National procedure

 

The national procedure is mainly used in cases where Finland is the first EU Member State in which the marketing authorisation is sought for. In most cases this means that the applicant later intends to use of Finland as the Reference Member State in a Mutual Recognition Procedure. The Finnish Medicines Agency is expected to process the application, which should be compiled in accordance with the Fimea regulation, within 210 days of its receipt.

The Finnish Medicines Agency for will assess the efficacy, safety and quality of the medicine in question and, if necessary, employ outside experts in the process.