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Nieuwe biovigilantieformulieren vanaf nu beschikbaar | FAGG
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href="/nl/nieuws" title="Nieuws">Nieuws</a></li> <li class="breadcrumb__item"><span class="visually-hidden">Current Page:</span>Nieuwe biovigilantieformulieren vanaf nu beschikbaar</li> </ol> </nav> </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> <h1 class="page__title"> <span>Nieuwe biovigilantieformulieren vanaf nu beschikbaar</span> </h1> <article class="node node--type-news node--view-mode-full node--promoted"> <div class="node__content"> <div class="field field--name-field-publication-date field--type-datetime field--label-above"> <div class="field__item">Datum: 21/03/2025</div> </div> <div class="clearfix field--text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><p><strong>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.</strong></p> <p>Elk jaar moeten de Belgische weefselinstellingen en ziekenhuizen alle ernstige ongewenste voorvallen (SAE's) en bijwerkingen (SAR's) die zich voordoen bij de verwerking en het gebruik van weefsels en cellen melden aan de cel Biovigilantie en Hemovigilantie van het FAGG. </p> <p><strong>Vier formulieren</strong><br /> Hiervoor stelt het FAGG vier nieuwe formulieren ter beschikking:</p> <ul> <li><a href="https://www.fagg.be/sites/default/files/2025%20Formulier%20SoHO%20repro%20Melding%2BBevestiging%20SAE.docx" target="_blank">een formulier voor SAE's van het voortplantingssysteem</a>;</li> <li><a href="https://www.fagg.be/sites/default/files/2025%20Formulier%20SoHO%20repro%20Melding%2BBevestiging%20SAR.docx" target="_blank">een formulier voor SAR's van het voortplantingssysteem</a>;</li> <li><a href="https://www.fagg.be/sites/default/files/2025%20Formulier%20SoHO%20non%20repro%20Melding%2BBevestiging%20SAE.docx" target="_blank">een formulier voor SAE's van het niet-voortplantingssysteem</a>;</li> <li><a href="https://www.fagg.be/sites/default/files/2025%20Formulier%20SoHO%20non%20repro%20Melding%2BBevestiging%20SAR.docx" target="_blank">een formulier voor SAR's van het niet-voortplantingssysteem</a>.</li> </ul> <p>Deze formulieren vergemakkelijken de verplichte melding door instellingen voor menselijk lichaamsmateriaal (SoHO-instellingen) en ziekenhuizen en maken een betere overgang mogelijk naar meldingen via een elektronisch systeem dat momenteel wordt ontwikkeld.</p> <p>De nieuwe biovigilantieformulieren houden ook rekening met de nieuwe <a href="https://eur-lex.europa.eu/legal-content/NL/TXT/?uri=OJ:L_202401938" target="_blank">Verordening (EU) 2024/1938</a> betreffende kwaliteits- en veiligheidsnormen voor lichaamsmaterialen die bedoeld zijn voor toepassing op de mens. </p> <p>Tot slot zorgen de formulieren ervoor dat de Europese vereisten voor de jaarlijkse rapportering door het FAGG worden nageleefd. Al deze verbeteringen zullen de kwaliteit en veiligheid van de verschillende stoffen van menselijke oorsprong (SoHO) verder garanderen.</p> <p><a href="https://www.fagg.be/nl/menselijk_gebruik/gezondheidsproducten/menselijk_lichaamsmateriaal/biovigilantie/nieuwe" target="_blank">Download de nieuwe formulieren via onze website.</a><br /> </p> </div> </div> <div class="back-button"> <a href="javascript:history.back()">Terug</a> </div> </article> <div class="views-element-container block--last-updated block block--views block--views--last-updated-block-1 block--region-content-bottom" id="block-fagg-last-updated"> <div><div class="view view--name-last-updated view--display-block-1 view--id-last_updated view--display-id-block_1 js-view-dom-id-ba4a5bc738a86030ba906098e1e9ff5b518249b56b61226e8732eabfbbc2efd7"> <div class="view__content"> <div class="view__row"><div><span>Laatste update op <time datetime="2025-03-21T09:32:23+01:00" class="datetime">21/03/2025</time> </span></div></div> </div> </div> </div> </div> </main> <div class="page__section page__section--sidebar-second"> <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-29" 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="/nl/notification_effets">Het melden van bijwerkingen en/ of incidenten</a></h3> </div> </div> </div> </div> </div> </div> </div> <div class="page__wrapper page__wrapper--footer"> <footer class="page__section page__section--footer container"> <div class="copyright">© 2016 - FAGG</div> <div id="block-menu-block-8" class="block--menu-footer block block--menu-block-settings-override block--menu-block-settings-override--menu-menu-footer-nl block--region-footer"> <ul class="menu"> <li class="menu__item"><a href="/nl/privacy" class="menu__link" hreflang="nl" data-drupal-link-system-path="node/104716">Privacy</a> </li> <li class="menu__item"><a href="/nl/disclaimer" title="Disclaimer" class="menu__link" hreflang="nl" data-drupal-link-system-path="node/103926">Disclaimer</a> </li> </ul> </div> </footer> </div> </div> <script type="application/json" data-drupal-selector="drupal-settings-json">{"path":{"baseUrl":"\/","pathPrefix":"nl\/","currentPath":"node\/110124","currentPathIsAdmin":false,"isFront":false,"currentLanguage":"nl"},"pluralDelimiter":"\u0003","suppressDeprecationErrors":true,"multiselect":{"widths":250},"data":{"extlink":{"extTarget":false,"extTargetNoOverride":false,"extNofollow":false,"extNoreferrer":false,"extFollowNoOverride":false,"extClass":"ext","extLabel":"(externe link)","extImgClass":false,"extSubdomains":true,"extExclude":"","extInclude":"","extCssExclude":"","extCssExplicit":"","extAlert":false,"extAlertText":"Deze link leidt naar een externe website. 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