Therapeutic Goods Regulations 1990

This regulation applies if the Secretary receives an application:

made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and

to which regulation 16G does not apply.

For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.

For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:

if the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or

if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or

otherwise—255 working days;