{"id":894,"date":"2021-08-06T12:40:43","date_gmt":"2021-08-06T15:40:43","guid":{"rendered":"https:\/\/ondawebhost4.com.br\/vita\/en\/?post_type=noticias&#038;p=894"},"modified":"2022-04-18T14:23:07","modified_gmt":"2022-04-18T17:23:07","slug":"ema-update-of-the-guideline-on-post-authorisation-procedural-advice-for-users-of-the-centralised-procedure","status":"publish","type":"noticias","link":"https:\/\/www.vitapharmaconsulting.com\/en\/news\/2021\/08\/06\/ema-update-of-the-guideline-on-post-authorisation-procedural-advice-for-users-of-the-centralised-procedure\/","title":{"rendered":"EMA &#8211; Update of the Guideline on post-authorisation procedural advice for users of the centralised procedure"},"content":{"rendered":"<p class=\"\">In July, the European Medicines Agency (EMA) has updated its Guideline on post-authorisation procedural advice for users of the centralised procedure.<\/p>\n<p class=\"\">The Q&amp;A document has been updated from the April 2021 version EMEA-H-19984\/03 Rev. 92 to the July 23, 2021 version EMEA-H-19984\/03 Rev. 93.<\/p>\n<p class=\"\">Please find below the questions updated in this new version of Q&amp;A:<\/p>\n<ul data-rte-list=\"default\">\n<li>\n<p class=\"\">3.7. How shall I present my type II Variation application? <strong>Rev. Jul 2021<\/strong><\/p>\n<\/li>\n<li>\n<p class=\"\">3.8. How shall I present my application for a new or modified therapeutic indication? <strong>Rev. Jul 2021<\/strong><\/p>\n<\/li>\n<li>\n<p class=\"\">7.3.2. How should non-clinical and\/or clinical study reports be provided? <strong>Rev. Jul 2021<\/strong><\/p>\n<\/li>\n<li>\n<p class=\"\">7.4.1. What can be considered an editorial change and how can it be submitted as part of a type IA\/IB\/II variation? <strong>Rev. Jul 2021<\/strong><\/p>\n<\/li>\n<li>\n<p class=\"\">15.9. Under which procedure should I submit my PAM? <strong>Rev. Jul 2021<\/strong><\/p>\n<\/li>\n<li>\n<p class=\"\">15.12. How shall my submission of PAM be handled (timetable), and what could be the outcome of the evaluation? <strong>Rev. Jul 2021<\/strong><\/p>\n<\/li>\n<li>\n<p class=\"\">19.4. How shall my Transfer of Marketing Authorisation application be handled (timetable)? <strong>Rev. Jul 2021<\/strong><\/p>\n<\/li>\n<li>\n<p class=\"\">19.7. How to handle planned\/ongoing variations procedures during the Transfer of Marketing Authorisation? <strong>Rev. Jul 2021<\/strong><\/p>\n<\/li>\n<li>\n<p class=\"\">19.11. Can I include changes to manufacturing sites in my Transfer of Marketing Authorisation application? <strong>Rev. Jul 2021<\/strong><\/p>\n<\/li>\n<li>\n<p class=\"\">19.13. Can I change the name of a medicinal product as part of a transfer application? <strong>Rev. Jul 2021<\/strong><\/p>\n<\/li>\n<li>\n<p class=\"\">19.15. Who should I contact if I have a question when preparing my application or during the procedure? <strong>Rev. Jul 2021<\/strong><\/p>\n<\/li>\n<li>\n<p class=\"\">23. Marketing status updates <strong>Rev. Jul 2021<\/strong><\/p>\n<\/li>\n<li>\n<p class=\"\">23.1. What is the meaning of \u201cactual marketing\u201d \/ \u201cplacing on the market\u201d? <strong>Rev. Jul 2021<\/strong><\/p>\n<\/li>\n<li>\n<p class=\"\">23.2. What is the meaning of \u201ccessation of placing on the market\u201d? <strong>Rev. Jul 2021<\/strong><\/p>\n<\/li>\n<li>\n<p class=\"\">23.3. What is the aim of monitoring the marketing status of medicinal products? <strong>Rev. Jul 2021<\/strong><\/p>\n<\/li>\n<li>\n<p class=\"\">23.4. What information should be reported to the Agency on the marketing status of CAPs? <strong>Rev. Jul 2021<\/strong><\/p>\n<\/li>\n<li>\n<p class=\"\">23.5. When to report the marketing status overview of centrally authorised products to the Agency? <strong>Rev. Jul 2021<\/strong><\/p>\n<\/li>\n<li>\n<p class=\"\">23.6. How to report marketing status updates to the Agency for CAPs? <strong>Rev. Jul 2021<\/strong><\/p>\n<\/li>\n<li>\n<p class=\"\">23.7. When and how to notify marketing cessations for nationally authorised products to the Agency? <strong>NEW Jul 2021<\/strong><\/p>\n<\/li>\n<li>\n<p class=\"\">23.8. How will the Agency inform the Member States?<strong> Rev. Jul 2021<\/strong><\/p>\n<\/li>\n<li>\n<p class=\"\">23.9. How should I request the withdrawal of my central marketing authorisation? <strong>NEW Jul 2021<\/strong><\/p>\n<\/li>\n<li>\n<p class=\"\">23.10. Which information does the Agency publish about the marketing status of EU medicinal products? <strong>Rev. Jul 2021<\/strong><\/p>\n<\/li>\n<li>\n<p class=\"\">24.1. What is the sunset clause? <strong>Rev. Jul 2021<\/strong><\/p>\n<\/li>\n<li>\n<p class=\"\">24.2. Does the sunset clause apply to existing medicinal products?<strong> Rev. Jul 2021<\/strong><\/p>\n<\/li>\n<li>\n<p class=\"\">24.2. Does the sunset clause apply to existing medicinal products? <strong>Rev. Jul 2021<\/strong><\/p>\n<\/li>\n<li>\n<p class=\"\">24.6. In case of a protection period to be respected before placing the medicinal product on the market, when will the sunset clause period start? <strong>Rev. Jul 2021<\/strong><\/p>\n<\/li>\n<li>\n<p class=\"\">24.7. How to request an exemption to sunset clause provision for centrally-authorised products? <strong>Rev. Jul 2021<\/strong><\/p>\n<\/li>\n<\/ul>\n<p class=\"\" data-rte-preserve-empty=\"true\">\n<p class=\"\">Access the full document through the link: <a href=\"https:\/\/bit.ly\/3lDt5CQ\" target=\"_blank\" rel=\"noopener\">https:\/\/bit.ly\/3lDt5CQ<\/a><\/p>\n<p class=\"\" data-rte-preserve-empty=\"true\">\n<p class=\"\"><strong>Count on Vita to assist your company in developing drug products registration and post-registration projects in Latin America.<\/strong><\/p>\n","protected":false},"author":1,"featured_media":895,"template":"","meta":{"inline_featured_image":false,"_links_to":"","_links_to_target":""},"categorias":[24],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v20.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>EMA - Update of the Guideline on post-authorisation procedural advice for users of the centralised procedure - 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\/2021\/08\/06\/ema-update-of-the-guideline-on-post-authorisation-procedural-advice-for-users-of-the-centralised-procedure\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EMA - Update of the Guideline on post-authorisation procedural advice for users of the centralised procedure - Vita\" \/>\n<meta property=\"og:description\" content=\"In July, the European Medicines Agency (EMA) has updated its Guideline on post-authorisation procedural advice for users of the centralised procedure. 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