Procedures after the first marketing autorisation

The division Marketing Authorisation (variations and renewals) manages the requests of variations, renewals, radiations of an already authorised product or parallel import dossiers for medicines for human use. If you wish to contact the division Marketing Authorisation (variations and renewals), you can consult the following link.

Should you wish to submit a new application for authorisation for a medicinal product for human use via the centralised procedure, the mutual recognition procedure, the decentralised procedure or the national procedure? The division Marketing Authorisation (human use) can provide you all the necessary information (Dutch/French).

Last updated on 08/07/2020