Reprint as at 16 October 2008
Medicines Act 1981
Public Act 1981 No 118 Date of assent 23 October 1981
Contents
Page Title 7 1 Short Title and commencement 7 2 Interpretation 7 3 Meaning of medicine, new medicine, prescription 18 medicine, and restricted medicine 4 Meaning of therapeutic purpose 21 5 Meaning of selling by wholesale, selling by retail, and 22 selling in circumstances corresponding to retail sale
5A Relationship with Hazardous Substances and New 22 Organisms Act 1996 5A Meaning of holding an interest in a pharmacy 23 5B Meaning of operating a pharmacy 23
Changes authorised by section 17C of the Acts and Regulations Publication Act 1989 have been made in this eprint.
Ageneraloutlineofthesechangesissetoutinthenotesattheendofthiseprint,togetherwith other explanatory material about this eprint.
Part 1 Application and administration of Act
6 Act to bind Crown 24 7 Principals and agents 24
8 Advisory and technical committees 25 9 Medicines Classification Committee 25 10 Medicines Review Committee established 27 11 Deputies of members 27 12 Committee may appoint subcommittees 28 13 Functions, powers, and procedures of Medicines Review 28 Committee 14 Servicing of committees 29 15 Appointment of officers 30 16 ExerciseofpowersofDirector-Generalandotherofficers 30
Part 2 Dealings with medicines and medical devices
17 Manufacturers, wholesalers, packers of medicines, and 31 operators of pharmacies to be licensed 18 Sale of medicines by retail 32 19 Administering prescription medicines 34 20 Restrictions on sale or supply of new medicines 35 21 Applications for Minister’s consent 36 22 ProcedureinrespectofapplicationsforMinister’sconsent 38 23 Minister may give provisional consent 39 23A Interpretation 41 23B Protection of confidential supporting information about 43 innovative medicines 23C Circumstances where protection under section 23B does 44 not apply 24 Distribution of changed medicines restricted 45
24A Assessment of qualifying new medicines 47 24B ProcedureifDirector-Generaldeclinestograntapproval 48
Approval of medicines required for use in special emergency
24D Approval of medicines required for use in special 49 emergency 24E Notification or publication of approval 49 24F Duration of approval 49 24G Consequences of expiry of approval 50
25 Exemptions for practitioners and others 50 26 Exemptions for pharmacists 51 27 Exemptions for veterinarians and certain registered health 52 practitioners 28 Exemptions in respect of herbal remedies 53 29 Exemptionformedicinerequiredbymedicalpractitioner 54 30 Exemption for clinical trial 54 31 Exemptions for agents and employees 57 32 Exemptions for natural therapists and others 58 32A Exemptions in respect of importation by the Crown 58 33 Exemptions in respect of procuring and exporting 60 medicines 34 Exemption for sale by wholesale of medicines that are not 60 prescription, restricted, or pharmacy-only medicines
35 Revocation and suspension of consents 60 36 Control of established medicines 61 37 Powers of Minister to prohibit import, etc, of medicines 62 38 Restrictions on sale of medical devices 62 39 Adulteration of medicines 64 40 Compliance with standards 64 41 Duty of importer or manufacturer to report untoward 65 effects of medicines 42 Duty of importer and manufacturer to have and produce 65 specifications of medicines
Restrictions on operation of pharmacies
42A Every pharmacy must be under supervision of pharmacist 66 42B Security of pharmacies 66 42C Restriction on authorised prescribers holding interest in 67 pharmacies
43 Restrictions on possession of prescription medicines 67 44 Containers and packages of medicines 69 45 Records 70 46 Custody of medicines 70 47 Storage and delivery of medicines 71 48 Powers of Minister to prohibit prescribing, etc 72 48A Powers of Councils and Boards 73 49 Restrictions on supply to particular persons 74 49A Statements regarding persons dependent on prescription 75
medicines or restricted medicines
Part 3 Provisions relating to licences
50 Applications for licences 77 51 Grant of licences 78 52 Effect of licences 80 53 Duration of licences 81 54 Display of licences 82 55 Register of licences 82 55A Additional criteria to be satisfied by pharmacy operators 82 55B Licensing authority may require further information 83 55C Mandatory condition of licence to operate pharmacy. 84
Restrictions on persons allowed to operate pharmacies
55D Restriction on companies operating pharmacies 84 55E Restriction on individuals operating or holding majority 85
interest in pharmacies 55F Prohibition on operating or holding of majority interest 87
in more than 5 pharmacies 55G Exemption for mortgagees in possession 87
56 Interpretation 88 57 Restrictions on advertisements 88 58 Further restrictions on advertisements 90 59 Advertisements to contain true name of advertiser 91 60 Exemption for certain advertisements 92 61 Misleading branding 93 62 Regulations relating to advertisements 93
64 Further provisions relating to seizure and detention of 97
articles 65 District Court may order return of property or 98
compensation 66 Powers to require information 100 67 Power to require name and address of seller 101 68 Source of information or reports need not be disclosed 101 69 Procuring samples for analysis 101 70 Analysis of sample and certificate of analyst 103 71 Evidence of analysis 103 72 Special provisions relating to imported consignments 104 73 Certain matters presumed 106 74 Certificates of Director-General or Medical Officer of 106
Health 75 Obstruction of officers 107 76 Penalty for false statement 108 76A Offences in relation to authorised prescribers 108 77 Jurisdiction of District Courts 109 78 General penalty 109 79 Liability of principal for acts of agents, etc 109 80 Strict liability 110 81 Further defences 111 82 Liability of persons named on labels 112 83 Cancellation of licence 114 84 Payment of expenses of analysis on conviction 115 85 Forfeiture on conviction 115 86 Courts may order withdrawal of goods from circulation 115 87 Notification of conviction of practitioners, etc 116
88 Refusal of licensing authority to grant licence 117 89 Right of appeal to High Court 117 90 Proceedings before Court 118 91 Further provisions relating to appeals 119 92 Court may state case for Court of Appeal 119 93 Appeal to Court of Appeal in certain cases 120
94 Interpretation 121 95 Application of Act to related products 121
96 Certain provisions to apply to related products as if 121 medicines
Part 7A Restrictions on specified biotechnical procedures
96A Interpretation 122 96B Restrictions on specified biotechnical procedures 124 96C Authorisation of particular procedures 124 96D Authorisation of class of procedure 125 96E Criteria for authorisations 125 96F Advice on applicability of criteria 126 96G Applications 128 96H No compensation 128 96I Enforcement powers 128 96J Expiry of Part 129
Part 8 Miscellaneous provisions
97 Dutyofofficertoprocuresamplesforanalysisonrequest 129 98 Statement by Director-General 130 99 Director-Generaltopublishlistsofgeneralsalemedicines 130 100 PowerofCourttorestrictpublicationofnameofmedicine 130 101 Examination of Customs entries 131 102 Protection of persons acting under authority of Act 131 103 Service of documents 132 104 Amendment of Schedule 1 133 105 Regulations 133 105A Regulations relating to practitioners, veterinarians, and 140 registered midwives 105B Regulations relating to designated prescribers 141 105C Orders in Council providing for exemption from, or 143 modifications of, restrictions on pharmacy ownership and operation 106 Minister may classify medicines by notice in the Gazette 143 107 Power to obtain information for purposes of regulations 144 108 Specified publications 144 109 Relationship with Misuse of Drugs Act 1975 145 110 Relationship with Hazardous Substances and New 146 Organisms Act 1996 111 Amendment of and effect on Animal Remedies Act 146 1967[Repealed] 112 Amendment of Consumer Information Act 146 1969[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) In this Act, unless the context otherwise requires,— Administer means administer to a human being, either— 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 a Note
This Act is administered in the Ministry of Health.
Reprinted as at16 October 2008 Medicines Act 1981 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 1 Short Title and commencement
2 Interpretation