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Medicines Act 1981

Restrictions on specified biotechnical procedures

96F: Advice on applicability of criteria

You could also call this:

"Getting advice on rules for new medicines and treatments"

Illustration for Medicines Act 1981

You can get advice on certain criteria for biotechnical procedures. The Minister can set up a committee or ask another group for advice. They can also ask the person who made the application to get advice from a committee. You have the right to make submissions on the criteria. A committee must consider your submissions before giving advice. The Minister can agree with the applicant to pay for some costs. The Minister can also pay for costs if the examination will benefit the public. If the Minister is trying to reach an agreement, they can stop the committee from considering the application. The committee must follow the Minister's direction. Parts 2 and 3 of the Inquiries Act 2013 apply to the committee's establishment and procedures, you can find more information on this here for Part 2 and here for Part 3.

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View the original legislation for this page at https://legislation.govt.nz/act/public/1986/0120/latest/link.aspx?id=DLM56537.

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96G: Applications, or

"Asking the Minister for Permission to Use a Medicine"

Part 7ARestrictions on specified biotechnical procedures

96FAdvice on applicability of criteria

  1. For the purpose of obtaining advice of the kind referred to in section 96E(3)(a) in relation to an application, the Minister may do any 1 or more of the following:

  2. establish a committee to advise on the criteria in question:
    1. request a body or a committee or an association of persons formed or recognised by or under an enactment to advise on the criteria in question:
      1. request the person who made the application under section 96G (in this section referred to as the applicant) to obtain advice on the criteria in question from a committee consisting of persons nominated by the Minister.

        1. A committee or body or an association of persons that is to provide advice for the purposes of section 96E(3)(a) may provide that advice only after it has—

        2. given interested parties and members of the public a reasonable opportunity to make submissions in writing or orally, or both; and
          1. taken any such submissions into account.

            1. Parts 2 and 3 of the Inquiries Act 2013 apply, with all necessary modifications, to the establishment and procedures of a committee that is to be, or has been, established under subsection (1) as if it were an inquiry established that Act.

            2. The Minister may agree with an applicant whose application relates to the work of a committee, body, or association established or requested under subsection (1)(a) or (b) that the applicant will pay, or contribute towards the payment of, any costs incurred or to be incurred by the committee or body or association in the examination of aspects of the applicant's application that, in the Minister's opinion, could have significant commercial benefits (whether or not that examination also benefits the public).

            3. The Minister may agree with an applicant whose application relates to the work of a committee of persons nominated by the Minister under subsection (1)(c) that the Minister will pay, or contribute towards the payment of, any costs incurred or to be incurred by the committee in the examination of aspects of the applicant's application that, in the Minister's opinion, are likely to benefit the public (whether or not that examination also has commercial benefits).

            4. If the Minister is, under subsection (4), attempting to reach an agreement with the applicant, the Minister may direct the committee, body, or association concerned not to consider any matters relating to the applicant's application until agreement under subsection (4) has been reached; and the committee or body or association must give effect to that direction.

            Notes
            • Section 96F: inserted, on , by section 6 of the Medicines (Restricted Biotechnical Procedures) Amendment Act 2002 (2002 No 14).
            • Section 96F(3): replaced, on , by section 104 of the Pae Ora (Healthy Futures) Act 2022 (2022 No 30).