Consultation: Medicine shortages and discontinuations - Reportable medicines and timeframes for reporting discontinuations

While the consultation is open you can make a submission at our consultation hub.

We review the submissions. After that the submissions and our decision will be available on the same consultation page.

About this consultation

We are seeking feedback on proposed improvements to TGA’s regulatory framework for medicine shortages and discontinuations in Australia. Specifically:

1. Add more critical non-prescription medicines to the list of reportable medicines, which would require sponsors of those medicines to report shortages and discontinuations to the TGA.
2. Update the Therapeutic Goods Act 1989 to enable the TGA to require detailed supply information from sponsors of any medicines, not just reportable medicines.
3. Require sponsors to provide 12 months’ notice to the TGA of a decision to permanently discontinue supply of any reportable medicine in Australia.

These proposed changes are in response to feedback about the challenges and barriers associated with medicine shortages and discontinuations.

All recent consultations can be found on our TGA Consultation hub.