Reprint as at 16 October 2008

Medicines Act 1981

Public Act	1981 No 118
Date of assent	23 October 1981

Note

Changes authorised by section 17C of the Acts and Regulations Publication Act 1989 have been made in this eprint.

A general outline of these changes is set out in the notes at the end of this eprint, together with other explanatory material about this eprint.

This Act is administered in the Ministry of Health.

Title

1 Short Title and commencement

2 Interpretation

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

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

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

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 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

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

77 Jurisdiction of District Courts

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 practitioners, veterinarians, and registered midwives

105B Regulations relating to designated prescribers

105C Orders in Council providing for exemption from, or modifications of, restrictions on pharmacy ownership and operation

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

114B Expiry of section 114A

115 Repeals

Schedule 1

Schedule 2
Enactments repealed

Reprint notes

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:

New Zealand Legislation: Acts

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