Document ID: chunk:federal_register_of_legislation:F2025C00036:reg:75
Version: federal_register_of_legislation:F2025C00036
Segment Type: reg
Provision Reference: reg 75
Character Range: 467058–468414

75  Clinical trials
 (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.
 (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.
 (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.
 (4) The amendment of Schedule 5A made by Part 2 of Schedule 9 to the amending regulations applies in relation to:
 (a) requests made on or after 1 January 2020 to give information acquired before, on or after 1 January 2020; and
 (b) things mentioned in regulation 12AC done on or after 1 January 2020;
in relation to a clinical trial that began before, on or after 1 January 2020.

Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020