{"id":8145,"date":"2025-02-28T14:00:44","date_gmt":"2025-02-28T14:00:44","guid":{"rendered":"https:\/\/els-solutions.com\/cms\/dev\/?p=8145"},"modified":"2025-02-28T17:05:04","modified_gmt":"2025-02-28T17:05:04","slug":"new-rules-for-medicine-export-control-in-portugal-2","status":"publish","type":"post","link":"https:\/\/els-solutions.com\/en\/new-rules-for-medicine-export-control-in-portugal-2\/","title":{"rendered":"New Rules for Medicine Export Control in Portugal"},"content":{"rendered":"<div data-olk-copy-source=\"MessageBody\">\n<div data-olk-copy-source=\"MessageBody\">\n<p data-start=\"73\" data-end=\"245\">In February 2025, <strong data-start=\"91\" data-end=\"168\">INFARMED \u2013 the National Authority for Medicines and Health Products, I.P.<\/strong>, introduced new rules for controlling the export of medicines in Portugal.<\/p>\n<p data-start=\"247\" data-end=\"429\">These measures aim to ensure that essential medicines remain available in Portuguese pharmacies\u2014an issue highlighted in the <a href=\"https:\/\/els-solutions.com\/en\/infarmeds-new-medicine-availability-regulation-in-portugal\/\"><strong data-start=\"371\" data-end=\"426\">new Regulation on Medicines Availability Management<\/strong>.<\/a><\/p>\n<\/div>\n<div data-olk-copy-source=\"MessageBody\">\n<h2>What Are the Main Changes?<\/h2>\n<p>To strengthen the control of medicines leaving the country, INFARMED has published two key documents: <strong data-start=\"571\" data-end=\"617\">Circular Informativa No. 012\/CD\/100.20.200 <\/strong>and <strong data-start=\"622\" data-end=\"651\">Deliberation No. 234\/2025.<\/strong><\/p>\n<h3>Now, there are two essential lists:<\/h3>\n<ol>\n<li data-start=\"693\" data-end=\"811\"><strong data-start=\"696\" data-end=\"733\">The Prior Notification List (LNP)<\/strong> \u2013 Medicines that can be exported, provided INFARMED is notified in advance.<\/li>\n<li data-start=\"812\" data-end=\"939\"><strong data-start=\"815\" data-end=\"874\">The List of Temporarily Prohibited Medicines for Export<\/strong> \u2013 Medicines that cannot be exported due to a risk of shortages<\/li>\n<\/ol>\n<p data-start=\"941\" data-end=\"1075\">To reduce unnecessary bureaucracy in reporting obligations, only <strong data-start=\"1006\" data-end=\"1032\">wholesale distributors<\/strong> are now required to communicate exports.<\/p>\n<\/div>\n<h3 data-start=\"1077\" data-end=\"1111\">Exceptions for Special Cases<\/h3>\n<p>It is important to note that, in exceptional circumstances, even medicines with suspended export status can be sent abroad. INFARMED may authorize exports in cases of:<\/p>\n<ul>\n<li data-start=\"1283\" data-end=\"1308\"><strong data-start=\"1285\" data-end=\"1306\">Natural disasters<\/strong><\/li>\n<li data-start=\"1309\" data-end=\"1326\"><strong data-start=\"1311\" data-end=\"1324\">Conflicts<\/strong><\/li>\n<li data-start=\"1327\" data-end=\"1358\"><strong data-start=\"1329\" data-end=\"1356\">Urgent humanitarian aid<br \/>\n<\/strong><\/li>\n<\/ul>\n<h2>Impact on the Pharmaceutical Market<\/h2>\n<\/div>\n<p data-start=\"1403\" data-end=\"1594\">The new rules place greater responsibility on <strong data-start=\"1449\" data-end=\"1475\">wholesale distributors<\/strong>, requiring them to closely monitor the updated lists of restricted medicines and ensure compliance with regulations.<\/p>\n<p data-start=\"1596\" data-end=\"1772\">On the other hand, <strong data-start=\"1615\" data-end=\"1647\">manufacturers and pharmacies<\/strong> benefit from a <strong data-start=\"1663\" data-end=\"1685\">simplified process<\/strong>, as they are no longer required to submit reports on medicine exports or dispensing.<\/p>\n<h2>Continuous Market Monitoring by INFARMED<\/h2>\n<p data-start=\"1822\" data-end=\"2118\">INFARMED continues to ensure ongoing monitoring of the pharmaceutical market through the <strong data-start=\"1911\" data-end=\"1960\">Information System for Export Control (SIEXP)<\/strong>. The lists of controlled medicines are <strong data-start=\"2000\" data-end=\"2049\">regularly updated and published transparently<\/strong>, ensuring greater predictability and compliance within the sector.<\/p>\n<p data-start=\"2120\" data-end=\"2288\">These measures align with <strong data-start=\"2146\" data-end=\"2176\">European Union regulations<\/strong>, which allow national controls to protect medicine supply, provided they are <strong data-start=\"2254\" data-end=\"2285\">temporary and proportionate<\/strong>.<\/p>\n<p data-start=\"2290\" data-end=\"2470\">With these new rules, Portugal aims to balance participation in the <strong data-start=\"2358\" data-end=\"2397\">international pharmaceutical market<\/strong> while ensuring that its population has access to essential treatments.<\/p>\n<p data-start=\"2290\" data-end=\"2470\">For more information, visit the <strong data-start=\"2507\" data-end=\"2536\">official <a href=\"https:\/\/www.infarmed.pt\/web\/infarmed\/infarmed\/-\/journal_content\/56\/15786\/10982859\">INFARMED<\/a> website<\/strong> or consult the<strong><a href=\"https:\/\/diariodarepublica.pt\/dr\/detalhe\/deliberacao\/234-2025-907742765\"> <em data-start=\"2552\" data-end=\"2573\">Di\u00e1rio da Rep\u00fablica<\/em>.<\/a><\/strong><\/p>\n<p data-start=\"2622\" data-end=\"2687\">If you have any questions, <a href=\"https:\/\/els-solutions.com\/en\/?page_id=6453\"><strong data-start=\"2649\" data-end=\"2662\">ELS Group<\/strong> <\/a>is here to assist you!<\/p>\n<p data-start=\"2689\" data-end=\"2764\" data-is-last-node=\"\" data-is-only-node=\"\">Contact your local <a href=\"https:\/\/els-solutions.com\/en\/where-are-we\/\"><strong data-start=\"2711\" data-end=\"2729\">ELS consultant<\/strong><\/a> or email <strong data-start=\"2739\" data-end=\"2763\"><a rel=\"noopener\" data-start=\"2741\" data-end=\"2761\">info@elssolutions.pt<\/a><\/strong>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>INFARMED has introduced stricter export controls to prevent medicine shortages. Wholesale distributors must report exports, while manufacturers and pharmacies face less bureaucracy. These measures align with EU regulations, ensuring transparency and protecting national supply.<\/p>\n","protected":false},"author":9,"featured_media":8151,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[164,189,130,122,61,102],"tags":[202,62,103],"class_list":["post-8145","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-els-group-en","category-geral-en","category-infarmed-en","category-medical-devices","category-news","category-noticias-en","tag-infarmed-en","tag-news","tag-regulations"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>New Rules for Medicine Export Control in Portugal<\/title>\n<meta name=\"description\" content=\"Learn about Portugal\u2019s new medicine export rules by INFARMED, ensuring drug availability and simplifying pharma compliance.\" \/>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"New Rules for Medicine Export Control in Portugal\" \/>\n<meta property=\"og:description\" content=\"Learn about Portugal\u2019s new medicine export rules by INFARMED, ensuring drug availability and simplifying pharma compliance.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/els-solutions.com\/en\/new-rules-for-medicine-export-control-in-portugal-2\/\" \/>\n<meta property=\"og:site_name\" content=\"ELS Group - 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