Document ID: chunk:federal_register_of_legislation:F2025C00036:clause:5a_3:p2
Version: federal_register_of_legislation:F2025C00036
Segment Type: clause
Provision Reference: sch 5A cl 3 (pt 2/2)
Character Range: 539928–545967

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:
                                                                                                                                                                                                                                                                                                                                                                                                  (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 any trial site not covered by the notification referred to in paragraph (a) and must do so before:
                                                                                                                                                                                                                                                                                                                                                                                                  (iii) the goods begin to be used at that site, 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
                                                                                                                                                                                                                                                                                                                                                                                                  (hb) the notification referred to in paragraph (ha) must be accompanied by the relevant notification fee referred to in paragraph (b) of column 2 of item 14 in the table in clause 3 of Schedule 9 or paragraph (b) of the column headed "Matter" in item 17 of the table in Part 2 of Schedule 9A; and
                                                                                                                                                                                                                                                                                                                                                                                                  (i) the sponsor must comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial (whether or not the sponsor is conducting the trial); and
                                                                                                                                                                                                                                                                                                                                                                                                  (j) if a body or organisation is conducting the trial for the sponsor, that body or organisation must comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and
                                                                                                                                                                                                                                                                                                                                                                                                  (k) the sponsor (if the sponsor is conducting the trial), or the body or organisation conducting the trial for the sponsor, must allow an authorised officer to do the things mentioned in regulation 12AC