Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:
(a) Part 3-2 (except sections 30EA, 31A and 31C to 31F);
(b) Division 4 of Part 3-2A.
(2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:
(a) Part 3-2 (except sections 30EA, 31A and 31C to 31F);
(b) Division 4 of Part 3-2A.
(3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.
(4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3-2 or Division 4 of Part 3-2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.
Limited exemptions
(5) For therapeutic goods exempt under paragraph (a) of item 5 of the table in Schedule 5, the exemption is subject to the condition that the exemption only has effect in relation to the importation.
(6) For therapeutic goods exempt under paragraph (b) of item 5 of the table in Schedule 5, the exemption is subject to the condition that the exemption only has effect in relation to the manufacture.
(7) For therapeutic goods exempt under paragraph (c) of item 5 of the table in Schedule 5, the exemption is subject to the condition that the exemption only has effect in relation to the supply by the intermediate supplier.