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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 registration@fagg.be. 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.

As the FAMHP will be closed between Christmas and New Year, we advise you to foresee December 15, 2014 as the final date for submitting requests for new marketing authorisations, variations, renewals and requests for parallel importation for medicines for human use or veterinary use. The validation of dossiers submitted after this date will only start on January 5, 2015.

On the 27th of May a new Regulation on clinical trials was published in the European Official Journal. This new Regulation will replace the national legislation on clinical studies with medicinal products. In Belgium, this is described in the Law on experiments on the human person.

As the FAMHP will be closed between Christmas and New Year, we advise you to foresee December 13, 2013 as the final date for submitting requests for new marketing authorisations, variations, renewals and requests for parallel importation for medicines for human use or veterinary use. The validation of dossiers submitted after this date will only start on January 3, 2014.

The FAMHP has updated the list of dossier types for which it wishes to receive your submission via the «Common European Submission Platform » (CESP)

From the 1st September 2013 the new NeeS validation criteria (v4.0) need to be used regarding the technical validation of marketing applications for human medicinal products. The NeeS checker v4.0 (September 2013 release) is therefore adapted.

The strategy document of famhp aimed at limitingb the sizes and types of packaging of narcotic medicines used for the treatment of pain, available in pharmacies open to the public, has been updated. Version 4.3 is now available.

For the entry into force of the Royal Decree (RD) of 17th June 2013 all medicines containing codeine or codeine derivatives (dihydrocodeine, ethylmorphine, thebacon), whether pharmaceutical products or magistral and officinal preparations, can only be delivered on prescription.

Following the publication in the Belgian Official Journal of the Royal Decree of 28th May 2013 amending the Royal Decree of 14th December 2006 on medicinal products for human and veterinary use, the famhp wrote three circulars on the new legislation about pharmacovigilance. Circular 599 concerns their practical application. Circulars 600 and 601 specify the new requirements concerning the local persons responsible for pharmacovigilance for medicinal products for human use and for medicinal products for veterinary use respectively.