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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.

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.

Since October 1, 2015 the famhp has new phone numbers. From now on you can contact us at this phone number: + 32 2 528 40 00 (reception).

To ensure that marketing autorisation holders are kept informed about the progress of their submitted files (obtaining a new licence, as well as variations, notifications and renewals), our IT-system sends out automatic mails. It seems, based on several notifications errors that we received, that certain e-mail addresses are no longer valid. An update of these addresses is necessary.

The federal agency for medicines and health products (famhp) published its annual report 2014 today.