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The Directorate-General INSPECTION of the FAMHP organises two information sessions on Friday 8th September and Monday 2nd October 2017 in the Storck room, SPF Emploi, 1 rue Ernest Blerotstraat, 1070 BRUSSELS.

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.

Following the success of the first session of the recast symposium, the FAMHP organises, as the competent authority, on Tuesday 13th June 2017 a second session of this symposium over the latest official information about the recast.

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.

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.

The document “Exemptions: procedure to be followed for medicines for human use” concerning the exemptions for the obligations for packaging and patient leaflet was recently updated.

A new version (3) of the document ‘National FAQ on variations’ is available.