Proposed new notifications process: registered medicines

26 July 2017

As identified in the Review of Medicines and Medical Devices Regulation (MMDR), we are improving our risk-based approach to the management of variations to registered medicines.

A key improvement is the introduction of a 'notifications' process for very low risk changes to all registered medicines.

Legislative changes

The amended Therapeutic Goods Regulations 1990 set out the types of variations that are processed as notifications.

For registered non-prescription medicines (OTC and registered complementary medicines), these came into effect from 1 July 2017.

Notifications to prescription medicines (biological medicines and chemical entities) will commence once further development of the new e-form for minor variation applications allows automated electronic processing of these variation types (before 1 January 2018).

Guidance

Guidance on the new notification process is provided below.

Proposed implementation timeframes

Pending the finalisation of legislative changes, we anticipate the following implementation timeframes:

Timing Activity
1 July 2017 Automated notification process implemented for registered non-prescription medicines
July 2017 The new e-form for minor variations to prescription medicines is available through the TBS portal
Before 1 January 2018 Automated notification process implemented for prescription medicines

Non-notification variations

Minor variation applications that are not notifications must continue to be requested using existing processes. Further information and guidance is available on the TGA website: