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It explains the document’s validity, subsequent supersession, and the governance process leading to adoption. The policy links public health protection and pharmacovigilance responsibilities with transparency through proactive and reactive disclosure of Individual Case Safety Reports, while ensuring compliance with EU legislation and personal data protection requirements.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/eudravigilance-access-policy-for-medicines-for-human-use/390659/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/eudravigilance-access-policy-for-medicines-for-human-use/390659.png","ImageObject",300,407,{"name":92,"@type":93},"acoobca","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-25","2026-09-25",true,{"@type":102,"interactionType":103,"userInteractionCount":44},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"What is the purpose of the EudraVigilance access policy for human medicines?","Question",{"text":112,"@type":113},"It provides defined levels of access to suspected adverse reactions reported to EudraVigilance for relevant stakeholders, supporting public health protection and pharmacovigilance activities.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"When was this access policy valid, and what happened to it afterward?",{"text":117,"@type":113},"The document was valid from 8 July 2011 to 21 November 2017. It is now superseded by a new version.",{"name":119,"@type":110,"acceptedAnswer":120},"How does the policy handle transparency and personal data protection?",{"text":121,"@type":113},"It treats proactive and reactive disclosure of Individual Case Safety Reports as complementary, releasing maximum data proactively while adhering to personal data protection requirements under EU rules.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},390659,1790662775,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":44,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":139,"language":140,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":67,"update_tm":144,"read_time":145,"preview_page_count":4},3985747870733,"https://ap-avatar.wpscdn.com/davatar_a8503ba1806abce46bf441b54a3ca4cd","23 August 2011 EMA/759287/2009 corr.  \nPatient Health Protection  \nEudraVigilance access policy for medicines for human use  \nThis document was valid from 8 July 2011 to 21 November  \n2017. It is now superseded by a new version.  \n\n| Draft agreed by the EudraVigilance Expert Working Group | December 2007 |\n| --- | --- |\n| Consultation with the EudraVigilance Steering Committee | February 2008 |\n| Consultation with the Heads of Medicines Agencies Human (HMA-h) for public consultation | April 2008 |\n| Adopted by EMA Management Board for public consultation | June 2008 |\n| Released for public consultation | December 2008 |\n| End of public consultation (deadline for comments) | March 2009 |\n| Consultation with the EudraVigilance Expert Working Group | September 2010 |\n| Consultation with the EudraVigilance Steering Committee | September 2010 |\n| Consultation with the CHMP Pharmacovigilance Working Party | September 2010 |\n| Consultation with the Committee for Human Medicinal Products (CHMP) | October 2010 |\n| Consultation with the Patients’ and Consumers’ Working Party | October 2010 |\n| Consultation with the Health Care Professional Working Group | October 2010 |\n| Consultation with the Heads of Medicines Agencies Human (HMA-h) | October 2010 |\n| Adopted by the EMA Management Board | December 2010 |\n| Coming into force | 8 July 2011 |\n\n7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8668  \nE-mail info@ema.europa.eu Website [www.ema.europa.eu](www.ema.europa.eu) An agency of the European Union  \n© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.  \nTable of contents  \nExecutive summary ..................................................................................... 3  \n1. Background ............................................................................................. 4  \n2. Introduction ............................................................................................ 5  \n3. Objectives of the EudraVigilance access policy........................................ 5  \n4. EudraVigilance and medicinal products for human use ............................ 5  \n5. Access to data held in EudraVigilance...................................................... 7  \n5.1. Stakeholder groups ............................................................................................ 7  \n5.2. Overview .......................................................................................................... 7  \n5.3. General principles .............................................................................................. 9  \n5.3.1. ICSR types ................................................................................................... 10  \n5.3.2. Primary and secondary report sources .............................................................. 10  \n5.3.3. Individual cases, ICSRs and classification rules .................................................. 10  \n5.3.4. Access to EudraVigilance data and access tools .................................................. 11  \n5.4. Access by stakeholder group .............................................................................. 11  \n5.4.1. Group I: Medicines regulatory authorities in the EEA, the European Commission and the Agency ............................................................................................................ 11  \n5.4.2. Group II: Healthcare professionals and the general public ................................... 12  \n5.4.3. Group III: Marketing authorisation holders and sponsors ..................................... 14  \n5.4.4. Group IV: Research organisations .................................................................... 15  \n6. Implementation of the EudraVigilance access policy ............................. 16  \nAnnex 1: EudraVigilance human data elements ........................................ 18  \nAnnex 2: Ex","cbCaisB0Whl73qBy","https://ap.wps.com/l/cbCaisB0Whl73qBy","pdf",436798,39,"English","# Executive summary\n# Background\n# Introduction\n# Objectives of the EudraVigilance access policy\n# EudraVigilance and medicinal products for human use\n# Access to data held in EudraVigilance\n## Stakeholder groups\n## Overview\n## General principles\n## Access by stakeholder group\n# Implementation of the EudraVigilance access policy\n# Annex 1: EudraVigilance human data elements\n# Annex 2: Examples for aggregated data outputs\n# Annex 3: Acronyms\n# References","[{\"question\":\"What is the purpose of the EudraVigilance access policy for human medicines?\",\"answer\":\"It provides defined levels of access to suspected adverse reactions reported to EudraVigilance for relevant stakeholders, supporting public health protection and pharmacovigilance activities.\"},{\"question\":\"When was this access policy valid, and what happened to it afterward?\",\"answer\":\"The document was valid from 8 July 2011 to 21 November 2017. It is now superseded by a new version.\"},{\"question\":\"How does the policy handle transparency and personal data protection?\",\"answer\":\"It treats proactive and reactive disclosure of Individual Case Safety Reports as complementary, releasing maximum data proactively while adhering to personal data protection requirements under EU rules.\"}]","EudraVigilance access policy for medicines for human use | PDF",1790337595,98]