Medicinal products for human use

Public consultation on draft legislative proposals to strengthen and rationalise the EU system of pharmacovigilance

Period of consultation

From 5 December 2007 to 1 February 2008.

Contributions to and results of the consultation

A summary of the responses is available here.

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' Organisation
  2. European Patients Forum
  3. ECPC - European Cancer Patient Coalition
  4. EURORDIS - Rare Diseases Europe
  5. EATG - European AIDS Treatment Group

Healthcare professionals and academics

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


  1. EMEA CMDh - Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human of the European Medicines Agency
  2. EMEA PhVWP - Pharmacovigilance Working Party of the European Medicines Agency
  3. EMEA CHMP - Committee for Human Medicinal Products
  4. EMEA - European Medicines Agency : [25a] - [25b]
  5. Maltese Government
  6. Hungarian National Institute of Pharmacy
  7. AGES - Austrian Medicines Agency
  8. FAMHP - Belgian Federal Agency for Medicines and Health Products
  9. French Government
  10. German Federal Ministry of Health in consultation with the Federal Institute for Pharmaceutical and Medicinal Products and the Paul-Ehrlich Institute
  11. CBG / MEB - Medicines Evaluation Board (the Netherlands) and the Ministry of Health, Welfare and Sports
  12. DKMA - Danish Medicines Agency
  13. AIFA - Italian National Pharmacovigilance Committee
  14. MHRA - UK Medicines and Healthcare products Regulatory Agency
  15. SUKL - Czech State Institute for Drug Control
  16. The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of Poland
  17. Infarmed I.P.
  18. MPA - Medical Products Agency (Sweden)
  19. State Institute for Drug Control (Slovakia)
  20. Prof. dr. A.C. van Grootheest, Netherlands Pharmacovigilance Centre, Lareb
  21. Norwegian Medicines Agency
  22. Patrick Salmon, Irish Medicines Board
  23. Health Canada
  24. Spanish Government


  1. EFPIA - European Federation of Pharmaceutical Industries Associations
  2. AESGP - Association of the European Self-Medication Industry
  3. EGA - The European Generic Medicines Association
  4. EBE - European Biopharmaceutical Enterprises
  5. EuropaBio
  6. EVM - European Vaccine Manufacturers
  7. GIRP - European Association of Pharmaceutical Full-Line Wholesalers
  8. ECHAMP - European Coalition on Homeopathic and Anthroposophic Medicinal Products
  9. ABPI - The Association of the British Pharmaceutical Industry
  10. BPI - German Pharmaceutical Industry Association
  11. PhRMA - Pharmaceutical Research and Manufacturers of America
  12. CSL Behring GmbH
  13. Galpharm
  14. GE Healthcare
  15. Gurdyal Kalsi, MDS pharma services
  16. Johnson and Johnson : [63a] - [63b]
  17. Merck
  18. Norvartis
  19. Organon (Schering-Plough Corporation)
  20. Pfizer
  21. Pharmiceutics LLC
  22. PhytoLab GmbH & Co. KG
  23. Reckitt Benckiser Healthcare
  24. Combino Pharm
  25. Wyeth Pharmaceuticals
  26. Zentiva
  27. Dr Wolfgang Matthies, Medical Consulting and Qualified Person of Pharmacovigilance for Ecolab Europe
  28. VAD - Verband der Arzneimittelimporteure


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

The consultation document

The consultation document can be downloaded here.

Protection of personal data

The policy on "protection of individuals with regard to the processing of personal data by the Community institutions" is based on Regulation (EC) N° 45/2001 of the European Parliament and of the Council of 18 December 2000. More information is available here.

Additional information: