Under the auspices of the Belgian Chairmanship of the Council of Europe, the European Directorate for the Quality of Medicines & Healthcare (EDQM) organised as part of the celebration of its 50th anniversary, together with the Belgian Federal Agency for Medicines and Health Products (FAMHP) a journalist’s workshop to present the activities of the two institutions and discuss the role the media can play in issues directly affecting patients such as the fight against falsification of medicines and the usage, perception and quality of generic medicines.
As the FAMHP will be closed between Christmas and New Year, we advise you to foresee December 15, 2014 as the final date for submitting requests for new marketing authorisations, variations, renewals and requests for parallel importation for medicines for human use or veterinary use. The validation of dossiers submitted after this date will only start on January 5, 2015.
On the 27th of May a new Regulation on clinical trials was published in the European Official Journal. This new Regulation will replace the national legislation on clinical studies with medicinal products. In Belgium, this is described in the Law on experiments on the human person.