{"id":8084,"date":"2025-02-20T15:20:15","date_gmt":"2025-02-20T15:20:15","guid":{"rendered":"https:\/\/els-solutions.com\/cms\/dev\/?p=8084"},"modified":"2025-02-20T15:26:18","modified_gmt":"2025-02-20T15:26:18","slug":"infarmed-anuncia-novo-regulamento-de-medicamentos","status":"publish","type":"post","link":"https:\/\/els-solutions.com\/pt-pt\/infarmed-anuncia-novo-regulamento-de-medicamentos\/","title":{"rendered":"Novas Regras para a Gest\u00e3o da Disponibilidade de Medicamentos em Portugal"},"content":{"rendered":"<div data-olk-copy-source=\"MessageBody\">\n<div data-olk-copy-source=\"MessageBody\">\n<p>Foi publicada, no Di\u00e1rio da Rep\u00fablica, a <a href=\"https:\/\/diariodarepublica.pt\/dr\/detalhe\/deliberacao\/233-2025-907742764\">Delibera\u00e7\u00e3o n.\u00ba 233\/2025<\/a>, relativa ao Regulamento de Gest\u00e3o da Disponibilidade de Medicamentos, que atualiza o regulamento anterior de 2019.<\/p>\n<p>Estas novas regras resultam da experi\u00eancia adquirida pelo<strong> INFARMED<\/strong> \u2013 Autoridade Nacional do Medicamento e Produtos de Sa\u00fade, I.P., e por todo o setor de comercializa\u00e7\u00e3o e distribui\u00e7\u00e3o de medicamentos em Portugal ao longo dos \u00faltimos anos.<\/p>\n<h3>Qual o seu objetivo?<\/h3>\n<p>Esta atualiza\u00e7\u00e3o,<strong> fruto da avalia\u00e7\u00e3o da disponibilidade de medicamentos a n\u00edvel nacional e europeu<\/strong>, visa melhorar o <strong>acesso a medicamentos em Portugal,<\/strong> considerando tamb\u00e9m as iniciativas europeias para refor\u00e7ar as cadeias de abastecimento de medicamentos cr\u00edticos.<\/p>\n<h3>Responsabilidades Refor\u00e7adas para os Intervenientes do Setor<\/h3>\n<p>O regulamento clarifica e amplia as responsabilidades dos diversos agentes do setor, incluindo:<\/p>\n<ul>\n<li><strong>Titulares de autoriza\u00e7\u00e3o de introdu\u00e7\u00e3o no mercado<\/strong> (AIM);<\/li>\n<li><strong>Distribuidores por grosso<\/strong>;<\/li>\n<li><strong>Farm\u00e1cias<\/strong>;<\/li>\n<li><strong>Servi\u00e7os farmac\u00eauticos hospitalares;<\/strong><\/li>\n<li>Outras entidades legalmente habilitadas a dispensar medicamentos ao p\u00fablico.<\/li>\n<\/ul>\n<h3>Medidas para Mitigar Situa\u00e7\u00f5es de Escassez<\/h3>\n<p>Com intuito de prevenir e mitigar futuras situa\u00e7\u00f5es de rutura de medicamentos, o Infarmed, em articula\u00e7\u00e3o com as entidades do setor, implementar\u00e1 medidas como:<\/p>\n<ul>\n<li><strong>Distribui\u00e7\u00e3o controlada de medicamentos<\/strong>;<\/li>\n<li><strong>Aloca\u00e7\u00e3o de stocks sob orienta\u00e7\u00e3o do Infarmed<\/strong>;<\/li>\n<li><strong>Monitoriza\u00e7\u00e3o de stocks e movimentos de medicamentos<\/strong>;<\/li>\n<li><strong>Defini\u00e7\u00e3o de orienta\u00e7\u00f5es espec\u00edficas para distribui\u00e7\u00e3o, prescri\u00e7\u00e3o e dispensa<\/strong>;<\/li>\n<li><strong>Identifica\u00e7\u00e3o de alternativas terap\u00eauticas<\/strong>.<\/li>\n<\/ul>\n<p>Em situa\u00e7\u00f5es de escassez, os titulares de AIM e distribuidores por grosso dever\u00e3o<strong> garantir mecanismos adicionais de controlo de stocks<\/strong>, incluindo a cria\u00e7\u00e3o de canais SOS para o abastecimento urgente das farm\u00e1cias.<\/p>\n<\/div>\n<h3>Exporta\u00e7\u00e3o de Medicamentos &#8211; Regulamenta\u00e7\u00e3o Complementar<\/h3>\n<\/div>\n<p>Tamb\u00e9m foi publicado no<strong><a href=\"http:\/\/diariodarepublica.pt\/dr\/detalhe\/deliberacao\/234-2025-907742765\"> Di\u00e1rio da Rep\u00fablica<\/a><\/strong> o Regulamento sobre o Controlo de Transa\u00e7\u00f5es de Medicamentos para o Exterior, juntamente com o Regulamento de Gest\u00e3o da Disponibilidade do Medicamento. Este documento responde \u00e0s necessidades identificadas no <a href=\"https:\/\/www.infarmed.pt\/documents\/15786\/10901776\/Relat%C3%B3rio+2024\/2f02f60e-ef04-a5b1-7962-be7d5ef353a2\">Relat\u00f3rio de Gest\u00e3o da Disponibilidade de Medicamentos<\/a> 2024 do Infarmed I.P., refor\u00e7ando o controlo da exporta\u00e7\u00e3o para garantir o abastecimento nacional.<\/p>\n<p>Representando um passo importante para mitigar a escassez e garantir a disponibilidade de medicamentos em Portugal. Estas medidas mais rigorosas de monitoriza\u00e7\u00e3o e distribui\u00e7\u00e3o refor\u00e7a a colabora\u00e7\u00e3o entre o Infarmed e os diversos intervenientes do setor e ser\u00e1 mais um passo a uma maior uma maior estabilidade no abastecimento e uma resposta mais eficaz \u00e0s situa\u00e7\u00f5es de escassez.<\/p>\n<div data-olk-copy-source=\"MessageBody\">\n<p>Para mais informa\u00e7\u00f5es sobre\u00a0<strong>quest\u00f5es regulat\u00f3rias<\/strong>, a\u00a0<strong>ELS<\/strong>\u00a0poder\u00e1 ajudar.<\/p>\n<p><span class=\" author-d-iz88z86z86za0dz67zz78zz78zz74zz68zjz80zz71z9iz90z9z84zmz66zz71znz68znz69zz87z3z89zhz65zz89zybhz84zz79zkwtz79zsz76zdz122zjz80z7\">Por favor entre em contato com o seu\u00a0<a href=\"https:\/\/els-solutions.com\/onde-estamos\/\" target=\"_blank\" rel=\"noopener\">consultor local da ELS<\/a>\u00a0<\/span><span class=\" author-d-iz88z86z86za0dz67zz78zz78zz74zz68zjz80zz71z9iz90z9z84zmz66zz71znz68znz69zz87z3z89zhz65zz89zybhz84zz79zkwtz79zsz76zdz122zjz80z7\">ou atrav\u00e9s do email:\u00a0<strong>info@elssolutions.pt<\/strong><\/span><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>A nova regulamenta\u00e7\u00e3o atualiza as regras de disponibilidade de medicamentos em Portugal, refor\u00e7ando as cadeias de abastecimento e controlando mais rigorosamente as exporta\u00e7\u00f5es para evitar faltas.<\/p>\n","protected":false},"author":9,"featured_media":8086,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[84,67,68,53,60,69],"tags":[],"class_list":["post-8084","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-anvisa","category-els","category-els-group","category-geral","category-noticias","category-questoes-regulatorias"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.4 - 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