[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-seo-178122-105":3,"detail-sidebar-cat-1-en-105":81,"doc-detail-178122-en":127},{"code":4,"msg":5,"data":6},0,"ok",{"site_id":7,"language":8,"slug":9,"title":10,"keywords":11,"description":12,"schema_data":13,"social_meta":74,"head_meta":76,"extra_data":78,"updated_unix":80},105,"en","early-access-to-medicines-scheme-eams-abridged-risk-management-plan-rmp-template-version-11-guidance-structure","Early Access to Medicines Scheme (EAMS) Abridged Risk Management Plan (RMP) Template - Version 1.1 - Guidance Structure","","Guidance explains how to prepare an abridged Early Access to Medicines Scheme (EAMS) risk management plan (RMP) for medicines used under EAMS in the UK. It clarifies when an abridged RMP can be used (when an approved UK RMP exists for the relevant authorised indication) and when the full EAMS RMP template is required. The document outlines required RMP sections, including product overview, safety specification focusing on Module SVIII, an EAMS-specific pharmacovigilance plan, further efficacy study plans when required by MHRA, and risk minimisation with cross-references to the approved RMP.",{"@graph":14,"@context":73},[15,34,56],{"@type":16,"itemListElement":17},"BreadcrumbList",[18,23,27,31],{"item":19,"name":20,"@type":21,"position":22},"https://docshare.wps.com","Home","ListItem",1,{"item":24,"name":25,"@type":21,"position":26},"https://docshare.wps.com/template/","Template",2,{"item":28,"name":29,"@type":21,"position":30},"https://docshare.wps.com/template/forms/","Forms",3,{"item":32,"name":10,"@type":21,"position":33},"https://docshare.wps.com/template/early-access-to-medicines-scheme-eams-abridged-risk-management-plan-rmp-template-version-11-guidance-structure/178122/",4,{"url":32,"name":10,"@type":35,"image":36,"author":41,"headline":10,"publisher":44,"fileFormat":47,"inLanguage":8,"description":12,"dateModified":48,"datePublished":49,"encodingFormat":47,"isAccessibleForFree":50,"interactionStatistic":51},"DigitalDocument",{"url":37,"@type":38,"width":39,"height":40},"https://docshare.wps.com/thumbnails/early-access-to-medicines-scheme-eams-abridged-risk-management-plan-rmp-template-version-11-guidance-structure/178122.png","ImageObject",442,249,{"name":42,"@type":43},"Levi","Person",{"url":19,"name":45,"@type":46},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-10-23","2026-09-02",true,{"@type":52,"interactionType":53,"userInteractionCount":55},"InteractionCounter",{"@type":54},"ViewAction",7,{"@type":57,"mainEntity":58},"FAQPage",[59,65,69],{"name":60,"@type":61,"acceptedAnswer":62},"When can the abridged EAMS RMP template be used instead of the full template?","Question",{"text":63,"@type":64},"The abridged template can be used when an RMP is already approved for the product in a relevant UK authorised indication and the important safety concerns are expected to be the same under EAMS.","Answer",{"name":66,"@type":61,"acceptedAnswer":67},"What is required in Part II for the abridged RMP?",{"text":68,"@type":64},"Part II requires only Module SVIII - Summary of the safety concerns, with a summary of each safety concern identified in previous Modules of Part II.",{"name":70,"@type":61,"acceptedAnswer":71},"What determines whether Part IV must include plans for further efficacy studies?",{"text":72,"@type":64},"Part IV must be completed if MHRA requires efficacy or effectiveness studies as part of the terms of the positive opinion; otherwise a cross-reference to the accompanying approved RMP for marketing authorisation can be used.","https://schema.org",{"og:url":32,"og:type":75,"og:title":10,"og:site_name":45,"og:description":12},"article",{"robots":77,"canonical":32},"index,follow",{"doc_id":79,"site_id":7},178122,1788330490,{"code":4,"msg":82,"data":83},"success",[84,89,94,99,104,109,113,118,123],{"id":85,"doc_module":22,"doc_module_name":25,"category_name":86,"show_sort_weight":87,"slug":88},11,"Presentations",90,"presentations",{"id":90,"doc_module":22,"doc_module_name":25,"category_name":91,"show_sort_weight":92,"slug":93},12,"Resumes",80,"resumes",{"id":95,"doc_module":22,"doc_module_name":25,"category_name":96,"show_sort_weight":97,"slug":98},14,"Invoices",70,"invoices",{"id":100,"doc_module":22,"doc_module_name":25,"category_name":101,"show_sort_weight":102,"slug":103},15,"Posters",60,"posters",{"id":105,"doc_module":22,"doc_module_name":25,"category_name":106,"show_sort_weight":107,"slug":108},16,"Social Media",50,"social-media",{"id":110,"doc_module":22,"doc_module_name":25,"category_name":29,"show_sort_weight":111,"slug":112},17,40,"forms",{"id":114,"doc_module":22,"doc_module_name":25,"category_name":115,"show_sort_weight":116,"slug":117},18,"Letters",30,"letters",{"id":119,"doc_module":22,"doc_module_name":25,"category_name":120,"show_sort_weight":121,"slug":122},21,"Paper Templates",5,"papers-templates",{"id":124,"doc_module":22,"doc_module_name":25,"category_name":125,"show_sort_weight":4,"slug":126},158,"General","general-158",{"code":4,"msg":82,"data":128},{"doc_id":79,"user_id":129,"nickname":42,"user_avatar":130,"doc_module":22,"category_id":110,"category_name":29,"doc_title":10,"doc_description":12,"doc_content":131,"file_id":132,"file_url":133,"file_type":134,"file_size":135,"view_count":55,"is_deleted":4,"is_public":22,"is_downloadable":22,"audit_status":22,"page_count":136,"language":137,"language_code":8,"site_id":7,"html_lang":8,"table_of_contents":138,"faqs":139,"seo_title":140,"seo_description":12,"update_tm":80,"read_time":141},7971461740909,"https://ap-avatar.wpscdn.com/davatar_155a257f0dc6eb9ab79c44ca47cae57d","Guidance on the Early Access to Medicines Scheme (EAMS) abridged risk management plan (RMP)\nAll EAMS applications require an EAMS RMP.   The template below is for an abridged EAMS RMP and can be used in the case that there is an RMP approved for the product in an authorized indication in the UK that is relevant to the use through EAMS. This would usually apply for a drug authorized for marketing for which the important safety concerns can be expected to be the same to those in its use through EAMS.\nThe RMP approved for the authorized product in the UK must be submitted alongside the abridged EAMS RMP.\nIn the case where the drug does not have a marketing authorization in the UK in an appropriate indication, the full EAMS RMP template should be used\nIn brief, the structure of the EAMS RMP is as follows\nPart I: Product overview\nPart II: Safety specification – only “Module SVIII - Summary of the safety concerns” is required in this Part\nPart III: Pharmacovigilance Plan – this section is specific for EAMS\nPart IV: Plans for further efficacy studies - This section must be completed in the event that any efficacy or effectiveness studies are required by MHRA as part of the terms of the positive opinion.  If such post-opinion studies are not a requirement, a simple cross reference to the accompanying approved RMP for the marketing authorisation can be accepted.\nPart V: Risk minimization plan – If routine risk minimization only is needed and no additional risk minimisation, a simple cross reference to the accompanying approved RMP for the marketing authorisation can be accepted.\nPart VI: Annexes – Any annexes which are identical to those in the accompanying approved RMP for the marketing authorisation can be omitted and replaced with a cross reference to the relevant annex of the accompanying approved RMP.\nBlue highlighting – indicates a notable difference compared with the EU RMP rev 2\nIn addition to the green text in the template below, please refer to MHRA guidance on pharmacovigilance procedures, GVP V, the EU RMP rev 2 template and the \u0013 HYPERLINK \"https://www.gov.uk/guidance/apply-for-the-early-access-to-medicines-scheme-eams\" \u0014Guidance on applying to the EAMS\u0015 for further reference.\n\u000f\nEarly Access to Medicines Scheme (EAMS) abridged risk management plan (RMP) template (version 1.1)\n\u003CEnter a version no>\n\u003CEnter a date>\n\u003CEnter a date>\nData lock point for this RMP \t\t\t\tVersion number\nDate of final sign off\nVersion number of last agreed RMP:\n\u003CEnter a version no>\nVersion number\nQPPV Name\nQPPV Signature\nTable of Contents\n\u0003\n\u0013 TOC \\o \"1-3\" \\h \\z \\u \u0014\u0013 HYPERLINK \\l \"_Toc59634426\" \u0014Table of Contents\t\u0013 PAGEREF _Toc59634426 \\h \u00143\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc59634427\" \u0014Part I: Product(s) Overview\t\u0013 PAGEREF _Toc59634427 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc59634428\" \u0014Part II: Safety specification\t\u0013 PAGEREF _Toc59634428 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc59634429\" \u0014Part II: Module SVIII - Summary of the safety concerns\t\u0013 PAGEREF _Toc59634429 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc59634430\" \u0014Part III: Pharmacovigilance Plan\t\u0013 PAGEREF _Toc59634430 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc59634431\" \u0014III.1\tRoutine pharmacovigilance activities\t\u0013 PAGEREF _Toc59634431 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc59634432\" \u0014III.2\tAdditional pharmacovigilance activities\t\u0013 PAGEREF _Toc59634432 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc59634433\" \u0014III.3\tTable of on-going and planned additional PhV activities\t\u0013 PAGEREF _Toc59634433 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc59634434\" \u0014Part IV: Plans for further efficacy studies\t\u0013 PAGEREF _Toc59634434 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc59634435\" \u0014IV.1\tSummary of Post-opinion efficacy development plan\t\u0013 PAGEREF _Toc59634435 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc59634436\" \u0014Part V: Risk minimisation measures\t\u0013 PAGEREF _Toc59634436 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc59634437\" \u0014V.1\tSummary table of risk minimisation measures\t\u0013 PAGEREF _Toc59634437 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc59634438\" \u0014V.2 Details of Additional risk minimisation measures (if applicable)\t\u0013 PAGEREF _Toc59634438 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc59634439\" \u0014Part VI: A","cbCaivEsKqQLOqwQ","https://ap.wps.com/l/cbCaivEsKqQLOqwQ","docx",479620,22,"English","# Table of Contents\n## Part I: Product(s) Overview\n## Part II: Safety specification\n## Part II: Module SVIII - Summary of the safety concerns\n## Part III: Pharmacovigilance Plan\n## Part IV: Plans for further efficacy studies\n## Part V: Risk minimisation measures\n## Part VI: Annexes","[{\"question\":\"When can the abridged EAMS RMP template be used instead of the full template?\",\"answer\":\"The abridged template can be used when an RMP is already approved for the product in a relevant UK authorised indication and the important safety concerns are expected to be the same under EAMS.\"},{\"question\":\"What is required in Part II for the abridged RMP?\",\"answer\":\"Part II requires only Module SVIII - Summary of the safety concerns, with a summary of each safety concern identified in previous Modules of Part II.\"},{\"question\":\"What determines whether Part IV must include plans for further efficacy studies?\",\"answer\":\"Part IV must be completed if MHRA requires efficacy or effectiveness studies as part of the terms of the positive opinion; otherwise a cross-reference to the accompanying approved RMP for marketing authorisation can be used.\"}]","Early Access to Medicines Scheme (EAMS) Abridged Risk Management Plan (RMP) Template - Version 1.1 - Guidance Structure | DOCX",8]