Proposed new notifications process: registered medicines
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.
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 on the new notification process is provided below.
- Notifications process: Requests to vary registered medicines where quality, safety and efficacy are not affected (Version 1.0)
Proposed implementation timeframes
Pending the finalisation of legislative changes, we anticipate the following implementation timeframes:
|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|
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:
- Process to change a registered OTC medicine
- Online applications for registered complementary medicines
- Minor variations to prescription medicines, Appendix 1: Variation change types - chemical entities
- Minor variations to prescription medicines: Appendix 2: Variation change types - biological medicines