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Medicines Act 1981

Dealings with medicines and medical devices

22B: Recognised regulatory authorities

You could also call this:

"Who the Minister says can help regulate medicines"

Illustration for Medicines Act 1981

The Minister can declare a person or body to be a recognised regulatory authority. You need to know they can do this if they are satisfied the person or body regulates medicines and operates in a similar framework to New Zealand. They must also co-operate with the Director-General and use international guidelines. The Minister can make this declaration by putting a notice in the Gazette. The Minister can revoke the declaration if the authority no longer meets the criteria. The recognised regulatory authority must conduct their business and release reports in English. They must also use international guidelines and standards consistent with those used in New Zealand. The Minister's decision is final and can be changed if the authority no longer meets the criteria.

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View the original legislation for this page at https://legislation.govt.nz/act/public/1986/0120/latest/link.aspx?id=LMS1555615.

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Topics:
Health and wellbeing > Public health
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"What special words mean in the Medicines Act"

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Part 2Dealings with medicines and medical devices

22BRecognised regulatory authorities

  1. The Minister may, by notice in the Gazette, declare a person or body (whether in New Zealand or overseas) to be a recognised regulatory authority if the Minister is satisfied that the person or body—

  2. is a regulator of medicines; and
    1. operates in a regulatory framework similar to that provided under this Act and other legislation relevant to—
      1. the matters that they must take into account in making decisions as a regulator; and
        1. the decision-making process; and
        2. has a formal framework for co-operation with the Director-General; and
          1. uses international guidelines and standards in relation to medicines consistent with those used under this Act; and
            1. conducts their business and releases reports in English.

              1. The Minister may revoke a declaration under subsection (1) if the Minister is satisfied that the recognised regulatory authority no longer meets 1 or more of the criteria in subsection (1).

              Notes
              • Section 22B: inserted, on , by section 7 of the Medicines Amendment Act 2025 (2025 No 66).