Key documents

The European Medicines Agency (EMA) makes available documents on key areas of the EMA's work with patients and careers and their organisations.

Framework for interaction with patients and consumers, and related documents

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Engagement framework: European Medicines Agency and patients, consumers and their organisations (PDF/768.25 KB)

Adopted

First published: 14/02/2006
Last updated: 07/02/2022
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Rules of engagement for patients’ organisations and their representatives in repurposing activities and impact on involvement in EMA activities (PDF/144.6 KB)

First published: 06/07/2020
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Criteria to be fulfilled by patient, consumer and healthcare professional organisations involved in European Medicines Agency (EMA) activities (PDF/90.76 KB)

First published: 07/02/2005
Last updated: 11/06/2018
EMA/MB/24913/2005 Rev.3
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Principles on the involvement of young patients/consumers within EMA activities (PDF/441.52 KB)

Adopted

First published: 19/07/2017
Last updated: 19/07/2017
EMA/494077/2016
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Outcome Report on Pilot to involve patients in benefit/risk discussions at CHMP meetings (PDF/180.88 KB)

First published: 08/05/2017
Last updated: 08/05/2017
EMA/191955/2017
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The role of members representing patients' and healthcare professionals' organisations on EMA scientific committees (PDF/282.11 KB)

First published: 19/12/2011
Last updated: 28/10/2019
EMA/351699/2018

Annual reports

Annual highlights

Supporting documents for involvement in EMA activities

small format video Icon Training webinar for annual confirmation of eligibility

Table of contents

Framework for interaction with patients and consumers, and related documents

Engagement framework: European Medicines Agency and patients, consumers and their organisations (PDF/768.25 KB)

Rules of engagement for patients’ organisations and their representatives in repurposing activities and impact on involvement in EMA activities (PDF/144.6 KB)

Criteria to be fulfilled by patient, consumer and healthcare professional organisations involved in European Medicines Agency (EMA) activities (PDF/90.76 KB)

Principles on the involvement of young patients/consumers within EMA activities (PDF/441.52 KB)

Outcome Report on Pilot to involve patients in benefit/risk discussions at CHMP meetings (PDF/180.88 KB)

The role of members representing patients' and healthcare professionals' organisations on EMA scientific committees (PDF/282.11 KB)

Annual reports

Stakeholder engagement report 2020-2021 (PDF/984.93 KB)

Stakeholder engagement report 2018-2019 (PDF/2.3 MB)

Stakeholder engagement report 2017 (PDF/4.46 MB)

Annexes - Stakeholder engagement annual report 2017 (PDF/448.84 KB)

European Medicines Agency’s interaction with patients, consumers, healthcare professionals and their organisations - Annual report 2016 (PDF/1.99 MB)

European Medicines Agency’s interaction with patients, consumers, healthcare professionals and their organisations - Annual report 2015 (PDF/1.23 MB)

Consolidated final report on the activities of patients’ and consumers’ working party and healthcare professionals’ working party topic groups (2015) (PDF/568.38 KB)

Annual report on European Medicines Agency’s interaction with patients, consumers, healthcare professionals and their organisations (2014) (PDF/1.34 MB)

Annual report on European Medicines Agency’s interaction with patients, consumers, healthcare professionals and their organisations (2013) (PDF/706.93 KB)

Sixth annual report on the interaction with patients' and consumers' organisations (2012) (PDF/482.93 KB)

Fifth report on the interaction with patients' and consumers' organisations (2011) (PDF/305.09 KB)

Fourth report on the progress of the interaction with patients' and consumers' organisations (2010) and results / analysis of the degree of satisfaction of patients and consumers involved in European Medicines Agency act... (PDF/322.55 KB)

Third report on the progress of the interaction with patients' and consumers' organisations during 2009 (PDF/256.67 KB)

Second report on the progress of the interaction with patients' and consumers' organisations and analysis of the degree of satisfaction of patients / consumers involved in European Medicines Agency activities during 2008 (PDF/949.15 KB)

First report on the progress of the interaction with patients’ and consumers’ organisations and analysis of the degree of satisfaction of patients and consumers involved in European Medicines Agency activities during 200... (PDF/375.36 KB)

Annual highlights

Stakeholder engagement highlights 2021 (PDF/127.69 KB)

Stakeholder engagement highlights 2020 (PDF/384.49 KB)

Stakeholder engagement highlights 2019 (PDF/619.88 KB)

Stakeholder engagement highlights 2018 (PDF/963.97 KB)

Stakeholder engagement highlights 2017 (PDF/852.64 KB)

Stakeholder engagement highlights 2016 (PDF/839.32 KB)

Supporting documents for involvement in EMA activities

Pilot phase for CHMP early contact with patient / consumer organisations (PDF/145.21 KB)

Pilot on early dialogue with patient organisations for orphan marketing authorisation applications: Outcome Report (PDF/442.63 KB)

Assessment of patient, consumer and healthcare professional organisations’ compliance with EMA eligibility criteria (PDF/246.4 KB)

Involvement of patients in scientific advice procedures at the European Medicines Agency (PDF/718.15 KB)

Involvement of patients in Scientific Advisory Group and Ad Hoc Expert meetings at EMA (PDF/701.2 KB)

Training manual - Review of European Medicines Agency documents addressed to the general public by patients and consumers (PDF/169.56 KB)

Sample eligibility form - Patients and consumers (PDF/731.85 KB)

Archive

Standard operating procedure for evaluation procedure for eligibility of patients', consumers' and healthcare professionals’ organisations (PDF/174.64 KB)

Standard operating procedure for re-evaluation and financial re-assessment procedures for eligible patients', consumers' and healthcare professionals’ organisations (PDF/218.8 KB)

Rules of involvement of members of patients' and/or consumers' and healthcare professionals' organisations in committee related activities (PDF/54.57 KB)

Procedure for review of information on medicinal products by patients' and consumers' organisations (PDF/112.14 KB)

Incorporating patients' views during evaluation of benefit-risk by the European Medicines Agency scientific committees (PDF/178.54 KB)

Pilot phase to involve patients in benefit / risk discussions at CHMP meetings (PDF/108.09 KB)

Outcome report on pilot phase for participation of patient representatives in scientific advisory group (SAG) meetings (PDF/125.29 KB)

Reflection paper on the further involvement of patients and consumers in the Agency’s activities (PDF/286 KB)

Report from experience acquired from pilot phase participation of patients / consumers representatives in the Pharmacovigilance Working Party (PhVWP) and proposal for participation of patients’ / consumers’ representativ... (PDF/89.72 KB)

Proposal for involvement and participation of patients consumers representatives in the meetings of the Committee for Medicinal Products for Human Use Pharmacovigilance Working Party (PDF/57.85 KB)

Comments received on European Medicines Agency Committee for Medicinal Products for Human Use Working Group with Patients' Organisations: Outcome of discussions: Recommendations and proposals for action (PDF/112.88 KB)

European Medicines Agency/Committee for Medicinal Products for Human Use Working Group with Patients' Organisations - Outcome of discussions: Recommendations and proposals for action (PDF/183.01 KB)

European Medicines Agency/Committee for Proprietary Medicinal Products Working Group with Patients' Organisations - Outcome of discussions: Recommendations and proposals for action (PDF/164 KB)

Information on benefit-risk of medicines: patients', consumers' and healthcare professionals' expectations (PDF/308.72 KB)

Questions and answers on the CHMP review of the recommendations on the use of pandemic H1N1 vaccines (PDF/40.09 KB)

Pharmaceutical forum working group on information to patients: report on pillar II: statutory information on medicines (PDF/43.15 KB)

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