The Therapeutic Goods Administration is experiencing system issues linked to global Microsoft outages. Some services may be disrupted and we may take longer to respond to email and phone contact during this time.
While the consultation is open, you can make a submission at 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.
The Therapeutic Goods Administration (TGA) is seeking feedback on proposed actions to address ambiguity in compliance with applicable standards for listed medicines.
Under the Therapeutic Goods Act 1989 (the Act), the person who holds the listing of a medicine on the Australian Register of Therapeutic Goods (ARTG) (the Sponsor) is required to ensure that all therapeutic goods intended for inclusion on the ARTG comply with applicable standards. Ensuring product quality and labelling meets established standards supports the safety and efficacy of medicines supplied to the Australian public.
There is currently a lack of clarity for Sponsors as to whether requirements in the United States Pharmacopeia-National Formulary (USP-NF) for dietary supplements are mandatory requirements for medicines listed in the ARTG and supplied in Australia.
The proposed actions outlined in this consultation seek to address this uncertainty.