Key documents

  • Email
  • Help

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

Table of contents

Framework and related documents

Back to top

Document(s) Language Status First published Last updated Effective Date
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    
Brochure - Working with patients and consumers BG = bălgarski   09/11/2008 24/03/2011  
Brochure - Working with patients and consumers ES = español   09/11/2008 24/03/2011  
Brochure - Working with patients and consumers CS = čeština   09/11/2008 24/03/2011  
Brochure - Working with patients and consumers DA = dansk   09/11/2008 24/03/2011  
Brochure - Working with patients and consumers DE = Deutsch   09/11/2008 24/03/2011  
Brochure - Working with patients and consumers ET = eesti keel   09/11/2008 24/03/2011  
Brochure - Working with patients and consumers EL = elliniká   09/11/2008 24/03/2011  
Brochure - Working with patients and consumers EN = English   09/11/2008 24/03/2011  
Brochure - Working with patients and consumers FR = français   09/11/2008 24/03/2011  
Brochure - Working with patients and consumers IT = italiano   09/11/2008 24/03/2011  
Brochure - Working with patients and consumers LV = latviešu valoda   09/11/2008 24/03/2011  
Brochure - Working with patients and consumers LT = lietuvių kalba   09/11/2008 24/03/2011  
Brochure - Working with patients and consumers HU = magyar   09/11/2008 24/03/2011  
Brochure - Working with patients and consumers MT = Malti   09/11/2008 24/03/2011  
Brochure - Working with patients and consumers NL = Nederlands   09/11/2008 24/03/2011  
Brochure - Working with patients and consumers PL = polski   09/11/2008 24/03/2011  
Brochure - Working with patients and consumers PT = português   09/11/2008 24/03/2011  
Brochure - Working with patients and consumers RO = română   09/11/2008 24/03/2011  
Brochure - Working with patients and consumers SK = slovenčina   09/11/2008 24/03/2011  
Brochure - Working with patients and consumers SL = slovenščina   09/11/2008 24/03/2011  
Brochure - Working with patients and consumers FI = suomi   09/11/2008 24/03/2011  
Brochure - Working with patients and consumers SV = svenska   09/11/2008 24/03/2011  
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    
Framework on the interaction between the European Medicines Agency and patients' and consumers' organisations (English only) adopted 14/02/2006    

Annual progress reports

Back to top

Document(s) Language Status First published Last updated Effective Date
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

Back to top

Document(s) Language Status First published Last updated Effective Date
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 20/10/2011  
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 19/12/2011  
Glossary of terms and abbreviations for representatives of patients' and consumers' organisations (English only)   16/12/2010    

Recommendations and proposals for action

Back to top

Document(s) Language Status First published Last updated Effective Date
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    

Other documents of interest

Back to top

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    
Questions and answers on biosimilar medicines (similar biological medicinal products) ES = español   30/10/2008    
Questions and answers on biosimilar medicines (similar biological medicinal products) CS = čeština   30/10/2008    
Questions and answers on biosimilar medicines (similar biological medicinal products) DA = dansk   30/10/2008    
Questions and answers on biosimilar medicines (similar biological medicinal products) DE = Deutsch   30/10/2008    
Questions and answers on biosimilar medicines (similar biological medicinal products) ET = eesti keel   30/10/2008    
Questions and answers on biosimilar medicines (similar biological medicinal products) EL = elliniká   30/10/2008    
Questions and answers on biosimilar medicines (similar biological medicinal products) EN = English   30/10/2008    
Questions and answers on biosimilar medicines (similar biological medicinal products) FR = français   30/10/2008    
Questions and answers on biosimilar medicines (similar biological medicinal products) IT = italiano   30/10/2008    
Questions and answers on biosimilar medicines (similar biological medicinal products) LV = latviešu valoda   30/10/2008    
Questions and answers on biosimilar medicines (similar biological medicinal products) LT = lietuvių kalba   30/10/2008    
Questions and answers on biosimilar medicines (similar biological medicinal products) HU = magyar   30/10/2008    
Questions and answers on biosimilar medicines (similar biological medicinal products) MT = Malti   30/10/2008    
Questions and answers on biosimilar medicines (similar biological medicinal products) NL = Nederlands   30/10/2008    
Questions and answers on biosimilar medicines (similar biological medicinal products) PL = polski   30/10/2008    
Questions and answers on biosimilar medicines (similar biological medicinal products) PT = português   30/10/2008    
Questions and answers on biosimilar medicines (similar biological medicinal products) RO = română   30/10/2008    
Questions and answers on biosimilar medicines (similar biological medicinal products) SK = slovenčina   30/10/2008    
Questions and answers on biosimilar medicines (similar biological medicinal products) SL = slovenščina   30/10/2008    
Questions and answers on biosimilar medicines (similar biological medicinal products) FI = suomi   30/10/2008    
Questions and answers on biosimilar medicines (similar biological medicinal products) SV = svenska   30/10/2008    
Questions and answers on generic medicines BG = bălgarski   09/07/2007 29/03/2011  
Questions and answers on generic medicines ES = español   09/07/2007 29/03/2011  
Questions and answers on generic medicines CS = čeština   09/07/2007 29/03/2011  
Questions and answers on generic medicines DA = dansk   09/07/2007 29/03/2011  
Questions and answers on generic medicines DE = Deutsch   09/07/2007 29/03/2011  
Questions and answers on generic medicines ET = eesti keel   09/07/2007 29/03/2011  
Questions and answers on generic medicines EL = elliniká   09/07/2007 29/03/2011  
Questions and answers on generic medicines EN = English   09/07/2007 29/03/2011  
Questions and answers on generic medicines FR = français   09/07/2007 29/03/2011  
Questions and answers on generic medicines IT = italiano   09/07/2007 29/03/2011  
Questions and answers on generic medicines LV = latviešu valoda   09/07/2007 29/03/2011  
Questions and answers on generic medicines LT = lietuvių kalba   09/07/2007 29/03/2011  
Questions and answers on generic medicines HU = magyar   09/07/2007 29/03/2011  
Questions and answers on generic medicines MT = Malti   09/07/2007 29/03/2011  
Questions and answers on generic medicines NL = Nederlands   09/07/2007 29/03/2011  
Questions and answers on generic medicines PL = polski   09/07/2007 29/03/2011  
Questions and answers on generic medicines PT = português   09/07/2007 29/03/2011  
Questions and answers on generic medicines RO = română   09/07/2007 29/03/2011  
Questions and answers on generic medicines SK = slovenčina   09/07/2007 29/03/2011  
Questions and answers on generic medicines SL = slovenščina   09/07/2007 29/03/2011  
Questions and answers on generic medicines FI = suomi   09/07/2007 29/03/2011  
Questions and answers on generic medicines SV = svenska   09/07/2007 29/03/2011  
Pharmaceutical forum working group on information to patients: report on pillar II: statutory information on medicines (English only)   10/10/2006