{"id":4295,"date":"2023-01-30T15:40:41","date_gmt":"2023-01-30T14:40:41","guid":{"rendered":"https:\/\/dev.e-vis.se\/?page_id=4295"},"modified":"2026-01-08T10:58:39","modified_gmt":"2026-01-08T09:58:39","slug":"mah","status":"publish","type":"page","link":"https:\/\/e-vis.se\/en\/mah\/","title":{"rendered":"MAH"},"content":{"rendered":"\n<div class=\"wp-block-cover alignfull hero\" style=\"min-height:442px;aspect-ratio:unset;\" id=\"hero\"><span aria-hidden=\"true\" class=\"wp-block-cover__background has-neve-link-color-background-color has-background-dim-100 has-background-dim\"><\/span><div class=\"wp-block-cover__inner-container is-layout-flow wp-block-cover-is-layout-flow\">\n<div class=\"wp-block-columns hero-first-block is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column hero-image-box has-neve-link-color-background-color has-background is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:50%\"><div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1280\" height=\"766\" src=\"https:\/\/e-vis.se\/wp-content\/uploads\/2022\/12\/producent-kopia-1280x766.png\" alt=\"\" class=\"wp-image-3574\" srcset=\"https:\/\/e-vis.se\/wp-content\/uploads\/2022\/12\/producent-kopia-1280x766.png 1280w, https:\/\/e-vis.se\/wp-content\/uploads\/2022\/12\/producent-kopia-640x383.png 640w, https:\/\/e-vis.se\/wp-content\/uploads\/2022\/12\/producent-kopia-768x460.png 768w, https:\/\/e-vis.se\/wp-content\/uploads\/2022\/12\/producent-kopia.png 1398w\" sizes=\"auto, (max-width: 1280px) 100vw, 1280px\" \/><\/figure>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:50%\">\n<h2 class=\"wp-block-heading has-nv-text-dark-bg-color has-text-color\">MAH<\/h2>\n\n\n\n<p>Each Marketing Authorisation Holder (MAH) which markets at least one product covered by the Falsified Medicines Directive (FMD) within a national territory must have a contract with the National Medicines Verification Organisation (NMVO) as from February 9th, 2019.<\/p>\n\n\n\n<p>e-VIS (e-Verifikation i Sverige) is the Swedish non-commercial association who manages the SMVS (Swedish Medicines Verification System)<\/p>\n<\/div>\n<\/div>\n<\/div><\/div>\n\n\n\n<div style=\"height:80px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-neve-link-color-color has-text-color\">Pharmaceutical Companies (MAHs)<\/h2>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<p>As of 9 February 2019, marketing authorised holders are obliged to place two safety features on the packaging of most prescription medicines and some over-the-counter medicines in the European Union: a unique identifier (a 2-dimension barcode) and an anti-tampering device, in accordance with Commission Delegated Regulation (EU) 2016\/161.&nbsp;The goal is to prevent falsified medicines from reaching patients through the legal supply chain.<\/p>\n\n\n\n<p>Each MAH which markets at least one product within a national territory must have a contract with the National Medicines Verification Organisation (NMVO) and pay the national fee.<\/p>\n\n\n\n<p>e-VIS (e-Verifikation i Sverige) is the Swedish non-commercial association who manages the SMVS (Swedish Medicines Verification System).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Contract<\/h2>\n\n\n\n<p>Enquiries and information about on-boarding send an email to <a href=\"mailto:administration@e-vis.se\" target=\"_blank\" rel=\"noreferrer noopener\">administration@e-vis.se<\/a><\/p>\n\n\n\n<p>Information needed: <\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Full name of MAH*<br>*Based on information given to the <em>Swedish Medical Product Agency (L\u00e4kemedelsverket<\/em>)<\/li>\n\n\n\n<li>Address<\/li>\n\n\n\n<li>VAT number, if not applicable company registration number<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Annual fee<\/h2>\n\n\n\n<p>e-VIS charges an adjusted flat fee model per MAH.<br><br>The costs of the repositories system shall be borne by the manufacturers of medicinal products bearing the safety features, in accordance with Article 54a(2)(e) of Directive 2001\/83\/EC.<\/p>\n\n\n\n<p><strong>Annual flat fee per MAH for 2026: SEK 63 000<\/strong> (currency: Swedish krona)<br><em>Fee exclusive of value added tax (VAT)<\/em><br><em>Please note that this fee has remained unchanged since 2022.<\/em><\/p>\n\n\n\n<p><strong>Annual flat fee per MAH for 2025:<\/strong> <strong>SEK<\/strong> <strong>63&nbsp;000<\/strong> (currency: Swedish krona)<br><em>Fee exclusive of value added tax (VAT)<\/em><br><em>Please note that this fee has remained unchanged since 2022.<\/em><\/p>\n\n\n\n<p><strong>Reduced Fee<\/strong> <br>MAH\u2019s with pharmaceuticals within scope for FMD,Rx, OTC and vaccines, on the Swedish Market and with a registered net sales less than SEK 1 000 000 (one million) can apply for a reduced fee. <br>Detailed information and instructions in the annual fee documents.<br><strong>Note: <\/strong>Reduction in fee does not apply for MAH\u2019s within the same group<br><br>To apply for a reduced fee, notify e-VIS at <a href=\"mailto:administration@e-vis.se\" target=\"_blank\" rel=\"noreferrer noopener\">administration@e-vis.se<\/a><br><\/p>\n\n\n<div class=\"document widget\"><div class=\"doc-block\"><h4 id=\"e-vis-arsavgifter-for-mah-annual-fees\">e-VIS \u00e5rsavgifter f\u00f6r MAH\/Annual fees<\/h4><div class=\"docs\"><div><a class=\"dok-file\" href=\"https:\/\/e-vis.se\/wp-content\/uploads\/2024\/09\/e-VIS_Annual_Fee_2025_FINAL.pdf\" target=\"_blank\">e-VIS Annual Fee 2025<\/a><\/div><div><a class=\"dok-file\" href=\"https:\/\/e-vis.se\/wp-content\/uploads\/2025\/09\/e-VIS_Annual_Fee_2026_FINAL.pdf\" target=\"_blank\">e-VIS Annual Fee 2026<\/a><\/div><\/div><\/div><\/div>\n\n\n<h2 class=\"wp-block-heading\">Preparations for companies<\/h2>\n\n\n\n<p><em>Manufacturers of medicines covered by the Regulation<\/em><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Establish an interface to the European Hub according to the requirements from the EMVO<\/li>\n\n\n\n<li>Identify the \u201cOn-Boarding Partner\u201d within the company and the point of connection to the European Hub<\/li>\n\n\n\n<li>Execute the Contract process and Technical on-boarding according to the EMVO requirements<\/li>\n\n\n\n<li>Develop procedures for uploading information about safety features to the European Hub for the packs to be released for sale \u2013 and only these, not discarded packs, reference samples, etc.<\/li>\n\n\n\n<li>Initiate serialisation and uploading to the European Hub<\/li>\n\n\n\n<li>If products labelled with safety features were released to the Swedish market before 9 February 2019 ensure that these packs are uploaded retrospective<\/li>\n<\/ul>\n\n\n\n<p><em>Marketing Authorisation Holders (MAHs) or other parties responsible for products on the Swedish market<\/em><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Ensure that the manufacturers involved, including contract manufacturers outside Europe, can meet the requirements of the Regulation according to the applicable time schedule<\/li>\n<\/ul>\n\n\n\n<p><em>Marketing Authorisation Holders (MAHs) who engage contract manufacturers<\/em><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Check\/ensure the contract manufacturer\u2019s implementation plans<\/li>\n\n\n\n<li>Decide on how information about safety features will be uploaded to the European Hub \u2013 usually via a contact point for the product owner\u2019s company. (See information about On-Boarding to EU Hub)<\/li>\n<\/ul>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:33%\">\n<div class=\"wp-block-buttons is-vertical is-layout-flex wp-container-core-buttons-is-layout-8cf370e7 wp-block-buttons-is-layout-flex\"><\/div>\n<\/div>\n<\/div>\n\n\n<div class=\"faq\"><div class=\"faq-block\"><h4 id=\"costs\">1. Costs<\/h4><div class=\"accordion\"><h5 class=\"accordion-header\">1.1. The pharmaceutical industry is responsible for the cost of the databases. What is the cost?<\/h5><div class=\"accordion-content\"><p>The pharmaceutical industry is responsible for the cost of the databases, Article 54a(2)(e) of Directive 2001\/83\/EC.<\/p>\n<p>Each MAH which markets at least one product within a national territory must have a contract with the National Medicines Verification Organisation (NMVO) and pay the national fee.<\/p>\n<p>e-VIS charges a flat fee per MAH.<\/p>\n<div class=\"tlid-input input\">\n<div class=\"source-wrap\">\n<div class=\"input-full-height-wrapper tlid-input-full-height-wrapper\">\n<div class=\"source-input\">\n<div class=\"source-footer-wrap source-or-target-footer\">\n<div class=\"character-count tlid-character-count\">The fee is decided by the e-VIS board and notified to the MAHs with a signed contract no later than 30 September annually.<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p>For detailed information see the Annual fee for the current year.<\/p>\n<\/div><h5 class=\"accordion-header\">1.2. When do you start to pay?<\/h5><div class=\"accordion-content\"><p>The annual fee shall be paid to e-VIS when the contract is signed.<\/p>\n<\/div><h5 class=\"accordion-header\">1.3. Are there additional fees that the company should plan for?<\/h5><div class=\"accordion-content\"><p>e-VIS charges a flat fee per MAH and no additional fees.<\/p>\n<p>EMVO charges a one-time on-boarding fee.\u00a0 Further details at <a href=\"https:\/\/emvo-medicines.eu\/knowledge-database\/\" target=\"_blank\" rel=\"noopener\"><strong>Knowledge DB<\/strong><\/a><\/p>\n<\/div><\/div><\/div><div class=\"faq-block\"><h4 id=\"auditing-e-vis\">2. Auditing e-VIS<\/h4><div class=\"accordion\"><h5 class=\"accordion-header\">2.1. Should e-VIS be qualified and inspected as a supplier by manufacturers or other actors (end-users)?<\/h5><div class=\"accordion-content\"><p>The below answer has been prepared in consultation with the Medical Products Agency.<\/p>\n<p>There is no requirement for an actor having an agreement with e-VIS to regularly audit e-VIS.<\/p>\n<p>The main rule is that a supplier who performs a service on behalf of an actor, who is responsible according to the regulations, must be audited regularly. Auditing is done in relation to the agreement, but also in relation to the applicable regulations that govern the requirements of the service.<\/p>\n<p>In operating the national repositories system for safety features, e-VIS does not perform any service on behalf of wholesalers, pharmacies or other actors, in the sense that e-VIS takes on a task that according to the delegated regulation is the responsibility of any of the other actors. The tasks performed by e-VIS according to the regulation (EU) 2016\/161 are direct requirements specified for e-VIS.<\/p>\n<p>Based on the above reason auditing of e-VIS is not regulated in MAH agreements or Terms and Conditions agreed with end users. Agreements should be updated with details on audit performance in case an audit after all is agreed between e-VIS and the actor having an agreement with e-VIS. In addition, such audit should be coordinated in order that as many actors as possible would benefit from the audit and as small disturbance in e-VIS activities as possible.<\/p>\n<\/div><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"<p>Pharmaceutical Companies (MAHs) As of 9 February 2019, marketing authorised holders are obliged to place two safety features on the packaging of most prescription medicines and some over-the-counter medicines in the European Union: a unique identifier (a 2-dimension barcode) and an anti-tampering device, in accordance with Commission Delegated Regulation (EU) 2016\/161.&nbsp;The goal is to prevent&hellip;&nbsp;<a href=\"https:\/\/e-vis.se\/en\/mah\/\" rel=\"bookmark\">Read More &raquo;<span class=\"screen-reader-text\">MAH<\/span><\/a><\/p>\n","protected":false},"author":3,"featured_media":4456,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"neve_meta_sidebar":"","neve_meta_container":"","neve_meta_enable_content_width":"on","neve_meta_content_width":100,"neve_meta_title_alignment":"","neve_meta_author_avatar":"","neve_post_elements_order":"","neve_meta_disable_header":"","neve_meta_disable_footer":"","neve_meta_disable_title":"on","neve_meta_reading_time":"","footnotes":""},"class_list":["post-4295","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"featured_image_src":"https:\/\/e-vis.se\/wp-content\/uploads\/2023\/02\/default-img-evis.png","yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.1.1 - 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