1. August 30, 2022

    The FAMHP is looking for a new administrator-general

    The mandate of Xavier De Cuyper, administrator-general of the FAMHP has ended. Xavier De Cuyper has been the agency's top manager since 2007 and has reached the age limit for holding a mandate within the federal government. A new selection procedure to appoint his successor was published by the Federal Government Selection Office (Selor).

    Source: FAMHP

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  2. August 30, 2022

    Accelerating Clinical Trials in the EU: publication of 2022-2026 workplan

    The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published the 2022-2026 workplan of the Accelerate Clinical Trials in the EU (ACT EU) initiative. The workplan has been prepared based on the recommendations of the European medicines agencies network strategy to 2025 and the European Commission’s Pharmaceutical Strategy for Europe.

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  3. August 19, 2022

    Call for candidates pilot project “e-PIL”: paper leaflet makes way for electronic leaflet

    The FAMHP supports the pilot project “e-PIL” initiated by the pharmaceutical industry in Belgian and Luxembourg hospitals. In the context of this project, the package leaflet of certain medicines on the market in Belgium and Luxembourg is no longer put on paper in the box of the medicine, but is only available online on controlled websites.

    Source: FAMHP

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  4. July 28, 2022

    Call for Belgian laboratories to apply to become the European Union reference laboratory for in vitro diagnostic medical devices

    The European Commission has launched a call for laboratories of Member States to apply to become European Union reference laboratories (EURLs) for in vitro diagnostic (IVD) medical devices. The possible designation of such EURLs is provided for in article 100 of the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

    Source: FAMHP

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  5. July 25, 2022

    IFAPP Today newsletter - July-August 2022

    Source: IFAPP

    Please find here the link to the IFAPP TODAY newsletter of July-August 2022.

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  6. July 25, 2022

    Unavailability of Caprelsa 100 mg 30 film-coated tablets: recommendations for specialist physicians and hospital pharmacists

    Het geneesmiddel Caprelsa 100 mg 30 filmomhulde tabletten, dat wordt gebruikt in de oncologie, zal van 26 juli 2022 tot 9 september 2022 onbeschikbaar zijn in België. Het Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG) doet daarom aanbevelingen.

    Le médicament Caprelsa 100 mg 30 comprimés pelliculés, utilisé en oncologie, sera indisponible en Belgique du 26 juillet 2022 au 9 septembre 2022. L'Agence fédérale des médicaments et des produits de santé (AFMPS) émet donc des recommandations.

    Source: FAMHP

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  7. July 14, 2022

    PRAC July 2022 – New measures for medicinal products containing nomegestrol or chlormadinone and start of assessment of neurodevelopmental disorders when using topiramate

    During its July 2022 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA)  recommends new measures to minimise the risk of meningioma with medicines containing nomegestrol or chlormadinone. The PRAC also starts the review on the risk of neurodevelopmental disorders with topiramate.

    Source: FAMHP

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  8. July 5, 2022

    Antibiotics: amoxicillin for injection/infusion again available under the trade name Delamoxyle

    The availability of appropriate antimicrobial medicines is important to fight antimicrobial resistance. The FAMHP strives to keep or to bring essential antimicrobial products on the market and to keep healthcare professionals and patients well informed. Again, as a result of those efforts:  amoxicillin for injection/infusion has been back on the market in Belgium since April.

    Source: FAMHP

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  9. July 5, 2022

    The online medicinal products database gets an update

    The FAMHP online medicinal products database contains information on all medicinal products for human and veterinary use authorised in Belgium. Some new functions have been added in this new version. This makes it easier to search for new medicinal products or active ingredients.

    Source: FAMHP

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  10. June 30, 2022

    The FAMHP publishes its annual report for 2021: all figures and results, trends, activities related to COVID-19 and testimonials from our staff

    2021 was the year we gradually returned to our normal way of working at the FAMHP. The high workload caused by the pandemic remained present, but numerous other important projects awaited us, such as the implementation of several European legislations. In addition to the traditional facts and figures, the 2021 annual report includes testimonials that demonstrate the commitment and professionalism of our staff.  

    Source: FAMHP

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