Instrument of approval under section 23 of the Therapeutic Goods Act 1989

Instrument of Approval under the Therapeutic Goods Act 1989

Approved manner for making applications under section 23 of the Therapeutic Goods Act 1989 in relation to the listing of medicines under section 26A and the listing of kits under section 26

I, Lyndall Soper, Assistant Secretary, Complementary and OTC Medicines Branch, a delegate of the Secretary of the Department of Health for the purposes of section 23 of the Therapeutic Goods Act 1989 (the Act):

REVOKE any previous approvals made under paragraph 23(1)(a) of the Act in relation to:

1. an application for the listing of medicine under section 26A of the Act; or
2. an application for the listing of a kit for supply in Australia under section 26 of the Act; and

APPROVE for the purposes of paragraph 23(1)(a) of the Act, the following manner for each of the applications specified below:

3. in relation to an application for the listing of medicine under section 26A of the Act - the online application form accessed via the General Listing link under the Listed Medicine heading within the Applications tab of TGA Business Services on the Therapeutic Goods Administration website; and
4. in relation to an application for the listing of a kit for supply in Australia under section 26 of the Act - the online application form accessed via the Medicine Kit link underthe Listed Medicine heading within the Applications tab of TGA Business Services on the Therapeutic Goods Administration website.

This approval has effect from 9 September 2016.

Lyndall Soper
Delegate of the Secretary

8 September 2016