We have changed the way to make submissions.
Submissions now should be provided through our consultation hub.
This consultation closes on 10 November 2022.
The Therapeutic Goods Administration (TGA) is conducting a public consultation seeking feedback on whether certain international scientific guidelines should be adopted.
International scientific guidelines are not limited to prescription medicines, but may also apply to over-the-counter (OTC), complementary and some listed medicines. While guidelines that are adopted in Australia are generally not mandated by legislation, they provide guidance to sponsors to assist them to meet the legislative requirements and any deviation from a Guideline relevant to an application to register or vary the registration of a medicine must be justified.
For more information on the international scientific guidelines, and to participate in the consultation, please visit the consultation hub.
Timetable
The consultation opens on Thursday 29 September 2022. Interested parties should respond by close of business Thursday 10 November 2022.
Enquiries
For enquiries relating to the consultation or your submission please email euguidelines@health.gov.au.
All recent TGA consultations can be found at the TGA consultation hub.