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 the documents listed in the Best Practice Guide on the Processing of renewals in the Mutual Recognition and Decentralised procedures.
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 portal.
Fees?
You will find more information on the fees to be paid on the FAMHP website.
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