{"id":8878,"date":"2026-11-03T12:06:24","date_gmt":"2026-11-03T16:06:24","guid":{"rendered":"https:\/\/www.vouga.com.py\/?p=8878"},"modified":"2026-11-03T12:07:54","modified_gmt":"2026-11-03T16:07:54","slug":"dinavisa-introduce-nuevas-disposiciones-para-el-sector-farmaceutico-y-otros-productos-regulados-en-paraguay","status":"publish","type":"post","link":"https:\/\/www.vouga.com.py\/en\/dinavisa-introduce-nuevas-disposiciones-para-el-sector-farmaceutico-y-otros-productos-regulados-en-paraguay\/","title":{"rendered":"DINAVISA introduces new regulations for Paraguay's pharmaceutical sector and other regulated products"},"content":{"rendered":"<p class=\"wp-block-paragraph\"><strong>Four recent resolutions establish new procedures and requirements for medicines intended to treat rare diseases, compassionate-use imports, nicotine pouches and advanced therapy medicinal products.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Paraguay's National Directorate of Health Surveillance (DINAVISA) has issued four resolutions introducing new procedures, requirements and marketing authorization rules for pharmaceutical products and other regulated products in Paraguay.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>New procedure for medicines intended to treat rare diseases<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Resolution No. 391\/2026, dated September 23, 2026, establishes a special marketing authorization procedure for medicines intended to treat rare diseases, defined as conditions affecting one in 2,000 people or fewer.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The procedure provides for processing periods of 60 to 180 business days, depending on the case, and a five-year validity period for the marketing authorization.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The resolution is already in effect.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>New requirements for compassionate-use imports<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Through Resolution No. 396\/2026, dated September 25, 2026, DINAVISA introduces new requirements for companies involved in importing medicines and medical devices without marketing authorization for compassionate use.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">These requirements include authorization from the manufacturer or exporter.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The resolution also establishes a 10-business-day response period.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The resolution is already in effect.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Mandatory registration for nicotine pouches<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Resolution No. 412\/2026, dated October 1, 2026, introduces specific regulations for nicotine pouches in Paraguay for the first time.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Its main provisions include mandatory sanitary registration, a ban on advertising and child-resistant packaging requirements.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The resolution also sets a maximum nicotine content of 16.7 mg per pouch.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">It took effect on October 26, 2026.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>New regulatory framework for advanced therapy medicinal products<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">DINAVISA has also established a regulatory framework for advanced therapy medicinal products (ATMPs), covering gene therapies, somatic cell therapies, tissue-engineered products and combined therapies.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The regulation requires marketing authorization and provides for technical evaluation periods of 90 to 180 days, depending on the case.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">It also establishes patient follow-up periods ranging from 5 to 10 years.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The resolution is already in effect.<\/p>","protected":false},"excerpt":{"rendered":"<p>Cuatro resoluciones recientes establecen procedimientos y requisitos relacionados con medicamentos para enfermedades raras, importaciones por uso compasivo, bolsas de nicotina y medicamentos de terapias avanzadas. La Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA) emiti\u00f3 cuatro resoluciones que introducen nuevos procedimientos, requisitos y disposiciones de registro sanitario para el sector farmac\u00e9utico y otros productos regulados en Paraguay. [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":8880,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"iawp_total_views":3,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-8878","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>DINAVISA introduce nuevas disposiciones para el sector farmac\u00e9utico y otros productos regulados en Paraguay - Vouga Abogados<\/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.vouga.com.py\/en\/dinavisa-introduce-nuevas-disposiciones-para-el-sector-farmaceutico-y-otros-productos-regulados-en-paraguay\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"DINAVISA introduce nuevas disposiciones para el sector farmac\u00e9utico y otros productos regulados en Paraguay - Vouga Abogados\" \/>\n<meta property=\"og:description\" content=\"Cuatro resoluciones recientes establecen procedimientos y requisitos relacionados con medicamentos para enfermedades raras, importaciones por uso compasivo, bolsas de nicotina y medicamentos de terapias avanzadas. La Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA) emiti\u00f3 cuatro resoluciones que introducen nuevos procedimientos, requisitos y disposiciones de registro sanitario para el sector farmac\u00e9utico y otros productos regulados en Paraguay. 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