Renewal

According to article 9 of the Royal Decree of 3rd July 1969 (French version) relating to the registration of medicinal products, the registration of a medicinal product was valid 5 years and was renewable for a five-year period, at the request of the person responsible for the MA, introduced during the 3 months preceding the deadline.

Following the application of the new pharmaceutical legislation transposing Directive 2004/27/EC establishing a Community Code on medicinal products for human use (amending Directive 2001/83/EC), including the Law of 1 May 2006 (French version) amending the Law of 25th March 1964 (French version) on medicinal products and the Royal Decree of 14th December 2006 (French version) (part 1 - part 2) on medicinal products for human and veterinary use, registration or marketing authorisation of a medicine has now an indefinite period of validity after a first renewal, unless for justifiable reasons related to pharmacovigilance, it is decided to extend for 5 years even a marketing authorisation or a registration.

Circular 490 (French version) of 3rd May 2007 (+ addendum + application form + guidance) specify the circumstances under which an application for renewal of registration or marketing authorisation of a medicinal product should or should not be introduced with effect from 01/01/2007, date of application of the aforementioned Decree of 14/12/2006.

From june 2013 any application for renewal of a national Marketing Authorisation for a medicinal product for human use, granted under the national procedure or MRP procedure, must be submitted at least 9 months before the expiry of the validity. No periodic safety report must be added to the dossier, but the dossier must contain all the documents as described in Annex 3 of the ‘Best Practice Guide on the Processing of renewals in the Mutual Recognition and Decentralised procedures’.

Applications may be submitted via e-mail to the following address: dispatching@fagg-afmps.be (link sends e-mail)

Files on CD Rom or DVD should be sent to the following address:

Federal Agency for Medicines and Health Products
Marketing authorisation Division – Variations & Renewals
Dispatching Unit
Eurostation II
Place Victor Horta 40/40
1060 Brussels

It is also possible to submit a renewal dossier via CESP (Common European Submission Portal). More practical information about the use of CESP, can be consulted through the website of CESP.

Since 1st June 2016 the use of the electronic application form for the submission of a renewal of a marketing authorisation is obliged. This form can be consulted through the following link: http://esubmission.ema.europa.eu/eaf/index.html.

The fee for a renewal can be consulted through the following link: https://www.fagg-afmps.be/sites/default/files/downloads/reg-EN-2016-01.pdf.

Last updated on 18/07/2017