Renewal of marketing authorisations
The renewal procedure involves a review of the latest safety issues related to pharmacovigilance, such as the adverse reactions caused by the product. Provisions concerning the renewal of marketing authorisations are given in the Fimea’s Administrative Regulation 2/2013 entitled ‘Applying for and maintaining a marketing authorisation and registration for a medicinal product’.
An application for the renewal of a marketing authorisation must be filed with the Finnish Medicines Agency at least six months prior to the date when the current marketing authorisation expires.
No variations to the marketing authorisation may be notified or applied for in connection with its renewal.