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Medicines Act 1981

Dealings with medicines and medical devices

22: Procedure in respect of applications for Minister's consent

You could also call this:

"How the Minister decides if a new medicine can be sold"

Illustration for Medicines Act 1981

When you apply for the Minister's consent to distribute a medicine, the Minister will consider all the information about the medicine. He will look at the details you provided under section 21 and other relevant matters. The Minister will also think about the good the medicine can do compared to the risk of it harming someone's health. If the Minister is not sure about giving consent, he will ask a committee to look at the matter and make a recommendation. The committee will report back to the Minister with a suggestion on what decision to make. If the committee suggests refusing consent, the Minister will tell you the reasons why and let you know what the committee said. You can then object to the recommendation in writing within 20 working days. The Minister will consider your objection and may ask another committee to review the matter before making a decision.

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View the original legislation for this page at https://legislation.govt.nz/act/public/1986/0120/latest/link.aspx?id=DLM55060.

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Part 2Dealings with medicines and medical devices

22Procedure in respect of applications for Minister's consent

  1. On receipt of an application for his consent to the distribution of a medicine for the purposes of section 20(2), the Minister shall—

  2. consider all the particulars and information relating to the medicine submitted under section 21, and such other matters as appear to him to be relevant; and
    1. as far as practicable, weigh the likely therapeutic value of the medicine against the risk (if any) of the use of the medicine injuriously affecting the health of any person.

      1. If, after complying with subsection (1), the Minister is not satisfied that he should give his consent to the distribution of the medicine, he shall refer the matter to the appropriate committee, which shall consider the matter, and shall report on it to the Minister with a recommendation as to the decision that the Minister should make.

      2. On receipt of the recommendation of the appropriate committee under subsection (2), the Minister shall, before making his decision, if the recommendation is to refuse consent to the distribution of the medicine, notify the applicant for consent of the terms of the recommendation, and of the reasons for it.

      3. The applicant for consent may, within 20 working days after being notified under subsection (3) of the recommendation of the appropriate committee, object to the recommendation in writing to the Minister.

      4. On receipt of an objection under subsection (4), the Minister shall, before making his decision, refer the matter to the Medicines Review Committee, which shall convene such meeting or meetings as may be necessary for it to consider the matter, and shall report on it to the Minister with a recommendation as to the decision that the Minister should make.

      Compare
      • Medicines Act 1968 ss 20(3), 21 (UK)
      Notes
      • Section 22(4): amended, on , by section 15 of the Medicines Amendment Act 2025 (2025 No 66).