Medicines Act 1981

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Reprint as at 21 February 2018

Coat of Arms of New Zealand

Medicines Act 1981

Public Act
 
1981 No 118
Date of assent
 
23 October 1981
Commencement
 
see section 1(2)
Note

Changes authorised by subpart 2 of Part 2 of the Legislation Act 2012 have been made in this official reprint.

Note 4 at the end of this reprint provides a list of the amendments incorporated.

This Act is administered by the Ministry of Health.

Contents

Title
1Short Title and commencement
2Interpretation
3Meaning of medicine, new medicine, prescription medicine, and restricted medicine
3AMeaning of medical device
4Meaning of therapeutic purpose
5Meaning of selling by wholesale, selling by retail, and selling in circumstances corresponding to retail sale
5ARelationship with Hazardous Substances and New Organisms Act 1996
5AMeaning of holding an interest in a pharmacy
5BMeaning of operating a pharmacy
Part 1
Application and administration of Act
Application
6Act to bind Crown
7Principals and agents
Administration
8Advisory and technical committees
9Medicines Classification Committee
10Medicines Review Committee established
11Deputies of members
12Committee may appoint subcommittees
13Functions, powers, and procedures of Medicines Review Committee
14Servicing of committees
15Appointment of officers
16Exercise of powers of Director-General and other officers
Part 2
Dealings with medicines and medical devices
17Manufacturers, wholesalers, packers of medicines, and operators of pharmacies to be licensed
18Sale of medicines by retail
19Administering prescription medicines
20Restrictions on sale or supply of new medicines
21Applications for Minister’s consent
22Procedure in respect of applications for Minister’s consent
23Minister may give provisional consent
23AInterpretation
23BProtection of confidential supporting information about innovative medicines
23CCircumstances where protection under section 23B does not apply
24Distribution of changed medicines restricted
Qualifying new medicines
24AAssessment of qualifying new medicines
24BProcedure if Director-General declines to grant approval
Approval of medicines required for use in special emergency
24CInterpretation
24DApproval of medicines required for use in special emergency
24ENotification or publication of approval
24FDuration of approval
24GConsequences of expiry of approval
Exemptions
25Exemptions for practitioners and others
26Exemptions for pharmacists
27Exemptions for veterinarians and certain registered health practitioners
28Exemptions in respect of herbal remedies
29Exemption for medicine required by medical practitioner
30Exemption for clinical trial
31Exemptions for agents and employees
32Exemptions for natural therapists and others
32AExemptions in respect of importation by the Crown
33Exemptions in respect of procuring and exporting medicines
34Exemption for sale by wholesale of medicines that are not prescription, restricted, or pharmacy-only medicines
Quality and standards
35Revocation and suspension of consents
36Control of established medicines
37Powers of Minister to prohibit import, etc, of medicines
38Restrictions on sale of medical devices
39Adulteration of medicines
40Compliance with standards
41Duty of importer or manufacturer to report untoward effects of medicines
42Duty of importer and manufacturer to have and produce specifications of medicines
Restrictions on operation of pharmacies
42AEvery pharmacy must be under supervision of pharmacist
42BSecurity of pharmacies
42CRestriction on authorised prescribers and delegated prescribers holding interest in pharmacies
Miscellaneous provisions
43Restrictions on possession of prescription medicines
44Containers and packages of medicines
45Records
46Custody of medicines
47Storage and delivery of medicines
47AEffect of grant of delegated prescribing rights
48Powers of Minister to prohibit prescribing, etc
48APowers of councils and boards
49Restrictions on supply to particular persons
49AStatements regarding persons dependent on prescription medicines or restricted medicines
Part 3
Provisions relating to licences
50Applications for licences
51Grant of licences
52Effect of licences
53Duration of licences
54Display of licences
55Register of licences
55AAdditional criteria to be satisfied by pharmacy operators
55BLicensing authority may require further information
55CMandatory condition of licence to operate pharmacy
Restrictions on persons allowed to operate pharmacies
55DRestriction on companies operating pharmacies
55ERestriction on individuals operating or holding majority interest in pharmacies
55FProhibition on operating or holding of majority interest in more than 5 pharmacies
55GExemption for mortgagees in possession
Part 4
Medical advertisements
56Interpretation
57Restrictions on advertisements
58Further restrictions on advertisements
59Advertisements to contain true name of advertiser
60Exemption for certain advertisements
61Misleading branding
62Regulations relating to advertisements
Part 5
Enforcement
63Powers of officers
64Further provisions relating to seizure and detention of articles
65District Court may order return of property or compensation
66Powers to require information
67Power to require name and address of seller
68Source of information or reports need not be disclosed
69Procuring samples for analysis
70Analysis of sample and certificate of analyst
71Evidence of analysis
72Special provisions relating to imported consignments
73Certain matters presumed
74Certificates of Director-General or Medical Officer of Health
75Obstruction of officers
76Penalty for false statement
76AOffences in relation to authorised prescribers and delegated prescribers
77Jurisdiction of District Court
78General penalty
79Liability of principal for acts of agents, etc
80Strict liability
81Further defences
82Liability of persons named on labels
83Cancellation of licence
84Payment of expenses of analysis on conviction
85Forfeiture on conviction
86Courts may order withdrawal of goods from circulation
87Notification of conviction of practitioners, etc
Part 6
Appeals
88Refusal of licensing authority to grant licence
89Right of appeal to High Court
90Proceedings before court
91Further provisions relating to appeals
92Court may state case for Court of Appeal
93Appeal to Court of Appeal in certain cases
Part 7
Related products
94Interpretation
95Application of Act to related products
96Certain provisions to apply to related products as if medicines
Part 7A
Restrictions on specified biotechnical procedures
96AInterpretation
96BRestrictions on specified biotechnical procedures
96CAuthorisation of particular procedures
96DAuthorisation of class of procedure
96ECriteria for authorisations
96FAdvice on applicability of criteria
96GApplications
96HNo compensation
96IEnforcement powers
96JExpiry of Part
Part 8
Miscellaneous provisions
97Duty of officer to procure samples for analysis on request
98Statement by Director-General
99Director-General to publish lists of general sale medicines
100Power of court to restrict publication of name of medicine
101Examination of Customs entries
102Protection of persons acting under authority of Act
103Service of documents
104Amendment of Schedule 1
105Regulations
105ARegulations relating to veterinarians and authorised prescribers who are not designated prescribers
105BRegulations relating to designated prescribers
105COrders in Council providing for exemption from, or modifications of, restrictions on pharmacy ownership and operation
105DRegulations relating to delegated prescribers
105EPower of Director-General to specify prescription medicines for delegated prescribers
105FIncorporation by reference
106Minister may classify medicines by notice in the Gazette
107Power to obtain information for purposes of regulations
108Specified publications
109Relationship with Misuse of Drugs Act 1975
110Relationship with Hazardous Substances and New Organisms Act 1996
111Amendment of and effect on Animal Remedies Act 1967 [Repealed]
112Amendment of Consumer Information Act 1969 [Repealed]
113Amendment of Ombudsmen Act 1975
114Transitional
114ACertain persons deemed to have licence to operate pharmacy [Expired]
114BExpiry of section 114A
115Repeals
Schedule 1
Schedule 2
Enactments repealed
Schedule 3
Incorporation by reference
Human Assisted Reproductive Technology Act 2004
Reprint notes

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