Medicines Act 1981

Summary of changes

These summaries explain recent changes to the law. They are generated by AI comparing versions of the legislation, so they might oversimplify, miss details, or get things wrong. Learn more about how we track these changes.

6 December 2025

  • The definition of consent has been updated to include consent by verification for the sale, distribution, and advertising of new medicines
  • The Medicines Classification Committee's composition, membership, and quorum requirements have been revised
  • The application process for the Minister's consent has been revised, including changes to required particulars and timeframes
  • The protection of confidential supporting information has been updated to include applications for consent by verification
  • Timeframes for restricting the distribution of changed medicines and for requiring further information have been amended
  • Exemptions for medicine required by specified practitioners and for clinical trials have been broadened and updated
  • The Minister's power to revoke or suspend consents has been amended to include section 22D and to use inclusive language
  • Section 42C has been repealed, and the right of appeal to the High Court has been updated to include section 22D

Affected provisions

  1. 2: Interpretation
    The definition of consent has been updated to include consent by verification for the sale, distribution, and advertising of new medicines
  2. 9: Medicines Classification Committee
    The Medicines Classification Committee's composition, membership, and quorum requirements have been revised
  3. 20: Restrictions on sale or supply of new medicines
    The definition of consent has been updated to include consent by verification for the sale, distribution, and advertising of new medicines
  4. 21: Applications for Minister's consent
    The application process for the Minister's consent has been revised, including changes to required particulars and timeframes
  5. 22: Procedure in respect of applications for Minister's consent
    The application process for the Minister's consent has been revised, including changes to required particulars and timeframes
  6. 23A: Interpretation
    The definition of consent has been updated to include consent by verification for the sale, distribution, and advertising of new medicines; The protection of confidential supporting information has been updated to include applications for consent by verification
  7. 23: Minister may give provisional consent
    The application process for the Minister's consent has been revised, including changes to required particulars and timeframes
  8. 23C: Circumstances where protection under section 23B or 23BA does not apply
    The protection of confidential supporting information has been updated to include applications for consent by verification
  9. 24: Distribution of changed medicines restricted
    Timeframes for restricting the distribution of changed medicines and for requiring further information have been amended
  10. 29: Exemption for medicine required by specified practitioners
    Exemptions for medicine required by specified practitioners and for clinical trials have been broadened and updated
  11. 30: Exemption for clinical trial
    Exemptions for medicine required by specified practitioners and for clinical trials have been broadened and updated
  12. 35: Revocation and suspension of consents
    The Minister's power to revoke or suspend consents has been amended to include section 22D and to use inclusive language
  13. 42C: Restriction on authorised prescribers and delegated prescribers holding interest in pharmacies
    Section 42C has been repealed, and the right of appeal to the High Court has been updated to include section 22D
  14. 89: Right of appeal to High Court
    Section 42C has been repealed, and the right of appeal to the High Court has been updated to include section 22D