{"id":1100,"date":"2025-12-23T10:57:50","date_gmt":"2025-12-23T13:57:50","guid":{"rendered":"https:\/\/www.vitapharmaconsulting.com\/en\/?post_type=noticias&#038;p=1100"},"modified":"2025-12-23T10:57:50","modified_gmt":"2025-12-23T13:57:50","slug":"infarmed-mandatory-submission-of-national-pharmacovigilance-contact-details-via-the-smuh-alter-portal","status":"publish","type":"noticias","link":"https:\/\/www.vitapharmaconsulting.com\/en\/news\/2025\/12\/23\/infarmed-mandatory-submission-of-national-pharmacovigilance-contact-details-via-the-smuh-alter-portal\/","title":{"rendered":"INFARMED &#8211; Mandatory submission of national pharmacovigilance contact details via the SMUH-ALTER Portal"},"content":{"rendered":"<p><span data-contrast=\"auto\">On 30 October 2025, INFARMED published the\u00a0<\/span><b><span data-contrast=\"auto\">Informative Circular No. 125\/CD\/550.20.001<\/span><\/b><span data-contrast=\"auto\">, introducing a new procedure for Marketing Authorization Holders (MAHs) in Portugal to\u00a0submit\u00a0and update national pharmacovigilance contact details.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;201341983&quot;:0,&quot;335557856&quot;:16777215,&quot;335559739&quot;:0,&quot;335559740&quot;:360}\">\u00a0<\/span><\/p>\n<p><b><span data-contrast=\"auto\">What\u00a0has\u00a0changed?<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;201341983&quot;:0,&quot;335557856&quot;:16777215,&quot;335559739&quot;:0,&quot;335559740&quot;:360}\">\u00a0<\/span><\/p>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"5\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">From the date of this circular, all MAHs must\u00a0submit\u00a0their national pharmacovigilance contacts\u00a0<\/span><b><span data-contrast=\"auto\">exclusively through the SMUHALTER portal<\/span><\/b><span data-contrast=\"auto\">, under the \u201cPV National Contact Submission\u201d section.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;201341983&quot;:0,&quot;335557856&quot;:16777215,&quot;335559739&quot;:0,&quot;335559740&quot;:360}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"5\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">The deadline for compliance with this requirement is\u00a0<\/span><b><span data-contrast=\"auto\">January 31, 2026<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;201341983&quot;:0,&quot;335557856&quot;:16777215,&quot;335559739&quot;:0,&quot;335559740&quot;:360}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"5\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">At the time of submission, a cover letter must be uploaded using the template provided by INFARMED. The cover letter must be correctly completed, dated, and signed.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;201341983&quot;:0,&quot;335557856&quot;:16777215,&quot;335559739&quot;:0,&quot;335559740&quot;:360}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"5\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"auto\">Submission of contacts through previously used channels is no longer valid.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;201341983&quot;:0,&quot;335557856&quot;:16777215,&quot;335559739&quot;:0,&quot;335559740&quot;:360}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"5\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"5\" data-aria-level=\"1\"><span data-contrast=\"auto\">The portal\u00a0facilitates\u00a0the electronic management of operational pharmacovigilance contacts, ensuring record-keeping, traceability, and compliance with regulatory requirements.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;201341983&quot;:0,&quot;335557856&quot;:16777215,&quot;335559739&quot;:0,&quot;335559740&quot;:360}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"5\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"6\" data-aria-level=\"1\"><span data-contrast=\"auto\">This obligation does not apply to:<\/span><span data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;201341983&quot;:0,&quot;335557856&quot;:16777215,&quot;335559739&quot;:0,&quot;335559740&quot;:360}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"5\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1440,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"2\"><span data-contrast=\"auto\">Medicinal products authorized through the centralized procedure, for which the specific update procedure\u00a0indicated\u00a0by INFARMED (via email)\u00a0remains\u00a0in effect.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;201341983&quot;:0,&quot;335557856&quot;:16777215,&quot;335559739&quot;:0,&quot;335559740&quot;:360,&quot;469777462&quot;:[1440],&quot;469777927&quot;:[0],&quot;469777928&quot;:[0]}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"5\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1440,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"2\"><span data-contrast=\"auto\">New marketing\u00a0authorization applications, which continue to follow the standard MA dossier process.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;201341983&quot;:0,&quot;335557856&quot;:16777215,&quot;335559739&quot;:0,&quot;335559740&quot;:360,&quot;469777462&quot;:[1440],&quot;469777927&quot;:[0],&quot;469777928&quot;:[0]}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><b><span data-contrast=\"auto\">Purpose of the measure<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;201341983&quot;:0,&quot;335557856&quot;:16777215,&quot;335559739&quot;:0,&quot;335559740&quot;:360}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">The implementation of submission through the SMUHALTER portal aims to modernize and increase the efficiency of the national pharmacovigilance system by centralizing contact management and\u00a0facilitating\u00a0communication between INFARMED and MAHs. This will contribute to strengthening the safety of medicines in Portugal.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;201341983&quot;:0,&quot;335557856&quot;:16777215,&quot;335559739&quot;:0,&quot;335559740&quot;:360}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">For more\u00a0information,\u00a0please\u00a0see<\/span><span data-contrast=\"auto\">\u00a0<\/span><a href=\"https:\/\/www.infarmed.pt\/documents\/15786\/1147401\/Submiss%C3%A3o+do+Contacto+sobre+quest%C3%B5es+de+farmacovigil%C3%A2ncia+a+n%C3%ADvel+nacional+no+Portal+SMUH-ALTER\/cfe5acda-881c-62d9-7770-927acb4c4f75%22%20\/t%20%22_new\"><b><span data-contrast=\"none\">Circular Informativa n\u00ba 125\/CD\/550.20.001<\/span><\/b><\/a><span data-contrast=\"auto\">\u00a0<\/span><span data-contrast=\"auto\">and\u00a0<\/span><a href=\"https:\/\/www.infarmed.pt\/web\/infarmed\/noticias\/-\/journal_content\/56\/15786\/11875241?utm_source=chatgpt.com%22%20\\t%20%22_new\"><b><span data-contrast=\"none\">comunicado do INFARMED<\/span><\/b><\/a><span data-contrast=\"auto\">.\u00a0<\/span><\/p>\n","protected":false},"author":3,"featured_media":1101,"template":"","meta":{"inline_featured_image":false,"_links_to":"","_links_to_target":""},"categorias":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v20.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>INFARMED - Mandatory submission of national pharmacovigilance contact details via the SMUH-ALTER Portal - Vita<\/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:\/\/www.vitapharmaconsulting.com\/en\/news\/2025\/12\/23\/infarmed-mandatory-submission-of-national-pharmacovigilance-contact-details-via-the-smuh-alter-portal\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"INFARMED - Mandatory submission of national pharmacovigilance contact details via the SMUH-ALTER Portal - Vita\" \/>\n<meta property=\"og:description\" content=\"On 30 October 2025, INFARMED published the\u00a0Informative Circular No. 125\/CD\/550.20.001, introducing a new procedure for Marketing Authorization Holders (MAHs) in Portugal to\u00a0submit\u00a0and update national pharmacovigilance contact details.\u00a0 What\u00a0has\u00a0changed?\u00a0 From the date of this circular, all MAHs must\u00a0submit\u00a0their national pharmacovigilance contacts\u00a0exclusively through the SMUHALTER portal, under the \u201cPV National Contact Submission\u201d section.\u00a0 The deadline for compliance... 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