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.
December 20 and 22, 2015 : final dates for submitting dossiers « Marketing Authorisation/ Registration » and « « Research & Development »
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.
To the attention of the holders of Mas for medicinal products for human use : update of the document ‘New definition of the approval date in SmPC and leaflet’
The document ‘New definition of the approval date in SmPC and leaflet’ was recently subject to adjustments.
To the attention of the holders of Mas for medicinal products : update of the document "Exemptions: procedure to be followed for medicines for human use"
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.
To the attention of the holders of MA for medicinal products for human use : update of the FAQ on Variations.
A new version (3) of the document ‘National FAQ on variations’ is available.
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 It seems, based on several notifications errors that we received, that certain e-mail addresses are no longer valid.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.
To the attention of holders of MA’s: new definition for the approval date mentioned in SmPC and PIL.
When the administratively closing of a variation or renewal leads to an update of the marketing authorization (MA), a new methodology to determine the approval date mentioned in the summary of product characteristics (SmPC) and patient leaflet (PIL) will be used from 15/6/15.
Due to an underemployment within the Call Center Registration in 2014, this resulted in a delay in the processing of the daily requests send to email@example.com. In the meantime the team has been expanded and a procedure has been worked out in order to absorb the delayed requests. As for the new requests, a workflow has been worked out in order to increase the efficiency.