Drugs, Poisons and Controlled Substances Regulations 2017
15BSchedule 9 permits issued for clinical trials only
Start here
Get a plain-English read of 15B
Turn the raw legal text into a practical explanation grounded in Drugs, Poisons and Controlled Substances Regulations 2017.
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.