Framework for interaction with patients and consumers, and related documents
Engagement framework: European Medicines Agency and patients, consumers and their organisations
English (EN) (768.25 KB - PDF)
Rules of engagement for patients’ organisations and their representatives in repurposing activities and impact on involvement in EMA activities
English (EN) (144.6 KB - PDF)
Criteria to be fulfilled by patient, consumer and healthcare professional organisations involved in European Medicines Agency (EMA) activities
English (EN) (90.76 KB - PDF)
Principles on the involvement of young patients/consumers within EMA activities
English (EN) (441.52 KB - PDF)
Outcome Report on Pilot to involve patients in benefit/risk discussions at CHMP meetings
English (EN) (180.88 KB - PDF)
The role of members representing patients' and healthcare professionals' organisations on EMA scientific committees
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.
English (EN) (282.11 KB - PDF)
Annual reports
Stakeholder engagement report 2020-2021
English (EN) (984.93 KB - PDF)
Stakeholder engagement report 2018-2019
English (EN) (2.3 MB - PDF)
Stakeholder engagement report 2017
English (EN) (4.46 MB - PDF)
Annexes - Stakeholder engagement annual report 2017
English (EN) (448.84 KB - PDF)
European Medicines Agency’s interaction with patients, consumers, healthcare professionals and their organisations - Annual report 2016
English (EN) (1.99 MB - PDF)
European Medicines Agency’s interaction with patients, consumers, healthcare professionals and their organisations - Annual report 2015
English (EN) (1.23 MB - PDF)
Consolidated final report on the activities of patients’ and consumers’ working party and healthcare professionals’ working party topic groups (2015)
English (EN) (568.38 KB - PDF)
Annual report on European Medicines Agency’s interaction with patients, consumers, healthcare professionals and their organisations (2014)
Annual report 2014
English (EN) (1.34 MB - PDF)
Annual report on European Medicines Agency’s interaction with patients, consumers, healthcare professionals and their organisations (2013)
The current report outlines the Agency’s interaction with patients, consumers, healthcare professionals and their representative organisations during 2013.
English (EN) (706.93 KB - PDF)
Sixth annual report on the interaction with patients' and consumers' organisations (2012)
English (EN) (482.93 KB - PDF)
Fifth report on the interaction with patients' and consumers' organisations (2011)
English (EN) (305.09 KB - PDF)
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...
English (EN) (322.55 KB - PDF)
Third report on the progress of the interaction with patients' and consumers' organisations during 2009
English (EN) (256.67 KB - PDF)
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
English (EN) (949.15 KB - PDF)
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...
English (EN) (375.36 KB - PDF)
Annual highlights
Stakeholder engagement highlights 2022
English (EN) (319.24 KB - PDF)
Stakeholder engagement highlights 2021
English (EN) (127.69 KB - PDF)
Stakeholder engagement highlights 2020
English (EN) (384.49 KB - PDF)
Stakeholder engagement highlights 2019
English (EN) (619.88 KB - PDF)
Stakeholder engagement highlights 2018
English (EN) (963.97 KB - PDF)
Stakeholder engagement highlights 2017
English (EN) (852.64 KB - PDF)
Stakeholder engagement highlights 2016
English (EN) (839.32 KB - PDF)
Supporting documents for involvement in EMA activities
CHMP early contact with patient and healthcare professional organisations: process and FAQs
English (EN) (440.23 KB - PDF)
Pilot phase for CHMP early contact with patient / consumer organisations
English (EN) (145.21 KB - PDF)
Pilot on early dialogue with patient organisations for orphan marketing authorisation applications: Outcome Report
English (EN) (442.63 KB - PDF)
Assessment of patient, consumer and healthcare professional organisations’ compliance with EMA eligibility criteria
English (EN) (246.4 KB - PDF)
Involvement of patients in scientific advice procedures at the European Medicines Agency
English (EN) (718.15 KB - PDF)
Involvement of patients in Scientific Advisory Group and Ad Hoc Expert meetings at EMA
Involvement of patients in Scientific Advisory Group and Ad Hoc Expert meetings at EMA
English (EN) (701.2 KB - PDF)
Training manual - Review of European Medicines Agency documents addressed to the general public by patients and consumers
English (EN) (169.56 KB - PDF)
Sample eligibility form - Patients and consumers
English (EN) (731.85 KB - PDF)
Bilateral meetings with eligible organisations
Archive
Standard operating procedure for evaluation procedure for eligibility of patients', consumers' and healthcare professionals’ organisations
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.
English (EN) (174.64 KB - PDF)
Standard operating procedure for re-evaluation and financial re-assessment procedures for eligible patients', consumers' and healthcare professionals’ organisations
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.
English (EN) (218.8 KB - PDF)
Rules of involvement of members of patients' and/or consumers' and healthcare professionals' organisations in committee related activities
English (EN) (54.57 KB - PDF)
Procedure for review of information on medicinal products by patients' and consumers' organisations
English (EN) (112.14 KB - PDF)
Incorporating patients' views during evaluation of benefit-risk by the European Medicines Agency scientific committees
English (EN) (178.54 KB - PDF)
Pilot phase to involve patients in benefit / risk discussions at CHMP meetings
English (EN) (108.09 KB - PDF)
Outcome report on pilot phase for participation of patient representatives in scientific advisory group (SAG) meetings
English (EN) (125.29 KB - PDF)
Reflection paper on the further involvement of patients and consumers in the Agency’s activities
English (EN) (286 KB - PDF)
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...
English (EN) (89.72 KB - PDF)
Proposal for involvement and participation of patients consumers representatives in the meetings of the Committee for Medicinal Products for Human Use Pharmacovigilance Working Party
English (EN) (57.85 KB - PDF)
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
English (EN) (112.88 KB - PDF)
European Medicines Agency/Committee for Medicinal Products for Human Use Working Group with Patients' Organisations - Outcome of discussions: Recommendations and proposals for action
English (EN) (183.01 KB - PDF)
European Medicines Agency/Committee for Proprietary Medicinal Products Working Group with Patients' Organisations - Outcome of discussions: Recommendations and proposals for action
English (EN) (164 KB - PDF)
Information on benefit-risk of medicines: patients', consumers' and healthcare professionals' expectations
English (EN) (308.72 KB - PDF)
Questions and answers on the CHMP review of the recommendations on the use of pandemic H1N1 vaccines
English (EN) (40.09 KB - PDF)
Pharmaceutical forum working group on information to patients: report on pillar II: statutory information on medicines
English (EN) (43.15 KB - PDF)