Healthcare professionals: Key documents

The European Medicines Agency (EMA) makes available documents on key areas of the EMA's work with healthcare professionals.

Framework for interaction with healthcare professionals, and related documents

EMA / eligible healthcare professional organisations policy officers’ group (HCP POG) pilot: one-year review

Reference Number: EMA/26892/2022

Revised framework for interaction between the European Medicines Agency and healthcare professionals and their organisations

Reference Number: EMA/89918/2016

Revised framework for interaction between the European Medicines Agency and healthcare professionals Revised framework of interaction between EMA and healthcare professionals - Annex II - EMA activities where healthcare professionals are involved

Reference Number: EMA/677917/2016

Revised framework for interaction between the European Medicines Agency and healthcare professionals - Annex I – Action plan

Reference Number: EMA/705066/2016

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

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

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

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 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)

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.

Annual highlights

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

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

Reference Number: EMA/188551/2023 rev. 1

Early dialogue with healthcare professional organisations for marketing authorisation applications: 1-year report

Reference Number: EMA/225343/2024

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

Reference Number: EMA/698917/2017

Sample eligibility form - Healthcare professionals

• Training webinar for annual confirmation of eligibility
• Glossary of the main regulatory terms used on this website and in European Medicines Agency documents

Bilateral meetings with eligible organisations

• European Society of Cardiology (ESC) bilateral meeting

Archive

EMA consultation on the proposal of a collaboration framework with Academia

Reference Number: EMA/791692/2015

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

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

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

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

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

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.

Framework for interaction between the European Medicines Agency and healthcare professionals

Reference Number: EMA/688885/2010Summary:

This framework, as requested by the EMA Management Board, describes the objectives and the terms of reference for the Agency’s interaction with healthcare professionals in relation to medicines for human use.

Report from the first European Medicines Agency workshop with healthcare professional organisations

Reference Number: EMEA/124808/2006 corr.

European Medicines Agency / Committee for Medicinal Products for Human Use Working Group with Healthcare Professionals' Organisations (HCP WG) - Final recommendations and proposals for action

AdoptedReference Number: EMEA/185036/2008

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

Reference Number: EMEA/40926/2009

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

Reference Number: EMEA/109974/2006