Patients and consumers: Key documents

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

Framework for interaction with patients and consumers

Select the expandable panel below (via the arrow) to access the documents related to the revised framework for interaction with healthcare professionals, including annexes, action plans, and related documents.

Framework for interaction documents

Engagement framework: European Medicines Agency and patients, consumers and their organisations

Adopted

Rules of engagement for patients’ organisations and their representatives in repurposing activities and impact on involvement in EMA activities

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

Reference Number: EMA/MB/24913/2005 Rev.3

Principles on the involvement of young patients/consumers within EMA activities

Adopted Reference Number: EMA/494077/2016

Outcome Report on Pilot to involve patients in benefit/risk discussions at CHMP meetings

Reference Number: EMA/191955/2017

The role of members representing patients' and healthcare professionals' organisations on EMA scientific committees

Reference Number: EMA/351699/2018 Rev.2 Summary:

The purpose of this paper is to clarify the role of representatives of patient and healthcare professional organisations within the different EMA scientific committees, focusing in particular on their role as members of such committees. The aim is to provide guidance to current members as well as those who are considering applying for membership of a committee at the EMA. For this purpose, this document addresses the role, workload, challenges and the added value of the patients and healthcare professional representatives in the committees. It also covers the work involved outside of the committee and other related aspects.

Annual reports

Select the expandable panel below (via the arrow) to access annual and stakeholder engagement reports, including summaries of EMA activities and working party contributions.

Stakeholder engagement reports

Stakeholder engagement report 2022-2023

Stakeholder engagement report 2020-2021

Stakeholder engagement report 2018-2019

Stakeholder engagement report 2017

Annexes - Stakeholder engagement annual report 2017

European Medicines Agency’s interaction with patients, consumers, healthcare professionals and their organisations - Annual report 2016

Reference Number: EMA/260003/2016

European Medicines Agency’s interaction with patients, consumers, healthcare professionals and their organisations - Annual report 2015

Reference Number: EMA/727872/2015

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

Reference Number: EMA/225307/2017

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

Adopted Reference Number: EMA/9496/2015 Summary:

Annual report 2014

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

Adopted Reference Number: EMA/103410/2014 Summary:

The current report outlines the Agency’s interaction with patients, consumers, healthcare professionals and their representative organisations during 2013.

Sixth annual report on the interaction with patients' and consumers' organisations (2012)

Adopted Reference Number: EMA/272219/2013

Fifth report on the interaction with patients' and consumers' organisations (2011)

Adopted Reference Number: EMA/507517/2012

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...

Adopted Reference Number: EMA/MB/632696/2011

Third report on the progress of the interaction with Patients' and Consumers' Organisations during 2009: Management Board meeting 7 October 2010

Reference Number: EMA/MB/599720/2010

Third report on the progress of the interaction with patients' and consumers' organisations during 2009

Adopted Reference Number: EMA/MB/117170/2010

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

Adopted Reference Number: EMEA/259449/2009

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...

Adopted Reference Number: EMEA/478814/2007

Annual highlights

Select the expandable panel below (via the arrow) to view key public engagement highlights, including patient and consumer contributions and EMA outreach activities.

Public engagement highlights

Public engagement highlights 2024

Public engagement highlights 2023

Public engagement highlights 2022

Public engagement highlights 2021

Public engagement highlights 2020

Public engagement highlights 2019

Public engagement highlights 2018

Public engagement highlights 2017

Public engagement highlights 2016

Supporting documents for involvement in EMA activities

Select the expandable panel below (via the arrow) to access supporting documents for involvement in EMA activities, including guidance, pilot reports, and training materials for patients and consumers.

Involvement with EMA guidance documents

CHMP early contact with patient and healthcare professional organisations: process and FAQs

Reference Number: EMA/188551/2023 rev. 1

Pilot phase for CHMP early contact with patient / consumer organisations

Reference Number: EMA/97615/20212021

Pilot on early dialogue with patient organisations for orphan marketing authorisation applications: Outcome Report

Reference Number: EMA/665019/2022

Assessment of patient, consumer and healthcare professional organisations’ compliance with EMA eligibility criteria

Reference Number: EMA/698917/2017

Involvement of patients in scientific advice procedures at the European Medicines Agency

Involvement of patients in Scientific Advisory Group and Ad Hoc Expert meetings at EMA

Training manual - Review of European Medicines Agency documents addressed to the general public by patients and consumers

Reference Number: EMA/115803/2007 Rev. 5

Sample eligibility form - Patients and consumers

Archive

Select the expandable panel below (via the arrow) to access archived EMA documents, including SOPs, pilot reports, guidance, and outcome reports from past patient and consumer engagement activities.

Archived documents

Standard operating procedure for evaluation procedure for eligibility of patients', consumers' and healthcare professionals’ organisations

Adopted Reference Number: SOP/H/3390 Legal effective date: 13/03/2015 Summary:

The purpose of this SOP is to ensure a consistent and efficient approach in the evaluation procedure for eligibility criteria of patients', consumers' and healthcare professionals’ organisations applying to be involved in the activities of the Agency.

Standard operating procedure for re-evaluation and financial re-assessment procedures for eligible patients', consumers' and healthcare professionals’ organisations

Adopted Reference Number: SOP/H/3417 Legal effective date: 13/03/2015 Summary:

The purpose of this SOP is to ensure a consistent and efficient approach in the re-evaluation procedure

for eligibility criteria of patients', consumers' and healthcare professionals’ organisations involved in the activities of the Agency.

Rules of involvement of members of patients' and/or consumers' and healthcare professionals' organisations in committee related activities

Adopted Reference Number: EMEA/483439/2008 rev. 1

Procedure for review of information on medicinal products by patients' and consumers' organisations

Reference Number: EMA/174255/2010 Rev. 2

Incorporating patients' views during evaluation of benefit-risk by the European Medicines Agency scientific committees

Reference Number: EMA/413422/2013 Rev1

Pilot phase to involve patients in benefit / risk discussions at CHMP meetings

Reference Number: EMA/372554/2014 Rev1

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

Adopted Reference Number: EMA/850028/2011

Reflection paper on the further involvement of patients and consumers in the Agency’s activities

Adopted Reference Number: EMA/MB/753771/2009

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...

Adopted Reference Number: EMA/355206/2009

Proposal for involvement and participation of patients consumers representatives in the meetings of the Committee for Medicinal Products for Human Use Pharmacovigilance Working Party

Reference Number: EMEA/261645/2008Endorsed

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

Reference Number: EMEA/18153/2005 Final

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

Adopted Reference Number: EMEA/149479/2004 Final

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

Reference Number: EMEA/CPMP/5819/04

Information on benefit-risk of medicines: patients', consumers' and healthcare professionals' expectations

Reference Number: EMEA/40926/2009

Questions and answers on the CHMP review of the recommendations on the use of pandemic H1N1 vaccines

Reference Number: EMEA/666809/2009

Pharmaceutical forum working group on information to patients: report on pillar II: statutory information on medicines

Reference Number: EMEA/109974/2006