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Proposed new notifications process: registered medicines
In 2017, we introduced a 'notifications' process for very low risk changes to biologicals and to registered medicines. This process was implemented in two stages:
- notifications to registered non-prescription medicines launched in July 2017
- notifications to biologicals and prescription medicines launched in December 2017.
The new notifications processes are part of our improved risk-based approach to the management of variations. These have been implemented in response to recommendations arising from the Review of Medicines and Medical Devices Regulation (MMDR) and to help align the biologicals framework and our regulation of medicines.
The process for registered medicines
Under the notifications process, an applicant uses an electronic form to request that certain types of changes be made to their medicines. As part of this request, the applicant will be required to make legal assurances that all of the conditions specific to the variation are met.
Once the relevant fee is paid, the request is automatically processed:
- the change is approved
- an acknowledgement letter is sent and
- the affected ARTG entries updated.
The sponsor can then make these changes to their medicine.
Note: Manual processing and approval is still required for notifications to biologicals.
Guidance on the notification process and the types of changes allowed to be notified is provided below.
- Notifications process: Requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected
Further information and guidance on minor variations is available at: