Therapeutic Goods Regulations 1990

For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:

Part 3‑2 (except sections 30EA, 31A and 31C to 31F);

Division 4 of Part 3‑2A.

The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.

Subregulation (1) ceases to have effect on 1 July 2019, subject to subregulations (4) and (5).

If:

a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and

the application passes preliminary assessment on or before 30 June 2019;

If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.

While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.