Document ID: chunk:federal_register_of_legislation:F2025C00036:clause:5a_3:p1
Version: federal_register_of_legislation:F2025C00036
Segment Type: clause
Provision Reference: sch 5A cl 3 (pt 1/2)
Character Range: 531112–540955

3         Therapeutic goods to be used in a clinical trial solely for experimental purposes in humans                                                                                                                                                                                                                                                                                             (a) the sponsor must notify the Secretary:
                                                                                                                                                                                                                                                                                                                                                                                                  (i) in a form approved by the Secretary; and
                                                                                                                                                                                                                                                                                                                                                                                                  (ii) in accordance with the requirements (if any) determined by the Secretary for the form of notification;
                                                                                                                                                                                                                                                                                                                                                                                                   about the trial and the therapeutic goods covered by the trial and must do so before:
                                                                                                                                                                                                                                                                                                                                                                                                  (iii) the goods begin to be used in the trial, unless subparagraph (iv) applies; or
                                                                                                                                                                                                                                                                                                                                                                                                  (iv) if the sponsor seeks the Secretary's agreement to the notification being given before the end of a period nominated by the sponsor and the Secretary agrees to this—the end of that nominated period; and
                                                                                                                                                                                                                                                                                                                                                                                                   that the sponsor intends to sponsor a clinical trial using specified goods; and
                                                                                                                                                                                                                                                                                                                                                                                                  (b) the notification referred to in paragraph (a) must be accompanied by the relevant notification fee referred to in paragraph (a) of column 2 of item 14 in the table in clause 3 of Schedule 9 or paragraph (a) of the column headed "Matter" in item 17 of the table in Part 2 of Schedule 9A; and
                                                                                                                                                                                                                                                                                                                                                                                                  (c) the approval of the goods for this purpose must be given by the sponsor (if the sponsor is conducting the trial), or by the body or organisation conducting the trial for the sponsor, having regard to the advice of the ethics committee that has, or will assume, responsibility for monitoring the conduct of the trial; and
                                                                                                                                                                                                                                                                                                                                                                                                  (d) the terms of the approval by the sponsor, body or organisation referred to in paragraph (c) must be no less restrictive than the terms advised by the ethics committee; and
                                                                                                                                                                                                                                                                                                                                                                                                  (e) the Secretary must not, at any time:
                                                                                                                                                                                                                                                                                                                                                                                                       (i) have become aware that to conduct or continue the trial would be contrary to the public interest; and
                                                                                                                                                                                                                                                                                                                                                                                                       (ii) have directed that the trial not be conducted, or be stopped; and
                                                                                                                                                                                                                                                                                                                                                                                                  (f) the sponsor (if the sponsor is conducting the trial), or the body or organisation conducting the trial for the sponsor, must not receive, or have received, advice from the ethics committee that is inconsistent with the continuation of the trial; and
                                                                                                                                                                                                                                                                                                                                                                                                  (g) the conditions set out in regulation 12AD must be complied with, as if that regulation applied to a person using therapeutic goods under this item; and
                                                                                                                                                                                                                                                                                                                                                                                                  (h) the goods are not either or both of the following:
                                                                                                                                                                                                                                                                                                                                                                                                       (i) a Class 4 biological that has not received clinical trial approval for an equivalent indication from a national regulatory agency with comparable regulatory requirements;
                                                                                                                                                                                                                                                                                                                                                                                                       (ii) a Class 4 biological that does not have a history of previous usage that is supported by clinical evidence received by the TGA; and
                                                                                                                                                                                                                                                                                                                                                                                                  (ha) the sponsor must notify the Secretary: