{"id":4874,"date":"2023-10-26T13:48:15","date_gmt":"2023-10-26T11:48:15","guid":{"rendered":"https:\/\/bemvo.be\/?page_id=4874"},"modified":"2026-08-24T15:28:01","modified_gmt":"2026-08-24T13:28:01","slug":"belgian-regulation-eng","status":"publish","type":"page","link":"https:\/\/bemvo.be\/index.php\/knowledge-database\/belgian-regulation-eng\/","title":{"rendered":"REGULATION"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"4874\" class=\"elementor elementor-4874\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-70940d3 e-flex e-con-boxed e-con e-parent\" data-id=\"70940d3\" 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-5d9239c elementor-widget elementor-widget-heading\" data-id=\"5d9239c\" 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\">Regulation<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-579c25f elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"579c25f\" 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-3667e4e\" data-id=\"3667e4e\" 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-6299da0 elementor-widget elementor-widget-text-editor\" data-id=\"6299da0\" 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 Federal Agency for Medicines and Health Products (FAMHP\/FAGG\/AFMPS) has published the guidelines and Q&amp;A documents related to the Falsified Medicines Directive.<\/p><p>They are available in\u00a0Dutch;\u00a0French and<a class=\"\" href=\"https:\/\/www.famhp.be\/en\/human_use\/medicines\/medicines\/MA_procedures\/famhp_guidelines_for_implementing_the_safety_features_in\" target=\"_blank\" rel=\"noopener noreferrer\"> English<\/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-e86d0d3 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"e86d0d3\" 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-759e171\" data-id=\"759e171\" 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-961e0a8 elementor-widget elementor-widget-text-editor\" data-id=\"961e0a8\" 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>According to Art. 19 of the Delegated Regulation (<a href=\"https:\/\/op.europa.eu\/en\/publication-detail\/-\/publication\/ba995577-528f-44cc-8ac9-22b0449fd522\" target=\"_blank\" rel=\"noopener\">DR 2016\/161<\/a>), manufacturers have to fulfil as well the requirements on wholesalers as set forth in Art. 20 (a), 22, 23, and 24 of the DR. However, the DR does not define that manufacturers need to do this via direct access to the national system.<\/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-d8837e9 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"d8837e9\" 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-d8040fd\" data-id=\"d8040fd\" 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-fab3d65 elementor-widget elementor-widget-spacer\" data-id=\"fab3d65\" 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-1c7de61 e-flex e-con-boxed e-con e-parent\" data-id=\"1c7de61\" 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-9686cae e-n-tabs-mobile elementor-widget elementor-widget-n-tabs\" data-id=\"9686cae\" data-element_type=\"widget\" data-e-type=\"widget\" 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=\"157838510\" 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-1578385101\" data-tab-title-id=\"e-n-tab-title-1578385101\" class=\"e-n-tab-title\" aria-selected=\"true\" data-tab-index=\"1\" role=\"tab\" tabindex=\"0\" aria-controls=\"e-n-tab-content-1578385101\" style=\"--n-tabs-title-order: 1;\">\n\t\t\t\t\t\t<span class=\"e-n-tab-title-text\">\n\t\t\t\tGENERAL\t\t\t<\/span>\n\t\t<\/button>\n\t\t\t\t<button id=\"e-n-tab-title-1578385102\" data-tab-title-id=\"e-n-tab-title-1578385102\" class=\"e-n-tab-title\" aria-selected=\"false\" data-tab-index=\"2\" role=\"tab\" tabindex=\"-1\" aria-controls=\"e-n-tab-content-1578385102\" style=\"--n-tabs-title-order: 2;\">\n\t\t\t\t\t\t<span class=\"e-n-tab-title-text\">\n\t\t\t\tBELGIAN VERIFICATION SYSTEM\t\t\t<\/span>\n\t\t<\/button>\n\t\t\t\t<button id=\"e-n-tab-title-1578385103\" data-tab-title-id=\"e-n-tab-title-1578385103\" class=\"e-n-tab-title\" aria-selected=\"false\" data-tab-index=\"3\" role=\"tab\" tabindex=\"-1\" aria-controls=\"e-n-tab-content-1578385103\" style=\"--n-tabs-title-order: 3;\">\n\t\t\t\t\t\t<span class=\"e-n-tab-title-text\">\n\t\t\t\tEUROPEAN HUB\t\t\t<\/span>\n\t\t<\/button>\n\t\t\t\t<button id=\"e-n-tab-title-1578385104\" data-tab-title-id=\"e-n-tab-title-1578385104\" class=\"e-n-tab-title\" aria-selected=\"false\" data-tab-index=\"4\" role=\"tab\" tabindex=\"-1\" aria-controls=\"e-n-tab-content-1578385104\" style=\"--n-tabs-title-order: 4;\">\n\t\t\t\t\t\t<span class=\"e-n-tab-title-text\">\n\t\t\t\tEMVO\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-1578385101\" role=\"tabpanel\" aria-labelledby=\"e-n-tab-title-1578385101\" data-tab-index=\"1\" style=\"--n-tabs-title-order: 1;\" class=\"e-active elementor-element elementor-element-4483cad e-con-full e-flex e-con e-child\" data-id=\"4483cad\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-23ff00a e-flex e-con-boxed e-con e-child\" data-id=\"23ff00a\" 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-4e4a8e1 elementor-widget elementor-widget-text-editor\" data-id=\"4e4a8e1\" 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<section class=\"elementor-section elementor-top-section elementor-element elementor-element-9f54265 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"9f54265\" data-element_type=\"section\" data-e-type=\"section\"><div class=\"elementor-container elementor-column-gap-default\"><div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-78b45b7\" data-id=\"78b45b7\" data-element_type=\"column\" data-e-type=\"column\"><div class=\"elementor-widget-wrap elementor-element-populated\"><div class=\"elementor-element elementor-element-b88f03a elementor-widget elementor-widget-heading\" data-id=\"b88f03a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\"><div class=\"elementor-widget-container\"><h2 class=\"elementor-heading-title elementor-size-default\">SAFETY FEATURES FOR MEDICINAL PRODUCTS FOR HUMAN USE<\/h2><\/div><\/div><\/div><\/div><\/div><\/section><section class=\"elementor-section elementor-top-section elementor-element elementor-element-0d4a1d7 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"0d4a1d7\" data-element_type=\"section\" data-e-type=\"section\"><div class=\"elementor-container elementor-column-gap-default\"><div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-5364293\" data-id=\"5364293\" data-element_type=\"column\" data-e-type=\"column\"><div class=\"elementor-widget-wrap elementor-element-populated\"><div class=\"elementor-element elementor-element-9ddb873 elementor-widget elementor-widget-text-editor\" data-id=\"9ddb873\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\"><div class=\"elementor-widget-container\"><p>The European Commission has prepared some specific answers to facilitate the implementation of the Delegated Regulation in a\u00a0<a href=\"https:\/\/bemvo.be\/wp-content\/uploads\/2024\/06\/qa_safetyfeature_en_0.pdf\" target=\"_blank\" rel=\"noopener\">QUESTION AND ANSWER DOCUMENT<\/a>.<\/p><\/div><\/div><\/div><\/div><\/div><\/section>\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<div class=\"elementor-element elementor-element-1740cd2 elementor-widget elementor-widget-accordion\" data-id=\"1740cd2\" 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-2431\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-2431\" 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 connection to the national system needed?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2431\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-2431\"><p>There are two types of connections possible to the national system. A connection for wholesalers and a connection for pharmacies (public and hospital). If the manufacturer, marketing authorization holder or the 3rd party logistics partner of the MAH has a wholesaling licence in Belgium, a wholesaler type connection to the national system can be requested by registering in the Distribution Registration section, taking into account Question 5.11 in the Q&amp;A version 17 of the EU commission.<\/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-2432\" class=\"elementor-tab-title\" data-tab=\"2\" role=\"button\" aria-controls=\"elementor-tab-content-2432\" 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 connection to the national system needed?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2432\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"region\" aria-labelledby=\"elementor-tab-title-2432\"><p>There are two types of connections possible to the national system. A connection for wholesalers and a connection for pharmacies (public and hospital). If the manufacturer, marketing authorization holder or the 3rd party logistics partner of the MAH has a wholesaling licence in Belgium, a wholesaler type connection to the national system can be requested by registering in the Distribution Registration section, taking into account Question 5.11 in the Q&amp;A version 17 of the EU commission.<\/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-2433\" class=\"elementor-tab-title\" data-tab=\"3\" role=\"button\" aria-controls=\"elementor-tab-content-2433\" 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\">Batches released as from 9 February 2019 should as soon as possible remove the linear barcode with the UBC. What is the definition of \u2018Release\u2019?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2433\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"3\" role=\"region\" aria-labelledby=\"elementor-tab-title-2433\"><p>The \u2018Release\u2019 is defined as the moment when the Qualified Person is giving the approval for release of the batch to 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-2434\" class=\"elementor-tab-title\" data-tab=\"4\" role=\"button\" aria-controls=\"elementor-tab-content-2434\" 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\">Belgium has the possibility to extend the implementation to a later date than 9th February 2019. Will Belgium use this possibility?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2434\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"4\" role=\"region\" aria-labelledby=\"elementor-tab-title-2434\"><p>The national competent authorities have decided that Belgium will not extend the implementation period and expect the stakeholders to be ready by 9th February 2019.<\/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-2435\" class=\"elementor-tab-title\" data-tab=\"5\" role=\"button\" aria-controls=\"elementor-tab-content-2435\" 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 Belgium be ready to accept the 2D matrix barcode on the packaging?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2435\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"5\" role=\"region\" aria-labelledby=\"elementor-tab-title-2435\"><p>2D matrix barcodes can be put on the packaging as from mid 2017. During the transition period, for reimbursable products that are bearing the Unique Barcode (UBC) with the serial number today, this linear barcode needs to remain on the packaging until August 2018. From that date on, packs with only the 2D matrix code will be allowed on the market.<\/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-2436\" class=\"elementor-tab-title\" data-tab=\"6\" role=\"button\" aria-controls=\"elementor-tab-content-2436\" 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 products are to be considered for FMD in Belgium?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2436\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"6\" role=\"region\" aria-labelledby=\"elementor-tab-title-2436\"><p>The Directive 2011\/22\/EU is adding point 54(o) to the Directive 2001\/83\/EC stating that the safety features need to be applied \u201cfor medicinal products other than radio pharmaceuticals referred to in article 54a (1)\u2026\u201d The scope of FMD in Belgium has been defined by the competent authorities: \u2013 All products subject to prescription<br \/>\u2013 Plus the Black list (DR annex 2)<br \/>\u2013 Minus the White list (DR annex 1)<br \/>\u2013 Plus all reimbursable products that are bearing a serial code (UBC) today, except if they are on the White list<\/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<\/div>\n\t\t<div id=\"e-n-tab-content-1578385102\" role=\"tabpanel\" aria-labelledby=\"e-n-tab-title-1578385102\" data-tab-index=\"2\" style=\"--n-tabs-title-order: 2;\" class=\" elementor-element elementor-element-182e038 e-con-full e-flex e-con e-child\" data-id=\"182e038\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9f5f8d9 elementor-widget elementor-widget-accordion\" data-id=\"9f5f8d9\" 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-1671\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-1671\" 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 case that, through a derogation, a pack from another market is being delivered, will the code from this other country be readable and transmitted to the EU Hub?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-1671\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-1671\"><p>Depending on the setup of the scanner of the concerned distribution stakeholder, the scanner will be able to read the \u2018alternative\u2019 coding scheme of the 2D barcode. In case the scanner cannot read the 2D, the stakeholder must enter the code manually so the verification or decommissioning can be done in the repository of the concerned country through the EU Hub connection.<\/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-1672\" class=\"elementor-tab-title\" data-tab=\"2\" role=\"button\" aria-controls=\"elementor-tab-content-1672\" 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 case that, through a derogation, a pack from another market is being delivered, will the code from this other country be readable and transmitted to the EU Hub?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-1672\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"region\" aria-labelledby=\"elementor-tab-title-1672\"><p>Depending on the setup of the scanner of the concerned distribution stakeholder, the scanner will be able to read the \u2018alternative\u2019 coding scheme of the 2D barcode. In case the scanner cannot read the 2D, the stakeholder must enter the code manually so the verification or decommissioning can be done in the repository of the concerned country through the EU Hub connection.<\/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-1673\" class=\"elementor-tab-title\" data-tab=\"3\" role=\"button\" aria-controls=\"elementor-tab-content-1673\" 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 we register to the Belgian Verification System, is there a deadline for bringing the FMD-designed packs in the supply chain?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-1673\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"3\" role=\"region\" aria-labelledby=\"elementor-tab-title-1673\"><p>There is no deadline to bring the new packs on the market other than 9th February 2019. We suggest however to progress as soon as possible given the different aspects that need to be considered and implemented: connection to the verification system, adapting production lines, reviewing internal processes, \u2026<\/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-1674\" class=\"elementor-tab-title\" data-tab=\"4\" role=\"button\" aria-controls=\"elementor-tab-content-1674\" 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 MAH is working with local distribution partners and local repackaging partners. Can they have a connection to the National Verification System and under which conditions?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-1674\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"4\" role=\"region\" aria-labelledby=\"elementor-tab-title-1674\"><p>The EMVS system (Hub and national system) has been designed that MAH and their 3rd party logistics partners can have access through the connection of the OnBoarding Partner. This connection, besides loading the product pack data, can also be used for verification and decommissioning. However, if the MAH or his 3rd party logistics partner is owner of a wholesaling license in Belgium, the concerned company can request for a \u201cwholesaler type\u201d connection by registrating in the Distributor Registration section.<\/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-1675\" class=\"elementor-tab-title\" data-tab=\"5\" role=\"button\" aria-controls=\"elementor-tab-content-1675\" 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 scanning of the 2D barcode, will the pharmacist see the PC, SN, expiry date and batch number on his screen or will it generate just one long number that is checked in the database for these 4 numbers?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-1675\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"5\" role=\"region\" aria-labelledby=\"elementor-tab-title-1675\"><p>The way the result of the scanning of the 2D matrix code is displayed and processed in the system of the pharmacists depends on the way his software vendor is developing the functionality. The pharmacists\u2019 system will contain a Gtin-to-CNK conversion table allowing the system to display all needed product information for the pharmacist.<\/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-1676\" class=\"elementor-tab-title\" data-tab=\"6\" role=\"button\" aria-controls=\"elementor-tab-content-1676\" 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 GD. Luxembourg also use the Belgian Verification repository?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-1676\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"6\" role=\"region\" aria-labelledby=\"elementor-tab-title-1676\"><p>Yes, the end users in GD Luxembourg will also be connected to the Belgian Verification repository. Therefore, the data for all products that officially registered in Belgium and\/or in GD Luxembourg will need to be loaded in the Belgian repository. The MAHs that have signed an agreement with the BeMVO and\/or the LMVO will receive the technical details and guidelines on how the data for the two countries needs to be uploaded in the Country Specific Master data.<\/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-1677\" class=\"elementor-tab-title\" data-tab=\"7\" role=\"button\" aria-controls=\"elementor-tab-content-1677\" 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 the On Boarding Partner (OBP) of the MAHs be able to upload product and pack data for Belgium and Luxembourg?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-1677\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"7\" role=\"region\" aria-labelledby=\"elementor-tab-title-1677\"><p>The OBPs, acting on behalf of the Marketing Authorisation Holders, can already upload the product master data today to the Hub. The Batch and Pack data (pack codes) for Belgium and Luxembourg can only be uploaded when the Belgian Verification system is connected to the Production environment of the Hub. This connection is scheduled for end of January 2018 (but can be subject to change). MAHs that have signed an agreement with the BeMVO will be informed about the exact date of the Go Live of the connection and will also receive the loading guidelines for the Belgian and Luxembourg data. MAHs that did not sign the agreement with the BeMVO or LMVO will not be able to upload the pack data.<\/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<\/div>\n\t\t<div id=\"e-n-tab-content-1578385103\" role=\"tabpanel\" aria-labelledby=\"e-n-tab-title-1578385103\" data-tab-index=\"3\" style=\"--n-tabs-title-order: 3;\" class=\" elementor-element elementor-element-2b88d57 e-con-full e-flex e-con e-child\" data-id=\"2b88d57\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9cb0379 elementor-widget elementor-widget-accordion\" data-id=\"9cb0379\" 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-1641\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-1641\" 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 establish a connection to the EU Hub?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-1641\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-1641\"><p>The procedure to register and connect to the EU Hub is described on the EMVO-Medicines.eu website in the section On-Boarding.<\/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-1642\" class=\"elementor-tab-title\" data-tab=\"2\" role=\"button\" aria-controls=\"elementor-tab-content-1642\" 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 establish a connection to the EU Hub?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-1642\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"region\" aria-labelledby=\"elementor-tab-title-1642\"><p>The procedure to register and connect to the EU Hub is described on the EMVO-Medicines.eu website in the section Onboarding.<\/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-1643\" class=\"elementor-tab-title\" data-tab=\"3\" role=\"button\" aria-controls=\"elementor-tab-content-1643\" 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 connection between the EU Hub and the Belgian national system? Do the codes need to be loaded in both systems?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-1643\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"3\" role=\"region\" aria-labelledby=\"elementor-tab-title-1643\"><p>The product master data and the unique codes for the individual packs need to be uploaded in the Hub. The onboarding and loading procedures are documented on the EMVO-medicines.eu website. The codes will then automatically be downloaded to the national systems, including the BMVS (Belgian Verification system), referred to in the product master data. Important to be aware that the codes can only be loaded when the connection between the Hub and the National system is active. The files with unique pack codes are only kept active for 24 hours on the Hub. If the connection to the national system is not ready, the file with the codes will be deleted after 24 hours and the codes will have to be reloaded at a later stage.<\/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-1644\" class=\"elementor-tab-title\" data-tab=\"4\" role=\"button\" aria-controls=\"elementor-tab-content-1644\" 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 the manufacturer be able to upload the product data and pack codes to the EU Hub for different MAH\u2019s?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-1644\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"4\" role=\"region\" aria-labelledby=\"elementor-tab-title-1644\"><p>The uploading of the product and pack data is done through a \u2018OnBoarding Partner\u2019 (OBP). Such OBP can group the data coming from different Manufacturers &amp; MAH\u2019s from the same corporation, including data coming from contracted manufacturing organizations and 3rd party logistic partners. For more details, please consult the OnBoarding information on the EMVO-medicines.eu website.<\/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-1645\" class=\"elementor-tab-title\" data-tab=\"5\" role=\"button\" aria-controls=\"elementor-tab-content-1645\" 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 MAH responsible for uploading the data in the EU Hub or can he select who does the uploading?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-1645\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"5\" role=\"region\" aria-labelledby=\"elementor-tab-title-1645\"><p>The local MAH is only managing the distribution where the manufacturing is done in a central location and also done by a contract manufacturing organisation. The corporate organisation can opt to regroup all loading activity through one OnBoarding Partner (OBP). The OBP needs to register to the EU Hub and organise the internal processes to load the data from the different locations. More information on the different options is available on the EMVO-Medicines.eu website in the section Onboarding.<\/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<\/div>\n\t\t<div id=\"e-n-tab-content-1578385104\" role=\"tabpanel\" aria-labelledby=\"e-n-tab-title-1578385104\" data-tab-index=\"4\" style=\"--n-tabs-title-order: 4;\" class=\" elementor-element elementor-element-72a630a e-flex e-con-boxed e-con e-child\" data-id=\"72a630a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-5469e74 e-con-full e-flex e-con e-child\" data-id=\"5469e74\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b3f9694 elementor-widget elementor-widget-heading\" data-id=\"b3f9694\" 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\"><span style=\"white-space: normal\">KNOWLEDGE DATABASE EMVO<\/span><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bcf6bf6 elementor-widget elementor-widget-text-editor\" data-id=\"bcf6bf6\" 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<section class=\"elementor-section elementor-top-section elementor-element elementor-element-beddde2 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"beddde2\" data-element_type=\"section\" data-e-type=\"section\"><div class=\"elementor-container elementor-column-gap-default\"><div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-5e1b413\" data-id=\"5e1b413\" data-element_type=\"column\" data-e-type=\"column\"><div class=\"elementor-widget-wrap elementor-element-populated\"><div class=\"elementor-element elementor-element-f9ef0ab elementor-widget elementor-widget-text-editor\" data-id=\"f9ef0ab\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\"><div class=\"elementor-widget-container\"><p><span style=\"color: #555555;\">EMVO has prepared a specific <\/span><a class=\"\" style=\"background-color: #ffffff;\" href=\"https:\/\/emvo-medicines.eu\/resources\/?e-filter-ca2c643-post_tag=qa\" target=\"_blank\" rel=\"noreferrer noopener\">FAQ LIST<\/a><span style=\"color: #555555;\"> for the Marketing Authorisation Holders, explaining key facts related to their connection to the European Hub.<\/span><\/p><\/div><\/div><\/div><\/div><\/div><\/section>\t\t\t\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\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\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Regulation The Federal Agency for Medicines and Health Products (FAMHP\/FAGG\/AFMPS) has published the guidelines and Q&amp;A documents related to the Falsified Medicines Directive. They are available in\u00a0Dutch;\u00a0French and English. According to Art. 19 of the Delegated Regulation (DR 2016\/161), manufacturers have to fulfil as well the requirements on wholesalers as set forth in Art. 20 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":4879,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-4874","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>REGULATION - 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\/knowledge-database\/belgian-regulation-eng\/\" \/>\n<meta property=\"og:locale\" content=\"nl_NL\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"REGULATION - Bemvo\" \/>\n<meta property=\"og:description\" content=\"Regulation The Federal Agency for Medicines and Health Products (FAMHP\/FAGG\/AFMPS) has published the guidelines and Q&amp;A documents related to the Falsified Medicines Directive. They are available in\u00a0Dutch;\u00a0French and English. According to Art. 19 of the Delegated Regulation (DR 2016\/161), manufacturers have to fulfil as well the requirements on wholesalers as set forth in Art. 20 [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/bemvo.be\/index.php\/knowledge-database\/belgian-regulation-eng\/\" \/>\n<meta property=\"og:site_name\" content=\"Bemvo\" \/>\n<meta property=\"article:modified_time\" content=\"2026-08-24T13:28:01+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Verwachte leestijd\" \/>\n\t<meta name=\"twitter:data1\" content=\"16 minuten\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/bemvo.be\\\/index.php\\\/knowledge-database\\\/belgian-regulation-eng\\\/\",\"url\":\"https:\\\/\\\/bemvo.be\\\/index.php\\\/knowledge-database\\\/belgian-regulation-eng\\\/\",\"name\":\"REGULATION - Bemvo\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/bemvo.be\\\/#website\"},\"datePublished\":\"2023-10-26T11:48:15+00:00\",\"dateModified\":\"2026-08-24T13:28:01+00:00\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/bemvo.be\\\/index.php\\\/knowledge-database\\\/belgian-regulation-eng\\\/#breadcrumb\"},\"inLanguage\":\"nl-NL\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/bemvo.be\\\/index.php\\\/knowledge-database\\\/belgian-regulation-eng\\\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/bemvo.be\\\/index.php\\\/knowledge-database\\\/belgian-regulation-eng\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/bemvo.be\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"KNOWLEDGE DATABASE\",\"item\":\"https:\\\/\\\/bemvo.be\\\/?page_id=4879\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"REGULATION\"}]},{\"@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":"REGULATION - 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\/knowledge-database\/belgian-regulation-eng\/","og_locale":"nl_NL","og_type":"article","og_title":"REGULATION - Bemvo","og_description":"Regulation The Federal Agency for Medicines and Health Products (FAMHP\/FAGG\/AFMPS) has published the guidelines and Q&amp;A documents related to the Falsified Medicines Directive. They are available in\u00a0Dutch;\u00a0French and English. According to Art. 19 of the Delegated Regulation (DR 2016\/161), manufacturers have to fulfil as well the requirements on wholesalers as set forth in Art. 20 [&hellip;]","og_url":"https:\/\/bemvo.be\/index.php\/knowledge-database\/belgian-regulation-eng\/","og_site_name":"Bemvo","article_modified_time":"2026-08-24T13:28:01+00:00","twitter_card":"summary_large_image","twitter_misc":{"Verwachte leestijd":"16 minuten"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/bemvo.be\/index.php\/knowledge-database\/belgian-regulation-eng\/","url":"https:\/\/bemvo.be\/index.php\/knowledge-database\/belgian-regulation-eng\/","name":"REGULATION - Bemvo","isPartOf":{"@id":"https:\/\/bemvo.be\/#website"},"datePublished":"2023-10-26T11:48:15+00:00","dateModified":"2026-08-24T13:28:01+00:00","breadcrumb":{"@id":"https:\/\/bemvo.be\/index.php\/knowledge-database\/belgian-regulation-eng\/#breadcrumb"},"inLanguage":"nl-NL","potentialAction":[{"@type":"ReadAction","target":["https:\/\/bemvo.be\/index.php\/knowledge-database\/belgian-regulation-eng\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/bemvo.be\/index.php\/knowledge-database\/belgian-regulation-eng\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/bemvo.be\/"},{"@type":"ListItem","position":2,"name":"KNOWLEDGE DATABASE","item":"https:\/\/bemvo.be\/?page_id=4879"},{"@type":"ListItem","position":3,"name":"REGULATION"}]},{"@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\/"}}]}},"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/bemvo.be\/index.php\/wp-json\/wp\/v2\/pages\/4874","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/bemvo.be\/index.php\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/bemvo.be\/index.php\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/bemvo.be\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/bemvo.be\/index.php\/wp-json\/wp\/v2\/comments?post=4874"}],"version-history":[{"count":50,"href":"https:\/\/bemvo.be\/index.php\/wp-json\/wp\/v2\/pages\/4874\/revisions"}],"predecessor-version":[{"id":12000,"href":"https:\/\/bemvo.be\/index.php\/wp-json\/wp\/v2\/pages\/4874\/revisions\/12000"}],"up":[{"embeddable":true,"href":"https:\/\/bemvo.be\/index.php\/wp-json\/wp\/v2\/pages\/4879"}],"wp:attachment":[{"href":"https:\/\/bemvo.be\/index.php\/wp-json\/wp\/v2\/media?parent=4874"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}