Закон «О лекарственных препаратах» 1981 года (в редакции от 16.10.2008 г.), Новая Зеландия, WIPO Lex

Reprinted as at16 October 2008			s 2
113		Amendment of Ombudsmen Act 1975	147
114		Transitional	147
114A		Certain persons deemed to have licence to operate	148
pharmacy
114B	Expiry of section 114A		149
115	Repeals		149
Schedule 1			149
Schedule 2			151
Enactments repealed

An Act to consolidate and amend the law relating to the manufacture, sale, and supply of medicines, medical devices, and related products

BE IT ENACTED by the General Assembly of New Zealand in Parliament assembled, and by the authority of the same, as follows:

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 theGovernor-GeneralbyOrderinCouncil,anddifferentdates may be so appointed in respect of different provisions of this Act.

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): Byexternalapplication,whetherbydirectcontactwith

the body or not;— and every reference in this Act to administering a substance orarticleisareferencetoadministeringiteitherinitsexisting stateorafterithasbeendissolvedordispersedin,ordilutedor mixed with, some substance in which it is tobe administered Advertisement hasthemeaningassignedtothattermbysec

tion 56 of this Act Advertising material means material used or intended to be used as an advertisement

Analyst means—

(a): AnypersonwhoisdesignatedbytheMinisterbynotice 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:

Analyst: this definition was substituted, as from 1 July 1992, by section 2(1) Medicines Amendment Act 1992 (1992 No 50). See section 3 of that Act for the transitional provisions.

Animal includes a bird, a fish, and a reptile; but does not in

clude a human being

Animal: this definition was amended, as from 28 May 2002, by section 5 Medicines (Restricted Biotechnical Procedures) Amendment Act 2002 (2002 No 14), by inserting the words “; 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
(a): Curing, diagnosing, treating, controlling, or preventing any disease in animals; or
(b): Destroying or preventing parasites on or in animals, or
(c): Maintainingorimprovingthehealth,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 Animalremedy: thisdefinitionwassubstituted,asfrom2July2001,bysection

85 AgriculturalCompoundsandVeterinaryMedicinesAct1997(1997No87). See Part 8 (comprising sections 87 to 122) of that Act as to the transitional provisions. See clause 2 Agricultural Compounds and Veterinary Medicines Act Commencement Order 2001 (SR 2001/100).

Appropriatecommittee meansacommitteeappointedunder

section 8(1) of this Act Approved laboratory means a laboratory approved by the Minister by notice in the Gazette for the purposes of this Act Approvedlaboratory: thisdefinitionwasinserted,asfrom1July1992,bysec

tion 2(2) Medicines Amendment Act 1992 (1992 No 50).

authorised prescriber means a practitioner, registered mid wife, or designated prescriber. authorisedprescriber: thisdefinitionwasinserted,asfrom18September2004,

by section 3(1) Medicines Amendment Act 2003 (2003 No 50).

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 one or more modes of transport, without immediate repacking; and
(c): Fittedwithdevicespermittingitsreadyhandlingandits 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 one cubic metre or

more;— andincludesthenormalaccessoriesandequipmentofthecontainer,whenimportedwiththecontainerandusedexclusively withit;butdoesnotincludeanyvehicle,oranyordinarypacking 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,inrelationtoamedicineormedicaldevice,means

thebottle,jar,box,packet,orotherreceptaclethatcontainsor 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. controlled drug: this definition was inserted, as from 22 October 2003, by sec

tion 3(1) Medicines Amendment Act (No 3) 2003 (2003 No 84).

Cosmetic meansanysubstanceormixtureofsubstancesused 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 it by sec tion 2(1) of the Customs and Excise Act 1996

Customs or the Customs: these definitions were inserted, as from 1 October 1996, by section 289(1) Customs and Excise Act 1996 (1996 No 27).

Decision includes requirement Dentifricemeansanysubstanceormixtureofsubstancesused orrepresentedforuseforthepurposeofcleansingthemouths

or teeth (natural or artificial) of human beings; and includes any denture fixative dentistmeansahealthpractitionerwhois,orisdeemedtobe,

registeredwiththeDentalCouncilofNewZealandestablished by the Health Practitioners Competence Assurance Act 2003 as a practitioner of the profession of dentistry Dentist: this definition was substituted, as from 15 October 1999, by section

2(1) Medicines Amendment Act 1999 (1999 No 117).

dentist: this definition was substituted, as from 18 September 2004, by section 3(3) Medicines Amendment Act 2003 (2003 No 50).

Designated prescriber means a person, other than a practitioner 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 class or description of prescription medicines subject to the satisfaction of requirements specified in or imposed under those regulations; and
(b): Satisfiesanyapplicablerequirementrelatingtocompetency,qualifications,ortrainingspecifiedinorimposed under regulations made under this Act:

Designated prescriber: this definition was inserted, as from 15 October 1999, by section 2(3) Medicines Amendment Act 1999 (1999 No 117).

Director-GeneralmeanstheDirector-GeneralofHealth;and, except in section 98 of this Act, includes any other officer of theMinistryofHealthexercising,withtheauthorityoftheDirector-General, any functions conferred on the Director-General by this Act Director-General: this definition was substituted, as from 1 July 1993, by sec

tion 32 HealthReforms (Transitional Provisions) Act1993 (1993 No 23).

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): thepackaging,labelling,recording,anddeliveryofthat medicine.

dispensing: thisdefinitionwasinserted,asfrom18September2004,bysection 3(2) Medicines Amendment Act 2003 (2003 No 50).

ERMA means the Environmental Risk Management Au thority established under the Hazardous Substances and New Organisms Act 1996 ERMA: this definition was inserted, as from 30 October 2003, by section 3

Medicines Amendment Act (No 2) 2003 (2003 No 56).

Examine includes weigh, count, and measure Healthserviceshasthesamemeaningasithasinsection 2 of the Health and Disability Commissioner Act 1994 Health services: this definition was inserted, as from 15 October 1999, by sec tion 2(3) Medicines Amendment Act 1999 (1999 No 117).

Herbal remedy means a medicine (not being or containing a prescriptionmedicine,orarestrictedmedicine,orapharmacyonly medicine) consisting of—

(a): Anysubstanceproducedbysubjectingaplanttodrying, 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 mean ing of section 58(4) of the Health and Disability Services (Safety) Act 2001 Hospital: paragraph (aa) was inserted, as from 8 March 1985, by section 3(1)

Medicines Amendment Act 1985 (1985 No 29).

Hospital: this definition was substituted, as from 1 July 1993, by section 32 Health Reforms (Transitional Provisions) Act 1993 (1993 No 23).

Hospital: this definition was substituted, as from 1 October 2002, by section 58(1) HealthandDisabilityServices (Safety) Act2001 (2001No93). See sec tion 11 of that Act for transitional provisions.

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 the Cus toms in accordance with the Customs and Excise Act 1996 Importer: this definition was amended, as from 1 October 1996, by section

289(1) Customs and Excise Act 1996 (1996 No 27) by substituting the words “Customs and Excise Act 1996”for the words “Customs Act 1966”.

Label,inrelationtoacontainerofamedicine,meansanywritten,pictorial,orotherdescriptivemattermarkedonoraffixed tothecontainer;andtolabel,labelled,andlabellinghavecorresponding 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

Licensing authority: this definition was amended, as from 1 April 1984, by section98AreaHealthBoardsAct1983(1983No134),byinsertingthewords“or (as the case may require) the area health district”.

Licensing authority: thisdefinition was amended, as from 1 July 1993,by sec tion 32 Health Reforms (Transitional Provisions) Act 1993 (1993 No 23), by omitting the words “or (as the case may require) the area healthdistrict”.

licensingauthority: thisdefinitionwassubstituted,asfrom18September2004, by section 3(3) Medicines Amendment Act 2003 (2003 No 50).

Manufacture, in relation to a medicine, includes any process carriedoutinthecourseofmakingthemedicine;butdoesnot include—

(a): Dissolving or dispersing the medicine in, or diluting or mixingitwith,someothersubstanceusedasamedium for the purpose of administering the medicine to a particular person:
(a): Anyultrasonictherapyapparatuswithinthemeaningof section 2 of the Physiotherapy Amendment Act 1953:
(b): Except in section 38 of this Act, any irradiating appar atuswithinthemeaningofsection 2(1) ofthe Radiation Protection Act 1965:
(c): Any 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 article that is not a medical device for the purposes of this Act:

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 Officer of Health: this definition was amended, as from 1 April 1984, by section 98 Area Health Boards Act 1983 (1983 No 134), by inserting the words“or under the Area Health Boards Act1983 by anarea health board”.

Medical Officer of Health: this definition was amended, as from 1 July 1993, bysection 32 HealthReforms(TransitionalProvisions)Act1993(1993No23) by omitting the words “or under the Area Health Boards Act 1983 by an area health board”.

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 Medical practitioner: this definition was substituted, as from 1 July 1996, by

section143(1)MedicalPractitionersAct1995(1995No95). See clause2Medical Practitioners Act Commencement Order 1996 (SR 1996/162).

medical practitioner: this definition was substituted, as from 18 September 2004, by section 3(3) Medicines Amendment Act 2003 (2003 No 50).

Medicine, new medicine, pharmacy-only medicine, prescription medicine, and restricted medicine have the mean ings assigned to those terms by section 3 of this Act

Medicines Review Committee means the committee estab lished under section 10 of this Act

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 neworganism: thisdefinitionwasinserted,asfrom30October2003,bysection

3 Medicines Amendment Act (No 2) 2003 (2003 No 56).

Officer means—

(a): Any officer of the Ministry of Health:
(b): Anypersonappointedundersection 15 ofthisActtobe

an officer:

Officer: paragraph (a) was amended, as from 1 April 1984, by section 98 Area Health Boards Act 1983 (1983 No 134) by inserting the words “or of any area health board”.

Officer: this definition was substituted, as from 1 July 1993, by section 32 Health Reforms (Transitional Provisions) Act 1993 (1993 No 23).

Optician[Repealed]

Optician: this definition was repealed, as from 18 September 2004, by section 3(3) Medicines Amendment Act 2003 (2003 No 50).

[Repealed]

Pack means to enclose in a container for the purpose of sale

or supply Package,inrelationtoanymedicineormedicaldevice,means anybox,packet,orotherreceptacleinwhichoneormorecontainers of the medicine or device, are or are to be enclosed; and,whereanysuchbox,packet,orotherreceptacleisoristo beitselfenclosedinoneormoreotherboxes,packets,orother 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 pharmacist: thisdefinitionwassubstituted,asfrom18September2004,bysec

tion 3(3) Medicines Amendment Act 2003 (2003 No 50).

pharmacy means a place where pharmacy practice is carried on pharmacy: this definition was substituted, as from 18 September 2004, by sec

tion 3(3) Medicines Amendment Act 2003 (2003 No 50).

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): thesaleofprescriptionmedicines,restrictedmedicines, or pharmacy-only medicines

pharmacypractice: thisdefinitionwasinserted,asfrom18September2004,by section 3(4) Medicines Amendment Act 2003 (2003 No 50).

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

qualifyingnewmedicine: thisdefinitionwasinserted,asfrom30October2003, by section 3 Medicines Amendment Act (No 2) 2003 (2003 No 56).

qualifying organism meansanew organism thatis or is contained in a qualifying new medicine. qualifyingorganism: this definition was inserted, as from 30October 2003, by

section 3 Medicines Amendment Act (No 2) 2003 (2003 No 56).

registered health professional means a health practitioner who is, or is deemed to be, registered with an authority establishedorcontinuedbythe HealthPractitionersCompetence AssuranceAct2003 asapractitionerofaparticularhealthprofession Registeredhealthprofessional: thisdefinitionwasinserted,asfrom15October

1999, by section 2(3) Medicines Amendment Act 1999 (1999 No 117).

registered health professional: this definition was substituted, as from 18 Sep tember 2004, by section3(3) Medicines Amendment Act2003 (2003 No 50).

registered midwife means a health practitioner who is, or is deemed to be, registered with the Midwifery Council establishedbythe HealthPractitionersCompetenceAssuranceAct 2003 as a practitioner of the profession of midwifery. Registered midwife: this definition was inserted, as from 28 August 1990, by

section 19 Nurses Amendment Act 1990 (1990 No 107).

registeredmidwife: thisdefinitionwassubstituted,asfrom18September2004, by section 3(3) Medicines Amendment Act 2003 (2003 No 50).

Relatedproductandnewrelatedproducthavethemeanings

assigned to those terms by section 94 of this Act 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 forsale,orcausingorallowingtobesold,orofferedor 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

Sellingbywholesale,sellingbyretail,andsellingincircumstances corresponding to retail sale have the meanings as signed to those terms by section 5 of this Act

Standing order means—

(a): A written instruction issued by a practitioner or registeredmidwife, inaccordance withanyapplicableregulations, authorising any specified class of persons engaged in the delivery of health services to supply and administer any specified class or description of prescriptionmedicinesorcontrolleddrugstoanyspecified class of persons, in circumstances specified in the instruction, without a prescription:
(b): Awritteninstructionissuedbyaveterinarian,inaccordance 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, or midwife, 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 medicinesorrestrictedmedicinestoanyspecifiedclass ofpersons,incircumstancesspecifiedintheinstruction:
(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 medicinesorrestrictedmedicinestoanyspecifiedclass of animals, in circumstances specified in the instruction.

Standingorder: thisdefinitionwasinserted,asfrom15October1999,bysection 2(3) Medicines Amendment Act 1999 (1999 No 117).

Standingorder: paragraphs(a)and(b)ofthisdefinitionwereamended,asfrom 22October2003,bysection 3(2) MedicinesAmendmentAct(No3)2003(2003 No84)byinsertingthewords “orcontrolleddrugs”afterthewords “prescription medicines”.

Standing order: paragraphs (c) and (d) of this definition were inserted, as from 22October2003,bysection 3(3) MedicinesAmendmentAct(No3)2003(2003 No 84).

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 of this Act

Vehicle includes an aircraft, a hovercraft, and a ship Veterinarian means a person who is registered as a veter inarian or specialist within the meaning of section 4 of the Veterinarians Act 2005. Veterinarian: this definition was inserted, as from 15 October 1999, by section 2(2) Medicines Amendment Act 1999 (1999 No 117).

Veterinarian: this definition was amended, as from 22December 2005, by sec tion 105 Veterinarians Act 2005 (2005 No 126) by substituting the words “or specialist within the meaning of section 4 of the Veterinarians Act 2005” for the words “under the Veterinarians Act 1994”.

Veterinary surgeon[Repealed]

Veterinary surgeon: this definition was repealed, as from 15 October 1999, by section 2(2) Medicines Amendment Act 1999 (1999 No 117).

[Repealed]

(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): Any notice given by the Minister in the Gazette for the pur posesof subsection(1)ofthissectionshallbedeemed tobea regulationforthepurposesofthe Regulations(Disallowance) Act 1989 and the Acts Interpretation Act 1924. Compare: 1960No97s2(1);1969No7s2(1);1975No116s31(1);1979No

27 s 2(1); Medicines Act 1968 (UK), ss 130(9), 132(1); SR 1964/64, reg 2(1); SR 1969/193, reg 2(1); SR 1973/79, reg 2(1)

Subsections (2) and (3) were inserted, as from 1 July 1992, by section 2(3) Medicines Amendment Act 1992 (1992 No 50).

Meaning of medicine, new medicine, prescription medicine, and restricted medicine

(1): Subject to subsection (2) of this section, in this Act, unless the context otherwise requires, the term medicine means any substanceorarticle,otherthanamedicaldevice,thatismanufactured, imported, sold, or supplied wholly or principally—

(2): In this Act, unless the context otherwise requires, the term medicine does not include—

(3): In this Act, unless the context otherwise requires,— New medicine means—

(iii) in accordance with a standing order

Pharmacy-only medicine: this definition was substituted, as from 22 October 2003,by section 4(1)Medicines Amendment Act(No3)2003 (2003 No 84).

Prescription medicine means a medicine that is declared by regulationsmadeunderthisActorbyanoticegivenundersection 106 tobeonethat,exceptasmaybepermittedbyregulations made under this Act, may be—

(a): Soldbyretailonlyunderaprescriptiongivenbyapractitioner, registered midwife, veterinarian, or a designated prescriber; and

Prescriptionmedicine: thisdefinitionwassubstituted,asfrom15October1999, by section 3(2) Medicines Amendment Act 1999 (1999 No 117).

restricted medicine means a medicine that is declared by regulations made under this Act or by a notice given under section 106 to be one that, except as may be permitted by the regulations, may be—

(a): sold by retail only by a pharmacist in a pharmacy or hospital; or

Restricted medicine: this definition was substituted, as from 22 October 2003, by section 4(2) Medicines Amendment Act (No 3) 2003 (2003 No 84). Compare: Medicines Act 1968 (UK), s 130(1), (3), (5), (7)

Subsection(1)(b)(ii)wassubstituted,asfrom15October1999,bysection 3(1) Medicines Amendment Act 1999 (1999 No 117).

4 Meaning of therapeutic purpose In this Act, unless the context otherwise requires, the term therapeutic purpose means—

(a): Treating or preventing disease; or
(b): Diagnosing disease or ascertaining the existence, degree, or extent of a physiological condition; or
(c): Effecting contraception; or
(d): Inducing anaesthesia; or
(e): Altering the shape, structure, size, or weight of the human body; or
(f): Otherwisepreventingorinterferingwiththenormaloperation of a physiological function, whether permanentlyortemporarily,andwhetherbywayofterminating

s 5	Medicines Act 1981 Reprinted as at16 October 2008
	orreducingorpostponing,orincreasingoraccelerating,
	the operation of that function, or in any other way; or
	(g) Cleaning, soaking, or lubricating contact lenses.
	Compare: Medicines Act 1968 (UK) s 130(2)
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 refer
	ence 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 one 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 com
	mercial laboratory; or
	(ii) Using it in any process of manufacture or trade
	not involving the resale of that thing.
(2)	InthisActeveryreferencetosellinganythingbyretailisaref
	erencetosellingittoapersonwhomthevendorbelievestobe
	buying it for a purpose other than one specified in subsection
	(1) of this section.
(3)	In this Act every reference to supplying anything in circum
	stances corresponding to retail sale is a reference to supplying
	it, otherwise than by way of sale, to a person whom the sup
	plier believes to be receiving it for a purpose other than one
	specified in subsection (1) of this section.
	Compare: Medicines Act 1968 (UK), s 131
5A	Relationship with Hazardous Substances and New
	Organisms Act 1996
	In relation to medicines that are or contain hazardous sub
	stancesorneworganisms,therequirementsofthisActaread
	ditional to the requirements of the Hazardous Substances and
	New Organisms Act 1996.
	Section 5A was inserted, as from 30 October 2003, by section 4 Medicines Amendment Act (No 2) 2003 (2003 No 56).

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 estateorinterestinthepharmacy(whetherbywayofsharesin acompanyorbywayofcharge,loan,guarantee,indemnity,or otherwise)thataffectstheownership,management,orcontrol of the pharmacy practice carried on in the pharmacy.
(2): For the purposes of subsection (1), a person acquires a direct orindirectestateorinterestinapharmacyiftheacquisitionis 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.

(4) Despitesubsection (3) ,anycovenant,condition,orstipulation, 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. Compare: 1970 No 143 s 2(2)-(4) A second section 5A was inserted, as from 18 September 2004, by section 4 Medicines Amendment Act 2003 (2003 No 50).

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,orisresponsibleforthemanagement orcontrolofahospitalinwhichthereisapharmacy;or
(c): establishes, or is responsible for the management or control of a pharmacy carried on, on a not for profit basis.

Section 5B was inserted, as from 18 September 2004, by section 4 Medicines Amendment Act 2003 (2003 No 50).

Part 1 Application and administration of Act

Application

6 Act to bind Crown

This Act shall bind the Crown. Compare: 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) of thissection,everypersonshallbedeemedtomanufacture,sell, supply,pack,orlabelanymedicinewhetherhedoessoonhis ownaccount or astheagent or employee of anyotherperson; 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 agentoremployeeofanotherpersonwhoisnotsoauthorised, thatotherpersonshallnotbeheldtohavemanufactured,sold, supplied, packed, or labelled that medicine.
(3): ForthepurposesofthisAct,whileapersonwhoisauthorised byorunderthisActtomanufacture,sell,supply,pack,orlabel 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,thatother personshallnotbeheld tobe inpossession of that medicine.
(4): ForthepurposesofthisAct,anynaturalpersonwhomanufactures, sells, supplies, packs, or labels a medicine while work

ing 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 of this Act, to manufacture, sell, supply, pack, or label that medicine, shall be deemed to be the agent or employee of the responsible person or the person so authorised, and in any such case the responsible person or personsoauthorisedshallbedeemedtobetheprincipaloremployer of the first-mentioned person, without prejudice to the liability of any other person under section 79 of this Act. Compare: 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 thepurposesofthisAct,andmayfromtimetotimedetermine 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 accord ance with the Fees and Travelling Allowances Act 1951, and theprovisionsofthatActshallapplyaccordinglyasifthecommittee were a statutory Board within the meaning ofthatAct.
(3): Subject to the provisions of this Act and of any regulations madeunderthisAct,everysuchcommitteemaydetermineits own procedure. Compare: 1960 No 97 s 5; 1969 No 7 s 20; 1979 No 27 s 8

9 Medicines Classification Committee

(1): TheMinistershallappointundersection 8 ofthisActanadvisorycommitteetobecalledtheMedicinesClassificationCommittee,whosedutyitshallbetomakerecommendationstothe Minister in respect of the classification of any medicines as prescription medicines or restricted medicines or pharmacy-only medicines under this Act.
(2): The Committee shall also consider and report to the Minister onsuchothermattersinrelationtoanyofthepurposesofthis ActasmayfromtimetotimebereferredtoitbytheMinister.
(5): Any member of the Committee may at any time be removed from office by the Minister for disability, neglect of duty, or misconductprovedtothesatisfactionoftheMinister,ormayat anytimeresignhisofficebywritingaddressedtotheMinister.
(6): If any member of the Committee dies, resigns, or is removed fromoffice,thevacancysocreatedshallbefilledinthemanner in which the appointment to the vacant office was originally made,andinthecaseofavacancyintheofficeofanominated member, every person so appointed shall beappointed for the residue of the term for which his predecessor was appointed.
(7): Unlesshesoonervacateshisofficeundersubsection (6) ofthis section,everynominatedmemberoftheCommitteeshallcontinue 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. Compare: 1960 No 97 s 6; 1967 No 108 s 2; 1979 No 28 s 5(1)

Section 9(3)(c) was amended, as from 1 July 1993, by section 32 of Health Reforms (Transitional Provisions) Act 1993 (1993 No 23) by substituting the word“Ministry”for the word “Department”.

10 Medicines Review Committee established

(1): Withoutlimitingsection 8 ofthisAct,forthepurposesofthis Act there shall be a committee, to be called the Medicines Review Committee.
(3): TheMinistershallalsoappoint1personwithwideexperience in the practice of natural therapy to act as a member of the Committeewheneveranymatterrelatingtothepracticeofnatural therapy is before the Committee.
(4): There may be paid out of money appropriated by Parliament forthepurposetothemembersoftheCommitteeremuneration by way of fees, salary, or allowances and travelling allowancesandexpensesinaccordancewiththe FeesandTravelling Allowances Act 1951, and the provisions of that Act shall apply accordingly as if the committee were a statutory Board within the meaning of that Act. Compare: 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): InanycasewheretheMinisterissatisfiedthatanymemberof the Medicines Review Committee is incapacitated by illness orabsenceorothersufficientcausefromperformingtheduties of his office, the Minister may appoint adeputy to act for that member during his incapacity.
(2): Nopersonshallbeappointedadeputyundersubsection (1) of this section unless he is eligible for membership of the Com mittee under the same provision of section 10 of this Act as the member in whose place he is to act.
(3): Everydeputyappointedunderthissectionshall,whileheacts assuch,bedeemedtobeamemberoftheCommittee,andany deputyactingforthechairmanshallhaveallthepowersofthe chairman.
(4): Noappointmentofadeputyandnoactsdonebyhimassuch, andnoactsdonebytheCommitteewhileanydeputyisacting assuch,shallbequestionedinanyproceedingsontheground that the occasion for his appointment had not arisen or had ceased. Compare: 1979 No 27 s 14

12 Committee may appoint subcommittees

(1): TheMedicinesReviewCommitteemayfromtimetotimeappoint such subcommittees comprising 2 or more members of theCommitteeasitthinksfittohearanddeterminesuchmattersastheCommitteemayfromtimetotimedelegatetothem.
(2): Notwithstanding subsection (1) of this section, where the Committee delegates to any subcommittee any matter relating to the practice of natural therapy, the person appointed under section 10(3) of this Act shall act as a member of the subcommittee.
(3): Everysubcommitteeappointedunderthissectionshallbesubject in all things to the control of the Committee, and may at any time be discharged, altered, or reconstituted by the Committee.
(4): Anydelegationunderthissectionmayatanytimeberevoked by the Committee. Compare: 1979 No 27 s 17

13 Functions, powers, and procedures of Medicines Review Committee

(2): On receipt of an objection made in accordance with section 22(4) of this Act, and of a deposit by the objector of the pre scribedamount,theCommitteeshallinquireintotheobjection and report its findings to the Minister as soon as practicable.
(3): Onreceiptofanappealmadeinaccordancewithsection 88 of this Act, the Committee shall inquire into and determine the appeal as soon as practicable.
(4): Incarryingoutitsinquiriesundersubsection (2) orsubsection (3) ofthissection,theCommitteeshallnotbeboundtofollow 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): EveryreportbytheCommitteetotheMinisteronanobjection shallincludearecommendationastothedecisiontheMinister 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): Subjecttoanyordermadeundersubsection (6) ofthissection, the Committee shall, on completing its deliberations on any objection,refundtotheobjectorthedepositpaidbyhimunder subsection (2) of this section.
(8): Subjecttotheprovisionsofthissectionandofanyregulations 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 of this Act, and the Medicines Review Committee, with such staff, accommodation, services, and other facilities as appear to him to be necessary or expedient for the proper performance of its functions by that committee.

15 Appointment of officers

(1): There may from time to time be appointed under the State Sector Act1988 suchofficersasarerequired for the purposes of this Act.
(2): TheDirector-Generalmayfromtimetotimeappointanyperson, not being an officer of the Public Service, as an officer, either in a part or full time capacity, for the purposes of this Act.
(3): Any appointment under subsection (2) of this section 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;andmaybemadeinrespectofNewZealandgenerally or in respect of any specified area or areas.
(4): There may be paid out of money appropriated by Parliament forthepurposetoanypersonappointedundersubsection (2) of thissectionsuchremunerationasmaybefixedbytheDirectorGeneral.

(5) Nopersonappointedundersubsection (2) ofthissectionshall bedeemedbyreasonofthatappointmenttobeemployedinthe serviceofHerMajestytheQueenforthepurposesoftheState SectorAct1988orthe GovernmentSuperannuationFundAct 1956 . Compare: 1960 No 97 s 7; 1969 No 7 s 19; 1979 No 27 s 9 Subsection15(1)wasamended,asfrom1April1984,bysection98AreaHealth Boards Act 1983 (1983 No 134) by inserting the words “or the Area Health BoardsAct1983”. Thosewordswereomitted,asfrom1July1993,bysection 32 Health Reforms (Transitional Provisions) Act 1993 (1993 No 23).

Section 15(2) was substituted, as from 1 July 1993, by section 32 Health Re forms (Transitional Provisions) 1993 (1993 No 23).

Section15(4)wasamended,asfrom1July1993,bysection 32 HealthReforms (TransitionalProvisions)1993(1993No23)by substitutingthewords “by the Director-General”for the words “by the Minister with the concurrence of the Minister of Finance”.

The references to the State Sector Act 1988 were substituted, as from 1 April 1988, for references to the State Services Act 1962 pursuant to section 90(a) State Sector Act 1988 (1988 No 20).

16 Exercise of powers of Director-General and other officers

(2): Subjecttosubsection (1) ofthissection,eachMedicalOfficer ofHealthemployedintheMinistryofHealth,andeveryother officeroftheMinistryofHealth,shallexercisethepowersand functionsconferredonhimbythisActsubjecttothedirection and control of the Director-General of Health and of every other officer of the Ministry of Health to whom he is subordinate.

(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. Compare: 1979 No 27 s 10 Subsection (2) was amended, as from 1 April 1984, by section 98 Area Health Boards 1983 (1983 No 134) by inserting the words “or of any area health board”.

Subsection(2)wasfurtheramended,asfrom1July1993,bysection 32 Health Reforms(TransitionalProvisions)1993(1993No23)bysubstitutingthewords“Ministry”wherever it appears, for the word “Department”.

Subsection(1A)wasinserted,asfrom1April1984,bysection98AreaHealth Boards Act 1983 (1983 No 134) and repealed, as from 1 July 1993, by section 32 Health Reforms (Transitional Provisions) 1993 (1993 No 23).

Part 2 Dealings with medicines and medical devices

17 Manufacturers, wholesalers, packers of medicines, and operators of pharmacies to be licensed

(1) Exceptasprovidedinsections 25to34 ofthisAct,orasmaybe permittedbyregulationsmadeunderthisAct,nopersonshall, in the course of any business carried on by that person,—

(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 of this Act.

(2) Every person who contravenes subsection (1) commits an of fenceandisliableonsummaryconvictiontoafinenotexceeding $40,000. Compare: 1960 No 97 ss 8, 12(1), 14(1); 1969 No 44 s 3; 1979 No 28 s 6(1);

1979 No 27 ss 19, 20

Theheadingtosection17wasamended,asfrom18September2004,bysection 5(1) Medicines Amendment Act 2003 (2003 No 50) by substituting the words “packersofmedicines,andoperatorsofpharmacies”forthewords “andpackers of medicines”.

Subsection (1)(c) was substituted, as from 18 September 2004, by section 5(2) Medicines Amendment Act 2003 (2003 No 50).

Subsection (1)(d) was inserted, as from 18 September 2004, by section 5(2) Medicines Amendment Act 2003 (2003 No 50).

Subsection (2) was substituted, as from 18 September 2004, by section 5(3) Medicines Amendment Act 2003 (2003 No 50).

18 Sale of medicines by retail

(1) Exceptasprovidedinsections 25 , 27 ,and 30to33 ofthisAct, orasmaybepermittedbyregulationsmadeunderthisAct,no person shall, in the course of any business carried on by that person, sell by retail, or supply in circumstances correspondingtoretailsale,ordistributebywayofgiftorloanorsample or in any other way,—

(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): anyrestrictedmedicineunlessthemedicineissold,supplied, or distributed by a pharmacist in a pharmacy or hospital; or

(2) No person may sell by retail any prescription medicine otherwise than under a prescription given by a practitioner, registered midwife, veterinarian, or designated prescriber.

(2A) No person may supply, in circumstances corresponding to retail sale, any prescription medicine otherwise than—

(a) Under a prescription given by a practitioner, registered midwife, veterinarian, or designated prescriber; or

(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 or

(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—

the Summary Offences Act 1981,— otherwise than pursuant to any authority to do so expressly conferred by a licence held by him under Part 3 of this Act, andinaccordancewithanyconditionsorrestrictionsspecified in the licence.

(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 prescriptionmedicineincontraventionofsubsection (1) ofthissection commits an offence and is liable to imprisonment for a term not exceeding 6 months or a fine not exceeding $40,000.
(6): EverypersoncommitsanoffenceagainstthisActwhocontravenes any of the provisions of this section (otherwise than in

circumstancesthatconstituteanoffenceagainstsubsection (5) of this section). Compare: 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 regs 12, 65; Medicines Act 1968 (UK) ss 52 to 54

Subsection (1)(a) was substituted, as from 15 October 1999, by section 4(1) Medicines Amendment Act 1999 (1999 No 117).

Subsection (1)(a) was substituted, as from 18 September 2004, by section 6(1) Medicines Amendment Act 2003 (2003 No 50).

Subsection (1)(aa) was inserted, as from 15 October 1999, by section 4(1) Medicines Amendment Act 1999 (1999 No 117).

Subsection (1)(aa) was repealed, as from 18 September 2004, by section 6(1) Medicines Amendment Act 2003 (2003 No 50).

Subsection (1)(b) and (c) was substituted, as from 18 September 2004, by sec tion 6(1) Medicines Amendment Act 2003 (2003 No 50).

Subsection (2) was amended, as from 28 August 1990, by section 20 Nurses Amendment Act 1990 (1990 No 107) by inserting the words “, or registered midwife,”.

Subsection (2) was substituted, as from 15 October 1999, by section 4(2) Medicines Amendment Act 1999 (1999 No 117).

Subsections (2A) and (2B) were inserted, as from 15 October 1999, by section 4(2) Medicines Amendment Act 1999 (1999 No 117).

Subsection (3)(b) was substituted, as from 15 October 1999, by section 4(3) Medicines Amendment Act 1999 (1999 No 117).

Subsection (5) was amended, as from 18 September 2004, by section 6(2) Medicines Amendment Act 2003 (2003 No 50) by substituting the expression“$40,000”for the expression “$1,000”.

19 Administering prescription medicines

(2): Despitesubsection (1) ,aprescriptionmedicinemaybeadmin istered where permitted by section 25 or by regulations made under this Act.
(3): EverypersoncommitsanoffenceagainstthisActwhocontra venes subsection (1).
(4)

Subsection (1) was amended, as from 28 August 1990, by section 21 Nurses AmendmentAct1990(1990No107)byinsertingthewords“orregisteredmidwife”.

Section 19 was substituted, as from 15 October 1999, by section 5 Medicines Amendment Act 1999 (1999 No 117).

Subsection (4) was repealed, as from 18 September 2004, by section 7 Medicines Amendment Act 2003 (2003 No 50).

20 Restrictions on sale or supply of new medicines

(1): Exceptasprovidedinsections 25 , 26(4) , 28 , 30 , 31 ,and 32 of this Act, this section applies to new medicines.
(3): Noconsentgivenunderthissectionshallbedeemedtowarrant the safety or efficacy of the medicine to which the consent relates.
(5): In any proceedings for an offence against subsection (4) of this section in which it is alleged that this section applies to a medicinebyreasonofsubsection (1) ofthissection,itshallbe presumedthatthemedicineisamedicinetowhichthissection applies until the contrary is proved.
(6): Theprovisionsofthissectionareinadditionto,andnotinsubstitutionfor,theprovisionsofanyotherenactmentprohibiting, regulating, or restricting the sale or distribution of medicines, and nothing in any such other enactment shall authorise any persontoactincontraventionoftheprovisionsofthissection;

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 Environmental RiskManagementAuthorityestablishedunderthe Hazardous Substances and New Organisms Act 1996 of the consent or provisionalconsentandanyconditionattachedtothatconsent.

(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 and in force immediately before the commencement of this Actshallbedeemedforthepurposesofthissectionandsection 35 of this Act to have been given under this section. Compare: 1969 No 7 s 12 Subsection (4) was substituted, as from 19May 1998, by section11 Copyright (Removal of Prohibition on Parallel Importing) Amendment Act 1998 (1998 No 20).

Subsection (6A) was inserted, as from 2 July 2001, by section 149 Hazardous Substances and New Organisms Act 1996 (1996 No 30). See Parts 11 to 16 of that Act (comprising sections 151 to 259) as to the transitional provisions. See clause 2 HazardousSubstancesandNewOrganismsActCommencementOrder (No 2) 2001 (SR 2001/171).

21 Applications for Minister’s consent

(3): Notwithstanding anything in subsection (1) of this section, in the case of a medicine to which section 20 of this Act applies byvirtueofsubsection (1) ofthatsection,thenoticedeposited with the Director-General under section 24 of this Act shall, subjecttosubsections (4) and (5) ofthissection,beasufficient application for the consent of the Minister under the said sec tion 20.

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. Compare: 1969 No 7 s 13 Subsection (1)(a)was repealed, asfrom 8March1985,bysection2Medicines Amendment Act 1985 (1985 No 29).

Subsection(1)(ca)wasinserted,asfrom8August1990,bysection2Medicines Amendment Act (No 2) 1990 (1990 No 97).

22 ProcedureinrespectofapplicationsforMinister’sconsent

(2): If,aftercomplyingwithsubsection (1) ofthissection,theMinisterisnotsatisfiedthatheshouldgivehisconsenttothedistribution 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): Onreceiptoftherecommendationoftheappropriatecommitteeundersubsection (2) ofthissection,theMinistershall,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): Theapplicantforconsentmay,within28daysafterbeingnotifiedundersubsection (3) ofthissectionoftherecommendation oftheappropriatecommittee,objecttotherecommendationin writing to the Minister.
(5): On receipt of an objection under subsection (4) of this sec tion, 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. Compare: Medicines Act 1968 (UK), ss 20(3), 21

23 Minister may give provisional consent

(1): Notwithstanding sections 20 to 22 of this Act, the Minister may,bynoticeinthe Gazette,inaccordancewiththissection, give his provisional consent to the sale or supply or use of a newmedicinewhereheisoftheopinionthatitisdesirablethat themedicinebesold,supplied,orusedonarestrictedbasisfor the treatment of a limited number of patients.

purposes of this section,— as he thinks fit.

(4) Subjecttosubsections (4A) and (5) ofthissection,everyprovisional consent given under this section shall have effect for 2 years or such shorter period as the Minister may determine, and shall then expire.

(4A) TheMinistermay,bynoticeinthe Gazette, fromtime to time renew any provisional consent given under this section for a period not exceeding 2 years on any one occasion.

(4B) Subsections (3) and (5) of this section shall apply to any re newal of a provisional consent given under subsection (4A) of this section as if it were a provisional consent given under subsection (1) of this section.

(5) If,duringthecurrencyofaprovisionalconsentgiveninrespect of any medicine, the Minister grants a consent under section 20 ofthisActinrespectofthesamemedicine,theprovisional consent shall be deemed to be revoked. Subsection(2)(a)wasamended,asfrom8August1990,bysection3Medicines

AmendmentAct(No2)1990(1990No97)bysubstitutingtheexpression “(b) and (ca)”for the expression “(a) and (b)”.

Subsection(4)wasamended,asfrom23February1987,bysection2Medicines Amendment Act 1987 (1987 No 9) by substituting the word “subsection”for the words “subsections (4A) and”.

Subsections(4A)and(4B)wereinserted,asfrom23February1987,bysection 2 Medicines Amendment Act 1987 (1987 No 9).

23A Interpretation

Inthissection,andinsections 23B and 23C ofthisAct,unless the context otherwise requires,— Applicant means—

(a): A person who makes or has made, as the case may be, an application; and
(b): Apersononwhosebehalfanapplicationis,orhasbeen,

made, as the case may be: Application meansanapplicationfortheconsentoftheMin ister under section 20 of this Act, or for the provisional con sentoftheMinisterundersection 23 ofthisAct,inrelationto a medicine

Commencement date means the date this section, and sec tions 23B, and 23C of this Act come into force Confidential information includes—

(a): Trade secrets; and
(a): In,orinrelationto,aninnovativemedicineapplication; and

cantforprovisionalconsentforthatmedicine)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 ingredientofthemedicinetowhichtheapplication 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 means—

(a) In relation to confidential supporting information, relating to an innovative medicine application, received by the Minister after the commencement date, a period commencingonthedatethatinformationisreceivedby the Minister and ending,—

(i) Where—

(A): The Minister has either notified consent, not being provisional consent, in the Gazette under section 20 of this Act, or refused to grant such consent, in relation to the medicine that is the subject of the innovative medicine application; and
(B): The date of that notification or refusal is not more than 5 years after the Minister received an application in relation to that medicine,—

on thedate 5 years after the date of that notification or refusal; or

(ii) Inanyothercase,onthedate5yearsaftertheinnovative 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 toaninnovative medicineapplication,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 notified or notifies consent, not being provisional consent, in the Gazette undersection 20 ofthisAct,orrefused or refuses to grant such consent, in relation to the medicine that was the subject of the innovative medicine application; and
(B): Thedateofthatnotificationorrefusalisor was, as the case may be, not more than 5 years after the Minister received an application in relation to that medicine,—

on thedate 5 years after the date of that notification or refusal; or

(ii) Inanyothercase,onthedate5yearsaftertheinnovative medicine application to which that information related was received by the Minister:

WTO Country means a country that is a party to the Agreement establishing the World Trade Organization adopted at Marrakesh on the 15th day of April 1994. Sections 23A to 23C were inserted, as from 1 January 1995, by section 2

Medicines Amendment Act 1994 (1994 No 128). See regulation 2 Medicines Amendment Act Commencement Order 1994 (SR 1994/298).

23B Protection of confidential supporting information about innovative medicines

WheretheMinisterreceives,orreceivednotmorethan5years beforethecommencementdate,aninnovativemedicineapplication and confidential supporting information, the Minister, duringtheprotectedperiodinrelationtothatconfidentialsupporting information,—

(a): Shalltakereasonablestepstoensurethatthatconfidential 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.

Sections 23A to 23C were inserted, as from 1 January 1995, by section 2 Medicines Amendment Act 1994 (1994 No 128). See regulation 2 Medicines Amendment Act Commencement Order 1994 (SR 1994/298).

23C Circumstances where protection under section 23B does not apply

(1): Notwithstanding section 23B of this Act, the Minister may, duringtheprotectedperiodinrelationtoconfidentialsupporting information,—

(2): The power to grant consent under subsection (1)(a)(i) of this section may be exercised by a person other than the applicant referred to in that subsection if—

Sections 23A to 23C were inserted, as from 1 January 1995, by section 2 Medicines Amendment Act 1994 (1994 No 128). See regulation 2 Medicines Amendment Act Commencement Order 1994 (SR 1994/298).

24 Distribution of changed medicines restricted

(1): If at any time a material change of a kind specified in sub section (2) of this section is made by the manufacturer of a medicine,whetherinNewZealandorelsewhere,andwhether 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 of this Act applies to the medicine by virtue of paragraph (a) or paragrap h (b) or paragraph (c) of the definition of the term new medicine in section 3(3) of this Act, deposit with the Director-General a notice in writinginEnglish describing the changeandgivingparticulars,sofarastheyareknown,ofany effectthatthechangemighthaveonthesafetyandefficacyof the medicine.

(2): Subsection (1) ofthissectionappliestoeverymaterialchange in any of the following matters:

(3): Except as provided in sections 25, 27, 28, 29, and 30 of this Act,orwiththepriorwrittenconsentoftheDirector-General, no person shall—

sample, or in any other way— untilaftertheexpiryofatleast90daysafterthedateonwhich such notice is deposited with the Director-General.

(4): Within 45 days after the receipt of any notice in accordance with subsection (1) of this section, 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, in formation, or samples required by or under subsection (1) or subsection (4) of this section, is of the opinion, at any time within the period specifiedinsubsection(3) ofthissection,—

(a): Thatthechangeisofsuchacharacterordegreethatthe medicine ought not, without the consent of the Minister,—

(b): That he is insufficiently informed, for the purposes of paragraph (a) of this subsection, in respect of—

for testing, the medicine,— he shall refer the medicine to the Minister, and forthwith informtheimporterormanufacturerbynoticeinwritingthathe has done so.

(6): Every person commits an offence against this Act who—

(7): A person who commits an offence under subsection (6) is li able on conviction—

$100,000. Compare: 1969 No 7 ss 14, 39(5)

Subsection (1A) was inserted, as from 8 August 1990, by section 4 Medicines Amendment Act (No 2) 1990 (1990 No 97).

Subsection (7) was inserted, as from 19 May 1998, by section 12 Copyright (Removal of Prohibition on Parallel Importing) Amendment Act 1998 (1998 No 20).

Qualifying new medicines

This heading was inserted, as from 30 October 2003, by section 5 Medicines Amendment Act (No 2) 2003 (2003 No 56).

24A Assessment of qualifying new medicines TheDirector-Generalmaygrantanapprovalundersection 38I ofthe HazardousSubstancesandNewOrganismsAct1996 for the release of a qualifying new medicine if he or she—

(a): has the consent of the Minister to do so; and
(b): is acting under a delegation from ERMA given under section 19 of that Act.

Sections 24A to 24G were inserted, as from 30 October 2003, by section 5 Medicines Amendment Act (No 2) 2003 (2003 No 56).

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—

(b): the Minister must not consent under section 20 or give provisionalconsentundersection 23 tothedistribution, sale, or advertising of the medicine unless the Minister receives written advice from ERMA that the medicine has been approved for release under the Hazardous Substances and New Organisms Act 1996.

Sections 24A to 24G were inserted, as from 30 October 2003, by section 5 Medicines Amendment Act (No 2) 2003 (2003 No 56).

Approval of medicines required for use inspecial emergency

This heading was inserted, as from 30 October 2003, by section 5 Medicines Amendment Act (No 2) 2003 (2003 No 56).

24C Interpretation

In sections 24D to 24G, unless the context otherwise re

quires,— hazardoussubstancehasthesamemeaningasinsection 2(1) of the Hazardous Substances and New Organisms Act 1996 responsibleMinisterhasthesamemeaningasinsection 49A

of the Hazardous Substances and New Organisms Act 1996 specialemergencyhasthesamemeaningasinsection 49A of the Hazardous Substances and New Organisms Act 1996. Sections 24A to 24G were inserted, as from 30 October 2003, by section 5

Medicines Amendment Act (No 2) 2003 (2003 No 56).

24D Approval of medicines required for use in special emergency

(1): An application may be made to the Minister for approval to distribute,sell,oradvertiseinaspecialemergencyamedicine that is or contains a hazardous substance or new organism.

Sections 24A to 24G were inserted, as from 30 October 2003, by section 5 Medicines Amendment Act (No 2) 2003 (2003 No 56).

24E Notification or publication of approval Theapprovalofanapplicationundersection 24D mustbenotified in the Gazette. Sections 24A to 24G were inserted, as from 30 October 2003, by section 5

Medicines Amendment Act (No 2) 2003 (2003 No 56).

24F Duration of approval An approval of an application under section 24D takes effect onthedayspecifiedintheapproval,andexpiresontheearlier of—

(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): ifparagraph (a) orparagraph (b) doesnotapply,2years after the date on which the approval is granted.

Sections 24A to 24G were inserted, as from 30 October 2003, by section 5 Medicines Amendment Act (No 2) 2003 (2003 No 56).

24G Consequences of expiry of approval

On the expiry of an approval of an application under section 24D , the medicine to which the approval applies must not be distributed or used unless authorised by or under any other provision of this Act. Sections 24A to 24G were inserted, as from 30 October 2003, by section 5

Medicines Amendment Act (No 2) 2003 (2003 No 56).

Exemptions

25 Exemptions for practitioners and others

(3): Subsection (1) appliesdespitesections 17to24 ,butissubject to the other provisions of this Act and any regulations made under this Act.
(4)

Subsection (1)(a), (d), (e), and (f) were amended, as from 28 August 1990, by section22NursesAmendmentAct1990(1990No107)byinsertingthewords“or registered midwife”.

Section 25 was substituted, as from 15 October 1999, by section 6 Medicines Amendment Act 1999 (1999 No 117).

Subsection (4) was repealed, as from 18 September 2004, by section 8 Medicines Amendment Act 2003 (2003 No 50).

26 Exemptions for pharmacists

(1): Notwithstanding section 17 of this Act, but subject to sub sections (2) and (3) of this section and to the other provi sionsofthisActandtoanyregulationsmadeunderthisAct,a pharmacistmaymanufacture,pack,label,sell,andsupplyany medicine.
(4): Subject to subsection (2) of this section, nothing in section 20 or section 24 of this Act shall apply in respect of the sale or supply by a pharmacist of a medicine compounded by that pharmacist to suit the needs of a particular person. Compare: 1960 No 97 ss 11(1), (2)(c), 13(1)(a), (2), 14(1)(a)

27 Exemptions for veterinarians and certain registered health practitioners

Notwithstanding anything in section 17 or section 18 of this Act, but subject to the other provisions of this Act and to any regulations made under this Act,—

(a): Any veterinarian may manufacture, sell, supply, or administeramedicineforthetreatmentofananimalunder thecareofthatveterinarianorunderthecareofanother veterinarian,andmaypackorlabelthemedicineforthe purposes of any such sale or supply:

Compare: 1969 No 7 s 18(3)(g)(i), (ii)

Theheadingtosection27wasamended,asfrom18September2004,bysection 9(1) Medicines Amendment Act 2003 (2003 No 50) by substituting the words “certain registered health practitioners”for the word “opticians”.

Section 27 was amended, as from 15 October 1999, by section 7 Medicines Amendment Act 1999 (1999 No 117) by substituting the word “veterinarian” for the words “veterinary surgeon”, wherever they appear.

Paragraph (b) was substituted, as from 18 September 2004, by section 9(2) Medicines Amendment Act 2003 (2003 No 50).

Paragraph (c)(ii) was substituted, as from 18 September 2004, by section 9(3) Medicines Amendment Act 2003 (2003 No 50).

28 Exemptions in respect of herbal remedies

(1): Notwithstandingsection 17 ofthisAct,butsubjecttotheother provisions of this Act and to any regulations made under this Act, any person may, in the course of a business carried on bythatperson,manufacture,pack,andlabel,orsellorsupply, any herbal remedy 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.

Compare: Medicines Act 1968 (UK), ss 12, 56

29 Exemption for medicine required by medical practitioner

(2): Every person who, for the purposes of subsection (1) of this section,sellsorsuppliestoanypractitioneranymedicinethat is a new medicine by virtue of paragraph (a) of the definition ofthetermnewmedicineinsection 3(3) ofthisActbeforethe consentoftheMinistertothedistributionofthatmedicinehas been notified in the Gazette shall, as soon as practicable after theendofeverymonthinwhichhehassosoldorsuppliedany such medicine, report that sale orsupply to the Director-Generalinwriting,namingthepractitionerandpatient,describing themedicine,andidentifyingtheoccasionwhenandtheplace where the medicine was so sold or supplied.
(3): Without limiting section 48 of this Act, if any person fails to comply with subsection (2) of this section, the Minister may, inthemannerprescribedinthatsectionbutwithoutcomplying with subsection (2) of that section, prohibit that person from selling and supplying any new medicine to which subsection

(2) of this section applies before the consent of the Minister to the distribution of that medicine has been notified in the Gazette. Compare: 1969 No 7 s 16

30 Exemption for clinical trial

(5): AtanytimeafteraclinicaltrialhasbeenapprovedbytheDirector-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 sub section (2), and paragraphs (c), (d), and (g) of subsection (3), ofthissectionshallapplyinrespectofeverysuchapplication.
(6): The Director-General may at any time, by notice in writing giventoanapplicant,requiretheapplicanttosupplysuchfurther information and particulars as he thinks fit relating to a clinical trial or to the identity and qualifications of an investigator.

(iii) Supply to the Director-General a copy of the results of the trial on its completion.

(8) TheDirector-Generalmayatanytime,bynoticeinwritingto theapplicant,revokeorsuspendhisapprovalofaclinicaltrial. Compare: 1969 No 7 s 15 Subsection (1) was amended, as from 1 October 1990, by section 57 Health ResearchCouncilAct1990(1990No68)bysubstitutingthereference “Health ResearchCouncilofNewZealand”forthereference“MedicalResearchCouncil of New Zealand”.

Subsection(2)(ca)wasinserted,asfrom8August1990,bysection5Medicines Amendment Act (No 2) 1990 (1990 No 97).

31 Exemptions for agents and employees

(1) Notwithstanding sections 17 to 24 of this Act, but subject to subsections (2) and (3) of this section and to the other provi sionsofthisActandtoanyregulationsmadeunderthisAct,—

(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 or section 27 of thisActtosell,supply,pack,orlabelanymedicineother than a restricted medicine; and
(c): Any authority conferred by section 28(2) of this Act to sell or supply a herbal remedy; and
(d): Any authority conferred by section 30 of this Act to

manufacture, sell, supply, pack, or label a medicine— 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) of this section to sell, supply, pack, or label a medicine shall,—

(a): Inthecaseofasalebyretail,orsupplyincircumstances corresponding to retail sale, of prescription medicines, extend and apply only to the sale and supply of those medicinesby,orunderthesupervisionof,apharmacist, responsibleperson,orotherpersonlicensedtosellthose medicines:
(b): Inthecaseofthepackingorlabellingofmedicines,extend and apply only to the packing and labelling of the medicines by, or under the supervision of, a pharma

cist,responsibleperson,orotherpersonlicensedtosell medicines.

(3) Subsection (1) of this section 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, imposedbyorunderthisAct, towhichthatperson’sprincipal or employer is subject.

(4) Subsection (3)(a) does not apply in respect of any authority conferred by section 26 on a pharmacist or on a pharmacist employedorengagedbyapersonwhoisnotapharmacistbut who holds a licence to operate a pharmacy. Compare: 1960 No 97 ss 13(1)(a), (f), (6), 14(1) Subsection (4) was inserted, as from 18 September 2004, by section 10 Medicines Amendment Act 2003 (2003 No 50).

32 Exemptions for natural therapists and others Notwithstanding sections 17 and 20 to 24 of this Act or any thinginanylicence,butsubjecttotheotherprovisionsofthis Act and to any regulations made under this Act, any natural therapistorotherpersonmaymanufacture,pack,label,sellby retail, or supply in circumstances corresponding to retail sale, any medicine that neither is nor contains—

(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) NotwithstandinganythinginthisAct,butsubjecttosubsection

(2) of thissection,theCrownmay, inrespect ofanymedicine approvedbytheDirector-Generalforthepurposesofthissection,—

(a): Import the medicine into New Zealand; and
(b): Sellthemedicine,ordistributeitbywayofgiftorloan orsampleorinanyotherway,oradvertiseitforsale,or advertise the availability of it—

and, subject to subsection (2) of this section, in doing any of thosethings,itshallnotbenecessaryfortheCrowntocomply with any of the provisions of this Act.

(2): Nothing in subsection (1) of this section limits or affects the applicationtotheCrownofsections 20 , 44 ,and 45 ofthisAct.
(3): Section 50(2) ofthisAct,totheextentthatitrelatestothepaymentofafeeontheapplicationforalicencetosellamedicine by wholesale, applies to the Crown in the same way as it appliestootherpersonsinanycasewheretheCrownwould,but forsubsection (1) ofthissection,berequiredtoobtainalicence tosellamedicineimportedbytheCrownundersubsection (1) of this section by wholesale.
(4): Nothinginsection 24 ofthisActpreventsapersonwhoholds a licence to sell a medicine imported by the Crown under subsection (1) of this section by wholesale from selling the medicine, or supplying it by way of gift or loan or sample or in any other way.
(6): Nothinginsubsection (5) ofthissectionaffectsadutyorobligation imposed on a pharmacist in relation to the sale, sup-ply,ordispensingofamedicineunderthe SocialSecurityAct 1964 .
(8): In this section the term sell includes the matters specified in paragraph s (a) to (c) of the definition of that term in section 2 of this Act. Section32Awasinserted,asfrom31July1989,bysection2MedicinesAmend

ment Act 1989 (1989 No 59).

Section32Awassubstituted,asfrom1August1990,bysection2(1)Medicines Amendment Act 1990 (1990 No 69).

33 Exemptions in respect of procuring and exporting medicines

Notwithstanding sections 17 to 24 of this Act or anything in anylicence,butsubjecttotheotherprovisionsofthisActand to any regulations made under this Act,—

(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 personinNewZealand,whetherpursuanttoaprescription or otherwise.

34 Exemption for sale by wholesale of medicines that are not prescription, restricted, or pharmacy-only medicines

Section 17 of this Act does not apply in respect of the sale by wholesale ofa medicinethatis not a prescription medicine or a restricted medicine or a pharmacy-only medicine. Section 34 was substituted, as from 23 February 1987, by section 3 Medicines

Amendment Act 1987 (1987 No 9).

Quality and standards

35 Revocation and suspension of consents

(2): Where a consent is suspended under this section, it shall be deemed for the purposes of subsections (2) and (4) of section 20 of this Act not to have been granted. Compare: Medicines Act 1968 (UK), s 28, Schedule 2

36 Control of established medicines

(1): Without limiting subsection (5) of section 24 of this Act, if the Director-General has reason to believe that any medicine, notbeinganewmedicine,maybeunsafeorineffectiveforthe therapeutic purpose for which it is sold, he may, by notice in writing to an importer or manufacturer in New Zealand, state thereasonsforhisbeliefandrequiretheimporterormanufacturer to satisfy him of the safety or efficacy of that medicine.
(2): If the Director-General is not satisfied, by evidence supplied tohimpursuanttoanoticeundersubsection (1) ofthissection orotherwise,ofthesafetyandefficacyofamedicinetowhich 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 medicinetotheappropriatecommittee,andshallforthwithby notice in writing inform the importer or manufacturer that he has done so.
(4): TheMinistermayatanytime,byalikenotice,revokeanynoticegivenundersubsection (3) ofthissection,orvary,revoke, or add to any conditions imposed in any such notice.
(5): Everypersoncommitsanoffenceandisliabletoimprisonment for a term not exceeding 6 months or a fine not exceeding $5,000 who sells or supplies any medicine in contravention of a notice given under subsection (3) of this section, or of a conditionimposedinanysuchnoticeorinanoticegivenunder subsection (4) of this section.

37 Powers of Minister to prohibit import, etc, of medicines

(1): TheMinistermayfromtimetotime,bynoticeinthe Gazette, prohibit the import, manufacture, packing, sale, possession, supply,administration,orotheruseofmedicinesofanyspecifieddescriptionormedicaldevicesofanyspecifiedkind,either absolutelyorsubjecttosuchconditionsashethinksfit,forany specifiedperiodnotexceeding1year;butheshallnotexercise this power more than once in respect of medicines or medical devices so specified.
(2): WheretheMinistergivesanoticeundersubsection (1) ofthis section,heshall,onthewrittenrequestofanyperson,statehis reasons for doing so.
(3): EverypersoncommitsanoffenceagainstthisActwhocontra venes any notice given under subsection (1) of this section. Compare: 1960 No 97 s 28; 1967 No 108 s 3

38 Restrictions on sale of medical devices

(2): IftheDirector-Generalhasreasontobelievethatanymedical 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 sub section (2) of this section, or such further time as the Dir ector-Generalmayallow,evidenceofthesafetyofthemedical device.
(4): If the Director-General is not satisfied, by evidence supplied tohimpursuanttoanoticeundersubsection (3) ofthissection 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) of thissectionrequirethemanufacturerorimportertosupplyhim 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 powersinrespectofaparticularkindofmedicaldevice,orthat hehasinformedanypersonthatheissatisfiedofthesafetyof aparticularkindofmedicaldevice,shallnotpreventhimfrom exercising any such power in respect of that kind of medical device where new information comes to his attention.
(7): Inanyproceedingsforanoffenceagainstthissectioninwhich 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): Everypersoncommitsanoffenceandisliabletoimprisonment for a term not exceeding 6 months or a fine not exceeding $5,000 who,—

(a): Having received a notice under subsection (2) of this sectionand failed to comply with subsection(3)ofthis section, sells the medical device; or
(b): Having received a notice under subsection (4) of this section,sellsthemedicaldevicebeforehehasbeennotified by the Director-General that he is satisfied of the safety of the medical device.

39 Adulteration of medicines

(2): EverypersoncommitsanoffenceagainstthisActwhocontra venes subsection (1) of this section. Compare: Medicines Act 1968 (UK), s 63

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 articleunderanamethatislikelytocausethepersontowhom the substance or article is sold or supplied to believe that that person is purchasing or otherwise acquiring that medicine, or thatmedicaldevice,orasubstancecontainingthatingredient, unless the substance or article, or the ingredient of the substance or article, complies with the standard.
(2): If a persons sells an article to a purchaser in response to a requestforamedicineoramedicaldeviceofakindforwhich astandardisprescribed,heshallbedeemedtosellamedicine ormedicaldeviceofthatkindandundersuchadescriptionas is specified in subsection (1) of this section unless he clearly notifies the purchaser at the time of sale that the article is not of that kind.
(4): EverypersoncommitsanoffenceagainstthisActwhocontra venes subsection (1) of this section. Compare: 1969 No 7 ss 6, 39(1); Medicines Act 1968 (UK), s 65

41 Duty of importer or manufacturer to report untoward effects of medicines

(1): IfatanytimetheimporterormanufacturerinNewZealandof any medicine has reason to believe that any substantial untowardeffectshavearisenfromtheuseofthemedicinewhether in New Zealand or elsewhere, the importer or manufacturer shall forthwith notify the Director-General of the nature of thoseeffectsandthecircumstancesinwhichtheyhavearisen, so far as they are known to him.
(2): EverypersoncommitsanoffenceagainstthisActandisliable to a fine not exceeding $1,000 who fails to comply with sub section (1) of this section. Compare: 1969 No 7 ss 17, 39(5)

42 Duty of importer and manufacturer to have and produce specifications of medicines

(2): Every importer or manufacturer in New Zealand shall, on demand, supply to an officer the details and certificates referred to in subsection (1) of this section.

$100,000.

Subsection (3) was substituted, as from19 May1998,by section 13Copyright (Removal of Prohibition on Parallel Importing) Amendment Act 1998 (1998 No 20).

Restrictions on operation of pharmacies

Th section heading was inserted, as from 18 September 2004, by section 11 Medicines Amendment Act 2003 (2003 No 50).

42A Everypharmacymustbeundersupervisionofpharmacist

No person may operate any pharmacy that is not for the time being under the immediate supervision and control of a pharmacist. Compare: 1970 No 143 s 41

Sections 42A to 42C were inserted, as from 18 September 2004, by section 11 Medicines Amendment Act 2003 (2003 No 50).

42B Security of pharmacies

(1): Everypersonwhooperatesapharmacymustensurethatevery prescription medicine or restricted medicine in the pharmacy isatalltimessecuredinawaythatpreventsthepublicgaining 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 aresecuredinawaythatpreventsthepublicgainingaccessto the medicines.
(4): The requirements imposed by subsections (1) and (2) are in addition to the requirements imposed by section 47 or any regulations made under this Act. Sections 42A to 42C were inserted, as from 18 September 2004, by section 11

Medicines Amendment Act 2003 (2003 No 50).

42C Restriction on authorised prescribers holding interest in pharmacies

(1): No authorised prescriber may hold an interest in a pharmacy otherthanapharmacyforwhichtheperson holds a licence to operate,exceptwiththeconsentofthelicensingauthorityand in accordance with any conditions or restrictions imposed by that authority.
(2): No person who has an interest in a pharmacy may permit or enableanyauthorisedprescribertoholdoracquirethatorany other interest in the pharmacy contrary to subsection (1).
(3): Thelicensingauthoritymaynotgiveitsconsentundersubsection (1) unlessitissatisfiedthattherearesufficientsafeguards topreventtheissueofprescriptions,themannerinwhichprescriptions are issued, or the other provision of health care by the authorised prescriber from being influenced by the commercial or financial interests of the authorised prescriber or any other person holding an interest in the pharmacy. Sections 42A to 42C were inserted, as from 18 September 2004, by section 11

Medicines Amendment Act 2003 (2003 No 50).

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.
(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,theonusofprovingthathehadareasonableexcuse (whether by reason of the fact that one or more of the provi sions of paragraphs (a) to (e) of subsection (2) of this section 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): EverypersoncommitsanoffenceagainstthisActwhocontra venes subsection (1) of this section.

(6) In this section, authorised prescriber means a practitioner, registered midwife, or designated prescriber. Compare: 1960 No 97 s 26; 1969 No 44 s 7 Subsection(2)(c)wassubstituted,asfrom28August1990,bysection23Nurses Amendment Act 1990 (1990 No 107).

Subsection (2) was substituted, as from 15 October 1999, by section 8 Medicines Amendment Act 1999 (1999 No 117).

Subsection (6) was inserted, as from 15 October 1999, by section 8(2) Medicines Amendment Act 1999 (1999 No 117).

44 Containers and packages of medicines

(2): Notwithstandingsubsection (1)(a)(ii) ofthissection,where—

(a): Thecontainerbearsalabelwithdirectionstotheeffect thatthewholeofthecontentsmustbeusedimmediately 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) EverypersoncommitsanoffenceagainstthisActwhocontra venes subsection (1) of this section. Compare: 1960 No 97 s 22

45 Records

(1): Every person who, in the course of any business, manufactures,packs,orsells,orsuppliesincircumstancescorresponding 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,orsells,orsuppliesincircumstancescorrespondingtoretailsale,anymedicineshallatalltimespermitanyofficer,oranymemberofthePolice,toinspectandmakecopies of any such record, and shall at all times on demand afford to any officer or to any member of the Police all further information in his possession with respect to any dealings by that person relating to medicines.

46 Custody of medicines

(1): Every person commits an offence against this Act who has anymedicineinhischargeorpossession(whetherforthepurposesofsaleorforanyotherpurpose)otherwisethaninacontainerconformingtotherelevantrequirements(ifany)ofthis

(2): Itisadefencetoachargebroughtundersubsection (1) ofthis section if the defendant proves that, at the material time,—

Compare: 1960 No 97 s 24

47 Storage and delivery of medicines

(2): Nopersonshallpackanymedicine,orprepareitforuse,inany room,oron any tableorbench,thatis usedforthepurposeof 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 medicinethatiskeptforthetimebeingwithinanybuildingor vehicle shall leave that building or vehicle unattended, unless he has taken all reasonable steps to secure that building or vehicle,orthepartofitinwhichthemedicineiskept,against unlawful entry.
(4): Nopersonshalldeliveronretailsale,orincircumstancescorrespondingtoretailsale,anymedicineotherwisethanthrough the postorby handing itor causing ittobe handedtotheperson,oranotherpersonreasonablybelievedtobeactingonthat person’sbehalf,towhom itisaddressed or for whoseuse it is intended.
(5): Every person commits an offence against this Act who, without reasonable excuse, contravenes any of the provisions of this section. Compare: 1960 No 97 s 25; 1969 No 44 s 6

48 Powers of Minister to prohibit prescribing, etc

(3): TheMinistermayatanytime,bynoticeintheGazette,revoke

any notice given under subsection (1).

Subsection (1)(a) was amended, as from 28 August 1990, by section 24(1) Nurses Amendment Act 1990 (1990 No 107) by inserting the words “or registered midwife”.

Subsection (2)(ba) was inserted, as from 28 August 1990, by section 24(2) Nurses Amendment Act 1990 (1990 No 107).

Section 48 was substituted, and section 48A was inserted, as from 15 October 1999, by section 9 Medicines Amendment Act 1999 (1999 No 117).

Subsection (2)(c) was amended, as from 18 September 2004, by section 12(1) MedicinesAmendmentAct2003(2003No50)bysubstitutingthewords“Pharmacy Council”for the words “Council of the Pharmaceutical Society of New Zealand”.

Subsection (2)(d) was amended, as from 18 September 2004, by section 12(2) Medicines Amendment Act 2003 (2003 No 50) by inserting the words “the Midwifery Council or”after the words “on the recommendation of”.

Subsection (2)(f) was amended, as from 18 September 2004, by section 12(3) Medicines Amendment Act 2003 (2003 No 50) by substituting the words “authorityundertheHealthPractitionersCompetenceAssuranceAct2003”forthe words“Council or Board”.

48A Powers of Councils and Boards

(1): Despite anything in any other Act, each Council or Board re ferred to in section 48 has jurisdictionto inquire intoany pre scribingofordealinginmedicinesbyamemberoftheprofessionwithwhichitisconcerned,andanyotherincidentalmatter, for the purpose of considering and determining whether or not to make a recommendation to the Minister under that section,whensuchprescribingordealinghasbeenbroughtor otherwise comes to its attention.
(2): Forthepurposesofsubsection (1) ,eachsuchCouncilorBoard has and may exercise any powers with respect to summoningwitnesses,administeringoaths,hearingevidenceandother matters of procedure, and with respect to the payment and receiving of costs and expenses, conferred on it or any disciplinarycommitteeordisciplinarytribunal,inrelationtodisciplinaryproceedings,bytheenactmentunderwhichtheCouncil or Board is constituted.
(3): Despite subsection (2), it is not necessary, unless the Council orBoardsorequires,foranyotherbodytoconductaninvestigationorinquiryortoberepresentedattheinquiryconducted by the Council or Board.
(4): Withoutprejudicetotheliabilityofanypersonunderanyother provision of this Act, a person who contravenes any notice givenundersection 48(1) commitsanoffenceagainstthisAct. Section 48 was substituted, and section 48A was inserted, as from 15 October

1999, by section 9 Medicines Amendment Act 1999 (1999 No 117).

49 Restrictions on supply to particular persons

(1): Inthissectionthetermrestrictedpersonmeansapersonwho is the subject of a notice given under subsection (2) of this section and for the time being in force.

hemay from time to time, by noticeinsuchformashe thinks fit, prohibit, subject to such conditions and exceptions as he may prescribe in the notice, any practitioner, registered midwife, or designated prescriber from issuing prescriptions for the supply of, and any person from supplying, that or any similar prescription medicine or that or any similar restricted medicine, to the restricted person.

(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) of this section to be served on the restricted person, but a failure to comply with this requirement shall not invalidate the notice.

Compare: SR 1964/64, reg 20A; SR 1969/45, reg 6

Subsection(2)wasamended,asfrom28August1990,bysection25Medicines AmendmentAct1990(1990No107)byinsertingthewords“orregisteredmidwife”.

Subsection(2)wasamended,asfrom15October1999,bysection 10 Medicines Amendment Act 1999 (1999 No 117) by substituting the words “, registered midwife, or designated prescriber”for the words “or registered midwife”.

49A Statements regarding persons dependent on prescription medicines or restricted medicines

(1): If a Medical Officer of Health has reason to believe that any personisorislikelytobecomedependentonanyprescription medicineorrestrictedmedicine,theMedicalOfficerofHealth may,forthepurposeofpreventingorrestrictingthesupplyof 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 persontoalloranyofthemembersofalloranyoftheclasses of persons set out in subsection (3) of this section.
(2): Everystatementmadeundersubsection (1) ofthissectionshall beprivilegedunlessthepublicationisprovedtobemadewith malice.
(4): Nothinginsubsection (1) orsubsection (2) ofthissectionshall limitoraffectanyrightordutythataMedicalOfficerofHealth may otherwise possess to publish a statement to any person.
(5): EverypersoncommitsanoffenceagainstthisActwho,except inthecourse of dutyasamemberofaclassset outinsubsection (3) ofthissectionorasanofficerorservantoftheCrown, publishesanyinformationobtained,whetherbythatpersonor any other person, from a statement made pursuant to subsection (1) ofthissection,oranycommentonanysuchstatement. Section 49A was inserted, as from 23 February 1987, by section 4 Medicines

Amendment Act 1987 (1987 No 9).

Subsection (3)(a) and (b) were substituted, as from 1 July 1993, by section 32 Health Reforms (Transitional Provisions) Act 1993 (1993 No 23).

Subsection (3)(b) was amended, as from 1 July 1998, by section 5(4) Health andDisabilityServicesAmendmentAct1998(1998No74)bysubstitutingthe words“the Health Funding Authority”for the words “regional health authorities”.

Subsection (3)(b) was amended, as from 1 January 2001, by section 111(1) New Zealand Public Health and Disability Act 2000 (2000 No 91) by substituting the words “any district health board established by or under section 19 oftheNewZealandPublicHealthandDisabilityAct2000”forthewords “the HealthFunding Authorityconstituted undertheHealth andDisabilityServices Act 1993”.

Subsection (3)(c) was substituted, as from 1 July 1993, by section 32 Health Reforms (Transitional Provisions) Act 1993 (1993 No 23).

Subsection (3)(c) was substituted, as from 1 October 2002, by section 58(1) HealthandDisabilityServices(Safety)Act2001 (2001No 93). See section 11 of that Act for transitional provisions.

Subsection(3)(d)wassubstituted,asfrom1June2005,bysection 206 Corrections Act 2004 (2004 No 50). See clause 2 Corrections Act Commencement Order 2005 (SR 2005/52).

Subsection(3)(ga)and(gb)wereinserted,asfrom15October1999,bysection 11 Medicines Amendment Act 1999 (1999 No 117).

Section49A(3)(h): amended,on1October2008,bysection130(1)ofthePolic ing Act 2008 (2008 No 72).

Part 3 Provisions relating to licences 50 Applications for licences

(1): Everyapplicationforalicencemustbemadeintheprescribed form to the Director-General or to any person designated for the purpose by the Director-General bynotice 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): Theapplicationshallindicatethedescriptionsofthemedicines 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 subsectio n (1) is satisfied that an application complies with the re quirements of this section and of any regulations made under thisActthatareapplicabletotheapplication,thepersonmust refer the application to the licensing authority. Compare: 1960No97 s15; 1979 No 27s 35;MedicinesAct 1968 (UK), s 18 Subsection(1)wasamended,asfrom8March1985,bysection3(2)Medicines AmendmentAct1985(1985No29)byinsertingthewords“or(asthecasemay require) the area health district”.

Subsection(1)wasamended,asfrom1July1993,bysection 32 HealthReforms (TransitionalProvisions)Act1993(1993No23)byomittingthewords “or(as the case may require) the area health district”.

Subsection (1) was substituted, as from 18 September 2004, by section 13(1) Medicines Amendment Act 2003 (2003 No 50).

Subsections(4)and(5)weresubstituted,asfrom18September2004,bysection 13(2) Medicines Amendment Act 2003 (2003 No 50).

51 Grant of licences

(1) Subject to subsection (2) of this section and to sections 52, 55A , and 55B, on receiving an application, the licensing au thority shall issue a licence, in accordance with regulations made under this Act, to the applicant if he is satisfied in respect of all the following matters:

(a): That the requirements of section 50 of this Act have been complied with:
(b): That,inthecaseofanapplicationmadebyanaturalperson 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 of this Act:
(d): That,inthecaseofanapplicationmadebyanaturalpersononhisownbehalf,theapplicant,or,inthecaseofan application made on behalf of a body corporate, every person proposed to bea responsible person for the purposes of the licence applied for, has a sufficient knowledgeoftheobligationsofalicenseeandofthehazards associatedwiththemedicinesinwhichitisproposedto deal:
(e): Thatthepremisesandequipmentthattheapplicantproposes to use are suitable and adequate for the purposes for which the licence is sought:
(f): Thatadequatearrangementshavebeenmadeoraretobe made for the making, maintaining, and safekeeping of adequaterecordsinrespectofmedicinesthataremanufactured, 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.

(2): Except as may be permitted by regulations made under this Act, the licensing authority shall not issue a licence to sell medicinesbyretailinrespectofanypremisesotherthanashop thatis opentothe publicand is situatedat least 10 kilometres by the most practicable route from a pharmacy in respect of whichalicencetooperatehasbeen,orisdeemedtohavebeen, 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): Alicenceshallbeintheprescribedformandshallbesubjectto suchconditions(ifany)asmaybeimposedontheissueofthe licenceoratany time thereafter,byorpursuanttoregulations made under this Act.
(5): A licence to sell a medicine may be combined with a licence to pack that medicine.

(6A) Ifthelicensingauthorityissatisfiedthattheholderofalicence tooperateapharmacyhasfailedtocomplywithanyconditions affectingthelicence,thelicensingauthoritymay,insteadofor aswellasexercisingthepowersconferredbysubsection (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) Apenaltyimposedundersubsection(6A)mayberecoveredin acourtofcompetentjurisdictionasadebtduetothelicensing authority.

(7) Ifthelicensingauthorityrefusestoissuealicence,orattaches conditions to a licence, or cancels a licence under this section or under section 55A, and the applicant for the licence or the licensee requests him to give his reasons for such refusal, or for the attachment of such conditions, or for the cancellation ofthelicence,thelicensingauthorityshallstatehisreasonsin writing to that person accordingly. Compare: 1960 No 97 s 16; 1979 No 27 s 36 Subsection (1) was amended, as from 18 September 2004, by section 14(1) MedicinesAmendmentAct2003(2003No50)bysubstitutingthewords “sections 52, 55A, and 55B”for the words “section 52 of this Act”.

Subsection (1)(f) was amended, as from 18 September 2004, by section 14(2) Medicines Amendment Act 2003 (2003 No 50) by inserting the words “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”.

Subsection (2) was amended, as from 18 September 2004, by section 14(3) Medicines Amendment Act 2003 (2003 No 50) by inserting the words “in respectofwhichalicencetooperatehasbeen,orisdeemedtohavebeen,issued”.

Subsections (6A) and (6B) were inserted, as from 18 September 2004, by sec tion 14(4) Medicines Amendment Act 2003 (2003 No 50).

Subsection (7) was amended, as from 18 September 2004, by section 14(5) Medicines Amendment Act 2003 (2003 No 50) by inserting the words “under this section or under section 55A”after the words “cancels a licence”.

52 Effect of licences

(2): Alicencetosellmedicinesbyretailshallnotauthorisethesale byretail,orthesupplyincircumstancescorrespondingtoretail sale, of any prescription medicine or any restricted medicine.
(3): A licence shall be subject to any conditions prescribed in respect of licences of that kind by regulations made under this Act, and such other conditions as may be imposed on the licence (including, without limitation, any conditions that restrictorprohibitthelicenceholderfromundertakinganyspecified activity or using any specified process).

(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 medicineelsewherethaninthepremisesspecifiedordescribed in the licence. Compare: 1960 No 97 s 17; 1979 No 27 s 37 Subsection (1)(e) was inserted, as from 18 September 2004, by section 15(1) Medicines Amendment Act 2003 (2003 No 50).

Subsection (3) was amended, as from 18 September 2004, by section 15(2) Medicines Amendment Act 2003 (2003 No 50) by inserting the words “(including, without limitation, any conditions that restrict or prohibit the licence holderfromundertakinganyspecifiedactivityorusinganyspecifiedprocess)”.

53 Duration of licences

(1): Subjecttosubsections (2) and (3) andtosection 55G ,everylicence,unlesssoonercancelledundersection 55A(3) orsection 83 , continues in force for a period of 1 year and thenexpires.
(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): Ifalicenseeappliesforanewlicencenotmorethan3months 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. Compare: 1960 No 97 s 18; 1979 No 27 s 38

Subsection (1) was substituted, as from 18 September 2004, by section 16 Medicines Amendment Act 2003 (2003 No 50).

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 licencefor 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): EverypersoncommitsanoffenceagainstthisActwhocontravenessubsection (1) ,orfailstoproducehislicenceasrequired by subsection (2), of this section. Compare: 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. Compare: 1960 No 97 s 20

55A Additional criteria to be satisfied by pharmacy operators

(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 sub section (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 licenceis suspended under subsection (2) a reasonable opportunitytobeheardandafterconsideringanyevidenceadduced or submissions made by the licensee, the licensing authorityisnotsatisfiedthattheholdersatisfiesallofthecriteria 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 licenceis 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 setoutinsubsection (1) ,thelicensingauthoritymustreinstate the licence. Sections 55A to 55G were inserted, as from 18 September 2004, by section 17

Medicines Amendment Act 2003 (2003 No 50).

55B Licensing authority may require further information

(1): The licensing authority, may for one 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.
(3): Iftheapplicantfailstosupplytheinformationrequestedwithin 30 days of the date of the request, or within any further time allowed by the licensing authority, the application lapses. Sections 55A to 55G were inserted, as from 18 September 2004, by section 17

Medicines Amendment Act 2003 (2003 No 50).

55C Mandatory condition of licence to operate pharmacy. Itisaconditionofeverylicencetooperateapharmacythatthe holder of the licence must not request or require any pharmacistwhoisemployedorengagedindutiesatapharmacytoact in a way that is inconsistent with the applicable professional or ethical standards of pharmacy practice. Sections 55A to 55G were inserted, as from 18 September 2004, by section 17

Medicines Amendment Act 2003 (2003 No 50).

Restrictions on persons allowed to operatepharmacies

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.
(3): Subsection (2)(e) ceasestoapplytoacompanyifthereisorare a change or changes in the ownership of shares representing 25% of the sharecapital of the company afterthe commencement of this section.

Compare: 1970 No 143 s 42

Sections 55A to 55G were inserted, as from 18 September 2004, by section 17 Medicines Amendment Act 2003 (2003 No 50).

Section 55D(4): amended, on 3 December 2007, by section 445 of the Insol vency Act 2006 (2006 No 55).

55E Restriction on individuals operating or holding majority interest in pharmacies

(2): For the purposes of subsection (1), a person does not hold an interestinapharmacymerelybyreasonoftheperson’smembershipofacompany,orofanyotherbodyofpersons(whether corporate or unincorporate) other than a partnership, that is lawfully carrying on business in a pharmacy.

(5) Inthissectionandinsection 55F ,majorityinterest,inrelation toapharmacy,meansaninterestinthepharmacyofmorethan 50% of the value of the business or businesses undertaken in the pharmacy. Compare: 1970 No 143 s 43 Sections 55A to 55G were inserted, as from 18 September 2004, by section 17 Medicines Amendment Act 2003 (2003 No 50).

Section 55E(3) pharmacist paragraph (b): amended, on 3 December 2007, by section 445 of the Insolvency Act 2006 (2006 No 55).

55F Prohibition on operating or holding of majority interest in more than 5 pharmacies

(2): Subsection (1) doesnotapplytoanypersonreferredtoinsec tion 55E(3), to the extent that 1 or more pharmacies, or inter ests in 1 or more pharmacies, are lawfully included in the estateorpropertythatthepersonisadministering,unlesssection 55E(4) applies.
(3): Subsection (1) does not apply to any person who, while at tempting 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 conditionsthatthelicensingauthorityimposes,anyextendedperiod or periods permitted by the authority.

(4) Subsection (3) is subject to sections 55D and 55E. Compare: 1970 No 143 s 45 Sections 55A to 55G were inserted, as from 18 September 2004, by section 17 Medicines Amendment Act 2003 (2003 No 50).

55G Exemption for mortgagees in possession

(1) Despitesections 55D and 55E ,amortgageeinpossessionofa pharmacy may be granted a licence to operate that pharmacy foraperiodof3monthsor,subjecttoanyconditionsthatthelicensingauthorityimposes,foranyextendedperiodorperiods permitted by the licensing authority.

(2) In this section, mortgagee in possession has the same mean ing as in section 4 of the Property Law Act 2007. Compare: 1970 No 143 s 47. Sections 55A to 55G were inserted, as from 18 September 2004, by section 17 Medicines Amendment Act 2003 (2003 No 50).

Section55G(2): amended,on1January2008,bysection364(1)oftheProperty Law Act 2007 (2007 No 91).

Part 4 Medical advertisements

56 Interpretation

InthisPartofthisAct,unlessthecontextotherwiserequires,— Advertisementmeansanywords,whetherwritten,printed,or spoken,andanypictorialrepresentationordesign,usedorappearingtobeusedtopromotethesaleofmedicinesormedical devices or the use of any method of treatment; and includes any trade circular, any label, and any advertisement in a trade

journal; and advertising and advertised have corresponding meanings Medical advertisement means an advertisement relating, or

likely to cause any person to believe that it relates, to any medicine or medical device or any ingredient or component thereof, or to any method of treatment

Method of treatment means any method of treatment for rewardundertaken,orrepresentedtobeundertaken,foratherapeutic purpose

Publish means—

(a): Insert in any newspaper or other periodical publication printed or published in New Zealand; or
(b): SendtoanypersonthroughthePostOfficeorotherwise; 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 1976; or
(e): BringtothenoticeofthepublicinNewZealandinany

other manner. Compare: 1969 No 7 s 2; 1979 No 27 s 2

57 Restrictions on advertisements

(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) of this section. Compare: 1960 No 97 s 29; 1969 No 7 s 8; SR 1964/64, reg 21

58 Further restrictions on advertisements

(2): EverypersoncommitsanoffenceagainstthisActwhocontravenes any of the provisions of subsection (1) of this section.
(3): It shall be a good defence in a prosecution for an offence againstparagraph(a)orparagraph(b)ofsubsection(1)ofthis section if the defendant proves that the matter claimed, indicated, or suggested in the advertisement is true. Compare: 1969 No 7 ss 10, 39(3)

59 Advertisements to contain true name of advertiser

(2): In the case of a body corporate, it shall be sufficient compli ance with subsection (1) of this section if, instead of the ad dress 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): Anystatementthatiscontainedinanymedicaladvertisement 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 thepersonforwhomoronwhosebehalftheadvertisementhas been published.
(5): Everypersoncommitsanoffenceandisliabletoafinenotexceeding$1,000whocontravenessubsection (1) ofthissection. Compare: 1969 No 7 s 9

60 Exemption for certain advertisements Without limiting any power to make regulations under this Act, nothing in section 57(1)(g) or section 58 or section 59 of this Act shall apply to any medical advertisement that—

(a): Is distributed only to persons referred to in section 58(1)(c)(ii) of this Act; or
(b): Iscontainedinapublicationthatintheordinarycourse 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,isdistributedsolelytopersonsclaimingtobe availableforconsultationbyotherpersonsfortherapeutic purposes and to persons privatelyconsulting them.

Compare: 1969 No 7 s 11

61 Misleading branding

(2): EverypersoncommitsanoffenceagainstthisActwhocontra venes subsection (1) of this section. Compare: 1969 No 7 s 7

62 Regulations relating to advertisements

(1) Withoutlimitingsection 105 ofthisActbutsubjecttosubsec tion (2) of this section, the Governor-General may from time to time, by Order in Council, make regulations for all or any of the following purposes:

(a) Requiring and regulating the insertion in any medical advertisement,oranyparticularclassofmedicaladvertisement,ofsuchinformationorwarning,orkindofinformation or warning, concerning any unwanted, incidental,oruntowardeffectsofmedicinesofthedescription,orofmedicaldevicesofthekind,orofthemethod 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

thatkind,orofthatmethodoftreatment,asmaybeprescribed:

(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): EnablingtheMinistertorequire,afterconsultationwith 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 particularmedicaladvertisementorclassofmedicaladvertisement, and to give directions with respect to the location,size,andappearanceofanysuchinsertionand withrespecttoothermattersincidentalthereto,andproviding 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) Anyregulationsmadeundersubsection (1)(a) ofthissection—

(a): ShallbemadeonlyontherecommendationoftheMinister after consultation with such organisations or bodies as the Minister considers likely to be substantially affected by the regulations; and
(b): Shallbedesignedtoachieveafairandbalancedindication of the potential effects of the medicine or medical device or method of treatment advertised; and
(c): Shallnotrequirethedisclosureofinformationthatmay reasonably be regarded as confidential, or that cannot reasonably be expected to be in the possession of the persononwhosebehalftheadvertisementispublished, or the inclusion of which in the advertisement is otherwise impracticable.

Compare: 1969 No 7 s 46(1)(r), (s), (2)

Part 5 Enforcement 63 Powers of officers

(3): Ondemandbyanypersoninanypremisesorvehicle,orclaiming any interest in any article, in or in respect of which any power is exercised under this section, the officer exercising the power shall identifyhimselfand produce evidencethathe is an officer.
(4)

Subsection (4) was repealed, as from 1 April 1987, by section 25(1) Official Information Amendment Act 1987 (1987 No 8).

64 Further provisions relating to seizure and detention of articles

(1): If any officer seizes any article under section 63 of this Act in any premises or vehicle that is not in the occupation or use of the owner of the article, he shall forthwith give notice in writingoftheseizuretotheowner,ortotheconsignororconsignee, or to the agent of the owner, of the article, if his name and address are on or attached to the article or are otherwise known tothe officer, andtheaddress isthat of aplaceinNew Zealand.
(2): Subject to subsection (3) of this section, where any article is seized under paragraph (i) or paragraph (j) of section 63(2) of this Act, it may, at the option of the officer concerned, be detainedinthepremisesorvehiclewhereitwasorderedtobe seized, or removed to another place and detained there, at the expense of the owner at the time of the seizure.
(4): If, within the time limited by section 65(1) of this Act, the seizedarticlehasnotbeenreleasedandnoapplicationfordisallowance of that seizure has been made under that section or any such application has been dismissed, the article shall becomethepropertyoftheCrown;andtheownerofthearticleat thetimeoftheseizureshallbeliableforanycostsorexpenses incurred in the disposition of that article.
(6): If any article seized under section 63 of this Act is not de stroyed or otherwise disposed of under this section, it shall be returned to the person from whom it was seized when the officer concerned is satisfied of the matters referred to in sub section (3) of this section. Compare: 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) of this Act, may, within 7 days thereafter, apply to a District Court for an order—

(2): On any such application, the Court may dismiss it, or, subject to subsections (3) and (4) of this section, order—

from its seizure, detention, or removal, and any trans

port 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 disallowedorthatthedetentionofthesubstanceorarticlebeterminatedinwholeorinpartshallbemadeiftheCourtisofthe opinion that the purpose to which that substance or article or that part is intended to be put will probably involve the commissionofanoffenceagainstthisAct,oranyregulationmade underthisAct,orthatthecontinueddetentionofthatsubstance orarticleorthatpartisexpedientforthepurposeofitsproduction in any pending proceedings under this Act.
(4): No order for the payment of compensation shall be made exceptinrespectofasubstanceorarticleorpartthat,intheopinionoftheCourt,oughtnottohavebeenseizedorcontinuedto 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): EveryapplicationtotheCourtunderthissectionshallbemade and dealt with by way of originating application filed in the officeoftheCourtnearest totheplacewherethesubstanceor article in dispute was seized or ordered to be detained.
(7): The applicant shall serve notice of his application on the respondentonorbeforethedateonwhichhefilesitintheCourt.
(8): Except as modified by subsections (6) and (7) of this section, the rules of procedure for the time being in force under the District Courts Act 1947 shall apply with respectto everyap plication to the Court under this section.
(9): EveryordermadebytheCourtunderthissectionshallbefinal and binding on all parties.
(10): Nothing in this section shall limit or affect the Customs and Excise Act 1996 or any other enactment. Compare: 1969 No 7 s 22; 1979 No 27 s 49; SR 1964/64, reg 20(f)

Subsection(10)wasamended,asfrom1October1996,bysection 289(1) Customs and Excise Act 1996 (1996 No 27) by substituting the words “Customs and Excise Act 1996”for the words “Customs Act 1966”.

66 Powers to require information

(1) Without limiting section 63 of this Act, where the Director- General or a Medical Officer of Health reasonably suspects that any person is in possession—

(a): Of any medicine or medical device for the purpose of sale; or
(b): Ofanysubstanceorarticleforthepurposeofthemanufacture, packing, sale, or supply of any medicine or medical device; or
(c): Ofanyadvertisingmaterialorlabellingmaterialforuse

as an advertisement or label,— inbreachofthisActorofanyregulationsmadeunderthisAct, hemayrequirethatpersontoproduceforhisinspection,orto producetoanyofficerspeciallyauthorisedbyhimforthepurpose,anybooks,documents,orotherrecordsdealingwiththe 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 causeto bemadecopies of or extractsfromanysuch books,documents,orotherrecords,andthecopiesofextracts, certifiedassuchbyhimorbyanyspeciallyauthorisedofficer, shallbedeemedtobetrueandcorrectcopiesorextracts,unless the contrary is proved.
(3): EverypersoncommitsanoffenceagainstthisActwhorefuses 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. Compare: 1960 No 97 s 40; 1969 No 7 s 27; 1979 No 27 s 50

Subsection(4)wasrepealed,asfrom1April1987,section 25(1) OfficialInformation Amendment Act 1987 (1987 No 8).

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, withoutreasonableexcuse,tocomplywithanyrequirementof an officer under subsection (1) of this section. Compare: 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,orthenameofanypersonwhogavesuchinformation; 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. Compare: 1969 No 7 s 37; 1979 No 27 s 52

69 Procuring samples for analysis

(2): For the purposes of subsection (1) of this section, an officer may require the person in possession of a substance or an art

101

iclethattheofficerreasonablybelievestobeamedicine,orhis 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): Whereanysuchsubstanceorarticleiskeptforretailsaleinan unopenedcontainer,nopersonshallberequiredbyanyofficer to sell less than the whole of the contents of the container.
(6): The procuring of a prescription medicine by an officer under this section shall not, for the purposes of section 18(2) of this Act, be a sale or supply of that medicine.
(7): EverypersoncommitsanoffenceagainstthisActwhorefuses orfails tocomplywithanydemand orrequisitionmadebyan 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, bedeemedtobethesellerofthesubstanceor,asthecasemay be, the agent or employee of the seller. Compare: 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): Anycertificateoftheresultofananalysisgivenbyananalyst 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): WhenanysampleisprocuredbyanofficerunderthisActand submittedforanalysis,thepersonfromwhomthesamplewas 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 copyofthereportmadebytheanalystinrespectofthesample.
(5)

(6) Every person commits an offence against this Act who publishes or causes to be published any advertisement relating to anymedicineormedicaldevicewhichstatesthatthemedicine or medical device has been analysed by an analyst under this Act, or quotesor purports to quote the findings of any analyst under this Act in relation to the medicine or medical device, whetherornotthosefindingsaregiveninanycertificateorreport prepared for the purposes of this Act. Compare: 1969 No 7 s 25; 1979 No 27 s 55 Subsection (5) was repealed, as from 1 April 1987, by section 25(1) Official Information Amendment Act 1987 (1987 No 8).

71 Evidence of analysis

(1): Subject to subsections (2) and (3) of this section, in any pro ceedings for an offence against this Act, a certificate purporting to be signed by an analyst in the prescribed form shall, in theabsenceofevidencetothecontrary,besufficientevidence oftheauthorityofthepersonwhosignedthecertificateandof the facts stated in the certificate.
(2): A certificate referred to in subsection (1) of this section shall be admissible in evidence only if—

(a) At least 14 clear days before the hearing at which the certificateistendered,acopyofthatcertificate(inadd

103

itiontothecopyrequiredbysection 77(4) ofthisActto beservedwiththesummons)isserved,byoronbehalf of the prosecutor, on the defendant, and the defendant is, at the same time, informed in writing that the prosecutor does not propose to call the analyst as a witness at the hearing; and

(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): Nocertificatereferredtoinsubsection (1) ofthissectionshall be admissible in evidence if the Court, of its own motion, directsthat the result ofthe analysis shallbedisregarded unless that result is proved by the oral evidence of the analyst.
(4): No certificate of an analyst and no other evidence of an analysisunderthisActshallberuledinadmissibleordisregarded byreasononlyofthefactthatanyoftheprovisionsofthisAct orofanyregulationsmadeunderthisActrelatingtothetaking or analysing of samples have not been strictly complied with, iftherehasbeenreasonablecompliancewiththoseprovisions. Compare: 1969 No 7 s 36; 1979 No 27 s 56

72 Special provisions relating to imported consignments

(2): Where an officer seizes any goods under this section, he shall servenoticeofhisactiononthe importerofthegoods;and,if the goods are still under the control of the Customs, he shall also serve a copy of the notice on the Customs who shall ensure that the goods are not delivered from the control of the Customs without the written consent of the officer.
(3): Where any goods are seized under this section, section 65 of this Act shall apply with all necessary modifications.
(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 1996 in the case of uncustomed or prohibited goods. Compare: 1979 No 27 s 57

Subsection(1)(b)wasamended,asfrom1October1996,bysection 289(1) Customs and Excise Act 1996 (1996 No 27) by substituting the word “Customs” for the words “Collector of Customs”.

Subsection (1)(g) was amended, as from 1 October 1996, by section 289(1) CustomsandExciseAct1996(1996No27)bysubstitutingthewords“Customs and Excise Act 1996”for the words “Customs Act 1966”.

Subsection (2) was amended, as from 1 October 1996, by section 289(1) Cus toms and Excise Act 1996 (1996 No 27) by substituting the word “Customs” for the words “Collector of Customs”.

Subsection (4) was amended, as from 1 October 1996, by section 289(1) Cus toms and Excise Act 1996 (1996 No 27) by substituting the words “Customs and Excise Act 1996”for the words “Customs Act 1966”.

73 Certain matters presumed

(1): In any prosecution for an offence against this Act or against anyregulationsmadeunderthisAct,itshallbepresumed,until thecontraryisproved,thatthecontentsofacontainerconform 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 thatis anewmedicine byvirtueofsection 3(3)(c)ofthis Act, it shallbepresumed thatthemedicineisanewmedicineuntil the contrary is proved. Compare: 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 beatruecopybythe officer who made it pursuant to section 63(2)(h) of this Act or the person who was caused by the Director-General or the Medical Officer of Health to make it pursuant to section 66(2) of this Act shall be deemed to be a true and correct copy until the contrary is proved.
(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 sec tion 55 of this Act; or
(b): Stating that on a date specified in the certificate the nameofanypersondidnotappearinthesaidregisteras a licensee, or any particulars specified in the certificate did not appear in the said register—

shall,withoutproofofthesignatureofthelicensingauthority, be sufficient evidence until the contrary is proved of the facts set out in the certificate. Compare: 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.

107

givetoanofficeranyinformation,ortoproduceorpermit an officer to examine and make copies of and extractsfromanybooks,documents,orotherrecords,that thatofficerisexpresslyauthorisedbythisActtorequire tobe givenorproduced or toexamineormake,ormay reasonably require tobegiven 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.

Compare: 1969 No 7 s 29; 1979 No 27 s 59

76 Penalty for false statement

(2): Every person who commits an offence against this section is liabletoimprisonmentforatermnotexceeding6monthsora fine not exceeding $1,000. Compare: 1960 No 97 s 47; 1969 No 44 s 10; 1979 No 27 s 60

76A Offences in relation to authorised prescribers Every pharmacist, person licensed to operate a pharmacy, or operatorormanagerofapharmacycommitsanoffenceagainst this Act who gives, offers, or agrees to give to any authorised prescriber or to any other person any money or other consideration as a commission on prescriptions. Compare: 1970 No 143 s 49(1)(a). Section76Awasinserted,asfrom18September2004,bysection 18 Medicines Amendment Act 2003 (2003 No 50).

77 Jurisdiction of District Courts

(1): EveryoffenceagainstthisActoragainstanyregulationsmade under this Act shall be punishable on summary conviction.
(2): Notwithstanding anything in section 14 of the Summary Proceedings Act 1957, any information in respect of any offenceagainstthisActoragainstanyregulationsmadeunder this Act may be laid at any time within 1 year after the time when the matter of the information arose.
(3): The summons in any such proceedings shall not be made returnableinlessthan14daysfromthedayonwhichitisserved.
(4): Thereshallbeservedwiththesummonsinanysuchproceedingsacopyoftheanalyst’scertificateorreport(ifany)relating to the prosecution. Compare: 1969 No 7 s 38; 1979 No 27 s 61

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 to imprisonment for a term not exceeding 3 months or a fine not exceeding $500, and, if the offence is a continuing one, to a further fine not exceeding $50 for every day or part of a day during which the offence has continued. Compare: 1969 No 7 s 39; 1979 No 27 s 62

79 Liability of principal for acts of agents, etc

(1): WhereanoffenceiscommittedagainstthisActoragainstany regulations made under this Act by any person acting as the agent or employee of another person, that other person shall, withoutprejudicetotheliabilityofthefirst-mentionedperson, 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) of this section, where any proceedings are brought by virtue of that subsection it shall be a good defence to the charge if the defendant provesthattheoffencewascommittedwithouthisknowledge 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 thisActoragainstanyregulationsmadeunderthisAct,every directorandeverypersonconcernedinthemanagementofthe body corporate shall be guilty of a like offence if it is proved thattheactthatconstitutedtheoffencetookplacewithhisauthority,permission,orconsent,orthatheknewtheoffencewas tobeorwasbeingcommittedandfailedtotakeallreasonable steps to prevent or stop it. Compare: 1969 No 7 s 30; 1979 No 27 s 63

80 Strict liability

(1): In any prosecution for selling a medicine or medical device contrarytoanyprovisionofthisActorofanyregulationmade under this Act, it shall not be necessary for the prosecution to prove that the defendant intended to commit an offence.
(4): In any such prosecution, evidence that the defendant took a step not specified in the written notice required by subsection (3) ofthissectionshallnot,exceptwiththeleaveoftheCourt, be admissible for the purpose of supporting a defence under subsection (2) of this section. Compare: 1969 No 7 s 31

81 Further defences

(3): Subject to subsection (4) of this section, it shall be a good defenceinaprosecutionforsellingorsupplyinganymedicine

or medical device contrary to any provision of this Act or of anyregulationsmadeunderthisActifthedefendantproves—

(a): Thathepurchasedthearticlesoldorsuppliedbyhimin 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): Thathecouldnotwithreasonablediligencehaveascertained that the sale or supply of the article would constitute the offence charged against him.

(4): Neither subsection (1) nor subsection (3) of this section shall apply unless, within 7 days after the service of the summons, orwithinsuchfurthertimeastheCourtmayallow,thedefendant has delivered to the prosecutor a copy of the warranty or statement, if any, and a written notice to the effect that he in tends to rely on it or on subsection (3) of this section, 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 orinsuchacontainer,heshallbeentitledtothebenefitofthis sectioninthesamemannerandtothesameextentashisprincipaloremployerwouldhavebeenifhehadbeenthedefendant. Compare: 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 containerinwhichitwasenclosedwhenpurchasedbytheperson who sells or supplies the substance or article, and which hasnotsincethat purchasebeenopenedbythatpersonorany agent or employee of that person, every person who appears from any statement or label on or attached to the container to be—

(2): Subject to subsection (3) of this section, it shall be a defence in a prosecution under subsection (1) of this section if the de fendant proves—

(3): Subsection (2) of this section shall not apply unless, within 7 day

Закон «О лекарственных препаратах» 1981 года (в редакции от 16.10.2008 г.), Новая Зеландия

Имеющиеся тексты

Reprint as at 16 October 2008

Note

This Act is administered in the Ministry of Health.

1 Short Title and commencement

2 Interpretation

Analyst means—

Sellingbywholesale,sellingbyretail,andsellingincircumstances corresponding to retail sale have the meanings as signed to those terms by section 5 of this Act

Meaning of medicine, new medicine, prescription medicine, and restricted medicine

5A Meaning of holding an interest in a pharmacy

Part 1 Application and administration of Act

6 Act to bind Crown

7 Principals and agents

8 Advisory and technical committees

16 Exercise of powers of Director-General and other officers

Part 2 Dealings with medicines and medical devices

17 Manufacturers, wholesalers, packers of medicines, and operators of pharmacies to be licensed

18 Sale of medicines by retail

19 Administering prescription medicines

20 Restrictions on sale or supply of new medicines

21 Applications for Minister’s consent

22 ProcedureinrespectofapplicationsforMinister’sconsent

23 Minister may give provisional consent

23A Interpretation

23B Protection of confidential supporting information about innovative medicines

23C Circumstances where protection under section 23B does not apply

24 Distribution of changed medicines restricted

24C Interpretation

24D Approval of medicines required for use in special emergency

24G Consequences of expiry of approval

25 Exemptions for practitioners and others

26 Exemptions for pharmacists

27 Exemptions for veterinarians and certain registered health practitioners

28 Exemptions in respect of herbal remedies

29 Exemption for medicine required by medical practitioner

30 Exemption for clinical trial

31 Exemptions for agents and employees

33 Exemptions in respect of procuring and exporting medicines

34 Exemption for sale by wholesale of medicines that are not prescription, restricted, or pharmacy-only medicines

35 Revocation and suspension of consents

36 Control of established medicines

37 Powers of Minister to prohibit import, etc, of medicines

38 Restrictions on sale of medical devices

39 Adulteration of medicines

40 Compliance with standards

41 Duty of importer or manufacturer to report untoward effects of medicines

42 Duty of importer and manufacturer to have and produce specifications of medicines

42A Everypharmacymustbeundersupervisionofpharmacist

42B Security of pharmacies

42C Restriction on authorised prescribers holding interest in pharmacies

43 Restrictions on possession of prescription medicines

44 Containers and packages of medicines

45 Records

46 Custody of medicines

47 Storage and delivery of medicines

48 Powers of Minister to prohibit prescribing, etc

49 Restrictions on supply to particular persons

49A Statements regarding persons dependent on prescription medicines or restricted medicines

Part 3 Provisions relating to licences 50 Applications for licences

51 Grant of licences

52 Effect of licences

53 Duration of licences

54 Display of licences

55 Register of licences

55A Additional criteria to be satisfied by pharmacy operators

55B Licensing authority may require further information

55D Restriction on companies operating pharmacies

55E Restriction on individuals operating or holding majority interest in pharmacies

55F Prohibition on operating or holding of majority interest in more than 5 pharmacies

55G Exemption for mortgagees in possession

56 Interpretation

57 Restrictions on advertisements

58 Further restrictions on advertisements

59 Advertisements to contain true name of advertiser

61 Misleading branding

62 Regulations relating to advertisements

64 Further provisions relating to seizure and detention of articles

65 District Court may order return of property or compensation

66 Powers to require information