Consultation on the sunsetting Therapeutic Goods Order No.70C - Standards for Export Only Medicine

Overview

Therapeutic Goods Order No. TGO 70C (TGO 70C) – Standards for Export Only Medicine (https://www.legislation.gov.au/F2014L00683/asmade/text) is a relevant standard for therapeutic goods which are listed for export only in the Australian Register of Therapeutic Goods (ARTG). TGO 70C is due to sunset on 1 October 2024. The Therapeutic Goods Administration (TGA) Export Unit as part of the Prescription Medicines Authorisation Branch (PMAB) is reviewing the sunsetting TGO with the intention to replace this with a new instrument (i.e. a new TGO) with a number of minor amendments/changes which aim to expand options and increase flexibility for industry whilst safeguarding product safety and quality prior to export. 

The TGA proposes to replace the sunsetting TGO with a new instrument that will contain the following minor amendments:

• Reference to current standards (pharmacopoeia);
• Minor formatting and clarification of existing requirements.

Further information is available in the attached TGO70 consultation paper.

Why your views matter

Export only medicines cover a wide range of medicines such as prescription medicines, complementary medicines, medicinal cannabis, over-the-counter medicines, and cosmetic type medicines such as sunscreens. 

TGO 70C is specifically designed to ensure that appropriate safety and quality benchmarks apply to export only medicines. This is complemented by provisions in other TGA standards to expressly carve out export only medicines from their scope.

It is expected that the impact of replacing the current TGO with a new instrument that is current and clearly sets out the requirements for export only medicines, will be positive and welcomed by sponsors and industry. The likely impacts include: a clearer understanding for sponsors of the standards that can be used to facilitate the listing of an export only medicine in the ARTG; in addition to a more fit-for-purpose TGO which keeps pace with medical advancements and drug discovery, whilst ensuring product quality and safety is balanced with minimally required regulatory burden.

The TGA Export Unit welcomes any type of feedback from all impacted stakeholders including but not limited to sponsors, manufacturers and peak industry organisations.

What happens next

We will be reviewing and analysing all feedback received and updating the results on this page.