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Medicines Act 1981

Dealings with medicines and medical devices

23: Minister may give provisional consent

You could also call this:

"The Minister can give temporary approval for a new medicine to be sold or used."

Illustration for Medicines Act 1981

The Minister can give provisional consent for a new medicine to be sold or used. You need to apply for this consent and the Minister will decide if it is a good idea. The Minister can put conditions on the consent, like who can buy the medicine. The provisional consent lasts for two years, or a shorter time decided by the Minister. The Minister can renew the consent for another two years if needed. If the Minister gives full consent for the medicine, the provisional consent is no longer needed. A notice is given when the Minister makes a decision about provisional consent. This notice is a type of secondary legislation, which has its own publication requirements, as explained in Part 3 of the Legislation Act 2019. You can find more information about this in the Legislation Act.

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View the original legislation for this page at https://legislation.govt.nz/act/public/1986/0120/latest/link.aspx?id=DLM55061.

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

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

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23A: Interpretation, or

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Part 2Dealings with medicines and medical devices

23Minister may give provisional consent

  1. Notwithstanding sections 20 to 22, the Minister may, by notice, in accordance with this section, give provisional consent to the sale or supply or use of a new medicine if the Minister is of the opinion that it is desirable that the medicine be sold, supplied, or used.

  2. An application for the Minister's provisional consent under this section shall—

  3. be made in accordance with paragraphs (b) and (ca) of section 21(1):
    1. be addressed to the Director-General:
      1. state, or be accompanied by a statement of, the particulars specified in paragraphs (a) to (h) of section 21(2):
        1. be determined by the Minister in accordance with section 22.

          1. On giving his provisional consent under this section, the Minister may impose—

          2. such conditions relating to the persons to whom the medicine may be sold or supplied; or
            1. such conditions relating to the area in which the medicine may be distributed; or
              1. such other conditions, not being inconsistent with the purposes of this section,—
                  1. as he thinks fit.

                1. Subject to subsections (4A) and (5), every provisional consent given under this section shall have effect for 2 years or such shorter period as the Minister may determine, and shall then expire.

                2. The Minister may, by notice, from time to time renew any provisional consent given under this section for a period not exceeding 2 years on any one occasion.

                3. Subsections (3) and (5) shall apply to any renewal of a provisional consent given under subsection (4A) as if it were a provisional consent given under subsection (1).

                4. If, during the currency of a provisional consent given in respect of any medicine, the Minister grants a consent under section 20 in respect of the same medicine, the provisional consent shall be deemed to be revoked.

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

                Notes
                • Section 23(1): replaced, on , by section 4 of the Medicines Amendment Act 2021 (2021 No 16).
                • Section 23(1): amended, on , by section 3 of the Secondary Legislation Act 2021 (2021 No 7).
                • Section 23(2)(a): amended, on , by section 3 of the Medicines Amendment Act (No 2) 1990 (1990 No 97).
                • Section 23(4): amended, on , by section 2(1) of the Medicines Amendment Act 1987 (1987 No 9).
                • Section 23(4A): inserted, on , by section 2(2) of the Medicines Amendment Act 1987 (1987 No 9).
                • Section 23(4A): amended, on , by section 3 of the Secondary Legislation Act 2021 (2021 No 7).
                • Section 23(4B): inserted, on , by section 2(2) of the Medicines Amendment Act 1987 (1987 No 9).
                • Section 23(6): inserted, on , by section 3 of the Secondary Legislation Act 2021 (2021 No 7).