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  • 21.12.2015: final date for submitting requests for "STA"

    09-12-2015

    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.

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  • December 20 and 22, 2015 : final dates for submitting dossiers « Marketing Authorisation/ Registration » and « « Research & Development »

    13-11-2015

    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.

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  • New version of « e-Submission guidelines » (v2.13)

    04-11-2015

    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.

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ALL NEWS

Last updated on 23 September 2015

PIL and SPC
of a medicine

(PIL: patient information leaflet SPC: summary of product characteristics)

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