Key documents

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This page contains documents on key areas of the Agency's work with patients and consumers.

 

Table of contents


Framework and related documents

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Document(s) Language Status First published Last updated Effective Date
Incorporating patients' views during evaluation of benefit-risk by the European Medicines Agency scientific committees (English only)   26/09/2014 24/10/2014  
Pilot phase to involve patients in benefit / risk discussions at CHMP meetings (English only)   26/09/2014 24/10/2014  
The role of patients as members of the European Medicines Agency human scientific committees (English only)   19/12/2011    
Outcome report on pilot phase for participation of patient representatives in scientific advisory group (SAG) meetings (English only) adopted 15/12/2011    
Working with patients and consumers (English only)   09/11/2008 22/04/2015  
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    
Revised framework on the interaction between the European Medicines Agency and patients' and consumers' and their organisations (English only) adopted 14/02/2006 22/12/2014  
Revised framework for interaction between the European Medicines Agency and patients and consumers and their organisations: Annex I – Action plan (English only)   22/12/2014    
Revised framework for interaction between the European Medicines Agency and patients and consumers and their organisations: Annex II - EMA activities where patients and consumers are involved (English only)   22/12/2014    

Annual reports

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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    
Guidance for implementation of eligibility requirements (English only)   20/05/2015    
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  

Recommendations and proposals for action

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Training and support

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Other documents of interest

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Document(s) Language Status First published Last updated Effective Date
Information on benefit-risk of medicines: patients', consumers' and healthcare professionals' expectations (English only)   10/07/2009    
Questions and answers on biosimilar medicines (similar biological medicinal products) BG = bălgarski   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) ES = español   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) CS = čeština   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) DA = dansk   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) DE = Deutsch   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) ET = eesti keel   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) EL = elliniká   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) EN = English   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) FR = français   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) IT = italiano   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) LV = latviešu valoda   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) LT = lietuvių kalba   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) HU = magyar   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) MT = Malti   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) NL = Nederlands   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) PL = polski   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) PT = português   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) RO = română   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) SK = slovenčina   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) SL = slovenščina   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) FI = suomi   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) SV = svenska   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) HR = Hrvatski   30/10/2008 28/09/2012  
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  
Pharmaceutical forum working group on information to patients: report on pillar II: statutory information on medicines (English only)   10/10/2006