New instructions for the submission of an application for renewing a marketing authorization

Since 1st September 2010 any application for renewal of a marketing authorisation (MA) for a medicine for human use, granted under the national procedure, must be submitted to the Marketing Authorisation Division – Variations & Renewals of the FAMHP.

Under the provisions of Article 6 of the law of March 25th 1964 on drugs, a MA is valid for 5 years.

The validity of the MA can be extended after the 5 years at the request of the MA holder. After this extension the MA is valid for an unlimited period unless, for justified grounds relating to pharmacovigilance, it is decided to prolong the MA for 5 years.

Article 37 of Royal Decree of 14th December 2006 on medicinal products for human and veterinary use states that the application for renewal of the MA must be submitted at least six months before the expiry of its validity.

An application for renewal must be submitted for medicines for which an application for renewal has not yet been introduced (first renewal) and for which a second renewal is sought for reasons of surveillance.

Previously the applications for renewal of MA were sent to the Vigilance Division.

Since 1st September 2010 they must be sent to the Marketing Authorization Division – Variations & Renewals

or by e-mail at the following address: dispatching@fagg-afmps.be 

or by post to the following address:
Federal Agency for Medicines and Health Products
Marketing Authorization Division – Variations & Renewals
Dispatching Unit
Eurostation II
Place Victor Horta 40/40
1060 Brussels

 

Last updated on 25/01/2013