Commonwealth Numbered Regulations

THERAPEUTIC GOODS LEGISLATION AMENDMENT (2021 MEASURES NO. 1) REGULATIONS 2021 (F2021L00450) - SCHEDULE 1

Therapeutic Goods Regulations 1990

1  After regulation 15

Insert:

15AA   Clinical trial registries

                   For the purposes of subparagraph 26AF(2)(b)(ii) of the Act, the following registries are prescribed:

                     (a)  a primary registry that at any time is in the World Health Organisation's International Clinical Trials Registry Platform, as the registry exists from time to time;

                     (b)  the database known as ClinicalTrials.gov, as the database exists from time to time.

2  After regulation 16GI

Insert:

16GIA   Period for paying evaluation fee for application under subsection 26BD(1) of the Act

                   For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.

3  Regulation 43AAGG

Omit "For section 44A", substitute "For the purposes of paragraph 63(3)(b)".