Responsible for the service Finnish Medicines Agency Fimea
Renewals and variation applications
After a marketing authorisation has been granted, the holder of a marketing authorisation or registration is obliged to actively maintain the marketing authorisation or registration.
The holder of a marketing authorisation for a medicinal product or traditional herbal medicinal product must notify the authority of all changes that will affect the marketing authorisation documentation of the produ ...
Text edited by: Finnish Medicines Agency Fimea