Following the indexing of the fees for the missions undertaken by the Federal Agency for Medicines and Health Products (FAMHP) the tables have been adapted and came into effect on 01.01.2010.
New regulation for variations of the dossiers for marketing authorization for medicines for human use: warning
The new "variations" regulation came into force on 01/01/2010. Given the technical problems encountered during the update of the computer programme to send mails automatically following the introduction of a dossier, new versions of these mails corresponding to the new regulation, which should have been available from 01/01/2010, were not ready on that date. Everything will be done to make the necessary adjustments as quickly as possible.
Belgium participates in an operation in the fight against internet sales of counterfeit and illegal medicines (PANGEA II).
From 16th to 20th November 2009 an international coordination programme focusing on internet sales of counterfeit and illegal medicines was undertaken. The aim was to draw attention to the risks of selling medicines via the internet. This was the fifth operation by the MHRA (Medicines and Healthcare products Regulatory Agency, United Kingdom).
The European Medicines Agency (EMEA) is warning that young children may experience fever after their second dose of the pandemic influenza vaccine Pandemrix. This risk, which is already present after the administration of the first dose of this vaccine, is higher after the administration of the second dose.
The European Medicines Agency (EMEA) issued, as part of the A/H1N1v influenza pandemic, the first report in the weekly update on the monitoring of adverse reactions related to vaccines and antiviral medicines used in Europe.
As part of the national campaign of vaccination against influenza virus A/H1N1v, the Federal Agency for Medicines and Health Products (FAMHP) has implemented a programme to monitor adverse reactions of the vaccine used in Belgium (Pandemrix). This programme fits into the European risk management plan and completes it. A first report is now available.
The Federal Agency for Medicines and Health Products has recently approved a type II variation introduced by the company Merial for the extension of 6 weeks for the shelf life of the vaccine BTVPUR AlSap 8 against the bluetong virus (BTV) serotype 8. This exceptional approval applies only to some batches of BTVPUR AlSap 8, in order to meet the needs of the compulsory BTV vaccination campaign which ends on 31st December 2009.
Any holder of Belgian marketing authorisation (MA) or registration of medicines for human or veterinary use must notify the Federal Agency for Medicines and Health Products (FAMHP) the name of the person responsible for pharmacovigilance. Circulars 544 and 545 are a reminder of that obligation and provide practical information about it.
European Medicines Agency (EMEA) makes recommendations to minimise risk of nephrogenic systemic fibrosis with gadolinium-containing contrast agents. In Belgium, they are marketed under the following names: Dotarem, Gadovist, Magnegita, Magnevist, Multihance, Omniscan, Optimark, Prohance et Vasovist.
Information session on Friday 11th December for applicants for marketing authorisation (MA) for medicinal products for human use
pharma.be (General Association of Pharmaceuticals Manufacturers) and FeBelGen (Federation of Belgian generic drugs companies) are organising, in collaboration with the Federal Agency for Medicines and Health Products (FAMHP) an information session on how to manage applications for Marketing Authorisation for medicinal products for human use. This will take place on Friday 11 December at 1 pm in Sodehotel la Woluwe (Avenue E. Mounier 5, 1200 Brussels)