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Medicines Act 1981

Restrictions on specified biotechnical procedures

96E: Criteria for authorisations

You could also call this:

"Rules for Approving New Medical Procedures"

Illustration for Medicines Act 1981

The Minister can approve an application for a biotechnical procedure if they think it is safe. You need to show that the procedure does not pose a big risk to people's health or safety. The Minister also wants to know that any risks will be managed and that ethical, cultural, and spiritual issues have been addressed. When the Minister talks about issues, they mean problems that come from the procedure itself or the technology used. They want to know that these issues have been thought about and dealt with. If the Minister is not sure about an application, they can ask for advice from experts. They will then think about the application again, using the advice they got, to decide what to do. You can find more information about how this law was changed by looking at the Medicines (Restricted Biotechnical Procedures) Amendment Act 2002.

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View the original legislation for this page at https://legislation.govt.nz/act/public/1986/0120/latest/link.aspx?id=DLM56535.

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96D: Authorisation of class of procedure, or

"The Governor-General can approve certain medical procedures if they meet rules."

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96F: Advice on applicability of criteria, or

"Getting advice on rules for new medicines and treatments"

Part 7ARestrictions on specified biotechnical procedures

96ECriteria for authorisations

  1. The Minister may grant or recommend an authorisation sought by an application under section 96G only if satisfied that the application relates to the conduct of a specified biotechnical procedure or class of specified biotechnical procedure that meets each of the following criteria:

  2. the conduct of the procedure or class of procedure does not pose an unacceptable risk to the health or safety of the public:
    1. any risks posed by the conduct of the procedure or class of procedure will be appropriately managed:
      1. any ethical issues have been adequately addressed:
        1. any cultural issues have been adequately addressed:
          1. any spiritual issues have been adequately addressed.

            1. A reference in any of paragraphs (c) to (e) of subsection (1) to issues is a reference to issues raised—

            2. by the conduct of the procedure or class of procedure to which the application relates; and
              1. by any technology involved in that conduct.

                1. If the Minister is not satisfied that the conduct of the procedure or class of procedure to which the application relates meets any 1 or more of the criteria specified in subsection (1), the Minister—

                2. may direct that advice on the question whether or not the conduct of the procedure or class of procedure meets that criterion (or, as the case may be, those criteria) be obtained from persons who, in the Minister's opinion, are appropriately qualified, or have the appropriate expertise, to advise on the question; and
                  1. after obtaining that advice, may resume his or her consideration of the application on the basis of that advice.

                    Notes
                    • Section 96E: inserted, on , by section 6 of the Medicines (Restricted Biotechnical Procedures) Amendment Act 2002 (2002 No 14).