Practical information on the renewals of licenses for marketing a medicinal product for human use.
Since the implementation of the new pharmaceutical legislation that converts the European directive 2004/27/EU into Belgian law, an authorisation for marketing a medicinal product (Marketing Authorisation (MA)) for human use is valid for 5 years. After a first renewal, this converts to unlimited validity.
In some cases the decision can be taken to extend the MA once for a period of five years for reasons of pharmacovigilance.
Composition of an application
From June 2013, an application for renewal of a national MA must be submitted via the national or MRP procedure at least nine months prior to the expiration of validity.
The file must contain all documents listed in annex 3 of the Best Practice Guide on the Processing of renewals in the Mutual Recognition and Decentralised procedures. For generic medicines or medicines with a bibliographic reference authorised via the national procedure, the clinical oversight from module 2 may be limited to a clinical opinion by an expert. An application consisting of just a cover letter and an electronic application form as described in point 3.5 of the Best Practice Guide on the Processing of renewals in the Mutual Recognition and Decentralised procedures is not acceptable for national renewals.
Since 1 January 2016, the use of the electronic form for the submission of a file to renew the MA is obligatory.
How to submit the application
- The applications are preferably submitted via the CESP (Common European Submission Portal). More practical information via the CESP.
- You may also submit a renewal file via email@example.com.
- Files on CD-ROM or DVD are sent to:
Federal Agency for Medicines and Health Products
DG POST authorisation / Marketing Authorisation Division / Variations & Renewals / Dispatching
Avenue Galilée - Galileelaan 5/03
You will find more information on the fees to be paid on the FAMHP website.