Pending marketing authorisation applications

Pursuant to the Act on the Openness of Government Activities (621/1999), the Finnish Medicines Agency Fimea maintains a list of all marketing authorisation applications currently being processed at Fimea, and updates the list every two weeks.

The list contains information on the applicant, the nature of the application, the start time of the process and the number of applications, grouped according to the ATC classification and the active substance. The list does not include marketing authorisations being applied through the centralised procedure; requests for information concerning these authorisations should be submitted to the European Medicines Agency (EMA).

Requests concerning other Fimea documents should be submitted to the following address:

Finnish Medicines Agency Fimea
Registry
P.O. Box 55 (Mannerheimintie 166)
FI-00034 FIMEA, FINLAND