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 authorization 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 authorization 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 authorization 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.
Since 1st September 2010 any application for renewal of a marketing authorization for a medicinal product for human use, granted under the national procedure, can no longer be sent to the Vigilance Division of DG POST Authorization, but must be submitted to the Marketing Authorization Division - Variations & Renewals.
Applications may be submitted via e-mail to the following address: dispatching@fagg-afmps.be
Files on CD Rom or DVD should be sent 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
Given the number of renewal dossiers being handled and the enormous workload that required by the careful assessment of these dossiers in order to grant a registration or marketing authorization for an unlimited period, a backlog has occurred.
The Directorate General Post of the Federal Agency for Medicines and Health Products (FAMHP) decided to take further measures to remedy this backlog of five-year renewal dossiers of registrations / MAs for medicinal products for human use granted under the national procedure.
To facilitate the processing of these renewal dossiers, a new procedure involving the following key elements has been implemented:
- The information to be provided by MA holders upon submission of the dossier must be well defined.
- The period granted to the firms to answer to requests for additionnal information will be limited to 6 months.
- Whenever possible, the FAMHP will try to forward with his first letter to the firm (1st round) all the comments on the dossier. Firms should also endeavour to provide a complete answer to this first letter to avoid lengthening the procedure.
- A risk analysis will be conducted for non-marketed medicinal products.
- Firms should consider the Core Safety Profile agreed in the PSUR Work Sharing procedure for writing the summary of product characteristics (SPC) and the patient leaflet of the concerned medicinal product.
- The SPC and the leaflet of a "copied" medicine or of a generic medicine must be aligned with the documents of the original medicine.