{"id":3494,"date":"2023-09-18T12:48:56","date_gmt":"2023-09-18T10:48:56","guid":{"rendered":"https:\/\/dev.bemvo.be\/?page_id=3494"},"modified":"2026-08-21T13:48:32","modified_gmt":"2026-08-21T11:48:32","slug":"marketing-authorisation-holder-nl","status":"publish","type":"page","link":"https:\/\/bemvo.be\/index.php\/ik-ben\/marketing-authorisation-holder-nl\/","title":{"rendered":"MARKETING AUTHORISATION HOLDER NL"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"3494\" class=\"elementor elementor-3494\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-83866cf e-flex e-con-boxed e-con e-parent\" data-id=\"83866cf\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7e7e2e5 elementor-widget elementor-widget-heading\" data-id=\"7e7e2e5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Marketing Authorisation Holder<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-ffe9367 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"ffe9367\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-ec4278c\" data-id=\"ec4278c\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-0e90b42 elementor-widget elementor-widget-image\" data-id=\"0e90b42\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"2240\" height=\"750\" src=\"https:\/\/i0.wp.com\/bemvo.be\/wp-content\/uploads\/2023\/06\/banners-website-4.png?fit=2240%2C750&amp;ssl=1\" class=\"attachment-full size-full wp-image-734\" alt=\"mah\" srcset=\"https:\/\/i0.wp.com\/bemvo.be\/wp-content\/uploads\/2023\/06\/banners-website-4.png?w=2240&amp;ssl=1 2240w, https:\/\/i0.wp.com\/bemvo.be\/wp-content\/uploads\/2023\/06\/banners-website-4.png?resize=300%2C100&amp;ssl=1 300w, https:\/\/i0.wp.com\/bemvo.be\/wp-content\/uploads\/2023\/06\/banners-website-4.png?resize=1024%2C343&amp;ssl=1 1024w, https:\/\/i0.wp.com\/bemvo.be\/wp-content\/uploads\/2023\/06\/banners-website-4.png?resize=768%2C257&amp;ssl=1 768w, https:\/\/i0.wp.com\/bemvo.be\/wp-content\/uploads\/2023\/06\/banners-website-4.png?resize=1536%2C514&amp;ssl=1 1536w, https:\/\/i0.wp.com\/bemvo.be\/wp-content\/uploads\/2023\/06\/banners-website-4.png?resize=2048%2C686&amp;ssl=1 2048w, https:\/\/i0.wp.com\/bemvo.be\/wp-content\/uploads\/2023\/06\/banners-website-4.png?resize=720%2C241&amp;ssl=1 720w, https:\/\/i0.wp.com\/bemvo.be\/wp-content\/uploads\/2023\/06\/banners-website-4.png?w=1600&amp;ssl=1 1600w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-a53f270 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"a53f270\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-7b1fa4e\" data-id=\"7b1fa4e\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-e6e4d07 elementor-widget elementor-widget-heading\" data-id=\"e6e4d07\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">MOETEN VOLGENDE INSTRUCTIES  ZO VLUG ALS MOGELIJK UITVOEREN<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-9cb625d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"9cb625d\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-ac0a15f\" data-id=\"ac0a15f\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5c08f6f elementor-widget elementor-widget-text-editor\" data-id=\"5c08f6f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li>CORRECTE gegevens in de EU-HUB voor alle geserialiseerde verpakkingen opladen voordat ze worden gedistribueerd naar de toeleveringsketen. <br \/>Correct betekent dat alle gegevens, inclusief de vervaldatum, 100% hetzelfde moeten zijn als de gegevens in de 2D matrixcode.<\/li><li>Nieuwe release van de EU HUB: let op de nieuwe verplichte velden in de velden Product Master Data (PMD) en Product Pack Data (PDD) van de EU HUB.\u00a0<br \/><a href=\"https:\/\/bemvo.be\/wp-content\/uploads\/2024\/11\/EMVO_LoA_0340_20241001_EU-Hub-Release-1.16-Reminder-deployment-dates-upcoming-changes-workshops.pdf\" target=\"_blank\" rel=\"noopener\">EMVO_LoA_0340_20241001_EU-Hub-Release-1.16-Reminder-deployment-dates-upcoming-changes-workshops<\/a><\/li><li><b><strong>Als u de nieuwe verplichte velden niet invult, kunnen gegevens niet worden ge\u00fcpload in de EU Hub.<br \/><\/strong><\/b><b><strong><a href=\"https:\/\/bemvo.be\/wp-content\/uploads\/2024\/11\/QA-Document-on-Product-Master-Data-version-4.pdf\" target=\"_blank\" rel=\"noopener\">EMVO QA-Document-on-Product-Master-Data<\/a><br \/><\/strong><\/b><\/li><li>De GTIN-CNK (nationale code voor BE) combinatie voor elk geneesmiddel op de Belgische markt onmiddellijk doorgeven aan het APB om problemen met de toeleveringsketen te voorkomen. Hoewel FMD-verpakkingen de GTIN dragen, werkt de hele Belgische toeleveringsketen nog voornamelijk met de CNK.<br \/>Info moet gestuurd worden naar <span style=\"color: #0171bb;\"><strong>gtin@apb.be<\/strong><\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-fbc0467 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"fbc0467\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-16d123b\" data-id=\"16d123b\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-7e29b5d elementor-widget elementor-widget-heading\" data-id=\"7e29b5d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">TERUGROEP INSTRUCTIES<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-3cd1372 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3cd1372\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-59cb2d0\" data-id=\"59cb2d0\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-78a2196 elementor-widget elementor-widget-text-editor\" data-id=\"78a2196\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Volgens de gedelegeerde verordening moet een partij die is teruggeroepen of uit de handel is genomen, voor de betreffende markten uit het EMVS-systeem verwijderd worden.<\/p><p>Het gebruik van terugroep- en intrekkingsfuncties in het EMVS kan de veiligheid in de geneesmiddelendistributie verder verbeteren door te voorkomen dat deze verpakkingen aan pati\u00ebnten worden verstrekt.<\/p><p><a href=\"https:\/\/bemvo.be\/wp-content\/uploads\/2026\/03\/Recall-and-withdrawal-in-NMVS-Belux-recommendations-March-2026.pdf\" target=\"_blank\" rel=\"noopener\">Recall and withdrawal in NMVS Belux recommendations March 2026<\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-2e8588d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"2e8588d\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-ad856aa\" data-id=\"ad856aa\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-9638c91 elementor-widget elementor-widget-heading\" data-id=\"9638c91\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">REGISTRATIE<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-cdb53c3 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"cdb53c3\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-9b5bf11\" data-id=\"9b5bf11\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-b44c5c7 elementor-widget elementor-widget-heading\" data-id=\"b44c5c7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">WIE MOET ZICH REGISTREREN?<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-ee0ef81 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"ee0ef81\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-3a248d3\" data-id=\"3a248d3\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-853c6cd elementor-widget elementor-widget-text-editor\" data-id=\"853c6cd\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Elke houder van een vergunning voor het in de handel brengen van geneesmiddelen die binnen het Belgische toepassingsgebied van FMD vallen en gecommercialiseerd worden, moet zich registreren en een\u00a0 <a href=\"https:\/\/bemvo.be\/index.php\/kennisdatabank\/documenten\/#contract\" target=\"_blank\" rel=\"noopener\">contract <\/a>met BeMVO ondertekenen.\u00a0<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-ff27f06 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"ff27f06\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-701b054\" data-id=\"701b054\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-32a5306 elementor-widget elementor-widget-heading\" data-id=\"32a5306\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">FMD TOEPASSINGSGEBIED IN BELGIE<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-c1c5600 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"c1c5600\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-22603db\" data-id=\"22603db\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-c253bb5 elementor-widget elementor-widget-text-editor\" data-id=\"c253bb5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Deze tabel legt het algemene principe van de FMD-werkingssfeer voor Belgi\u00eb uit: <a href=\"https:\/\/bemvo.be\/wp-content\/uploads\/2023\/05\/Scope-matrix-v-4.0-20APR2017-1.pdf\" target=\"_blank\" rel=\"noopener\"><strong>SCOPE_TABLE<\/strong><\/a><br \/>Voor een gedetailleerde verificatie per product\/verpakking verwijzen we ook naar de <a href=\"https:\/\/geneesmiddelendatabank.fagg-afmps.be\/menselijk-gebruik\" target=\"_blank\" rel=\"noopener\"><strong>PRODUCTDATABASE<\/strong><\/a> die wordt beheerd door het Federaal Geneesmiddelenagentschap (FAGG\/AFMPS). <br \/>Als u de betreffende verpakking selecteert, geeft een vlag aan of de betreffende verpakking voor Belgi\u00eb binnen het toepassingsgebied van FMD valt of niet.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-93dae2b elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"93dae2b\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-c483cfe\" data-id=\"c483cfe\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5838ef7 elementor-widget elementor-widget-heading\" data-id=\"5838ef7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">BIJDRAGEN<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-a2b398b elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"a2b398b\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-e572d6b\" data-id=\"e572d6b\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-4f411f4 elementor-widget elementor-widget-text-editor\" data-id=\"4f411f4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Er is een <span style=\"color: #0171bb;\"><strong>\u00e9\u00e9nmalige registratiebijdrage <\/strong><\/span>en een <span style=\"color: #0171bb;\"><strong>jaarlijkse bijdrage<\/strong><\/span>. De jaarlijkse bijdrage wordt elk jaar herzien en in het vierde kwartaal van het voorgaande jaar aan de MAH&#8217;s medegedeeld.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-d99cb1e elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"d99cb1e\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-cf40f6e\" data-id=\"cf40f6e\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-aeb7aef elementor-widget elementor-widget-heading\" data-id=\"aeb7aef\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">REGISTRATIE BIJDRAGE<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-8299381 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"8299381\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-da4c0db\" data-id=\"da4c0db\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-6cc9294 elementor-widget elementor-widget-text-editor\" data-id=\"6cc9294\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>De \u00e9\u00e9nmalige registratie bijdrage bedraagt <strong><span style=\"color: #0171bb;\">\u20ac 10 000<\/span><\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-3d43d18 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3d43d18\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-7939c74\" data-id=\"7939c74\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2752125 elementor-widget elementor-widget-heading\" data-id=\"2752125\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">JAARLIJKSE BIJDRAGE<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-26a0182 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"26a0182\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-9112f33\" data-id=\"9112f33\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-ede1d8e elementor-widget elementor-widget-text-editor\" data-id=\"ede1d8e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Er zijn 3 categorie\u00ebn jaarlijkse bijdragen, afhankelijk van de omzet van de MAH voor de producten binnen het toepassingsgebied.<\/p><p>Elk jaar wordt het niveau van de bijdrage voor elk van de categorie\u00ebn herzien in functie van de financieringsbehoeften van de BeMVO.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-4ec878d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"4ec878d\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-eb4e87e\" data-id=\"eb4e87e\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-728cef9 elementor-widget elementor-widget-heading\" data-id=\"728cef9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">DE BIJDRAGEN<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-88a3131 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"88a3131\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-2330db9\" data-id=\"2330db9\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-7d0bbf2 elementor-widget elementor-widget-text-editor\" data-id=\"7d0bbf2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<table width=\"605\"><tbody><tr><td width=\"113\"><p style=\"text-align: center;\"><strong>BIJDRAGE<\/strong><\/p><\/td><td style=\"text-align: center;\" width=\"104\"><p><strong>OMZET<\/strong><\/p><\/td><td style=\"text-align: center;\" width=\"113\"><p><strong>STANDARD<\/strong><\/p><\/td><td style=\"text-align: center;\" width=\"161\"><p><span style=\"color: #000000;\"><strong>\u00a040% KORTING<\/strong><\/span><\/p><\/td><td width=\"113\"><p style=\"text-align: center;\"><strong>\u00a0FORMULIER<\/strong><\/p><\/td><\/tr><tr><td width=\"113\"><p>STANDARD<\/p><\/td><td width=\"104\"><p>&gt; 1 000 000 Euro<\/p><\/td><td width=\"113\"><p style=\"text-align: center;\">\u20ac 8 000 VAT EXCL<\/p><\/td><td width=\"161\"><p style=\"text-align: center;\"><strong><span style=\"color: #0171bb;\">\u20ac 4 800 VAT EXCL\u00a0<\/span><\/strong><\/p><\/td><td width=\"113\"><p style=\"text-align: center;\">\u00a0<a href=\"https:\/\/bemvo.be\/wp-content\/uploads\/2025\/11\/form-request-reduced-flat-fee-2026-standard.docx\" target=\"_blank\" rel=\"noopener\">FORM\u00a0<\/a><\/p><\/td><\/tr><tr><td width=\"113\"><p>MEDIUM<\/p><\/td><td width=\"104\"><p>&lt; 1 000 000 Euro<\/p><\/td><td width=\"113\"><p style=\"text-align: center;\">\u20ac 5 000 VAT EXCL<\/p><\/td><td width=\"161\"><p style=\"text-align: center;\"><strong><span style=\"color: #0171bb;\">\u20ac 3 000\u00a0 VAT EXCL<\/span><\/strong><\/p><\/td><td width=\"113\"><p style=\"text-align: center;\"><a href=\"https:\/\/bemvo.be\/wp-content\/uploads\/2025\/11\/form-request-reduced-flat-fee-2026-medium.docx\" target=\"_blank\" rel=\"noopener\">FORM<\/a><\/p><\/td><\/tr><tr><td width=\"113\"><p>LOW<\/p><\/td><td width=\"104\"><p>&lt; 100 000 Euro<\/p><\/td><td width=\"113\"><p style=\"text-align: center;\">\u20ac 2 000 VAT EXCL<\/p><\/td><td width=\"161\"><p style=\"text-align: center;\"><strong><span style=\"color: #0171bb;\">\u20ac 1 200 VAT EXCL<\/span><\/strong><\/p><\/td><td width=\"113\"><p style=\"text-align: center;\"><a href=\"https:\/\/bemvo.be\/wp-content\/uploads\/2025\/11\/form-request-reduced-flat-fee-2026-low.docx\" target=\"_blank\" rel=\"noopener\">FORM<\/a><\/p><\/td><\/tr><\/tbody><\/table>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-c565258 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"c565258\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-4dba4f3\" data-id=\"4dba4f3\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5f32241 elementor-widget elementor-widget-text-editor\" data-id=\"5f32241\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Omzet wordt als volgt bepaald:\u00a0<\/strong><\/p><p>De totale omzetwaarde gerealiseerd in Jaar-2 voor de producten die behoren aan de vergunninghouder en die binnen het FMD toepassingsgebied vallen in het jaar waarin de jaarlijkse bijdrage van toepassing is.<\/p><p>Voorbeeld: de categorie van de jaarlijkse bijdrage voor 2026 wordt bepaald op de FMD-producten die in januari 2026 aan de vergunninghouder behoren en op de omzet voor deze producten in 2024 (zelfs als deze producten toen nog niet aan de vergunninghouder behoorden).<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-bdbe598 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"bdbe598\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-98aae30\" data-id=\"98aae30\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-36a11d8 elementor-widget elementor-widget-text-editor\" data-id=\"36a11d8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>BELANGRIJK<\/strong><\/p><ul><li>Om in aanmerking te komen voor een <span style=\"color: #0171bb;\">40% korting<\/span>, moeten we dit aanvraagformulier <span style=\"color: #0171bb;\">v\u00f3\u00f3r 10 januari <\/span>volledig ingevuld ontvangen hebben. <strong><span style=\"color: #0171bb;\">Bij latere aanvragen wordt automatisch de standaard fee zonder korting (\u20ac 8 000) aangerekend, dit ongeacht de omzet.<\/span><\/strong><\/li><li>De MAH moet het initiatief nemen en een aanvraag indienen om in aanmerking te komen voor een verminderde jaarlijkse vergoeding.<\/li><li>De MAH moet de lagere omzet voor de producten binnen het toepassingsgebied voldoende bewijzen.<br \/>Dergelijk bewijs kan bijvoorbeeld zijn: offici\u00eble financi\u00eble rekeningen, verslagen van een bedrijfsrevisor, externe gegevens voor marktmetingen, &#8230;<\/li><li>De documentatie moet steeds de lijst bevatten van de geneesmiddelen die in dit verband in overweging werden genomen.<br \/>BeMVO kan op elk moment bijkomende informatie vragen.<\/li><li>BeMVO behoudt zich het recht voor om het verzoek naar eigen goeddunken af te wijzen, onafhankelijk van de elementen en informatie die door de MAH worden verstrekt.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t<div class=\"elementor-element elementor-element-3224736 e-flex e-con-boxed e-con e-parent\" data-id=\"3224736\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7b3d56a elementor-widget elementor-widget-heading\" data-id=\"7b3d56a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">ALGEMENE VERKOOPSVOORWAARDEN<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-67ad800 e-flex e-con-boxed e-con e-parent\" data-id=\"67ad800\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5998d88 elementor-widget elementor-widget-text-editor\" data-id=\"5998d88\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Lees <a href=\"https:\/\/bemvo.be\/wp-content\/uploads\/2025\/02\/BeMVO-Algemene-voorwaarden-factuur.pdf\" target=\"_blank\" rel=\"noopener\">hier<\/a> onze algemene verkoopsvoorwaarden.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-6430aed elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6430aed\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-6b48bbe\" data-id=\"6b48bbe\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-cde4f66 elementor-widget elementor-widget-heading\" data-id=\"cde4f66\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">LUXEMBURG (LMVO)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-cee241c elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"cee241c\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-6e19147\" data-id=\"6e19147\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-4690c09 elementor-widget elementor-widget-text-editor\" data-id=\"4690c09\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Hoewel Belgi\u00eb en Luxemburg hetzelfde Nationale Geneesmiddelen Verificatiesysteem (NMVS) hebben, dat wordt beheerd door BeMVO, wordt de beheerstaak voor Luxemburg uitgevoerd door de <a href=\"https:\/\/www.lmvo.lu\/mah\" target=\"_blank\" rel=\"noopener\"><strong>LMVO<\/strong> <\/a>(Luxembourg Medicines Verification Organisation).<\/p><p>De registratie- en jaarlijkse vergoeding dekt alleen het deel voor Belgi\u00eb. In het geval dat de MAH ook actief is op de markt in Luxemburg (of alleen in Luxemburg en niet in Belgi\u00eb), moet de MAH een overeenkomst hebben met de LMVO.<\/p><p>Hieronder vindt u de instructies voor het laden van verpakkingen op de Luxemburgse markt in het Belgische NMVS:<\/p><p><a href=\"https:\/\/bemvo.be\/wp-content\/uploads\/2023\/05\/BE-LU-data-loading-specs-LMVO-V2.1.pdf\" target=\"_blank\" rel=\"noopener\">BE-LU LAADVOORSCHRIFTEN<\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-1834c2f elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"1834c2f\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-8fbc8f5\" data-id=\"8fbc8f5\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-dd96cac elementor-widget elementor-widget-spacer\" data-id=\"dd96cac\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t<div class=\"elementor-element elementor-element-3872149 e-flex e-con-boxed e-con e-parent\" data-id=\"3872149\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Marketing Authorisation Holder MOETEN VOLGENDE INSTRUCTIES ZO VLUG ALS MOGELIJK UITVOEREN CORRECTE gegevens in de EU-HUB voor alle geserialiseerde verpakkingen opladen voordat ze worden gedistribueerd naar de toeleveringsketen. Correct betekent dat alle gegevens, inclusief de vervaldatum, 100% hetzelfde moeten zijn als de gegevens in de 2D matrixcode. Nieuwe release van de EU HUB: let op [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":739,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-3494","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>MARKETING AUTHORISATION HOLDER NL - Bemvo<\/title>\n<meta name=\"description\" content=\"Elke houder van een vergunning voor het in de handel brengen van geneesmiddelen die binnen het Belgische toepassingsgebied van FMD vallen en gecommercialiseerd worden, moet zich registreren en een CONTRACTUELE OVEREENKOMST met BeMVO ondertekenen.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/bemvo.be\/index.php\/ik-ben\/marketing-authorisation-holder-nl\/\" \/>\n<meta property=\"og:locale\" content=\"nl_NL\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MARKETING AUTHORISATION HOLDER NL - 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