Patients and consumers: Key documents

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

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

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

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

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

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

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

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

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

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

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

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

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...

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

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

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...

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

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

Pilot phase for CHMP early contact with patient / consumer organisations

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

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

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

Sample eligibility form - Patients and consumers

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

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

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

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

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

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

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

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

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...

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

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

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

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

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

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

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