Letters regarding marketing authorisations

Amendments are being made to how letters regarding marketing authorisations and variations will be confirmed by the agency

The Icelandic Medicines Agency announces that as of 15 December 2023 changes will be made to how letters regarding marketing authorisations will be confirmed by the agency.

The changes affect letters including issuing of new marketing authorisations, renewals, withdrawals, suspensions and variations. The changes also affect letters regarding accepted applications for temporary exemptions from Icelandic labelling. The changes consist of amendments to how letters are prepared and delivered. As of 15 December 2023, the aforementioned letters will no longer be signed with electronic signatures and only delivered electronically via email.

Also announced is an amendment being made to the preparation and delivery of confirmations of type IA variations. As of 15 December 2023, letters regarding these confirmations will no longer be sent from the agency. IA variations will instead be confirmed via email.

Last updated: December 14, 2023
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