{"id":132,"date":"2023-04-28T15:17:43","date_gmt":"2023-04-28T13:17:43","guid":{"rendered":"https:\/\/dev.bemvo.be\/?page_id=132"},"modified":"2026-03-26T09:04:02","modified_gmt":"2026-03-26T08:04:02","slug":"marketing-authorisation-holders","status":"publish","type":"page","link":"https:\/\/bemvo.be\/index.php\/i-am\/marketing-authorisation-holders\/","title":{"rendered":"Marketing Authorisation Holder eng"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"132\" class=\"elementor elementor-132\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-4edfe23 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"4edfe23\" 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-78bc5c2\" data-id=\"78bc5c2\" 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-302f057 elementor-widget__width-inherit elementor-widget elementor-widget-wp-widget-media_image\" data-id=\"302f057\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"wp-widget-media_image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\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=\"image wp-image-734  attachment-full size-full\" alt=\"mah\" style=\"max-width: 100%; height: auto;\" 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<\/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-e6d7d09 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"e6d7d09\" 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-d1cc1e1\" data-id=\"d1cc1e1\" 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-2702052 elementor-widget elementor-widget-text-editor\" data-id=\"2702052\" 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<h2>MUST DO ASAP<\/h2>\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-02c9412 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"02c9412\" 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-4ecf26d\" data-id=\"4ecf26d\" 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-3e4c566 elementor-widget elementor-widget-text-editor\" data-id=\"3e4c566\" 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>Load CORRECT data in the EU-HUB for all serialized packs before they are distributed to the supply chain.\u00a0<br \/>Correct means that all data, including the expiry date, must be 100% the same as the data in the 2D matrix code.<\/li><li>New release of the EU Hub: please be aware of the new mandatory fields within the Product Master Data (PMD) and Product Pack Data (PDD) fields of the 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\">EMVO_LoA_0340_20241001_EU-Hub-Release-1.16-Reminder-deployment-dates-upcoming-changes-workshops<\/a><\/li><li><strong>Not filling in the new mandatory fields will result in data not being able to be uploaded in the EU Hub\u00a0<br \/><a href=\"https:\/\/bemvo.be\/wp-content\/uploads\/2024\/11\/EMVO-QA-Document-on-Product-Master-Data.pdf\">EMVO QA-Document-on-Product-Master-Data<\/a><br \/><\/strong><\/li><li>Communicate immediately the GTIN-CNK (national code for BE) combination for each medicinal product on the Belgian market to the APB to avoid supply chain issues. Although FMD packs are carrying the GTIN, the entire Belgian supply chain is still mainly operating with the CNK.\u00a0<br \/>Communication must be sent to <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-ea20e4c elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"ea20e4c\" 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-ffcfc4d\" data-id=\"ffcfc4d\" 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-93a5288 elementor-widget elementor-widget-heading\" data-id=\"93a5288\" 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\">RECALL INSTRUCTIONS<\/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-003b4da elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"003b4da\" 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-70df9dc\" data-id=\"70df9dc\" 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-678508a elementor-widget elementor-widget-text-editor\" data-id=\"678508a\" 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>The delegated regulation states that a batch subject to a recall, or subject to withdrawal, should be decommissioned in the EMVS system for the affected markets. Usage of recall and withdrawal functionalities in the EMVS can further improve security in the medicine distribution by preventing that recalled or withdrawn packs are dispensed to patients.<\/p><p><a href=\"https:\/\/bemvo.be\/wp-content\/uploads\/2026\/03\/Recall-and-withdrawal-in-NMVS-Belux-recommendations-March-2026.pdf\">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-373af4b elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"373af4b\" 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-8b41380\" data-id=\"8b41380\" 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-70e61f6 elementor-widget elementor-widget-heading\" data-id=\"70e61f6\" 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\">REGISTRATION<\/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-98dc125 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"98dc125\" 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-a30de9b\" data-id=\"a30de9b\" 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-4c210b8 elementor-widget elementor-widget-heading\" data-id=\"4c210b8\" 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\">WHO?<\/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-986f80f elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"986f80f\" 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-938a688\" data-id=\"938a688\" 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-e5b3463 elementor-widget elementor-widget-text-editor\" data-id=\"e5b3463\" 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>Each Marketing Authorisation Holder, responsible for medicinal products within the Belgian scope of FMD and commercialized in Belgium, must register and sign a <a href=\"https:\/\/bemvo.be\/index.php\/knowledge-database\/documents-eng\/#registration\" target=\"_blank\" rel=\"noopener\"><span style=\"color: #0171bb;\"><strong>contractual agreement<\/strong><\/span><\/a> with 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-1a046ad elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"1a046ad\" 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-b04b890\" data-id=\"b04b890\" 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-bb59302 elementor-widget elementor-widget-heading\" data-id=\"bb59302\" 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 SCOPE IN BELGIUM<\/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-0b281b9 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"0b281b9\" 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-eeb6b2b\" data-id=\"eeb6b2b\" 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-a790ec5 elementor-widget elementor-widget-text-editor\" data-id=\"a790ec5\" 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>This table explains the overall principle of the FMD scope for Belgium: <a href=\"https:\/\/bemvo.be\/wp-content\/uploads\/2023\/05\/Scope-matrix-v-4.0-20APR2017-1.pdf\" target=\"_blank\" rel=\"noopener\">Scope_table<\/a><br \/>For a detailed verification by product\/pack we refer also to the\u00a0<a style=\"background-color: #ffffff; color: #3a9ad9;\" href=\"https:\/\/medicinesdatabase.be\/human-use\" target=\"_blank\" rel=\"noopener\">product database\u00a0<\/a>managed by the Federal Medicines Agency (FAGG\/AFMPS \/ FAMHP).\u00a0<br \/>Selecting the concerned pack, a flag indicates if the concerned pack is within the FMD scope or not for Belgium.<\/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-854fb67 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"854fb67\" 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-4aac8ae\" data-id=\"4aac8ae\" 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-1565ca5 elementor-widget elementor-widget-heading\" data-id=\"1565ca5\" 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\">FEES<\/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-46a8c69 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"46a8c69\" 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-08d5b0b\" data-id=\"08d5b0b\" 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-058eeb5 elementor-widget elementor-widget-text-editor\" data-id=\"058eeb5\" 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>The participation fee is composed of a <span style=\"color: #0171bb;\"><strong>one-time registration fee<\/strong><\/span> and an <span style=\"color: #0171bb;\"><strong>annual fee<\/strong><\/span>. The annual fee is reviewed each year and communicated to the MAHs in the fourth quarter of the preceding year.<\/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-c6dc3ce elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"c6dc3ce\" 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-51b0da3\" data-id=\"51b0da3\" 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-1b812f8 elementor-widget elementor-widget-heading\" data-id=\"1b812f8\" 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\">REGISTRATION FEE<\/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-df2f70e elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"df2f70e\" 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-be3550f\" data-id=\"be3550f\" 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-459ed32 elementor-widget elementor-widget-text-editor\" data-id=\"459ed32\" 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>The one-time registration fee is set to <strong><span style=\"color: #0171bb;\">\u20ac10 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-57af642 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"57af642\" 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-f33fdc5\" data-id=\"f33fdc5\" 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-89cf84a elementor-widget elementor-widget-heading\" data-id=\"89cf84a\" 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\">ANNUAL FEE <\/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-4ad05b3 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"4ad05b3\" 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-ca4b3a1\" data-id=\"ca4b3a1\" 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-6caa530 elementor-widget elementor-widget-text-editor\" data-id=\"6caa530\" 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>There are 3 annual fee categories, depending on the turnover of the MAH for the products within the scope.<\/p><p>Standard fee, Medium fee, Low fee.<\/p><p>However, each year, the level of the fee for each of the categories is reviewed in function of the financing needs of the 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-477e5ff elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"477e5ff\" 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-cc7a6a3\" data-id=\"cc7a6a3\" 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-0665931 elementor-widget elementor-widget-text-editor\" data-id=\"0665931\" 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>FEE<\/strong><\/p><\/td><td style=\"text-align: center;\" width=\"104\"><p><strong>T.O.<\/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% REDUCTION<\/strong><\/span><\/p><\/td><td width=\"113\"><p style=\"text-align: center;\"><strong>\u00a0FORM<\/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-12e8ac0 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"12e8ac0\" 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-17f5c1b\" data-id=\"17f5c1b\" 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-8731c9a elementor-widget elementor-widget-text-editor\" data-id=\"8731c9a\" 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>Turnover is defined as:<br \/><\/strong><br \/>The total sales value realized in Year-2 for the products belonging to the MAH and that are within the FMD scope in the year in which the annual fee is applicable.<\/p><p>Example: the annual fee category for 2026 is determined on the FMD products belonging to the MAH in January 2026 and on the turnover for these products in 2024 (even if these products did not belong to the MAH at that time).<\/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-df1720a elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"df1720a\" 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-54519d0\" data-id=\"54519d0\" 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-789092c elementor-widget elementor-widget-text-editor\" data-id=\"789092c\" 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>IMPORTANT<\/strong><\/p><ul><li>To benefit from <span style=\"color: #0171bb;\">40% of the reduced fees<\/span>, we must receive the <span style=\"color: #0171bb;\"><strong>application form<\/strong><\/span> fully completed <strong><span style=\"color: #0171bb;\">before 10th January<\/span>. <span style=\"color: #0171bb;\">Later applications will be charged the standard flat fee (\u20ac 8 000), regardless the turnover.<\/span><\/strong><\/li><li>The MAH must take the initiative and request to be eligible for a reduced annual flat fee and therefore submit the application form. The MAH must sufficiently prove the lower turnover for the products within scope.<br \/>Such proof can be for example: official financial accounts, reports from a company auditor, external market measurement data, \u2026<\/li><li>The documentation must always include the list of Medicinal Products that have been considered in this regard.<\/li><li>BeMVO can request at any moment additional information.<\/li><li>BeMVO reserves the right to reject the request at its own discretion, independent of the elements and information provided by the MAH.<\/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-de6b983 e-flex e-con-boxed e-con e-parent\" data-id=\"de6b983\" 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-1b1d05b elementor-widget elementor-widget-heading\" data-id=\"1b1d05b\" 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\">GENERAL TERMS<\/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-32daf06 e-flex e-con-boxed e-con e-parent\" data-id=\"32daf06\" 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-e33295a elementor-widget elementor-widget-text-editor\" data-id=\"e33295a\" 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>Read our general terms <a href=\"https:\/\/bemvo.be\/wp-content\/uploads\/2025\/02\/BeMVO-Algemene-voorwaarden-factuur.pdf\" target=\"_blank\" rel=\"noopener\">here<\/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\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-2864ff0 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"2864ff0\" 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-e84c9d3\" data-id=\"e84c9d3\" 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-f53ffa7 elementor-widget elementor-widget-heading\" data-id=\"f53ffa7\" 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\">LUXEMBOURG (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-4da1692 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"4da1692\" 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-e183b8b\" data-id=\"e183b8b\" 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-3320baa elementor-widget elementor-widget-text-editor\" data-id=\"3320baa\" 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>Although Belgium and Luxembourg share the same National Medicines Verification System (NMVS) managed by BeMVO, the governance for Luxembourg is managed by the\u00a0<a class=\"\" href=\"http:\/\/lmvo.lu\/\" target=\"_blank\" rel=\"noopener\">LMVO\u00a0<\/a>(Luxembourg Medicines Verification Organisation).<\/p><p>The registration and annual fee covers only the part for Belgium. In case the MAH is also active on the market in Luxembourg (or only in Luxembourg and not Belgium), the MAH should have an agreement with the LMVO.<\/p><p style=\"text-align: left;\">Hereunder you can find the loading instructions to the Belgian NMVS for packs on the market in Luxembourg:<\/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 LOADING SPECS<\/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-7c959e9 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7c959e9\" 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-c321939\" data-id=\"c321939\" 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-b941147 elementor-widget elementor-widget-spacer\" data-id=\"b941147\" 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-4520655 e-flex e-con-boxed e-con e-parent\" data-id=\"4520655\" 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>MUST DO ASAP Load CORRECT data in the EU-HUB for all serialized packs before they are distributed to the supply chain.\u00a0Correct means that all data, including the expiry date, must be 100% the same as the data in the 2D matrix code. New release of the EU Hub: please be aware of the new mandatory [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":4696,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-132","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Marketing Authorisation Holder eng - Bemvo<\/title>\n<meta name=\"description\" content=\"Each Marketing Authorisation Holder, responsible for medicinal products within the Belgian scope of FMD and commercialized in Belgium, must register and sign a contractual agreement with BeMVO.\" \/>\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\/i-am\/marketing-authorisation-holders\/\" \/>\n<meta property=\"og:locale\" content=\"nl_NL\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Marketing Authorisation Holder eng - 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