We can monitor non-prescription medicines that are supplied in the Australian market by conducting compliance reviews. These can include desk top auditing or testing of product samples available in the marketplace.
This monitoring program ensures non-prescription medicines comply with relevant regulatory requirements supporting safety, quality and efficacy.
Post-market compliance reviews inform regulatory measures that we may impose to safeguard Australian consumers.
Post-market reviews of listed and assessed listed medicines
Rather than conducting pre-market assessment, the TGA assures the safety of listed and assessed listed medicines through post-market reviews.
Post-market reviews ensure that listed and assessed listed medicines comply with applicable regulatory standards and requirements, for example, ensuring sponsors have manufactured their medicine in accordance with Good Manufacturing Practice (GMP).
Where a post-market review identifies compliance issues, the non-prescription medicine may be cancelled from the Australian Register of Therapeutic Goods (ARTG).
We currently use random selection and information from external sources (for example, suspected adverse reactions and marketplace surveillance) to identify medicines for post-market review.
See: Listed medicine compliance reviews and Listed medicine compliance rating scheme for more information.