenediol

139

Androstenedione

140

Anecortave

141

Angiotensinamide

142

Anidulafungin

143

Anistreplase

144

Antazoline; except for ophthalmic use

145

Antibiotic substances; except when specified elsewhere in this schedule

146

Antigens

147

Antihistamines; except when specified elsewhere in this schedule

148

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

149

Antisera; for injection

150

Apixaban

151

Apocynum spp

152

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

153

Apraclonidine

154

Aprepitant

155

Apronal

156

Aprotinin

157

Arecoline

158

Aripiprazole

159

Aristolochia spp; at all strengths

160

Aristolochic acid; at all strengths

161

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

162

Artemether

163

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

164

Asenapine

165

Asparaginase

166

Aspirin; for injection; when combined with caffeine, paracetamol, or salicylamide

167

Astemizole

168

Atamestane

169

Atazanavir

170

Atenolol

171

Atomoxetine

172

Atorvastatin

173

Atosiban

174

Atovaquone

175

Atracurium

176

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

177

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

178

Atropine methonitrate

179

Auranofin

180

Aurothiomalate sodium

181

Avanafil

182

Aviptadil

183

Axitinib

184

Azacitidine

185

Azacyclonol

186

Azapropazone

187

Azaribine

188

Azatadine; except when specified elsewhere in this schedule

189

Azathioprine

190

Azelaic acid; except for dermal use

191

Azelastine; except when specified elsewhere in this schedule

192

Azithromycin

193

Azlocillin

194

Aztreonam

195

Bacampicillin

196

Bacitracin

197

Baclofen

198

Balsalazide

199

Bambuterol

200

Bamethan

201

Bamipine

202

Barbital

203

Barbiturates

204

Basiliximab

205

Bazedoxifene

206

Becaplermin

207

Beclamide

208

Beclomethasone; except when specified elsewhere in this schedule

209

Belatacept

210

Belimumab

211

Bemegride

212

Benactyzine

213

Benazepril

214

Bendamustine

215

Bendrofluazide

216

Benethamine penicillin

217

Benorylate

218

Benoxaprofen

219

Benperidol

220

Benserazide

221

Benzathine penicillin

222

Benzatropine

223

Benzhexol

224

Benzilonium

225

Benzocaine; except when specified elsewhere in this schedule; except in dermal preparations containing 2% or less of total anaesthetic substances; except in lozenges containing 30 milligrams or less of total anaesthetic substances per dosage unit

226

Benzodiazepines

227

Benzoyl metronidazole

228

Benzoyl peroxide; except for external use in medicines containing 10% or less

229

Benzthiazide

230

Benzydamine; for internal use

231

Benzylpenicillin

232

Bepridil

233

Beractant

234

Besifloxacin

235

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

236

Betahistine

237

Betamethasone

238

Betaxolol

239

Bethanechol

240

Bethanidine

241

Bevacizumab

242

Bevantolol

243

Bexarotene

244

Bezafibrate

245

Bicalutamide

246

Bifonazole; except for dermal use

247

Bimatoprost

248

Biperiden

249

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

250

Bisoprolol

251

Bithionol; at all strengths

252

Bivalirudin

253

Bleomycin

254

Boceprevir

255

Bolandiol

256

Bolasterone

257

Bolazine

258

Boldenone

259

Bolenol

260

Bolmantalate

261

Boron, including borax and boric acid; except for internal use in medicines containing 6 milligrams or less per recommended daily dose; except in dermal medicines for use other than paediatric use containing 0.35% or less; except when present as an excipient

262

Bortezomib

263

Bosentan

264

Botulinum toxins

265

Bretylium

266

Brimonidine

267

Brinzolamide

268

Bromazepam

269

Bromocriptine

270

Bromoform

271

Brompheniramine; except when specified elsewhere in this schedule

272

Bromvaletone

273

Brotizolam

274

Brugmansia spp

275

Buclizine; except for oral use

276

Budesonide; except when specified elsewhere in this schedule

277

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

278

Bumetanide

279

Buniodyl sodium; at all strengths

280

Buphenine

281

Bupivacaine

282

Buprenorphine

283

Bupropion

284

Buserelin

285

Buspirone

286

Busulphan

287

Butacaine

288

Butobarbital

289

Butoconazole; except for vaginal use

290

Butorphanol

291

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

292

Butyl nitrite

293

Butylchloral hydrate

294

Cabazitaxel

295

Cabergoline

296

Cacalia spp; at all strengths

297

Cadmium

298

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

299

Calcitonin

300

Calcitriol

301

Calcium carbimide

302

Calcium polystyrene sulphonate

303

Calotropis gigantea

304

Calotropis procera

305

Calusterone

306

Camazepam

307

Camphorated oil

308

Camphotamide

309

Canagliflozin

310

Canakinumab

311

Candesartan

312

Candicidin

313

Cannabidiol

314

Capecitabine

315

Capreomycin

316

Captodiame

317

Captopril

318

Capuride

319

Caramiphen

320

Carbachol

321

Carbamazepine

322

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

323

Carbazochrome

324

Carbenicillin

325

Carbenoxolone; for internal use

326

Carbetocin

327

Carbidopa

328

Carbimazole

329

Carbocromen

330

Carboplatin

331

Carboprost

332

Carbromal

333

Carbutamide

334

Carbuterol

335

Carindacillin

336

Carisoprodol

337

Carmustine

338

Carprofen

339

Carvedilol

340

Caspofungin

341

Catumaxomab

342

Cefacetrile

343

Cefaclor

344

Cefaloridine

345

Cefamandole

346

Cefapirin

347

Cefazolin

348

Cefepime

349

Cefetamet

350

Cefixime

351

Cefodizime

352

Cefonicid

353

Cefoperazone

354

Cefotaxime

355

Cefotetan

356

Cefotiam

357

Cefoxitin

358

Cefpirome

359

Cefpodoxime

360

Cefsulodin

361

Ceftaroline fosamil

362

Ceftazidime

363

Ceftibuten

364

Ceftolozane

365

Ceftriaxone

366

Cefuroxime

367

Celecoxib

368

Celiprolol

369

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

370

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

371

Cephalexin

372

Cephalothin

373

Cephradine

374

Cerivastatin

375

Certolizumab pegol

376

Ceruletide

377

Cetirizine; except for oral use

378

Cetrorelix

379

Cetuximab

380

Chenodeoxycholic acid

381

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

382

Chloralformamide

383

Chloralose

384

Chlorambucil

385

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

386

Chlorandrostenolone

387

Chlorazanil

388

Chlorcyclizine

389

Chlordiazepoxide

390

Chlormerodrin

391

Chlormethiazole

392

Chlormezanone

393

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

394

Chloroquine

395

Chlorothiazide

396

Chlorotrianisene

397

Chloroxydienone

398

Chloroxymesterone

399

Chlorpheniramine; except when specified elsewhere in this schedule

400

Chlorphentermine

401

Chlorpromazine

402

Chlorpropamide

403

Chlorprothixene

404

Chlorquinaldol

405

Chlortetracycline

406

Chlorthalidone

407

Chlorzoxazone

408

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

409

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

410

Chorionic gonadotrophin; except in pregnancy test kits

411

Chymopapain

412

Ciclacillin

413

Ciclesonide

414

Ciclopirox; except for external use

415

Cidofovir

416

Cilastatin

417

Cilazapril

418

Cilostazol

419

Cimetidine; except when specified elsewhere in this schedule

420

Cinacalcet

421

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

422

Cinchophen

423

Cinoxacin

424

Ciprofloxacin

425

Cisapride

426

Cisatracurium

427

Cisplatin

428

Citalopram

429

Cladribine

430

Clarithromycin

431

Clavulanic acid

432

Clemastine; except for oral use

433

Clemizole

434

Clenbuterol

435

Clevidipine

436

Clidinium

437

Clindamycin

438

Clioquinol; at all strengths

439

Clobazam

440

Clobetasol

441

Clobetasone; except when specified elsewhere in this schedule

442

Clocortolone

443

Clodronic acid

444

Clofarabine

445

Clofazimine

446

Clofenamide

447

Clofibrate

448

Clomiphene

449

Clomipramine

450

Clomocycline

451

Clonazepam

452

Clonidine

453

Clopamide

454

Clopidogrel

455

Clorexolone

456

Clorprenaline

457

Clostebol

458

Clotiazepam

459

Clotrimazole; except in medicines for vaginal or external use

460

Cloxacillin

461

Cloxazolam

462

Clozapine

463

Cobalt

464

Cobicistat

465

Cocaine; except when specified elsewhere in this schedule

466

Codeine; except when specified elsewhere in this schedule

467

Co-dergocrine

468

Colaspase

469

Colchicine

470

Colchicum

471

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

472

Colestipol

473

Colestyramine

474

Colfosceril

475

Colistin

476

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

477

Collagenase clostridium histolyticum

478

Conium maculatum; at all strengths

479

Convallaria keiski

480

Convallaria majalis

481

Corifollitropin alfa

482

Coronilla spp

483

Corticosterone

484

Corticotrophin

485

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

486

Cotarnine; at all strengths

487

Co-trimoxazole

488

Coumarin

489

Crizotinib

490

Crofelemer

491

Crotalaria spp; at all strengths

492

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

493

Crystal violet

494

Curare

495

Cyclandelate

496

Cyclizine; except when specified elsewhere in this schedule

497

Cyclobenzaprine

498

Cyclofenil

499

Cycloheximide

500

Cyclopenthiazide

501

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

502

Cyclophosphamide

503

Cyclopropane

504

Cycloserine

505

Cyclosporin

506

Cyclothiazide

507

Cycrimine

508

Cymarin

509

Cynoglossum spp; at all strengths

510

Cyproheptadine; except for oral use

511

Cyproterone

512

Cysteamine

513

Cytarabine

514

Dabigatran

515

Dabrafenib mesilate

516

Dacarbazine

517

Daclizumab

518

Dactinomycin

519

Dalfopristin

520

Dalteparin

521

Danaparoid

522

Danazol

523

Danthron

524

Dantrolene

525

Dapagliflozin

526

Dapoxetine

527

Dapsone

528

Daptomycin

529

Darbepoetin

530

Darifenacin

531

Darunavir

532

Dasabuvir

533

Dasatinib

534

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

535

Daunorubicin

536

Deanol

537

Debrisoquine

538

Decamethonium

539

Deferasirox

540

Deferiprone

541

Deflazacort

542

Degarelix

543

Dehydrochloromethyltestosterone

544

Dehydrocorticosterone

545

Delavirdine

546

Delorazepam

547

Demecarium

548

Demeclocycline

549

Denosumab

550

Deoxycortone

551

Deoxyribonuclease; except for external use

552

Desferrioxamine

553

Desflurane

554

Desipramine

555

Desirudin

556

Deslanoside

557

Desloratadine; except for oral use

558

Deslorelin

559

Desmopressin

560

Desogestrel

561

Desonide

562

Desoximetasone

563

Desvenlafaxine

564

Dexamethasone

565

Dexamfetamine

566

Dexchlorpheniramine; except when specified elsewhere in this schedule

567

Dexfenfluramine

568

Dexmedetomidine

569

Dextromethorphan; except when specified elsewhere in this schedule

570

Dextromoramide

571

Dextropropoxyphene

572

Dextrorphan

573

Di-iodohydroxy quinoline; except for vaginal use

574

Di-isopropylamine dichloroacetate

575

Diazepam

576

Diazoxide

577

Dibenzepin

578

Dibotermin

579

Dibrompropamidine; except for ophthalmic use

580

Dichloralphenazone

581

Dichlorophen

582

Dichlorphenamide

583

Diclofenac; in preparations for the treatment of solar keratosis; except when specified elsewhere in this schedule; except in preparations for external use other than for the treatment of solar keratosis

584

Dicloxacillin

585

Dicyclomine

586

Didanosine

587

Dienoestrol

588

Dienogest

589

Diethazine

590

Diethylcarbamazine

591

Diethylstilbestrol

592

Diflorasone

593

Diflucortolone

594

Diflunisal

595

Digitalis lanata

596

Digitalis purpurea

597

Digitoxin

598

Digoxin

599

Digoxin-specific antibody fragment

600

Dihydralazine

601

Dihydrocodeine

602

Dihydroergotoxine

603

Dihydrolone

604

Dihydrotachysterol

605

Diltiazem

606

Dimenhydrinate; except when specified elsewhere in this schedule

607

Dimercaprol

608

Dimethandrostanolone

609

Dimethazine

610

Dimethindene; except for oral use

611

Dimethothiazine

612

Dimethoxanate

613

Dimethyl fumarate

614

Dimethyl sulphoxide

615

Dinitrocresols

616

Dinitronaphthols

617

Dinitrophenols

618

Dinitrothymols

619

Dinoprost

620

Dinoprostone

621

Diperodon

622

Diphemanil; except for dermal use

623

Diphenhydramine; except when specified elsewhere in this schedule

624

Diphenidol

625

Diphenoxylate; except when specified elsewhere in this schedule

626

Diphenylpyraline

627

Diphtheria, tetanus and pertussis (acellular, component) vaccine; except when administered in a single dose to a person 18 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

628

Diphtheria toxoid

629

Diphtheria vaccine

630

Dipivefrin

631

Dipyridamole

632

Dirithromycin

633

Disopyramide

634

Distigmine

635

Disulfiram

636

Disulphamide

637

Ditiocarb

638

Dobutamine

639

Docetaxel

640

Dofetilide

641

Dolasetron

642

Dolutegravir

643

Domperidone

644

Donepezil

645

Dopamine

646

Dopexamine

647

Doripenem

648

Dornase

649

Dorzolamide

650

Dothiepin

651

Doxantrazole

652

Doxapram

653

Doxazosin

654

Doxepin

655

Doxorubicin

656

Doxycycline

657

Doxylamine; except when specified elsewhere in this schedule

658

Dronedarone

659

Droperidol

660

Drospirenone

661

Drostanolone

662

Drotrecogin

663

Duboisia leichhardtii; except when specified elsewhere in this schedule

664

Duboisia myoporides; except when specified elsewhere in this schedule

665

Dulcin; at all strengths

666

Duloxetine

667

Dutasteride

668

Dydrogesterone

669

Econazole; except in medicines for vaginal or dermal use

670

Ecothiopate

671

Ectylurea

672

Eculizumab

673

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

674

Edoxudine

675

Edrophonium

676

Efalizumab

677

Efavirenz

678

Eflornithine

679

Eletriptan

680

Eltrombopag olamine

681

Elvitegravir

682

Emepronium

683

Emetine; in medicines containing more than 0.2%

684

Empagliflozin

685

Emtricitabine

686

Enalapril

687

Enestebol

688

Enflurane

689

Enfuvirtide

690

Enobosarm

691

Enoxacin

692

Enoxaparin

693

Enoximone

694

Enprostil

695

Entacapone

696

Entecavir

697

Enzalutamide

698

Ephedrine

699

Epicillin

700

Epinastine

701

Epirubicin

702

Epitiostanol

703

Eplerenone

704

Epoetins

705

Epoprostenol

706

Eprosartan

707

Eptifibatide

708

Ergocalciferol; in medicines containing more than 25 micrograms per recommended daily dose

709

Ergometrine

710

Ergot

711

Ergotamine

712

Ergotoxine

713

Eribulin

714

Erlotinib

715

Ertapenem

716

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

717

Erythromycin

718

Erythropoietin

719

Escitalopram

720

Esmolol

721

Esomeprazole

722

Estazolam

723

Estramustine

724

Estropipate

725

Etanercept

726

Ethacrynic acid

727

Ethambutol

728

Ethamivan

729

Ethanolamine; for injection

730

Ethchlorvynol

731

Ether; for anaesthesia

732

Ethinamate

733

Ethinyloestradiol

734

Ethionamide

735

Ethisterone

736

Ethoglucid

737

Ethoheptazine

738

Ethopropazine

739

Ethosuximide

740

Ethotoin

741

Ethoxzolamide

742

Ethyl chloride; for inhalation

743

Ethyl loflazepate

744

Ethyldienolone

745

Ethylhexanediol; at all strengths

746

Ethyloestrenol

747

Ethynodiol

748

Etidocaine

749

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

750

Etilefrine

751

Etodolac

752

Etofenamate; except for external use

753

Etonogestrel

754

Etoposide

755

Etoricoxib

756

Etravirine

757

Etretinate

758

Everolimus

759

Exemestane

760

Exenatide

761

Ezetimibe

762

Factor VIII inhibitor bypassing fraction

763

Famciclovir; except when specified elsewhere in this schedule

764

Famotidine; except when specified elsewhere in this schedule

765

Fampridine

766

Farfugium japonicum; at all strengths

767

Febuxostat

768

Felbinac; except for external use

769

Felodipine

770

Felypressin; except when combined with a local anaesthetic and used in practice by a dental therapist registered with the Dental Council

771

Fenbufen

772

Fenclofenac

773

Fenfluramine

774

Fenofibrate

775

Fenoldopam

776

Fenoprofen

777

Fenoterol

778

Fenpipramide

779

Fenpiprane

780

Fentanyl

781

Ferric carboxymaltose

782

Fexofenadine; except for oral use

783

Fibrin

784

Fibrinolysin; except for external use

785

Fidaxomicin

786

Filgrastim

787

Finasteride

788

Fingolimod

789

Flecainide

790

Fleroxacin

791

Floctafenine

792

Fluanisone

793

Fluclorolone

794

Flucloxacillin

795

Fluconazole; except when specified elsewhere in this schedule

796

Flucytosine

797

Fludarabine

798

Fludiazepam

799

Fludrocortisone

800

Flufenamic acid

801

Flumazenil

802

Flumethasone

803

Flumethiazide

804

Flunisolide

805

Flunitrazepam

806

Fluocinolone

807

Fluocinonide

808

Fluocortin

809

Fluocortolone

810

Fluorescein; for injection

811

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

812

Fluorometholone

813

Fluorouracil

814

Fluoxetine

815

Fluoxymesterone

816

Flupenthixol

817

Fluphenazine

818

Flurandrenolone

819

Flurazepam

820

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

821

Fluroxene

822

Fluspirilene

823

Flutamide

824

Fluticasone; except when specified elsewhere in this schedule

825

Fluvastatin

826

Fluvoxamine

827

Folic acid; for injection except in parenteral nutrition replacement preparations

828

Folinic acid; for injection

829

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

830

Follistatin

831

Follitropin

832

Fomivirsen

833

Fondaparinux

834

Formebolone

835

Formestane

836

Formoterol

837

Fosamprenavir

838

Fosaprepitant

839

Foscarnet

840

Fosfestrol

841

Fosinopril

842

Fosphenytoin

843

Fotemustine

844

Framycetin

845

Fulvestrant

846

Furaltadone

847

Furazabol

848

Furazolidone

849

Furosemide

850

Fusidic acid

851

Gabapentin

852

Galantamine

853

Galanthus spp

854

Gallamine

855

Galsulfase

856

Ganciclovir

857

Ganirelix

858

Gatifloxacin

859

Gefitinib

860

Gemcitabine

861

Gemeprost

862

Gemfibrozil

863

Gemifloxacin

864

Gemtuzumab ozogamicin

865

Gentamicin

866

Gestodene

867

Gestonorone

868

Gestrinone

869

Ghrelin

870

Gitalin

871

Glatiramer acetate

872

Glibenclamide

873

Glibornuride

874

Gliclazide

875

Glimepiride

876

Glipizide

877

Glisoxepide

878

Glutathione; for injection

879

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

880

Glycopyrronium

881

Glymidine

882

Golimumab

883

Gonadorelin

884

Gonadotrophic hormones; except when specified elsewhere in this schedule

885

Goserelin

886

Gramicidin

887

Granisetron

888

Grepafloxacin

889

Griseofulvin

890

Guaiphenesin; for oral use in medicines containing more than 2% or 200 milligrams per dose form except when specified elsewhere in this schedule; 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

891

Guanabenz

892

Guanethidine

893

Guanidine

894

Hachimycin

895

Haematin

896

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

897

Halazepam

898

Halcinonide

899

Halofantrine

900

Halofenate

901

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

902

Halothane

903

Haloxazolam

904

Halquinol; for internal use

905

Heliotropium spp; at all strengths

906

Hemerocallis

907

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

908

Hepatitis A vaccine

909

Hepatitis B vaccine

910

Hetacillin

911

Hexachlorophane; in medicines containing more than 3%

912

Hexamethonium

913

Hexarelin

914

Hexetidine; for internal use

915

Hexobendine

916

Hexocyclium

917

Hexoprenaline

918

Histamine; in medicines containing more than 0.5%

919

Homatropine

920

Human chorionic gonadotrophin; except in pregnancy test kits

921

Human growth hormone secretagogues

922

Human papillomavirus vaccine

923

Human protein C

924

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

925

Hydralazine

926

Hydrargaphen

927

Hydrochlorothiazide

928

Hydrocortisone; except when specified elsewhere in this schedule

929

Hydrocyanic acid; except when specified elsewhere in this schedule; except in medicines containing 1 microgram or less per litre or per kilogram

930

Hydroflumethiazide

931

Hydromorphone

932

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

933

Hydroxychloroquine

934

Hydroxyephedrine

935

Hydroxyphenamate

936

Hydroxyprogesterone

937

Hydroxystenozol

938

Hydroxyurea

939

Hydroxyzine

940

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

941

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

942

Hyoscine butylbromide; except when specified elsewhere in this schedule

943

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

944

Hyoscyamus niger; except when specified elsewhere in this schedule; except in medicines containing 300 micrograms or less of total solanaceous alkaloids per litre or per kilogram

945

Hypothalamic releasing factors

946

Hypromellose; for injection; except in intraocular viscoelastic products

947

Ibandronic acid

948

Ibogaine

949

Ibritumomab tiuxetan

950

Ibrutinib

951

Ibufenac

952

Ibuprofen; except when specified elsewhere in this schedule

953

Ibuterol

954

Ibutilide

955

Icatibant

956

Idarubicin

957

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

958

Idursulfase

959

Ifosfamide

960

Iloprost

961

Imatinib

962

Imiglucerase

963

Imipenem

964

Imipramine

965

Imiquimod

966

Immunoglobulins

967

Indacaterol

968

Indapamide

969

Indinavir

970

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

971

Indoprofen

972

Indoramin

973

Infliximab

974

Influenza and coryza vaccines; for injection; for nasal use

975

Influenza vaccine; except when administered to a person 18 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

976

Ingenol mebutate

977

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

978

Insulins

979

Interferons

980

Interleukins

981

Iodothiouracil

982

Ipamorelin

983

Ipecacuanha; except in medicines containing less than 0.2% of emetine

984

Ipilimumab

985

Ipratropium; except for nasal use

986

Ipriflavone

987

Iprindole

988

Iproniazid

989

Irbesartan

990

Irinotecan

991

Iron; for injection except in parenteral nutrition replacement preparations

992

Isoaminile

993

Isoamyl nitrite

994

Isobutyl nitrite

995

Isocarboxazid

996

Isoconazole; except in medicines for vaginal or dermal use

997

Isoetarine

998

Isoflurane

999

Isometheptene

1000

Isoniazid

1001

Isoprenaline

1002

Isoprinosine

1003

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

1004

Isosorbide dinitrate

1005

Isosorbide mononitrate

1006

Isotretinoin

1007

Isoxicam

1008

Isoxsuprine

1009

Isradipine

1010

Itraconazole

1011

Ivabradine

1012

Ivacaftor

1013

Ivermectin

1014

Ixabepilone

1015

Japanese encephalitis vaccine

1016

Juniperus sabina; at all strengths

1017

Kanamycin

1018

Ketamine

1019

Ketanserin

1020

Ketazolam

1021

Ketoconazole; except for dermal use

1022

Ketoprofen; except when specified elsewhere in this schedule; except for dermal use

1023

Ketorolac

1024

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

1025

Khellin

1026

Labetalol

1027

Lacidipine

1028

Lacosamide

1029

Lamivudine

1030

Lamotrigine

1031

Lanatosides

1032

Lanreotide

1033

Lansoprazole; except when specified elsewhere in this schedule

1034

Lanthanum

1035

Lapatinib

1036

Laronidase-rch

1037

Laropiprant

1038

Latamoxef

1039

Latanoprost

1040

Laudexium

1041

Lauromacrogols; for injection

1042

Lead

1043

Ledipasvir

1044

Lefetamine

1045

Leflunomide

1046

Lenalidomide

1047

Lenograstim

1048

Lepirudin

1049

Leptazol

1050

Lercanidipine

1051

Letrozole

1052

Leucovorin; for injection

1053

Leuprorelin

1054

Levallorphan

1055

Levamisole

1056

Levetiracetam

1057

Levobunolol

1058

Levobupivacaine

1059

Levocabastine; except for nasal or ophthalmic use

1060

Levocetirizine; except for oral use

1061

Levodopa

1062

Levomepromazine

1063

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

1064

Levosimendan

1065

Lidoflazine

1066

Lignocaine; 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 dental therapist registered with the Dental Council; for oral use except in throat lozenges containing 30 milligrams or less per dose form; for ophthalmic use except when used in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board; for external use in medicines containing more than 10%

1067

Ligularia dentata; at all strengths

1068

Linagliptin

1069

Lincomycin

1070

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

1071

Linezolid

1072

Liothyronine

1073

Liraglutide

1074

Lisinopril

1075

Lisuride

1076

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

1077

Lixisenatide

1078

Lodoxamide; except in medicines for ophthalmic use

1079

Lofexidine

1080

Lomefloxacin

1081

Lomustine

1082

Loperamide; except when specified elsewhere in this schedule

1083

Lopinavir

1084

Loprazolam

1085

Loracarbef

1086

Loratadine; except for oral use

1087

Lorazepam

1088

Lormetazepam

1089

Losartan

1090

Loteprednol

1091

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

1092

Loxapine

1093

Lumefantrine

1094

Lumiracoxib

1095

Lurasidone

1096

Luteinising hormone

1097

Lymecycline

1098

Macitentan

1099

Mafenide

1100

Mannomustine

1101

Maprotiline

1102

Maraviroc

1103

Mazindol

1104

Measles vaccine

1105

Mebanazine

1106

Mebeverine

1107

Mebhydrolin

1108

Mebolazine

1109

Mebutamate

1110

Mecamylamine

1111

Mecasermin

1112

Mecillinam

1113

Meclocycline

1114

Meclofenamate

1115

Meclofenoxate

1116

Meclozine; except when specified elsewhere in this schedule

1117

Medazepam

1118

Medigoxin

1119

Medroxyprogesterone

1120

Medrysone

1121

Mefenamic acid; except when specified elsewhere in this schedule

1122

Mefloquine

1123

Mefruside

1124

Megestrol

1125

Melagatran

1126

Melanocyte stimulating compounds

1127

Melatonin

1128

Melengestrol

1129

Melia azedarach; at all strengths

1130

Meloxicam

1131

Melphalan

1132

Memantine

1133

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

1134

Menotrophin

1135

Mepacrine

1136

Mepenzolate

1137

Mephenesin

1138

Mephentermine

1139

Mepindolol

1140

Mepitiostane

1141

Mepivacaine

1142

Meprobamate

1143

Meptazinol

1144

Mepyramine; except when specified elsewhere in this schedule

1145

Mequitazine

1146

Mercaptomerin

1147

Mercaptopurine

1148

Mercurochrome; except when specified elsewhere in this schedule

1149

Mercury; except when specified elsewhere in this schedule; except in medicines containing 1 milligram or less per litre or per kilogram

1150

Meropenem

1151

Mersalyl

1152

Mesabolone

1153

Mesalazine

1154

Mesna

1155

Mestanolone

1156

Mesterolone

1157

Mestranol

1158

Metamfetamine

1159

Metandienone

1160

Metaraminol

1161

Metenolone

1162

Metergoline

1163

Metformin

1164

Methacholine

1165

Methacycline

1166

Methadone

1167

Methallenoestril

1168

Methandriol

1169

Methanthelinium

1170

Methazolamide

1171

Methdilazine; except for oral use

1172

Methicillin

1173

Methimazole

1174

Methisazone

1175

Methixene

1176

Methocarbamol

1177

Methohexitone

1178

Methoin

1179

Methotrexate

1180

Methoxamine; except for external use

1181

Methoxsalen

1182

Methoxyflurane

1183

Methsuximide

1184

Methyclothiazide

1185

Methyl aminolevulinate

1186

Methyl androstanolone

1187

Methyl clostebol

1188

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

1189

Methyl salicylate; for internal use except when present as an excipient in medicines containing 1.04% or less per dose form

1190

Methyl trienolone

1191

Methyldopa

1192

Methylene blue; for injection

1193

Methylergometrine

1194

Methylnaltrexone

1195

Methylpentynol

1196

Methylphenidate

1197

Methylphenobarbital

1198

Methylprednisolone

1199

Methyltestosterone

1200

Methylthiouracil

1201

Methyprylon

1202

Methysergide

1203

Metoclopramide; except when specified elsewhere in this schedule

1204

Metolazone

1205

Metoprolol

1206

Metribolone

1207

Metrifonate

1208

Metronidazole

1209

Metyrapone

1210

Mexiletine

1211

Mezlocillin

1212

Mianserin

1213

Mibefradil

1214

Mibolerone

1215

Micafungin

1216

Miconazole; except when specified elsewhere in this schedule; except in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board

1217

Midazolam

1218

Midodrine

1219

Mifepristone

1220

Miglitol

1221

Miglustat

1222

Milrinone

1223

Minocycline

1224

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

1225

Mirabegron

1226

Mirtazapine

1227

Misoprostol

1228

Mitobronitol

1229

Mitomycin

1230

Mitoxantrone

1231

Mitragyna speciosa

1232

Mitragynine

1233

Mivacurium

1234

Moclobemide

1235

Modafinil

1236

Molgramostim

1237

Molindone

1238

Mometasone; except when specified elsewhere in this schedule

1239

Monobenzone

1240

Monoclonal antibodies; except in pregnancy test kits

1241

Montelukast

1242

Moperone

1243

Morazone

1244

Moricizine

1245

Morphine; except when specified elsewhere in this schedule

1246

Motrazepam

1247

Motretinide

1248

Moxifloxacin

1249

Mumps vaccine

1250

Mupirocin

1251

Muraglitazar

1252

Muromonab

1253

Mustine

1254

Mycophenolic acid

1255

Nabilone

1256

Nabumetone

1257

Nadolol

1258

Nadroparin

1259

Nafarelin

1260

Naftidrofuryl

1261

Nalbuphine

1262

Nalidixic acid

1263

Nalmefene

1264

Nalorphine

1265

Naloxone

1266

Naltrexone

1267

Nandrolone

1268

Naproxen; except when specified elsewhere in this schedule

1269

Naratriptan

1270

Natalizumab

1271

Natamycin

1272

Nateglinide

1273

Nebacumab

1274

Nebivolol

1275

Nedocromil

1276

Nefazodone

1277

Nefopam

1278

Nelfinavir

1279

Neomycin

1280

Neostigmine

1281

Nepafenac

1282

Nerium oleander

1283

Nesiritide

1284

Netilmicin

1285

Nevirapine

1286

Nialamide

1287

Nicardipine

1288

Nicergoline

1289

Nicofuranose

1290

Nicorandil

1291

Nicotine; 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

1292

Nicotinic acid except nicotinamide; in medicines containing more than 250 milligrams per dose form

1293

Nicoumalone

1294

Nifedipine

1295

Nifenazone

1296

Nikethamide

1297

Nilotinib

1298

Nilutamide

1299

Nimesulide

1300

Nimetazepam

1301

Nimodipine

1302

Nimorazole

1303

Nintedanib

1304

Niridazole

1305

Nisoldipine

1306

Nitisinone

1307

Nitrazepam

1308

Nitrendipine

1309

Nitric oxide

1310

Nitrofurantoin

1311

Nitrofurazone

1312

Nitrous oxide; when supplied for inhalation

1313

Nitroxoline

1314

Nizatidine; except when specified elsewhere in this schedule

1315

Nomegestrol

1316

Nomifensine

1317

Noradrenaline

1318

Norandrostenolone

1319

Norbolethone

1320

Norclostebol

1321

Nordazepam

1322

Norelgestromin

1323

Norethandrolone

1324

Norethisterone

1325

Norfloxacin

1326

Norgestrel

1327

Noribogaine

1328

Normethandrone

1329

Nortriptyline

1330

Noxiptyline

1331

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

1332

Nystatin; except when specified elsewhere in this schedule; except in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board

1333

Obinutuzumab

1334

Ocriplasmin

1335

Octamylamine

1336

Octatropine

1337

Octreotide

1338

Octyl nitrite

1339

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

1340

Oestriol

1341

Oestrogens

1342

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

1343

Ofatumumab

1344

Ofloxacin

1345

Olanzapine

1346

Oleandomycin

1347

Oleandrin

1348

Olmesartan

1349

Olodaterol

1350

Olopatadine

1351

Olsalazine

1352

Omalizumab

1353

Ombitasvir

1354

Omeprazole; except when specified elsewhere in this schedule

1355

Ondansetron

1356

Opipramol

1357

Opium; except when specified elsewhere in this schedule

1358

Orciprenaline

1359

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

1360

Ornidazole

1361

Ornipressin

1362

Orphenadrine

1363

Orthopterin

1364

Oseltamivir; except when specified elsewhere in this schedule

1365

Ouabain

1366

Ovandrotone

1367

Oxabolone

1368

Oxacillin

1369

Oxaliplatin

1370

Oxandrolone

1371

Oxaprozin

1372

Oxazepam

1373

Oxazolam

1374

Oxcarbazepine

1375

Oxedrine; in medicines containing more than 30 milligrams per recommended daily dose

1376

Oxetacaine; except for internal use

1377

Oxiconazole; except when specified elsewhere in this schedule

1378

Oxitropium

1379

Oxolamine

1380

Oxolinic acid

1381

Oxpentifylline

1382

Oxprenolol

1383

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

1384

Oxybutynin

1385

Oxycodone

1386

Oxymesterone

1387

Oxymetholone

1388

Oxyphenbutazone

1389

Oxyphencyclimine

1390

Oxyphenisatin; at all strengths

1391

Oxyphenonium

1392

Oxytetracycline

1393

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

1394

Paclitaxel

1395

Palifermin

1396

Paliperidone

1397

Palivizumab

1398

Palonosetron

1399

Pamaquin

1400

Pamidronic acid

1401

Pancreatic enzymes; in medicines containing more than 20 000 BP units of lipase activity

1402

Pancuronium

1403

Panitumumab

1404

Pantoprazole; except when specified elsewhere in this schedule

1405

Papaveretum

1406

Papaverine; for injection

1407

Paracetamol; except when specified elsewhere in this schedule

1408

Paraldehyde

1409

Paramethadione

1410

Paramethasone

1411

Parecoxib

1412

Paricalcitol

1413

Paromomycin

1414

Paroxetine

1415

Pasireotide

1416

Pazopanib

1417

Pecazine

1418

Pefloxacin

1419

Pegaptanib

1420

Pegfilgrastim

1421

Peginterferon

1422

Pegvisomant

1423

Pemetrexed

1424

Pemoline

1425

Pempidine

1426

Penbutolol

1427

Penciclovir; except for external use for the treatment of herpes labialis

1428

Penicillamine

1429

Pentaerythrityl tetranitrate

1430

Pentagastrin

1431

Pentamethonium

1432

Pentamidine

1433

Pentazocine

1434

Penthienate

1435

Pentolinium

1436

Pentosan polysulfate sodium

1437

Pentoxifylline

1438

Perampanel

1439

Pergolide

1440

Perhexiline

1441

Pericyazine

1442

Perindopril

1443

Permethrin; in medicines containing more than 5%

1444

Perphenazine

1445

Pertussis antigen

1446

Pertussis (whooping cough) vaccine

1447

Pertuzumab

1448

Pethidine

1449

Phenacemide

1450

Phenacetin; except when present as an excipient

1451

Phenaglycodol

1452

Phenazone; except for external use

1453

Phenazopyridine

1454

Phenelzine

1455

Pheneticillin

1456

Phenformin

1457

Phenglutarimide

1458

Phenindione

1459

Pheniramine; except when specified elsewhere in this schedule

1460

Phenisatin

1461

Phenobarbital

1462

Phenol; for injection

1463

Phenolphthalein

1464

Phenoperidine

1465

Phenoxybenzamine

1466

Phenoxymethylpenicillin

1467

Phensuximide

1468

Phentermine

1469

Phenthimentonium

1470

Phentolamine

1471

Phenylbutazone

1472

Phenylephrine; except when specified elsewhere in this schedule

1473

Phenylpropanolamine

1474

Phenyltoloxamine

1475

Phenytoin

1476

Pholcodine; except when specified elsewhere in this schedule

1477

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

1478

Phthalylsulfathiazole

1479

Physostigmine

1480

Picric acid

1481

Picrotoxin

1482

Pilocarpine; except in medicines containing 0.025% or less

1483

Pimecrolimus

1484

Pimozide

1485

Pinacidil

1486

Pinazepam

1487

Pindolol

1488

Pioglitazone

1489

Pipecuronium

1490

Pipemidic acid

1491

Pipenzolate

1492

Piperacillin

1493

Piperidine

1494

Piperidolate

1495

Pipobroman

1496

Pipothiazine

1497

Pipradrol

1498

Piracetam

1499

Pirbuterol

1500

Pirenoxine

1501

Pirenzepine

1502

Piretanide

1503

Piroxicam; except for external use

1504

Pirprofen

1505

Pitavastatin

1506

Pituitary hormones

1507

Pivampicillin

1508

Pizotifen

1509

Plerixafor

1510

Plicamycin

1511

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

1512

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

1513

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

1514

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

1515

Polidexide

1516

Poliomyelitis vaccine

1517

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

1518

Polyestradiol

1519

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

1520

Polymyxin

1521

Polysulfated glycosaminoglycans; for injection except in intraocular viscoelastic products

1522

Polythiazide

1523

Pomalidomide

1524

Poractant alfa

1525

Posaconazole

1526

Potassium bromide

1527

Potassium perchlorate

1528

Practolol

1529

Pradofloxacin

1530

Pralatrexate

1531

Pralidoxime

1532

Pramipexole

1533

Pramocaine

1534

Prampine

1535

Prasterone

1536

Prasugrel

1537

Pravastatin

1538

Prazepam

1539

Praziquantel

1540

Prazosin

1541

Prednisolone

1542

Prednisone

1543

Pregabalin

1544

Pregnenolone

1545

Prenalterol

1546

Prenylamine

1547

Prilocaine; for injection except when used as a local anaesthetic in practice by a dental therapist registered with the Dental Council; except when specified elsewhere in this schedule

1548

Primaquine

1549

Primidone

1550

Probenecid

1551

Probucol

1552

Procainamide

1553

Procaine

1554

Procaine penicillin

1555

Procarbazine

1556

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

1557

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

1558

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

1559

Progestogens

1560

Proglumide

1561

Proguanil

1562

Prolintane

1563

Promazine

1564

Promethazine; except when specified elsewhere in this schedule

1565

Promoxolane

1566

Propafenone

1567

Propamidine; except for ophthalmic use

1568

Propanidid

1569

Propantheline

1570

Propetandrol

1571

Propionibacterium acnes

1572

Propofol

1573

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

1574

Propylthiouracil

1575

Propyphenazone

1576

Proquazone

1577

Proscillaridin

1578

Prostaglandins

1579

Protamine

1580

Prothionamide

1581

Prothipendyl

1582

Protirelin

1583

Protoveratrines

1584

Protriptyline

1585

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

1586

Prucalopride

1587

Pseudoephedrine

1588

Pulmonaria spp; at all strengths

1589

Pyrazinamide

1590

Pyridinolcarbamate

1591

Pyridostigmine

1592

Pyridoxal; in medicines containing more than 200 milligrams per recommended daily dose

1593

Pyridoxamine; in medicines containing more than 200 milligrams per recommended daily dose

1594

Pyridoxine; in medicines containing more than 200 milligrams per recommended daily dose

1595

Pyrimethamine

1596

Pyrvinium

1597

Quazepam

1598

Quetiapine

1599

Quinagolide

1600

Quinapril

1601

Quinbolone

1602

Quinethazone

1603

Quinidine

1604

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

1605

Quinisocaine

1606

Quinupristin

1607

Rabeprazole

1608

Rabies vaccine

1609

Raloxifene

1610

Raltegravir

1611

Raltitrexed

1612

Ramipril

1613

Ranibizumab

1614

Ranitidine; except when specified elsewhere in this schedule; except in medicines containing 150 milligrams or less per dose unit when sold in the manufacturer’s original pack containing not more than 7 days’ supply

1615

Rapacuronium

1616

Rasagiline

1617

Rasburicase

1618

Rauwolfia serpentina

1619

Rauwolfia vomitoria

1620

Razoxane

1621

Reboxetine

1622

Regorafenib

1623

Remestemcel-L

1624

Remifentanil

1625

Remoxipride

1626

Repaglinide

1627

Reserpine

1628

Retapamulin

1629

Reteplase

1630

Retigabine

1631

Ribavirin

1632

Ridaforolimus

1633

Rifabutin

1634

Rifampicin

1635

Rifamycin

1636

Rifapentine

1637

Rifaximin

1638

Rilpivirine

1639

Riluzole

1640

Rimexolone

1641

Rimiterol

1642

Rimonabant

1643

Riociguat

1644

Risedronic acid

1645

Risperidone

1646

Ritodrine

1647

Ritonavir

1648

Rituximab

1649

Rivaroxaban

1650

Rivastigmine

1651

Rizatriptan; except when specified elsewhere in this schedule

1652

Rocuronium

1653

Rofecoxib

1654

Roflumilast

1655

Rolitetracycline

1656

Romidepsin

1657

Romiplostim

1658

Ropinirole

1659

Ropivacaine

1660

Rosiglitazone

1661

Rosoxacin

1662

Rosuvastatin

1663

Rotavirus vaccine

1664

Rotigotine

1665

Roxibolone

1666

Roxithromycin

1667

Rubella vaccine

1668

Ruboxistaurin

1669

Rupatadine

1670

Ruxolitnib

1671

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

1672

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

1673

Salbutamol

1674

Salcatonin

1675

Salmeterol

1676

Sapropterin

1677

Saquinavir

1678

Saxagliptin

1679

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

1680

Scopolia carniolica

1681

Secbutabarbital

1682

Secobarbital

1683

Selective androgen receptor modulators

1684

Selegiline

1685

Selenium; except when specified elsewhere in this schedule; except for oral use in medicines containing 150 micrograms or less per recommended daily dose; except for external use in medicines containing 3.5% or less of selenium sulphide

1686

Selexipag

1687

Serelaxin

1688

Sermorelin

1689

Sertindole

1690

Sertraline

1691

Serum, dried human

1692

Sevelamer

1693

Sevoflurane

1694

Sex hormones and all substances having sex hormone activity

1695

Sialoepoetin

1696

Sibutramine

1697

Silandrone

1698

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

1699

Silicones; for injection

1700

Siltuximab

1701

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

1702

Simeprevir

1703

Simvastatin

1704

Sirolimus

1705

Sisomicin

1706

Sitagliptin

1707

Sitaxentan

1708

Sodium bromide

1709

Sodium cellulose phosphate; for internal use

1710

Sodium cromoglycate; except for nasal and ophthalmic use

1711

Sodium morrhuate; for injection

1712

Sodium nitroprusside

1713

Sodium phosphate; in oral laxative preparations

1714

Sodium polystyrene sulphonate

1715

Sodium tetradecyl sulphate; for injection

1716

Sofosbuvir

1717

Solasadine

1718

Solifenacin

1719

Somatostatin

1720

Somatropin

1721

Sontoquine

1722

Sorafenib

1723

Sotalol

1724

Sparfloxacin

1725

Sparteine

1726

Spectinomycin

1727

Spiramycin

1728

Spirapril

1729

Spironolactone

1730

Stanolone

1731

Stanozolol

1732

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

1733

Stavudine

1734

Stenbolone

1735

Steroid hormones

1736

Stilboestrol

1737

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

1738

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

1739

Streptodornase

1740

Streptokinase

1741

Streptomycin

1742

Strontium ranelate

1743

Strophanthins

1744

Strophanthus spp

1745

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

1746

Styramate

1747

Succimer

1748

Sufentanil

1749

Sugammadex

1750

Sulbactam

1751

Sulconazole; except for dermal use

1752

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

1753

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

1754

Sulfadimethoxine

1755

Sulfadimidine

1756

Sulfadoxine

1757

Sulfafurazole

1758

Sulfaguanidine

1759

Sulfamerazine

1760

Sulfamethizole

1761

Sulfamethoxazole

1762

Sulfamethoxydiazine

1763

Sulfamethoxypyridazine

1764

Sulfametrole

1765

Sulfamonomethoxine

1766

Sulfamoxole

1767

Sulfaphenazole

1768

Sulfapyridine

1769

Sulfasalazine

1770

Sulfathiazole

1771

Sulfatroxazole

1772

Sulfinpyrazone

1773

Sulfomyxin

1774

Sulfonmethane

1775

Sulindac

1776

Sultamicillin

1777

Sulthiame

1778

Sumatriptan; except when specified elsewhere in this schedule

1779

Sunitinib

1780

Suprofen

1781

Sutilains

1782

Suxamethonium

1783

Suxethonium

1784

T cell receptor antibody

1785

Tacrine

1786

Tacrolimus

1787

Tadalafil and its structural analogues

1788

Tafluprost

1789

Taliglucerase alfa

1790

Tamoxifen

1791

Tamsulosin

1792

Tanacetum vulgare; in medicines containing more than 0.8% of oil of tansy

1793

Tapentadol

1794

Tasonermin

1795

Tazarotene

1796

Tazobactam

1797

Tegafur

1798

Tegaserod

1799

Teicoplanin

1800

Telaprevir

1801

Telbivudine

1802

Telithromycin

1803

Telmisartan

1804

Temazepam

1805

Temozolomide

1806

Temsirolimus

1807

Tenecteplase

1808

Teniposide

1809

Tenofovir

1810

Tenoxicam

1811

Terazosin

1812

Terbinafine; except in medicines for dermal use

1813

Terbutaline

1814

Terfenadine

1815

Teriflunomide

1816

Teriparatide

1817

Terlipressin

1818

Terodiline

1819

Teropterin

1820

Tesamorelin

1821

Testolactone

1822

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

1823

Tetanus antitoxin

1824

Tetanus toxoid

1825

Tetanus vaccine

1826

Tetrabenazine

1827

Tetracosactrin

1828

Tetracycline

1829

Tetraethylammonium

1830

Tetrahydrocannabinol

1831

Tetrazepam

1832

Tetroxoprim

1833

Thalidomide

1834

Thenyldiamine

1835

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

1836

Thevetia peruviana

1837

Thevetin

1838

Thiambutosine

1839

Thiazosulfone

1840

Thiethylperazine

1841

Thioacetazone

1842

Thiocarlide

1843

Thioguanine

1844

Thiomesterone

1845

Thiopentone

1846

Thiopropazate

1847

Thioproperazine

1848

Thioridazine

1849

Thiotepa

1850

Thiothixene

1851

Thiouracil

1852

Thiourea; except in medicines containing 0.1% or less

1853

Thymoxamine

1854

Thyroid

1855

Thyrotrophin

1856

Thyrotrophin-releasing factor

1857

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

1858

Tiagabine

1859

Tiaprofenic acid

1860

Tiaramide

1861

Tibolone

1862

Ticagrelor

1863

Ticarcillin

1864

Ticlopidine

1865

Tiemonium

1866

Tienilic acid

1867

Tigecycline

1868

Tigloidine

1869

Tiletamine

1870

Tilidine

1871

Tiludronic acid

1872

Timolol

1873

Tinidazole

1874

Tinzaparin

1875

Tioconazole; except in medicines for vaginal or dermal use

1876

Tiotropium

1877

Tipepidine

1878

Tiprinavir

1879

Tirilazad

1880

Tirofiban

1881

Tobramycin

1882

Tocainide

1883

Tocilizumab

1884

Tolazamide

1885

Tolazoline

1886

Tolbutamide

1887

Tolcapone

1888

Tolfenamic acid

1889

Tolmetin

1890

Tolonium

1891

Tolpropamine

1892

Tolrestat

1893

Tolterodine

1894

Tolvaptan

1895

Topiramate

1896

Topotecan

1897

Torasemide

1898

Toremifene

1899

Toxoids; for injection

1900

Tramadol

1901

Trametinib dimethyl sulfoxide

1902

Trandolapril

1903

Tranexamic acid

1904

Tranylcypromine

1905

Trastuzumab

1906

Trastuzumab emtansine

1907

Travoprost

1908

Trazodone

1909

Trenbolone

1910

Treosulphan

1911

Treprostinil

1912

Trestolone

1913

Tretamine

1914

Tretinoin

1915

Triacetyloleandomycin

1916

Triamcinolone; except when specified elsewhere in this schedule

1917

Triamterene

1918

Triaziquone

1919

Triazolam

1920

Trichlormethiazide

1921

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

1922

Trichloroethylene

1923

Trichodesma africana; at all strengths

1924

Triclofos

1925

Tricyclamol

1926

Tridihexethyl

1927

Trifluoperazine

1928

Trifluperidol

1929

Triflupromazine

1930

Trimeprazine; except when specified elsewhere in this schedule

1931

Trimetaphan

1932

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

1933

Trimipramine

1934

Trimustine

1935

Trinitrophenol

1936

Trioxysalen

1937

Triparanol; at all strengths

1938

Triple antigen vaccine

1939

Triprolidine; except when specified elsewhere in this schedule

1940

Triptorelin

1941

Troglitazone

1942

Trometamol; for injection in medicines containing more than 3%

1943

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

1944

Tropisetron

1945

Trovafloxacin

1946

Troxidone

1947

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

1948

Tuberculin

1949

Tuberculosis vaccine

1950

Tubocurarine

1951

Tulobuterol

1952

Typhoid vaccine

1953

Umeclidinium bromide

1954

Unoprostone

1955

Uracil

1956

Urapidil

1957

Urethane

1958

Urofollitropin

1959

Urokinase

1960

Ursodeoxycholic acid

1961

Ustekinumab

1962

Vaccines; except when specified elsewhere in this schedule

1963

Vaccinia virus vaccine

1964

Valaciclovir

1965

Valdecoxib

1966

Valganciclovir

1967

Valnoctamide

1968

Valproic acid

1969

Valsartan

1970

Vancomycin

1971

Vandetanib

1972

Vardenafil and its structural analogues

1973

Varenicline

1974

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

1975

Vasopressin

1976

Vecuronium

1977

Vedolizumab

1978

Velaglucerase alfa

1979

Vemurafenib

1980

Venlafaxine

1981

Verapamil

1982

Veratrum spp

1983

Vernakalant

1984

Verteporfin

1985

Veruprevir

1986

Vidarabine

1987

Vigabatrin

1988

Vilanterol

1989

Vildagliptin

1990

Viloxazine

1991

Vinblastine

1992

Vincamine

1993

Vincristine

1994

Vindesine

1995

Vinflunine

1996

Vinorelbine

1997

Vinyl ether

1998

Virginiamycin

1999

Vismodegib

2000

Visnadine

2001

Vitamin A; for internal use in medicines containing more than 3 milligrams of retinol equivalents per recommended daily dose except in parenteral nutrition replacement preparations; for external use in medicines containing more than 1%

2002

Vitamin D; for internal use in medicines containing more than 25 micrograms per recommended daily dose except in parenteral nutrition replacement preparations

2003

Voriconazole

2004

Vorinostat

2005

Vortioxetine

2006

Warfarin

2007

Xamoterol

2008

Xanthinol nicotinate

2009

Ximelagatran

2010

Xipamide

2011

Yellow fever vaccine

2012

Yohimbine

2013

Zafirlukast

2014

Zalcitabine

2015

Zaleplon

2016

Zanamivir

2017

Zidovudine

2018

Zimeldine

2019

Zinc; for internal use in medicines containing more than 25 milligrams 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 in parenteral nutrition replacement preparations

2020

Ziprasidone

2021

Zoledronic acid

2022

Zolmitriptan; except when specified elsewhere in this schedule

2023

Zolpidem

2024

Zonisamide

2025

Zopiclone

2026

Zoster immunoglobulin, human

2027

Zoxazolamine

2028

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; except when specified elsewhere in this schedule

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 anxiety or insomnia; for oral use for the treatment of anxiety or 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; in medicines containing more than 5%

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 anxiety or insomnia; for oral use for the treatment of anxiety or 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 anxiety or insomnia; for oral use for the treatment of anxiety or 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 anxiety or insomnia; for oral use for the treatment of anxiety or 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 anxiety or insomnia; for oral use for the treatment of anxiety or 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 anxiety or insomnia; for oral use for the treatment of anxiety or 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

Guaiphenesin; 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

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 hyrocortisone; 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; 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 except when sold by nurses recognised by their professional body as having competency in the field of sexual and reproductive health

48

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

49

Malathion; for external use in medicines containing more than 2%

50

Mannityl hexanitrate

51

Meclozine; in a pack size of up to 10 dosage units for the treatment of anxiety or 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 anxiety or insomnia; for oral use for the treatment of anxiety or 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

57

Nicotinyl alcohol; in medicines containing more than 100 milligrams per dose form

58

Nystatin; for the treatment of oral candidiasis; for vaginal use

59

Omeprazole; in tablets or capsules containing 20 milligrams or less when sold in a pack approved by the Minister or the Director-General for distribution as a restricted medicine

60

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

61

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

62

Oxiconazole; for vaginal use

63

Pantoprazole; in tablets or capsules containing 20 milligrams or less of pantoprazole when sold in a pack approved by the Minister or the Director-General for distribution as a restricted medicine

64

Pheniramine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for the treatment of anxiety or insomnia; for oral use for the treatment of anxiety or insomnia when sold in the manufacturer’s original pack containing not more than 10 dosage units

65

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

66

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

67

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

68

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

69

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

70

Promethazine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for the treatment of anxiety or insomnia; for oral use for the treatment of anxiety or insomnia when sold in the manufacturer’s original pack containing not more than 10 dosage units

71

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

72

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

73

Santonin

74

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

75

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

76

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

77

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

78

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

79

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

80

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

81

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

82

Tioconazole; for vaginal use

83

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

84

Trimeprazine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for the treatment of anxiety or insomnia; for oral use for the treatment of anxiety or insomnia when sold in the manufacturer’s original pack containing not more than 10 dosage units

85

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

86

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

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%

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; for nasal use; 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%

19

Benzydamine; for external use except for dermal use

20

Bephenium

21

Bifonazole; for dermal use except in medicines for tinea pedis only or in shampoos containing 1% or less

22

Bisacodyl

23

Bromhexine

24

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

25

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

26

Carbetapentane; in medicines containing more than 0.5%

27

Carbocisteine

28

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

29

Chlophedianol

30

Chlorbutol; in medicines containing 5% or less and more than 0.5%

31

Chloroform; in medicines other than for anaesthesia containing more than 0.5%

32

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

33

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

34

Cinchocaine; for external use in medicines containing 0.5% or less

35

Cinnamedrine

36

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

37

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

38

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

39

Colocynth

40

Creosote; in medicines containing more than 10%

41

Cresols; in medicines containing more than 3%

42

Datura spp; for oral use in liquid form in medicines containing 0.03% or less and 0.3 milligrams or less per dose and not more than 1.2 milligrams per recommended daily dose of total solanaceous alkaloids; in solid dose form in medicines containing 0.3 milligrams or less per dose form and not more than 1.2 milligrams per recommended daily dose of total solanaceous alkaloids

43

Delphinium staphisagria; in medicines containing more than 0.2%

44

Desloratadine; for oral use

45

Dexchlorpheniramine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with 1 or more other therapeutically active ingredients either when in the bedtime dose of a day/night pack containing dexchlorpheniramine or when at least 1 of the other active ingredients is a sympathomimetic decongestant

46

Dextromethorphan; in liquid form containing more than 0.25% or in solid dose form containing more than 15 milligrams per dose form when in packs containing not more than 600 milligrams and with a recommended daily dose of not more than 120 milligrams; in medicines for the treatment of the symptoms of cough and cold in children aged 6–12 years

47

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

48

Diclofenac; in solid dose form in medicines containing 12.5 milligrams or less per dose form in packs containing not more than 30 tablets or capsules and with a recommended daily dose of not more than 75 milligrams

49

Diphenoxylate; in liquid form containing in each millilitre not more than 0.5 milligrams of diphenoxylate calculated as base and not less than 5 micrograms of atropine sulphate; in solid dose form containing not more than 2.5 milligrams of diphenoxylate calculated as base and not less than 5 micrograms of atropine sulphate

50

Dimenhydrinate; for oral use in a sealed container of not more than 10 tablets or capsules for the prevention or treatment of motion sickness in adults or children over 2 years of age except when sold at a transport terminal or aboard a ship or aircraft

51

Diphenhydramine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with 1 or more other therapeutically active ingredients either when in the bedtime dose of a day/night pack containing diphenhydramine or when at least 1 of the other active ingredients is a sympathomimetic decongestant; for oral use in a sealed container of not more than 10 tablets or capsules for the prevention or treatment of motion sickness in adults and children over 2 years of age except when sold at a transport terminal or aboard a ship or aircraft

52

Doxylamine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with 1 or more other therapeutically active ingredients either when in the bedtime dose of a day/night pack containing doxylamine or when at least 1 of the other active ingredients is a sympathomimetic decongestant

53

Duboisia leichhardtii; for oral use in liquid form in medicines containing 0.03% or less and 0.3 milligrams or less per dose and not more than 1.2 milligrams per recommended daily dose of total solanaceous alkaloids; in solid dose form in medicines containing 0.3 milligrams or less per dose form and not more than 1.2 milligrams per recommended daily dose of total solanaceous alkaloids

54

Duboisia myoporides; for oral use in liquid form in medicines containing 0.03% or less and 0.3 milligrams or less per dose and not more than 1.2 milligrams per recommended daily dose of total solanaceous alkaloids; in solid dose form in medicines containing 0.3 milligrams or less per dose form and not more than 1.2 milligrams per recommended daily dose of total solanaceous alkaloids

55

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

56

Etafedrine

57

Ether; in medicines containing more than 10%

58

Etofenamate; for external use

59

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

60

Felbinac; for external use

61

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

62

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

63

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

64

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

65

Folic acid; for oral use in medicines containing more than 500 micrograms per recommended daily dose

66

Folinic acid; for oral use in medicines containing more than 500 micrograms per recommended daily dose

67

Formaldehyde; in medicines containing more than 5%

68

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

69

Glutaraldehyde

70

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

71

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

72

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

73

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

74

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

75

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

76

Hyoscyamus niger; 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 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

77

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

78

Indanazoline

79

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

80

Iodine; for external use in medicines containing more than 2.5%; for internal use in medicines containing 300 micrograms or more per recommended daily dose

81

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

82

Ipomoea spp; except ipomoea batatas

83

Ipratropium; for nasal use

84

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

85

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

86

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

87

Jalap resin

88

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

89

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

90

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

91

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

92

Levocetirizine; for oral use

93

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

94

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

95

Lithium; for dermal use in medicines containing 1% or less but more than 0.01%; except when present as an excipient in dermal medicines containing 0.25% or less

96

Lobelia inflata; except in medicines for smoking or burning

97

Lobeline; except when in medicines for smoking or burning

98

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

99

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

100

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 5 days’ supply

101

Mebendazole

102

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

103

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

104

Mepyramine; for dermal use

105

Mercuric oxide; for ophthalmic use

106

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

107

Mercury; for external use in medicines containing 0.5% or less

108

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

109

Methoxyphenamine

110

Methylephedrine

111

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

112

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

113

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

114

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

115

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

116

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

117

Niclosamide

118

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

119

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

120

Noscapine

121

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

122

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

123

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

124

Oxetacaine; for internal use

125

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

126

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

127

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

128

Papaverine; except for injection

129

Paracetamol; in liquid form; in suppositories; in tablets or capsules containing 500 milligrams or less and in packs containing more than 10 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

130

Paraformaldehyde; in medicines containing more than 5%

131

Penciclovir; for external use for the treatment of herpes labialis

132

Phedrazine

133

Phenazone; for external use

134

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

135

Phenol; in medicines other than for injection containing more than 3%

136

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

137

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

138

Piperazine

139

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

140

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

141

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

142

Potassium; for internal use: in slow-release or enteric coated forms; 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

143

Potassium chlorate; except in medicines containing 10% or less

144

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

145

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

146

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

147

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

148

Pyrantel

149

Pyrethrins; in medicines containing more than 10%

150

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

151

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 150 milligrams or less per dose unit when sold in the manufacturer’s original pack containing not more than 7 days’ supply

152

Salicylamide

153

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

154

Sennosides

155

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

156

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

157

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

158

Sodium nitrite; except for use as an excipient

159

Sodium picosulphate; in oral laxative preparations

160

Squill; in medicines containing more than 1%

161

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

162

Sulconazole; for dermal use

163

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

164

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

165

Tetrachloroethylene

166

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

167

Thiabendazole

168

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

169

Tramazoline

170

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

171

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

172

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

173

Tuaminoheptane

174

Tymazoline

175

Xylenols; in medicines containing more than 3%

176

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

177

Zinc chloride; for dermal use in medicines containing more than 5%

Schedule 2

Form 1 Application for licence to manufacture, hawk, sell, or pack medicine

[Before completing this form you should make yourself familiar with the provisions of the Medicines Act 1981 and the Medicines Regulations 1984, especially those parts that deal with licences.

This form may be used to apply for licences to manufacture, pack, sell, or hawk medicines. It is divided into 7 parts. Every applicant must complete either Part 1 or Part 2, and must also complete at least one of Parts 3, 4, 5, 6, and 7.

Every application must be accompanied by the prescribed fee for each licence applied for (viz, regulation 61, Medicines Regulations 1984).]

The form must be completed in type, or in block capitals.

Part 1

[To be completed where the applicant is an individual applying for a licence on his own behalf.]

Name of applicant: [surname] [first names]

I am a New Zealand resident: Yes/No

Date of birth: [day/month/year]

Address (home):

Name of business:

Street address of business premises:

 
 

Postal address:

General nature of business:

Position of applicant (for example, “owner”, “manager” etc):

 
 

Have you previously held a licence to manufacture, pack, sell, or hawk medicines? Yes/No

If yes give details:

 
 

Have you ever been declined, or had revoked, a licence to manufacture, pack, sell, or hawk medicines? Yes/No

If yes give details:

 
 

Part 2

[To be completed where the applicant is an officer of a body corporate applying for a licence on behalf of the body corporate.]

Name of body corporate:

The body corporate is incorporated in New Zealand Yes/No

Street address of body corporate:

 
 

Postal address:

General nature of business of body corporate:

 

Name of person completing this form: [surname] [first names]

 
 

Position in body corporate of person completing form:

 

Details of persons nominated to be responsible persons under the Medicines Act 1981:

NameDate of birthPosition in body corporate
 
 

Have any of the above nominees ever been declined, or had revoked, a licence to manufacture, pack, sell, or hawk medicines? Yes/No

If yes give details:

 
 

Have any of the above nominees ever been a licensee or responsible person under the Restricted Drugs Act 1960 or the Medicines Act 1981? Yes/No

If yes give details:

 
 

Part 3

Application to manufacture medicines

I hereby make application for a licence to manufacture the medicines listed below (attach extra list if insufficient space provided here). Indicate (by reference to one of the following paragraphs) which of the following classes the medicines come within:

(a)

antibiotics, or preparations of antibiotics:

(b)

vaccines and sera:

(c)

sterile preparations:

(d)

hormones and steroid preparations:

(e)

preparations, other than vitamins, having a dose of 5 milligrams or less per unit dose:

(f)

antineoplastic agents and immunosuppressant agents other than steroid preparations:

(g)

other medicines not included in paragraphs (a) to (f), above.

Appropriate designationTrade name of medicineClass
 
 
 
 
 
 

Premises where manufacture (including packing and labelling) of the medicines will be carried out:

 

I enclose the fee of:

 

Signature of applicant (or Common Seal where applicant is a body corporate):

Date:

Part 4

Application to pack medicines

I hereby make application for a licence to pack the medicines listed below (attach extra list if insufficient space provided here). Indicate in the third column whether the medicine is a prescription medicine, restricted medicine, or pharmacy-only medicine.

Appropriate designationTrade name of medicineClass
 
 
 
 
 
 

Premises where packing and labelling will be carried out:

 
 

I enclose the fee of:

Signature of applicant (or Common Seal where applicant is a body corporate):

Date:

Part 5

Application to sell medicines by wholesale

I hereby make application to sell by wholesale the following medicines (attach extra list if insufficient space provided here):

 
 
 
 
 

Premises from where medicines are to be sold:

 
 

I enclose the fee of:

Signature of applicant (or Common Seal where applicant is a body corporate):

Date:

Part 6

Application to sell medicines by retail

I hereby make application to sell by retail the following medicines (attach extra list if insufficient space provided here):

 
 
 
 
 

Premises from where medicines are to be sold:

 
 

I declare the above premises are more than 10 kilometres by road from the nearest pharmacy.

The reasons for this application are:

 
 
 
 
 

I enclose the fee of:

Signature of applicant (or Common Seal where applicant is a body corporate):

Date:

Part 7

Application to hawk medicines

I hereby make application for a licence to hawk medicines.

Premises where stock of medicines will be kept:

 
 

Place where records of sale of medicines will be kept:

 
 

Geographical area in which it is proposed to hawk medicines:

 
 

Persons or classes of persons to whom it is proposed to hawk medicines:

 
 

Name and maximum quantity of medicines intended to be transported when hawking:

 
 

I enclose the fee of:

Signature of applicant (or Common Seal where applicant is a body corporate):

Date:

Schedule 2 form 1 heading: substituted, on 18 September 2004, by regulation 9(1)(a) of the Medicines Amendment Regulations 2004 (SR 2004/300).

Schedule 2 form 1 Part 1: amended, on 18 September 2004, by regulation 9(1)(b) of the Medicines Amendment Regulations 2004 (SR 2004/300).

Schedule 2 form 1 Part 2: amended, on 18 September 2004, by regulation 9(1)(c) of the Medicines Amendment Regulations 2004 (SR 2004/300).

Form 1A Application for licence to operate pharmacy made (by employee or agent) on behalf of company

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

Important information

Before filling out this application please note the following important information:

  • this form may be used by an employee or agent who is making an application on behalf of a company:

  • you must make yourself familiar with the provisions of the Medicines Act 1981 and the Medicines Regulations 1984, in particular those provisions relating to licensing and operating pharmacies:

  • the following must accompany this application:

    • the prescribed fee:

    • a completed statutory declaration:

  • it is an offence to make a false statutory declaration:

  • the licensing authority may require you to supply additional information at a later date (see section 55B of the Medicines Act 1981). If you do not supply that information within 30 days of the request, this application will lapse.

Please complete the following:

Applicant and company

I, [full name of employee or agent of company], [position in company], make this application for a licence to operate a pharmacy on behalf of [name of company], which—

(a)

was incorporated in New Zealand on [date of incorporation]; and

(b)

has the following board members:

[full names of all board members].

The address of the company is [address].

The following persons are nominated to be responsible persons for the purposes of the licence under the Medicines Act 1981:

[full names, dates of birth, and positions held].

Street address and description of pharmacy

The street address of the pharmacy to which this application relates is [street address].

The pharmacy will comprise the following part or parts of that street address: [specify the part or parts of the street address that are to be a pharmacy or attach a line drawing showing the part or parts].

Interests held in pharmacy

Note: Before filling out this part of the form please read section 5A of the Medicines Act 1981, which sets out the meaning of holding an interest in a pharmacy.

The following person(s) or company (or companies) hold an interest in the pharmacy (as defined in section 5A of the Medicines Act 1981) to which this application relates: [name(s) of person(s) or company (or companies), their address(es), and the particulars of the interest held (or “none” if applicable)].

The following person(s) who hold an interest in the pharmacy to which this applicaton relates is a (or are) practioner(s) (or registered midwife (midwives)) (or designated prescriber(s)): [name of the interest holder(s) and his or her relevant position (or “none” if applicable)].

Eligibility to hold licence

*The share capital of the company is more than 50% owned by [full name of pharmacist] who is a pharmacist† (or [full names of pharmacists] who are pharmacists) and effective control of the company is vested in the above-named pharmacist (or pharmacists).

†In this context, a pharmacist
(a)

means a health practitioner who is, or is deemed to be, registered with the Pharmacy Council established by the Health Practitioners Competence Assurance Act 2003 as a practitioner of the profession of pharmacy; and

(b)

includes an administrator of the estate of a deceased pharmacist, and an assignee within the meaning of the Insolvency Act 1967 of the estate of a pharmacist, until—

(i)

the expiry of the period of 1 year after the date of the death of the deceased pharmacist, or the date on which the pharmacist was adjudicated bankrupt; or

 

or

(ii)

subject to any conditions that the licensing authority proposes, the extended period or periods permitted by the licensing authority.

or

*The pharmacy to which this application relates is in a hospital owned or operated by the company. [Specify details.]

or

*[Specify other ground in section 55D(2) of the Medicines Act 1981 that makes the company eligible to hold a licence.]

*Delete if inapplicable.

Practices and procedures for pharmacists working in pharmacy

The following practices and procedures will be in place to ensure that any pharmacist* who is employed or engaged in duties in the pharmacy to which this application relates is not requested or required to act in a way that is inconsistent with the applicable professional or ethical standards of the pharmacy practice: [specify relevant practices and procedures].

*In this context, a pharmacist means a health practitioner who is, or is deemed to be, registered with the Pharmacy Council established by the Health Practitioners Competence Assurance Act 2003 as a practitioner of the profession of pharmacy.

Other pharmacies

The company operates the following pharmacy (or pharmacies): [name(s) and address(es) of pharmacy (or pharmacies) (or "none" if applicable)].

[Specify number, or “none” if applicable] of those pharmacies are (or is) currently for sale.

*Mortgagee in possession

The company is a mortgagee in possession† of the pharmacy to which this application relates.

*Delete if inapplicable.

†For the purposes of this application a mortgagee in possession has the same meaning as in section 4 of the Property Law Act 2007.

Signature of applicant:

Declaration

I, [full name of agent or employee of the company], of [place], [occupation], solemnly and sincerely declare that the statements made in the above application are true and correct.

I make this solemn declaration conscientiously believing the same to be true and by virtue of the Oaths and Declarations Act 1957.

Declared at [place, date] before me:

[Signature]
Justice of the Peace
(or other person authorised to take a statutory declaration)

Schedule 2 form 1A: inserted, on 18 September 2004, by regulation 10 of the Medicines Amendment Regulations 2004 (SR 2004/300).

Schedule 2 form 1A: amended, on 1 January 2008, by regulation 4 of the Medicines (Property Law Act 2007) Amendment Regulations 2007 (SR 2007/382).

Form 1B Application for licence to operate pharmacy made by person who is individual (or employee or agent of body corporate that is not company)

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

Important information

Before filling out this application please note the following important information:

  • this form may be used by—

    • an individual who is applying for a licence to operate a pharmacy; or

    • an employee or agent of a body corporate (other than a company) who is applying for a licence to operate a pharmacy on behalf of that body corporate (for example, an application made on behalf of a partnership or friendly society):

  • you must make yourself familiar with the provisions of the Medicines Act 1981 and the Medicines Regulations 1984, in particular those provisions relating to licensing and operating pharmacies:

  • the following must accompany this application:

    • the prescribed fee:

    • a completed statutory declaration:

  • it is an offence to make a false statutory declaration:

  • the licensing authority may require you to supply additional information at a later date (see section 55B of the Medicines Act 1981). If you do not supply that information within 30 days of the request, this application will lapse.

Please complete the following:

Application (and body corporate)

I, [full name], of [address], being a resident of New Zealand, apply for a licence to operate a pharmacy on—

*my own behalf.

*on behalf of the body corporate called [name of body corporate], which—

(a)

is not a company, but is a [specify the type of body corporate]; and

(b)

was incorporated in New Zealand on [date]; and

(c)

has the following board members (or trustees) (or partners): [full names of board members (or trustees) (or partners)].

*Delete if inapplicable.

My address (or The address of the body corporate) is [address].

*I was born on [date].

or

*I hold the office of [specify office held] within the above-named body corporate. The following persons are nominated to be responsible persons under the Medicines Act 1981:

[full names, dates of birth, and positions held].

*Delete if inapplicable.
Street address and description of pharmacy

The street address of the pharmacy to which this application relates is [street address].

The pharmacy will comprise the following part or parts of that street address: [specify the part or parts of the street address that are to be a pharmacy or attach a line drawing showing the part or parts].

Interests held in pharmacy

Note: Before filling out this part of the form please read section 5A of the Medicines Act 1981, which sets out the meaning of holding an interest in a pharmacy.

The following person(s) or company (or companies) hold an interest in the pharmacy (as defined in section 5A of the Medicines Act 1981) to which this application relates: [name(s) of person(s) or company (or companies), their address(es), and the particulars of the interest held (or “none” if applicable)].

The following person(s) who hold an interest in the pharmacy to which this applicaton relates is a (or are) practioner(s) (or registered midwife (midwives)) (or designated prescriber(s)): [name of the interest holder(s) and his or her relevant position (or “none” if applicable)].

Eligibility to hold licence

*I am (or [Name of person in body corporate who has the majority interest] is) a pharmacist for the purposes of this application because I am (or he or she is) a health practitioner who is, or is deemed to be, registered with the Pharmacy Council established by the Health Practitioners Competence Assurance Act 2003 as a practitioner of the profession of pharmacy.

or

*I am (or The body corporate is) a pharmacist because [specify part of the definition of pharmacist in section 55E(3) of the Medicines Act 1981] applies.

or

*The pharmacy I am (or The body corporate is) applying to operate is in a hospital owned or operated by me (or the body corporate).

[Specify details.]

or

*I am (or The body corporate is) eligible to operate a pharmacy because [specify other ground in section 55E(1) of the Medicines Act 1981 that makes person or body corporate eligible to hold a licence].

*Delete if inapplicable.

Practices and procedure for pharmacists working in pharmacy

The following practices and procedures will be in place to ensure that any pharmacist* who is employed or engaged in duties in the pharmacy to which this application relates is not requested or required to act in a way that is inconsistent with the applicable professional or ethical standards of the pharmacy practice: [specify practices and procedures].

*In this context, a pharmacist means a health practitioner who is, or is deemed to be, registered with the Pharmacy Council established by the Health Practitioners Competence Assurance Act 2003 as a practitioner of the profession of pharmacy.

Other pharmacies

I operate (or have a majority interest in) (or The body corporate operates) the following pharmacy (or pharmacies): [name(s) and address(es) of the pharmacy (or pharmacies) (or “none” if applicable).]

[Specify number, or “none” if applicable] of those pharmacies are (or is) currently for sale.

*Mortgagee in possession

I am (or The body corporate is) the mortgagee in possession† of the pharmacy to which this application relates.

*Delete if inapplicable.

†For the purposes of this application a mortgagee in possession has the same meaning as in section 4 of the Property Law Act 2007.

Signature of applicant:

Declaration

I [full name of applicant], of [place], [occupation], solemnly and sincerely declare that the statements made in the above application are true and correct.

I make this solemn declaration conscientiously believing the same to be true and by virtue of the Oaths and Declarations Act 1957.

Declared at [place, date] before me:

[Signature]
Justice of the Peace
(or other person authorised to take a statutory declaration)

Schedule 2 form 1B: inserted, on 18 September 2004, by regulation 10 of the Medicines Amendment Regulations 2004 (SR 2004/300).

Schedule 2 form 1B: amended, on 1 August 2011, by regulation 28 of the Medicines Amendment Regulations 2011 (SR 2011/245).

Form 2 Licence to manufacture medicines

(Issued pursuant to the Medicines Act 1981)

Licence No:

Name of licensee:

Address of licensee:

Name of responsible persons:

 
 
 

The *licensee or every responsible person named above is hereby authorised pursuant to section 51 of the Medicines Act 1981 to manufacture, pack, label, and sell by wholesale the following medicines or classes of medicines:

 
 

*Delete whichever does not apply.

The authority granted by this licence is subject to the following conditions:

(1)

The manufacture, packing, labelling, or sale of the medicines shall be carried out in accordance with the Medicines Act 1981 and the Medicines Regulations 1984.

(2)

[Further conditions imposed by the licensing authority]:

This licence shall expire on [date].

[Signature]
(Licensing authority)

Schedule 2 form 2: amended, on 18 September 2004, by regulation 9(2)(a) of the Medicines Amendment Regulations 2004 (SR 2004/300).

Schedule 2 form 2: amended, on 18 September 2004, by regulation 9(2)(b) of the Medicines Amendment Regulations 2004 (SR 2004/300).

Form 3 Licence to hawk medicines

(Issued pursuant to the Medicines Act 1981)

Licence No:

Name of licensee:

Address of licensee:

Names of responsible persons:

 
 
 
 
 

The *licensee or every responsible person named above is hereby authorised pursuant to section 51 of the Medicines Act 1981 to hawk the following medicines:

 
 
 
 

*Delete whichever does not apply.

The authority granted by this licence is subject to the following conditions:

(1)

All sales shall be made in accordance with the Medicines Act 1981 and the Medicines Regulations 1984.

(2)

The stock of medicines held by the licensee or responsible person shall be stored only at the following place or places:

(3)

The records of sale shall be kept at the following premises:

(4)

Sales shall only be made within the following geographical area:

(5)

Sales shall only be made to the following persons or classes of persons:

(6)

[Further conditions imposed by the licensing authority]:

 

This licence shall expire on [date].

[Signature]
(Licensing authority)

Schedule 2 form 3: amended, on 18 September 2004, by regulation 9(3)(a) of the Medicines Amendment Regulations 2004 (SR 2004/300).

Schedule 2 form 3: amended, on 18 September 2004, by regulation 9(3)(b) of the Medicines Amendment Regulations 2004 (SR 2004/300).

Form 4 Licence to sell medicines by wholesale

(Issued pursuant to the Medicines Act 1981)

Licence No:

Name of licensee:

Address of licensee:

Name of responsible persons:

 
 
 
 
 

Address of business premises:

 
 

The *licensee or every responsible person named above is hereby authorised pursuant to section 51 of the Medicines Act 1981 to sell by wholesale the following medicines:

 
 
 
 
*Delete whichever does not apply.

The authority granted by this licence is subject to the following conditions:

(1)

The sale of the above medicines shall not take place other than at the business premises set out above.

(2)

All sales shall be made in accordance with the Medicines Act 1981 and the Medicines Regulations 1984.

(3)

[Further conditions imposed by the licensing authority]:

 

This licence shall expire on [date].

[Signature]
(Licensing authority)

Schedule 2 form 4: amended, on 18 September 2004, by regulation 9(3)(a) of the Medicines Amendment Regulations 2004 (SR 2004/300).

Schedule 2 form 4: amended, on 18 September 2004, by regulation 9(3)(b) of the Medicines Amendment Regulations 2004 (SR 2004/300).

Form 5 Licence to sell medicines by retail

(Issued pursuant to the Medicines Act 1981)

Licence No:

Name of licensee:

Address of licensee:

Name of responsible persons:

 
 
 
 
 

Address of business premises:

 
 

The *licensee or every responsible person named above is hereby authorised pursuant to section 51 of the Medicines Act 1981 to sell by retail, and supply in circumstances corresponding to retail sale, the following medicines:

 
 
 
 
*Delete whichever does not apply.

The authority granted by this licence is subject to the following conditions:

(1)

The sale of the above medicines shall not take place other than at the business premises set out above.

(2)

All sales shall be made in accordance with the Medicines Act 1981 and the Medicines Regulations 1984.

(3)

[Further conditions imposed by the licensing authority]:

 

This licence shall expire on [date].

[Signature]
(Licensing authority)

Schedule 2 form 5: amended, on 18 September 2004, by regulation 9(3)(a) of the Medicines Amendment Regulations 2004 (SR 2004/300).

Schedule 2 form 5: amended, on 18 September 2004, by regulation 9(3)(b) of the Medicines Amendment Regulations 2004 (SR 2004/300).

Form 6 Licence to pack medicines

(Issued pursuant to the Medicines Act 1981)

Licence No:

Name of licensee:

Address of licensee:

Names of responsible persons:

 
 
 
 

Address of business premises:

 
 

The *licensee or every responsible person named above is hereby authorised pursuant to section 51 of the Medicines Act 1981 to pack or label for the purpose of sale, and sell by wholesale the following medicines:

 
 
 
 
 
*Delete whichever does not apply.

The authority granted by this licence is subject to the following conditions:

(1)

The packing, labelling, or sale of the medicines shall be carried out in accordance with the Medicines Act 1981 and the Medicines Regulations 1984.

(2)

[Further conditions imposed by the licensing authority]:

 
 

This licence shall expire on [date].

[Signature]
(Licensing authority)

Schedule 2 form 6: amended, on 18 September 2004, by regulation 9(3)(a) of the Medicines Amendment Regulations 2004 (SR 2004/300).

Schedule 2 form 6: amended, on 18 September 2004, by regulation 9(3)(b) of the Medicines Amendment Regulations 2004 (SR 2004/300).

Form 7 Licence to operate pharmacy

r 46(1)(f)

Section 51, Medicines Act 1981

Licence No:

This licence to operate a pharmacy is granted to [full name of person or body corporate] of [address] and authorises—

  • the establishment of a pharmacy at [location] (or in the following part or parts of [location]: [specify relevant part or parts]); and

  • the carrying on of pharmacy practice in that pharmacy.

*Names of responsible persons for body corporate:

 
 
 
 
 
*Delete if inapplicable.

The pharmacy must be operated in accordance with the duties and obligations in the Medicines Act 1981.

This licence is subject to the following conditions:

(a)

the holder of this licence must not request or require any pharmacist who is employed or engaged in duties at the above-named pharmacy to act in a way that is inconsistent with the applicable professional or ethical standards of pharmacy practice:

(b)

[specify any other conditions].

This licence expires on [date].

[Signature]
(Licensing authority)

Schedule 2 form 7: added, on 18 September 2004, by regulation 11 of the Medicines Amendment Regulations 2004 (SR 2004/300).

Schedule 3 Loose sheet data sheet requirements

[Revoked]

r 53(2)

Schedule 3: revoked, on 1 August 2011, by regulation 29 of the Medicines Amendment Regulations 2011 (SR 2011/245).

Schedule 4 Hawker’s Medicines book

r 56(2)(a)

Name of medicineFormStrengthPage
 
 
 
 
Date

Name and address of supplier of medicine

or

Name and address of person to whom medicine sold

Order NoInOutBalance
 
 
 
 
 
 
 
 
 

Schedule 5 Analyst’s certificate under the Medicines Act 1981

r 60

I, [name], an analyst under the Medicines Act 1981, certify that on [date] there was submitted to me by [name and address of the officer from whom the sample was received] an officer within the meaning of that Act, a sample of [name or description of sample] for analysis in a [nature of the package in which the sample was enclosed, and how it was labelled, marked, and sealed] and that the same has been analysed and that the result of the analysis is as follows [analysis and observations]: 

Date:

[Signature]
Analyst

Schedule 5A Licence fees

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

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

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

Schedule 6 Regulations revoked

r 62

Part ARestricted drugs

Restricted Drugs Regulations 1964 (SR 1964/64)
Restricted Drugs Regulations 1964, Amendment No 1 (SR 1966/84)
Restricted Drugs Regulations 1964, Amendment No 2 (SR 1967/250)
Restricted Drugs Regulations 1964, Amendment No 3 (SR 1969/95)
Restricted Drugs Regulations 1964, Amendment No 4 (SR 1969/193)
Restricted Drugs Regulations 1964, Amendment No 5 (SR 1971/55)
Restricted Drugs Regulations 1964, Amendment No 6 (SR 1972/53)
Restricted Drugs Regulations 1964, Amendment No 7 (SR 1972/163)
Restricted Drugs Regulations 1964, Amendment No 8 (SR 1973/111)
Restricted Drugs Regulations 1964, Amendment No 9 (SR 1974/93)
Restricted Drugs Regulations 1964, Amendment No 10 (SR 1974/133)
Restricted Drugs Regulations 1964, Amendment No 11 (SR 1975/25)
Restricted Drugs Regulations 1964, Amendment No 12 (SR 1977/130)
Restricted Drugs Regulations 1964, Amendment No 13 (SR 1978/52)
Restricted Drugs Regulations 1964, Amendment No 14 (SR 1979/37)
Restricted Drugs Regulations 1964, Amendment No 15 (SR 1979/273)
Restricted Drugs Regulations 1964, Amendment No 16 (SR 1981/120)
Restricted Drugs Regulations 1964, Amendment No 17 (SR 1982/32)
Restricted Drugs Regulations 1964, Amendment No 18 (SR 1982/248)
Restricted Drugs Regulations 1964, Amendment No 19 (SR 1983/132)
Restricted Drugs Regulations 1964, Amendment No 20 (SR 1983/289)
Restricted Drugs Regulations 1964, Amendment No 21 (SR 1984/78)

Part BRestricted drugs licences

Restricted Drug Licences Regulations 1961 (SR 1961/39)
Restricted Drug Licences Regulations 1961, Amendment No 1 (SR 1963/123)
Restricted Drug Licences Regulations 1961, Amendment No 2 (SR 1983/133)

Part CTherapeutic drugs (permitted sales)

Therapeutic Drugs (Permitted Sales) Regulations 1978 (SR 1978/34)
Therapeutic Drugs (Permitted Sales) Regulations 1978, Amendment No 1 (SR 1978/230)
Therapeutic Drugs (Permitted Sales) Regulations 1978, Amendment No 2 (SR 1979/168)
Therapeutic Drugs (Permitted Sales) Regulations 1978, Amendment No 3 (SR 1980/114)
Therapeutic Drugs (Permitted Sales) Regulations 1978, Amendment No 4 (SR 1980/264)
Therapeutic Drugs (Permitted Sales) Regulations 1978, Amendment No 5 (SR 1981/119)
Therapeutic Drugs (Permitted Sales) Regulations 1978, Amendment No 6 (SR 1981/324)
Therapeutic Drugs (Permitted Sales) Regulations 1978, Amendment No 7 (SR 1982/189)
Therapeutic Drugs (Permitted Sales) Regulations 1978, Amendment No 8 (SR 1983/20)
Therapeutic Drugs (Permitted Sales) Regulations 1978, Amendment No 9 (SR 1983/73)
Therapeutic Drugs (Permitted Sales) Regulations 1978, Amendment No 10 (SR 1983/147)
Therapeutic Drugs (Permitted Sales) Regulations 1978, Amendment No 11 (SR 1983/205)
Therapeutic Drugs (Permitted Sales) Regulations 1978, Amendment No 12 (SR 1984/41)

P G Millen,
Clerk of the Executive Council.

Issued under the authority of the Legislation Act 2012.

Date of notification in Gazette: 7 June 1984.

Reprints notes
1 General

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

2 Legal status

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

3 Editorial and format changes

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

4 Amendments incorporated in this reprint

Medicines Amendment Regulations (No 2) 2015 (LI 2015/180)

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)