15ADocuments to accompany application for Schedule 9 permit

15A Documents to accompany application for Schedule 9 permit

(1) Subject to subregulation (2), an application under section 33A of the Act must be accompanied by the following—

(a) a copy of a document issued by a human research ethics committee approving the human clinical trial in relation to which the application is made; and

(b) a copy of the protocol for that trial; and

(c) for each patient in respect of whom the application is made, a copy of a consent form relating to that trial that is signed by the patient.

(2) An application under section 33A of the Act need not be accompanied by a document that has previously accompanied a different application made under that section.

Reg. 15B inserted by S.R. No. 96/2022 reg. 10.