Medicines Act 1981

1: Short Title and commencement
1: This Act may be cited as the Medicines Act 1981.
2: This Act shall come into force on a date to be appointed by the Governor-General by Order in Council, and different dates may be so appointed in respect of different provisions of this Act.
3: An order under this section is secondary legislation ( see Part 3 The following table is small in size and has 3 columns that are grouped under the heading Legislation Act 2019 requirements for secondary legislation made under this section. Legislation Act 2019 requirements for secondary legislation made under this section Publication PCO must publish it on the legislation website and notify it in the Gazette LA19 s 69(1)﻿(c) Presentation The Minister must present it to the House of Representatives LA19 s 114 cl 32(1)﻿(a) Disallowance It may be disallowed by the House of Representatives LA19 ss 115 116 This note is not part of the Act. Section 1(2) brought into force 1 August 1984 Medicines Act Commencement Order 1984 Section 1(3) inserted 28 October 2021 section 3 Secondary Legislation Act 2021
2: Interpretation
1: In this Act, unless the context otherwise requires,— administer
a: orally or by injection or by introduction into the body in any other way; or
b: by external application, whether by direct contact with the body or not;— and every reference in this Act to administering a substance or article is a reference to administering it either in its existing state or after it has been dissolved or dispersed in, or diluted or mixed with, some substance in which it is to be administered advertisement section 56 advertising material analyst
a: any person who is designated by the Minister by notice
b: any person who works in an approved laboratory and who is authorised, by the analyst in charge of that laboratory, to act as an analyst for the purposes of this Act, either generally or in any particular case animal ; but does not include a human being animal food
a: is manufactured or imported only as food for animals; and
b: if sold or supplied in New Zealand, is so sold or supplied only as food for animals animal remedy remedy
a: curing, diagnosing, treating, controlling, or preventing any disease in animals; or
b: destroying or preventing parasites on or in animals; or
c: maintaining or improving the health, condition, productivity, or appearance of any animal; or
d: capturing or immobilising any animal;— but does not include any preparation, substance, or product which is used primarily as a food for animals appropriate committee section 8(1) approved laboratory associate coroner Coroners Act 2006 authorised prescriber
a: a nurse practitioner; or
b: an optometrist; or
c: a practitioner; or
d: a registered midwife; or
e: a designated prescriber bulk cargo container
a: of a permanent character and accordingly strong enough to be suitable for repeated use; and
b: specially designed to facilitate the carriage of goods by 1 or more modes of transport, without immediate repacking; and
c: fitted with devices permitting its ready handling and its transfer from one mode of transport to another; and
d: so designed as to be easy to fill and empty; and
e: having an internal volume of 1 cubic metre or more;— and includes the normal accessories and equipment of the container, when imported with the container and used exclusively with it; but does not include any vehicle, or any ordinary packing case, crate, box, or other similar article used for packing business
a: a professional practice; and
b: any activity carried on for reward by any person carrier container controlled drug section 2(1) Coroner Coroners Act 2006 cosmetic
a: any perfume:
b: any deodorant:
c: any insect repellant:
d: any dusting powder Customs the Customs has the meaning given to Customs in section 5(1) decision delegated prescriber delegated prescribing order delegated prescribing rights section 105(1)﻿(qaa) dentifrice dentist Health Practitioners Competence Assurance Act 2003 designated prescriber , nurse practitioner, optometrist,
a: belongs to a class of registered health professionals authorised by regulations made under this Act to prescribe any specified prescription medicines, or any
b: satisfies any applicable requirement relating to competency, qualifications, or training specified in or imposed under regulations made under this Act Director-General section 98 disease dispensing
a: the preparation of that medicine for sale to the public (whether in response to the issue of a prescription or a request by an individual to be supplied with the medicine); and
b: the packaging, labelling, recording, and delivery of that medicine EPA section 7 examine health services section 2 herbal remedy
a: any substance produced by subjecting a plant to drying, crushing, or any other similar process; or
b: a mixture comprising 2 or more such substances only; or
c: a mixture comprising 1 or more such substances with water or ethyl alcohol or any inert substance hospital section 58(4) importer
a: the owner of any goods; or
b: entitled to the possession of any goods; or
c: beneficially interested in any goods— on or at any time after the importation of those goods and before they have ceased to be subject to the control of Customs in accordance with the Customs and Excise Act 2018 label to label labelled labelling labelling material licence licensed licensee licensee corporation licensing authority
a: means the Director-General; and
b: to avoid doubt, includes any person or persons acting as the Director-General's delegate as a consequence of a delegation under clauses 2 3 manufacture
a: dissolving or dispersing the medicine in, or diluting or mixing it with, some other substance used as a medium for the purpose of administering the medicine to a particular person:
b: incorporating the medicine in any animal food medical device section 3A Medical Officer of Health Health Act 1956 section 22 medical practitioner Health Practitioners Competence Assurance Act 2003 medicine new medicine pharmacy-only medicine prescription medicine restricted medicine section 3 Medicines Review Committee section 10 Minister new organism section 2A nurse practitioner
a: is, or is deemed to be, registered with the Nursing Council of New Zealand continued by section 114(1)﻿(a)
b: holds a current practising certificate Nursing Council section 114(1)﻿(a) officer
a: any officer of the Ministry of Health:
b: any person appointed under section 15 optometrist
a: who is, or is deemed to be, registered with the Optometrists and Dispensing Opticians Board as a practitioner of optometry; and
b: for whom the Optometrists and Dispensing Opticians Board has authorised a scope of practice that includes prescribing medicines Optometrists and Dispensing Opticians Board section 114(1)﻿(a) pack package pharmacist Health Practitioners Competence Assurance Act 2003 pharmacy pharmacy practice
a: the compounding and dispensing of prescription medicines, restricted medicines, or pharmacy-only medicines:
b: the supply of a medicine by a pharmacist to suit the needs of a particular person:
c: the sale of prescription medicines, restricted medicines, or pharmacy-only medicines plant practitioner qualifying new medicine
a: is or contains a new organism; and
b: meets the criteria set out in section 38I(3) qualifying organism registered health professional Health Practitioners Competence Assurance Act 2003 registered midwife Health Practitioners Competence Assurance Act 2003 regulations related product new related product section 94 responsible authority section 5(1) responsible person sell
a: barter; and
b: offering or attempting to sell, or having in possession for sale, or exposing for sale, or sending or delivering for sale, or causing or allowing to be sold, or offered or exposed for sale; and
c: supplying by way of gift or sample for the purpose of promoting a sale;— and sale selling by wholesale selling by retail selling in circumstances corresponding to retail sale section 5 standing order
a: a written instruction issued by a practitioner, registered midwife, nurse practitioner, or optometrist or controlled drugs
b: a written instruction issued by a veterinarian, in accordance with any applicable regulations, authorising any specified class of persons to supply and administer any specified class or description of prescription medicines or controlled drugs
c: a written instruction issued by a practitioner, registered midwife, nurse practitioner, or optometrist
d: a written instruction issued by a veterinarian in accordance with any applicable regulations, authorising any specified class of persons to supply and administer any specified class or description of pharmacy-only medicines or restricted medicines to any specified class of animals, in circumstances specified in the instruction substance therapeutic purpose section 4 vehicle veterinarian or specialist within the meaning of section 4
2: Any approval by the Minister of a laboratory as an approved laboratory for the purposes of this Act may be given on such terms and conditions as the Minister thinks fit and as are specified in the notice approving that laboratory.
3: A notice under this section is secondary legislation ( see Part 3 1960 No 97 s 2(1) 1969 No 7 s 2(1) 1975 No 116 s 31(1) 1979 No 27 s 2(1) SR 1964/64 r 2(1) SR 1969/193 r 2(1) SR 1973/79 r 2(1); Medicines Act 1968 ss 130(9), 132(1) (UK) The following table is small in size and has 3 columns that are grouped under the heading Legislation Act 2019 requirements for secondary legislation made under this section. Legislation Act 2019 requirements for secondary legislation made under this section Publication PCO must publish it on the legislation website and notify it in the Gazette LA19 s 69(1)﻿(c) Presentation The Minister must present it to the House of Representatives LA19 s 114 cl 32(1)﻿(a) Disallowance It may be disallowed by the House of Representatives LA19 ss 115 116 This note is not part of the Act. Section 2(1) analyst substituted 1 July 1992 section 2(1) Medicines Amendment Act 1992 Section 2(1) analyst amended 28 October 2021 section 3 Secondary Legislation Act 2021 Section 2(1) animal amended 28 May 2002 Medicines (Restricted Biotechnical Procedures) Amendment Act 2002 Section 2(1) animal remedy substituted 2 July 2001 section 85 Agricultural Compounds and Veterinary Medicines Act 1997 Section 2(1) approved laboratory inserted 1 July 1992 section 2(2) Medicines Amendment Act 1992 Section 2(1) approved laboratory amended 28 October 2021 section 3 Secondary Legislation Act 2021 Section 2(1) associate coroner inserted 5 April 2023 section 36 Coroners Amendment Act 2023 Section 2(1) authorised prescriber replaced 1 July 2014 section 4(1) Medicines Amendment Act 2013 Section 2(1) controlled drug inserted 22 October 2003 section 3(1) Medicines Amendment Act (No 3) 2003 Section 2(1) Coroner inserted 5 April 2023 section 36 Coroners Amendment Act 2023 Section 2(1) Customs the Customs inserted 1 October 1996 section 289(1) Customs and Excise Act 1996 Section 2(1) Customs the Customs amended 1 October 2018 section 443(3) Customs and Excise Act 2018 Section 2(1) delegated prescriber inserted 1 July 2014 section 4(6) Medicines Amendment Act 2013 Section 2(1) delegated prescribing order inserted 1 July 2014 section 4(6) Medicines Amendment Act 2013 Section 2(1) delegated prescribing rights inserted 1 July 2014 section 4(6) Medicines Amendment Act 2013 Section 2(1) dentist substituted 18 September 2004 section 3(3) Medicines Amendment Act 2003 Section 2(1) designated prescriber inserted 15 October 1999 section 2(3) Medicines Amendment Act 1999 Section 2(1) designated prescriber amended 1 July 2014 section 4(2)﻿(a) Medicines Amendment Act 2013 Section 2(1) designated prescriber amended 1 July 2014 section 4(2)﻿(b) Medicines Amendment Act 2013 Section 2(1) Director-General substituted 1 July 1993 section 32 Health Sector (Transfers) Act 1993 Section 2(1) dispensing inserted 18 September 2004 section 3(2) Medicines Amendment Act 2003 Section 2(1) EPA inserted 1 July 2011 section 53(1) Environmental Protection Authority Act 2011 Section 2(1) ERMA repealed 1 July 2011 section 53(1) Environmental Protection Authority Act 2011 Section 2(1) health services inserted 15 October 1999 section 2(3) Medicines Amendment Act 1999 Section 2(1) hospital substituted 1 October 2002 section 58(1) Health and Disability Services (Safety) Act 2001 Section 2(1) importer amended 1 October 2018 section 443(3) Customs and Excise Act 2018 Section 2(1) licensing authority substituted 18 September 2004 section 3(3) Medicines Amendment Act 2003 Section 2(1) licensing authority amended 7 August 2020 section 135 Public Service Act 2020 Section 2(1) medical device replaced 1 July 2014 section 4(3) Medicines Amendment Act 2013 Section 2(1) Medical Officer of Health amended 1 July 1993 section 32 Health Sector (Transfers) Act 1993 Section 2(1) medical practitioner substituted 18 September 2004 section 3(3) Medicines Amendment Act 2003 Section 2(1) new organism inserted 30 October 2003 section 3 Medicines Amendment Act (No 2) 2003 Section 2(1) nurse practitioner replaced 31 January 2018 section 4 Medicines Amendment Act 2016 Section 2(1) Nursing Council inserted 1 July 2014 section 4(6) Medicines Amendment Act 2013 Section 2(1) officer substituted 1 July 1993 section 32 Health Sector (Transfers) Act 1993 Section 2(1) optician repealed 18 September 2004 section 3(3) Medicines Amendment Act 2003 Section 2(1) optometrist inserted 1 July 2014 section 4(6) Medicines Amendment Act 2013 Section 2(1) Optometrists and Dispensing Opticians Board inserted 1 July 2014 section 4(6) Medicines Amendment Act 2013 Section 2(1) pharmacist substituted 18 September 2004 section 3(3) Medicines Amendment Act 2003 Section 2(1) pharmacy substituted 18 September 2004 section 3(3) Medicines Amendment Act 2003 Section 2(1) pharmacy practice inserted 18 September 2004 section 3(4) Medicines Amendment Act 2003 Section 2(1) qualifying new medicine inserted 30 October 2003 section 3 Medicines Amendment Act (No 2) 2003 Section 2(1) qualifying organism inserted 30 October 2003 section 3 Medicines Amendment Act (No 2) 2003 Section 2(1) registered health professional substituted 18 September 2004 section 3(3) Medicines Amendment Act 2003 Section 2(1) registered midwife substituted 18 September 2004 section 3(3) Medicines Amendment Act 2003 Section 2(1) regulations inserted 1 July 2014 section 4(6) Medicines Amendment Act 2013 Section 2(1) responsible authority inserted 1 July 2014 section 4(6) Medicines Amendment Act 2013 Section 2(1) standing order inserted 15 October 1999 section 2(3) Medicines Amendment Act 1999 Section 2(1) standing order amended 1 July 2014 section 4(4) Medicines Amendment Act 2013 Section 2(1) standing order amended 22 October 2003 section 3(2) Medicines Amendment Act (No 3) 2003 Section 2(1) standing order amended 22 October 2003 section 3(2) Medicines Amendment Act (No 3) 2003 Section 2(1) standing order added 22 October 2003 section 3(3) Medicines Amendment Act (No 3) 2003 Section 2(1) standing order amended 1 July 2014 section 4(5) Medicines Amendment Act 2013 Section 2(1) standing order added 22 October 2003 section 3(3) Medicines Amendment Act (No 3) 2003 Section 2(1) veterinarian added 15 October 1999 section 2(2) Medicines Amendment Act 1999 Section 2(1) veterinarian amended 22 December 2005 section 105 Veterinarians Act 2005 Section 2(1) veterinary surgeon repealed 15 October 1999 section 2(2) Medicines Amendment Act 1999 Section 2(2) added 1 July 1992 section 2(3) Medicines Amendment Act 1992 Section 2(3) replaced 28 October 2021 section 3 Secondary Legislation Act 2021
3: Meaning of medicine, new medicine, prescription medicine, and restricted medicine
1: In this Act, unless the context otherwise requires, medicine
a: means any substance or article that—
i: is manufactured, imported, sold, or supplied wholly or principally for administering to 1 or more human beings for a therapeutic purpose; and
ii: achieves, or is likely to achieve, its principal intended action in or on the human body by pharmacological, immunological, or metabolic means; and
b: includes any substance or article—
i: that is manufactured, imported, sold, or supplied wholly or principally for use as a therapeutically active ingredient in the preparation of any substance or article that falls within paragraph (a); or
ii: of a kind or belonging to a class that is declared by regulations to be a medicine for the purposes of this Act; but
c: does not include—
i: a medical device; or
ii: any food within the meaning of section 2
iii: any radioactive material within the meaning of section 5(1)
iv: any animal food in which a medicine (within the meaning of paragraph (a) or (b)) is incorporated; or
v: any animal remedy; or
vi: any substance or article of a kind or belonging to a class that is declared by regulations not to be a medicine for the purposes of this Act.
2:
3: In this Act, unless the context otherwise requires,— new medicine
a: any medicine that has not been generally available in New Zealand—
i: before the commencement of this Act; or
ii: at any time during the period of 5 years immediately preceding the date on which it is proposed to become so available:
b: any medicine that, immediately before the commencement of Part 2 section 12 of the Food and Drug Act 1969
c: any medicine that becomes a medicine within the meaning of this Act for the first time after the commencement of this Act:
d: any medicine that is referred to the Minister under section 24(5) pharmacy-only medicine section 106
a: sold by retail only—
i: in a pharmacy or hospital; or
ii: in any shop described in section 51(2) Part 3
b: supplied in circumstances corresponding to retail sale only—
i: in a pharmacy or hospital; or
ii: in any shop described in section 51(2) Part 3
iii: in accordance with a standing order prescription medicine section 106
a: sold by retail only under a prescription given by an authorised prescriber, veterinarian, or delegated prescriber; and
b: supplied in circumstances corresponding to retail sale only—
i: under a prescription given by an authorised prescriber, veterinarian, or delegated prescriber; or
ii: in accordance with a standing order; and
c: administered only in accordance with—
i: a prescription given by an authorised prescriber, veterinarian, or delegated prescriber; or
ii: a standing order restricted medicine section 106
a: sold by retail only by a pharmacist in a pharmacy or hospital; or
b: supplied in circumstances corresponding to retail sale only—
i: by a pharmacist in a pharmacy or hospital; or
ii: in accordance with a standing order. Medicines Act 1968 s 130(1), (3), (5), (7) (UK) Section 3(1) replaced 1 July 2014 section 5(1) Medicines Amendment Act 2013 Section 3(1)﻿(c)﻿(iii) amended 7 March 2017 section 99 Radiation Safety Act 2016 Section 3(2) repealed 1 July 2014 section 5(1) Medicines Amendment Act 2013 Section 3(3) pharmacy-only medicine substituted 22 October 2003 section 4(1) Medicines Amendment Act (No 3) 2003 Section 3(3) prescription medicine replaced 1 July 2014 section 5(3) Medicines Amendment Act 2013 Section 3(3) restricted medicine substituted 22 October 2003 section 4(2) Medicines Amendment Act (No 3) 2003
3A: Meaning of medical device
In this Act, unless the context otherwise requires, medical device
a: means any device, instrument, apparatus, appliance, or other article that—
i: is intended to be used in, on, or for human beings for a therapeutic purpose; and
ii: does not achieve its principal intended action in or on the human body by pharmacological, immunological, or metabolic means (but may be assisted in its function by such means); and
b: includes a material that—
i: is intended to be used in or on human beings for a therapeutic purpose; and
ii: does not achieve its principal intended action in or on the human body by pharmacological, immunological, or metabolic means (but may be assisted in its function by such means); and
c: also includes—
i: anything that is intended to be used with a device, instrument, apparatus, appliance, article, or material referred to in paragraph (a) or (b) to enable the device, instrument, apparatus, appliance, article, or material to be used as its manufacturer intends; and
ii: any device, instrument, apparatus, appliance, article, or material of a kind or belonging to a class that is declared by regulations to be a medical device for the purposes of this Act; but
d: does not include a device, instrument, apparatus, appliance, article, or material of a kind or belonging to a class that is declared by regulations not to be a medical device for the purposes of this Act. Section 3A inserted 1 July 2014 section 6 Medicines Amendment Act 2013
4: Meaning of therapeutic purpose
In this Act, unless the context otherwise requires, therapeutic purpose
a: preventing, diagnosing, monitoring, alleviating, treating, curing, or compensating for, a disease, ailment, defect, or injury; or
b: influencing, inhibiting, or modifying a physiological process; or
c: testing the susceptibility of persons to a disease or ailment; or
d: influencing, controlling, or preventing conception; or
e: testing for pregnancy; or
f: investigating, replacing, or modifying parts of the human anatomy. Section 4 replaced 1 July 2014 section 7 Medicines Amendment Act 2013
5: Meaning of selling by wholesale, selling by retail, and selling in circumstances corresponding to retail sale
1: In this Act, unless the context otherwise requires, every reference to selling anything by wholesale is a reference to selling it to a person whom the vendor believes to be buying it—
a: for the purpose of—
i: selling or supplying it; or
ii: administering it or causing it to be administered to 1 or more human beings— in the course of a business carried on by that person; or
b: for the purpose of—
i: using it in any scientific, educational, or commercial laboratory; or
ii: using it in any process of manufacture or trade not involving the resale of that thing.
2: In this Act every reference to selling anything by retail is a reference to selling it to a person whom the vendor believes to be buying it for a purpose other than one specified in subsection (1).
3: In this Act every reference to supplying anything in circumstances corresponding to retail sale is a reference to supplying it, otherwise than by way of sale, to a person whom the supplier believes to be receiving it for a purpose other than one specified in subsection (1). Medicines Act 1968 s 131 (UK)
5A: Relationship with Hazardous Substances and New Organisms Act 1996
In relation to medicines that are or contain hazardous substances or new organisms, the requirements of this Act are additional to the requirements of the Hazardous Substances and New Organisms Act 1996 First section 5A inserted 30 October 2003 section 4 Medicines Amendment Act (No 2) 2003
5A: Meaning of holding an interest in a pharmacy
1: For the purposes of this Act, a person holds an interest in a pharmacy if the person has, or acquires, any direct or indirect estate or interest in the pharmacy (whether by way of shares in a company or by way of charge, loan, guarantee, indemnity, or otherwise) that affects the ownership, management, or control of the pharmacy practice carried on in the pharmacy.
2: For the purposes of subsection (1), a person acquires a direct or indirect estate or interest in a pharmacy if the acquisition is made in the person's name, or in the name of a nominee, or the acquisition is made by the person by means of any device or arrangement.
3: Despite subsections (1) and (2),—
a: a person does not hold an interest in a pharmacy merely by—
i: making, in good faith and in the ordinary course of business to facilitate the carrying on of the pharmacy, any loan of money; or
ii: holding any security for repayment of that loan:
b: a person does not hold an interest in a pharmacy that is being carried on by an administrator of the estate of a deceased pharmacist, or by an administrator of the estate of a deceased operator of a pharmacy, merely by holding an interest in that estate.
4: Despite subsection (3), any covenant, condition, or stipulation, expressed or implied in any contract or agreement restricting the operator of a pharmacy in the purchase of pharmaceutical requirements or other stock in trade is to be treated, for the purposes of this Act, as a device or arrangement affecting the management and control of the pharmacy practice carried on in that pharmacy. 1970 No 143 s 2(2)–(4) Second section 5A inserted 18 September 2004 section 4 Medicines Amendment Act 2003
5B: Meaning of operating a pharmacy
For the purposes of this Act, a person operates a pharmacy if the person—
a: establishes, or carries on business in, a pharmacy; or
b: establishes, owns, or is responsible for the management or control of a hospital in which there is a pharmacy; or
c: establishes, or is responsible for the management or control of a pharmacy carried on, on a not for profit basis. Section 5B inserted 18 September 2004 section 4 Medicines Amendment Act 2003
5C: Transitional, savings, and related provisions
The transitional, savings, and related provisions set out in Schedule 1AA Section 5C inserted 25 May 2021 section 5 Medicines Amendment Act 2021
1: Application and administration of Act
Application
6: Act to bind Crown
This Act shall bind the Crown. 1960 No 97 s 55 1969 No 7 s 5 1979 No 27 s 3
7: Principals and agents
1: For the purposes of this Act, but subject to subsection (2), every person shall be deemed to manufacture, sell, supply, pack, or label any medicine whether he does so on his own account or as the agent or employee of any other person; and references to things done by a person in the course of a business shall be deemed to include references to things done by an agent or employee of that person in the course of that business.
2: For the purposes of this Act, if a person who is authorised by or under this Act to manufacture, sell, supply, pack, or label a medicine does so, in accordance with that authority, as the agent or employee of another person who is not so authorised, that other person shall not be held to have manufactured, sold, supplied, packed, or labelled that medicine.
3: For the purposes of this Act, while a person who is authorised by or under this Act to manufacture, sell, supply, pack, or label a medicine has that medicine in his custody or under his control as the agent or employee of another person who is not so authorised, that other person shall not be held to be in possession of that medicine.
4: For the purposes of this Act, any natural person who manufactures, sells, supplies, packs, or labels a medicine while working under the supervision and control of a responsible person or of another natural person authorised by or under this Act, otherwise than by section 32 section 79 1960 No 97 s 2(2)–(5) 1979 No 27 s 6 Administration
8: Advisory and technical committees
1: The Minister may from time to time appoint such advisory or technical committees as he thinks fit to advise him for any of the purposes of this Act, and may from time to time determine the functions of any such committee.
2: There may be paid out of money appropriated by Parliament for the purpose to the members of any committee appointed under this section remuneration by way of fees, salary, or allowances and travelling allowances and expenses in accordance with the Fees and Travelling Allowances Act 1951
3: Subject to the provisions of this Act and of any regulations made under this Act, every such committee may determine its own procedure. 1960 No 97 s 5 1969 No 7 s 20 1979 No 27 s 8
9: Medicines Classification Committee
1: The Minister shall appoint under section 8
2: The Committee shall also consider and report to the Minister on such other matters in relation to any of the purposes of this Act as may from time to time be referred to it by the Minister.
3: The Committee shall consist of—
a: 2 persons, to be nominated by the New Zealand Medical Association:
b: 2 persons, to be nominated by the Pharmaceutical Society of New Zealand:
c: 2 persons, being officers of the Ministry
4: The members of the Committee shall hold office—
a: in the case of any member appointed under subsection (3)﻿(c), during the pleasure of the Minister:
b: in the case of any other member, for a term of 3 years, subject to subsection (5), but any such member may be reappointed for 1 further term.
5: Any member of the Committee may at any time be removed from office by the Minister for disability, neglect of duty, or misconduct proved to the satisfaction of the Minister, or may at any time resign his office by writing addressed to the Minister.
6: If any member of the Committee dies, resigns, or is removed from office, the vacancy so created shall be filled in the manner in which the appointment to the vacant office was originally made, and in the case of a vacancy in the office of a nominated member, every person so appointed shall be appointed for the residue of the term for which his predecessor was appointed.
7: Unless he sooner vacates his office under subsection (6), every nominated member of the Committee shall continue in office until his successor comes into office, notwithstanding that the term for which he was appointed may have expired.
8: The powers of the Committee shall not be affected by any vacancy in its membership.
9: At any meeting of the Committee, 4 members shall form a quorum. 1960 No 97 s 6 1967 No 108 s 2 1979 No 28 s 5(1) Section 9(3)﻿(c) amended 1 July 1993 section 32 Health Sector (Transfers) Act 1993
10: Medicines Review Committee established
1: Without limiting section 8
2: The Committee shall consist of 6 members appointed by the Minister, of whom 1 shall be appointed by the Minister as chairman, and shall include at least—
a: 1 person with wide experience in the practice of medicine:
b: 1 person with wide experience in the practice of pharmacy:
c: 1 person with wide experience in the pharmaceutical manufacturing industry:
d: 1 person with wide experience in a form of chemistry other than pharmaceutical chemistry.
3: The Minister shall also appoint 1 person with wide experience in the practice of natural therapy to act as a member of the Committee whenever any matter relating to the practice of natural therapy is before the Committee.
4: There may be paid out of money appropriated by Parliament for the purpose to the members of the Committee remuneration by way of fees, salary, or allowances and travelling allowances and expenses in accordance with the Fees and Travelling Allowances Act 1951 1960 No 97 s 6 1967 No 51 s 6(3) 1967 No 108 s 2 1979 No 28 s 5(1)
11: Deputies of members
1: In any case where the Minister is satisfied that any member of the Medicines Review Committee is incapacitated by illness or absence or other sufficient cause from performing the duties of his office, the Minister may appoint a deputy to act for that member during his incapacity.
2: No person shall be appointed a deputy under subsection (1) unless he is eligible for membership of the Committee under the same provision of section 10
3: Every deputy appointed under this section shall, while he acts as such, be deemed to be a member of the Committee, and any deputy acting for the chairman shall have all the powers of the chairman.
4: No appointment of a deputy and no acts done by him as such, and no acts done by the Committee while any deputy is acting as such, shall be questioned in any proceedings on the ground that the occasion for his appointment had not arisen or had ceased. 1979 No 27 s 14
12: Committee may appoint subcommittees
1: The Medicines Review Committee may from time to time appoint such subcommittees comprising 2 or more members of the Committee as it thinks fit to hear and determine such matters as the Committee may from time to time delegate to them.
2: Notwithstanding subsection (1), where the Committee delegates to any subcommittee any matter relating to the practice of natural therapy, the person appointed under section 10(3)
3: Every subcommittee appointed under this section shall be subject in all things to the control of the Committee, and may at any time be discharged, altered, or reconstituted by the Committee.
4: Any delegation under this section may at any time be revoked by the Committee. 1979 No 27 s 17
13: Functions, powers, and procedures of Medicines Review Committee
1: The functions of the Medicines Review Committee shall be as follows:
a: to inquire into any objection to the terms of a recommendation of the appropriate committee made under section 22(2)
b: to hear appeals under section 88
2: On receipt of an objection made in accordance with section 22(4)
3: On receipt of an appeal made in accordance with section 88
4: In carrying out its inquiries under subsection (2) or subsection (3), the Committee shall not be bound to follow any formal procedure, but shall observe the rules of natural justice, and shall consider all submissions made by or on behalf of the objector or appellant.
5: Every report by the Committee to the Minister on an objection shall include a recommendation as to the decision the Minister should make in respect of the matter to which the objection relates.
6: The Committee may make such order as to costs as it thinks fit.
7: Subject to any order made under subsection (6), the Committee shall, on completing its deliberations on any objection, refund to the objector the deposit paid by him under subsection (2).
8: Subject to the provisions of this section and of any regulations made under this Act, the Committee may determine its own procedure.
14: Servicing of committees
The Minister shall provide every committee appointed under section 8
15: Appointment of officers
1: There may from time to time be appointed under the Public Service Act 2020
2: The Director-General may from time to time appoint any person, not being an officer of the public service
3: Any appointment under subsection (2) may be made either generally for the purposes of this Act or for any specified purpose, or for the exercise of any specified power or function of an officer under this Act, or for any specified period; and may be made in respect of New Zealand generally or in respect of any specified area or areas.
4: There may be paid out of money appropriated by Parliament for the purpose to any person appointed under subsection (2) such remuneration as may be fixed by the Director-General
5: No person appointed under subsection (2) shall be deemed by reason of that appointment to be employed in the service of Her Majesty the Queen for the purposes of the Public Service Act 2020 Government Superannuation Fund Act 1956 1960 No 97 s 7 1969 No 7 s 19 1979 No 27 s 9 Section 15(1) amended 7 August 2020 section 135 Public Service Act 2020 Section 15(1) amended 1 July 1993 section 32 Health Sector (Transfers) Act 1993 Section 15(2) substituted 1 July 1993 section 32 Health Sector (Transfers) Act 1993 Section 15(2) amended 7 August 2020 section 135 Public Service Act 2020 Section 15(4) amended 1 July 1993 section 32 Health Sector (Transfers) Act 1993 Section 15(5) amended 7 August 2020 section 135 Public Service Act 2020
16: Exercise of powers of Director-General and other officers
1: The Director-General, every Medical Officer of Health, and every other officer, shall exercise the powers and functions conferred on him by this Act subject to the direction and control of the Minister.
2: Subject to subsection (1), each Medical Officer of Health employed in the Ministry Ministry Ministry
1A:
3: Where, by virtue of any provision of this Act, a reasonable belief in any particular state of affairs is a prerequisite for the exercise of any power by an officer, it shall be sufficient if the officer exercises that power at the direction of any other officer who is superior to him and who, at the time of giving the direction, held such a belief in that state of affairs. 1979 No 27 s 10 Section 16(2) amended 1 July 1993 section 32 Health Sector (Transfers) Act 1993 Section 16(2) amended 1 April 1984 Area Health Boards 1983 Section 16(1A) repealed 1 July 1993 section 32 Health Sector (Transfers) Act 1993
2: Dealings with medicines and medical devices
17: Manufacturers, wholesalers,
packers of medicines, and operators of pharmacies
1: Except as provided in sections 25 to 34
a: manufacture any medicine; or
b: sell any medicine by wholesale; or
c: pack or label any medicine; or
d: operate any pharmacy,— otherwise than in accordance with a licence issued under Part 3
2: Every person who contravenes subsection (1) commits an offence and is liable on 1960 No 97 ss 8, 12(1), 14(1) 1969 No 44 s 3 1979 No 27 ss 19, 20 1979 No 28 s 6(1) Section 17 heading amended 18 September 2004 section 5(1) Medicines Amendment Act 2003 Section 17(1)﻿(c) substituted 18 September 2004 section 5(2) Medicines Amendment Act 2003 Section 17(1)﻿(d) added 18 September 2004 section 5(2) Medicines Amendment Act 2003 Section 17(2) substituted 18 September 2004 section 5(3) Medicines Amendment Act 2003 Section 17(2) amended 1 July 2013 section 413 Criminal Procedure Act 2011
18: Sale of medicines by retail
1: Except as provided in sections 25 27 30 to 33
a: any prescription medicine unless—
i: the medicine is sold, supplied, or distributed by a pharmacist in a pharmacy or hospital; or
ii: the medicine is supplied in accordance with a standing order by a person who is authorised to supply and administer any specified class or description of prescription medicine under that standing order; or
aa:
b: any restricted medicine unless the medicine is sold, supplied, or distributed by a pharmacist in a pharmacy or hospital; or
c: any pharmacy-only medicine unless the medicine is sold, supplied, or distributed by—
i: a person under the supervision of a pharmacist in a pharmacy or a hospital; or
ii: a person who sells, supplies, or distributes the medicine in any shop described in section 51(2) Part 3
2: No person may sell by retail any prescription medicine otherwise than under a prescription given by an authorised prescriber, a veterinarian, or a delegated prescriber
2A: No person may supply, in circumstances corresponding to retail sale, any prescription medicine otherwise than—
a: under a prescription given by an authorised prescriber, a veterinarian, or a delegated prescriber
b: in accordance with a standing order.
2B: Despite subsections (2) and (2A), a person may sell by retail, or supply, in circumstances corresponding to retail sale, any prescription medicine, where permitted by section 25 section 30 section 31 section 69
3: Except as may be permitted by regulations made under this Act, no person shall hawk any prescription medicine or restricted medicine or pharmacy-only medicine—
a: from house to house; or
b: in any public place within the meaning of section 2 otherwise than pursuant to any authority to do so expressly conferred by a licence held by him under Part 3
4: Except as may be permitted by regulations made under this Act, no person shall sell any medicine by means of an automatic vending machine or by auctioning the medicine.
5: Every person who sells or supplies or distributes a prescription medicine in contravention of subsection (1) commits an offence and is liable to imprisonment for a term not exceeding 6 months or a fine not exceeding $40,000
6: Every person commits an offence against this Act who contravenes any of the provisions of this section (otherwise than in circumstances that constitute an offence against subsection (5)). 1960 No 97 ss 8(1), (4), 9, 13(1) 1969 No 7 ss 18, 39(6) 1969 No 44 s 3 SR 1964/64 rr 12, 65 Medicines Act 1968 ss 52–54 (UK) Section 18(1)﻿(a) substituted 18 September 2004 section 6(1) Medicines Amendment Act 2003 Section 18(1)﻿(aa) repealed 18 September 2004 section 6(1) Medicines Amendment Act 2003 Section 18(1)﻿(b) substituted 18 September 2004 section 6(1) Medicines Amendment Act 2003 Section 18(1)﻿(c) substituted 18 September 2004 section 6(1) Medicines Amendment Act 2003 Section 18(2) substituted 15 October 1999 section 4(2) Medicines Amendment Act 1999 Section 18(2) amended 1 July 2014 section 9 Medicines Amendment Act 2013 Section 18(2A) inserted 15 October 1999 section 4(2) Medicines Amendment Act 1999 Section 18(2A)﻿(a) amended 1 July 2014 section 9 Medicines Amendment Act 2013 Section 18(2B) inserted 15 October 1999 section 4(2) Medicines Amendment Act 1999 Section 18(3)﻿(b) substituted 15 October 1999 section 4(3) Medicines Amendment Act 1999 Section 18(5) amended 18 September 2004 section 6(2) Medicines Amendment Act 2003
19: Administering prescription medicines
1: A prescription medicine may be administered to any person only in accordance with—
a: the directions of the authorised prescriber or delegated prescriber
b: a standing order.
2: Despite subsection (1), a prescription medicine may be administered where permitted by section 25
3: Every person commits an offence against this Act who contravenes subsection (1).
4: Section 19 substituted 15 October 1999 section 5 Medicines Amendment Act 1999 Section 19(1)﻿(a) amended 1 July 2014 section 10 Medicines Amendment Act 2013 Section 19(4) repealed 18 September 2004 section 7 Medicines Amendment Act 2003
20: Restrictions on sale or supply of new medicines
1: Except as provided in sections 25 26(4) 28 30 31 32
2: No person shall—
a: sell; or
b: distribute by way of gift or loan or sample or in any other way; or
c: advertise the availability of— any medicine to which this section applies before the consent or provisional consent oft he Minister to the distribution of the medicine has been given by notice, or otherwise than in accordance with such conditions as may be imposed by the Minister on giving his or her consent or provisional consent and set out in the notice.
3: No consent given under this section shall be deemed to warrant the safety or efficacy of the medicine to which the consent relates.
4: A person who contravenes subsection (2) commits an offence, and is liable on conviction—
a: in the case of an individual, to imprisonment for a term not exceeding 6 months or a fine not exceeding $20,000:
b: in the case of a body corporate, to a fine not exceeding $100,000.
5: In any proceedings for an offence against subsection (4) in which it is alleged that this section applies to a medicine by reason of subsection (1), it shall be presumed that the medicine is a medicine to which this section applies until the contrary is proved.
6: The provisions of this section are in addition to, and not in substitution for, the provisions of any other enactment prohibiting, regulating, or restricting the sale or distribution of medicines, and nothing in any such other enactment shall authorise any person to act in contravention of the provisions of this section; but in the event of any conflict, the provisions of this section shall prevail.
6A: The Minister, after having given consent or provisional consent to the distribution of any medicine in accordance with this Act, shall give written notification to the EPA
7: Any consent that was given in respect of any medicine by the Minister under section 12(2) of the Food and Drug Act 1969 section 35
8: A notice under subsection (2) is secondary legislation ( see Part 3 1969 No 7 s 12 The following table is small in size and has 3 columns that are grouped under the heading Legislation Act 2019 requirements for secondary legislation made under this section. Legislation Act 2019 requirements for secondary legislation made under this section Publication The maker must publish it in the Gazette LA19 ss 73 74(1)﻿(a) cl 14 The Ministry of Foreign Affairs and Trade considers that the secondary legislation may have international transparency obligations under the CPTPP s 75 LA19 ss 74(2) 75 Presentation It is not required to be presented to the House of Representatives because a transitional exemption applies under Schedule 1 LA19 s 114 cl 32(1)﻿(a) Disallowance It may be disallowed by the House of Representatives LA19 ss 115 116 This note is not part of the Act. Section 20(2) amended 28 October 2021 section 3 Secondary Legislation Act 2021 Section 20(4) substituted 19 May 1998 section 11 Copyright (Removal of Prohibition on Parallel Importing) Amendment Act 1998 Section 20(6A) inserted 2 July 2001 section 149 Hazardous Substances and New Organisms Act 1996 Section 20(6A) amended 1 July 2011 section 53(1) Environmental Protection Authority Act 2011 Section 20(8) inserted 28 October 2021 section 3 Secondary Legislation Act 2021
21: Applications for Minister's consent
1: Every application for the Minister's consent under section 20
a:
b: be made in the true name of the manufacturer or importer or proprietor, or the proposed manufacturer or importer or proprietor, in New Zealand of the medicine, by that person or by his duly authorised agent:
c: be addressed to the Director-General:
ca: be accompanied by the prescribed fee:
d: state, or be accompanied by a statement of, the particulars specified in subsection (2).
2: The particulars required by subsection (1)﻿(d) are the following:
a: the business address of the person in whose name the application is made, and, where that person is not the manufacturer of the medicine and of each of the principal ingredients of the medicine, the true name and business address of each such manufacturer:
b: the name under which the medicine will be distributed:
c: details of the method of manufacture of the medicine:
d: a full statement of the ingredients named by the descriptive or non-proprietary names of the medicine, including details of the quantities in which they are present:
e: a description of the quality of the raw materials used in the manufacture of the medicine:
f: a description of the form or forms of the medicine:
g: the proposed or recommended dosage and frequency of dose, and the manner in which the medicine will be recommended to be administered, applied, or otherwise used:
h: the purposes for which the medicine will be recommended to be used, and the claims or representations to be made in respect of its usefulness:
i: reports of any tests made to establish the safety of the medicine for the purposes for which and in the manner in which it is intended to be used:
j: reports of any tests made to control the strength, quality, purity, or safety of the medicine and of the method of testing:
k: any reports relating to the efficacy of the medicine:
l: a translation into English, authenticated in such manner as the Director-General may require, of any report referred to in paragraph (i) or paragraph (j) or paragraph (k) that is not in English:
m: any evidence to show that the distribution in any country other than New Zealand of the medicine in the form and for the purposes that it is proposed to be distributed in New Zealand has been approved or consented to by the appropriate authorities in that country:
n: the intended method of distribution of the medicine in New Zealand:
o: a coloured specimen of every label and other descriptive matter proposed to be used on or included in, or to accompany, packages or containers containing the medicine:
p: the name and address of the place or places where the manufacture, preparation, or packing is intended to be carried out.
3: Notwithstanding anything in subsection (1), in the case of a medicine to which section 20 section 24 section 20
4: At any time before the publication of a notice section 20
a: such samples of the medicine; and
b: such further information or particulars concerning the medicine, or the manufacture, intended sale, distribution, or advertising of the medicine,— as the Director-General may specify in his notice.
5: The Director-General may, if he thinks fit, require any person to verify by statutory declaration any statement in an application made, or in any further information or particulars supplied, under this section and signed by that person. 1969 No 7 s 13 Section 21(1)﻿(a) repealed (without coming into force) 8 March 1985 Medicines Amendment Act 1985 Section 21(1)﻿(ca) inserted 8 August 1990 Medicines Amendment Act (No 2) 1990 Section 21(4) amended 28 October 2021 section 3 Secondary Legislation Act 2021
22: Procedure in respect of applications for Minister's consent
1: On receipt of an application for his consent to the distribution of a medicine for the purposes of section 20(2)
a: consider all the particulars and information relating to the medicine submitted under section 21
b: as far as practicable, weigh the likely therapeutic value of the medicine against the risk (if any) of the use of the medicine injuriously affecting the health of any person.
2: If, after complying with subsection (1), the Minister is not satisfied that he should give his consent to the distribution of the medicine, he shall refer the matter to the appropriate committee, which shall consider the matter, and shall report on it to the Minister with a recommendation as to the decision that the Minister should make.
3: On receipt of the recommendation of the appropriate committee under subsection (2), the Minister shall, before making his decision, if the recommendation is to refuse consent to the distribution of the medicine, notify the applicant for consent of the terms of the recommendation, and of the reasons for it.
4: The applicant for consent may, within 28 days after being notified under subsection (3) of the recommendation of the appropriate committee, object to the recommendation in writing to the Minister.
5: On receipt of an objection under subsection (4), the Minister shall, before making his decision, refer the matter to the Medicines Review Committee, which shall convene such meeting or meetings as may be necessary for it to consider the matter, and shall report on it to the Minister with a recommendation as to the decision that the Minister should make. Medicines Act 1968 ss 20(3), 21 (UK)
23: Minister may give provisional consent
1: Notwithstanding sections 20 to 22
2: An application for the Minister's provisional consent under this section shall—
a: be made in accordance with paragraphs (b) and (ca) section 21(1)
b: be addressed to the Director-General:
c: state, or be accompanied by a statement of, the particulars specified in paragraphs (a) to (h) of section 21(2)
d: be determined by the Minister in accordance with section 22
3: On giving his provisional consent under this section, the Minister may impose—
a: such conditions relating to the persons to whom the medicine may be sold or supplied; or
b: such conditions relating to the area in which the medicine may be distributed; or
c: such other conditions, not being inconsistent with the purposes of this section,— as he thinks fit.
4: Subject to subsections (4A) and
4A: The Minister may, by notice
4B: Subsections (3) and (5) shall apply to any renewal of a provisional consent given under subsection (4A) as if it were a provisional consent given under subsection (1).
5: If, during the currency of a provisional consent given in respect of any medicine, the Minister grants a consent under section 20
6: A notice under this section is secondary legislation ( see Part 3 The following table is small in size and has 3 columns that are grouped under the heading Legislation Act 2019 requirements for secondary legislation made under this section. Legislation Act 2019 requirements for secondary legislation made under this section Publication The maker must publish it in the Gazette LA19 ss 73 74(1)﻿(a) cl 14 The Ministry of Foreign Affairs and Trade considers that the secondary legislation may have international transparency obligations under the CPTPP s 75 LA19 ss 74(2) 75 Presentation It is not required to be presented to the House of Representatives because a transitional exemption applies under Schedule 1 LA19 s 114 cl 32(1)﻿(a) Disallowance It may be disallowed by the House of Representatives LA19 ss 115 116 This note is not part of the Act. Section 23(1) replaced 25 May 2021 section 4 Medicines Amendment Act 2021 Section 23(1) amended 28 October 2021 section 3 Secondary Legislation Act 2021 Section 23(2)﻿(a) amended 8 August 1990 Medicines Amendment Act (No 2) 1990 Section 23(4) amended 23 February 1987 Medicines Amendment Act 1987 Section 23(4A) inserted 23 February 1987 Medicines Amendment Act 1987 Section 23(4A) amended 28 October 2021 section 3 Secondary Legislation Act 2021 Section 23(4B) inserted 23 February 1987 Medicines Amendment Act 1987 Section 23(6) inserted 28 October 2021 section 3 Secondary Legislation Act 2021
23A: Interpretation
In this section, and in sections 23B 23C applicant
a: a person who makes or has made, as the case may be, an application; and
b: a person on whose behalf an application is, or has been, made, as the case may be application section 20 section 23 commencement date sections 23B 23C confidential information
a: trade secrets; and
b: information with a commercial value that would, or would be likely to, be diminished by disclosure of the information confidential supporting information
a: in, or in relation to, an innovative medicine application; and
b: about the medicine that is or was, as the case may be, the subject of that application ingredient innovative medicine application
a: in relation to an application made after the commencement date, an application that refers to an active ingredient—
i: that is an active ingredient of the medicine to which the application relates; and
ii: that has not, before that application is received by the Minister, been referred to in any other application (except in an application by the applicant for provisional consent for that medicine) as an active ingredient of a medicine; and
b: in relation to an application made before the commencement date, an application that referred to an active ingredient—
i: that is or was, as the case may be, an active ingredient of the medicine to which the application related; and
ii: that had not, before that application was received by the Minister, been referred to in any other application (except in an application by the applicant for provisional consent for that medicine) as an active ingredient of a medicine protected period
a: in relation to confidential supporting information, relating to an innovative medicine application, received by the Minister after the commencement date, a period commencing on the date that information is received by the Minister and ending,—
i: where—
A: the Minister has given notice of consent, not being provisional consent, under section 20
B: the date of publication of the notice of consent or the date of the refusal on the date 5 years after the date of that notification or refusal; or
ii: in any other case, on the date 5 years after the innovative medicine application to which that information relates is or was, as the case may be, received by the Minister:
b: in relation to confidential supporting information, relating to an innovative medicine application, received by the Minister not more than 5 years before the commencement date, a period commencing on the commencement date and ending,—
i: where—
A: the Minister has given or gives notice of consent, not being provisional consent, under section 20
B: the date of publication of the notice of consent or the date of the refusal on the date 5 years after the date of that notification or refusal; or
ii: in any other case, on the date 5 years after the innovative medicine application to which that information related was received by the Minister WTO country Section 23A inserted 1 January 1995 Medicines Amendment Act 1994 Section 23A confidential information replaced 8 November 2016 section 11 Agricultural Compounds and Veterinary Medicines Amendment Act 2016 Section 23A(a)﻿(i)﻿(A) protected period replaced 28 October 2021 section 3 Secondary Legislation Act 2021 Section 23A(a)﻿(i)﻿(B) protected period amended 28 October 2021 section 3 Secondary Legislation Act 2021 Section 23A(b)﻿(i)﻿(A) protected period replaced 28 October 2021 section 3 Secondary Legislation Act 2021 Section 23A(b)﻿(i)﻿(B) protected period amended 28 October 2021 section 3 Secondary Legislation Act 2021
23B: Protection of confidential supporting information about innovative medicines
Where the Minister receives, or received not more than 5 years before the commencement date, an innovative medicine application and confidential supporting information, the Minister, during the protected period in relation to that confidential supporting information,—
a: shall take reasonable steps to ensure that that confidential supporting information is kept confidential to the Minister; and
b: shall not use that confidential supporting information for the purposes of determining whether to grant any other application. Section 23B inserted 1 January 1995 Medicines Amendment Act 1994
23C: Circumstances where protection under section 23B does not apply
1: Notwithstanding section 23B
a: disclose that confidential supporting information, or use that confidential supporting information for the purposes of determining whether to grant any application other than the application to which it relates or related, as the case may be,—
i: with the consent of the applicant who made the application to which the confidential supporting information relates or related; or
ii: if that disclosure or use is, in the opinion of the Minister, necessary to protect the health or safety of members of the public; or
b: if, in the opinion of the Minister, the relevant committee, adviser, government department, statutory body, or person will take reasonable steps to ensure the confidential supporting information is kept confidential, disclose that confidential supporting information to—
i: an advisory or technical committee appointed under section 8
ii: the Medicines Classification Committee appointed under section 9
iii: the Medicines Review Committee established under section 10
iv: any adviser for the purpose of obtaining advice about the medicine to which the confidential supporting information relates; or
v: a government department or statutory body for the purposes of the government department or statutory body; or
c: disclose that confidential supporting information to any 1 or more of the following—
i: the World Health Organisation:
ii: the Food and Agriculture Organisation:
iii: any regulatory agency of a WTO country:
iv: any person or organisation, or a person or organisation within a class or classes of persons or organisations, approved by regulations made under this Act.
2: The power to grant consent under subsection (1)﻿(a)﻿(i) may be exercised by a person other than the applicant referred to in that subsection if—
a: that applicant—
i: has notified the Minister in writing that that other person may grant that consent; and
ii: has not notified the Minister in writing that that person's authority to grant that consent has been withdrawn; or
b: that applicant's rights in respect of the relevant confidential supporting information have been transferred to that person and the applicant or that other person has notified the Minister in writing of the transfer. Section 23C inserted 1 January 1995 Medicines Amendment Act 1994
24: Distribution of changed medicines restricted
1: If at any time a material change of a kind specified in subsection (2) is made by the manufacturer of a medicine, whether in New Zealand or elsewhere, and whether or not he was the manufacturer of the medicine before that change, the importer or manufacturer in New Zealand of the medicine shall, unless he is of the opinion that section 20 section 3(3)
1A: Every notice deposited with the Director-General under subsection (1) shall be accompanied by the prescribed fee.
2: Subsection (1) applies to every material change in any of the following matters:
a: the purpose for which the medicine is represented to be used, or the recommended dosage, or the recommended manner of administration:
b: the labelling of the medicine, or of any container or package in which the medicine is packed, or any descriptive matter accompanying or enclosed in any such medicine, container, or package:
c: the strength, quality, or purity of the medicine:
d: the methods of manufacture of the medicine, or the facilities for testing its strength, quality, purity, or safety:
e: the location of the premises in which the medicine is manufactured.
3: Except as provided in sections 25 27 28 29 30
a: sell any medicine in respect of which there has been made a material change of which notice is required to be deposited with the Director-General under subsection (1); or
b: supply any such medicine by way of gift or loan or sample, or in any other way— until after the expiry of at least 90 days after the date on which such notice is deposited with the Director-General.
4: Within 45 days after the receipt of any notice in accordance with subsection (1), the Director-General may, by written notice to the importer or manufacturer, require the importer or manufacturer to supply such further information or particulars, or such samples, as the Director-General may require with respect to any matter set out in the importer's or manufacturer's notice.
5: If the Director-General, after considering the particulars, information, or samples required by or under subsection (1) or subsection (4), is of the opinion, at any time within the period specified in subsection (3),—
a: that the change is of such a character or degree that the medicine ought not, without the consent of the Minister,—
i: to be distributed in New Zealand; or
ii: to be represented, recommended, advertised, or labelled in the terms set out in the notice; or
b: that he is insufficiently informed, for the purposes of paragraph (a), in respect of—
i: the strength, quality, purity, safety, or efficacy of the medicine; or
ii: the methods of manufacture of, or the facilities for testing, the medicine,— he shall refer the medicine to the Minister, and forthwith inform the importer or manufacturer by notice in writing that he has done so.
6: Every person commits an offence against this Act who—
a: fails to comply with subsection (1) or subsection (4); or
b: contravenes subsection (3).
7: A person who commits an offence under subsection (6) is liable on conviction—
a: in the case of an individual, to imprisonment for a term not exceeding 3 months or a fine not exceeding $20,000:
b: in the case of a body corporate, to a fine not exceeding $100,000. 1969 No 7 ss 14, 39(5) Section 24(1A) inserted 8 August 1990 Medicines Amendment Act (No 2) 1990 Section 24(7) added 19 May 1998 section 12 Copyright (Removal of Prohibition on Parallel Importing) Amendment Act 1998 Qualifying new medicines Heading inserted 30 October 2003 section 5 Medicines Amendment Act (No 2) 2003
24A: Assessment of qualifying new medicines
The Director-General may grant an approval under section 38I
a: has the consent of the Minister to do so; and
b: is acting under a delegation from the EPA section 19 Section 24A inserted 30 October 2003 section 5 Medicines Amendment Act (No 2) 2003 Section 24A(b) amended 1 July 2011 section 53(1) Environmental Protection Authority Act 2011
24B: Procedure if Director-General declines to grant approval
If the Director-General declines to grant an approval because the new organism is not a qualifying new medicine, then—
a: the Director-General must—
i: inform the EPA
ii: provide the EPA the EPA Hazardous Substances and New Organisms Act 1996
b: the Minister must not consent under section 20 section 23 the EPA Hazardous Substances and New Organisms Act 1996 Section 24B inserted 30 October 2003 section 5 Medicines Amendment Act (No 2) 2003 Section 24B(a)﻿(i) amended 1 July 2011 section 53(1) Environmental Protection Authority Act 2011 Section 24B(a)﻿(ii) amended 1 July 2011 section 53(1) Environmental Protection Authority Act 2011 Section 24B(b) amended 1 July 2011 section 53(1) Environmental Protection Authority Act 2011 Approval of medicines required for use in special emergency Heading inserted 30 October 2003 section 5 Medicines Amendment Act (No 2) 2003
24C: Interpretation
In sections 24D to 24G hazardous substance section 2(1) responsible Minister section 49A special emergency section 49A Section 24C inserted 30 October 2003 section 5 Medicines Amendment Act (No 2) 2003
24D: Approval of medicines required for use in special emergency
1: An application may be made to the Minister for approval to distribute, sell, or advertise in a special emergency a medicine that is or contains a hazardous substance or new organism.
2: The Minister may approve an application under subsection (1) with or without conditions, as long as the Minister is satisfied that—
a: the special emergency has been declared and has not come to an end; and
b: the medicine is required for the special emergency; and
c: the application complies with subsection (3).
3: An application under subsection (1) must—
a: be accompanied by the prescribed application fee (if any); and
b: be in a form approved by the Director-General; and
c: be accompanied by any information that the Minister considers is necessary for determining whether or not to approve the application. Section 24D inserted 30 October 2003 section 5 Medicines Amendment Act (No 2) 2003
24E: Notification or publication of approval
The approval of an application under section 24D Gazette Section 24E inserted 30 October 2003 section 5 Medicines Amendment Act (No 2) 2003
24F: Duration of approval
An approval of an application under section 24D
a: the date of expiry (if any) of the special emergency specified by the responsible Minister in—
i: the declaration declaring the special emergency; or
ii: a later declaration declaring that the special emergency has ceased; or
b: the date of expiry (if any) specified by the responsible Minister in the approval, which must not be later than the date of expiry of the special emergency; or
c: if paragraph (a) or paragraph (b) does not apply, 2 years after the date on which the approval is granted. Section 24F inserted 30 October 2003 section 5 Medicines Amendment Act (No 2) 2003
24G: Consequences of expiry of approval
On the expiry of an approval of an application under section 24D Section 24G inserted 30 October 2003 section 5 Medicines Amendment Act (No 2) 2003 Exemptions
25: Exemptions for practitioners and others
1: An authorised prescriber may—
a: manufacture, pack, and label a medicine that is specially prepared for, or intended for administration to, a particular patient of that authorised prescriber:
b: sell or supply, or procure the sale or supply of, any medicine to any such patient or to a person who has the care of the patient:
c: administer, or procure the administration of, any medicine to any such patient:
d: at the request of another authorised prescriber, pack, and label a medicine that is specially prepared for, or intended for administration to, a particular patient of that other authorised prescriber:
e: at the request of another authorised prescriber, sell or supply a medicine to that other authorised prescriber, or to a person who has the care of the patient:
f: at the request of another authorised prescriber, administer a medicine to a particular patient of that other authorised prescriber.
2: Despite subsection (1), in relation to any new medicine the distribution of which is prohibited under section 20
a: paragraphs (a) and (d) of subsection (1) do not apply:
b: paragraphs (b), (c), (e), and (f) of that subsection apply only for the purpose of enabling the medicine to be administered to a particular patient who is known and identifiable at the time when the medicine is sold or supplied to the authorised prescriber.
3: Subsection (1) applies despite sections 17 to 24
4: Section 25 substituted 15 October 1999 section 6 Medicines Amendment Act 1999 Section 25(4) repealed 18 September 2004 section 8 Medicines Amendment Act 2003
26: Exemptions for pharmacists
1: Notwithstanding section 17
2: The authority conferred by subsection (1) shall extend only to the manufacture, packing, labelling, selling, or supplying of medicines,—
a: in the case of a pharmacist employed in a hospital, in the course of that pharmacist's employment as a pharmacist in that hospital:
b: in any other case, by a pharmacist in a pharmacy.
3: Subsection (1) shall not authorise—
a: the sale or supply of any medicine, except—
i: pursuant to an order given or a request made by the person to whom the medicine is sold or supplied; or
ii: in the ordinary course of business with reference to the needs expressed by that person; or
b: the sale or supply of a prescription medicine otherwise than pursuant to a prescription.
4: Subject to subsection (2), nothing in section 20 section 24 1960 No 97 ss 11(1), (2)﻿(c), 13(1)﻿(a), (2), 14(1)﻿(a)
27: Exemptions for
veterinarians certain registered health practitioners Notwithstanding anything in section 17 section 18
a: any veterinarian veterinarian veterinarian
b:
c: any person may sell or supply—
i: to a veterinarian veterinarian veterinarian
ii: 1969 No 7 s 18(3)﻿(g)﻿(i), (ii) Section 27 heading amended 18 September 2004 section 9(1) Medicines Amendment Act 2003 Section 27 heading amended 15 October 1999 section 7 Medicines Amendment Act 1999 Section 27(a) amended 15 October 1999 section 7 Medicines Amendment Act 1999 Section 27(b) repealed 1 July 2014 section 16(1) Medicines Amendment Act 2013 Section 27(c)﻿(i) amended 15 October 1999 section 7 Medicines Amendment Act 1999 Section 27(c)﻿(ii) repealed 1 July 2014 section 16(2) Medicines Amendment Act 2013
28: Exemptions in respect of herbal remedies
1: Notwithstanding section 17
2: Notwithstanding anything in sections 17 20 to 24
a: under a designation that specifies only the plant from which it is made and the process to which the plant has been subjected during the production of the remedy, and does not apply any other name to the remedy; and
b: without any written recommendation (whether by means of a labelled container or package or a leaflet or in any other way) as to the use of the remedy. Medicines Act 1968 ss 12, 56 (UK)
29: Exemption for medicine required by medical practitioner
1: Neither section 20 section 24
a: the supply by any person to any medical practitioner, on the medical practitioner's request, of any medicine required by that medical practitioner for the treatment of a particular patient currently under that medical practitioner's care; or
b: the administration by any medical practitioner of any such medicine to any such patient.
2: Every person who, for the purposes of subsection (1), sells or supplies to any practitioner any medicine that is a new medicine by virtue of paragraph (a) of the definition of the term new medicine in section 3(3) Legislation Act 2019
3: Without limiting section 48 published under the Legislation Act 2019 1969 No 7 s 16 Section 29(2) amended 28 October 2021 section 3 Secondary Legislation Act 2021 Section 29(3) amended 28 October 2021 section 3 Secondary Legislation Act 2021
30: Exemption for clinical trial
1: Notwithstanding section 20 section 24 investigators Health Research Council of New Zealand
2: An application for the approval of the Director-General in respect of this section shall be made by the importer, manufacturer, or packer, or the intending manufacturer, packer, seller, or supplier, in New Zealand of the medicine, and shall—
a: be made in the prescribed manner (if any); and
b: be addressed to the Director-General; and
c: set out the true name of the applicant; and
ca: be accompanied by the prescribed fee; and
d: state, or be accompanied by a statement of, the particulars set out in subsection (3).
3: The particulars required by subsection (2)﻿(d) are the following:
a: the nature of the medicine, its identifying name or mark, and its chemical formula:
b: the purpose of the trial:
c: the names and qualifications of the investigators who will conduct the trial, and their curricula vitae:
d: a written consent to nomination from each of the investigators:
e: a copy of the information supplied to the investigators, particularly in relation to the safe use of the medicine:
f: a protocol of the trial, setting out—
i: the number of patients to be involved; and
ii: the form that the trial is to take, and the nature of the records to be kept; and
iii: the persons or classes of persons (if any) who are to be specially excluded from the trial; and
iv: any special measures proposed to be taken to ensure the safety of the patients:
g: the names and addresses of the institutions or laboratories where the medicines will be used by approved persons, and a description of the facilities that will be available to those persons.
4: The Director-General shall determine every application for his approval under this section within 45 days after the receipt of the application, and shall notify the applicant of his decision and (where he declines the application) the reasons for his decision.
5: At any time after a clinical trial has been approved by the Director-General, the applicant may apply to the Director-General for the approval of an investigator, notwithstanding that the name of that person did not appear in the application for approval of the clinical trial; and paragraphs (a) to (c) of subsection (2), and paragraphs (c), (d), and (g) of subsection (3), shall apply in respect of every such application.
6: The Director-General may at any time, by notice in writing given to an applicant, require the applicant to supply such further information and particulars as he thinks fit relating to a clinical trial or to the identity and qualifications of an investigator.
7: The distribution of any medicine under this section shall be subject to the following conditions:
a: the Director-General shall be informed, before the medicine is so distributed, of the identifying name or mark by which it may be recognised:
b: every label on every package or container of the medicine shall bear the words To be used by qualified investigators only
c: the importer or manufacturer shall, before so distributing the medicine, take all reasonable steps to ensure that every person to whom it is supplied is approved under this section as a person qualified to carry out, and has available the necessary facilities for, the trial to be conducted by him, and the medicine shall be used solely by that person or under his direction for the purposes of the trial:
d: the importer or manufacturer shall—
i: keep complete and accurate records of all quantities of the medicine supplied under this section:
ii: keep the Director-General informed of the progress of the trial by 6-monthly reports:
iii: supply to the Director-General a copy of the results of the trial on its completion.
8: The Director-General may at any time, by notice in writing to the applicant, revoke or suspend his approval of a clinical trial. 1969 No 7 s 15 Section 30(1) amended 1 October 1990 section 57 Health Research Council Act 1990 Section 30(2)﻿(ca) inserted 8 August 1990 Medicines Amendment Act (No 2) 1990
31: Exemptions for agents and employees
1: Notwithstanding sections 17 to 24
a: any authority conferred by a licence to manufacture, sell, supply, pack, or label any medicine other than a restricted medicine; and
b: any authority conferred by section 26 section 27
c: any authority conferred by section 28(2)
d: any authority conferred by section 30 shall extend and apply to any agent or employee of a person so authorised acting in the course of that person's agency or employment.
2: Except as provided in regulations made under this Act, any authority conferred by subsection (1) to sell, supply, pack, or label a medicine shall,—
a: in the case of a sale by retail, or supply in circumstances corresponding to retail sale, of prescription medicines, extend and apply only to the sale and supply of those medicines by, or under the supervision of, a pharmacist, responsible person, or other person licensed to sell those medicines:
b: in the case of the packing or labelling of medicines, extend and apply only to the packing and labelling of the medicines by, or under the supervision of, a pharmacist, responsible person, or other person licensed to sell medicines.
3: Subsection (1) shall not authorise a person to manufacture, sell, supply, pack, or label a medicine—
a: at any place, if that person's principal or employer is not authorised by or under this Act to manufacture, sell, supply, pack, or label (as the case may require) medicines at that place; or
b: otherwise than in accordance with any conditions, imposed by or under this Act, to which that person's principal or employer is subject.
4: Subsection (3)﻿(a) does not apply in respect of any authority conferred by section 26 1960 No 97 ss 13(1)﻿(a), (f), (6), 14(1) Section 31(4) added 18 September 2004 section 10 Medicines Amendment Act 2003
32: Exemptions for natural therapists and others
Notwithstanding sections 17 20 to 24
a: a prescription medicine; or
b: a restricted medicine; or
c: a pharmacy-only medicine,— for administration to a particular person after being requested by or on behalf of that person to use his own judgment as to the treatment required.
32A: Exemptions in respect of importation by the Crown
1: Notwithstanding anything in this Act, but subject to subsection (2), the Crown may, in respect of any medicine approved by the Director-General for the purposes of this section,—
a: import the medicine into New Zealand; and
b: sell the medicine, or distribute it by way of gift or loan or sample or in any other way, or advertise it for sale, or advertise the availability of it— and, subject to subsection (2), in doing any of those things, it shall not be necessary for the Crown to comply with any of the provisions of this Act.
2: Nothing in subsection (1) limits or affects the application to the Crown of sections 20 44 45
3: Section 50(2)
4: Nothing in section 24
5: Nothing in section 24
a: a pharmacist employed in a hospital in the course of that pharmacist's employment as a pharmacist in that hospital, selling a medicine imported by the Crown under subsection (1) or supplying it by way of gift or loan or sample or in any other way:
b: any other pharmacist, in any pharmacy, selling a medicine imported by the Crown under subsection (1), or supplying it by way of gift or loan or sample or in any other way.
6:
7: The powers conferred by this section to do anything in respect of a medicine include the power to do likewise in respect of any advertising material, container, label, labelling material, or package (as those terms are defined in section 2
8: In this section the term sell section 2 Section 32A substituted 1 August 1990 Medicines Amendment Act 1990 Section 32A(6) repealed 26 November 2018 section 459 Social Security Act 2018
33: Exemptions in respect of procuring and exporting medicines
Notwithstanding sections 17 to 24
a: any person may procure a medicine if the person from whom he procures that medicine is authorised by or under this Act to sell or supply the medicine to him:
b: any person may export, in the course or for the purpose of sale, any medicine that, at the time when it is exported, might lawfully be sold by a pharmacist to a person in New Zealand, whether pursuant to a prescription or otherwise.
34: Exemption for sale by wholesale of medicines that are not prescription, restricted, or pharmacy-only medicines
Section 17 Section 34 substituted 23 February 1987 Medicines Amendment Act 1987 COVID-19 vaccines Heading inserted 23 June 2022 section 4 Medicines Amendment Act 2022
34A: Director-General may authorise off-label administration of COVID-19 vaccines
1: This section applies if—
a: the Minister has given consent or provisional consent to a COVID-19 vaccine; and
b: a data sheet is approved for the vaccine under the regulations. Notice
2: The Director-General may, by notice, authorise the administration of the vaccine other than in accordance with the data sheet.
3: The notice may specify any 1 or more of the following matters in relation to the administration of the vaccine:
a: who it may be administered to:
b: the recommended number and frequency of doses:
c: the recommended manner of administration:
d: any circumstances in which it may be administered.
4: Before issuing a notice under this section, the Director-General must—
a: have regard to the likely therapeutic value of the proposed administration of the vaccine and the risk (if any) that the proposed administration of the vaccine may injuriously affect the health of any person; and
b: be satisfied that the proposed administration of the vaccine is an appropriate measure to manage the risks associated with the outbreak or spread of COVID-19. Effect of notice
5: A COVID-19 vaccine is not a new medicine for the purpose of section 20
a: a notice made under this section in relation to the vaccine; or
b: administration of the vaccine in accordance with the notice.
6: Any person or class of persons permitted by the Act or by regulations to administer the vaccine may administer the vaccine in accordance with the notice.
7: Nothing in this section limits section 24 Status of notice
8: A notice made under this section is secondary legislation ( see Part 3 The following table is small in size and has 3 columns that are grouped under the heading Legislation Act 2019 requirements for secondary legislation made under this section. Legislation Act 2019 requirements for secondary legislation made under this section Publication The maker must publish it in accordance with the Legislation (Publication) Regulations 2021 LA19 s 74(1)﻿(aa) Presentation The Minister must present it to the House of Representatives LA19 s 114 Disallowance It may be disallowed by the House of Representatives LA19 ss 115 116 This note is not part of the Act. Section 34A inserted 23 June 2022 section 4 Medicines Amendment Act 2022 Quality and standards
35: Revocation and suspension of consents
1: The Minister may at any time, by notice section 20 section 23
a: the medicine can no longer be regarded as a medicine that can be administered or used safely for the purposes indicated in the application for consent, or in a notice deposited under section 24
b: the specifications and standards with respect to the manufacture of the medicine that were included in the terms of a consent can no longer be regarded as satisfactory; or
c: the efficacy of the medicine can no longer be regarded as satisfactory.
2: Where a consent is suspended under this section, it shall be deemed for the purposes of subsections (2) and (4) of section 20
3: A notice under this section is secondary legislation ( see Part 3 Medicines Act 1968 s 28, Schedule 2 (UK) The following table is small in size and has 3 columns that are grouped under the heading Legislation Act 2019 requirements for secondary legislation made under this section. Legislation Act 2019 requirements for secondary legislation made under this section Publication The maker must publish it in the Gazette LA19 ss 73 74(1)﻿(a) cl 14 The Ministry of Foreign Affairs and Trade considers that the secondary legislation may have international transparency obligations under the CPTPP s 75 LA19 ss 74(2) 75 Presentation It is not required to be presented to the House of Representatives because a transitional exemption applies under Schedule 1 LA19 s 114 cl 32(1)﻿(a) Disallowance It may be disallowed by the House of Representatives LA19 ss 115 116 This note is not part of the Act. Section 35(1) amended 28 October 2021 section 3 Secondary Legislation Act 2021 Section 35(3) inserted 28 October 2021 section 3 Secondary Legislation Act 2021
36: Control of established medicines
1: Without limiting subsection (5) of section 24
2: If the Director-General is not satisfied, by evidence supplied to him pursuant to a notice under subsection (1) or otherwise, of the safety and efficacy of a medicine to which that notice relates, he may at any time after the expiration of 60 days from the date of that notice refer a description of the medicine to the appropriate committee, and shall forthwith by notice in writing inform the importer or manufacturer that he has done so.
3: In any case to which this section applies, the Minister may, by notice in writing to the importer or manufacturer,—
a: prohibit the importer or manufacturer, either indefinitely or for such period as may be specified in the notice, from selling or supplying the medicine; or
b: impose such conditions as may be specified in the notice on the sale or supply of the medicine by the importer or manufacturer.
4: The Minister may at any time, by a like notice, revoke any notice given under subsection (3), or vary, revoke, or add to any conditions imposed in any such notice.
5: Every person commits an offence and is liable on conviction Section 36(5) amended 1 July 2013 section 413 Criminal Procedure Act 2011
37: Powers of Minister to prohibit import, etc, of medicines
1: The Minister may from time to time, by notice
2: Where the Minister gives a notice under subsection (1), he shall, on the written request of any person, state his reasons for doing so.
3: Every person commits an offence against this Act who contravenes any notice given under subsection (1).
4: A notice under this section is secondary legislation ( see Part 3 1960 No 97 s 28 1967 No 108 s 3 The following table is small in size and has 3 columns that are grouped under the heading Legislation Act 2019 requirements for secondary legislation made under this section. Legislation Act 2019 requirements for secondary legislation made under this section Publication The maker must publish it in the Gazette LA19 ss 73 74(1)﻿(a) cl 14 The Ministry of Foreign Affairs and Trade considers that the secondary legislation may have international transparency obligations under the CPTPP s 75 LA19 ss 74(2) 75 Presentation It is not required to be presented to the House of Representatives because a transitional exemption applies under Schedule 1 LA19 s 114 cl 32(1)﻿(a) Disallowance It may be disallowed by the House of Representatives LA19 ss 115 116 This note is not part of the Act. Section 37(1) amended 28 October 2021 section 3 Secondary Legislation Act 2021 Section 37(4) inserted 28 October 2021 section 3 Secondary Legislation Act 2021
38: Restrictions on sale of medical devices
1: For the purposes of this section,—
a: the term medical device section 5(1)
b: a medical device is unsafe if the use of that device may be injurious to the health of the person using it or the person in respect of whom it is used:
c: 2 or more medical devices shall be deemed to be of the same kind, notwithstanding any minor differences or any difference in any name, if they are—
i: substantially similar to one another; and
ii: designed to be used in the same way; and
iii: sold for the same therapeutic purpose.
2: If the Director-General has reason to believe that any medical device may be unsafe, he may, by notice in writing to the importer or manufacturer in New Zealand, state the reasons for his belief, and require the importer or manufacturer to satisfy him of the safety of that medical device.
3: The importer or manufacturer shall supply to the Director-General, within 45 days after receiving the notice under subsection (2), or such further time as the Director-General may allow, evidence of the safety of the medical device.
4: If the Director-General is not satisfied, by evidence supplied to him pursuant to a notice under subsection (3) or otherwise of the safety of the medical device, he may at any time, within the period of 45 days following the receipt of that evidence, by a further notice under subsection (2) require the manufacturer or importer to supply him with further evidence of the safety of the medical device.
5: The fact that the Director-General does not exercise the powers conferred on him by this section in respect of a medical device shall not be deemed to warrant the safety of the medical device.
6: The Director-General may exercise the powers conferred on him by this section from time to time with respect to different importers or manufacturers of the same kind of medical devices, and the fact that he has not exercised any of those powers in respect of a particular kind of medical device, or that he has informed any person that he is satisfied of the safety of a particular kind of medical device, shall not prevent him from exercising any such power in respect of that kind of medical device where new information comes to his attention.
7: In any proceedings for an offence against this section in which it is alleged that 2 or more medical devices are of the same kind, it shall be presumed that those medical devices are of the same kind until the contrary is proved.
8: Every person commits an offence and is liable on conviction
a: having received a notice under subsection (2) and failed to comply with subsection (3), sells the medical device; or
b: having received a notice under subsection (4), sells the medical device before he has been notified by the Director-General that he is satisfied of the safety of the medical device. Section 38(1)﻿(a) amended 7 March 2017 section 99 Radiation Safety Act 2016 Section 38(8) amended 1 July 2013 section 413 Criminal Procedure Act 2011
39: Adulteration of medicines
1: No person shall—
a: add any substance to, or abstract any substance from, a medicine so as to affect injuriously the composition of the medicine, with intent that the medicine shall be sold or supplied in that state:
b: sell or supply any medicine the composition of which has been injuriously affected by the addition or abstraction of any substance.
2: Every person commits an offence against this Act who contravenes subsection (1). Medicines Act 1968 s 63 (UK)
40: Compliance with standards
1: If a standard is prescribed in respect of a medicine, or a medical device, or the ingredient of a medicine, no person shall, in the course of any business, sell or supply any substance or article under a name that is likely to cause the person to whom the substance or article is sold or supplied to believe that that person is purchasing or otherwise acquiring that medicine, or that medical device, or a substance containing that ingredient, unless the substance or article, or the ingredient of the substance or article, complies with the standard.
2: If a person sells an article to a purchaser in response to a request for a medicine or a medical device of a kind for which a standard is prescribed, he shall be deemed to sell a medicine or medical device of that kind and under such a description as is specified in subsection (1) unless he clearly notifies the purchaser at the time of sale that the article is not of that kind.
3: Notwithstanding that a medicine, or a medical device, or an ingredient of a medicine, otherwise conforms with the standard prescribed for that medicine, medical device, or ingredient, it shall be deemed not to conform with that standard if anything has been added to it—
a: the addition of which is not expressly required or permitted by regulations made under this Act; or
b: in a quantity or proportion greater or lesser than that so required or permitted; or
c: that does not comply with the standard (if any) prescribed for that kind of thing.
4: Every person commits an offence against this Act who contravenes subsection (1). 1969 No 7 ss 6, 39(1) Medicines Act 1968 s 65 (UK)
41: Duty of importer or manufacturer to report untoward effects of medicines
1: If at any time the importer or manufacturer in New Zealand of any medicine has reason to believe that any substantial untoward effects have arisen from the use of the medicine whether in New Zealand or elsewhere, the importer or manufacturer shall forthwith notify the Director-General of the nature of those effects and the circumstances in which they have arisen, so far as they are known to him.
2: Every person commits an offence against this Act and is liable on conviction 1969 No 7 ss 17, 39(5) Section 41(2) amended 1 July 2013 section 413 Criminal Procedure Act 2011
42: Duty of importer and manufacturer to have and produce specifications of medicines
1: No importer or manufacturer shall sell, or distribute by way of gift or loan or sample or in any other way, or advertise for sale, or advertise the availability of, any medicine other than a herbal remedy unless he is in possession of—
a: details of the specifications for testing the quality of that medicine; and
b: a certificate of the results of testing in respect of every batch of that medicine distributed or to be distributed in New Zealand.
2: Every importer or manufacturer in New Zealand shall, on demand, supply to an officer the details and certificates referred to in subsection (1).
3: A person who contravenes this section commits an offence, and is liable on conviction—
a: in the case of an individual, to imprisonment for a term not exceeding 3 months or a fine not exceeding $10,000:
b: in the case of a body corporate, to a fine not exceeding $100,000. Section 42(3) substituted 19 May 1998 section 13 Copyright (Removal of Prohibition on Parallel Importing) Amendment Act 1998 Restrictions on operation of pharmacies Heading inserted 18 September 2004 section 11 Medicines Amendment Act 2003
42A: Every pharmacy must be under supervision of pharmacist
No person may operate any pharmacy that is not for the time being under the immediate supervision and control of a pharmacist. 1970 No 143 s 41 Section 42A inserted 18 September 2004 section 11 Medicines Amendment Act 2003
42B: Security of pharmacies
1: Every person who operates a pharmacy must ensure that every prescription medicine or restricted medicine in the pharmacy is at all times secured in a way that prevents the public gaining ready access to the medicine.
2: Every person who operates a pharmacy must ensure that all medicines held in storage for the purposes of the pharmacy are secured in a way that prevents the public gaining access to the medicines.
3: Subsections (1) and (2) do not prevent a pharmacist engaged at the pharmacy or another person authorised by a pharmacist engaged at the pharmacy, from supplying any medicine to a member of the public.
4: The requirements imposed by subsections (1) and (2) are in addition to the requirements imposed by section 47 Section 42B inserted 18 September 2004 section 11 Medicines Amendment Act 2003
42C: Restriction on authorised prescribers
and delegated prescribers
1: No authorised prescriber or delegated prescriber
2: No person who has an interest in a pharmacy may permit or enable any authorised prescriber or delegated prescriber
3: The licensing authority may not give its consent under subsection (1) unless it is satisfied that there are sufficient safeguards to prevent the issue of prescriptions, the manner in which prescriptions are issued, or the other provision of health care by the authorised prescriber or delegated prescriber , or delegated prescriber, Section 42C inserted 18 September 2004 section 11 Medicines Amendment Act 2003 Section 42C heading amended 1 July 2014 section 22(1) Medicines Amendment Act 2013 Section 42C(1) amended 1 July 2014 section 22(2) Medicines Amendment Act 2013 Section 42C(2) amended 1 July 2014 section 22(3) Medicines Amendment Act 2013 Section 42C(3) amended 1 July 2014 section 22(4)﻿(a) Medicines Amendment Act 2013 Section 42C(3) amended 1 July 2014 section 22(4)﻿(b) Medicines Amendment Act 2013 Miscellaneous provisions
43: Restrictions on possession of prescription medicines
1: No person shall, without reasonable excuse, import, procure, receive, store, use, or otherwise have in his possession, any prescription medicine.
2: Without limiting the meaning of the expression reasonable excuse in subsection (1), a person has a reasonable excuse
a: the possession or act that might otherwise be a contravention of that subsection—
i: is that of a person, licensed or otherwise authorised under this Act or any regulations made under this Act, to manufacture, sell, supply, pack, or administer the medicine or to be in possession of it; and
ii: is necessary as incidental to the business, calling, or purpose for which the person is so licensed or otherwise authorised; or
b: the possession or act that might otherwise be a contravention of that subsection—
i: is that of a carrier, or an employee of a carrier; and
ii: is necessary or incidental to the business of that carrier; or
c: the possession or act that might otherwise be a contravention of that subsection—
i: is that of a person to whom the medicine has been lawfully supplied for his or her use, or for use by any other person, as a patient under the care of an authorised prescriber or a delegated prescriber or delegated prescriber
ii: is necessary or incidental to such use; or
d: the possession or act that might otherwise be a contravention of that subsection—
i: is that of a person who has possession of the medicine only for the purpose of administering it to the person for whom it has been prescribed; and
ii: is necessary or incidental to that purpose; or
e: the possession or act that might otherwise be a contravention of that subsection—
i: is that of a person in the service of the Crown; and
ii: is necessary or incidental to the performance of that person's duties.
3: In any proceedings under this section against any person in which it is proved that that person procured, received, stored, used, or otherwise had in his possession any prescription medicine, the onus of proving that he had a reasonable excuse (whether by reason of the fact that 1 or more of the provisions of paragraphs (a) to (e) of subsection (2) apply to his case or otherwise) shall lie on the defendant.
4: In any proceedings under this section, the fact that the defendant did not know that the medicine that is the subject of the prosecution was a prescription medicine is not by itself a reasonable excuse.
5: Every person commits an offence against this Act who contravenes subsection (1).
6: 1960 No 97 s 26 1969 No 44 s 7 Section 43(2) substituted 15 October 1999 section 8(1) Medicines Amendment Act 1999 Section 43(2)﻿(c)﻿(i) amended 1 July 2014 section 23(1)﻿(a) Medicines Amendment Act 2013 Section 43(2)﻿(c)﻿(i) amended 1 July 2014 section 23(1)﻿(b) Medicines Amendment Act 2013 Section 43(6) repealed 1 July 2014 section 23(2) Medicines Amendment Act 2013
44: Containers and packages of medicines
1: Except as may be permitted by regulations made under this Act, no person shall, in the course of any business, pack, store, sell, supply, or cause to be transported any medicine, unless—
a: the medicine is in a container that—
i: is impervious to the medicine; and
ii: is so constructed that it can be readily and effectively resealed after any portion of the contents has been used; and
iii: is of the prescribed character or type; and
iv: is labelled in the prescribed manner; and
b: if the container is enclosed in a package that is required to be of a prescribed character or type, or to be labelled in a prescribed manner, the package is of that character or type, or is labelled in that manner.
2: Notwithstanding subsection (1)﻿(a)﻿(ii), where—
a: the container bears a label with directions to the effect that the whole of the contents must be used immediately on opening; and
b: the quantity and nature of the contents are such that it is unlikely that less than the whole of the contents will be used on any one occasion— the container need not be of a type that can be readily and effectively resealed.
3: Every person commits an offence against this Act who contravenes subsection (1). 1960 No 97 s 22
45: Records
1: Every person who, in the course of any business, manufactures, packs, or sells, or supplies in circumstances corresponding to retail sale, any medicine shall keep, in some place of security at his place of business, such records as may be prescribed and shall retain them for such period as may be prescribed.
2: Every person who, in the course of any business, manufactures, packs, or sells, or supplies in circumstances corresponding to retail sale, any medicine shall at all times permit any officer, or any constable constable
3: Every person commits an offence against this Act who—
a: contravenes or fails to comply in any respect with any of the provisions of this section; or
b: obstructs or hinders any inspection under subsection (2). 1960 No 97 s 23 Section 45(2) amended 1 October 2008 section 116(a)﻿(ii) Policing Act 2008
46: Custody of medicines
1: Every person commits an offence against this Act who has any medicine in his charge or possession (whether for the purposes of sale or for any other purpose) otherwise than in a container conforming to the relevant requirements (if any) of this Act and of any regulations made under this Act, except in the course of manufacturing or packing that medicine.
2: It is a defence to a charge brought under subsection (1) if the defendant proves that, at the material time,—
a: the medicine was in the container in which he acquired it, and the container bore the label that it bore when he acquired the container:
b: the medicine had been necessarily removed from its container for the effective and lawful use of that medicine. 1960 No 97 s 24
47: Storage and delivery of medicines
1: No person who is in possession or charge of any prescription medicine or restricted medicine shall put it—
a: in any cupboard, box, shelf, or other place of storage in which articles of food or drink are stored or kept for ready use; or
b: in any place to which young children or unauthorised persons have ready access.
2: No person shall pack any medicine, or prepare it for use, in any room, or on any table or bench, that is used for the purpose of packing, preparing, or consuming any food or drink.
3: Except as otherwise provided in any regulations made under this Act, no person who is in possession, for the purposes of any business, of a prescription medicine or a restricted medicine that is kept for the time being within any building or vehicle shall leave that building or vehicle unattended, unless he has taken all reasonable steps to secure that building or vehicle, or the part of it in which the medicine is kept, against unlawful entry.
4: No person shall deliver on retail sale, or in circumstances corresponding to retail sale, any medicine otherwise than through the post or by handing it or causing it to be handed to the person, or another person reasonably believed to be acting on that person's behalf, to whom it is addressed or for whose use it is intended.
5: Every person commits an offence against this Act who, without reasonable excuse, contravenes any of the provisions of this section. 1960 No 97 s 25 1969 No 44 s 6
47A: Effect of grant of delegated prescribing rights
If regulations made under sections 105(1)﻿(qaa) and 105D
a: an authorised prescriber who is not a designated prescriber may, in accordance with the regulations, issue a delegated prescribing order to a specified person belonging to that class of registered health professional; and
b: the person to whom the delegated prescribing order is issued (the delegated prescriber) may prescribe specified prescription medicines, or a specified class or description of prescription medicines, in accordance with the terms of his or her delegated prescribing order. Section 47A inserted 1 July 2014 section 24 Medicines Amendment Act 2013
48: Powers of Minister to prohibit prescribing, etc
1: The Minister may at any time, by notice in the Gazette
a: prohibit any specified authorised prescriber, veterinarian, or delegated prescriber
b: prohibit, either generally or in relation to any particular class or description of medicines, any specified person from exercising all or any of the rights conferred by this Act, whether those rights are so conferred on persons generally or on a particular class to which that person belongs.
2: The Minister may not exercise any power conferred on him or her by subsection (1),—
a: in the case of a medical practitioner, except on the recommendation of the Medical Council of New Zealand; or
b: in the case of a dentist, except on the recommendation of the Dental Council of New Zealand; or
c: in the case of a pharmacist, except on the recommendation of the Pharmacy Council
d: in the case of a registered midwife or a nurse, except on the recommendation of the Midwifery Council or
e: in the case of a veterinarian, except on the recommendation of the Veterinary Council of New Zealand; or
ea: in the case of an optometrist, except on the recommendation of the Optometrists and Dispensing Opticians Board; or
f: in the case of any other designated prescriber or delegated prescriber, except on the recommendation of the responsible authority for the health profession to which the designated prescriber or delegated prescriber belongs.
3: The Minister may at any time, by notice in the Gazette Section 48 substituted 15 October 1999 section 9 Medicines Amendment Act 1999 Section 48(1)﻿(a) amended 1 July 2014 section 25(1) Medicines Amendment Act 2013 Section 48(2)﻿(c) amended 18 September 2004 section 12(1) Medicines Amendment Act 2003 Section 48(2)﻿(d) amended 18 September 2004 section 12(2) Medicines Amendment Act 2003 Section 48(2)﻿(ea) inserted 1 July 2014 section 25(2) Medicines Amendment Act 2013 Section 48(2)﻿(f) replaced 1 July 2014 section 25(3) Medicines Amendment Act 2013
48A: Powers of councils and boards
1: Despite anything in any other Act, each council or board referred to in section 48
2: For the purposes of subsection (1), each such council or board has and may exercise any powers with respect to summoning witnesses, administering oaths, hearing evidence and other matters of procedure, and with respect to the payment and receiving of costs and expenses, conferred on it or any disciplinary committee or disciplinary tribunal, in relation to disciplinary proceedings, by the enactment under which the council or board is constituted.
3: Despite subsection (2), it is not necessary, unless the council or board so requires, for any other body to conduct an investigation or inquiry or to be represented at the inquiry conducted by the council or board.
4: Without prejudice to the liability of any person under any other provision of this Act, a person who contravenes any notice given under section 48(1) Section 48A inserted 15 October 1999 section 9 Medicines Amendment Act 1999
49: Restrictions on supply to particular persons
1: In this section the term restricted person
2: Where a Medical Officer of Health is satisfied that any person—
a: is addicted or habituated to the use of any prescription medicine or restricted medicine or has been obtaining any prescription medicine or restricted medicine from several different sources; and
b: is likely to seek further supplies of that prescription medicine or restricted medicine, or prescriptions for the supply of that prescription medicine or restricted medicine,— he may from time to time, by notice in such form as he thinks fit, prohibit, subject to such conditions and exceptions as he may prescribe in the notice, any authorised prescriber or delegated prescriber
3: The Medical Officer of Health may at any time, by a like notice, revoke, or vary, or modify any prohibition, condition, or exception contained in a notice given by him under this section.
4: The Medical Officer of Health shall cause a copy of every notice under subsection (2) or subsection (3) to be served on the restricted person, but a failure to comply with this requirement shall not invalidate the notice.
5: Any person who is aggrieved by the issue of a notice under this section, or by the refusal of the Medical Officer of Health to revoke, vary, or modify any prohibition, condition, or exception contained in any such notice, may appeal in writing to the Minister whose decision shall be final.
6: Every person commits an offence against this Act who—
a: prescribes for or supplies to any person whom he knows to be a restricted person any prescription medicine or restricted medicine in contravention of a notice given under subsection (2) or subsection (3); or
b: being a restricted person, procures or attempts to procure a prescription or a prescription medicine or a restricted medicine from any person whom he knows is prohibited by a notice under subsection (2) or subsection (3) from issuing the prescription or supplying the medicine to the restricted person. SR 1964/64 r 20A SR 1969/45 r 6 Section 49(2) amended 1 July 2014 section 26 Medicines Amendment Act 2013
49A: Statements regarding persons dependent on prescription medicines or restricted medicines
1: If a Medical Officer of Health has reason to believe that any person is or is likely to become dependent on any prescription medicine or restricted medicine, the Medical Officer of Health may, for the purpose of preventing or restricting the supply of prescription medicines or restricted medicines to that person, or of assisting in the cure or mitigation or avoidance of the dependence of that person, publish statements relating to that person to all or any of the members of all or any of the classes of persons set out in subsection (3).
2: Every statement made under subsection (1) shall be privileged unless the publication is proved to be made with malice.
3: The classes of persons referred to in subsection (1) are as follows:
a: officers:
b: officers and employees of Health New Zealand established by section 11
c: people providing, or employed in providing, hospital care (within the meaning of the Health and Disability Services (Safety) Act 2001
d: managers of prisons within the meaning of the Corrections Act 2004
e: managers of treatment centres within the meaning of the Substance Addiction (Compulsory Assessment and Treatment) Act 2017
f: authorised prescribers:
g: delegated prescribers:
ga:
gb:
h: Police employees
i: persons who deal in prescription medicines or restricted medicines in the course of business.
4: Nothing in subsection (1) or subsection (2) shall limit or affect any right or duty that a Medical Officer of Health may otherwise possess to publish a statement to any person.
5: Every person commits an offence against this Act who, except in the course of duty as a member of a class set out in subsection (3) or as an officer or servant of the Crown, publishes any information obtained, whether by that person or any other person, from a statement made pursuant to subsection (1), or any comment on any such statement. Section 49A inserted 23 February 1987 Medicines Amendment Act 1987 Section 49A(3)﻿(a) substituted 1 July 1993 section 32 Health Sector (Transfers) Act 1993 Section 49A(3)﻿(b) replaced 1 July 2022 section 104 Pae Ora (Healthy Futures) Act 2022 Section 49A(3)﻿(c) substituted 1 October 2002 section 58(1) Health and Disability Services (Safety) Act 2001 Section 49A(3)﻿(d) substituted 1 June 2005 section 206 Corrections Act 2004 Section 49A(3)﻿(e) replaced 21 February 2018 section 122(1) Substance Addiction (Compulsory Assessment and Treatment) Act 2017 Section 49A(3)﻿(f) replaced 1 July 2014 section 27 Medicines Amendment Act 2013 Section 49A(3)﻿(g) replaced 1 July 2014 section 27 Medicines Amendment Act 2013 Section 49A(3)﻿(ga) repealed 1 July 2014 section 27 Medicines Amendment Act 2013 Section 49A(3)﻿(gb) repealed 1 July 2014 section 27 Medicines Amendment Act 2013 Section 49A(3)﻿(h) amended 1 October 2008 section 130(1) Policing Act 2008
3: Provisions relating to licences
50: Applications for licences
1: Every application for a licence must be made in the prescribed form to the Director-General or to any person designated for the purpose by the Director-General by notice in the Gazette
2: Every such application shall contain or be accompanied by such particulars, information, documents, samples, and other material as may be prescribed, and shall be accompanied by the prescribed fee.
3: The application shall indicate the descriptions of the medicines in respect of which the licence is sought, either by specifying those descriptions, or by reference to an appropriate general classification.
4: An application may be made either by an individual who is a New Zealand resident on the person's own behalf or by an appropriate officer of a body corporate that is incorporated in New Zealand on behalf of that body corporate.
5: If a person authorised to receive an application under subsection (1) is satisfied that an application complies with the requirements of this section and of any regulations made under this Act that are applicable to the application, the person must refer the application to the licensing authority. 1960 No 97 s 15 1979 No 27 s 35 Medicines Act 1968 s 18 (UK) Section 50(1) substituted 18 September 2004 section 13(1) Medicines Amendment Act 2003 Section 50(4) substituted 18 September 2004 section 13(2) Medicines Amendment Act 2003 Section 50(5) substituted 18 September 2004 section 13(2) Medicines Amendment Act 2003
51: Grant of licences
1: Subject to subsection (2) and to sections 52 55A 55B
a: that the requirements of section 50
b: that, in the case of an application made by a natural person on his own behalf, the applicant is a fit and proper person to hold the licence applied for, or, in the case of an application made on behalf of a body corporate, the applicant (body corporate) is of good repute:
c: that the applicant is not subject to any disqualification under section 83
d: that, in the case of an application made by a natural person on his own behalf, the applicant, or, in the case of an application made on behalf of a body corporate, every person proposed to be a responsible person for the purposes of the licence applied for, has a sufficient knowledge of the obligations of a licensee and of the hazards associated with the medicines in which it is proposed to deal:
e: that the premises and equipment that the applicant proposes to use are suitable and adequate for the purposes for which the licence is sought:
f: that adequate arrangements have been made or are to be made for the making, maintaining, and safekeeping of adequate records in respect of medicines that are manufactured, stored, packed, labelled, or sold in pursuance of the licence or, in the case of an application for a licence to operate a pharmacy, in respect of medicines that are manufactured, stored, packed, labelled, or sold on the premises or in any other place for which the licence to operate is sought
1A: In determining, under subsection (1)﻿(b), whether an applicant is a fit and proper person or of good repute (as the case requires), the licensing authority may take into account, among other things,—
a: any conviction of the applicant for—
i: an offence under this Act, or regulations made under it; or
ii: an offence under the Misuse of Drugs Act 1975
iii: a crime involving dishonesty (within the meaning of section 2(1)
b: any determination of a professional conduct committee.
2: Except as may be permitted by regulations made under this Act, the licensing authority shall not issue a licence to sell medicines by retail in respect of any premises other than a shop that is open to the public and is situated at least 10 kilometres by the most practicable route from a pharmacy in respect of which a licence to operate has been, or is deemed to have been, issued
3: The licensing authority shall not decline an application for a licence under this section without first giving the applicant a reasonable opportunity to be heard.
4: A licence—
a: must be in the prescribed form; and
b: is subject to—
i: any conditions that the licensing authority thinks fit; and
ii: any conditions specified in regulations.
4A: The licensing authority may, by written notice to the holder of a licence, revoke or amend any condition imposed under subsection (4)﻿(b)﻿(i) or add any new condition.
5: A licence to sell a medicine may be combined with a licence to pack that medicine.
6: If in any case the licensing authority is satisfied that the holder of a licence has failed or is failing to comply with any conditions attached to the licence, the licensing authority may cancel the licence.
6AA: The licensing authority may not cancel a licence under subsection (6) unless the holder has been given a reasonable opportunity to be heard, or to make written submissions, in relation to the matter.
6AAB: The licensing authority may suspend a licence for a reasonable period to enable the licensing authority to consider whether to cancel the licence under subsection (6).
6A: If the licensing authority is satisfied that the holder of a licence to operate a pharmacy has failed to comply with any conditions affecting the licence, the licensing authority may, instead of or as well as exercising the powers conferred by subsection (4A) or (6)
a: impose on the holder of the licence a penalty not exceeding $40,000:
b: forbid the licence holder or any person with an interest in the pharmacy from holding any interest in or operating a pharmacy for a period, not exceeding 5 years, specified by the licensing authority.
6B: A penalty imposed under subsection (6A) may be recovered in a court of competent jurisdiction as a debt due to the licensing authority.
7: If the licensing authority refuses to issue a licence, or attaches conditions to a licence, or cancels a licence under this section or under section 55A
8: In this section, professional conduct committee section 71 1960 No 97 s 16 1979 No 27 s 36 Section 51(1) amended 18 September 2004 section 14(1) Medicines Amendment Act 2003 Section 51(1)﻿(f) amended 18 September 2004 section 14(2) Medicines Amendment Act 2003 Section 51(1A) inserted 1 July 2014 section 28(1) Medicines Amendment Act 2013 Section 51(2) amended 18 September 2004 section 14(3) Medicines Amendment Act 2003 Section 51(4) replaced 1 July 2014 section 28(2) Medicines Amendment Act 2013 Section 51(4A) inserted 1 July 2014 section 28(2) Medicines Amendment Act 2013 Section 51(6) replaced 1 July 2014 section 28(3) Medicines Amendment Act 2013 Section 51(6AA) inserted 1 July 2014 section 28(3) Medicines Amendment Act 2013 Section 51(6AAB) inserted 1 July 2014 section 28(3) Medicines Amendment Act 2013 Section 51(6A) inserted 18 September 2004 section 14(4) Medicines Amendment Act 2003 Section 51(6A) amended 1 July 2014 section 28(4) Medicines Amendment Act 2013 Section 51(6B) inserted 18 September 2004 section 14(4) Medicines Amendment Act 2003 Section 51(7) amended 18 September 2004 section 14(5) Medicines Amendment Act 2003 Section 51(8) inserted 1 July 2014 section 28(5) Medicines Amendment Act 2013
52: Effect of licences
1: Subject to sections 20 24 25 to 34
a: a licence to manufacture medicines shall authorise the manufacture, packing and labelling, and sale by wholesale, of the medicines described in the licence:
b: a licence to pack medicines shall authorise the packing and labelling, and the sale by wholesale of the medicines described in the licence:
c: a licence to sell medicines by wholesale shall authorise the sale by wholesale of the medicines described in the licence:
d: a licence to sell medicines by retail shall authorise the sale by retail, and the supply in circumstances corresponding to retail sale, of the medicines described in the licence:
e: a licence to operate a pharmacy authorises the establishment of the pharmacy and the carrying on of pharmacy practice in the pharmacy.
2: A licence to sell medicines by retail shall not authorise the sale by retail, or the supply in circumstances corresponding to retail sale, of any prescription medicine or any restricted medicine.
3: A licence is subject to—
a: any conditions imposed by the licensing authority under section 51(4)﻿(b)﻿(i) or (4A)
b: any conditions specified in regulations.
4: Except as may be permitted by the terms of the licence, or by any regulations made under this Act, a licence shall not authorise the manufacture, packing and labelling, or sale of a medicine elsewhere than in the premises specified or described in the licence. 1960 No 97 s 17 1979 No 27 s 37 Section 52(1)﻿(e) added 18 September 2004 section 15(1) Medicines Amendment Act 2003 Section 52(3) replaced 1 July 2014 section 29(2) Medicines Amendment Act 2013
53: Duration of licences
1: Subject to subsections (2) and (3) and to section 55G section 55A(3) section 83
2: Any licence issued within the period of 2 months preceding the date of expiration of an existing licence that it is intended to supersede shall continue in force for a period of 1 year beginning on that date.
3: If a licensee applies for a new licence not more than 3 months and not less than 1 month before the date of expiration of an existing licence that the new licence is intended to supersede, and the application is not disposed of before that date, the existing licence shall continue in force until the application is disposed of. 1960 No 97 s 18 1979 No 27 s 38 Section 53(1) substituted 18 September 2004 section 16 Medicines Amendment Act 2003
54: Display of licences
1: Every licensee shall cause his current licence to be permanently exhibited in some conspicuous place where it can be readily seen by all persons having access to the premises to which the licence relates.
2: Every licensee who is authorised by his licence to sell medicines elsewhere than in his regular business premises shall produce his licence for inspection whenever required by an officer to do so, or, if he is unable to do so, shall produce it at the office of the licensing authority within 24 hours thereafter.
3: Every person commits an offence against this Act who contravenes subsection (1), or fails to produce his licence as required by subsection (2). 1960 No 97 s 19 1979 No 27 s 39
55: Register of licences
1: Every licensing authority shall keep at his office a register of the licences issued by the authority under this Act, and such other registers and records as may be prescribed.
2: Any person may have access to the register of licences for the purpose of inspection during the hours and upon the days appointed by regulations made under this Act or, if no such times are so appointed, at all reasonable times. 1960 No 97 s 20
55A: Additional criteria to be satisfied by pharmacy operators
1: The licensing authority must not grant an application for a licence to operate a pharmacy unless the authority is satisfied that, in addition to satisfying the criteria set out in section 51(1)
a: the applicant is a person who is qualified under any of sections 55D 55E 55G
b: the applicant is a person who is able to satisfy the condition set out in section 55C
2: If the licensing authority has reasonable grounds to believe that the holder of a licence to operate a pharmacy has ceased to be a person who satisfies each of the criteria set out in subsection (1), the licensing authority may suspend the licence for a reasonable period to enable the authority to consider the case.
3: If, after giving the holder of a licence to operate a pharmacy whose licence is suspended under subsection (2) a reasonable opportunity to be heard and after considering any evidence adduced or submissions made by the licensee, the licensing authority is not satisfied that the holder satisfies all of the criteria set out in subsection (1), the licensing authority may cancel the licence.
4: If, after giving the holder of a licence to operate a pharmacy whose licence is suspended under subsection (2) a reasonable opportunity to be heard and after considering any evidence adduced or submissions made by the licensee, the licensing authority is satisfied that the holder satisfies all of the criteria set out in subsection (1), the licensing authority must reinstate the licence. Section 55A inserted 18 September 2004 section 17 Medicines Amendment Act 2003
55B: Licensing authority may require further information
1: The licensing authority may, for 1 or more of the purposes set out in subsection (2), require an applicant for a licence to operate a pharmacy to supply information additional to that contained in the application.
2: The purposes referred to in subsection (1) are—
a: the determination of the nature of the interest held by any person in the pharmacy:
b: the assessment required by section 51(1)﻿(b)
c: the assessment required by section 55A(1)
3: If the applicant fails to supply the information requested within 30 days of the date of the request, or within any further time allowed by the licensing authority, the application lapses. Section 55B inserted 18 September 2004 section 17 Medicines Amendment Act 2003
55C: Mandatory condition of licence to operate pharmacy
It is a condition of every licence to operate a pharmacy that the holder of the licence must not request or require any pharmacist who is employed or engaged in duties at a pharmacy to act in a way that is inconsistent with the applicable professional or ethical standards of pharmacy practice. Section 55C inserted 18 September 2004 section 17 Medicines Amendment Act 2003 Restrictions on persons allowed to operate pharmacies Heading inserted 18 September 2004 section 17 Medicines Amendment Act 2003
55D: Restriction on companies operating pharmacies
1: No company may be granted a licence to operate a pharmacy unless any of paragraphs (a) to (e) of subsection (2) apply.
2: A company may be granted a licence to operate a pharmacy if—
a: at all times more than 50% of the share capital of the company is owned by a pharmacist or pharmacists, and effective control of the company is vested in that pharmacist or those pharmacists; or
b: it is exempt from the requirements set out in paragraph (a) under an Order in Council made under section 105C
c: it is deemed to have been issued with a licence under section 114A(2)
d: the pharmacy is in a hospital owned or operated by the company; or
e: it is a company that, at the commencement of this section, was lawfully operating a pharmacy.
3: Subsection (2)﻿(e) ceases to apply to a company if there is or are a change or changes in the ownership of shares representing 25% of the share capital of the company after the commencement of this section.
4: For the purposes of subsection (2), pharmacist Insolvency Act 2006
a: 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, has expired; or
b: subject to any conditions that the licensing authority proposes, the expiry of any extended period or periods permitted by the licensing authority. 1970 No 143 s 42 Section 55D inserted 18 September 2004 section 17 Medicines Amendment Act 2003 Section 55D(4) amended 3 December 2007 section 445 Insolvency Act 2006
55E: Restriction on individuals operating or holding majority interest in pharmacies
1: No person, either alone or in partnership, may be granted a licence to operate a pharmacy, or hold a majority interest, in a pharmacy unless—
a: the person is a pharmacist; or
b: the person is exempt from the requirements set out in paragraph (a) under an Order in Council made under section 105C
c: the person is deemed to have been issued with a licence under section 114A(2)
d: the pharmacy is in a hospital owned or operated by the person; or
e: the person, at the commencement of this section, was lawfully operating a pharmacy.
2: For the purposes of subsection (1), a person does not hold an interest in a pharmacy merely by reason of the person's membership of a company, or of any other body of persons (whether corporate or unincorporate) other than a partnership, that is lawfully carrying on business in a pharmacy.
3: For the purposes of subsection (1),— person pharmacist
a: an administrator of the estate of a deceased pharmacist:
b: an assignee, within the meaning of the Insolvency Act 2006
c: a liquidator carrying on a pharmacy under the authority of section 260 Schedule 6
d: a receiver or manager of the property of a company carrying on, subject to the Receiverships Act 1993
4: Subsection (3) does not entitle any person to carry on business in a pharmacy after—
a: the expiry of 1 year after the date of the death of the deceased pharmacist, or the date on which the pharmacist was adjudicated bankrupt, or the date of the first appointment of a liquidator, receiver, or manager, in respect of a company that has carried on a pharmacy; or
b: subject to any conditions that the licensing authority imposes, the expiry of any extended period or periods permitted by the licensing authority.
5: In this section and in section 55F majority interest 1970 No 143 s 43 Section 55E inserted 18 September 2004 section 17 Medicines Amendment Act 2003 Section 55E(3) pharmacist amended 3 December 2007 section 445 Insolvency Act 2006
55F: Prohibition on operating or holding of majority interest in more than 5 pharmacies
1: Despite sections 55D 55E
a: no company may operate more than 5 pharmacies:
b: no person referred to in section 55E(3)
2: Subsection (1) does not apply to any person referred to in section 55E(3) section 55E(4)
3: Subsection (1) does not apply to any person who, while attempting to sell 1 pharmacy of which the person is the operator, carries on business in no more than 5 other pharmacies for a period not exceeding 3 months, or, subject to any conditions that the licensing authority imposes, any extended period or periods permitted by the authority.
4: Subsection (3) is subject to sections 55D 55E
5: Subsection (1) does not apply to Health New Zealand established by section 11 1970 No 143 s 45 Section 55F inserted 18 September 2004 section 17 Medicines Amendment Act 2003 Section 55F(5) inserted 1 July 2022 section 104 Pae Ora (Healthy Futures) Act 2022
55G: Exemption for mortgagees in possession
1: Despite sections 55D 55E
2: In this section, mortgagee in possession section 4 1970 No 143 s 47 Section 55G inserted 18 September 2004 section 17 Medicines Amendment Act 2003 Section 55G(2) amended 1 January 2008 section 364(1) Property Law Act 2007
4: Medical advertisements
56: Interpretation
In this Part, unless the context otherwise requires,— advertisement advertising advertised medical advertisement method of treatment publish
a: insert in any newspaper or other periodical publication printed or published in New Zealand; or
b: send to any person through the Post Office or otherwise; or
c: deliver to any person or leave upon premises in the occupation of any person; or
d: broadcast within the meaning of the Broadcasting Act 1989
e: bring to the notice of the public in New Zealand in any other manner. 1969 No 7 s 2 1979 No 27 s 2 Section 56 publish amended 1 July 1989 section 89(1) Broadcasting Act 1989
57: Restrictions on advertisements
1: No person shall publish or cause to be published, either on that person's own account or as the agent or employee of the person seeking to promote the sale, any medical advertisement that—
a: directly or by implication qualifies or is contrary to any statement or other particulars required by regulations made under this Act to be marked on or attached to medicines or medical devices of the description, kind, or class, to which the medicines or medical devices advertised, or appearing to be advertised, belong or appear to belong, or on or to packages or containers enclosing medicines or medical devices of that description, kind, or class; or
b: is prohibited by any such regulations from being marked on or attached to, or on or to packages or containers enclosing, medicines or medical devices of that description, kind, or class; or
c: omits from the name or description of the medicines or medical devices advertised any word or words required by any such regulations to be included in the name or description marked on or attached to, or on or to packages or containers enclosing, medicines or medical devices of that description, kind, or class; or
d: fails to make any statement required by any such regulations to be made in an advertisement relating to medicines or medical devices of that description, kind, or class; or
e: makes any statement prohibited by any such regulations from being made in an advertisement relating to medicines or medical devices of that description, kind, or class; or
f: is false, or is likely to mislead any other person, with regard to the nature, quality, strength, purity, composition, origin, age, uses, or effects of medicines or medical devices of that description, kind, or class or of any ingredient or component thereof; or
g: directly or by implication states or suggests that medicines or medical devices of that description, kind, or class, cannot harm any person, or any person belonging to a particular class of persons, or is not habit-forming.
2: For the purposes of subsection (1), any words that must be included in an advertisement in order to avoid a contravention of that subsection shall, where they appear in an advertisement published by television or otherwise in a transitory manner on a screen, be disregarded unless they are exposed in clearly legible lettering for a length of time sufficient to enable them to be read by the ordinary viewer.
3: For the purposes of subsection (1)﻿(f), a medical advertisement shall be deemed to be likely to mislead any person with regard to the uses or effects of medicines or medical devices of a particular description, kind, or class, or of any ingredient or component thereof, if it is likely to mislead with regard to—
a: any purposes for which medicines or medical devices of that description, kind, or class, or any ingredient or component thereof, can be used with reasonable safety; or
b: any purposes for which such medicines or medical devices, or any such ingredient or component, cannot be so used; or
c: any effects that such medicines or medical devices, or any such ingredient or component, when used, or when used in any particular way referred to in the advertisement, produce or are intended to produce.
4: Without prejudice to any liability in respect of any offence against any regulations made under this Act, every person commits an offence against this Act who contravenes any of the provisions of subsection (1). 1960 No 97 s 29 1969 No 7 s 8 SR 1964/64 r 21
58: Further restrictions on advertisements
1: Subject to section 60
a: directly or by implication claims, indicates, or suggests that medicines of the description, or medical devices of the kind, or the method of treatment, advertised will prevent, alleviate, or cure any disease, or prevent, reduce, or terminate any physiological condition specified, or belonging to a class of disease or physiological condition specified, in Part 1
b: directly or by implication claims, indicates, or suggests that medicines of the description, or medical devices of the kind, or the method of treatment, advertised will prevent or cure any disease, or prevent or terminate any physiological condition specified, or belonging to a class of disease or physiological condition specified, in Part 2
c: directly or by implication claims, indicates, or suggests that a medicine of the description, or a medical device of the kind, or the method of treatment, advertised—
i: is a panacea or infallible; or
ii: is or has been used or recommended by a practitioner, nurse, or pharmacist, or by any other person qualified to provide therapeutic treatment in the course of a profession or occupation and registered under any enactment as a person so qualified, or by a person who is engaged in study or research in relation to any of those professions or occupations or the work performed by persons employed therein; or
iii: has beneficially affected the health of a particular person or class of persons, whether named or unnamed, and whether real or fictitious, referred to in the advertisement; or
d: invites correspondence or the sending of hair, blood, urine, or other bodily specimens or photographs for the purposes of diagnosis or treatment concerning any disease or physiological condition.
2: Every person commits an offence against this Act who contravenes any of the provisions of subsection (1).
3: It shall be a good defence in a prosecution for an offence against paragraph (a) or paragraph (b) of subsection (1) if the defendant proves that the matter claimed, indicated, or suggested in the advertisement is true. 1969 No 7 ss 10, 39(3)
59: Advertisements to contain true name of advertiser
1: Subject to subsection (2), no person shall publish, or cause or permit to be published, any medical advertisement that does not contain a statement of the true name of the person for whom or on whose behalf the advertisement is published, and the address of that person's place of residence or business.
2: In the case of a body corporate, it shall be sufficient compliance with subsection (1) if, instead of the address of the body corporate's place of business, the advertisement states the name of the place where the body corporate has its registered office, or, if it is not a registered company, other headquarters.
3: Any statement that is contained in any medical advertisement and purports to set forth the name of the person for whom or on whose behalf the advertisement is published, shall, until the contrary is proved, be sufficient evidence of the name of the person for whom or on whose behalf the advertisement has been published.
4: Nothing in this section applies to—
a: any medical advertisement that complies with any regulations made under this Act relating to the disclosure or otherwise of the name and address of the place of residence or business of the manufacturer or seller of the medicines of the description or medical devices of the kind advertised, or the agent of either of them; or
b: any medical advertisement relating to any description of medicines or any kind of medical devices in respect of which an exemption granted under or by virtue of this Act from the material provisions of any such regulations is for the time being in force.
5: Every person commits an offence and is liable on conviction 1969 No 7 s 9 Section 59(5) amended 1 July 2013 section 413 Criminal Procedure Act 2011
60: Exemption for certain advertisements
Without limiting any power to make regulations under this Act, nothing in section 57(1)﻿(g) section 58 section 59
a: is distributed only to persons referred to in section 58(1)﻿(c)﻿(ii)
b: is contained in a publication that in the ordinary course circulates solely or principally, or is distributed solely or principally, to those persons; or
c: not being an advertisement relating to a prescription medicine, or a restricted medicine, or a pharmacy-only medicine, is distributed solely to persons claiming to be available for consultation by other persons for therapeutic purposes and to persons privately consulting them. 1969 No 7 s 11
61: Misleading branding
1: No person shall sell any medicine or medical device—
a: that bears or has attached to it, or is enclosed in a package or container that bears or has attached to it, any false or misleading statement, word, brand, picture, label, 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 of the medicine or medical device enclosed in the package or container, or of any ingredient thereof; or
b: that has been packed, processed, or treated in a manner that is false or misleading in relation to any of the matters mentioned in paragraph (a).
2: Every person commits an offence against this Act who contravenes subsection (1). 1969 No 7 s 7
62: Regulations relating to advertisements
1: Without limiting section 105
a: requiring and regulating the insertion in any medical advertisement, or any particular class of medical advertisement, of such information or warning, or kind of information or warning, concerning any unwanted, incidental, or untoward effects of medicines of the description, or of medical devices of the kind, or of the method of treatment, advertised, and such statement or kind of statement of the precautions to be taken by any user of medicines of that description, or of medical devices of that kind, or of that method of treatment, as may be prescribed:
b: prohibiting the advertising of any specified description of medicine, or kind of medical device, or method of treatment, or of any specified class of medicine, medical device, or method of treatment, in any medical advertisement, or a particular class of medical advertisement, and prohibiting, or requiring and regulating, the mention in any medical advertisement of such matters relating to the composition, properties, nomenclature, origin, and use of medicines of the description or medical devices of the kind or the method of treatment advertised, as may be prescribed:
c: enabling the Minister to require, after consultation with such organisations as appear to him to represent any class or classes of persons whose interests might be affected by the requirement, the insertion of particular words specified by the Minister in, or the omission of particular words or other matter so specified from, any particular medical advertisement or class of medical advertisement, and to give directions with respect to the location, size, and appearance of any such insertion and with respect to other matters incidental thereto, and providing a right of appeal in respect of any such requirement or direction:
d: generally regulating medical advertisements or any particular class of medical advertisements, or medical advertisements relating to medicines of a particular description, or to medical devices of a particular kind, or to a particular method of treatment, or relating to particular classes of medicines, medical devices, or methods of treatment.
2: Any regulations made under subsection (1)﻿(a)—
a: shall be made only on the recommendation of the Minister after consultation with such organisations or bodies as the Minister considers likely to be substantially affected by the regulations; and
b: shall be designed to achieve a fair and balanced indication of the potential effects of the medicine or medical device or method of treatment advertised; and
c: shall not require the disclosure of information that may reasonably be regarded as confidential, or that cannot reasonably be expected to be in the possession of the person on whose behalf the advertisement is published, or the inclusion of which in the advertisement is otherwise impracticable.
3: Regulations under this section are secondary legislation ( see Part 3
4: If the regulations enable the Minister to make requirements or directions under subsection (1)﻿(c),—
a: those requirements or directions are secondary legislation ( see Part 3
b: the regulations must contain a statement to that effect. 1969 No 7 s 46(1)﻿(r), (s), (2) The following table is small in size and has 3 columns that are grouped under the heading Legislation Act 2019 requirements for secondary legislation referred to in subsection (3). Legislation Act 2019 requirements for secondary legislation referred to in subsection (3) Publication PCO must publish it on the legislation website and notify it in the Gazette LA19 s 69(1)﻿(c) Presentation The Minister must present it to the House of Representatives LA19 s 114 cl 32(1)﻿(a) Disallowance It may be disallowed by the House of Representatives LA19 ss 115 116 This note is not part of the Act. The following table is small in size and has 3 columns that are grouped under the heading Legislation Act 2019 requirements for secondary legislation referred to in subsection (4)﻿(a). Legislation Act 2019 requirements for secondary legislation referred to in subsection (4)﻿(a) Publication See the relevant publication, presentation, and disallowance table in the secondary legislation referred to in subsection (3) LA19 ss 73 74 cl 14 Presentation The Minister must present it to the House of Representatives, unless a transitional exemption applies under Schedule 1 LA19 s 114 cl 32 Disallowance It may be disallowed by the House of Representatives LA19 ss 115 116 This note is not part of the Act. Section 62(3) inserted 28 October 2021 section 3 Secondary Legislation Act 2021 Section 62(4) inserted 28 October 2021 section 3 Secondary Legislation Act 2021
5: Enforcement
63: Powers of officers
1: In this section the expression article to which this section applies
a: any medicine; and
b: any medical device; and
c: any cosmetic; and
d: any equipment used or intended to be used in connection with the manufacture, packing, or labelling of anything referred to in any of paragraphs (a) to (c); and
e: any package or container, and any advertising material or labelling material, used or intended to be used in any such connection.
2: An officer, and any other person assisting him and acting under his direct supervision, may at any reasonable time—
a: enter and inspect any premises (not being a dwellinghouse) or vehicle (including any fixtures, fittings, or appliances in the premises or vehicle) where the officer reasonably believes that any article to which this section applies is manufactured, packed, stored, or kept for sale:
b: enter any premises (not being a dwellinghouse) or vehicle where the officer reasonably believes that any books, documents, or other records are kept relating to any such manufacture, packing, storage, or keeping for sale:
c: open and examine any package or container that the officer reasonably believes contains any article to which this section applies:
d: examine any article to which this section applies:
e: examine any process of manufacture or packing of any article to which this section applies, and the means employed at any stage in the processes of manufacture or packing for testing the materials after they have been subjected to those processes:
f: subject to section 69
g: purchase or take—
i: any package or container in which the officer reasonably believes any medicine or medical device is intended to be packed for sale; or
ii: any advertising material or labelling material that the officer reasonably believes is intended for use in connection with the sale of any medicine or medical device, or to have been used for such purpose:
h: examine any books, documents, or other records that the officer reasonably believes contain information relevant to the enforcement of this Act or any regulations made under this Act, and make copies of or take extracts from any such records:
i: seize and detain any article to which this section applies, not being equipment, by means of or in relation to which the officer reasonably believes an offence against this Act or against any regulations made under this Act has been committed:
j: seize and detain any advertising material or labelling material that contravenes or does not comply with the requirements of this Act or any regulations made under this Act:
k: take photographs of any premises or vehicle, or any article to which this section applies, or any other thing, where or by means of or in relation to which the officer reasonably believes an offence against this Act or against any regulations made under this Act has been committed.
3: On demand by any person in any premises or vehicle, or claiming any interest in any article, in or in respect of which any power is exercised under this section, the officer exercising the power shall identify himself and produce evidence that he is an officer.
4: 1969 No 7 s 21(1), (2), (4) 1979 No 27 s 47(1)–(6) Section 63(4) repealed 1 April 1987 section 25(1) Official Information Amendment Act 1987
64: Further provisions relating to seizure and detention of articles
1: If any officer seizes any article under section 63
2: Subject to subsection (3), where any article is seized under paragraph (i) or paragraph (j) of section 63(2)
3: An officer shall release any article seized by him under section 63
a: that all the provisions of this Act and of any regulations made under this Act, to the extent that they are material, have been complied with in respect of the article; and
b: that the article is fit for the purpose for which it is intended to be sold or used.
4: If, within the time limited by section 65(1)
5: Without prejudice to the owner's liability under subsections (2) and (4), where the article was, at the time of the seizure, in the possession of a person who was not the owner and the identity of the owner is not known to the officer, the person in whose possession the article was at that time shall be liable for any costs and expenses incurred in the detention, removal, or disposition of that article.
6: If any article seized under section 63 1969 No 7 s 21(5)–(8)
65: District Court may order return of property or compensation
1: Any person claiming an interest in any substance or article seized under section 63(2)﻿(i) the District Court
a: that the seizure be disallowed and that the article be returned or otherwise made available to him:
b: that the Crown shall pay to him such sum by way of compensation for any depreciation in the value of the substance or article resulting from its seizure, detention, or removal as the court thinks fit.
2: On any such application, the court may dismiss it, or, subject to subsections (3) and (4), order—
a: that the seizure be disallowed in whole or in part; or
b: that the detention of the substance or article be terminated in whole or in part; or
c: that compensation be paid by the Crown for any depreciation in the value of the substance or article resulting from its seizure, detention, or removal, and any transport and storage costs,— and any such order may be made upon and subject to such terms and conditions as the court thinks fit.
3: No order that the seizure of the substance or article be disallowed or that the detention of the substance or article be terminated in whole or in part shall be made if the court is of the opinion that the purpose to which that substance or article or that part is intended to be put will probably involve the commission of an offence against this Act, or any regulation made under this Act, or that the continued detention of that substance or article or that part is expedient for the purpose of its production in any pending proceedings under this Act.
4: No order for the payment of compensation shall be made except in respect of a substance or article or part that, in the opinion of the court, ought not to have been seized or continued to be detained, as the case may be, and except to the extent that the court disallows the seizure or terminates the detention.
5: Where the court makes an order for the payment of any sum by way of compensation to any person under this section, the sum so awarded shall be recoverable by that person as a debt due from the Crown.
6: Every application to the court under this section shall be made and dealt with by way of originating application filed in the office of the court nearest to the place where the substance or article in dispute was seized or ordered to be detained.
7: The applicant shall serve notice of his application on the respondent on or before the date on which he files it in the court.
8: Except as modified by subsections (6) and (7), the rules of procedure for the time being in force under the District Court Act 2016
9: Every order made by the court under this section shall be final and binding on all parties.
10: Nothing in this section shall limit or affect the Customs and Excise Act 2018 1969 No 7 s 22 1979 No 27 s 49 SR 1964/64 r 20(f) Section 65(1) amended 1 March 2017 section 261 District Court Act 2016 Section 65(8) amended 1 March 2017 section 261 District Court Act 2016 Section 65(10) amended 1 October 2018 section 443(3) Customs and Excise Act 2018
66: Powers to require information
1: Without limiting section 63
a: of any medicine or medical device for the purpose of sale; or
b: of any substance or article for the purpose of the manufacture, packing, sale, or supply of any medicine or medical device; or
c: of any advertising material or labelling material for use as an advertisement or label,— in breach of this Act or of any regulations made under this Act, he may require that person to produce for his inspection, or to produce to any officer specially authorised by him for the purpose, any books, documents, or other records dealing with the importation, purchase, reception, manufacture, packing, storage, carriage, delivery, sale, or supply of any such medicine, medical device, substance, article, or material.
2: The Director-General or the Medical Officer of Health may make or cause to be made copies of or extracts from any such books, documents, or other records, and the copies of extracts, certified as such by him or by any specially authorised officer, shall be deemed to be true and correct copies or extracts, unless the contrary is proved.
3: Every person commits an offence against this Act who refuses or fails to comply with any requisition made pursuant to this section.
4:
5: For the purposes of this section, any goods that have been seized or ordered to be detained, whether pursuant to this Act or any other enactment, shall be deemed to be still in the possession of the person who had them in his possession when they were seized or ordered to be detained. 1960 No 97 s 40 1969 No 7 s 27 1979 No 27 s 50 Section 66(4) repealed 1 April 1987 section 25(1) Official Information Amendment Act 1987
67: Power to require name and address of seller
1: Any officer acting in the exercise of any of his powers under this Act may require any person who is in possession of any substance or article appearing to the officer to be a medicine or medical device for sale, or for delivery upon sale, to state correctly his name and address and, so far as he is aware of them, the name and address of the person from whom he obtained the substance or article.
2: Every person commits an offence against this Act who fails, without reasonable excuse, to comply with any requirement of an officer under subsection (1). 1969 No 7 s 28 1979 No 27 s 51
68: Source of information or reports need not be disclosed
No prosecutor or witness in any prosecution under this Act shall be compelled to disclose the fact that the prosecutor or witness received any information, or the nature of such information, or the name of any person who gave such information; and no officer appearing as a prosecutor or witness shall be compelled to produce any confidential reports or documents made or received by that officer in his official capacity, or to make any statement in relation thereto. 1969 No 7 s 37 1979 No 27 s 52
69: Procuring samples for analysis
1: When an officer intends to procure a sample of a substance or article for the purposes of analysis, he shall—
a: pay or tender the current market value of the sample to the owner thereof or the person from whom the sample is to be obtained:
b: before or forthwith after obtaining the sample, inform the owner of the sample or the person from whom the sample is obtained of his intention to submit the sample to an analyst.
2: For the purposes of subsection (1), an officer may require the person in possession of a substance or an article that the officer reasonably believes to be a medicine, or his employee or agent, to show and permit the inspection of any package or container enclosing the substance or article and to take therefrom the sample demanded.
3: Where any such substance or article is kept for retail sale in an unopened container, no person shall be required by any officer to sell less than the whole of the contents of the container.
4: Nothing in this section shall—
a: apply to the procuring of a sample of a substance or article from a vending machine if the officer obtains the sample by properly making payment for it and no person present admits to being in charge of the machine:
b: prevent an officer from taking or purchasing samples of substances or articles for examination otherwise than by way of analysis, but in any such case the officer shall pay or tender the current market value of the sample to the owner thereof or the person from whom the sample is to be obtained.
5: Notwithstanding anything in this section,—
a: an officer shall not be obliged to submit to an analyst any sample that he has obtained:
b: an officer may inspect, select, and take or purchase any sample for the purposes of analysis without complying with those sections, but in that event no regard shall be had to the result of any such analysis in any proceedings before any court in respect of an offence against this Act or against any regulations made under this Act.
6: The procuring of a prescription medicine by an officer under this section shall not, for the purposes of section 18(2)
7: Every person commits an offence against this Act who refuses or fails to comply with any demand or requisition made by an officer pursuant to this section.
8: For the purposes of this section, every person who is in possession of any substance or article that, in the opinion of the officer, is intended for sale shall, until the contrary is proved, be deemed to be the seller of the substance or, as the case may be, the agent or employee of the seller. 1960 No 97 s 33(1)–(5) 1969 No 7 s 23 1979 No 27 s 53
70: Analysis of sample and certificate of analyst
1: The certificate of the analyst shall be in the prescribed form.
2: Where any method of analysis of any substance or article is prescribed, an analyst shall use that method and shall declare in his certificate of analysis that he has done so.
3: Any certificate of the result of an analysis given by an analyst in pursuance of this section shall be signed by the analyst, but the analysis may be made by any person acting under the direction of the analyst.
4: When any sample is procured by an officer under this Act and submitted for analysis, the person from whom the sample was procured, or the manufacturer or importer of the substance or article, may, on payment of the prescribed fee, obtain a copy of the analyst's certificate or, if there is no such certificate, a copy of the report made by the analyst in respect of the sample.
5:
6: Every person commits an offence against this Act who publishes or causes to be published any advertisement relating to any medicine or medical device which states that the medicine or medical device has been analysed by an analyst under this Act, or quotes or purports to quote the findings of any analyst under this Act in relation to the medicine or medical device, whether or not those findings are given in any certificate or report prepared for the purposes of this Act. 1969 No 7 s 25 1979 No 27 s 55 Section 70(5) repealed 1 April 1987 section 25(1) Official Information Amendment Act 1987
71: Evidence of analysis
1: Subject to subsections (2) and (3), in any proceedings for an offence against this Act, a certificate purporting to be signed by an analyst in the prescribed form shall, in the absence of evidence to the contrary, be sufficient evidence of the authority of the person who signed the certificate and of the facts stated in the certificate.
2: A certificate referred to in subsection (1) shall be admissible in evidence only if—
a: at least 14 clear days before the hearing at which the certificate is tendered, a copy of that certificate (in addition to the copy required by section 77(4)
b: the defendant does not, by notice in writing given to the prosecutor at least 7 clear days before the hearing, require the analyst to be called by the prosecutor as a witness at the hearing.
3: No certificate referred to in subsection (1) shall be admissible in evidence if the court, of its own motion, directs that the result of the analysis shall be disregarded unless that result is proved by the oral evidence of the analyst.
4: No certificate of an analyst and no other evidence of an analysis under this Act shall be ruled inadmissible or disregarded by reason only of the fact that any of the provisions of this Act or of any regulations made under this Act relating to the taking or analysing of samples have not been strictly complied with, if there has been reasonable compliance with those provisions. 1969 No 7 s 36 1979 No 27 s 56
72: Special provisions relating to imported consignments
1: Where, in any port any officer takes any sample under section 69
a: the officer shall forthwith notify the importer that he has taken the sample:
b: subject to paragraphs (c) and (d), an officer shall direct the Customs
c: any such consignment may, with the approval of an officer, be removed at the expense of the importer from the port to a specified place if the importer undertakes in writing, in a form approved by the officer, that he will detain the consignment for such time as may be necessary to obtain results of analysis or to complete an examination:
d: where any such consignment is in a bulk cargo container, the officer may, in accordance with paragraph (c), approve the removal of that container to a specified place at which a sample can be taken:
e: where any consignment is to be removed to a specified place under paragraph (c) or paragraph (d), an officer shall mark it:
f: if, as a result of the analysis or examination, an officer reasonably believes that the consignment does not comply with any of the provisions of this Act or any regulations made under this Act, he may—
i: seize and detain the goods; or
ii: order the goods returned by the importer to their place of origin, or some other place outside New Zealand, at the expense of the importer; or
iii: permit the goods to be released subject to such conditions as he may specify, including a condition that a new label be substituted for any label on each or any package comprising part of the consignment:
g: nothing in paragraph (c) or paragraph (d) or paragraph (f)﻿(iii) shall limit or affect the Customs and Excise Act 2018
2: Where an officer seizes any goods under this section, he shall serve notice of his action on the importer of the goods; and, if the goods are still under the control of the Customs, he shall also serve a copy of the notice on the Customs
3: Where any goods are seized under this section, section 65
4: It shall be the duty of all officers of the Customs to assist in carrying out the provisions of this section, and to prevent the introduction into New Zealand of anything contrary to this Act; and for that purpose they may, in respect of anything so introduced or attempted to be introduced, exercise all the powers conferred by the Customs and Excise Act 2018 1979 No 27 s 57 Section 72(1)﻿(b) amended 1 October 1996 section 289(1) Customs and Excise Act 1996 Section 72(1)﻿(g) amended 1 October 2018 section 443(3) Customs and Excise Act 2018 Section 72(2) amended 1 October 1996 section 289(1) Customs and Excise Act 1996 Section 72(4) amended 1 October 2018 section 443(3) Customs and Excise Act 2018
73: Certain matters presumed
1: In any prosecution for an offence against this Act or against any regulations made under this Act, it shall be presumed, until the contrary is proved, that the contents of a container conform with any purported description of the contents shown on any label attached to the container.
2: In any prosecution for an offence against this Act or against any regulations made under this Act involving any medicine that is a new medicine by virtue of section 3(3)﻿(c) 1960 No 97 s 50A 1979 No 27 s 58
74: Certificates of Director-General or Medical Officer of Health
1: In any proceedings under this Act, a copy of a record or an extract therefrom made by an officer pursuant to this Act and certified to be a true copy by the officer who made it pursuant to section 63(2)﻿(h) section 66(2)
2: In any proceedings under this Act, a certificate purporting to be signed by a licensing authority—
a: relating to any contents of the register kept under section 55
b: stating that on a date specified in the certificate the name of any person did not appear in the said register as a licensee, or any particulars specified in the certificate did not appear in the said register— shall, without proof of the signature of the licensing authority, be sufficient evidence until the contrary is proved of the facts set out in the certificate. 1960 No 97 s 33(b) 1969 No 7 s 36
75: Obstruction of officers
1: Every person commits an offence against this Act who wilfully obstructs, hinders, resists, or deceives any officer in the execution of any powers conferred on that officer by or under this Act.
2: Without limiting subsection (1), every person shall be deemed to have obstructed an officer if—
a: except with the authority of an officer or under an order of a court, he removes, alters, or interferes in any way with any article seized or detained under this Act; or
b: except with the authority of an officer or of an analyst or under an order of a court, he erases, alters, opens, breaks, or removes any mark, seal, or fastening placed by an officer under this Act on any sample or part of a sample procured under this Act, other than a part of a sample or bottle or container left with the owner of the medicine from which the sample was taken or the person from whom the sample was procured; or
c: he refuses to sell to an officer, or to allow an officer to take, in the quantity that the officer reasonably requires as a sample, any medicine that appears to the officer to be intended for sale or to have been sold, or any advertising material or labelling material, that appears to the officer to be intended for use in connection with the sale of any article to which section 63
d: he refuses or fails to give an officer any assistance that that officer may reasonably require him to give, or to give to an officer any information, or to produce or permit an officer to examine and make copies of and extracts from any books, documents, or other records, that that officer is expressly authorised by this Act to require to be given or produced or to examine or make, or may reasonably require to be given or produced or to examine or make, or when required to give any such information or to produce any such books, documents, or other records, knowingly makes any false statement in respect thereof. 1969 No 7 s 29 1979 No 27 s 59
76: Penalty for false statement
1: Every person commits an offence against this Act who, for the purpose of obtaining, whether for himself or for any other person, the grant of any licence under this Act, or for any other purposes in relation to this Act,—
a: make any declaration or statement that he knows is false in any particular; or
b: utters, produces, or makes use of any such declaration or statement, or any document containing the same; or
c: utters, produces, or makes use of any document that he knows is not genuine.
2: Every person who commits an offence against this section is liable on conviction 1960 No 97 s 47 1969 No 44 s 10 1979 No 27 s 60 Section 76(2) amended 1 July 2013 section 413 Criminal Procedure Act 2011
76A: Offences in relation to authorised prescribers
and delegated prescribers Every pharmacist, person licensed to operate a pharmacy, or operator or manager of a pharmacy commits an offence against this Act who gives, offers, or agrees to give to any authorised prescriber or to any delegated prescriber 1970 No 143 s 49(1)﻿(a) Section 76A inserted 18 September 2004 section 18 Medicines Amendment Act 2003 Section 76A heading amended 1 July 2014 section 30(1) Medicines Amendment Act 2013 Section 76A amended 1 July 2014 section 30(2) Medicines Amendment Act 2013
77: Jurisdiction of District
Court
1:
2: Despite anything to the contrary in section 25
3: The summons in any such proceedings shall not be made returnable in less than 14 days from the day on which it is served.
4: There shall be served with the summons in any such proceedings a copy of the analyst's certificate or report (if any) relating to the prosecution. 1969 No 7 s 38 1979 No 27 s 61 Section 77 heading amended 1 March 2017 section 261 District Court Act 2016 Section 77(1) repealed 1 July 2013 section 413 Criminal Procedure Act 2011 Section 77(2) replaced 1 July 2013 section 413 Criminal Procedure Act 2011
78: General penalty
Every person who commits any offence against this Act for which no penalty is provided elsewhere than in this section is liable on conviction 1969 No 7 s 39 1979 No 27 s 62 Section 78 amended 1 July 2013 section 413 Criminal Procedure Act 2011
79: Liability of principal for acts of agents, etc
1: Where an offence is committed against this Act or against any regulations made under this Act by any person acting as the agent or employee of another person, that other person shall, without prejudice to the liability of the first-mentioned person, be liable under this Act in the same manner and to the same extent as if he had personally committed the offence.
2: Notwithstanding anything in subsection (1), where any proceedings are brought by virtue of that subsection it shall be a good defence to the charge if the defendant proves that the offence was committed without his knowledge and that he took all reasonable steps to prevent the commission of the offence.
3: Where any body corporate is convicted of an offence against this Act or against any regulations made under this Act, every director and every person concerned in the management of the body corporate shall be guilty of a like offence if it is proved that the act that constituted the offence took place with his authority, permission, or consent, or that he knew the offence was to be or was being committed and failed to take all reasonable steps to prevent or stop it. 1969 No 7 s 30 1979 No 27 s 63
80: Strict liability
1: In any prosecution for selling a medicine or medical device contrary to any provision of this Act or of any regulation made under this Act, it shall not be necessary for the prosecution to prove that the defendant intended to commit an offence.
2: Subject to subsection (3), it shall be a good defence in any such prosecution if the defendant proves—
a: that he did not intend to commit an offence against this Act or any regulations made under this Act; and
b: that he took all reasonable steps to ensure that the sale of the article would not constitute any such offence.
3: Except as provided in subsection (4), subsection (2) shall not apply unless, within 7 days after the service of the summons, or within such further time as the court may allow, the defendant has delivered to the prosecutor a written notice—
a: stating that he intends to rely on subsection (2); and
b: specifying the reasonable steps that he will claim to have taken.
4: In any such prosecution, evidence that the defendant took a step not specified in the written notice required by subsection (3) shall not, except with the leave of the court, be admissible for the purpose of supporting a defence under subsection (2). 1969 No 7 s 31
81: Further defences
1: Subject to subsections (2) and (4), it shall be a good defence in a prosecution for selling or supplying any medicine or medical device contrary to any provision of this Act or any regulations made under this Act if the defendant proves—
a: that he purchased the article sold or supplied by him in reliance on a written warranty or other written statement as to the nature of the article purchased, signed by or on behalf of the person from whom the defendant purchased the article; and
b: that if the article had truly conformed to the warranty or statement, the sale or supply of the article by the defendant would not have constituted the offence charged against him; and
c: that he had no reason to believe or suspect that the article sold or supplied by him did not conform to the warranty or statement; and
d: that at the time of the commission of the alleged offence, the article was in the same state as it was when he purchased it.
2: No warranty or statement shall be any defence under this section unless—
a: it was given or made by or on behalf of a person resident in New Zealand or a company having a registered office in New Zealand or a firm having a place of business in New Zealand; and
b: the signature to the warranty or statement is written by hand; and
c: the defendant proves that at the time he received the warranty or statement he took reasonable steps to ascertain, and did in fact believe, that the signature was that of the person from whom he purchased the article, or, as the case may be, of some person purporting to sign on behalf of the person from whom the defendant purchased the article.
3: Subject to subsection (4), it shall be a good defence in a prosecution for selling or supplying any medicine or medical device contrary to any provision of this Act or of any regulations made under this Act if the defendant proves—
a: that he purchased the article sold or supplied by him in a container and sold or supplied in the same container and in the same condition as the article was in at the time when he purchased it; and
b: that he could not with reasonable diligence have ascertained that the sale or supply of the article would constitute the offence charged against him.
4: Neither subsection (1) nor subsection (3) shall apply unless, within 7 days after the service of the summons, or within such further time as the court may allow, the defendant has delivered to the prosecutor a copy of the warranty or statement, if any, and a written notice to the effect that he intends to rely on it or on subsection (3), as the case may require, and specifying the name and address of the person from whom he received the warranty or statement or container, and has also, within the same time, sent by post a like notice of his intention to that person.
5: Where the defendant is an agent or employee of the person who purchased the article under such a warranty or statement or in such a container, he shall be entitled to the benefit of this section in the same manner and to the same extent as his principal or employer would have been if he had been the defendant. 1969 No 7 s 32
82: Liability of persons named on labels
1: If any medicine or medical device is sold or supplied in the container in which it was enclosed when purchased by the person who sells or supplies the substance or article, and which has not since that purchase been opened by that person or any agent or employee of that person, every person who appears from any statement or label on or attached to the container to be—
a: the person who has manufactured, imported, or packed the medicine or medical device; or
b: the person who is the owner of the rights of manufacture of the medicine or medical device, or who has packed it; or
c: the agent of any such person,— shall, unless he proves the contrary, be deemed to have so manufactured, imported, or packed the medicine or medical device, or, as the case may require, to be the agent of such a person, and shall be liable in the same manner and to the same extent as if he had actually sold or supplied the medicine or medical device at the time and place at which the sale or supply was made, and, if that sale or supply involved the commission of an offence against this Act, he shall be deemed to be a party to that offence.
2: Subject to subsection (3), it shall be a defence in a prosecution under subsection (1) if the defendant proves—
a: in the case of a prosecution relating to the condition of a medicine or medical device, that when the container left his possession, the medicine or medical device was in such a condition that its sale or supply then would not have involved the commission of the offence with which he is charged; or
b: in the case of a prosecution relating to manufacture, packing, or labelling, that the offence with which he is charged arises from an alteration made to the container or labelling since the container left his possession.
3: Subsection (2) shall not apply unless, within 7 days after the service of the summons, or within such further time as the court may allow, the defendant has delivered to the prosecutor a written notice—
a: stating that he intends to rely on subsection (2); and
b: identifying the person to whom the defendant consigned or delivered the medicine or medical device or explaining why the defendant is unable to identify that person.
4: Nothing in subsection (1) shall apply in respect of any offence against section 17 section 18 1969 No 7 s 33
83: Cancellation of licence
1: In any case where a licensee is convicted of an offence against this Act, or against any regulations made under this Act, the court may, in addition to or instead of imposing any other penalty,—
a: cancel the licence, either forthwith or with effect from such future date as may be specified by the court:
b: disqualify the licensee from obtaining any new licence for such period as the court may specify:
c: cause particulars of the conviction, and of any order made under paragraph (a) or paragraph (b) to be endorsed on the licence.
2: When a court cancels a licence pursuant to subsection (1), the licence shall cease to have effect either forthwith or on the date specified by the court, as the case may require.
3: When a court, pursuant to subsection (1), disqualifies a person from obtaining a new licence, no licence shall be issued to that person during the period specified by the court.
4: Any licence cancelled or required by the court for endorsement under this section shall be produced by the licensee in such manner and within such time as the court directs.
5: Every person commits an offence against this Act who, without reasonable excuse, fails to produce any licence in accordance with subsection (4).
6: For the purposes of Part 6
7: The particulars of any cancellation, disqualification, or endorsement under this section, and the particulars of the conviction relating thereto, shall be notified in writing to the Director-General by the Registrar of the court. 1960 No 97 s 21 1979 No 27 s 64 Section 83(6) amended 1 July 2013 section 413 Criminal Procedure Act 2011
84: Payment of expenses of analysis on conviction
1: Where any person is convicted of an offence against this Act or any regulations made under this Act, the court may order that all fees and other expenses incidental to the analysis of any medicine in respect of which the conviction is obtained shall be paid by the defendant.
2: All such fees and expenses shall be deemed to be part of the costs attending the conviction, and shall be recoverable accordingly. 1969 No 7 s 41 1979 No 27 s 65
85: Forfeiture on conviction
1: Where any person is convicted of an offence against this Act or any regulations made under this Act, the court may order that any medicine or medical device, or any advertising material or labelling material, to which the conviction relates, and any similar medicine, medical device, or material found on the premises of the defendant or in the defendant's possession at the time of the offence, together with all packages or containers containing the medicine, medical device, or material, shall be forfeited to the Crown.
2: Everything so forfeited to the Crown shall be disposed of as the Minister directs. 1969 No 7 s 40 1979 No 27 s 66
86: Courts may order withdrawal of goods from circulation
1: If any person who manufactures, packs, or imports medicines of any description, or medical devices of any kind, is convicted of an offence against section 61
2: If the court makes an order under subsection (1), the Director-General shall cause particulars of the order and of the offence in relation to which the order was made to be published in the Gazette
a: return them to the person who supplied them; or
b: remedy the matter in relation to which the offence was committed.
3: Every distributor, wholesaler, or retailer who takes action in accordance with paragraph (a) or paragraph (b) of subsection (2) may recover all the costs and expenses incurred in so acting (including, if action is taken under the said paragraph (a), the purchase price of the medicines or medical devices) from the person who supplied them as a debt due by that person to the distributor, wholesaler, or retailer.
4: Without limiting subsection (1), if any person referred to in that subsection is convicted of an offence against any of the provisions of sections 57 58 61
5: Where any person referred to in subsection (1) is convicted of an offence against any of sections 57 58 61 Gazette 1969 No 7 s 35
87: Notification of conviction of practitioners, etc
If a person who is a veterinarian, practitioner, pharmacist, nurse, optometrist, designated prescriber, or delegated prescriber is convicted of an offence against this Act or regulations made under it, the court must send particulars of the conviction to—
a: the Registrar of the Veterinary Council of New Zealand, if the person is a veterinarian; or
b: the responsible authority for the health profession to which the person belongs, in any other case. Section 87 replaced 1 July 2014 section 31 Medicines Amendment Act 2013
6: Appeals
88: Refusal of licensing authority to grant licence
1: Any person who is aggrieved by a decision—
a: of the Director-General made under section 30 section 38
b: of the licensing authority made under section 51 may appeal against that decision to the Medicines Review Committee.
2: Every appeal under subsection (1) shall be commenced within 28 days after the date on which the decision that is the subject of the appeal has been given to the person seeking to bring the appeal, or within such extended time as the Medicines Review Committee may allow.
3: On any such appeal, the Medicines Review Committee may confirm or reverse or modify the decision that is the subject of the appeal, as it thinks fit.
89: Right of appeal to High Court
1: Subject to subsections (2) and (3), any person who is aggrieved by—
a: a decision of the Minister refusing, revoking, or suspending any consent or approval, or imposing, varying, or adding to any conditions, under any of sections 20 23 24 35
b: a decision to issue a notice under section 36(3) section 37(1)
c: a decision of the Medicines Review Committee made under section 88 may appeal to the High Court.
2: The grounds on which an appeal may be brought under subsection (1) are—
a: that any relevant requirement of this Act or of any regulations made under this Act has not been complied with:
b: that the decision that is the subject of the appeal is unreasonable.
3: Every appeal under subsection (1) shall be commenced within 28 days after the date on which notice of the decision that is the subject of the appeal has been given to the person seeking to bring the appeal, or within such extended time as the court may allow.
4:
5: Subject to subsection (6), on any appeal under subsection (1), the court may—
a: by interim order, suspend the operation of the decision to which the appeal relates until the final determination of the proceedings:
b: dismiss the appeal, or make such modifications in the decision to which the appeal relates as it thinks fit, or quash the decision with or without substituting a new decision in its place.
6: The court shall not quash or modify the decision to which the appeal relates on any ground other than a ground specified in subsection (2). 1960 No 97 s 42 1979 No 27 s 67 Section 89(4) repealed 15 August 1991 section 3(4) Judicature Amendment Act 1991
90: Proceedings before court
1: At the hearing of an appeal under section 89
2: The court may, at any such hearing, receive as evidence any statement, document, information, or matter that may, in its opinion, assist it to deal effectually with the matters before it, whether or not it would be otherwise admissible in a court of law.
3: For the purpose of modifying any decision of the Medicines Review Committee, or substituting a new decision, the court shall have all the powers and discretions that the Medicines Review Committee had in respect of the same matter.
4: The court in its discretion may, having regard to the interests of all parties concerned and to the public interest, order that the hearing or any part of it shall be held in private.
5: Subject to the provision of this Act, the procedure in respect of any appeal under section 89 1979 No 27 s 68
91: Further provisions relating to appeals
1: Subject to any order made by the court pursuant to paragraph (a) of subsection (5) of section 89
2: No person shall be deprived of the right of appeal conferred by section 89
3: Where the High Court or the Court of Appeal modifies a decision of the Medicines Review Committee, or substitutes a new decision, the Minister, or the Director-General, or the licensing authority, as the case may require, shall take all necessary measures to implement the decision of the court. 1979 No 27 s 69
92: Court may state case for Court of Appeal
The Judge of the High Court may, on the application of any party to an appeal under section 89 1979 No 27 s 70
93: Appeal to Court of Appeal in certain cases
1: Any party to any appeal before the High Court under section 89
2: In determining whether to grant leave to appeal under this section, the court to which the application for leave is made shall have regard to the following matters:
a: whether any question of law or general principle is involved:
b: the importance of the issues to the parties:
c: such other matters as in the particular circumstances the court thinks fit.
3: The court granting leave under this section may in its discretion impose such conditions as it thinks fit, whether as to costs or otherwise.
4: For the purpose of determining any appeal under this Act, the Court of Appeal shall have the same powers and discretions as are conferred on the High Court by sections 89 90
5: The decision of the Court of Appeal on any appeal under this section shall be final.
6: Notwithstanding the preceding provisions of this section, the decision of the High Court shall have effect according to its terms, pending the determination of any appeal under this section, unless—
a: leave to appeal is given by the court whose decision is the subject of the appeal; and
b: that court, when giving such leave, directs that that decision shall not take effect pending the determination of the appeal.
7: Where the court gives any direction under paragraph (b) of subsection (6), the court may make such order with regard to the application of the decision to which the appeal under section 89 subsection (3) of section 91 1979 No 27 s 71
7: Related products
94: Interpretation
1: In this Part, unless the context otherwise requires, the term related product
a: any medicine:
aa: any medical device:
b: any substance or article of a kind or belonging to a class that is declared by regulations made under this Act to be a kind or class of substance or article that is not a related product for the purposes of this Act.
2: In this Part, unless the context otherwise requires, the term new related product
a: is not identical with any related product that could have been sold lawfully immediately before the commencement of this Part for the same therapeutic purpose as that claimed in respect of the new product; or
b: is of a kind that has been referred to the Minister under section 24(5) section 96(3) Section 94(1)﻿(aa) inserted 1 July 2014 section 33(1) Medicines Amendment Act 2013
95: Application of Act to related products
Except as provided in section 96
96: Certain provisions to apply to related products as if medicines
1: Sections 20 to 22 35
2: Subsections (1) and (2) of section 24
a: the reference in subsection (1) to the efficacy of the medicine shall be read as a reference only to the efficacy of the related product for a therapeutic purpose:
b: subsection (2)﻿(a) shall be read as applying only to the recommended dosage or the recommended manner of administration or use for a therapeutic purpose:
c: subsection (2)﻿(b) shall be read as applying only to any labelling or descriptive matter relating to a therapeutic purpose:
d: subsection (2)﻿(c) and subsection (2)﻿(d) shall be read as applying only to a material change that is relevant to a therapeutic purpose.
3: Subsections (3) to (6) of section 24 sections 37 40 44 Parts 4 5 section 83 Part 6 sections 98 107
4: All or any of the powers conferred by paragraphs (f), (g), (h), (i), (k), (l), and (y) of subsection (1) of section 105
7A: Restrictions on specified biotechnical procedures
Part 7A inserted 28 May 2002 Medicines (Restricted Biotechnical Procedures) Amendment Act 2002
96A: Interpretation
In this Part, unless the context otherwise requires,— biological material
a: the whole or part of any organ, bone, tissue, or cell; or
b: blood or body fluids specified biotechnical procedure xenotransplantation
a: means a medical procedure that involves the insertion or injection into a human being of any matter that consists of, or includes, living biological material of an animal, whether or not that biological material also includes biological material of a human being; and
b: includes the transfusion into a human being of any human blood or any human body fluid if the blood or the fluid has, as part of a biotechnical procedure, been in contact with living biological material of an animal. Section 96A inserted 28 May 2002 Medicines (Restricted Biotechnical Procedures) Amendment Act 2002 Section 96A cloned human organism repealed 21 August 2005 section 86(1) Human Assisted Reproductive Technology Act 2004 Section 96A cloning procedure repealed 21 August 2005 section 86(1) Human Assisted Reproductive Technology Act 2004 Section 96A genetically modified embryo repealed 21 August 2005 section 86(1) Human Assisted Reproductive Technology Act 2004 Section 96A genetically modified gamete repealed 21 August 2005 section 86(1) Human Assisted Reproductive Technology Act 2004 Section 96A germ-cell genetic procedure repealed 21 August 2005 section 86(1) Human Assisted Reproductive Technology Act 2004 Section 96A specified biotechnical procedure substituted 21 August 2005 section 86(2) Human Assisted Reproductive Technology Act 2004
96B: Restrictions on specified biotechnical procedures
1: No person may conduct a specified biotechnical procedure otherwise than in accordance with an authorisation under section 96C section 96D
2: Subsection (1) applies to a person who continues, after the commencement of this section, to conduct a specified biotechnical procedure that was begun before that commencement.
3: Every person commits an offence and is liable on Section 96B inserted 28 May 2002 Medicines (Restricted Biotechnical Procedures) Amendment Act 2002 Section 96B(3) amended 1 July 2013 section 413 Criminal Procedure Act 2011
96C: Authorisation of particular procedures
1: The Minister may, by notice in writing, authorise a person or a body of persons to conduct a particular specified biotechnical procedure.
2: The Minister may issue a notice under subsection (1) only if satisfied that the conduct of the procedure concerned meets each of the criteria specified in section 96E(1)
3: An authorisation granted by a notice under subsection (1) may be granted unconditionally or subject to any conditions that are specified in the notice.
4: The Minister may, at any time, by written notice, do any 1 or more of the following in relation to an authorisation granted under subsection (1):
a: vary the authorisation:
b: vary or revoke any condition subject to which the authorisation was granted:
c: make the authorisation subject to new conditions:
d: revoke the authorisation.
5: As soon as practicable after giving a notice under subsection (1) or subsection (4), the Minister must publish the notice in the Gazette Section 96C inserted 28 May 2002 Medicines (Restricted Biotechnical Procedures) Amendment Act 2002
96D: Authorisation of class of procedure
1: The Governor-General may, by Order in Council made on the recommendation of the Minister, authorise the conduct of 1 or more classes of specified biotechnical procedure.
2: The Minister may make a recommendation under subsection (1) only if satisfied that the conduct of every class of procedure concerned meets each of the criteria specified in section 96E(1)
3: An authorisation granted by an Order in Council under this section may be granted unconditionally or subject to any conditions specified in the order.
4: An order under this section is secondary legislation ( see Part 3 The following table is small in size and has 3 columns that are grouped under the heading Legislation Act 2019 requirements for secondary legislation made under this section. Legislation Act 2019 requirements for secondary legislation made under this section Publication PCO must publish it on the legislation website and notify it in the Gazette LA19 s 69(1)﻿(c) Presentation The Minister must present it to the House of Representatives LA19 s 114 cl 32(1)﻿(a) Disallowance It may be disallowed by the House of Representatives LA19 ss 115 116 This note is not part of the Act. Section 96D inserted 28 May 2002 Medicines (Restricted Biotechnical Procedures) Amendment Act 2002 Section 96D(4) inserted 28 October 2021 section 3 Secondary Legislation Act 2021
96E: Criteria for authorisations
1: The Minister may grant or recommend an authorisation sought by an application under section 96G
a: the conduct of the procedure or class of procedure does not pose an unacceptable risk to the health or safety of the public:
b: any risks posed by the conduct of the procedure or class of procedure will be appropriately managed:
c: any ethical issues have been adequately addressed:
d: any cultural issues have been adequately addressed:
e: any spiritual issues have been adequately addressed.
2: A reference in any of paragraphs (c) to (e) of subsection (1) to issues is a reference to issues raised—
a: by the conduct of the procedure or class of procedure to which the application relates; and
b: by any technology involved in that conduct.
3: If the Minister is not satisfied that the conduct of the procedure or class of procedure to which the application relates meets any 1 or more of the criteria specified in subsection (1), the Minister—
a: may direct that advice on the question whether or not the conduct of the procedure or class of procedure meets that criterion (or, as the case may be, those criteria) be obtained from persons who, in the Minister's opinion, are appropriately qualified, or have the appropriate expertise, to advise on the question; and
b: after obtaining that advice, may resume his or her consideration of the application on the basis of that advice. Section 96E inserted 28 May 2002 Medicines (Restricted Biotechnical Procedures) Amendment Act 2002
96F: Advice on applicability of criteria
1: For the purpose of obtaining advice of the kind referred to in section 96E(3)﻿(a)
a: establish a committee to advise on the criteria in question:
b: request a body or a committee or an association of persons formed or recognised by or under an enactment to advise on the criteria in question:
c: request the person who made the application under section 96G applicant
2: A committee or body or an association of persons that is to provide advice for the purposes of section 96E(3)﻿(a)
a: given interested parties and members of the public a reasonable opportunity to make submissions in writing or orally, or both; and
b: taken any such submissions into account.
3: Parts 2 3
4: The Minister may agree with an applicant whose application relates to the work of a committee, body, or association established or requested under subsection (1)﻿(a) or (b) that the applicant will pay, or contribute towards the payment of, any costs incurred or to be incurred by the committee or body or association in the examination of aspects of the applicant's application that, in the Minister's opinion, could have significant commercial benefits (whether or not that examination also benefits the public).
5: The Minister may agree with an applicant whose application relates to the work of a committee of persons nominated by the Minister under subsection (1)﻿(c) that the Minister will pay, or contribute towards the payment of, any costs incurred or to be incurred by the committee in the examination of aspects of the applicant's application that, in the Minister's opinion, are likely to benefit the public (whether or not that examination also has commercial benefits).
6: If the Minister is, under subsection (4), attempting to reach an agreement with the applicant, the Minister may direct the committee, body, or association concerned not to consider any matters relating to the applicant's application until agreement under subsection (4) has been reached; and the committee or body or association must give effect to that direction. Section 96F inserted 28 May 2002 Medicines (Restricted Biotechnical Procedures) Amendment Act 2002 Section 96F(3) replaced 1 July 2022 section 104 Pae Ora (Healthy Futures) Act 2022
96G: Applications
1: A person may, by application to the Minister, request the Minister to grant an authorisation under section 96C section 96D(1)
2: An application under subsection (1) must be in a form approved by the Director-General and must be accompanied by the prescribed fee.
3: If the Minister has, under section 96F(1)﻿(c) Section 96G inserted 28 May 2002 Medicines (Restricted Biotechnical Procedures) Amendment Act 2002
96H: No compensation
No compensation is payable by the Crown to any person for any loss or damage arising from the restrictions imposed by section 96B Section 96H inserted 28 May 2002 Medicines (Restricted Biotechnical Procedures) Amendment Act 2002
96I: Enforcement powers
1: Sections 63(1) 66 68 74(1) 85 section 96B
a: medical device
b: there were inserted in section 63(2)﻿(a) manufactured used,
c: there were inserted in section 63(2)﻿(b) manufacture use,
d: there were inserted in section 66(1)﻿(a) sale or for use in a specified biotechnical procedure (within the meaning of Part 7A
e: there were inserted in section 66(1) dealing with the importation use,
2: To avoid any doubt, subsection (1) does not limit the application of any of sections 75 76 79 84 section 96B Section 96I inserted 28 May 2002 Medicines (Restricted Biotechnical Procedures) Amendment Act 2002
96J: Expiry of Part
1: This Part expires on the close of 30 September 2025
2: The Governor-General may, by Order in Council, before the date specified in subsection (1), on the recommendation of the Minister, specify a later date in substitution for that date
3: An order under this section is secondary legislation ( see Part 3 2025-10-01 Part 7A of this Act The following table is small in size and has 3 columns that are grouped under the heading Legislation Act 2019 requirements for secondary legislation made under this section. Legislation Act 2019 requirements for secondary legislation made under this section Publication PCO must publish it on the legislation website and notify it in the Gazette LA19 s 69(1)﻿(c) Presentation The Minister must present it to the House of Representatives LA19 s 114 cl 32(1)﻿(a) Disallowance It may be disallowed by the House of Representatives LA19 ss 115 116 This note is not part of the Act. Section 96J inserted 28 May 2002 Medicines (Restricted Biotechnical Procedures) Amendment Act 2002 Section 96J(1) amended 29 September 2020 clause 3 Medicines (Deferral of Expiry of Part 7A) Order 2020 Section 96J(2) amended 24 May 2005 section 3(2) Medicines (Specified Biotechnical Procedures) Amendment Act 2005 Section 96J(3) replaced 28 October 2021 section 3 Secondary Legislation Act 2021
8: Miscellaneous provisions
97: Duty of officer to procure samples for analysis on request
1: Where any person, other than the manufacturer of the medicine or any agent or employee of the manufacturer, requests any officer in writing to procure a sample of any medicine and submit it for analysis for any purpose specified by that person, the officer, on payment by that person of the prescribed fee together with the cost of the sample, shall procure or arrange for another officer to procure a sample of the medicine and submit it for analysis for the specified purpose, unless he reasonably believes that the request is frivolous or vexatious.
2: Sections 69 70 1969 No 7 s 26
98: Statement by Director-General
1: The Director-General may, for the purpose of protecting the public, publish statements relating to medicines of any description or medical devices of any kind or to any matter contained or implied in advertisements, either generally or in any particular advertisement, or any class or classes of advertisements, relating to medicines of any description or medical devices of any kind.
2: Every statement published under this section shall be protected by qualified privilege. 1960 No 97 s 41 1969 No 7 s 42 1979 No 27 s 77
99: Director-General to publish lists of general sale medicines
1: The Director-General shall from time to time, in such manner as he thinks fit, publish a list or lists of general sale medicines.
2: In this section general sale medicines
100: Power of court to restrict publication of name of medicine
1: Where, in the course of proceedings in any court or before a Coroner, reference is made to any medicine, the court or Coroner may in its or his discretion order that the name of that medicine shall not be published in relation to those proceedings at any time before the expiration of a period of 5 years from the date of the final disposal of those proceedings.
2: Notwithstanding anything in subsection (1), no order made under that subsection shall apply to the publication of that name to scientists or to members of the legal, medical, dental, veterinary, nursing, or pharmaceutical professions, or to persons studying to become scientists or members of those professions, or to designated prescribers,
3: Where the publication of the name of a medicine is prohibited under this section in relation to any proceedings, no person shall, within the said period of 5 years, publish the name of that medicine or any name or particulars likely to lead to the identification of the description or class of medicine as the description or class of medicine to which the medicine referred to in those proceedings belonged.
4: Nothing in this section shall limit the provisions of any other enactment relating to the prohibition or regulation of the publication of reports or particulars relating to any judicial proceedings.
5: Every person commits an offence against this Act who contravenes subsection (3). 1960 No 97 s 43 1964 No 31 s 2 1979 No 27 s 78 Section 100(2) amended 15 October 1999 section 13 Medicines Amendment Act 1999
101: Examination of Customs entries
For the purposes of this Act, every officer shall have the right at all times, subject to the convenience of the Customs Customs 1969 No 7 s 43 1979 No 27 s 79 Section 101 amended 1 October 1996 section 289(1) Customs and Excise Act 1996
102: Protection of persons acting under authority of Act
No person who does any act in pursuance or intended pursuance of any of the functions conferred on him by or under this Act shall be under any civil or criminal liability in respect of the act, whether on the ground of want of jurisdiction, or mistake of law or fact, or on any other ground, unless he has acted in bad faith or without reasonable care. 1969 No 7 s 44 1979 No 27 s 80
103: Service of documents
1: Any document required or authorised under this Act, or under any regulations made under this Act, to be served on or given to any person may be served or given by delivering it to that person, or by leaving it at his usual or last known place of residence or business, or by posting it by registered letter addressed to him at his usual or last known place of residence or business.
2: Every such notice posted in accordance with subsection (1) shall be deemed, in the absence of proof to the contrary, to have been served or given at the time when the registered letter would be delivered in the ordinary course of post.
3: If the person is absent from New Zealand, the document may be served or given, in any manner referred to in subsection (1), on or to his agent in New Zealand.
4: If the person is deceased, the document may be served or given, in any manner referred to in subsection (1), on or to his personal representative.
5: If the person, or his place of residence or business, is not known, or if he is absent from New Zealand and has no known agent in New Zealand, or is deceased and has no personal representative, the document may be served or given in such manner as may be directed by a District Court Judge.
6: Notwithstanding anything in the foregoing provisions of this section, a District Court Judge may in any case make an order directing the manner in which any document is to be served or given or dispensing with the service or giving of any such document. 1979 No 27 s 81
104: Amendment of Schedule 1
1: The Governor-General may from time to time, by Order in Council, add to or omit from Part 1 Part 2
2: An order under this section is secondary legislation ( see Part 3 1969 No 7 s 45 The following table is small in size and has 3 columns that are grouped under the heading Legislation Act 2019 requirements for secondary legislation made under this section. Legislation Act 2019 requirements for secondary legislation made under this section Publication PCO must publish it on the legislation website and notify it in the Gazette LA19 s 69(1)﻿(c) Presentation The Minister must present it to the House of Representatives LA19 s 114 cl 32(1)﻿(a) Disallowance It may be disallowed by the House of Representatives LA19 ss 115 116 This note is not part of the Act. Section 104(2) inserted 28 October 2021 section 3 Secondary Legislation Act 2021
105: Regulations
1: The Governor-General may from time to time, by Order in Council made on the advice of the Minister tendered after consultation with such organisations or bodies as appear to the Minister to be representative of persons likely to be substantially affected by the regulations, make regulations for all or any of the following purposes:
a: prescribing forms, fees, registers, particulars, notifications, and records for the purposes of this Act, the method of keeping such registers and records
aaa: prescribing, in relation to any application or class of application under this Act, any of the following:
i: the manner in which the application must be made; and
ii: the information that must accompany or be contained in the application; and
iii: the manner in which the application must be determined by the decision-maker; and
iv: any matters that the decision-maker must take into account when determining the application:
aa: approving persons or organisations, or classes of persons or organisations, for the purposes of section 23C(1)﻿(c)﻿(iv)
b: prescribing qualifications for and conditions of licences under this Act; and providing for or regulating the custody, production, suspension, or revocation of licences:
c: permitting the manufacture, packing, labelling, administration, sale, or supply of medicines otherwise than pursuant to a licence under this Act and otherwise than in accordance with an authority conferred by this Act, subject to such conditions or restrictions (if any) as may be prescribed by or imposed under the regulations:
d: prohibiting, limiting, restricting, or imposing conditions on, either generally or in relation to particular cases or classes of case, or particular descriptions or classes of medicines, or particular classes of person, the prescribing, manufacture, packing, labelling, administration, sale, or supply of medicines pursuant to any provision of this Act:
e: prohibiting, limiting, restricting, or imposing conditions on the import, export, manufacture, packing, labelling, storage, sale, or supply of medicines of any description or medical devices of any kind:
f: withdrawing medicines and medical devices from sale:
g: regulating the situation, construction, sanitation, and use of premises in which medicines or medical devices are manufactured, packed, labelled, stored, sold, or supplied; prescribing the accommodation (including the amount of space) to be provided for any such purpose; prescribing standards of sanitation, cleanliness, temperature, and humidity, or other factors relating to the risks of deterioration or contamination, to be observed in connection with any such purpose; and prohibiting, or providing for the prohibition of, the use of particular premises or particular classes of premises for any such purpose:
h: regulating the manufacture, packing, labelling, storage, safe-keeping, and destruction of medicines and medical devices:
i: specifying, by name or description, substances or articles, or kinds or classes of substances or articles, that are, or are not, medicines or medical devices for the purposes of this Act:
j: specifying descriptions of medicines that are prescription medicines or restricted medicines or pharmacy-only medicines:
k: prescribing standards of composition, including standards of strength, weight, quality, purity, or quantity for any description or class of medicine or any kind or class of medical device or for anything contained in or added to or intended to be contained in or added to any medicine or medical device; prescribing standards of accuracy of performance for any kind or class of medical device; permitting the addition of a specified thing, or specified class of thing, in a specified quantity or proportion to medicines or medical devices, or to medicines of any specified description or class, or to medical devices of any specified kind or class, for which a standard is prescribed; and prohibiting the sale or supply of any medicine or medical device, not belonging to a description or class of medicine, or kind or class of medical device, for which a standard is prescribed, to which a specified thing or specified class of thing has been added or has been added in a quantity or proportion in excess of or less than a specified quantity or proportion:
l: prescribing and regulating the mode of labelling of packages and containers of medicines or medical devices or substances or articles used or intended for use in the manufacture, or as ingredients or parts, of any medicine or medical device; prescribing the matter to be contained or not to be contained in any such label and the nature and appearance of any package or container enclosing a particular description or class of medicine or particular kind or class of medical device; and permitting the sale or supply of medicines or medical devices otherwise than in packages and containers labelled in accordance, and otherwise conforming with, any such regulations:
m: prescribing methods to be used in the colouring of medicines of any description or class; requiring that any specified description or class of medicines shall be artificially coloured by the addition thereto of such colouring substance or substances as may be prescribed, in such proportion or proportions as may be prescribed; and prohibiting the sale or supply of any such medicine not so coloured:
n: prohibiting the use of any package or container of a kind specified or described in the regulations for any purpose other than the storage of medicines for internal use:
o: providing for the ascertainment, assessment, notification, and correction of damage to or leakage from packages or containers of medicines or medical devices, and the notification of any suspected contamination of medicines or medical devices sustained, in the course of storage or transportation by any means:
p: requiring persons who are engaged in the manufacture, import, packing, labelling, sale, or supply of any medicines, or who utilise any medicine in the course of or in connection with their profession, trade, or calling, or any occupation whether paid or unpaid, or who otherwise undertake the supply or administration of any medicine, to furnish information with respect to such matters and in such form as may be prescribed:
q: regulating the issue by authorised prescribers, veterinarians, and delegated prescribers of prescriptions for the supply of any medicine, including the transmission and storage of prescriptions
qa: authorising any class of registered health professional to prescribe specified prescription medicines, or a specified class or description of prescription medicines, in accordance with any conditions, limitations, requirements, or restrictions specified in or imposed under the regulations:
qaa: granting and regulating delegated prescribing rights:
qb: regulating the issue of standing orders, imposing conditions, limitations, requirements, or restrictions in relation to the contents of standing orders and their use, and providing for such other matters as are necessary or desirable for the administration of standing orders:
r: requiring any medical practitioner who attends a person whom he considers, or has reasonable grounds to suspect, is dependent (within the meaning of the regulations) on medicines of any description or class to furnish such particulars with respect to that person as may be prescribed:
s: prohibiting, regulating, or restricting the sale or supply of medicines to any person so dependent, and the issue of prescriptions for such sale or supply:
t: regulating the dispensing and compounding of medicines:
u: regulating the procedure of any committee established under this Act:
v: regulating and controlling the exercise of powers by officers:
w: applying any provision of this Act, subject to any exceptions and modifications that may be prescribed, that refers to things done in the course of a business carried on by a person, to things done by him or by his agent or employee in the course of any other activity specified or described in the regulations:
x: providing for the waiver of fees in whole or in part in particular cases or classes of cases and for the total or partial refund of fees:
y: prescribing offences in respect of the contravention of or non-compliance with any regulations made under this Act, and the amounts of fines that may be imposed in respect of any such offences, which fines shall be an amount not exceeding $500 and, where the offence is a continuing one, a further amount not exceeding $50 for every day or part of a day during which the offence has continued:
z: exempting, or providing for the exemption of, any persons or classes of persons, or excepting any description or class of medicines, or any description or classes of medical devices, from any provision of any regulation made under this Act that imposes conditions or obligations:
za: providing for such other matters as are contemplated by or necessary for giving full effect to the provisions of this Act and for its due administration.
2: Any regulations made under subsection (1) may—
a: apply to medicines or medical devices generally or to particular descriptions or classes of medicines, or particular kinds or classes of medical devices, specified or described in the regulations, and may make different provision for different descriptions or classes of medicines, or different kinds or classes of medical devices, so specified or described:
b: relate to any description or kind of substances or articles specified by their name or trade names, or to any class of substances or articles identified in such manner as may be appropriate:
c: identify
d: specify the circumstances in which any description or kind of substances or articles are or are not to be medicines, prescription medicines, restricted medicines, or medical devices, or any 2 or more of those things for the purposes of this Act:
e: provide for depriving particular persons of any rights, privileges, or exemptions conferred on any class of person to which those persons belong by this Act or any such regulations.
3: Any regulations made under subsection (1) may prescribe a standard by reference to the name or description of a medicine, and the standard applicable thereto, appearing in a monograph contained in a specified publication within the meaning of section 108(1)
4: Any reference included in any regulations pursuant to subsection (3) may be expressed to be to a particular edition of a specified publication or to a specified publication without mentioning a particular edition, and to medicines generally or to any particular description or descriptions or class or classes of medicines, and to monographs generally, or to any particular monograph or monographs or class or classes of monographs, and the following provisions shall apply in relation to any such reference:
a: if the regulations refer to a particular edition of a specified publication, the reference shall be construed as including all amendments, additions, and deletions made to that edition and published before the date on which the regulations are made:
b: if the regulations do not refer to a particular edition of a specified publication, the reference shall be construed as applying to the edition of the specified publication in force when the regulations are made, so long as that edition remains in force, and thereafter to every subsequent edition of that publication for the time being in force, and as extending to all amendments, additions, and deletions made to any such edition and published whether before, on, or after the date on which the regulations are made.
5: All or any of the powers conferred by paragraphs (g), (h), (k), and (l) of subsection (1) may be exercised in respect of any cosmetic or dentifrice (whether or not it is a related product within the meaning of Part 7
5A: For the purposes of subsection (1)﻿(qa),—
a: specified prescription medicines
b: specified class or description of prescription medicines
5B: Before issuing a notice under subsection (5A), the Director-General must consult with those organisations or bodies that appear to the Director-General to be representative of persons likely to be substantially affected by the notice.
6: Notwithstanding anything contained in any regulation made under this section, any person may, at any time within 12 months after the date of the commencement of the regulation, sell any medicine or medical device of which the sale is otherwise lawful, if he proves that at that date the medicine or medical device was part of the existing stock-in-trade in New Zealand of any person carrying on business there, and that since that date no act has been done whereby the medicine or medical device fails to conform to the regulation.
7: For the purposes of subsection (6) any goods purchased before the said date for importation into New Zealand shall be deemed to be part of the purchaser's stock-in-trade in New Zealand.
8: The following are secondary legislation ( see Part 3
a: regulations under this section:
b: a notice under subsection (5A). 1960 No 97 ss 4, 53 1969 No 7 s 46 1969 No 44 s 13 1979 No 27 s 82 The following table is small in size and has 3 columns that are grouped under the heading Legislation Act 2019 requirements for secondary legislation referred to in subsection (8)﻿(a). Legislation Act 2019 requirements for secondary legislation referred to in subsection (8)﻿(a) Publication PCO must publish it on the legislation website and notify it in the Gazette LA19 s 69(1)﻿(c) Presentation The Minister must present it to the House of Representatives LA19 s 114 cl 32(1)﻿(a) Disallowance It may be disallowed by the House of Representatives LA19 ss 115 116 This note is not part of the Act. The following table is small in size and has 3 columns that are grouped under the heading Legislation Act 2019 requirements for secondary legislation referred to in subsection (8)﻿(b). Legislation Act 2019 requirements for secondary legislation referred to in subsection (8)﻿(b) Publication The maker must publish it in the Gazette LA19 ss 73 74(1)﻿(a) cl 14 Presentation It is not required to be presented to the House of Representatives because a transitional exemption applies under Schedule 1 LA19 s 114 cl 32(1)﻿(a) Disallowance It may be disallowed by the House of Representatives LA19 ss 115 116 This note is not part of the Act. Section 105(1)﻿(a) amended 1 July 2014 section 35(1) Medicines Amendment Act 2013 Section 105(1)﻿(aaa) inserted 1 July 2014 section 35(2) Medicines Amendment Act 2013 Section 105(1)﻿(aa) inserted 1 January 1995 Medicines Amendment Act 1994 Section 105(1)﻿(i) replaced 1 July 2014 section 35(3) Medicines Amendment Act 2013 Section 105(1)﻿(q) substituted 15 October 1999 section 14 Medicines Amendment Act 1999 Section 105(1)﻿(q) amended 1 July 2014 section 35(4) Medicines Amendment Act 2013 Section 105(1)﻿(qa) replaced 1 July 2014 section 35(5) Medicines Amendment Act 2013 Section 105(1)﻿(qaa) inserted 1 July 2014 section 35(5) Medicines Amendment Act 2013 Section 105(1)﻿(qb) inserted 15 October 1999 section 14 Medicines Amendment Act 1999 Section 105(2)﻿(c) amended 22 October 2003 section 5 Medicines Amendment Act (No 3) 2003 Section 105(5A) inserted 1 July 2014 section 35(6) Medicines Amendment Act 2013 Section 105(5A)﻿(a) amended 28 October 2021 section 3 Secondary Legislation Act 2021 Section 105(5A)﻿(b) amended 28 October 2021 section 3 Secondary Legislation Act 2021 Section 105(5B) inserted 1 July 2014 section 35(6) Medicines Amendment Act 2013 Section 105(8) inserted 28 October 2021 section 3 Secondary Legislation Act 2021
105A: Regulations relating to veterinarians and authorised prescribers who are not designated prescribers
1: Without limiting the generality of section 105(1)﻿(d)
a: requiring any veterinarian, or authorised prescriber who is not a designated prescriber
i: to obtain any specified qualification or any qualification specified from time to time by notice in the Gazette
ii: to undertake specified training or any training specified from time to time by notice in the Gazette
iii: to demonstrate, to the satisfaction of the relevant professional organisation, that the person is sufficiently knowledgeable to safely prescribe prescription medicines or prescription medicines of a specified class or description:
b: requiring any veterinarian, or authorised prescriber who is not a designated prescriber Gazette
c: requiring any veterinarian, or authorised prescriber who is not a designated prescriber medicines
d: requiring any veterinarian, or authorised prescriber who is not a designated prescriber
e: prohibiting any veterinarian, or authorised prescriber who is not a designated prescriber
2: In this section, relevant professional organisation
a: in the case of a veterinarian or any class of veterinarian, the Veterinary Council of New Zealand:
b: in any other case, the responsible authority for the health profession to which the person belongs. Section 105A inserted 15 October 1999 section 15 Medicines Amendment Act 1999 Section 105A heading replaced 1 July 2014 section 36(1) Medicines Amendment Act 2013 Section 105A(1)﻿(a) amended 1 July 2014 section 36(2) Medicines Amendment Act 2013 Section 105A(1)﻿(b) amended 1 July 2014 section 36(2) Medicines Amendment Act 2013 Section 105A(1)﻿(c) amended 1 July 2014 section 36(2) Medicines Amendment Act 2013 Section 105A(1)﻿(c) amended 17 May 2005 section 3 Medicines Amendment Act 2005 Section 105A(1)﻿(d) amended 1 July 2014 section 36(2) Medicines Amendment Act 2013 Section 105A(1)﻿(e) amended 1 July 2014 section 36(2) Medicines Amendment Act 2013 Section 105A(2)﻿(a) replaced 1 July 2014 section 36(3) Medicines Amendment Act 2013 Section 105A(2)﻿(b) replaced 1 July 2014 section 36(3) Medicines Amendment Act 2013
105B: Regulations relating to designated prescribers
1: Without limiting the generality of section 105(1)﻿(d) or (qa)
a: requiring any person who belongs to any class of registered health professional authorised to prescribe prescription medicines of any specified class or description by regulations made under section 105(1)﻿(qa)
i: to obtain any specified qualification or any qualification specified from time to time by notice in the Gazette
ii: to undertake specified training or any training specified from time to time by notice in the Gazette
iii: to demonstrate, to the satisfaction of the relevant professional organisation, that the person is sufficiently knowledgeable to safely prescribe prescription medicines or prescription medicines of a specified class or description:
b: requiring any designated prescriber or any class of designated prescriber to undergo specified training or to undergo training specified from time to time by notice in the Gazette
c: requiring any designated prescriber or any class of designated prescriber to undergo an assessment of competence to prescribe prescription medicines
d: requiring any designated prescriber or any class of designated prescriber who prescribes prescription medicines of any specified class or description to undertake those duties under the supervision of—
i: a practitioner, or any specified class of practitioner; or
ii: a nurse practitioner:
e: prohibiting any person who fails to comply with any requirement imposed by or under regulations referred to in paragraphs (a) to (d) from prescribing prescription medicines or prescription medicines of any specified class or description.
2: In this section, relevant professional organisation authority under the Health Practitioners Competence Assurance Act 2003 Section 105B inserted 15 October 1999 section 15 Medicines Amendment Act 1999 Section 105B(1)﻿(c) amended 17 May 2005 section 4 Medicines Amendment Act 2005 Section 105B(1)﻿(d) replaced 31 January 2018 section 5 Medicines Amendment Act 2016 Section 105B(2) amended 18 September 2004 section 20 Medicines Amendment Act 2003
105C: Orders in Council providing for exemption from, or modifications of, restrictions on pharmacy ownership and operation
1: The Governor-General may, by Order in Council made on the recommendation of the Minister,—
a: exempt any person or class of person from any of the requirements of section 55D(2)﻿(a) section 55E(1)﻿(a)
b: modify the application of the provisions of section 55D(2)﻿(a) section 55E(1)﻿(a)
2: The Minister must not recommend the making of any Order in Council under subsection (1) unless in the opinion of the Minister—
a: health services or access to those services will be improved by the making of that Order in Council; and
b: the making of that Order in Council is necessary to meet the needs of the community in the particular location of the pharmacy or proposed pharmacy.
3: An order under this section is secondary legislation ( see Part 3
4: An order under this section that is not secondary legislation must be published on an Internet site maintained by or on behalf of the department.
5: The Minister’s reasons for recommending the making of the order must be published with the order. The following table is small in size and has 3 columns that are grouped under the heading Legislation Act 2019 requirements for secondary legislation made under this section. Legislation Act 2019 requirements for secondary legislation made under this section Publication PCO must publish it on the legislation website and notify it in the Gazette LA19 s 69(1)﻿(c) Presentation The Minister must present it to the House of Representatives LA19 s 114 cl 32(1)﻿(a) Disallowance It may be disallowed by the House of Representatives LA19 ss 115 116 This note is not part of the Act. Section 105C inserted 18 September 2004 section 21 Medicines Amendment Act 2003 Section 105C(3) replaced 28 October 2021 section 3 Secondary Legislation Act 2021 Section 105C(4) inserted 28 October 2021 section 3 Secondary Legislation Act 2021 Section 105C(5) inserted 28 October 2021 section 3 Secondary Legislation Act 2021
105D: Regulations relating to delegated prescribers
Without limiting the generality of section 105(1)﻿(d) or (qaa) section 105(1)﻿(qaa)
a: granting delegated prescribing rights to any class of registered health professional:
b: regulating the issue of delegated prescribing orders by authorised prescribers:
c: specifying the responsibilities of authorised prescribers who issue delegated prescribing orders:
d: imposing conditions, limitations, requirements, or restrictions in relation to the contents of delegated prescribing orders and their use:
e: requiring any person who belongs to any class of registered health professional with delegated prescribing rights, or a specified class of those persons, before commencing to prescribe prescription medicines or prescription medicines of a specified class or description under a delegated prescribing order, to satisfy 1 or more of the following requirements:
i: to obtain any specified qualification or any qualification specified from time to time by notice in the Gazette
ii: to undertake specified training or any training specified from time to time by notice in the Gazette
iii: to demonstrate, to the satisfaction of the responsible authority, that the person is sufficiently knowledgeable to safely prescribe prescription medicines or prescription medicines of a specified class or description:
f: requiring any delegated prescriber or any class of delegated prescriber to undergo specified training or to undergo training specified from time to time by notice in the Gazette
g: requiring any delegated prescriber or any class of delegated prescriber to undergo an assessment of competence to prescribe prescription medicines of a specified class or description (including an assessment at regular intervals):
h: prohibiting any person who fails to comply with any requirement imposed by or under regulations referred to in paragraphs (e) to (g) from prescribing prescription medicines or prescription medicines of any specified class or description. Section 105D inserted 1 July 2014 section 37 Medicines Amendment Act 2013
105E: Power of Director-General to specify prescription medicines for delegated prescribers
1: The Director-General may, by notice
2: Before issuing a notice under subsection (1), the Director-General must consult with those organisations or bodies that appear to the Director-General to be representative of persons likely to be substantially affected by the notice.
3: A notice under this section is secondary legislation ( see Part 3 The following table is small in size and has 3 columns that are grouped under the heading Legislation Act 2019 requirements for secondary legislation made under this section. Legislation Act 2019 requirements for secondary legislation made under this section Publication The maker must publish it in the Gazette LA19 ss 73 74(1)﻿(a) cl 14 Presentation It is not required to be presented to the House of Representatives because a transitional exemption applies under Schedule 1 LA19 s 114 cl 32(1)﻿(a) Disallowance It may be disallowed by the House of Representatives LA19 ss 115 116 This note is not part of the Act. Section 105E inserted 1 July 2014 section 37 Medicines Amendment Act 2013 Section 105E(1) amended 28 October 2021 section 3 Secondary Legislation Act 2021 Section 105E(3) inserted 28 October 2021 section 3 Secondary Legislation Act 2021
105F: Incorporation by reference
1: Regulations made under section 105
a: a standard, framework, code of practice, recommended practice, or requirement of an international or national organisation:
b: a standard, framework, code of practice, recommended practice, or requirement prescribed in any country or jurisdiction, or by any group of countries:
c: any other written material that deals with technical matters and that can reasonably be regarded as being too large or impractical to include in, or publish as part of, the regulations.
2: The provisions of Schedule 3 Section 105F inserted 1 July 2014 section 37 Medicines Amendment Act 2013
106: Minister may classify medicines by notice in the
Gazette
1: The Minister may, by notice
2: To the extent that any such notice is inconsistent with any provisions of any regulations made under section 105(1)﻿(j)
3: Every notice given under this section shall, unless sooner revoked by the Minister, remain in force for a period of 6 months commencing with the date on which it comes into force, and shall then cease to have effect.
4: A notice under this section is secondary legislation ( see Part 3 The following table is small in size and has 3 columns that are grouped under the heading Legislation Act 2019 requirements for secondary legislation made under this section. Legislation Act 2019 requirements for secondary legislation made under this section Publication The maker must publish it in the Gazette LA19 ss 73 74(1)﻿(a) cl 14 Presentation It is not required to be presented to the House of Representatives because a transitional exemption applies under Schedule 1 LA19 s 114 cl 32(1)﻿(a) Disallowance It may be disallowed by the House of Representatives LA19 ss 115 116 This note is not part of the Act. Section 106(1) amended 28 October 2021 section 3 Secondary Legislation Act 2021 Section 106(4) inserted 28 October 2021 section 3 Secondary Legislation Act 2021
107: Power to obtain information for purposes of regulations
1: In this section the term manufacturer
2: For the purpose of enabling the making of regulations under this Act, or the giving of any notice under section 106
3: The disclosure of any information pursuant to subsection (2) shall not prejudice any application subsequently made for a patent.
4: Every person commits an offence against this Act and is liable on conviction 1969 No 7 ss 39(5), 47 Section 107(4) amended 1 July 2013 section 413 Criminal Procedure Act 2011
108: Specified publications
1: In this section, and for the purposes of any regulations made under this Act, specified publication
a: the European Pharmacopoeia:
b: the British Pharmacopoeia:
c: the British Pharmaceutical Codex:
d: the United States Pharmacopoeia:
e: the United States National Formulary:
f: the Therapeutic Goods Standards of Australia.
2: Where any licence or consent or approval under this Act refers to a specified publication, but not to a particular edition of that publication, then, for the purpose of determining whether anything done, at a time when the licence, consent, or approval is in force, is done in accordance with the licence, consent, or approval, the reference shall, unless the licence, consent, or approval otherwise expressly provides, be construed as a reference to the current edition of that publication as in force at that time.
3: In this section any reference to the current edition of a specified publication as in force at a particular time is a reference to the edition of that publication in force at that time together with any amendments, additions, and deletions made to it up to that time. Medicines Act 1968 s 103(1), (2), (5) (UK)
109: Relationship with Misuse of Drugs Act 1975
1: Subject to subsection (3), in the case of a medicine that is a controlled drug within the meaning of the Misuse of Drugs Act 1975
2: Nothing in section 8
3: So long as a person is authorised by a licence under the Misuse of Drugs Act 1975 section 43
3A: A drug and substance checking service provider under the Misuse of Drugs Act 1975
3B: Subsection (3A)
4: Except as provided in subsections (1) and (2), this Act shall be read subject to the Misuse of Drugs Act 1975 Section 109(3A) inserted 7 December 2021 section 19 Drug and Substance Checking Legislation Act 2021 Section 109(3B) inserted 7 December 2021 section 19 Drug and Substance Checking Legislation Act 2021
110: Relationship with Hazardous Substances and New Organisms Act 1996
1: Subject to subsection (2), nothing in this Act shall affect or derogate from the Hazardous Substances and New Organisms Act 1996
2: In the event of any inconsistency between the provisions of the Hazardous Substances and New Organisms Act 1996 regulations made or EPA notices issued under that Act Section 110 substituted 2 July 2001 section 149 Hazardous Substances and New Organisms Act 1996 Section 110(2) amended 1 December 2017 section 55 Hazardous Substances and New Organisms Amendment Act 2015
111: Amendment of and effect on Animal Remedies Act 1967
Section 111 repealed 2 July 2001 section 86(1) Agricultural Compounds and Veterinary Medicines Act 1997
112: Amendment of Consumer Information Act 1969
Section 112 repealed 1 May 1987 section 49(2) Fair Trading Act 1986
113: Amendment of Ombudsmen Act 1975
Amendment(s) incorporated in the Act(s)
114: Transitional
1: Without limiting section 20 of the Acts Interpretation Act 1924
a: every person who, immediately before the commencement of Part 2 Restricted Drugs Act 1960
b: every person who, immediately before the commencement of Part 2 Restricted Drugs Act 1960
2: Subject to section 34
3: Notwithstanding the repeal by section 115 sections 12, 13, and 14 of the Food and Drug Act 1969
a: in respect of any application for the consent of the Minister under the said section 12 Part 2
b: in respect of any notice that was deposited with the Director-General under the said section 14 Part 2
114A: Certain persons deemed to have licence to operate pharmacy
Section 114A expired 18 September 2005 section 114B
114B: Expiry of section 114A
Section 114A Section 114B inserted 18 September 2004 section 22 Medicines Amendment Act 2003
115: Repeals
The enactments specified in Schedule 2