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. 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)
The transfer will become valid on the date of the decision or on a date separately agreed upon with the applicant. The new marketing authorisation
or registration holder shall submit a notification when the medicinal
product has been placed on the market with the new holder’s labelling. The packaging of the old and new marketing authorisation holder may not be simultaneously on the market. If the transfer to the new
holder of responsibilities and liability relating to the packages of the old
holder in connection with the transfer of the marketing authorisation or registration
has been included in the contract between the holders, the packages
of the old holder and the new one can be released simultaneously to
the market for a maximum of six months. The marketing authorisation
or registration holder shall present the request for simultaneous
marketing and the justification in connection with the application.