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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.

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 It seems, based on several notifications errors that we received, that certain e-mail addresses are no longer valid.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.

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.

The new edition of the electronic newsletter "VIG-NEWS" of the federal agency for medicines and health products (famhp) is now available. The VIG-NEWS is a selection of recent news concerning pharmacovigilance from different sources.

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.

Due to a reduction in the manufacturing capacity for the vaccines HAVRIX 1440 and HAVRIX JUNIOR 720 (GSK), used to protect adults and children against hepatitis A, and in order to limit the impact of these supply shortages, alternatives are being proposed The Superior Health Council (SHC) details the correct use of the proposed alternatives in advice number 9260: Recommendation concerning the risk on the shortage supply for hepatitis A vaccine.

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.