Outcome of the public consultation on the review of Regulation (EC) 1234/2008
This page lists all the contributors to the public consultation who provided comments on the "Review of Regulation EC 1234/2008". In total, 43 contributions were received.
A summary of the responses is available here.
Below are the public responses to the above-mentioned public consultation.
National authorities (14 contributions)
- Belgium FAGG-AFMPS Federal Agency for Medicines and Health Products
- Czech Republic Institute for State Control of Veterinary Biologicals and Medicaments
- Czech Republic State Institute for Drug Control and Ministry of Health
- Denmark Ministry of Health
- France Agence Nationale du Médicament Vétérinaire
- Germany BfArM PEI BVL
- Hungary Ministry of National Resources
- Italy Ministerio della Salute Dipartimento della Sanità Pubblica Veterinaria
- Lithuania States Medicines Control Agency
- Netherlands Ministry of Economic Affairs, Agriculture and Innovation
- Poland The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
- Spain AGEMED
- UK MHRA
- VMD - UK Veterinary Medicines Directorate
Industry (24 contributions)
Associations (14 contributions)
- AESGP – Association of the European Self-Medication Industry
- APIC – Active Pharmaceutical Ingredients Committee
- APREFAR – Portuguese Regulatory Professionals Association
- BPI – German Pharmaceutical Industry Association
- EAEPC – European Association of Euro-Pharmaceutical Companies
- EFPIA – European Federation of Pharmaceutical Industries and Associations, including:
- EBE - European Biopharmaceutical Enterprises
- EVM - European Vaccines Manufacturers Association
- EGA – European Generic Medicines Association
- EGGVP – European Group for Generic Veterinary Products
- EUCOPE – European Confederation of Pharmaceutical Entrepreneurs
- EUROPABIO – European Association for Bioindustries
- EVM – European Vaccines Manufacturers Association
- IFAH-Europe – International Federation for Animal Health – Europe
- IPFA – International Plasma Fractionation Association
Individual companies (10 contributions)
- Apotex Europe BV
- ELC GROUP
- LFB - Laboratoire du Fractionnement et des Biotechnologies, S.A.
- Laboratorios Maymó, S.A.
- Mundipharma Research Ltd.
- Sanofi-Aventis GmbH (Austria)
- Weleda AG
Other stakeholders (5 contributions)
- CMD(h) – Coordination Group for Mutual Recognition and Decentralised Procedures (human)
- CMD(v) – Coordination Group for Mutual Recognition and Decentralised Procedures (veterinary)
- Nilesh Sheth