The EU pharmacovigilance system

Strategy to better protect public health by strengthening and rationalising EU pharmacovigilance

Commission Pharmacovigilance Strategy: results of public consultation on draft legislative proposals

The individual consultation responses can be found by clicking on the name of the stakeholder below

Patients and consumers

  1. The European Consumers' Organisation (BEUC) pdf(404 KB)
  2. European Patients Forum pdf(103 KB)
  3. European Cancer Patient Coalition (ECPC) pdf(20 KB)
  4. Rare Diseases Europe (EURORDIS) pdf(97 KB)
  5. European AIDS Treatment Group (EATG)pdf(47 KB)

Healthcare professionals and academics

  1. Standing Committee of European Doctors (CPME) pdf(54 KB)
  2. European Association of Hospital Pharmacists (EAHP) pdf(86 KB)
  3. The Pharmaceutical Group of the European Union (PGEU) pdf(377 KB)
  4. EuroPharm Forum pdf(35 KB)
  5. The European Council for Classical Homeopathy and the European Forum for Complementary and Alternative Medicine (ECCH and EFCAM) pdf(115 KB)
  6. Association Française des Centres régionaux de Pharmacovigilance pdf(157 KB)
  7. Federal Union of German Associations of Pharmacists (ABDA) pdf(277 KB)
  8. International Federation of Catholic Pharmacists pdf(63 KB)
  9. European Pharmaceutical Students Association (EPSA) pdf(53 KB)
  10. Maria Del Zompa and Raffaella Ardau, Section of Clinical Pharmacology, University of Cagliari, Italy pdf(228 KB)
  11. Céline Villier, Pharmacist, Grenoble Regional Pharmacovigilance Centre pdf(61 KB)
  12. Mondor Hospital, Assistance Public, Hôpitaux de Paris pdf(105 KB)
  13. Professor Saad Shakir, Director, Drug Safety Research Unit, Southampton, UK pdf(62 KB)
  14. Professor Stephen Evans, London School of Hygiene and Tropical Medicine (LSHTM) pdf(49 KB)
  15. Patrick Waller, Consultancy in Pharmacovigilance and Pharmacoepidemiology, UK pdf(119 KB)
  16. Professor DK Theo Raynor, Professor of Pharmacy Practice, University of Leeds, UKpdf(128 KB)

Regulators

  1. Co-ordination Group for Mutual Recognition and Decentralised Procedures - human of the European Medicines Agency (EMEA CMDh) pdf(38 KB)
  2. Pharmacovigilance Working Party of the European Medicines Agency (EMEA PhVWP) pdf(250 KB)
  3. Committee for Human Medicinal Products (EMEA CHMP)pdf(105 KB)
  4. 25A. European Medicines Agency (EMEA)pdf(136 KB)
    25B. European Medicines Agency (EMEA) pdf(306 KB)
  5. Maltese Government pdf(115 KB)
  6. Hungarian National Institute of Pharmacy pdf(111 KB)
  7. Austrian Medicines Agency (AGES) pdf(377 KB)
  8. Belgian Federal Agency for Medicines and Health Products (FAMHP) pdf(169 KB)
  9. French Government pdf(152 KB)
  10. German Federal Ministry of Health in consultation with the Federal Institute for Pharmaceutical and Medicinal Products and the Paul-Ehrlich Institute pdf(83 KB)
  11. Medicines Evaluation Board (Netherlands) and the Ministry of Health, Welfare and Sports (CBG/MEB) pdf(2 MB)
  12. Danish Medicines Agency (DKMA) pdf(2 MB)
  13. Italian National Pharmacovigilance Committee (AIFA) pdf(131 KB)
  14. UK Medicines and Healthcare products Regulatory Agency (MHRA) pdf(66 KB)
  15. Czech State Institute for Drug Control (SUKL) pdf(164 KB)
  16. The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of Polandpdf(98 KB)
  17. Infarmed I.P. pdf(89 KB)
  18. Medical Products Agency, Sweden. (MPA) pdf(593 KB)
  19. State Institute for Drug Control, Slovakia pdf(113 KB)
  20. Prof. dr. A.C. van Grootheest, Netherlands Pharmacovigilance Centre, Lareb, pdf(65 KB)
  21. Norwegian Medicines Agency pdf(3 MB)
  22. Patrick Salmon, Irish Medicines Board pdf(20 KB)
  23. Health Canada pdf(228 KB)
  24. Spanish Governmentpdf(4 MB)

Industry

  1. European Federation of Pharmaceutical Industries Associations (EFPIA) pdf(566 KB)
  2. Association of the European Self-Medication Industry (AESGP) pdf(69 KB)
  3. The European Generic Medicines Association (EGA) pdf(585 KB)
  4. European Biopharmaceutical Enterprises (EBE) pdf(133 KB)
  5. EuropaBio pdf(118 KB)
  6. European Vaccine Manufacturers (EVM) pdf(97 KB)
  7. European Association of Pharmaceutical Full-Line Wholesalers (GIRP) pdf(102 KB)
  8. European Coalition on Homeopathic and Anthroposophic Medicinal Products (ECHAMP)pdf(37 KB)
  9. The Association of the British Pharmaceutical Industry (ABPI) pdf(14 KB)
  10. German Pharmaceutical Industry Association (BPI)pdf(33 KB)
  11. Pharmaceutical Research and Manufacturers of America (PhRMA) pdf(197 KB)
  12. CSL Behring GmbH pdf(157 KB)
  13. Galpharm pdf(25 KB)
  14. GE Healthcare pdf(65 KB)
  15. Gurdyal Kalsi, MDS pharma services pdf(38 KB)
  16. 63A. Johnson and Johnson
    63B. Johnson and Johnson pdf(190 KB)
  17. Merck pdf(111 KB)
  18. Norvartis pdf(244 KB)
  19. Organon (Schering-Plough Corporationpdf(73 KB))
  20. Pfizer pdf(221 KB)
  21. Pharmiceutics LLC pdf(137 KB)
  22. PhytoLab GmbH & Co. KG pdf(112 KB)
  23. Reckitt Benckiser Healthcare pdf(47 KB)
  24. Combino Pharm pdf(20 KB)
  25. Wyeth Pharmaceuticals pdf(239 KB)
  26. Zentiva pdf(97 KB)
  27. Dr Wolfgang Matthies, Medical Consulting and Qualified Person of Pharmacovigilance for Ecolab Europe pdf(64 KB)
  28. Verband der Arzneimittelimporteure (VAD)pdf(93 KB)

Others

  1. Health Action International Europe + Medicines in Europe Forum + International Society of Drug Bulletins pdf(137 KB)
  2. European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) pdf(116 KB)
  3. Association Internationale de la Mutualité (AIM) pdf(22 KB)
  4. European Social Health Insurance Forum (Medicine Evaluation Committee) pdf(28 KB)
  5. European Pharmaceutical Law Group pdf(108 KB)
  6. International Network of Safe Medication Practice Centres (INSMPC)pdf(108 KB)