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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).