{"id":239,"date":"2026-07-17T18:25:26","date_gmt":"2026-07-17T16:25:26","guid":{"rendered":"https:\/\/www.pqra.gr\/risk-management-plans-structure-and-substance\/"},"modified":"2026-07-17T18:29:14","modified_gmt":"2026-07-17T16:29:14","slug":"risk-management-plans-structure-and-substance","status":"publish","type":"post","link":"https:\/\/www.pqra.gr\/el\/risk-management-plans-structure-and-substance\/","title":{"rendered":"Risk Management Plans: Structure and Substance"},"content":{"rendered":"<p style=\"font-size:19px;line-height:1.7;color:#33414d;\"><strong>A Risk Management Plan is not a formality appended to a dossier. It is the document in which you commit, in writing, to how a product&#8217;s risks will be identified, characterised and minimised for the rest of its life.<\/strong><\/p>\n<p>RMPs are governed by GVP Module V, and the risk management system must be <em>proportionate<\/em> to the identified risks &mdash; a principle that cuts both ways. Over-engineering an RMP creates obligations you must then honour; under-engineering it invites regulatory challenge.<\/p>\n<h2>The structure<\/h2>\n<p>The EU RMP has seven parts:<\/p>\n<ul>\n<li><strong>Part I<\/strong> &mdash; Product overview.<\/li>\n<li><strong>Part II<\/strong> &mdash; Safety specification, built from modules SI to SVIII: epidemiology, non-clinical data, clinical trial exposure, populations not studied, post-authorisation experience, additional EU requirements, identified and potential risks, and the summary of safety concerns.<\/li>\n<li><strong>Part III<\/strong> &mdash; Pharmacovigilance plan.<\/li>\n<li><strong>Part IV<\/strong> &mdash; Post-authorisation efficacy studies.<\/li>\n<li><strong>Part V<\/strong> &mdash; Risk minimisation measures.<\/li>\n<li><strong>Part VI<\/strong> &mdash; Summary of the RMP.<\/li>\n<li><strong>Part VII<\/strong> &mdash; Annexes.<\/li>\n<\/ul>\n<h2>Routine versus additional measures<\/h2>\n<p>The product information is the key routine risk minimisation tool, alongside pack size, legal status and prescription controls. Additional measures &mdash; educational materials, controlled access programmes, pregnancy prevention programmes &mdash; carry a heavier burden: their effectiveness must be evaluated and reported, in Part V of the RMP and in the relevant PSUR section.<\/p>\n<h2>A nuance most people still get wrong<\/h2>\n<p>It is widely believed that the safety concerns listed in the RMP and the PSUR must match. Since GVP Module V Rev. 2 that has not been a requirement, and current EMA guidance is explicit that the two lists <strong>might legitimately differ<\/strong> &mdash; because Module V&#8217;s definitions apply in the context of risk management planning, based on benefit-risk impact and the need for further risk minimisation. Aligning them mechanically can be the wrong answer.<\/p>\n<h2>When to update<\/h2>\n<p>An RMP must be updated at the request of the EMA or a national authority, and whenever the risk management system is modified &mdash; particularly on new information that may significantly change the benefit-risk profile, or on reaching an important pharmacovigilance or risk minimisation milestone. Note too that an RMP may only be submitted alongside a PSUR where the change is a consequence of that PSUR.<\/p>\n<h2>Transparency<\/h2>\n<p>Since October 2023 the EMA publishes full RMPs for centrally authorised products rather than summaries. Your RMP is a public document &mdash; write it accordingly.<\/p>\n<h2>How PQRA helps<\/h2>\n<p>PQRA authors and maintains RMPs, designs and evaluates additional risk minimisation measures, and keeps your commitments deliverable.<\/p>\n<p><strong><a href=\"\/el\/contact\/\">Discuss your RMP &rarr;<\/a><\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>A Risk Management Plan is not a formality appended to a dossier. It is the document in which you commit, in writing, to how a product&#8217;s risks will be identified, characterised and minimised for the rest of its life. RMPs are governed by GVP Module V, and the risk management system must be proportionate to [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":254,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"saved_in_kubio":false,"_kadence_starter_templates_imported_post":false,"_swpsp_post_exclude":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-239","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Risk Management Plans: Structure and Substance - PQRA<\/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.pqra.gr\/el\/risk-management-plans-structure-and-substance\/\" \/>\n<meta property=\"og:locale\" content=\"el_GR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Risk Management Plans: Structure and Substance - PQRA\" \/>\n<meta property=\"og:description\" content=\"A Risk Management Plan is not a formality appended to a dossier. It is the document in which you commit, in writing, to how a product&#8217;s risks will be identified, characterised and minimised for the rest of its life. 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