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The Antimicrobials Working Party from the European Medicines Agency (EMA) has published an important reflection paper on off-label use and the application of the cascade system for antibiotic therapy in animals.

On 30th June 2017 the eighth BelVet-SAC (Belgian Veterinary Surveillance on Antibiotic Consumption) report was published, containing the results of antibiotic use in cattle breeding.

The new law on clinical trials has been published in the Belgian Official Gazette (Moniteur belge/Belgisch Staatsblad) on 22 May 2017. Following this occasion, the Federal Agency for Medicines and Health Products (FAMHP) will organise a symposium on clinical trials on 26 September 2017 in Brussels.

The VACCINES spearhead from the FAMHP organises a symposium on vaccinology on Saturday 9 th September 2017 at the Hotel Pullman (Brussels). 

In October 2018 the new clinical trial regulation 536/2014 (CTR) is foreseen to enter into force. This important change in legislation targets administrative simplification and harmonization in Europe.

The unit Scientific-Technical Advice & Knowledge Management has the pleasure to invite all those who are interested to the afternoon workshop “National & EU scientific regulatory support mechanisms and initiatives for innovation in drug development” organised by the federal agency for medicines & healthcare products (famhp) on Monday 02/05/2016.

As the famhp will be closed between Christmas and New Year, and to minimize the administrative backlog, we advise you to foresee December 21st, 2015 as the final date for submitting requests for national scientific and/or technical-regulatory advice. New requests for scientific and technical regulatory advice that are received after December 21st, 2015 will not be validated before we start our activities again on Monday January 4th, 2016.

As the famhp will be closed from Christmas to the New Year, we advise you to foresee December 20, 2015 as the final date on the one hand for submitting requests for new marketing authorisations, variations, renewals and requests for parallel importation for medicines for human use or veterinary use, on the other hand to foresee December 22, 2015 as the final date for the submissions introduced to the Division “Research & Development”. The validation of dossiers submitted after this date will only start on January 4, 2016.

The famhp has updated the e-Submission guidelines in order to underline the required use of the electronic application form starting from the 1st of January 2016.

The document ‘New definition of the approval date in SmPC and leaflet’ was recently subject to adjustments.