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

Public health community

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

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

Regulators

22. EMEA CMDh - Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human of the European Medicines Agency
23. EMEA PhVWP - Pharmacovigilance Working Party of the European Medicines Agency
24. EMEA CHMP - Committee for Human Medicinal Products
25. EMEA - European Medicines Agency : [25a] - [25b]
26. Maltese Government
27. Hungarian National Institute of Pharmacy
28. AGES - Austrian Medicines Agency
29. FAMHP - Belgian Federal Agency for Medicines and Health Products
30. French Government
31. German Federal Ministry of Health in consultation with the Federal Institute for Pharmaceutical and Medicinal Products and the Paul-Ehrlich Institute
32. CBG / MEB - Medicines Evaluation Board (the Netherlands) and the Ministry of Health, Welfare and Sports
33. DKMA - Danish Medicines Agency
34. AIFA - Italian National Pharmacovigilance Committee
35. MHRA - UK Medicines and Healthcare products Regulatory Agency
36. SUKL - Czech State Institute for Drug Control
37. The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of Poland
38. Infarmed I.P.
39. MPA - Medical Products Agency (Sweden)
40. State Institute for Drug Control (Slovakia)
41. Prof. dr. A.C. van Grootheest, Netherlands Pharmacovigilance Centre, Lareb
42. Norwegian Medicines Agency
43. Patrick Salmon, Irish Medicines Board
44. Health Canada
45. Spanish Government

Industry

48. EFPIA - European Federation of Pharmaceutical Industries Associations
49. AESGP - Association of the European Self-Medication Industry
50. EGA - The European Generic Medicines Association
51. EBE - European Biopharmaceutical Enterprises
52. EuropaBio
53. EVM - European Vaccine Manufacturers
54. GIRP - European Association of Pharmaceutical Full-Line Wholesalers
55. ECHAMP - European Coalition on Homeopathic and Anthroposophic Medicinal Products
56. ABPI - The Association of the British Pharmaceutical Industry
57. BPI - German Pharmaceutical Industry Association
58. PhRMA - Pharmaceutical Research and Manufacturers of America
59. CSL Behring GmbH
60. Galpharm
61. GE Healthcare
62. Gurdyal Kalsi, MDS pharma services
63. Johnson and Johnson : [63a] - [63b]
64. Merck
65. Norvartis
66. Organon (Schering-Plough Corporation)
67. Pfizer
68. Pharmiceutics LLC
69. PhytoLab GmbH & Co. KG
70. Reckitt Benckiser Healthcare
71. Combino Pharm
72. Wyeth Pharmaceuticals
73. Zentiva
74. Dr Wolfgang Matthies, Medical Consulting and Qualified Person of Pharmacovigilance for Ecolab Europe
75. VAD - Verband der Arzneimittelimporteure

Others

77. Health Action International Europe + Medicines in Europe Forum + International Society of Drug Bulletins
78. EMCDDA - European Monitoring Centre for Drugs and Drug Addiction
79. AIM - Association Internationale de la Mutualité
80. European Social Health Insurance Forum - Medicine Evaluation Committee
81. European Pharmaceutical Law Group
82. 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:

• Pharmacovigilance
• Pharmacovigilance - Major developments