{"id":8085,"date":"2025-02-20T15:20:15","date_gmt":"2025-02-20T15:20:15","guid":{"rendered":"https:\/\/els-solutions.com\/cms\/dev\/?p=8085"},"modified":"2025-02-21T16:18:43","modified_gmt":"2025-02-21T16:18:43","slug":"infarmeds-new-medicine-availability-regulation-in-portugal","status":"publish","type":"post","link":"https:\/\/els-solutions.com\/en\/infarmeds-new-medicine-availability-regulation-in-portugal\/","title":{"rendered":"New Regulation on Medicine Availability in Portugal"},"content":{"rendered":"<p data-start=\"150\" data-end=\"324\">INFARMED has reinstated new rules upon the Resolution No. 233\/2025 on the <strong data-start=\"181\" data-end=\"239\">Regulation for the Management of Medicine Availability<\/strong> that was published in the <em data-start=\"261\" data-end=\"282\">Di\u00e1rio da Rep\u00fablica<\/em>, updating the previous 2019 regulation.<\/p>\n<h3><strong data-start=\"330\" data-end=\"359\">Why was this update made?\u00a0<\/strong><\/h3>\n<p data-start=\"363\" data-end=\"596\">These <a href=\"https:\/\/diariodarepublica.pt\/dr\/detalhe\/deliberacao\/233-2025-907742764\">new rules<\/a> are based on the experience gained by INFARMED \u2013 the National Authority for Medicines and Health Products, I.P., and the entire pharmaceutical distribution and commercialization sector in Portugal over recent years.<\/p>\n<p data-start=\"598\" data-end=\"854\">This update, resulting from the assessment of medicine availability at both national and European levels, aims to <strong data-start=\"712\" data-end=\"755\">improve access to medicines in Portugal<\/strong>, while also considering European initiatives to strengthen supply chains for critical medicines.<\/p>\n<h3 data-start=\"856\" data-end=\"919\"><strong data-start=\"860\" data-end=\"917\">Strengthened Responsibilities for Sector Stakeholders<\/strong><\/h3>\n<p data-start=\"791\" data-end=\"1003\">The regulation clarifies and expands the responsibilities of various sector agents, including:<\/p>\n<ul>\n<li data-start=\"1019\" data-end=\"1064\"><strong data-start=\"1021\" data-end=\"1062\">Marketing Authorization Holders (MAH)<\/strong><\/li>\n<li data-start=\"1065\" data-end=\"1095\"><strong data-start=\"1067\" data-end=\"1093\">Wholesale Distributors<\/strong><\/li>\n<li data-start=\"1096\" data-end=\"1114\"><strong data-start=\"1098\" data-end=\"1112\">Pharmacies<\/strong><\/li>\n<li data-start=\"1115\" data-end=\"1149\"><strong data-start=\"1117\" data-end=\"1147\">Hospital Pharmacy Services<\/strong><\/li>\n<li data-start=\"1150\" data-end=\"1226\"><strong data-start=\"1152\" data-end=\"1224\">Other legally authorized entities dispensing medicines to the public<\/strong><\/li>\n<\/ul>\n<h3 data-start=\"1228\" data-end=\"1268\"><strong data-start=\"1232\" data-end=\"1266\">Measures to Mitigate Shortages<\/strong><\/h3>\n<p data-start=\"1270\" data-end=\"1407\">To prevent and mitigate future <strong data-start=\"1301\" data-end=\"1323\">medicine shortages<\/strong>, INFARMED, in coordination with sector entities, will implement measures such as:<\/p>\n<ul data-start=\"1409\" data-end=\"1663\">\n<li data-start=\"1409\" data-end=\"1453\"><strong data-start=\"1411\" data-end=\"1451\">Controlled distribution of medicines<\/strong><\/li>\n<li data-start=\"1454\" data-end=\"1504\"><strong data-start=\"1456\" data-end=\"1502\">Stock allocation under INFARMED\u2019s guidance<\/strong><\/li>\n<li data-start=\"1505\" data-end=\"1546\"><strong data-start=\"1507\" data-end=\"1544\">Stock and supply chain monitoring<\/strong><\/li>\n<li data-start=\"1547\" data-end=\"1612\"><strong data-start=\"1549\" data-end=\"1610\">Guidelines for distribution, prescription, and dispensing<\/strong><\/li>\n<li data-start=\"1613\" data-end=\"1663\"><strong data-start=\"1615\" data-end=\"1661\">Identification of therapeutic alternatives<\/strong><\/li>\n<\/ul>\n<h3 data-start=\"1867\" data-end=\"1920\"><strong data-start=\"1871\" data-end=\"1918\">Export of Medicines \u2013 Additional Regulation<\/strong><\/h3>\n<p data-start=\"1922\" data-end=\"2282\">The <strong data-start=\"1926\" data-end=\"1991\">Regulation on the Control of Medicine Transactions for Export<\/strong> was also published in the <a href=\"http:\/\/diariodarepublica.pt\/dr\/detalhe\/deliberacao\/234-2025-907742765\"><em data-start=\"2018\" data-end=\"2039\">Di\u00e1rio da Rep\u00fablica<\/em><\/a>, alongside the <strong data-start=\"2055\" data-end=\"2113\">Regulation for the Management of Medicine Availability<\/strong>. This document addresses the issues highlighted in INFARMED I.P.\u2019s 2024 Annual Report, strengthening <strong data-start=\"2215\" data-end=\"2279\">export controls to ensure national supply is not compromised<\/strong>.<\/p>\n<p data-start=\"2284\" data-end=\"2624\">This represents a <strong data-start=\"2302\" data-end=\"2322\">significant step<\/strong> in mitigating shortages and ensuring the availability of medicines in Portugal. These <strong data-start=\"2409\" data-end=\"2458\">stricter monitoring and distribution measures<\/strong> reinforce the collaboration between INFARMED and key sector players, contributing to <strong data-start=\"2544\" data-end=\"2621\">greater supply chain stability and a more effective response to shortages<\/strong>.<\/p>\n<h3 data-start=\"2626\" data-end=\"2660\"><strong data-start=\"2630\" data-end=\"2658\">Need Regulatory Support?<\/strong><\/h3>\n<p data-start=\"2662\" data-end=\"2703\">ELS can assist you with regulatory matters.<\/p>\n<p data-start=\"2705\" data-end=\"2786\">Please contact your <strong data-start=\"2725\" data-end=\"2749\">local ELS consultant<\/strong> or email: <strong data-start=\"2760\" data-end=\"2784\"><a rel=\"noopener\" data-start=\"2762\" data-end=\"2782\">info@elssolutions.pt<\/a><\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Resolution No. 233\/2025 updates medicine availability regulations, strengthening supply chains and export controls to prevent shortages in Portugal.<\/p>\n","protected":false},"author":9,"featured_media":8087,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[101,100,54,102,95],"tags":[62,103],"class_list":["post-8085","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-anvisa-en","category-brazil","category-general","category-noticias-en","category-regulations","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>INFARMED\u2019s New Medicine Availability Regulation in Portugal<\/title>\n<meta name=\"description\" content=\"A new regulation updates medicine availability rules in Portugal, reinforcing supply chains and to prevent shortages.\" \/>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" 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