As a sponsor, you have ongoing responsibilities while your therapeutic good remains on the ARTG.
Make changes through TGA Business services
You have access to your TGA Business service account to make changes to your medicine at any time.
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PageVary your Australian Register of Therapeutic Goods (ARTG) entry for your non-prescription medicine
Ongoing compliance of your non-prescription medicine
Your medicine can be randomly selected or targeted for a post-market review to ensure compliance. Remember that it is the sponsor's responsibility to remain compliant with any relevant legislation.
We can also target-review any advertising of your therapeutic good. Often this stems from investigating complaints received about advertising. See: Labelling and advertising non-prescription medicines for more information.
See: Compliance management for more information about remaining compliant.
Medicine recalls
Any medicine may be required to be recalled from the Australian market. You need to be aware of the processes around recalls and what your responsibilities are.
See: Manage a recall
Medicines shortages
Over the counter (OTC) medicines are required to report any medicine shortages.
See: Medicine shortages: Information for sponsors (suppliers)
Pharmacovigilance
The TGA has a Pharmacovigilance Inspection Program (PVIP) where we continually monitor and evaluate the safety and efficacy (performance) profile of therapeutic products and manage any risks associated with individual products.
The PVIP is a product vigilance program designed to facilitate the collection and evaluation of safety information relating to all medicines on the ARTG. It involves TGA representatives interviewing sponsors and reviewing documents in order to assess the sponsor's compliance with pharmacovigilance requirements.
This program is different to the post-market reviews of listed non-prescription medicines.
See: Pharmacovigilance inspection program for more information.