Key documents
The European Medicines Agency (EMA) makes available documents on key areas of the EMA's work with patients and careers and their organisations.
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Engagement framework: European Medicines Agency and patients, consumers and their organisations (PDF/768.25 KB)
Adopted
First published: 14/02/2006
Last updated: 07/02/2022 -
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Rules of engagement for patients’ organisations and their representatives in repurposing activities and impact on involvement in EMA activities (PDF/144.6 KB)
First published: 06/07/2020 -
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Criteria to be fulfilled by patient, consumer and healthcare professional organisations involved in European Medicines Agency (EMA) activities (PDF/90.76 KB)
First published: 07/02/2005
Last updated: 11/06/2018
EMA/MB/24913/2005 Rev.3 -
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Principles on the involvement of young patients/consumers within EMA activities (PDF/441.52 KB)
Adopted
First published: 19/07/2017
Last updated: 19/07/2017
EMA/494077/2016 -
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Outcome Report on Pilot to involve patients in benefit/risk discussions at CHMP meetings (PDF/180.88 KB)
First published: 08/05/2017
Last updated: 08/05/2017
EMA/191955/2017 -
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The role of members representing patients' and healthcare professionals' organisations on EMA scientific committees (PDF/282.11 KB)
First published: 19/12/2011
Last updated: 28/10/2019
EMA/351699/2018
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Stakeholder engagement report 2020-2021 (PDF/984.93 KB)
First published: 02/05/2022
Last updated: 10/05/2022 -
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Stakeholder engagement report 2018-2019 (PDF/2.3 MB)
First published: 21/12/2020 -
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Stakeholder engagement report 2017 (PDF/4.46 MB)
First published: 27/06/2018
Last updated: 27/06/2018 -
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Annexes - Stakeholder engagement annual report 2017 (PDF/448.84 KB)
First published: 27/06/2018
Last updated: 27/06/2018 -
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European Medicines Agency’s interaction with patients, consumers, healthcare professionals and their organisations - Annual report 2016 (PDF/1.99 MB)
First published: 16/06/2017
Last updated: 16/06/2017
EMA/260003/2016 -
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European Medicines Agency’s interaction with patients, consumers, healthcare professionals and their organisations - Annual report 2015 (PDF/1.23 MB)
First published: 21/06/2016
Last updated: 21/06/2016
EMA/727872/2015 -
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Consolidated final report on the activities of patients’ and consumers’ working party and healthcare professionals’ working party topic groups (2015) (PDF/568.38 KB)
First published: 30/05/2017
Last updated: 30/05/2017
EMA/225307/2017 -
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Annual report on European Medicines Agency’s interaction with patients, consumers, healthcare professionals and their organisations (2014) (PDF/1.34 MB)
Adopted
First published: 06/10/2015
Last updated: 06/10/2015
EMA/9496/2015 -
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Annual report on European Medicines Agency’s interaction with patients, consumers, healthcare professionals and their organisations (2013) (PDF/706.93 KB)
Adopted
First published: 08/10/2014
Last updated: 08/10/2014
EMA/103410/2014 -
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Sixth annual report on the interaction with patients' and consumers' organisations (2012) (PDF/482.93 KB)
Adopted
First published: 17/12/2013
Last updated: 17/12/2013
EMA/272219/2013 -
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Fifth report on the interaction with patients' and consumers' organisations (2011) (PDF/305.09 KB)
Adopted
First published: 10/10/2012
Last updated: 10/10/2012
EMA/507517/2012 -
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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... (PDF/322.55 KB)
Adopted
First published: 20/10/2011
Last updated: 20/10/2011
EMA/MB/632696/2011 -
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Third report on the progress of the interaction with patients' and consumers' organisations during 2009 (PDF/256.67 KB)
Adopted
First published: 22/11/2010
Last updated: 22/11/2010
EMA/MB/117170/2010 -
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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 (PDF/949.15 KB)
Adopted
First published: 01/10/2009
Last updated: 01/10/2009
EMEA/259449/2009 -
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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... (PDF/375.36 KB)
Adopted
First published: 07/02/2008
Last updated: 07/02/2008
EMEA/478814/2007
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Stakeholder engagement highlights 2021 (PDF/127.69 KB)
First published: 03/05/2022 -
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Stakeholder engagement highlights 2020 (PDF/384.49 KB)
First published: 19/04/2021 -
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Stakeholder engagement highlights 2019 (PDF/619.88 KB)
First published: 11/06/2020 -
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Stakeholder engagement highlights 2018 (PDF/963.97 KB)
First published: 11/06/2020 -
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Stakeholder engagement highlights 2017 (PDF/852.64 KB)
First published: 11/06/2020 -
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Stakeholder engagement highlights 2016 (PDF/839.32 KB)
First published: 11/06/2020
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Pilot phase for CHMP early contact with patient / consumer organisations (PDF/145.21 KB)
First published: 19/02/2021
EMA/97615/20212021 -
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Pilot on early dialogue with patient organisations for orphan marketing authorisation applications: Outcome Report (PDF/442.63 KB)
First published: 12/10/2022
EMA/665019/2022 -
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Assessment of patient, consumer and healthcare professional organisations’ compliance with EMA eligibility criteria (PDF/246.4 KB)
First published: 11/06/2018
Last updated: 07/10/2022
EMA/698917/2017 -
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Involvement of patients in scientific advice procedures at the European Medicines Agency (PDF/718.15 KB)
First published: 23/08/2013
Last updated: 19/10/2021 -
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Involvement of patients in Scientific Advisory Group and Ad Hoc Expert meetings at EMA (PDF/701.2 KB)
First published: 26/03/2015
Last updated: 19/10/2021 -
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Training manual - Review of European Medicines Agency documents addressed to the general public by patients and consumers (PDF/169.56 KB)
First published: 04/05/2010
Last updated: 23/01/2014
EMA/115803/2007 Rev. 5 -
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Sample eligibility form - Patients and consumers (PDF/731.85 KB)
First published: 10/07/2018
Last updated: 10/07/2018
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Standard operating procedure for evaluation procedure for eligibility of patients', consumers' and healthcare professionals’ organisations (PDF/174.64 KB)
Adopted
First published: 04/02/2013
Last updated: 17/03/2015
Legal effective date: 13/03/2015
SOP/H/3390 -
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Standard operating procedure for re-evaluation and financial re-assessment procedures for eligible patients', consumers' and healthcare professionals’ organisations (PDF/218.8 KB)
Adopted
First published: 04/02/2013
Last updated: 17/03/2015
Legal effective date: 13/03/2015
SOP/H/3417 -
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Rules of involvement of members of patients' and/or consumers' and healthcare professionals' organisations in committee related activities (PDF/54.57 KB)
Adopted
First published: 13/02/2009
Last updated: 13/02/2009
EMEA/483439/2008 rev. 1 -
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Procedure for review of information on medicinal products by patients' and consumers' organisations (PDF/112.14 KB)
First published: 24/11/2008
Last updated: 11/05/2010
EMA/174255/2010 Rev. 2 -
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Incorporating patients' views during evaluation of benefit-risk by the European Medicines Agency scientific committees (PDF/178.54 KB)
First published: 26/09/2014
Last updated: 24/10/2014
EMA/413422/2013 Rev1 -
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Pilot phase to involve patients in benefit / risk discussions at CHMP meetings (PDF/108.09 KB)
First published: 26/09/2014
Last updated: 24/10/2014
EMA/372554/2014 Rev1 -
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Outcome report on pilot phase for participation of patient representatives in scientific advisory group (SAG) meetings (PDF/125.29 KB)
Adopted
First published: 15/12/2011
Last updated: 15/12/2011
EMA/850028/2011 -
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Reflection paper on the further involvement of patients and consumers in the Agency’s activities (PDF/286 KB)
Adopted
First published: 17/12/2009
Last updated: 17/12/2009
EMA/MB/753771/2009 -
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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... (PDF/89.72 KB)
Adopted
First published: 10/12/2009
Last updated: 10/12/2009
EMA/355206/2009 -
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Proposal for involvement and participation of patients consumers representatives in the meetings of the Committee for Medicinal Products for Human Use Pharmacovigilance Working Party (PDF/57.85 KB)
First published: 11/03/2009
Last updated: 11/03/2009
EMEA/261645/2008Endorsed -
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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 (PDF/112.88 KB)
First published: 18/03/2005
Last updated: 18/03/2005
EMEA/18153/2005 Final -
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European Medicines Agency/Committee for Medicinal Products for Human Use Working Group with Patients' Organisations - Outcome of discussions: Recommendations and proposals for action (PDF/183.01 KB)
Adopted
First published: 17/03/2005
Last updated: 17/03/2005
EMEA/149479/2004 Final -
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European Medicines Agency/Committee for Proprietary Medicinal Products Working Group with Patients' Organisations - Outcome of discussions: Recommendations and proposals for action (PDF/164 KB)
First published: 20/04/2004
Last updated: 20/04/2004
EMEA/CPMP/5819/04 -
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Information on benefit-risk of medicines: patients', consumers' and healthcare professionals' expectations (PDF/308.72 KB)
First published: 10/07/2009
Last updated: 10/07/2009
EMEA/40926/2009 -
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Questions and answers on the CHMP review of the recommendations on the use of pandemic H1N1 vaccines (PDF/40.09 KB)
First published: 23/10/2009
Last updated: 23/10/2009
EMEA/666809/2009 -
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Pharmaceutical forum working group on information to patients: report on pillar II: statutory information on medicines (PDF/43.15 KB)
First published: 10/10/2006
Last updated: 10/10/2006
EMEA/109974/2006