{"id":1009,"date":"2021-02-23T15:18:36","date_gmt":"2021-02-23T18:18:36","guid":{"rendered":"https:\/\/www.vitapharmaconsulting.com\/en\/?post_type=noticias&#038;p=1009"},"modified":"2022-04-28T15:34:39","modified_gmt":"2022-04-28T18:34:39","slug":"ema-review-of-the-question-and-answer-documents-for-centralized-procedure","status":"publish","type":"noticias","link":"https:\/\/www.vitapharmaconsulting.com\/en\/news\/2021\/02\/23\/ema-review-of-the-question-and-answer-documents-for-centralized-procedure\/","title":{"rendered":"EMA &#8211; Review of the Question and Answer Documents for Centralized Procedure"},"content":{"rendered":"<article id=\"post-6035203f846eb10ada06be69\" class=\"BlogItem hentry author-lorena-pereira post-type-text\" data-item-id=\"6035203f846eb10ada06be69\">\n<div id=\"item-6035203f846eb10ada06be69\" class=\"sqs-layout sqs-grid-12 columns-12\" data-layout-label=\"Post Body\" data-type=\"item\" data-updated-on=\"1614094508910\">\n<div class=\"row sqs-row\">\n<div class=\"col sqs-col-12 span-12\">\n<div id=\"block-204746b2c5d32c09035d\" class=\"sqs-block html-block sqs-block-html\" data-block-type=\"2\">\n<div class=\"sqs-block-content\">\n<p class=\"\">On February 2021, the European Medicines Agency (EMA) published on its website an updated version of the document on post-authorisation procedural advice for users of the centralised procedure, which was last revised in January 2021.<\/p>\n<p class=\"\">This question-and-answer document is used as a guideline for marketing authorization holders and centralized procedure seekers, for relevant matters after the marketing authorization has been granted.<\/p>\n<p class=\"\">The latest version includes the following amendments and updates to chapters:<\/p>\n<ul data-rte-list=\"default\">\n<li>\n<p class=\"\">1. Type IA variations (paragraphs 1.4., 1.6., 1.10., 1.11. AND 1.15.).<\/p>\n<\/li>\n<li>\n<p class=\"\">2. Type IB variations (paragraphs 2.4., 2.11., 2.12 . And 2.14.).<\/p>\n<\/li>\n<li>\n<p class=\"\">Notifications (paragraphs 22.1., 22.3. AND 22.6.).<\/p>\n<\/li>\n<\/ul>\n<p class=\"\">Another important Q&amp;A document that was updated was on European Medicines Agency procedural advice for users of the centralised procedure for generic\/hybrid applications. The most recent versions of these guidance documents can be found at:<\/p>\n<ul data-rte-list=\"default\">\n<li>\n<p class=\"\">Questions and Answers on procedural advice for users of the centralised procedure for generic\/hybrid applications: <a href=\"https:\/\/bit.ly\/3umz7tB\" target=\"_blank\" rel=\"noopener\">https:\/\/bit.ly\/3umz7tB<\/a><\/p>\n<\/li>\n<li>\n<p class=\"\">Questions and Answers on post-authorisation procedural advice for users of the centralised procedure: <a href=\"https:\/\/bit.ly\/3spdSWl\" target=\"_blank\" rel=\"noopener\">https:\/\/bit.ly\/3spdSWl <\/a><\/p>\n<\/li>\n<\/ul>\n<p class=\"\" data-rte-preserve-empty=\"true\">\n<p class=\"\">Count on Vita to assist your company in developing drug products registration and post-registration projects in Latin America.<\/p>\n<p class=\"\">Contact us: <a href=\"mailto:info@vitaraconsulting.com\">info@vitaraconsulting.com<\/a><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"Blog-meta BlogItem-meta\"><time class=\"Blog-meta-item Blog-meta-item--date\" datetime=\"2021-02-23\">23 de fevereiro de 2021<\/time><\/div>\n<div class=\"BlogItem-share\">\n<div class=\"Share sqs-share-buttons\" data-item-identifier=\"6035203f846eb10ada06be69\" data-item-path=\"news\/2021\/2\/23\/ema-review-of-the-question-and-answer-documents-for-centralized-procedure\">\n<div class=\"Share-buttons\"><\/div>\n<\/div>\n<\/div>\n<section id=\"comments-6035203f846eb10ada06be69\" class=\"BlogItem-comments\">\n<div id=\"comments-6035203f846eb10ada06be69\" class=\"squarespace-comments\" data-item-id=\"6035203f846eb10ada06be69\" data-public-comment-count=\"0\" data-comment-state=\"2\"><\/div>\n<\/section>\n<\/article>\n<nav class=\"BlogItem-pagination clear\">\n<div class=\"BlogItem-pagination-link-content\"><\/div>\n<\/nav>\n","protected":false},"author":1,"featured_media":1010,"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 - Review of the Question and Answer Documents for Centralized 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\/02\/23\/ema-review-of-the-question-and-answer-documents-for-centralized-procedure\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EMA - Review of the Question and Answer Documents for Centralized Procedure - Vita\" \/>\n<meta property=\"og:description\" content=\"On February 2021, the European Medicines Agency (EMA) published on its website an updated version of the document on post-authorisation procedural advice for users of the centralised procedure, which was last revised in January 2021. 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