Manufacturing authorisations and/or distribution authorisations of medicines and registrations of active pharmaceutical ingredients are no longer automatically sent in paper format by post to the marketing authorisation holder. The FAMHP is now sending these documents in digital format by e-mail. Marketing authorisation holders can still request paper versions.
A manufacturing or distribution authorisation consists of:
- a first page with general information about the marketing authorisation holder (including name, administrative addresses and places of business),
- a manufacturing authorisation (Manufacturing and Import Authorisation, MIA),
- and/or a distribution authorisation (Wholesale Distributor Authorisation, WDA).
A registration for active pharmaceutical ingredients (Active Pharmaceutical Ingredient Registration, API REG) consists solely of the registration.
From now on the FAMHP will no longer send paper versions but will provide the documents in digital format via e-mail. A paper version can still be obtained on request.
The MIA, WDA and API REG can also be consulted in the EudraGMDP database. This database enables the exchange of information between the public and the competent national authorities in Europe. To guarantee the authenticity and validity of the information in the database, only the competent authorities can upload certificates.
Applications for certificates, SEEN statements and certified copies