EMA encourages companies to submit type I variations for 2020 by end of November

The European Medicines Agency (EMA) has advised marketing authorisation holders (MAH) to submit type IA and type IAIN variations for 2020 no later than Monday 30 November 2020.

This will enable EMA to acknowledge the validity of the submissions within the 30-day timeframe set out in Article 14 of Commission Regulation (EC) No 1234/2008, and before their annual closure between 24 December 2020 and 4 January 2020.

Type I variations are minor changes to a marketing authorisation of a medicine. Type IAIN and IA variations have no impact on the quality, safety or efficacy of the medicine. Type IAIN variations must be notified to the national competent authority (NCA) or EMA immediately following implementation, in order to ensure continuous supervision of the medicine. However, type IA variations can be notified to the NCA or EMA within 12 months of implementation.

MAHs planning to report a Brexit-related Type IA/IAIN variation after the cut-off date, i.e. in December 2020, will receive the acknowledgment of the validity of the submission within 30 days as usual.

Type IB variations must be notified to NCAs or EMA before implementation, but do not require a formal approval. Upon acknowledgement of receipt of a valid notification, the marketing authorisation holder must wait for 30 days to ensure that the notification is deemed acceptable by the NCA or EMA before implementation.

Type IB variations and groupings of type IB and type IA variations are encouraged to be submitted by 4 December 2020 for a start of procedure in 2020. For submissions received on or after 7 December 2020, the procedure may not start until January 2021.

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