Medicinal products for human use
Public consultation on the concept paper on implementing measures for the performance of pharmacovigilance activities
Period of consultation
From 8 September 2011 to 7 November 2011.
Contributions to and results of the consultation
A summary of the responses is available here.
Below are the public responses to the above-mentioned public consultation:
- abpi - Association of the British Pharmaceutical Industry
- AEFI - Spanish Association of Industrial Pharmacists
- AEMPS - Agencia Española de Medicamentos y Productos Sanitarios
- AESGP - Association Européenne des Spécialités Pharmaceutiques Grand Public / Association of the European Self-Medication Industry
- Aptalis Pharma Canada Inc.
- BARQA - The Research Quality Association
- Bausch + Lomb
- Vittorio Bertele & Silvio Garattini
- BEUC - the European Consumers' Organisation
- BHBIA - The British Healthcare Business Intelligence Association
- BIA - UK BioIndustry Association
- Laboratoire BIODIM
- BPI - Bundesverband der Pharmazeutischen Industrie e.v.
- CEFAR – Centre for Health Centre for Health Evaluation & Research
- Celgene Corporation
- Chugai Pharma UK LTD.
- CIPH - International Committee of Homeopathic Pharmacists
- COSTEFF - Alliance for cost-efficiency in healthcare
- DDCS - Drug Development Consulting Services S.A.
- DADA Consultancy B.V.
- Danish Medicines Agency
- EAEPC - European Association of Euro-Pharmaceutical Companies
- ECHAMP - European Coalition on Homeopathic and Anthroposophic Medicinal
- EFPIA - European Federation of Pharmaceutical Industries and Associations
- EGA – European Generic medicines Association
- EMA - European Medicines Agency
- EPDA - European Parkinson's Disease Association
- EphMRA - European Pharmaceutical Market Research Association
- EUCOPE - European Confederation of Pharmaceutical Entrepreneurs
- EuropaBio - European Association for Bioindustries
- FAMHP - Federal Agency for Medicines and Health Products (Belgium)
- GCP Records Managers Association
- Gilead Sciences International Limited
- F. Hoffmann – La Roche Ltd.
- IBA Pharma S.A. - CIS bio international
- ISDB - International Society of Drug Bulletins
- Janssen-Cilag NV/SA
- Karolinska Institutet
- KEPKA - Consumers Protection Center
- Lareb - Netherlands Pharmacovigilance Centre
- Maltese Medicines Authority
- Medwork Pharma Research and Consulting
- MHRA - Medicines and Healthcare products Regulatory Agency
- Merck Sharp & Dohme (Europe) Inc.
- Novo Nordisk A/S
- PEI - Paul-Ehrlich-Institut
- PGEU - Pharmaceutical Group of the European Union
- PHARMIG - Association of the Austrian pharmaceutical industry
- Evelyne PIERRON Consultants
- Office for Registration (Poland)
- PPTA - Plasma Protein Therapeutics Association
- Dr Reddy's
- Jean-Claude Roujeau M.D.
- Raimondo Russo M.D.
- Dr Sameer Shah
- Sanofi Pasteur MSD Ltd
- Takeda Pharma GmbH
- UMC- Uppsala Monitoring Centre
- Bert Van Leeuwen M.D. :  - 
All citizens and organisations (public and private) are welcome to contribute to this consultation.
Objective of the consultation
In order to harmonise the performance of the new pharmacovigilance activities introduced by the amended pharmacovigilance legislation (cf. Regulation (EU) No 1235/2010 and Directive 2010/84/EU) the Commission shall adopt several implementing measures. Those measures supplement essential details of the new pharmacovigilance system with the more technical details that have to be observed by marketing authorisation holders, national competent authorities and the European Medicines Agency in the daily practice of applying the new provisions.
With the public consultation the European Commission intends to describe the scope and content of the implementing measure which it is currently considering and seeks views and feedback from stakeholders on those issues.
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.
Specific privacy statement
Please consult the Privacy Statement to be downloaded here.