The EU's Better Regulation policy aims notably at simplifying and improving existing regulation. In this context, the “e-submission guidelines" concerning the electronic submission of dossiers for variation of marketing authorization of medicines for human use has been updated. The date of implementation of this new version has been set at 01.06.2010.
The FAMHP would like to bring to the attention of the Marketing Authorisation (MA) or registration holders of medicines the publication of a new version of the document concerning the application of measures relating to the sunset clause in Belgium for medicinal products authorised at the national level. This document outlines the basic rules of the sunset clause and provides all the information on exemptions.
In view of the incidents reported with the use of breast implants manufactured by the company PIP in France, the « Agence Française de Sécurité Sanitaire des Produits de Santé » (AFSSAPS) conducted an inspection. This has highlighted the use in the manufacture of these implants of a silicone gel different from the one approved. As a precaution, the FAMHP, like the AFSSAPS, asked distributors of these implants, pharmacists, physicians and persons who use them, to stop the distribution, delivery, use and export, waiting for the results of controls carried out by the AFSSAPS.