Key documents

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The European Medicines Agency (EMA) makes available documents on key areas of the EMA's work with patients and careers and their organisations.

Table of contents


Framework and related documents

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Annual reports

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Document(s) Language Status First published Last updated Effective Date
Annual report on European Medicines Agency’s interaction with patients, consumers, healthcare professionals and their organisations (2014) (English only) adopted 06/10/2015    
Annual report on European Medicines Agency’s interaction with patients, consumers, healthcare professionals and their organisations (2013) (English only) adopted 08/10/2014    
Sixth annual report on the interaction with patients' and consumers' organisations (2012) (English only) adopted 17/12/2013    
Fifth report on the interaction with patients' and consumers' organisations (2011) (English only) adopted 10/10/2012    
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 activities during 2010 (English only) adopted 20/10/2011    
Third report on the progress of the interaction with patients' and consumers' organisations during 2009 (English only) adopted 22/11/2010    
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 (English only) adopted 01/10/2009    
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 2007 (English only) adopted 07/02/2008    

Guidance for involvement

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Document(s) Language Status First published Last updated Effective Date
Standard operating procedure for evaluation procedure for eligibility of patients', consumers' and healthcare professionals’ organisations (English only) adopted 04/02/2013 17/03/2015 13/03/2015
Standard operating procedure for re-evaluation and financial re-assessment procedures for eligible patients', consumers' and healthcare professionals’ organisations (English only) adopted 04/02/2013 17/03/2015 13/03/2015
Practical information for patients visiting the European Medicines Agency (English only)   26/03/2015 11/02/2016  
Guidance for implementation of eligibility requirements (English only)   20/05/2015 20/05/2016  
Rules of involvement of members of patients' and/or consumers' and healthcare professionals' organisations in committee related activities (English only) adopted 12/02/2009    
Criteria to be fulfilled by patients’ and consumers’ organisations involved in European Medicines Agency activities (English only)   06/02/2005 19/06/2014  
Evaluation of financial information from patients’ consumers’ and healthcare professionals’ organisations for assessment of EMA ‘eligibility’ (English only)   19/06/2014 24/09/2014  
Procedure for review of information on medicinal products by patients' and consumers' organisations (English only)   24/11/2008 11/05/2010  
Training manual - Review of European Medicines Agency documents addressed to the general public by patients and consumers (English only)   04/05/2010 23/01/2014  

Archive

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Document(s) Language Status First published Last updated Effective Date
Outcome report on pilot phase for participation of patient representatives in scientific advisory group (SAG) meetings (English only) adopted 15/12/2011    
Outcome report on pilot phase for participation of patient representatives in scientific advisory group (SAG) meetings (English only) adopted 15/12/2011    
Reflection paper on the further involvement of patients and consumers in the Agency’s activities (English only) adopted 17/12/2009    
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’ representatives as observer to the PhVWP (English only) adopted 09/12/2009    
Proposal for involvement and participation of patients consumers representatives in the meetings of the Committee for Medicinal Products for Human Use Pharmacovigilance Working Party (English only)   11/03/2009    
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 only)   18/03/2005    
European Medicines Agency/Committee for Medicinal Products for Human Use Working Group with Patients' Organisations - Outcome of discussions: Recommendations and proposals for action (English only) adopted 17/03/2005    
European Medicines Agency/Committee for Proprietary Medicinal Products Working Group with Patients' Organisations - Outcome of discussions: Recommendations and proposals for action (English only)   20/04/2004    
Information on benefit-risk of medicines: patients', consumers' and healthcare professionals' expectations (English only)   10/07/2009    
Questions and answers on generic medicines BG = bălgarski   09/07/2007 07/12/2012  
Questions and answers on generic medicines ES = español   09/07/2007 07/12/2012  
Questions and answers on generic medicines CS = čeština   09/07/2007 07/12/2012  
Questions and answers on generic medicines DA = dansk   09/07/2007 07/12/2012  
Questions and answers on generic medicines DE = Deutsch   09/07/2007 07/12/2012  
Questions and answers on generic medicines ET = eesti keel   09/07/2007 07/12/2012  
Questions and answers on generic medicines EL = elliniká   09/07/2007 07/12/2012  
Questions and answers on generic medicines EN = English   09/07/2007 07/12/2012  
Questions and answers on generic medicines FR = français   09/07/2007 07/12/2012  
Questions and answers on generic medicines IT = italiano   09/07/2007 07/12/2012  
Questions and answers on generic medicines LV = latviešu valoda   09/07/2007 07/12/2012  
Questions and answers on generic medicines LT = lietuvių kalba   09/07/2007 07/12/2012  
Questions and answers on generic medicines HU = magyar   09/07/2007 07/12/2012  
Questions and answers on generic medicines MT = Malti   09/07/2007 07/12/2012  
Questions and answers on generic medicines NL = Nederlands   09/07/2007 07/12/2012  
Questions and answers on generic medicines PL = polski   09/07/2007 07/12/2012  
Questions and answers on generic medicines PT = português   09/07/2007 07/12/2012  
Questions and answers on generic medicines RO = română   09/07/2007 07/12/2012  
Questions and answers on generic medicines SK = slovenčina   09/07/2007 07/12/2012  
Questions and answers on generic medicines SL = slovenščina   09/07/2007 07/12/2012  
Questions and answers on generic medicines FI = suomi   09/07/2007 07/12/2012  
Questions and answers on generic medicines SV = svenska   09/07/2007 07/12/2012  
Questions and answers on generic medicines HR = Hrvatski   09/07/2007 07/12/2012  
Questions and answers on the CHMP review of the recommendations on the use of pandemic H1N1 vaccines (English only)   23/10/2009    
Pharmaceutical forum working group on information to patients: report on pillar II: statutory information on medicines (English only)   10/10/2006