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Greinasafn
December 17, 2021
09. Who is responsible for the payment of a MAH transfer? Current or proposed MAH?
December 17, 2021
08. What does a transfer of a marketing authorisation to a new MAH cost?
December 17, 2021
07. Is it possible to submit any variations while there is an ongoing MAH transfer procedure?
December 17, 2021
06. Can a change in MA transfer application be submitted while variations affecting the medicinal product are still pending?
December 17, 2021
05. Notification of a new representative – applies to all types of authorisation procedures
December 17, 2021
04. Once the MA is transferred to the new owner, for how long can stocks be sold using the details of the previous MA holder?
December 17, 2021
03. What is the estimated IMA´s timeframe for approval of a Marketing Authorisation Holder transfer?
December 17, 2021
02. Upon transfer of Marketing Authorisation for a medicinal product who shall apply for the transfer: the current or the proposed Marketing Authorisation Holder?
December 17, 2021
01. Transfer of a marketing authorisation for a medicinal product to a third party – applies to national, as well as DCP and MRP authorisations.