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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 Heads of Medicines Agencies (HMA) has published a statement of intent related to the replacement of the eAFs by the CESSP. As outlined in the eSubmission Roadmap, the current Common European Submission Platform (CESP) and the EMA eSubmission Gateway will be integrated into a Single Submission

During the Christmas holidays, famhp will be closed from Monday 26 December 2016 until Friday 30 December 2016 included.

The unit Scientific-Technical Advice & Knowledge Management has the pleasure to invite all those who are interested to the morning workshop “Famhp & EMA initiatives to support innovative drug development: implementation of a National Innovation Office as part of the EU Innovation Network” organised by the federal agency for medicines & healthcare products (famhp) on Thursday 01/12/2016. This interactive workshop will be held at famhp’s offices in Brussels and is free of charge..

The federal agency for medicines and healthcare products (famhp) prepares the implementation of a National Innovation Office in order to promote and facilitate the research and development of new innovative medecines in Belgium. In this context famhp has developed a questionnaire, in order to fine-tune famhp’s current plans for implementing a National Innovation Office and to align the objectives of the Innovation Office to the current and future needs of SME’s and academia.

The federal agency for medicines and health products (famhp) published its annual report 2015.

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.