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href="https://www.belgium.be/nl">www.belgium.be</a></span></small><img src="/profiles/contrib/openfed/modules/openfed_features/openfed_federalheader/assets/images/federalheader_logo.svg" alt="Logo van de Belgische federale overheid" class="block--openfed-federalheader__logo"> </div> </div> </div> <div class="page__wrapper page__wrapper--header"> <header class="page__section page__section--header container"> <div id="block-fagg-branding" class="block block--system block--system--fagg-branding block--region-header"> <a href="/nl" data-pattern="tooltip" title="Back to the home page" rel="home" class="block__branding"> <img src="/themes/custom/fagg/images/logo-afmps-nl.png" alt="Back to the home page" class="block__site-logo"> </a> <small class="block__site-slogan visually-hidden">Uw geneesmiddelen en gezondheidsproducten</small> </div> <div id="block-menu-block-6" class="block--menu-header block block--menu-block-settings-override block--menu-block-settings-override--menu-menu-header-nl block--region-header"> <ul class="menu"> <li class="menu__item menu__item--collapsed"><a href="/nl/fagg" class="menu__link" hreflang="nl" data-drupal-link-system-path="node/104821">Over het FAGG</a> </li> <li class="menu__item menu__item--collapsed"><a href="/nl/jobs" class="menu__link" hreflang="nl" data-drupal-link-system-path="node/104798">Werken bij het FAGG</a> </li> <li class="menu__item menu__item--collapsed"><a href="/nl/Publicaties" id="news" class="menu__link" data-drupal-link-system-path="node/104805">Publicaties</a> </li> <li class="menu__item"><a href="/nl/pers" class="menu__link" hreflang="nl" data-drupal-link-system-path="node/104796">Pers</a> </li> <li class="menu__item menu__item--collapsed"><a href="/nl/Contact%20-%20Enkele%20nuttige%20gegevens" id="contact" class="menu__link" data-drupal-link-system-path="node/104160">Contact</a> </li> <li class="menu__item"><a href="/nl/Klachten" id="Klachten" class="menu__link" data-drupal-link-system-path="node/104718">Klachten</a> </li> <li class="menu__item"><a href="https://www.vas.ehealth.fgov.be/portal/nl/" class="menu__link">Webportaal</a> </li> </ul> </div> <div class="views-exposed-form block--search-form block block--views block--views--search-page-1 block--region-header" data-drupal-selector="views-exposed-form-search-page-1" id="block-fagg-search-form"> <form action="/nl/search" method="get" id="views-exposed-form-search-page-1" accept-charset="UTF-8" class="form form--search"> <div class="views-exposed-form container-inline clearfix"> <div class="form-item form-item--type-textfield form-item--name-term js-form-item js-form-type-textfield js-form-item-term"> <label for="edit-term">Zoeken</label> <input placeholder="Zoeken" data-drupal-selector="edit-term" type="text" id="edit-term" name="term" value="" size="30" maxlength="128" class="form-text" /> </div> <div data-drupal-selector="edit-actions" class="form-actions js-form-wrapper form-wrapper" 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class="menu__item"><a href="/nl/menselijk_gebruik_0" class="menu__link" hreflang="nl" data-drupal-link-system-path="node/107034">Menselijk gebruik</a> </li> <li class="menu__item menu__item--collapsed"><a href="/nl/DIERGENEESKUNDIG_gebruik" title="Geneesmiddelen voor diergeneeskundig gebruik" class="menu__link" hreflang="nl" data-drupal-link-system-path="node/104059">Diergeneeskundig gebruik</a> </li> <li class="menu__item"><a href="/nl/public_information" class="menu__link" hreflang="nl" data-drupal-link-system-path="node/104752">Informatie voor het publiek</a> </li> <li class="menu__item"><a href="/nl/informatie_voor_professionelen" class="menu__link" hreflang="nl" data-drupal-link-system-path="node/106780">Informatie voor professionelen</a> </li> </ul> </div> </header> </div> <div class="page__wrapper page__wrapper--top"> <div class="page__section page__section--top container"> <div data-drupal-messages-fallback class="hidden"></div> </div> </div> <div class="page__wrapper page__wrapper--content"> <div class="container"> <div class="row"> <main class="page__section page__section--content" role="main"> <span id="main-content"></span> <div class="views-element-container block--news block block--views block--views--news-block-1 block--region-content" id="block-fagg-front-news"> <h2 class="block__title">Nieuws</h2> <div><div class="view view--name-news view--display-block-1 view--id-news view--display-id-block_1 js-view-dom-id-521f2120b915398d0bcb69624c75c49c8e77d0bb5654f4e835c63b8772b63823"> <div class="view__content"> <div class="view__row"> <article class="node node--type-news node--view-mode-teaser node--promoted"> <header class="node__title"> <h2> <a href="/nl/news/flash_vig_news_progestageen_geassocieerd_meningeoomrisico_huidige_situatie_en_aanbevelingen" rel="bookmark"> <span>Flash VIG-news : Progestageen-geassocieerd meningeoomrisico: huidige situatie en aanbevelingen</span> </a> </h2> </header> <div class="node__content"> <div class="field field--name-field-publication-date field--type-datetime field--label-hidden field__item"><time datetime="2025-03-21T08:28:47Z" class="datetime">21/03/2025</time> </div> <div class="clearfix field--text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item">Bepaalde progestagenen zijn geassocieerd met een verhoogd risico op meningeoom. Het FAGG herinnert gezondheidszorgbeoefenaars aan de maatregelen om het risico op meningeoom bij deze progestagenen te beperken.</div> <div class="node__links"> <ul class="links inline"><li><a href="/nl/news/flash_vig_news_progestageen_geassocieerd_meningeoomrisico_huidige_situatie_en_aanbevelingen" rel="tag" title="Flash VIG-news : Progestageen-geassocieerd meningeoomrisico: huidige situatie en aanbevelingen" hreflang="nl">Lees meer<span class="visually-hidden"> over Flash VIG-news : Progestageen-geassocieerd meningeoomrisico: huidige situatie en aanbevelingen</span></a></li></ul> </div> </div> </article> </div> <div class="view__row"> <article class="node node--type-news node--view-mode-teaser node--promoted"> <header class="node__title"> <h2> <a href="/nl/news/nieuwe_biovigilantieformulieren_vanaf_nu_beschikbaar" rel="bookmark"> <span>Nieuwe biovigilantieformulieren vanaf nu beschikbaar</span> </a> </h2> </header> <div class="node__content"> <div class="field field--name-field-publication-date field--type-datetime field--label-hidden field__item"><time datetime="2025-03-21T08:15:53Z" class="datetime">21/03/2025</time> </div> <div class="clearfix field--text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item">Bent u een Belgische weefselinstelling of een Belgisch ziekenhuis? Dan moet u vanaf nu alle ernstige ongewenste voorvallen (SAE's) en bijwerkingen (SAR's) melden aan de cel Biovigilantie van het FAGG via de nieuwe biovigilantieformulieren.</div> <div class="node__links"> <ul class="links inline"><li><a href="/nl/news/nieuwe_biovigilantieformulieren_vanaf_nu_beschikbaar" rel="tag" title="Nieuwe biovigilantieformulieren vanaf nu beschikbaar" hreflang="nl">Lees meer<span class="visually-hidden"> over Nieuwe biovigilantieformulieren vanaf nu beschikbaar</span></a></li></ul> </div> </div> </article> </div> <div class="view__row"> <article class="node node--type-news node--view-mode-teaser node--promoted"> <header class="node__title"> <h2> <a href="/nl/news/oproep_aan_belgische_laboratoria_om_zich_kandidaat_te_stellen_als_referentielaboratorium_van_0" rel="bookmark"> <span>Oproep aan Belgische laboratoria om zich kandidaat te stellen als referentielaboratorium van de Europese Unie voor medische hulpmiddelen voor in-vitrodiagnostiek </span> </a> </h2> </header> <div class="node__content"> <div class="field field--name-field-publication-date field--type-datetime field--label-hidden field__item"><time datetime="2025-03-19T10:07:36Z" class="datetime">19/03/2025</time> </div> <div class="clearfix field--text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item">De Europese Commissie heeft een tweede oproep gelanceerd voor de laboratoria van de lidstaten om zich kandidaat te stellen als referentielaboratorium van de Europese Unie voor medische hulpmiddelen voor in-vitrodiagnostiek. De aanwijzing van deze laboratoria is vermeld in artikel 100 van Verordening (EU) 2017/746 betreffende medische hulpmiddelen voor in-vitrodiagnostiek.</div> <div class="node__links"> <ul class="links inline"><li><a href="/nl/news/oproep_aan_belgische_laboratoria_om_zich_kandidaat_te_stellen_als_referentielaboratorium_van_0" rel="tag" title="Oproep aan Belgische laboratoria om zich kandidaat te stellen als referentielaboratorium van de Europese Unie voor medische hulpmiddelen voor in-vitrodiagnostiek " hreflang="nl">Lees meer<span class="visually-hidden"> over Oproep aan Belgische laboratoria om zich kandidaat te stellen als referentielaboratorium van de Europese Unie voor medische hulpmiddelen voor in-vitrodiagnostiek </span></a></li></ul> </div> </div> </article> </div> <div class="view__row"> <article class="node node--type-news node--view-mode-teaser node--promoted"> <header class="node__title"> <h2> <a href="/nl/news/ongereguleerde_geneesmiddelen_voor_geavanceerde_therapie_vormen_ernstige_gezondheidsrisicos" rel="bookmark"> <span>Ongereguleerde geneesmiddelen voor geavanceerde therapie vormen ernstige gezondheidsrisico's</span> </a> </h2> </header> <div class="node__content"> <div class="field field--name-field-publication-date field--type-datetime field--label-hidden field__item"><time datetime="2025-03-19T08:33:11Z" class="datetime">19/03/2025</time> </div> <div class="clearfix field--text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item">Het FAGG, het Europees Geneesmiddelenbureau (EMA) en de hoofden van de Europese geneesmiddelenagentschappen (HMA, Heads of Medicines Agencies) waarschuwen het publiek voor de gevaren van ongereguleerde geneesmiddelen voor geavanceerde therapie (ATMP's) die in de Europese Unie aan pati毛nten worden aangeboden, waaronder dendritische celtherapie毛n tegen kanker.</div> <div class="node__links"> <ul class="links inline"><li><a href="/nl/news/ongereguleerde_geneesmiddelen_voor_geavanceerde_therapie_vormen_ernstige_gezondheidsrisicos" rel="tag" title="Ongereguleerde geneesmiddelen voor geavanceerde therapie vormen ernstige gezondheidsrisico's" hreflang="nl">Lees meer<span class="visually-hidden"> over Ongereguleerde geneesmiddelen voor geavanceerde therapie vormen ernstige gezondheidsrisico's</span></a></li></ul> </div> </div> </article> </div> <div class="view__row"> <article class="node node--type-news node--view-mode-teaser node--promoted"> <header class="node__title"> <h2> <a href="/nl/news/regelgeving_voor_de_verstrekking_van_monsters_van_diergeneesmiddelen_en_rapportage_van_de" rel="bookmark"> <span>Regelgeving voor de verstrekking van monsters van diergeneesmiddelen en rapportage van de gegevens aan het FAGG: publicatie omzendbrief 657</span> </a> </h2> </header> <div class="node__content"> <div class="field field--name-field-publication-date field--type-datetime field--label-hidden field__item"><time datetime="2025-03-11T11:28:38Z" class="datetime">11/03/2025</time> </div> <div class="clearfix field--text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item">Het koninklijk besluit van 22 september 2024 over reclame voor geneesmiddelen voor diergeneeskundig gebruik bepaalt de regels voor de levering van monsters van diergeneesmiddelen. Omzendbrief 657 geeft praktische informatie over hoe deze regels moeten worden toegepast en nageleefd. </div> <div class="node__links"> <ul class="links inline"><li><a href="/nl/news/regelgeving_voor_de_verstrekking_van_monsters_van_diergeneesmiddelen_en_rapportage_van_de" rel="tag" title="Regelgeving voor de verstrekking van monsters van diergeneesmiddelen en rapportage van de gegevens aan het FAGG: publicatie omzendbrief 657" hreflang="nl">Lees meer<span class="visually-hidden"> over Regelgeving voor de verstrekking van monsters van diergeneesmiddelen en rapportage van de gegevens aan het FAGG: publicatie omzendbrief 657</span></a></li></ul> </div> </div> </article> </div> <div class="view__row"> <article class="node node--type-news node--view-mode-teaser node--promoted"> <header class="node__title"> <h2> <a href="/nl/news/het_jaarverslag_biovigilantie_2023_is_nu_beschikbaar" rel="bookmark"> <span>Het jaarverslag biovigilantie 2023 is nu beschikbaar</span> </a> </h2> </header> <div class="node__content"> <div class="field field--name-field-publication-date field--type-datetime field--label-hidden field__item"><time datetime="2025-03-06T06:52:38Z" class="datetime">06/03/2025</time> </div> <div class="clearfix field--text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item">Biovigilantie zorgt voor een systematische controle om een veiliger en effici毛nter gebruik van weefsels en cellen te garanderen, van de selectie van de donor tot de opvolging van de ontvanger. Het jaarverslag 2023 geeft een overzicht van alle voorvallen en bijwerkingen die plaatsvonden bij de behandeling en het gebruik van stoffen van menselijke oorsprong tussen 1 januari 2023 en 30 juni 2024.</div> <div class="node__links"> <ul class="links inline"><li><a href="/nl/news/het_jaarverslag_biovigilantie_2023_is_nu_beschikbaar" rel="tag" title="Het jaarverslag biovigilantie 2023 is nu beschikbaar" hreflang="nl">Lees meer<span class="visually-hidden"> over Het jaarverslag biovigilantie 2023 is nu beschikbaar</span></a></li></ul> </div> </div> </article> </div> <div class="view__row"> <article class="node node--type-news node--view-mode-teaser node--promoted"> <header class="node__title"> <h2> <a href="/nl/news/cyberveiligheid_fagg_doet_oproep_aan_bedrijven_en_organisaties_om_zich_te_registreren_in_het" rel="bookmark"> <span>Cyberveiligheid: FAGG doet oproep aan bedrijven en organisaties om zich te registreren in het kader van NIS2</span> </a> </h2> </header> <div class="node__content"> <div class="field field--name-field-publication-date field--type-datetime field--label-hidden field__item"><time datetime="2025-03-03T12:13:39Z" class="datetime">03/03/2025</time> </div> <div class="clearfix field--text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item">Met de inwerkingtreding van de NIS2-wet is het essentieel dat alle bedrijven en organisaties in Belgi毛 nagaan of zij onder deze nieuwe wetgeving vallen. Gebruik de scope test tool om te bepalen of uw organisatie aan de nieuwe wetgeving moet voldoen. Als dat het geval is moet dit geregistreerd zijn in het Safeonweb@work platform voor 18 maart 2025.</div> <div class="node__links"> <ul class="links inline"><li><a href="/nl/news/cyberveiligheid_fagg_doet_oproep_aan_bedrijven_en_organisaties_om_zich_te_registreren_in_het" rel="tag" title="Cyberveiligheid: FAGG doet oproep aan bedrijven en organisaties om zich te registreren in het kader van NIS2" hreflang="nl">Lees meer<span class="visually-hidden"> over Cyberveiligheid: FAGG doet oproep aan bedrijven en organisaties om zich te registreren in het kader van NIS2</span></a></li></ul> </div> </div> </article> </div> <div class="view__row"> <article class="node node--type-news node--view-mode-teaser node--promoted"> <header class="node__title"> <h2> <a href="/nl/news/critical_medicines_alliance_geeft_aanbevelingen_voor_de_aanpak_van_geneesmiddelentekorten_op" rel="bookmark"> <span>Critical Medicines Alliance geeft aanbevelingen voor de aanpak van geneesmiddelentekorten op Europees niveau</span> </a> </h2> </header> <div class="node__content"> <div class="field field--name-field-publication-date field--type-datetime field--label-hidden field__item"><time datetime="2025-02-28T12:31:28Z" class="datetime">28/02/2025</time> </div> <div class="clearfix field--text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item">In april 2024 werd de Critical Medicines Alliance opgericht onder het Belgisch voorzitterschap van de Raad van de Europese Unie. Het doel van de Alliantie is om samenwerking tussen beleidsmakers en stakeholders te stimuleren en een robuust en responsief systeem te ontwikkelen voor de levering van kritieke geneesmiddelen in de Europese Unie. Vandaag, op 28 februari 2025, stelt de Critical Medicines Alliance haar strategisch rapport voor. Dit rapport zal worden gebruikt als basis voor de nieuwe Europese wetgeving over geneesmiddelentekorten: de Critical Medicines Act.</div> <div class="node__links"> <ul class="links inline"><li><a href="/nl/news/critical_medicines_alliance_geeft_aanbevelingen_voor_de_aanpak_van_geneesmiddelentekorten_op" rel="tag" title="Critical Medicines Alliance geeft aanbevelingen voor de aanpak van geneesmiddelentekorten op Europees niveau" hreflang="nl">Lees meer<span class="visually-hidden"> over Critical Medicines Alliance geeft aanbevelingen voor de aanpak van geneesmiddelentekorten op Europees niveau</span></a></li></ul> </div> </div> </article> </div> </div> <div class="more-link"><a href="/nl/nieuws">Alle nieuws</a></div> </div> </div> </div> <article class="node node--type-page node--view-mode-full node--promoted"> <div class="node__content"> </div> </article> <div id="block-block-66" class="block block--block-content block--block-content--basic--full block--region-content-bottom"> <div 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href="https://www.fagg.be/nl/belgisch_voorzitterschap_van_de_raad_van_de_eu" target="_blank">Belgisch voorzitterschap<br /> #EU2024BE</a></h3> </div> </div> </div> <div id="block-farmainfo-bloc" class="block block--block-content block--block-content--basic--full block--region-sidebar-second"> <div class="clearfix field--text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><div class="highlight"><a href="https://farmainfo.be/"><img alt="Farmainfo_picture" data-entity-type="image" data-entity-uuid="0" height="149" src="/sites/default/files/Farmainfo.png" width="536" loading="lazy"></a></div> </div> </div> <div id="block-coronavirusnl" class="block block--block-content block--block-content--basic--full block--region-sidebar-second"> <div class="clearfix field--text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><div class="highlight"> <h3><a href="https://www.fagg.be/nl/informatie_over_het_coronavirus_covid_19" target="_blank">Coronavirus (Covid-19)</a> </h3> </div> </div> </div> <div id="block-blocnoticenl" class="block block--block-content block--block-content--basic--full block--region-sidebar-second"> <div class="clearfix field--text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><div class="block-search"> <h2>Zoek informatie over een vergund geneesmiddel </h2> <p class="MsoNormal"><span lang="EN-US" style="mso-ansi-language:EN-US">(bijsluiter, SKP, RMA, DHPC, s-RMP) <o:p> </o:p></span></p> <p class="rtecenter"><a href="https://geneesmiddelendatabank.be" target="_blank">Zoeken</a></p> </div> </div> </div> <div id="block-databankgeneesmiddelennl" class="block block--block-content block--block-content--basic--full block--region-sidebar-second"> <div class="clearfix field--text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><div class="highlight-3"> <h3>Databank van geschorste geneesmiddelen</h3> <ul> <li><a href="https://geneesmiddelendatabank.be/menselijk-gebruik/overzicht/geneesmiddelen-waarvan-de-vergunning-geschorst-is" target="_blank">menselijk gebruik</a></li> <li><a href="https://geneesmiddelendatabank.be/diergeneeskundig-gebruik/overzicht/geneesmiddelen-waarvan-de-vergunning-geschorst-is">diergeneeskundig gebruik</a></li> </ul> </div> </div> </div> <div id="block-zoekinformatiegeneesmiddelnl" class="block block--block-content block--block-content--basic--full block--region-sidebar-second"> <div class="clearfix field--text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><div class="block-search"> <h2>Zoek informatie over de beschikbaarheid van een geneesmiddel</h2> <p class="rtecenter"><a href="https://www.fagg.be/nl/items-HOME/Onbeschikbaarheid_van_geneesmiddelen" target="_blank">Algemene informatie</a></p> <p class="rtecenter"><a href="https://farmastatus.be/" target="_blank">Zoek een geneesmiddel</a></p> </div> </div> </div> <div id="block-block-100" class="block block--block-content block--block-content--basic--full block--region-sidebar-second"> <div class="clearfix field--text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><div class="highlight-3"> <h3><a href="/node/106703" target="_blank">Webportaal</a></h3> </div> </div> </div> <div id="block-block-109" class="block block--block-content block--block-content--basic--full block--region-sidebar-second"> <div class="clearfix field--text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><div class="highlight-3"> <h3><a href="https://databankklinischeproeven.be/" target="_blank">Databank klinische proeven</a></h3> </div> </div> </div> <div id="block-block-89" class="block block--block-content block--block-content--basic--full block--region-sidebar-second"> <div class="clearfix field--text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><div class="highlight-2"> <h3>Een probleem melden over een geneesmiddel voor menselijk gebruik?</h3> <ul> <li><a href="/node/106836">Bijwerking</a></li> <li><a href="/node/106833">Misbruik of verkeerd gebruik</a></li> <li><a href="/node/106829">Medicatiefout</a></li> <li><a href="/node/106828">Kwaliteitsgebrek</a></li> </ul> </div> </div> </div> <div id="block-block-88" class="block block--block-content block--block-content--basic--full block--region-sidebar-second"> <div class="clearfix field--text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><div class="highlight-2"> <h3>Bijwerkingen, ongewenste voorvallen en/of incidenten melden</h3> <ul> <li><a href="https://www.fagg.be/nl/diergeneeskundig_gebruik/geneesmiddelen/geneesmiddelen/farmacovigilantie/melden_van_bijwerkingen">Geneesmiddel voor diergeneeskundig gebruik</a></li> <li><a href="https://www.afmps.be/nl/MENSELIJK_gebruik/gezondheidsproducten/medische_hulpmiddelen_hulpstukken/materiovigilantie">Medisch hulpmiddel en/of hulpstuk</a></li> <li><a href="https://www.afmps.be/nl/MENSELIJK_gebruik/gezondheidsproducten/bloed_en_bloedbestanddelen/hemovigilantie">Bloed of bloedbestanddelen</a></li> <li><a href="https://www.afmps.be/nl/MENSELIJK_gebruik/gezondheidsproducten/menselijk_lichaamsmateriaal/biovigilantie">Menselijk lichaamsmateriaal</a></li> </ul> </div> </div> </div> <div id="block-block-35" class="block block--block-content block--block-content--basic--full block--region-sidebar-second"> <div class="clearfix field--text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><div class="highlight-1"> <h3><a href="https://farmastatus.be/" target="_blank">Meldingen over het in de handel brengen van een geneesmiddel via FarmaStatus</a></h3> </div> </div> </div> <div id="block-block-37" 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