While the consultation is open, you can make a submission through our TGA consultation hub.
We review the submissions carefully. After that, the submissions and our decision will be available on the same page at the TGA consultation hub.
Overview
The Therapeutic Goods Order No. 70C (TGO 70C) - Standards for Export Only Medicine - is a legislative instrument made under section 10 of the Therapeutic Goods Act 1989. It sets the relevant standards for therapeutic goods listed for export only in the Australian Register of Therapeutic Goods (ARTG) and is specifically designed to ensure the safety and quality of export only medicines. TGO 70C is due to sunset on 1 October 2024. As such, the Therapeutic Goods Administration (TGA) is reviewing the sunsetting TGO with the intention to replace it with a new instrument (i.e. a new TGO) with minor amendments which aim to expand options and increase flexibility for industry whilst safeguarding product safety and quality prior to export.
The TGA is conducting a public consultation and seeking feedback from interested parties on the proposed changes to replace the sunsetting TGO 70C with a new instrument that will contain the following minor amendments:
- Reference to current standards (pharmacopoeia)
- Minor formatting and clarification of existing requirements
Timetable
The consultation opens on Monday 15 July 2024. Interested parties must respond by close of business Monday 26 August 2024.
Enquiries
For enquiries relating to the consultation or your submission, please email tga.exports@health.gov.au.