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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