New Zealand Acts

MEDICINES ACT 1981

- As at 29 September 2025
- Act 118 of 1981

TABLE OF PROVISIONS

           Long 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

   6.      Act to bind Crown
   7.      Principals and agents
   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
           Note
   24A.    Assessment of qualifying new medicines
   24B.    Procedure if Director-General declines to grant approval
           Note
   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
   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
           Note
   34A.    Director-General may authorise off-label administration of COVID-19 vaccines
   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
           Note
   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
   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
           Note
   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
   Note

   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
   112.    Amendment of Consumer Information Act 1969
   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 1AA
           SCHEDULE 1
           SCHEDULE 2
           SCHEDULE 3