{"id":6074,"date":"2022-05-03T09:51:42","date_gmt":"2022-05-03T07:51:42","guid":{"rendered":"https:\/\/www.rapharm.eu\/en\/?p=6074"},"modified":"2022-05-12T21:46:14","modified_gmt":"2022-05-12T19:46:14","slug":"eu-leto-2022-je-poleg-zacetka-veljavnosti-prej-pripravljenih-delov-zakonodaje-na-podrocju-zdravil-zaznamovano-s-pripravami-na-spremembe-splosne-regulative-na-podrocju-zdravil","status":"publish","type":"post","link":"https:\/\/www.rapharm.eu\/en\/eu-leto-2022-je-poleg-zacetka-veljavnosti-prej-pripravljenih-delov-zakonodaje-na-podrocju-zdravil-zaznamovano-s-pripravami-na-spremembe-splosne-regulative-na-podrocju-zdravil\/","title":{"rendered":"EU: In addition to the entry into force of previously prepared parts of legislation in the field of medicines, 2022 is marked by preparations for changes to the general regulations in the field of medicines"},"content":{"rendered":"<style type=\"text\/css\"><\/style>\n<p>On 28 January\n2022 new legislation in the field of veterinary medicines, entered into force, which\naims to adapt regulations to current challenges, promoting innovation and\naccessibility of medicines, and stepping up EU efforts to combat AMR.<\/p>\n\n\n\n<p>On 31 January 2022, Regulation on Clinical Trials of Medicinal Products no. 536\/2014 (CTR), which is significantly delayed mainly due to waiting for the full functionality of the information system (CTIS \/ Clinical Trial Information System) with a centralized EU portal and database on clinical trials in the EU, which allows streamlining the reporting, evaluation, and monitoring of clinical trials in EU. Regulation no. 536\/2014 repeals the current Clinical Trials Directive no. 2001\/20 \/ EC, although transitional periods are foreseen for ongoing tests and those to be notified by the end of January 2023.<\/p>\n\n\n\n<p>A proposal for a\nrevision of pharmaceutical legislation is being prepared and will be available\nby the end of 2022, including a proposal for a revision of Directive 2001\/83 \/\nEC and Regulation (EC) No 726\/2004. In 2020, the European Commission published\na European Strategy for Medicines, emphasizing the importance of medicines for\npublic health, in particular meeting unmet health needs and access to\nmedicines, promoting industry competitiveness and innovation, strengthening the\nsupply chain, strategic EU autonomy and preparedness. and crisis response. At\nthe same time, he sees his enhanced role in guiding and creating global trends\nthrough cooperation and the application of common standards. The response of\nparticipants in the system was verified by sending a questionnaire answered by\nmanufacturers, distributors, academia, doctors, pharmacists, patients\u2026 In\nFebruary 2022, the Commission published a Synthesis Report and responses to a\npublic consultation on the revision of general pharmaceutical legislation,\nwhich will affect the expected final audit proposal.<\/p>\n\n\n\n<p><strong>Do you need\nadditional knowledge or assistance in meeting the requirements of\npharmaceutical legislation?<\/strong><\/p>\n\n\n\n<p>With the help of\nour educations and <a href=\"https:\/\/www.rapharm.eu\/en\/consulting-services\/\">consulting services<\/a>, we can help you meet the regulatory requirements\nin the field of medicines:<\/p>\n\n\n\n<p>\u2022 Regulatory\nseminars for individual pharmaceutical companies<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Complete regulation of medicines (for new employees or those in need of refreshment or deepening of knowledge)<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li> Selected areas of drug regulation (topics and target groups by agreement)<\/li><\/ul>\n\n\n\n<p>\u2022 Regulatory \/\nprofessional advice in the field of medicines (expert opinions, strategies,<\/p>\n\n\n\n<p>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; dossier evaluation, outsourcing\u2026<\/p>\n\n\n\n<p><strong>Resources: <\/strong><\/p>\n\n\n\n<p><a href=\"https:\/\/ec.europa.eu\/food\/animals\/animal-health\/vet-meds-med-feed_en\">Regulation\non&nbsp;veterinary medicinal products (VMPs)<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/ec.europa.eu\/food\/animals\/animal-health\/vet-meds-med-feed_en\">Regulation\non&nbsp;veterinary medicinal products (VMPs)<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32014R0536&amp;from=EN\">https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32014R0536&amp;from=EN<\/a><\/p>\n\n\n\n<figure class=\"wp-block-embed\"><div class=\"wp-block-embed__wrapper\">\nhttps:\/\/eur-lex.europa.eu\/legal-content\/SL\/TXT\/PDF\/?uri=CELEX:52020DC0761&#038;from=EN\n<\/div><\/figure>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On 28 January 2022 new legislation in the field of veterinary medicines, entered into force, which aims to adapt regulations to current challenges, promoting innovation and accessibility of medicines, and stepping up EU efforts to combat AMR. On 31 January 2022, Regulation on Clinical Trials of Medicinal Products no. 536\/2014 (CTR), which is significantly delayed&#8230;<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[45],"tags":[],"class_list":["post-6074","post","type-post","status-publish","format-standard","hentry","category-novice-en"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.9 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>EU: In addition to the entry into force of previously prepared parts of legislation in the field of medicines, 2022 is marked by preparations for changes to the general regulations in the field of medicines - raPHARM<\/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.rapharm.eu\/eu-leto-2022-je-poleg-zacetka-veljavnosti-prej-pripravljenih-delov-zakonodaje-na-podrocju-zdravil-zaznamovano-s-pripravami-na-spremembe-splosne-regulative-na-podrocju-zdravil\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EU: In addition to the entry into force of previously prepared parts of legislation in the field of medicines, 2022 is marked by preparations for changes to the general regulations in the field of medicines - raPHARM\" \/>\n<meta property=\"og:description\" content=\"On 28 January 2022 new legislation in the field of veterinary medicines, entered into force, which aims to adapt regulations to current challenges, promoting innovation and accessibility of medicines, and stepping up EU efforts to combat AMR. 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