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Medicines Act 1981
Dealings with medicines and medical devices
23B: Protection of confidential supporting information about innovative medicines

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 5CTransitional, savings, and related provisions

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

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 112Amendment of Consumer Information Act 1969 113Amendment of Ombudsmen Act 1975 114Transitional 114ACertain persons deemed to have licence to operate pharmacy 114BExpiry of section 114A 115Repeals

Schedule 1AA:
Transitional, savings, and related provisions

Schedule 1:

Schedule 2:
Enactments repealed

Schedule 3:
Incorporation by reference

Medicines Act 1981

Dealings with medicines and medical devices

23B: Protection of confidential supporting information about innovative medicines

You could also call this:

"Keeping secret information about new medicines safe"

When you apply for a new medicine, you might give the Minister some secret information to support your application. The Minister must keep this information secret during a certain period. You can think of this period as a time when your secrets are protected. The Minister will not use your secret information to decide about other medicine applications.

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This page was last updated on 27 October 2025

View the original legislation for this page at https://legislation.govt.nz/act/public/1986/0120/latest/link.aspx?id=DLM55085.

Topics:

Health and wellbeing > Healthcare servicesBusiness > Industry rulesBusiness > Intellectual property

23A: Interpretation, or

"What special words mean in the Medicines Act"

23C: Circumstances where protection under section 23B does not apply, or

"When your confidential medicine information is not protected"

Part 2Dealings with medicines and medical devices

23BProtection of confidential supporting information about innovative medicines

Where the Minister receives, or received not more than 5 years before the commencement date, an innovative medicine application and confidential supporting information, the Minister, during the protected period in relation to that confidential supporting information,—
shall take reasonable steps to ensure that that confidential supporting information is kept confidential to the Minister; and
shall not use that confidential supporting information for the purposes of determining whether to grant any other application.

Notes

Section 23B: inserted, on 1 January 1995, by section 2 of the Medicines Amendment Act 1994 (1994 No 128).