Details
- Status
- Closed
- Opening date
- Deadline
- Department
- Directorate-General for Health and Food Safety
Target audience
Public health community
Why we are consulting
Period of consultation
From 17 June 2010 to 10 September 2010.
Contributions to and results of the consultation
One submitting party (Actavis) requested not to publish its submission.
Below are the public responses to the above-mentioned public consultation:
- Accovion
- AESGP - Association of the European Self-Medication Industry
- Afssaps - Agence française de sécurité sanitaire des produits de santé
- Association of British Neurologists
- BfArM - Federal Institute for Drugs and Medical Devices
- Biogen Idec
- Bristol-Myers Squibb
- Cancer Research UK
- Centre for Clinical Intervention Research - Copenhagen Trial Unit
- Copenhagen University GCP-Unit
- CTFG - Clinical Trial Facilitation Group
- EFPIA - European Federation of Pharmaceutical Industries and Associations
- Elan Pharma International Ltd
- EMA - European Medicines Agency : [1] - [2]
- EORTC
- EQAC - European Quality Assurance Confederation
- EUCROF - European CRO Federation
- EuropaBio - The European Association for Bioindustries
- ESR - European Society of Radiology
- Gilead Sciences International Limited
- medac GmbH, Germany
- Merck Sharp & Dohme
- MHRA - Medicines and Healthcare Products Regulatory Agency
- Mundipharma Research Ltd
- NHS - National Health Service
- Norgine Ltd
- Novartis Pharmaceuticals
- Pfizer
- REVISE – Groupe de Reflexion sur la Vigilance et la Securité des Essais
- Hoffmann-La-Roche, Basel
- Royal College of Physicians
- Les Laboratoires Servier
- SGS - Life Science Services
- Takeda Pharma GmbH
- UCR - Uppsala Clinical Research Center
- University of Oxford : [1] - [2]
Targeted stakeholders
All stakeholders are invited to comment. Stakeholders who are not established within the European Union are likewise invited to comment.
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.