Medicines Act 1981

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Version as at 5 April 2023

Medicines Act 1981

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

Note

The Parliamentary Counsel Office has made editorial and format changes to this version using the powers under subpart 2 of Part 3 of the Legislation Act 2019.

Note 4 at the end of this version provides a list of the amendments included in it.

This Act is administered by the Ministry of Health.

	Title
1	Short Title and commencement
2	Interpretation
3	Meaning of medicine, new medicine, prescription medicine, and restricted medicine
3A	Meaning of medical device
4	Meaning of therapeutic purpose
5	Meaning of selling by wholesale, selling by retail, and selling in circumstances corresponding to retail sale
5A	Relationship with Hazardous Substances and New Organisms Act 1996
5A	Meaning of holding an interest in a pharmacy
5B	Meaning of operating a pharmacy
5C	Transitional, savings, and related provisions
	Part 1 Application and administration of Act
	Application
6	Act to bind Crown
7	Principals and agents
	Administration
8	Advisory and technical committees
9	Medicines Classification Committee
10	Medicines Review Committee established
11	Deputies of members
12	Committee may appoint subcommittees
13	Functions, powers, and procedures of Medicines Review Committee
14	Servicing of committees
15	Appointment of officers
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	Procedure in respect of applications for Minister’s consent
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
	Qualifying new medicines
24A	Assessment of qualifying new medicines
24B	Procedure if Director-General declines to grant approval
	Approval of medicines required for use in special emergency
24C	Interpretation
24D	Approval of medicines required for use in special emergency
24E	Notification or publication of approval
24F	Duration of approval
24G	Consequences of expiry of approval
	Exemptions
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
32	Exemptions for natural therapists and others
32A	Exemptions in respect of importation by the Crown
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
	COVID-19 vaccines
34A	Director-General may authorise off-label administration of COVID-19 vaccines
	Quality and standards
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
	Restrictions on operation of pharmacies
42A	Every pharmacy must be under supervision of pharmacist
42B	Security of pharmacies
42C	Restriction on authorised prescribers and delegated prescribers holding interest in pharmacies
	Miscellaneous provisions
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
47A	Effect of grant of delegated prescribing rights
48	Powers of Minister to prohibit prescribing, etc
48A	Powers of councils and boards
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
55C	Mandatory condition of licence to operate pharmacy
	Restrictions on persons allowed to operate pharmacies
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
	Part 4 Medical advertisements
56	Interpretation
57	Restrictions on advertisements
58	Further restrictions on advertisements
59	Advertisements to contain true name of advertiser
60	Exemption for certain advertisements
61	Misleading branding
62	Regulations relating to advertisements
	Part 5 Enforcement
63	Powers of officers
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
67	Power to require name and address of seller
68	Source of information or reports need not be disclosed
69	Procuring samples for analysis
70	Analysis of sample and certificate of analyst
71	Evidence of analysis
72	Special provisions relating to imported consignments
73	Certain matters presumed
74	Certificates of Director-General or Medical Officer of Health
75	Obstruction of officers
76	Penalty for false statement
76A	Offences in relation to authorised prescribers and delegated prescribers
77	Jurisdiction of District Court
78	General penalty
79	Liability of principal for acts of agents, etc
80	Strict liability
81	Further defences
82	Liability of persons named on labels
83	Cancellation of licence
84	Payment of expenses of analysis on conviction
85	Forfeiture on conviction
86	Courts may order withdrawal of goods from circulation
87	Notification of conviction of practitioners, etc
	Part 6 Appeals
88	Refusal of licensing authority to grant licence
89	Right of appeal to High Court
90	Proceedings before court
91	Further provisions relating to appeals
92	Court may state case for Court of Appeal
93	Appeal to Court of Appeal in certain cases
	Part 7 Related products
94	Interpretation
95	Application of Act to related products
96	Certain provisions to apply to related products as if medicines
	Part 7A Restrictions on specified biotechnical procedures
96A	Interpretation
96B	Restrictions on specified biotechnical procedures
96C	Authorisation of particular procedures
96D	Authorisation of class of procedure
96E	Criteria for authorisations
96F	Advice on applicability of criteria
96G	Applications
96H	No compensation
96I	Enforcement powers
96J	Expiry of Part
	Part 8 Miscellaneous provisions
97	Duty of officer to procure samples for analysis on request
98	Statement by Director-General
99	Director-General to publish lists of general sale medicines
100	Power of court to restrict publication of name of medicine
101	Examination of Customs entries
102	Protection of persons acting under authority of Act
103	Service of documents
104	Amendment of Schedule 1
105	Regulations
105A	Regulations relating to veterinarians and authorised prescribers who are not designated prescribers
105B	Regulations relating to designated prescribers
105C	Orders in Council providing for exemption from, or modifications of, restrictions on pharmacy ownership and operation
105D	Regulations relating to delegated prescribers
105E	Power of Director-General to specify prescription medicines for delegated prescribers
105F	Incorporation by reference
106	Minister may classify medicines by notice in the Gazette
107	Power to obtain information for purposes of regulations
108	Specified publications
109	Relationship with Misuse of Drugs Act 1975
110	Relationship with Hazardous Substances and New Organisms Act 1996
111	Amendment of and effect on Animal Remedies Act 1967 [Repealed]
112	Amendment of Consumer Information Act 1969 [Repealed]
113	Amendment of Ombudsmen Act 1975
114	Transitional
114A	Certain persons deemed to have licence to operate pharmacy [Expired]
114B	Expiry of section 114A
115	Repeals
	Schedule 1AA Transitional, savings, and related provisions
	Schedule 1
	Schedule 2 Enactments repealed
	Schedule 3 Incorporation by reference
	Notes

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

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Medicines Act 1981

Medicines Act 1981

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