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Medicines Act 1981

Dealings with medicines and medical devices - Quality and standards

35: Revocation and suspension of consents

You could also call this:

"When the Minister stops or pauses a medicine's approval for safety or quality reasons"

Illustration for Medicines Act 1981

The Minister can revoke or suspend a consent for a medicine at any time. You might wonder why this happens. It happens if the Minister thinks the medicine is no longer safe to use. The Minister can also revoke or suspend a consent if they think the standards for making the medicine are no longer satisfactory. They can do this if they think the medicine is no longer effective. When a consent is suspended, it is treated as if it was never given. A notice to revoke or suspend a consent is a type of secondary legislation, which has its own publication requirements, as outlined in Part 3 of the Legislation Act 2019. You can find more information about this in the Legislation Act. This helps you understand how notices work.

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View the original legislation for this page at https://legislation.govt.nz/act/public/1986/0120/latest/link.aspx?id=DLM55443.

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Part 2Dealings with medicines and medical devices
Quality and standards

35Revocation and suspension of consents

  1. The Minister may at any time, by notice, revoke, or suspend for such period as he may determine, any consent given under section 20 or section 23, if he is of the opinion that—

  2. the medicine can no longer be regarded as a medicine that can be administered or used safely for the purposes indicated in the application for consent, or in a notice deposited under section 24; or
    1. the specifications and standards with respect to the manufacture of the medicine that were included in the terms of a consent can no longer be regarded as satisfactory; or
      1. the efficacy of the medicine can no longer be regarded as satisfactory.

        1. Where a consent is suspended under this section, it shall be deemed for the purposes of subsections (2) and (4) of section 20 not to have been granted.

        2. A notice under this section is secondary legislation (see Part 3 of the Legislation Act 2019 for publication requirements).

        Compare
        • Medicines Act 1968 s 28, Schedule 2 (UK)
        Notes
        • Section 35(1): amended, on , by section 3 of the Secondary Legislation Act 2021 (2021 No 7).
        • Section 35(3): inserted, on , by section 3 of the Secondary Legislation Act 2021 (2021 No 7).