Instrument of approval under section 23(1)(a) of the Therapeutic Goods Act 1989: Export only medicine

Instrument of Approval under the Therapeutic Goods Act 1989

Approved manner for making an application under section 23 of the Therapeutic Goods Act 1989 in relation to the listing of export only medicine under section 26

I, Adrian Bootes, Assistant Secretary, Prescription Medicines Authorisation 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 an export only composite pack under section 26 of the Act; or

2. an application for the listing of all other export only therapeutic goods 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 an export only composite pack under section 26 of the Act - the online application form accessed via the Composite Pack link under the Export Only Medicine heading within the Applications tab of the TGA Business Services on the Therapeutic Goods Administration website; and
4. in relation to an application for the listing of all other export only therapeutic goods under section 26 of the Act - the online application form accessed via the General Listing link under the Export Only Medicine heading within the Applications tab of the TGA Business Services on the Therapeutic Goods Administration website.

This approval has effect from 14 November 2016.

Adrian Bootes
Delegate of the Secretary

10 November 2016