Victorian Numbered Regulations

DRUGS, POISONS AND CONTROLLED SUBSTANCES AMENDMENT (MDMA AND PSILOCYBINE) REGULATIONS 2023 (SR NO 61 OF 2023) - REG 13

After regulation 98 of the Principal Regulations insert —

        " 98A     Administration of Schedule 8 MDMA or Schedule 8 psilocybine—authorised psychedelic psychiatrists and certain registered medical practitioners

    (1)     An authorised psychedelic psychiatrist must not administer Schedule 8 MDMA or Schedule 8 psilocybine unless—

        (a)     the administration is for the medical treatment of a person other than the psychiatrist; and

        (b)     that person is under the psychiatrist's care; and

        (c)     the psychiatrist has taken all reasonable steps to ensure a therapeutic need exists for the Schedule 8 MDMA or Schedule 8 psilocybine; and

        (d)     the administration is not merely for the purpose of supporting the drug dependence of a person; and

        (e)     the psychiatrist has taken all reasonable steps to ascertain the identity of the person to whom the poison is to be administered; and

        (f)     the psychiatrist has complied with regulation 17A.

Penalty:     100 penalty units.

    (2)     A registered medical practitioner must not administer Schedule 8 MDMA or Schedule 8 psilocybine—

        (a)     unless—

              (i)     the administration is to a participant in a clinical trial that is approved by or notified to the Commonwealth Secretary under the Therapeutic Goods Act 1989 of the Commonwealth and     approved by a human research ethics committee; and

              (ii)     the medical practitioner is not the participant in the clinical trial; and

              (iii)     the administration is for the purpose of the clinical trial; and

              (iv)     the participant is under the medical practitioner's care; and

              (v)     the administration is not merely for the purpose of supporting the drug dependence of the participant; and

              (vi)     the medical practitioner has taken all reasonable steps to ascertain the identity of the participant to whom the Schedule 8 MDMA or Schedule 8 psilocybine is to be administered; and

              (vii)     the medical practitioner has complied with regulation 17A; or

        (b)     unless—

              (i)     the medical practitioner is authorised to do so under regulation 78A(1); and

              (ii)     the Schedule 8 MDMA or Schedule 8 psilocybine is administered for the treatment of another person; and

              (iii)     the Schedule 8 MDMA or Schedule 8 psilocybine is administered not merely for the purpose of supporting the drug dependence of that person; and

              (iv)     the medical practitioner has taken all reasonable steps to ascertain the identity of the person to whom the Schedule 8 MDMA or Schedule 8 psilocybine is to be administered.

Penalty:     100 penalty units.

        98B     Administration of Schedule 8 MDMA or Schedule 8 psilocybine—     nurse or nurse practitioner

A nurse or nurse practitioner must not administer Schedule 8 MDMA or Schedule 8 psilocybine—

        (a)     unless—

              (i)     the nurse or nurse practitioner is authorised to do so under regulation 78A(1); and

              (ii)     the Schedule 8 MDMA or Schedule 8 psilocybine is administered for the treatment of another person; and

              (iii)     the Schedule 8 MDMA or Schedule 8 psilocybine is administered not merely for the purpose of supporting the drug dependence of that person; and

              (iv)     the nurse or nurse practitioner has taken all reasonable steps to ascertain the identity of the person to whom the Schedule 8 MDMA or Schedule 8 psilocybine is to be administered; or

        (b)     unless—

              (i)     the administration is to a participant in a clinical trial that is approved by or notified to the Commonwealth Secretary under the Therapeutic Goods Act 1989 of the Commonwealth and     approved by a human research ethics committee; and

              (ii)         the nurse or nurse practitioner is authorised to do so under regulation 78A(2); and

              (iii)     the nurse or nurse practitioner is not the participant in the clinical trial; and

              (iv)     the administration is for the purpose of the clinical trial; and

              (v)     the administration is not merely for the purpose of supporting the drug dependence of the participant; and

              (vi)     the nurse or nurse practitioner has taken all reasonable steps to ascertain the identity of the participant to whom the Schedule 8 MDMA or Schedule 8 psilocybine is to be administered.

Penalty:     100 penalty units.".