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  • VIG-NEWS: January 2015 Edition

    03 February 2015

    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.

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  • Call Center “registration”: Expansion team in 2015

    21 January 2015

    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.

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  • Supply shortages for HAVRIX 1440 and HAVRIX JUNIOR 720 (GSK)

    12 January 2015

    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.

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  • EDQM, Council of Europe and FAHMP meet the media

    21 November 2014

    Under the auspices of the Belgian Chairmanship of the Council of Europe, the European Directorate for the Quality of Medicines & Healthcare (EDQM) organised as part of the celebration of its 50th anniversary, together with the Belgian Federal Agency for Medicines and Health Products (FAMHP) a journalist’s workshop to present the activities of the two institutions and discuss the role the media can play in issues directly affecting patients such as the fight against falsification of medicines and the usage, perception and quality of generic medicines.

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  • 15/12/14: deadline for the submission of dossiers for marketing authorisations

    14 November 2014

    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.

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  • New Regulation on clinical trials

    28 May 2014

    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.

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  • 13/12/13: deadline for the submission of dossiers for marketing authorisations

    20 November 2013

    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.

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  • Electronic submission of dossiers concerning marketing authorizations via CESP: update

    18 October 2013

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

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  • Electronic submissions for marketing applications for human medicinal products: new version of the checker

    30 August 2013

    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.

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  • Narcotics used for the treatment of pain: a new version of the document on the size and type of packaging

    29 July 2013

    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.

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Cette section présente les différentes nouvelles émises par l'AFMPS...

Last updated on 22 January 2013

5-year celebrations at famhp!

On this occasion the famhp has adopted a new visual identity and a new logo.

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PIL and SPC
of a medicine

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

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