Victorian Consolidated Regulations

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DRUGS, POISONS AND CONTROLLED SUBSTANCES REGULATIONS 2017 - REG 15B

Schedule 9 permits issued for clinical trials only

    (1)     The Secretary must not issue a Schedule 9 permit under section 33B of the Act authorising a medical practitioner to administer, supply or prescribe a Schedule 9 poison to a person unless the Secretary is satisfied that—

        (a)     a human clinical trial has been approved by a human research ethics committee; and

        (b)     the activity to be authorised by the permit is to be undertaken for the purposes of that trial.

    (2)     When issuing a Schedule 9 permit under section 33B of the Act, the Secretary must impose a condition under section 33B(2)(b) of the Act that the administration, supply or prescription of the Schedule 9 poison is only authorised to be undertaken for the purposes of the human clinical trial specified in the condition.



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