{"id":5307,"date":"2023-11-03T16:55:39","date_gmt":"2023-11-03T15:55:39","guid":{"rendered":"https:\/\/bemvo.be\/?page_id=5307"},"modified":"2024-09-24T14:15:14","modified_gmt":"2024-09-24T12:15:14","slug":"faq-mah","status":"publish","type":"page","link":"https:\/\/bemvo.be\/index.php\/bibliotheque\/faq-mah\/","title":{"rendered":"FAQ MAH fr"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"5307\" class=\"elementor elementor-5307\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b334830 e-flex e-con-boxed e-con e-parent\" data-id=\"b334830\" 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-562beeb elementor-widget elementor-widget-image\" data-id=\"562beeb\" 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=\"800\" height=\"268\" src=\"https:\/\/i0.wp.com\/bemvo.be\/wp-content\/uploads\/2023\/06\/banners-website-2-1.png?fit=800%2C268&amp;ssl=1\" class=\"attachment-large size-large wp-image-845\" alt=\"FAQ\" srcset=\"https:\/\/i0.wp.com\/bemvo.be\/wp-content\/uploads\/2023\/06\/banners-website-2-1.png?w=2240&amp;ssl=1 2240w, https:\/\/i0.wp.com\/bemvo.be\/wp-content\/uploads\/2023\/06\/banners-website-2-1.png?resize=300%2C100&amp;ssl=1 300w, https:\/\/i0.wp.com\/bemvo.be\/wp-content\/uploads\/2023\/06\/banners-website-2-1.png?resize=1024%2C343&amp;ssl=1 1024w, https:\/\/i0.wp.com\/bemvo.be\/wp-content\/uploads\/2023\/06\/banners-website-2-1.png?resize=768%2C257&amp;ssl=1 768w, https:\/\/i0.wp.com\/bemvo.be\/wp-content\/uploads\/2023\/06\/banners-website-2-1.png?resize=1536%2C514&amp;ssl=1 1536w, https:\/\/i0.wp.com\/bemvo.be\/wp-content\/uploads\/2023\/06\/banners-website-2-1.png?resize=2048%2C686&amp;ssl=1 2048w, https:\/\/i0.wp.com\/bemvo.be\/wp-content\/uploads\/2023\/06\/banners-website-2-1.png?resize=720%2C241&amp;ssl=1 720w, https:\/\/i0.wp.com\/bemvo.be\/wp-content\/uploads\/2023\/06\/banners-website-2-1.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\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-d400d12 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"d400d12\" 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-7d8adf5\" data-id=\"7d8adf5\" 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-2b5c7ca elementor-widget elementor-widget-text-editor\" data-id=\"2b5c7ca\" 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>This page is only available in English<\/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<div class=\"elementor-element elementor-element-878c7e9 e-flex e-con-boxed e-con e-parent\" data-id=\"878c7e9\" 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-133c97d e-n-tabs-mobile elementor-widget elementor-widget-n-tabs\" data-id=\"133c97d\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;horizontal_scroll&quot;:&quot;disable&quot;}\" data-widget_type=\"nested-tabs.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-tabs\" data-widget-number=\"20171133\" aria-label=\"Tabs. Open items met enter of spatie, sluit af met escape en navigeer met de pijltjestoetsen.\">\n\t\t\t<div class=\"e-n-tabs-heading\" role=\"tablist\">\n\t\t\t\t\t<button id=\"e-n-tab-title-201711331\" data-tab-title-id=\"e-n-tab-title-201711331\" class=\"e-n-tab-title\" aria-selected=\"true\" data-tab-index=\"1\" role=\"tab\" tabindex=\"0\" aria-controls=\"e-n-tab-content-201711331\" style=\"--n-tabs-title-order: 1;\">\n\t\t\t\t\t\t<span class=\"e-n-tab-title-text\">\n\t\t\t\tPACKS &amp; CODES\t\t\t<\/span>\n\t\t<\/button>\n\t\t\t\t<button id=\"e-n-tab-title-201711332\" data-tab-title-id=\"e-n-tab-title-201711332\" class=\"e-n-tab-title\" aria-selected=\"false\" data-tab-index=\"2\" role=\"tab\" tabindex=\"-1\" aria-controls=\"e-n-tab-content-201711332\" style=\"--n-tabs-title-order: 2;\">\n\t\t\t\t\t\t<span class=\"e-n-tab-title-text\">\n\t\t\t\tCONTRACTUAL\t\t\t<\/span>\n\t\t<\/button>\n\t\t\t\t\t<\/div>\n\t\t\t<div class=\"e-n-tabs-content\">\n\t\t\t\t<div id=\"e-n-tab-content-201711331\" role=\"tabpanel\" aria-labelledby=\"e-n-tab-title-201711331\" data-tab-index=\"1\" style=\"--n-tabs-title-order: 1;\" class=\"e-active elementor-element elementor-element-4058a38 e-con-full e-flex e-con e-child\" data-id=\"4058a38\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-413800e e-flex e-con-boxed e-con e-child\" data-id=\"413800e\" 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-3c8660f elementor-widget elementor-widget-accordion\" data-id=\"3c8660f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-accordion\">\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-6341\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-6341\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-arrow-alt-circle-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-arrow-circle-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">The product registrations for the European products are all done from one single location with a GTin code obtained from GS1 in the concerned country. Can this GTin code continue to be used in Belgium?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-6341\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-6341\"><p>The GTin code (14), constructed according to the GS1 standard, can be used in the 2D matrix in Belgium. There is no need to create a separate code. It is important that the MAH communicates the relation between the GTin and the CNK to the pharmacist association APB at\u00a0<a href=\"mailto:gtin@abp.be\">gtin@abp.be<\/a>.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-6342\" class=\"elementor-tab-title\" data-tab=\"2\" role=\"button\" aria-controls=\"elementor-tab-content-6342\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-arrow-alt-circle-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-arrow-circle-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">The product registrations for the European products are all done from one single location with a GTin code obtained from GS1 in the concerned country. Can this GTin code continue to be used in Belgium?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-6342\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"region\" aria-labelledby=\"elementor-tab-title-6342\"><p>The GTin code (14), constructed according to the GS1 standard, can be used in the 2D matrix in Belgium. There is no need to create a separate code. It is important that the MAH communicates the relation between the GTin and the CNK to the pharmacist association APB at\u00a0<a href=\"mailto:gtin@abp.be\">gtin@abp.be<\/a>.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-6343\" class=\"elementor-tab-title\" data-tab=\"3\" role=\"button\" aria-controls=\"elementor-tab-content-6343\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-arrow-alt-circle-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-arrow-circle-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Will there be a fifth element included in the 2D matrix code for Belgium?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-6343\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"3\" role=\"region\" aria-labelledby=\"elementor-tab-title-6343\"><p>No. The 2D matrix code in Belgium needs to contain the following elements: GTin (GS1 standard), random Unique Identifier (maximum 20 numeric or alphanumeric code), batch number, expiry date.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-6344\" class=\"elementor-tab-title\" data-tab=\"4\" role=\"button\" aria-controls=\"elementor-tab-content-6344\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-arrow-alt-circle-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-arrow-circle-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Is it mandatory to remove the CNK code post FMD implementation or can the CNK remain in human readable format?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-6344\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"4\" role=\"region\" aria-labelledby=\"elementor-tab-title-6344\"><p>The manufacturer can keep the CNK in human-readable format on the pack on a voluntary basis. The CNK in a linear barcode should be removed as soon as possible to avoid confusion. For all new batches released after 8\/2\/2019, the advice is to remove the UBC as soon as possible.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-6345\" class=\"elementor-tab-title\" data-tab=\"5\" role=\"button\" aria-controls=\"elementor-tab-content-6345\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-arrow-alt-circle-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-arrow-circle-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">How is the date of the release of a new batch defined?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-6345\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"5\" role=\"region\" aria-labelledby=\"elementor-tab-title-6345\"><p>The release date is the date that the QA responsible is releasing the batch for distribution in the Supply Chain.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-6346\" class=\"elementor-tab-title\" data-tab=\"6\" role=\"button\" aria-controls=\"elementor-tab-content-6346\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-arrow-alt-circle-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-arrow-circle-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Are other countries like France and The Netherlands ready to use the GTin codes?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-6346\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"6\" role=\"region\" aria-labelledby=\"elementor-tab-title-6346\"><p>Some countries are deviating from the standard to use the GTin or are having a mixed situation of GTin, NTin (and even PPN, specific national number). The best is to contact your local representative in the concerned country to retrieve information on the specific country requirements.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-6347\" class=\"elementor-tab-title\" data-tab=\"7\" role=\"button\" aria-controls=\"elementor-tab-content-6347\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-arrow-alt-circle-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-arrow-circle-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Is the exception for packs smaller than 10cm only valid in Belgian or is it a European rule?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-6347\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"7\" role=\"region\" aria-labelledby=\"elementor-tab-title-6347\"><p>This rule is valid for all participating countries as specified in the Delegated Regulation, Article 7.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-6348\" class=\"elementor-tab-title\" data-tab=\"8\" role=\"button\" aria-controls=\"elementor-tab-content-6348\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-arrow-alt-circle-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-arrow-circle-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">During the transition period, when will it be possible to discontinue to print the UBC (unique linear barcode) on the package and only have the 2D code for reimbursable products?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-6348\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"8\" role=\"region\" aria-labelledby=\"elementor-tab-title-6348\"><p>The new legislation will foresee that packs with only the 2D matrix code can be released to the Supply Chain as from August 2018. However, not all distribution stakeholders might be ready with the FMD implementation and carefulness is advised.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-6349\" class=\"elementor-tab-title\" data-tab=\"9\" role=\"button\" aria-controls=\"elementor-tab-content-6349\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-arrow-alt-circle-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-arrow-circle-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">The product that is distributed, is not delivered as such to the patients but is being processed by the pharmacies and decomposed in smaller units. Do we need to apply the safety features?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-6349\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"9\" role=\"region\" aria-labelledby=\"elementor-tab-title-6349\"><p>All packs that are in scope of FMD need to bear the safety features. The decommissioning needs to be done at the moment the original pack is opened by the pharmacist or hospital according article 28 of the regulation.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-63410\" class=\"elementor-tab-title\" data-tab=\"10\" role=\"button\" aria-controls=\"elementor-tab-content-63410\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-arrow-alt-circle-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-arrow-circle-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Can products that are not in scope for FMD also have a 2D matrix code?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-63410\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"10\" role=\"region\" aria-labelledby=\"elementor-tab-title-63410\"><p>Products that are not in scope for FMD in Belgium can also carry a 2D matrix code, but this code can only have 3 data elements: GTin code, Batch number and Expiry date. It is not allowed that they would carry a Unique Identifier.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-63411\" class=\"elementor-tab-title\" data-tab=\"11\" role=\"button\" aria-controls=\"elementor-tab-content-63411\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-arrow-alt-circle-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-arrow-circle-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Will a variation type IA be accepted for a FMD compliant notification?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-63411\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"11\" role=\"region\" aria-labelledby=\"elementor-tab-title-63411\"><p>An IA-variation is by definition a variation where no content evaluation of the submitted change is required. The implementation of the safety features happens by means of implementation of the new QRD template. This is possible with an IA-variation with an impact on the product information (this is, a change that requires the submission of the QRD-template) and where no content evaluation of the submitted document is needed.<br \/>So, the implementation of the safety features can be submitted with a type IA variation under the condition that<br \/>\u2022 the submission of the QRD-template is a requirement for the concerned variation, and<br \/>\u2022 that there are NO other changes implemented that would require an evaluation.<br \/>In case the implementation has an impact on the mock-up, then the proposal of the new mock-up cannot be part of the IA-variation because this would require an evaluation, but would require a submission with a separate notification art.34\u00a74 of RD of 14.12.2006.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-63412\" class=\"elementor-tab-title\" data-tab=\"12\" role=\"button\" aria-controls=\"elementor-tab-content-63412\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-arrow-alt-circle-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-arrow-circle-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">In which cases will FAMHP accept grouping of the submission?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-63412\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"12\" role=\"region\" aria-labelledby=\"elementor-tab-title-63412\"><p>The existing principles for grouping remain of application. FAMHP would allow for an additional possibility: for products approved under the national procedure and where the implementation of the safety features has no impact on the mock-ups of the concerned products, the notification for the implementation of the safety features for these products can be submitted in one variation. The variation will contain the adapted QRD-template for each concerned product. The fee will correspond with the grouping of a type IA-variation.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-63413\" class=\"elementor-tab-title\" data-tab=\"13\" role=\"button\" aria-controls=\"elementor-tab-content-63413\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-arrow-alt-circle-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-arrow-circle-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">If no change is planned before 2019 (no variation file) and the implementation has no impact on the readability of the pack, should a notification be submitted or can the notification be done by simple letter (cover letter) with the mention that the CNK is replaced by the 2D matrix code and has no impact on the readability? Can products that are not in scope for FMD also have a 2D matrix code?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-63413\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"13\" role=\"region\" aria-labelledby=\"elementor-tab-title-63413\"><p>The implementation plan from EMA\/CMDh indicates clearly that the notification of the implementation of the safety features need to be done by means of submission of an adapted QRD-template. The new QRD-template needs to be submitted as indicated in the implementation plan. For the national procedure products this can be done using the grouping described before.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-63414\" class=\"elementor-tab-title\" data-tab=\"14\" role=\"button\" aria-controls=\"elementor-tab-content-63414\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-arrow-alt-circle-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-arrow-circle-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">What need to be done for ongoing variations when an additional change is required due to FMD?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-63414\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"14\" role=\"region\" aria-labelledby=\"elementor-tab-title-63414\"><p>For products submitted through MRP, the FAMHP will apply the QRD templates approved by the Reference Member State. For products handled under the national procedure, the implementation of the safety features can be added to the dossier as long as the concerned documents have not yet been approved. Concerning the mock-ups, if the evaluation of the mock-up has not been started yet, a new proposal for the implementation of the safety features can be submitted, even if the QRD-template has not yet been adapted.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-63415\" class=\"elementor-tab-title\" data-tab=\"15\" role=\"button\" aria-controls=\"elementor-tab-content-63415\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-arrow-alt-circle-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-arrow-circle-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Will there be a \u201cstandard formulation\u201d for the confirmation that the changes \u201chave no impact on the readability of the packaging\u201d in the cover letter?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-63415\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"15\" role=\"region\" aria-labelledby=\"elementor-tab-title-63415\"><p>FAMHP has published the standard formulation on their website, together with other guidelines regarding FMD. Standard text for the declaration The undersigned [name of the person responsible for the information, company name]declares that the implementation of the safety features (the unique 2-D matrix barcode and the anti-tampering device) have no impact on the legibility of the mock-up, most recently approved by the FAMHP, of [name of medicinal product]. The undersigned bears full responsibility for this.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-63416\" class=\"elementor-tab-title\" data-tab=\"16\" role=\"button\" aria-controls=\"elementor-tab-content-63416\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-arrow-alt-circle-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-arrow-circle-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">When should Free Samples be decommissioned?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-63416\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"16\" role=\"region\" aria-labelledby=\"elementor-tab-title-63416\"><p>Article 41 of the Delegated Regulation states that medicinal products intended to be supplied as free samples, need to be indicated as free samples in the repository system and the decommissioning must be done before providing them to the persons qualified to prescribe them. Therefore, free samples can be decommissioned at any time between the moment they are qualified as free samples in the system and the moment when they are being distributed.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-63417\" class=\"elementor-tab-title\" data-tab=\"17\" role=\"button\" aria-controls=\"elementor-tab-content-63417\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-arrow-alt-circle-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-arrow-circle-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Is it mandatory that all packs on the market after 9 February 2019 contain the safety features?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-63417\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"17\" role=\"region\" aria-labelledby=\"elementor-tab-title-63417\"><p>Only the batches \u201creleased\u201d by the QP as from 9 February 2019 need to contain the safety features. Packs from batches released before 9 February 2019 and not yet carrying the safety feature are still allowed on the market after 9 February 2019 until their expiry date.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-63418\" class=\"elementor-tab-title\" data-tab=\"18\" role=\"button\" aria-controls=\"elementor-tab-content-63418\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-arrow-alt-circle-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-arrow-circle-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Should free samples carry the same GTIN code as the commercial product?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-63418\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"18\" role=\"region\" aria-labelledby=\"elementor-tab-title-63418\"><p>If the free sample is the same pack as the standard supplied pack, you can use the same GTIN code (or create another one if you prefer). If the free sample is a special pack (e.g. reduced pack size, \u2026), a different GTIN seems appropriate. Important is that the packs are decommissioned as free samples before they are distributed (art. 41 of the DR).<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-63419\" class=\"elementor-tab-title\" data-tab=\"19\" role=\"button\" aria-controls=\"elementor-tab-content-63419\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-arrow-alt-circle-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-arrow-circle-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">For Reimbursable products that are carrying a serial number in the linear barcode today, but that are on the \u201cwhite list\u201d (annex I of the DR), do they need to carry the safety features when distributed through public pharmacies?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-63419\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"19\" role=\"region\" aria-labelledby=\"elementor-tab-title-63419\"><p>Products that are on the \u201cwhite list\u201d (annex I of the DR) do not need to carry the safety features and should not have a Unique Identifier. This without impact on their reimbursement status.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-63420\" class=\"elementor-tab-title\" data-tab=\"20\" role=\"button\" aria-controls=\"elementor-tab-content-63420\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-arrow-alt-circle-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-arrow-circle-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">What is a GLN?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-63420\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"20\" role=\"region\" aria-labelledby=\"elementor-tab-title-63420\"><p>A GLN (Global Location Number) identifies each location with a unique number. For more information, consult GS1 website: <a href=\"https:\/\/www.gs1belu.org\/fr\/global-location-number-gln\" target=\"_blank\" rel=\"noopener\">GLN\u00a0<\/a><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-63421\" class=\"elementor-tab-title\" data-tab=\"21\" role=\"button\" aria-controls=\"elementor-tab-content-63421\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-arrow-alt-circle-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-arrow-circle-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">How is the relation between GTin and the CNK maintained?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-63421\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"21\" role=\"region\" aria-labelledby=\"elementor-tab-title-63421\"><p>The relation between GTin and CNK is maintained in a conversion table by the pharmacist association ABP. MAH\u2019s need to communicate the relation between their GTin and CNK prior to market access to\u00a0<a href=\"mailto:gtin@abp.be\">gtin@abp.be.<\/a><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-63422\" class=\"elementor-tab-title\" data-tab=\"22\" role=\"button\" aria-controls=\"elementor-tab-content-63422\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-arrow-alt-circle-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-arrow-circle-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">How should the Human Readable information be mentioned?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-63422\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"22\" role=\"region\" aria-labelledby=\"elementor-tab-title-63422\"><p>On instruction of the Belgian Medicines Agency, the product code (GTIN) must always be preceded by \u201cPC\u201d. The Serial number (UI) must always be preceded by \u201cSN\u201d.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-63423\" class=\"elementor-tab-title\" data-tab=\"23\" role=\"button\" aria-controls=\"elementor-tab-content-63423\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-arrow-alt-circle-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-arrow-circle-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Is it still allowed for a new batch to contain both the 2D matrix and the Linear barcode?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-63423\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"23\" role=\"region\" aria-labelledby=\"elementor-tab-title-63423\"><p>Batches released after 9\/2\/2019 should no longer contain the linear barcode, unless it is not immediately possible to remove them. In that case they should be removed as soon as possible.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-63424\" class=\"elementor-tab-title\" data-tab=\"24\" role=\"button\" aria-controls=\"elementor-tab-content-63424\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-arrow-alt-circle-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-arrow-circle-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Is it acceptable that a pack contains both the linear (UBC\/CBU) and the 2D Data Matrix code?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-63424\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"24\" role=\"region\" aria-labelledby=\"elementor-tab-title-63424\"><p>No, mainly to avoid possible confusion for the end user when scanning the pack. When both codes are present, the end user might not know which code to scan because the end user has no means of knowing if the pack was released before or after 09\/02\/2019.<br \/>The MAH\u2019s should replace the linear barcodes with the 2D Data Matrix code as soon as possible. Applicable legislation has been published by RIZIV\/INAMI. In case both the linear barcode and the 2D Data Matrix code is present, then the user should scan the 2D Data Matrix code.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-63425\" class=\"elementor-tab-title\" data-tab=\"25\" role=\"button\" aria-controls=\"elementor-tab-content-63425\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-arrow-alt-circle-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-arrow-circle-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Can the application of a label \u201cMedical Sample \u2013 Not for sale\u201d on a pack released before 09\/02\/2019 be considered as a repackaging in the sense defined in Art.48 of the Delegated Regulation (EU) 2016\/161?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-63425\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"25\" role=\"region\" aria-labelledby=\"elementor-tab-title-63425\"><p>No; packs released before 09\/02\/2019 do not need to be serialized prior to labelling them as \u201cMedical Sample\u201d. In case such packs are released after 09\/02\/2019 then these packs need to be decommissioned as \u201cFree Sample\u201d under the responsibility of the concerned MAH.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-63426\" class=\"elementor-tab-title\" data-tab=\"26\" role=\"button\" aria-controls=\"elementor-tab-content-63426\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-arrow-alt-circle-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-arrow-circle-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Are medicines that are available \u201cop schriftelijke aanvraag \/ sur demande \u00e9crite\u201d in scope for the Delegated Regulation (EU) 2016\/161?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-63426\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"26\" role=\"region\" aria-labelledby=\"elementor-tab-title-63426\"><p>No, these products are not allowed to carry the safety features.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-63427\" class=\"elementor-tab-title\" data-tab=\"27\" role=\"button\" aria-controls=\"elementor-tab-content-63427\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-arrow-alt-circle-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-arrow-circle-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Is it mandatory that the status of a serial code in the national verification system always corresponds to the real status of the pack?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-63427\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"27\" role=\"region\" aria-labelledby=\"elementor-tab-title-63427\"><p>Yes. When a pack is dispensed, destroyed or the batch is recalled (non-limitative list of examples), then the status of that pack needs to be updated accordingly (decommissioned) in the national verification system(s).<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-63428\" class=\"elementor-tab-title\" data-tab=\"28\" role=\"button\" aria-controls=\"elementor-tab-content-63428\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-arrow-alt-circle-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-arrow-circle-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Is it allowed to label a pack, which has been released before 09\/02\/2019 and that has no 2D Matrix code, with a unique linear barcode (UBC\/CBU) after 09\/02\/2019.<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-63428\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"28\" role=\"region\" aria-labelledby=\"elementor-tab-title-63428\"><p>Yes<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-63429\" class=\"elementor-tab-title\" data-tab=\"29\" role=\"button\" aria-controls=\"elementor-tab-content-63429\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-arrow-alt-circle-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-arrow-circle-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Is it required to submit a request to change the manufacturing authorization (MIA) and the wholesale authorization (WDA) (Art. 12bis & 12ter, law of 25\/03\/1964) to the FAMHP when implementing the equipment for applying the safety features (manufacturers) and for verification and decommissioning (wholesalers)?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-63429\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"29\" role=\"region\" aria-labelledby=\"elementor-tab-title-63429\"><p>No. The implementation and equipment will be inspected at the next routine inspection. However, the application of the safety features (2D Data Matrix code and anti-tampering device) can only be performed by holders of a manufacturing license (MIA; Art. 12bis Law 23\/03\/1964) with activity 1.5.2 Secondary package. In case you do not have an authorization for such activity, a request to obtain\/change the manufacturing authorization needs to be submitted.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-63430\" class=\"elementor-tab-title\" data-tab=\"30\" role=\"button\" aria-controls=\"elementor-tab-content-63430\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-arrow-alt-circle-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-arrow-circle-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">As a manufacturer I plan to outsource the serialisation of my products to a third party. Do I need to submit a request to the FAMHP to change my manufacturing authorisation (MIA) (Art. 12bis Law 25\/03\/1964) to include this subcontractor as an additional \u201cPlace of Execution\u201d on my manufacturing authorisation?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-63430\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"30\" role=\"region\" aria-labelledby=\"elementor-tab-title-63430\"><p>No. The application of the safety features is considered a full manufacturing activity. Therefore, the Marketing Authorisation Holder needs to submit a variation to the MA conform the variation regulation in order to add the subcontractor as a manufacturing site for the Marketing Authorisation.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-63431\" class=\"elementor-tab-title\" data-tab=\"31\" role=\"button\" aria-controls=\"elementor-tab-content-63431\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-arrow-alt-circle-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-arrow-circle-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Is a specific sequence of the data elements in the 2D matrix code required?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-63431\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"31\" role=\"region\" aria-labelledby=\"elementor-tab-title-63431\"><p>There is no mandatory sequence. However, several software systems have difficulties if the Product Code is not in 1st position. It is therefore strongly recommended to start always with the Product Code.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\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\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div id=\"e-n-tab-content-201711332\" role=\"tabpanel\" aria-labelledby=\"e-n-tab-title-201711332\" data-tab-index=\"2\" style=\"--n-tabs-title-order: 2;\" class=\" elementor-element elementor-element-4076f22 e-con-full e-flex e-con e-child\" data-id=\"4076f22\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-dd53906 e-flex e-con-boxed e-con e-child\" data-id=\"dd53906\" 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-303fe7d elementor-widget elementor-widget-accordion\" data-id=\"303fe7d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-accordion\">\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-5051\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-5051\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-arrow-alt-circle-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-arrow-circle-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Is it possible to register and contract different MAH\u2019s with only one form?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-5051\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-5051\"><p>No, this is not possible. The agreement, that includes the registration form, is a legal binding document that needs to be signed by the legal representative of the concerned MAH.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-5052\" class=\"elementor-tab-title\" data-tab=\"2\" role=\"button\" aria-controls=\"elementor-tab-content-5052\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-arrow-alt-circle-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-arrow-circle-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Is it possible to register and contract different MAH\u2019s with only one form?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-5052\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"region\" aria-labelledby=\"elementor-tab-title-5052\"><p>No, this is not possible. The agreement, that includes the registration form, is a legal binding document that needs to be signed by the legal representative of the concerned MAH.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-5053\" class=\"elementor-tab-title\" data-tab=\"3\" role=\"button\" aria-controls=\"elementor-tab-content-5053\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-arrow-alt-circle-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-arrow-circle-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Our company is 100% controlled by the central corporation and both the corporation and the local subsidiary are registered as MAH for a number of products. Do we need to register both entities or is one registration, by the local subsidiary or the central entity enough?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-5053\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"3\" role=\"region\" aria-labelledby=\"elementor-tab-title-5053\"><p>A registration is needed for EACH MAH that is registered in Belgium having at least one product in his portfolio that is in scope for FMD in Belgium, even if the different MAH\u2019s belong to the same corporation.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-5054\" class=\"elementor-tab-title\" data-tab=\"4\" role=\"button\" aria-controls=\"elementor-tab-content-5054\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-arrow-alt-circle-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-arrow-circle-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">What is the procedure to register to the Belgian Medicines Verification System?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-5054\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"4\" role=\"region\" aria-labelledby=\"elementor-tab-title-5054\"><p>The procedure is described on the website bemvo.be in the section Registration\/MAH. The registration requires the submission of the Registration Form and the signed Registration Agreement. The registration becomes fully active when the payment of the one-off registration fee is received by BeMVO.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-5055\" class=\"elementor-tab-title\" data-tab=\"5\" role=\"button\" aria-controls=\"elementor-tab-content-5055\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-arrow-alt-circle-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-arrow-circle-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">When will it be possible to receive information on the level of the Flat Fee applicable as of 2019?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-5055\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"5\" role=\"region\" aria-labelledby=\"elementor-tab-title-5055\"><p>The level of the Flat Fee will be dependent on the required budget for the system and the operations and of the number of MAH\u2019s that will active in Belgium in 2019 with products in scope. A preliminary estimate might be communicated in the second half of 2018.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-5056\" class=\"elementor-tab-title\" data-tab=\"6\" role=\"button\" aria-controls=\"elementor-tab-content-5056\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-arrow-alt-circle-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-arrow-circle-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Is the registration and Flat Fee the same for all companies?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-5056\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"6\" role=\"region\" aria-labelledby=\"elementor-tab-title-5056\"><p>BeMVO is aligned with the Blueprint guidelines from EMVO and the EU stakeholder associations and is applying the Flat Fee principle. The Fees are equal for each MAH.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-5057\" class=\"elementor-tab-title\" data-tab=\"7\" role=\"button\" aria-controls=\"elementor-tab-content-5057\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-arrow-alt-circle-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-arrow-circle-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Does the contract and registration form have to be signed by the MAH or can we have it signed by the legal representative of the MAH?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-5057\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"7\" role=\"region\" aria-labelledby=\"elementor-tab-title-5057\"><p>The registration and contract needs to be signed by the MAH. The MAH is the legal party responsible for bringing the products to the market and is also therefore the legal party that needs to enter into a contractual agreement with the BeMVO.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-5058\" class=\"elementor-tab-title\" data-tab=\"8\" role=\"button\" aria-controls=\"elementor-tab-content-5058\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-arrow-alt-circle-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-arrow-circle-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">What about centralized registered products where the MAH is a central located company abroad (eg the HQ). Do we have to pay the fee for these products or must this be done by our HQ?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-5058\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"8\" role=\"region\" aria-labelledby=\"elementor-tab-title-5058\"><p>The agreement needs to be signed by the MAH responsible for the registration of the products in Belgium (Marketing Authorisation Holder) The payment, as well as the further follow up of the project, can be managed by the local affiliated company. This is up to the MAH and corporate organisation to decide on their internal procedures.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-5059\" class=\"elementor-tab-title\" data-tab=\"9\" role=\"button\" aria-controls=\"elementor-tab-content-5059\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-arrow-alt-circle-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-arrow-circle-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">The products in our portfolio are not in scope of FMD. Can BeMVO confirm we do not need to register to the Belgian Verification system?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-5059\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"9\" role=\"region\" aria-labelledby=\"elementor-tab-title-5059\"><p>The BeMVO does not have a view on the product portfolio of the different MAH\u2019s. It is the responsibility of the MAH\u2019s to assess and decide if one of their products is in scope for FMD in Belgium. The definition of products that are in scope for Belgium is defined on the bemvo.be website. In case the MAH considers he is not in scope, we appreciate receiving confirmation by email on mah@bemvo.be.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-50510\" class=\"elementor-tab-title\" data-tab=\"10\" role=\"button\" aria-controls=\"elementor-tab-content-50510\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-arrow-alt-circle-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-arrow-circle-down\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Can the agreement between the MAH and the BeMVO be transferred to another MAH?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-50510\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"10\" role=\"region\" aria-labelledby=\"elementor-tab-title-50510\"><p>In case you have registered one MAH but decide at a later stage to move the products under this MAH to another MAH, then the agreement can be transferred to that other MAH.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\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\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\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-573b94b e-flex e-con-boxed e-con e-parent\" data-id=\"573b94b\" 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>This page is only available in English PACKS &amp; CODES CONTRACTUAL The product registrations for the European products are all done from one single location with a GTin code obtained from GS1 in the concerned country. Can this GTin code continue to be used in Belgium? The GTin code (14), constructed according to the GS1 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":3319,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-5307","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>FAQ MAH fr - Bemvo<\/title>\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\/bibliotheque\/faq-mah\/\" \/>\n<meta property=\"og:locale\" content=\"nl_NL\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FAQ MAH fr - Bemvo\" \/>\n<meta property=\"og:description\" content=\"This page is only available in English PACKS &amp; CODES CONTRACTUAL The product registrations for the European products are all done from one single location with a GTin code obtained from GS1 in the concerned country. Can this GTin code continue to be used in Belgium? The GTin code (14), constructed according to the GS1 [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/bemvo.be\/index.php\/bibliotheque\/faq-mah\/\" \/>\n<meta property=\"og:site_name\" content=\"Bemvo\" \/>\n<meta property=\"article:modified_time\" content=\"2024-09-24T12:15:14+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/bemvo.be\/wp-content\/uploads\/2023\/06\/banners-website-2-1-1024x343.png\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Verwachte leestijd\" \/>\n\t<meta name=\"twitter:data1\" content=\"29 minuten\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/bemvo.be\\\/index.php\\\/bibliotheque\\\/faq-mah\\\/\",\"url\":\"https:\\\/\\\/bemvo.be\\\/index.php\\\/bibliotheque\\\/faq-mah\\\/\",\"name\":\"FAQ MAH fr - Bemvo\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/bemvo.be\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/bemvo.be\\\/index.php\\\/bibliotheque\\\/faq-mah\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/bemvo.be\\\/index.php\\\/bibliotheque\\\/faq-mah\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/bemvo.be\\\/wp-content\\\/uploads\\\/2023\\\/06\\\/banners-website-2-1-1024x343.png\",\"datePublished\":\"2023-11-03T15:55:39+00:00\",\"dateModified\":\"2024-09-24T12:15:14+00:00\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/bemvo.be\\\/index.php\\\/bibliotheque\\\/faq-mah\\\/#breadcrumb\"},\"inLanguage\":\"nl-NL\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/bemvo.be\\\/index.php\\\/bibliotheque\\\/faq-mah\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"nl-NL\",\"@id\":\"https:\\\/\\\/bemvo.be\\\/index.php\\\/bibliotheque\\\/faq-mah\\\/#primaryimage\",\"url\":\"https:\\\/\\\/i0.wp.com\\\/bemvo.be\\\/wp-content\\\/uploads\\\/2023\\\/06\\\/banners-website-2-1.png?fit=2240%2C750&ssl=1\",\"contentUrl\":\"https:\\\/\\\/i0.wp.com\\\/bemvo.be\\\/wp-content\\\/uploads\\\/2023\\\/06\\\/banners-website-2-1.png?fit=2240%2C750&ssl=1\",\"width\":2240,\"height\":750,\"caption\":\"FAQ\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/bemvo.be\\\/index.php\\\/bibliotheque\\\/faq-mah\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/bemvo.be\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Biblioth\u00e8que\",\"item\":\"https:\\\/\\\/bemvo.be\\\/index.php\\\/bibliotheque\\\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"FAQ MAH fr\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/bemvo.be\\\/#website\",\"url\":\"https:\\\/\\\/bemvo.be\\\/\",\"name\":\"Bemvo\",\"description\":\"Belgian Medicines Verification Organisation vzw\",\"publisher\":{\"@id\":\"https:\\\/\\\/bemvo.be\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/bemvo.be\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"nl-NL\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/bemvo.be\\\/#organization\",\"name\":\"Belgian Medicines Verification Organisation\",\"url\":\"https:\\\/\\\/bemvo.be\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"nl-NL\",\"@id\":\"https:\\\/\\\/bemvo.be\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/i0.wp.com\\\/bemvo.be\\\/wp-content\\\/uploads\\\/2023\\\/04\\\/favicon.png?fit=382%2C132&ssl=1\",\"contentUrl\":\"https:\\\/\\\/i0.wp.com\\\/bemvo.be\\\/wp-content\\\/uploads\\\/2023\\\/04\\\/favicon.png?fit=382%2C132&ssl=1\",\"width\":382,\"height\":132,\"caption\":\"Belgian Medicines Verification Organisation\"},\"image\":{\"@id\":\"https:\\\/\\\/bemvo.be\\\/#\\\/schema\\\/logo\\\/image\\\/\"}}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"FAQ MAH fr - Bemvo","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/bemvo.be\/index.php\/bibliotheque\/faq-mah\/","og_locale":"nl_NL","og_type":"article","og_title":"FAQ MAH fr - Bemvo","og_description":"This page is only available in English PACKS &amp; CODES CONTRACTUAL The product registrations for the European products are all done from one single location with a GTin code obtained from GS1 in the concerned country. 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