Strategy to better protect public health by strengthening and rationalising EU pharmacovigilance - Responses to the public consultation on draft legislative proposals

These are the responses for the second part of the consultation conducted between 5 December 2007 and 1 February 2008.

To aid analysis, where joint responses were received from more than one organisation falling within the same stakeholder group these responses were counted only once. In contrast, if joint responses were received from organisations falling within different stakeholder groups these were counted separately.

In the list of individual responses provided below the number corresponds to the numbers listed against specific comments in Annex 1 of the summary of the consultation responses.

Below are the public responses to the above-mentioned public consultation.

Patients and consumers

  1. BEUC - The European Consumers' Organisationpdf(404 KB)
  2. European Patients Forumpdf(103 KB)
  3. ECPC - European Cancer Patient Coalitionpdf(20 KB)
  4. EURORDIS - Rare Diseases Europepdf(97 KB)
  5. EATG - European AIDS Treatment Grouppdf(47 KB)

Healthcare professionals and academics

  1. CPME - Standing Committee of European Doctorspdf(54 KB)
  2. EAHP - European Association of Hospital Pharmacistspdf(86 KB)
  3. PGEU - The Pharmaceutical Group of the European Unionpdf(377 KB)
  4. EuroPharm Forumpdf(35 KB)
  5. ECCH and EFCAM - The European Council for Classical Homeopathy and the European Forum for Complementary and Alternative Medicinepdf(115 KB)
  6. Association Française des Centres régionaux de Pharmacovigilancepdf(157 KB)
  7. ABDA - Federal Union of German Associations of Pharmacistspdf(277 KB)
  8. International Federation of Catholic Pharmacistspdf(63 KB)
  9. EPSA - European Pharmaceutical Students Associationpdf(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 Centrepdf(61 KB)
  12. Mondor Hospital, Assistance Public, Hôpitaux de Parispdf(105 KB)
  13. Professor Saad Shakir, Director, Drug Safety Research Unit, Southampton (UK)pdf(62 KB)
  14. LSHTM - Professor Stephen Evans, London School of Hygiene and Tropical Medicinepdf(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 (UK)pdf(128 KB)


  1. EMEA CMDh - Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human of the European Medicines Agencypdf(38 KB)
  2. EMEA PhVWP - Pharmacovigilance Working Party of the European Medicines Agencypdf(250 KB)
  3. EMEA CHMP - Committee for Human Medicinal Productspdf(105 KB)
  4. EMEA - European Medicines Agency : [25a]pdf(136 KB) - [25b]pdf(306 KB)
  5. Maltese Governmentpdf(115 KB)
  6. Hungarian National Institute of Pharmacypdf(111 KB)
  7. AGES - Austrian Medicines Agencypdf(377 KB)
  8. FAMHP - Belgian Federal Agency for Medicines and Health Productspdf(169 KB)
  9. French Governmentpdf(152 KB)
  10. German Federal Ministry of Health in consultation with the Federal Institute for Pharmaceutical and Medicinal Products and the Paul-Ehrlich Institutepdf(83 KB)
  11. CBG / MEB - Medicines Evaluation Board (the Netherlands) and the Ministry of Health, Welfare and Sportspdf(2 MB)
  12. DKMA - Danish Medicines Agencypdf(2 MB)
  13. AIFA - Italian National Pharmacovigilance Committeepdf(131 KB)
  14. MHRA - UK Medicines and Healthcare products Regulatory Agencypdf(66 KB)
  15. SUKL - Czech State Institute for Drug Controlpdf(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. MPA - Medical Products Agency (Sweden)pdf(593 KB)
  19. State Institute for Drug Control (Slovakia)pdf(113 KB)
  20. Prof. dr. A.C. van Grootheest, Netherlands Pharmacovigilance Centre, Larebpdf(65 KB)
  21. Norwegian Medicines Agencypdf(3 MB)
  22. Patrick Salmon, Irish Medicines Boardpdf(20 KB)
  23. Health Canadapdf(228 KB)
  24. Spanish Governmentpdf(4 MB)


  1. EFPIA - European Federation of Pharmaceutical Industries Associationspdf(566 KB)
  2. AESGP - Association of the European Self-Medication Industrypdf(69 KB)
  3. EGA - The European Generic Medicines Associationpdf(585 KB)
  4. EBE - European Biopharmaceutical Enterprisespdf(133 KB)
  5. EuropaBiopdf(118 KB)
  6. EVM - European Vaccine Manufacturerspdf(97 KB)
  7. GIRP - European Association of Pharmaceutical Full-Line Wholesalerspdf(102 KB)
  8. ECHAMP - European Coalition on Homeopathic and Anthroposophic Medicinal Productspdf(37 KB)
  9. ABPI - The Association of the British Pharmaceutical Industrypdf(14 KB)
  10. BPI - German Pharmaceutical Industry Associationpdf(33 KB)
  11. PhRMA - Pharmaceutical Research and Manufacturers of Americapdf(197 KB)
  12. CSL Behring GmbHpdf(157 KB)
  13. Galpharmpdf(25 KB)
  14. GE Healthcarepdf(65 KB)
  15. Gurdyal Kalsi, MDS pharma servicespdf(38 KB)
  16. Johnson and Johnson : [63a]pdf(107 KB) - [63b]pdf(190 KB)
  17. Merckpdf(111 KB)
  18. Norvartispdf(244 KB)
  19. Organon (Schering-Plough Corporation)pdf(73 KB)
  20. Pfizerpdf(221 KB)
  21. Pharmiceutics LLCpdf(137 KB)
  22. PhytoLab GmbH & Co. KGpdf(112 KB)
  23. Reckitt Benckiser Healthcarepdf(47 KB)
  24. Combino Pharmpdf(20 KB)
  25. Wyeth Pharmaceuticalspdf(239 KB)
  26. Zentivapdf(97 KB)
  27. Dr Wolfgang Matthies, Medical Consulting and Qualified Person of Pharmacovigilance for Ecolab Europepdf(64 KB)
  28. VAD - Verband der Arzneimittelimporteurepdf(93 KB)


  1. Health Action International Europe + Medicines in Europe Forum + International Society of Drug Bulletinspdf(137 KB)
  2. EMCDDA - European Monitoring Centre for Drugs and Drug Addictionpdf(116 KB)
  3. AIM - Association Internationale de la Mutualitépdf(22 KB)
  4. European Social Health Insurance Forum - Medicine Evaluation Committeepdf(28 KB)
  5. European Pharmaceutical Law Grouppdf(108 KB)
  6. INSMPC - International Network of Safe Medication Practice Centrespdf(2 MB)

Additional information: