Therapeutic Goods Regulations 1990

This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.

For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.

For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.