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, and related 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

AdoptedReference 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/351699/2018Summary:

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

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)

AdoptedReference Number: EMA/9496/2015Summary:

Annual report 2014

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

AdoptedReference Number: EMA/103410/2014Summary:

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)

AdoptedReference Number: EMA/272219/2013

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

AdoptedReference 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...

AdoptedReference Number: EMA/MB/632696/2011

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

AdoptedReference 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

AdoptedReference 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...

AdoptedReference Number: EMEA/478814/2007

Annual highlights

Stakeholder engagement highlights 2023

Stakeholder engagement highlights 2022

Stakeholder engagement highlights 2021

Stakeholder engagement highlights 2020

Stakeholder engagement highlights 2019

Stakeholder engagement highlights 2018

Stakeholder engagement highlights 2017

Stakeholder engagement highlights 2016

Supporting documents for involvement in EMA activities

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

Reference Number: EMA/188551/2023

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

Summary:

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

Training webinar for annual confirmation of eligibility

Bilateral meetings with eligible organisations

• Thalassaemia International Federation (TIF) bilateral meeting

Archive

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

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

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

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

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

AdoptedReference 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

AdoptedReference Number: EMA/850028/2011

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

AdoptedReference 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...

AdoptedReference 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

AdoptedReference 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