Transferring a marketing authorisation to a new holder
Transfers of a marketing authorisation to a new holder are national variation applications that do not require an application form. The processing time for an application is 120 days. Holder transfers are subject to a separate fee stated in the Decree on fees chargeable by the Finnish Medicines Agency (PDF). The transfer of marketing authorisation can also be applied during renewal, in which case the separate fee is not charged.
Only the current marketing authorisation holder can apply for a transfer of a marketing authorisation to a new holder.
Content of the application:
- cover letter
- a copy of the agreement between the current and new holder
- suggestions for an SPC, package leaflet and the mock-ups of the proposed labelling (see instructions on creating the files)
- If the medicinal product is in the market, a declaration signed by the QP on assuming responsibility and obligations for the previous holder’s packaging
The transfer will become valid on the date of the decision or on a date separately agreed upon with the applicant. The packaging of the old and new marketing authorisation holder may not be simultaneously on the market. If justified, Fimea may grant a permission to keep the old and new holder’ packages simultaneously on the market for a maximum of six months.