Commonwealth Consolidated Regulations

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THERAPEUTIC GOODS REGULATIONS 1990 - REG 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.



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