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eCTD format mandatory for MRP-procedures

From 1st of January 2018 the eCTD format will become mandatory for variations of human medicines via the Mutual Recognition Procedure (MRP).

Publication of the updated CTFG Q&A-Reference Safety Information (RSI) document

The Q&A-RSI document provides updated details on RSI requirements based on shared experiences since 2013.

Reporting the commercialisation of medicinal products to the FAMHP

Notice to pharmaceutical companies concerning the reporting of the commercialisation of medicinal products to the FAMHP.

December 18, 2017: final date for submitting dossiers during the Christmas holidays

During the Christmas holidays, the FAMHP will be closed from Monday December 25, 2017 until Monday January 1, 2018 included.

New from the FAMHP: the Flash VIG-news

Following the results of the satisfaction survey, the Vigilance Division will now publish brief reports on current topics via the Flash VIG-NEWS.

Delivery status of medicinal products on the FAMHP website: call for verification by marketing authorisations holders

In the interest of transparency, as of March 2018, the FAMHP will include the subcategories of the legal status of medicinal products with restricted medical prescription in the public database on the FAMHP website. From that date, the subcategory for medicinal products with restricted medical prescription will be offered to the physicians and pharmacists software. Holders of a marketing authorisation for a medicinal product (MA) may verify the legal status of their medicinal products before publication.

The FAMHP publishes its annual report 2016

The Federal Agency for Medicines and Health Products (FAMHP) published its annual report 2016.

Information session on auto control of the sector of medical devices 30 October 2017

Following the success of the two previous information sessions on this issue, the Directorate-General INSPECTION of the FAMHP organises a third information session on Monday 30 October 2017 in the Storck room, FPS Employment, 1 rue Ernest Blerotstraat, 1070 BRUSSELS.

Update on the new Clinical Trial Regulation pilot + call for candidates

As previously reported, the FAMHP has started a pilot for clinical trials in Belgium in collaboration with the new college charged with designation the ethics committee for the evaluation of clinical trials, the current ethics committees and sponsors of clinical trials.

Workshop on Pharmacometrics – 23 November 2017

Prior to the Pharmacometrics Network Benelux meeting, researchers from Ghent University (Universiteit Gent), Groningen University (Rijksuniversiteit Groningen) and the FAMHP will co‑organise an introductory workshop regarding the use of pharmacometrics.

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