2 Interpretation

(1)

In this Act, unless the context otherwise requires,—

administer means administer to a human being, either—

(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 has the meaning assigned to that term by section 56

advertising material means material used or intended to be used as an advertisement

analyst means—

(a)

any person who is designated by the Minister by notice in the Gazette as the analyst in charge of an approved laboratory; or

(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 includes a bird, a fish, and a reptile; but does not include a human being

animal food means any substance or article that—

(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 or remedy means any drug, remedy, or therapeutic preparation, or any biochemical substance, which is manufactured, imported, or advertised for sale or is sold for any of the following purposes:

(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 means a committee appointed under section 8(1)

approved laboratory means a laboratory approved by the Minister by notice in the Gazette for the purposes of this Act

authorised prescriber means—

(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 means an article of transport equipment, being a lift van, movable tank, or other similar structure,—

(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 includes—

(a)

a professional practice; and

(b)

any activity carried on for reward by any person

carrier includes every person engaged in carrying goods for hire or reward by any mode of transport, whether by land, water, or air

container, in relation to a medicine or medical device, means the bottle, jar, box, packet, or other receptacle that contains or is to contain it, not being a capsule, cachet, or other article in which the medicine or device is or is to be administered; and where any such receptacle is or is to be contained in another such receptacle, includes the former but does not include the latter receptacle

controlled drug has the same meaning as in section 2(1) of the Misuse of Drugs Act 1975

cosmetic means any substance or mixture of substances used or represented for use for the purpose of beautifying, improving, protecting, altering, or cleansing the hair, skin, or complexion of human beings; and includes—

(a)

any perfume:

(b)

any deodorant:

(c)

any insect repellant:

(d)

any dusting powder

Customs or the Customs has the meaning given to Customs in section 5(1) of the Customs and Excise Act 2018

decision includes requirement

delegated prescriber means a health practitioner to whom a delegated prescribing order has been issued

delegated prescribing order means a written instruction, issued in accordance with regulations by an authorised prescriber, authorising a health practitioner to prescribe prescription medicines

delegated prescribing rights means prescribing rights granted by regulations made under section 105(1)(qaa)

dentifrice means any substance or mixture of substances used or represented for use for the purpose of cleansing the mouths or teeth (natural or artificial) of human beings; and includes any denture fixative

dentist means a health practitioner who is, or is deemed to be, registered with the Dental Council of New Zealand established by the Health Practitioners Competence Assurance Act 2003 as a practitioner of the profession of dentistry

designated prescriber means a person, other than a practitioner, nurse practitioner, optometrist, or a registered midwife, who—

(a)

belongs to a class of registered health professionals authorised by regulations made under this Act to prescribe any specified prescription medicines, or any specified class or description of prescription medicines subject to the satisfaction of requirements specified in or imposed under those regulations; and

(b)

satisfies any applicable requirement relating to competency, qualifications, or training specified in or imposed under regulations made under this Act

Director-General means the Director-General of Health; and, except in section 98, includes any other officer of the Ministry of Health exercising, with the authority of the Director-General, any functions conferred on the Director-General by this Act

disease includes any injury, ailment, deformity, disorder, or adverse condition, whether of body or mind

dispensing, in relation to a medicine, includes, without limitation,—

(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 means the Environmental Protection Authority established by section 7 of the Environmental Protection Authority Act 2011

examine includes weigh, count, and measure

health services has the same meaning as it has in section 2 of the Health and Disability Commissioner Act 1994

herbal remedy means a medicine (not being or containing a prescription medicine, or a restricted medicine, or a pharmacy-only medicine) consisting of—

(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 includes a hospital care institution within the meaning of section 58(4) of the Health and Disability Services (Safety) Act 2001

importer means any person by or for whom any goods are imported; and includes the consignee of any goods; and also includes any person who is or becomes—

(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, in relation to a container of a medicine, means any written, pictorial, or other descriptive matter marked on or affixed to the container; and to label, labelled, and labelling have corresponding meanings

labelling material means material used or intended to be used as a label

licence means a licence issued under this Act; and licensed and licensee have corresponding meanings

licensee corporation means a corporation holding a licence under this Act

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 section 41 of the State Sector Act 1988

manufacture, in relation to a medicine, includes any process carried out in the course of making the medicine; but does not include—

(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 has the meaning given to it by section 3A

Medical Officer of Health means the Medical Officer of Health appointed under the Health Act 1956 for a health district; and includes any Deputy Medical Officer of Health; and also includes the Director-General of Health and other officers upon whom the functions of a Medical Officer of Health are conferred by section 22 of that Act

medical practitioner means a health practitioner who is, or is deemed to be, registered with the Medical Council of New Zealand continued by the Health Practitioners Competence Assurance Act 2003 as a practitioner of the profession of medicine

medicine, new medicine, pharmacy-only medicine, prescription medicine, and restricted medicine have the meanings assigned to those terms by section 3

Medicines Review Committee means the committee established under section 10

Minister means the Minister of Health

new organism has the same meaning as in section 2A of the Hazardous Substances and New Organisms Act 1996

nurse practitioner means a health practitioner who—

(a)

is, or is deemed to be, registered with the Nursing Council of New Zealand continued by section 114(1)(a) of the Health Practitioners Competence Assurance Act 2003 as a practitioner of the profession of nursing and whose scope of practice permits the performance of nurse practitioner functions; and

(b)

holds a current practising certificate

Nursing Council means the Nursing Council of New Zealand continued by section 114(1)(a) of the Health Practitioners Competence Assurance Act 2003

officer means—

(a)

any officer of the Ministry of Health:

(b)

any person appointed under section 15 to be an officer

optometrist means a person—

(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 means the Optometrists and Dispensing Opticians Board continued by section 114(1)(a) of the Health Practitioners Competence Assurance Act 2003

pack means to enclose in a container for the purpose of sale or supply

package, in relation to any medicine or medical device, means any box, packet, or other receptacle in which 1 or more containers of the medicine or device are or are to be enclosed; and, where any such box, packet, or other receptacle is or is to be itself enclosed in 1 or more other boxes, packets, or other receptacles, includes every such box, packet, or other receptacle

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

pharmacy means a place where pharmacy practice is carried on

pharmacy practice includes, without limitation, the following:

(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 includes any part of a plant

practitioner means a medical practitioner or a dentist

qualifying new medicine means a new medicine that—

(a)

is or contains a new organism; and

(b)

meets the criteria set out in section 38I(3) of the Hazardous Substances and New Organisms Act 1996

qualifying organism means a new organism that is or is contained in a qualifying new medicine

registered health professional means a health practitioner who is, or is deemed to be, registered with an authority established or continued by the Health Practitioners Competence Assurance Act 2003 as a practitioner of a particular health profession

registered midwife means a health practitioner who is, or is deemed to be, registered with the Midwifery Council established by the Health Practitioners Competence Assurance Act 2003 as a practitioner of the profession of midwifery

regulations means regulations made under this Act

related product and new related product have the meanings assigned to those terms by section 94

responsible authority has the meaning given to it in section 5(1) of the Health Practitioners Competence Assurance Act 2003

responsible person, in relation to a licensee corporation, means an agent or employee of that corporation who is a pharmacist or a person approved by the licensing authority as a responsible person for the purposes of the licence

sell includes—

(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 has a corresponding meaning

selling by wholesale, selling by retail, and selling in circumstances corresponding to retail sale have the meanings assigned to those terms by section 5

standing order means—

(a)

a written instruction issued by a practitioner, registered midwife, nurse practitioner, or optometrist, in accordance with any applicable regulations, authorising any specified class of persons engaged in the delivery of health services to supply and administer any specified class or description of prescription medicines or controlled drugs to any specified class of persons, in circumstances specified in the instruction, without a prescription:

(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 to any specified class of animals, in circumstances specified in the instruction, without a prescription:

(c)

a written instruction issued by a practitioner, registered midwife, nurse practitioner, or optometrist, in accordance with any applicable regulations, authorising any specified class of persons engaged in the delivery of health services to supply and administer any specified class or description of pharmacy-only medicines or restricted medicines to any specified class of persons, in circumstances specified in the instruction:

(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 means any natural or artificial substance, whether in solid or liquid form or in the form of a gas or vapour

therapeutic purpose has the meaning assigned to that term by section 4

vehicle includes an aircraft, a hovercraft, and a ship

veterinarian means a person who is registered as a veterinarian or specialist within the meaning of section 4 of the Veterinarians Act 2005.

(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 given by the Minister in the Gazette for the purposes of subsection (1) is—

(a)

a legislative instrument and a disallowable instrument for the purposes of the Legislation Act 2012 and must be presented to the House of Representatives under section 41 of that Act; and

(b)

a regulation for the purposes of the Interpretation Act 1999.

Compare: 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)

Section 2(1) analyst: substituted, on 1 July 1992, by section 2(1) of the Medicines Amendment Act 1992 (1992 No 50).

Section 2(1) animal: amended, on 28 May 2002, by section 5 of the Medicines (Restricted Biotechnical Procedures) Amendment Act 2002 (2002 No 14).

Section 2(1) animal remedy: substituted, on 2 July 2001, by section 85 of the Agricultural Compounds and Veterinary Medicines Act 1997 (1997 No 87).

Section 2(1) approved laboratory: inserted, on 1 July 1992, by section 2(2) of the Medicines Amendment Act 1992 (1992 No 50).

Section 2(1) authorised prescriber: replaced, on 1 July 2014, by section 4(1) of the Medicines Amendment Act 2013 (2013 No 141).

Section 2(1) controlled drug: inserted, on 22 October 2003, by section 3(1) of the Medicines Amendment Act (No 3) 2003 (2003 No 84).

Section 2(1) Customs or the Customs: inserted, on 1 October 1996, by section 289(1) of the Customs and Excise Act 1996 (1996 No 27).

Section 2(1) Customs or the Customs: amended, on 1 October 2018, by section 443(3) of the Customs and Excise Act 2018 (2018 No 4).

Section 2(1) delegated prescriber: inserted, on 1 July 2014, by section 4(6) of the Medicines Amendment Act 2013 (2013 No 141).

Section 2(1) delegated prescribing order: inserted, on 1 July 2014, by section 4(6) of the Medicines Amendment Act 2013 (2013 No 141).

Section 2(1) delegated prescribing rights: inserted, on 1 July 2014, by section 4(6) of the Medicines Amendment Act 2013 (2013 No 141).

Section 2(1) dentist: substituted, on 18 September 2004, by section 3(3) of the Medicines Amendment Act 2003 (2003 No 50).

Section 2(1) designated prescriber: inserted, on 15 October 1999, by section 2(3) of the Medicines Amendment Act 1999 (1999 No 117).

Section 2(1) designated prescriber: amended, on 1 July 2014, by section 4(2)(a) of the Medicines Amendment Act 2013 (2013 No 141).

Section 2(1) designated prescriber paragraph (a): amended, on 1 July 2014, by section 4(2)(b) of the Medicines Amendment Act 2013 (2013 No 141).

Section 2(1) Director-General: substituted, on 1 July 1993, by section 32 of the Health Sector (Transfers) Act 1993 (1993 No 23).

Section 2(1) dispensing: inserted, on 18 September 2004, by section 3(2) of the Medicines Amendment Act 2003 (2003 No 50).

Section 2(1) EPA: inserted, on 1 July 2011, by section 53(1) of the Environmental Protection Authority Act 2011 (2011 No 14).

Section 2(1) ERMA: repealed, on 1 July 2011, by section 53(1) of the Environmental Protection Authority Act 2011 (2011 No 14).

Section 2(1) health services: inserted, on 15 October 1999, by section 2(3) of the Medicines Amendment Act 1999 (1999 No 117).

Section 2(1) hospital: substituted, on 1 October 2002, by section 58(1) of the Health and Disability Services (Safety) Act 2001 (2001 No 93).

Section 2(1) importer: amended, on 1 October 2018, by section 443(3) of the Customs and Excise Act 2018 (2018 No 4).

Section 2(1) licensing authority: substituted, on 18 September 2004, by section 3(3) of the Medicines Amendment Act 2003 (2003 No 50).

Section 2(1) medical device: replaced, on 1 July 2014, by section 4(3) of the Medicines Amendment Act 2013 (2013 No 141).

Section 2(1) Medical Officer of Health: amended, on 1 July 1993, by section 32 of the Health Sector (Transfers) Act 1993 (1993 No 23).

Section 2(1) medical practitioner: substituted, on 18 September 2004, by section 3(3) of the Medicines Amendment Act 2003 (2003 No 50).

Section 2(1) new organism: inserted, on 30 October 2003, by section 3 of the Medicines Amendment Act (No 2) 2003 (2003 No 56).

Section 2(1) nurse practitioner: replaced, on 31 January 2018, by section 4 of the Medicines Amendment Act 2016 (2016 No 78).

Section 2(1) Nursing Council: inserted, on 1 July 2014, by section 4(6) of the Medicines Amendment Act 2013 (2013 No 141).

Section 2(1) officer: substituted, on 1 July 1993, by section 32 of the Health Sector (Transfers) Act 1993 (1993 No 23).

Section 2(1) optician: repealed, on 18 September 2004, by section 3(3) of the Medicines Amendment Act 2003 (2003 No 50).

Section 2(1) optometrist: inserted, on 1 July 2014, by section 4(6) of the Medicines Amendment Act 2013 (2013 No 141).

Section 2(1) Optometrists and Dispensing Opticians Board: inserted, on 1 July 2014, by section 4(6) of the Medicines Amendment Act 2013 (2013 No 141).

Section 2(1) pharmacist: substituted, on 18 September 2004, by section 3(3) of the Medicines Amendment Act 2003 (2003 No 50).

Section 2(1) pharmacy: substituted, on 18 September 2004, by section 3(3) of the Medicines Amendment Act 2003 (2003 No 50).

Section 2(1) pharmacy practice: inserted, on 18 September 2004, by section 3(4) of the Medicines Amendment Act 2003 (2003 No 50).

Section 2(1) qualifying new medicine: inserted, on 30 October 2003, by section 3 of the Medicines Amendment Act (No 2) 2003 (2003 No 56).

Section 2(1) qualifying organism: inserted, on 30 October 2003, by section 3 of the Medicines Amendment Act (No 2) 2003 (2003 No 56).

Section 2(1) registered health professional: substituted, on 18 September 2004, by section 3(3) of the Medicines Amendment Act 2003 (2003 No 50).

Section 2(1) registered midwife: substituted, on 18 September 2004, by section 3(3) of the Medicines Amendment Act 2003 (2003 No 50).

Section 2(1) regulations: inserted, on 1 July 2014, by section 4(6) of the Medicines Amendment Act 2013 (2013 No 141).

Section 2(1) responsible authority: inserted, on 1 July 2014, by section 4(6) of the Medicines Amendment Act 2013 (2013 No 141).

Section 2(1) standing order: inserted, on 15 October 1999, by section 2(3) of the Medicines Amendment Act 1999 (1999 No 117).

Section 2(1) standing order paragraph (a): amended, on 1 July 2014, by section 4(4) of the Medicines Amendment Act 2013 (2013 No 141).

Section 2(1) standing order paragraph (a): amended, on 22 October 2003, by section 3(2) of the Medicines Amendment Act (No 3) 2003 (2003 No 84).

Section 2(1) standing order paragraph (b): amended, on 22 October 2003, by section 3(2) of the Medicines Amendment Act (No 3) 2003 (2003 No 84).

Section 2(1) standing order paragraph (c): added, on 22 October 2003, by section 3(3) of the Medicines Amendment Act (No 3) 2003 (2003 No 84).

Section 2(1) standing order paragraph (c): amended, on 1 July 2014, by section 4(5) of the Medicines Amendment Act 2013 (2013 No 141).

Section 2(1) standing order paragraph (d): added, on 22 October 2003, by section 3(3) of the Medicines Amendment Act (No 3) 2003 (2003 No 84).

Section 2(1) veterinarian: added, on 15 October 1999, by section 2(2) of the Medicines Amendment Act 1999 (1999 No 117).

Section 2(1) veterinarian: amended, on 22 December 2005, by section 105 of the Veterinarians Act 2005 (2005 No 126).

Section 2(1) veterinary surgeon: repealed, on 15 October 1999, by section 2(2) of the Medicines Amendment Act 1999 (1999 No 117).

Section 2(2): added, on 1 July 1992, by section 2(3) of the Medicines Amendment Act 1992 (1992 No 50).

Section 2(3): replaced, on 5 August 2013, by section 77(3) of the Legislation Act 2012 (2012 No 119).