This page lists all the contributors to the public consultation who provided comments on the "Review of the Variations Guidelines EC 1234/2008". In total, 40 contributions were received.
A summary of the responses is available here.
Below are the public responses to the above-mentioned public consultation. The following respondents requested their responses not to be published: DSM Sinochem Pharmaceuticals and TEVA Pharmaceutical Industries.
Industry (28 contributions)
Associations (14 contributions)
- AESGP – Association of the European Self-Medication Industry
- APIC – Active Pharmaceutical Ingredients Committee
- BPI – German Pharmaceutical Industry Association
- ECHAMP – European Coalition on Homeopathic and Antroposophic Medicinal Products
- EFPIA – European Federation of Pharmaceutical Industries and Associations; EBE – European biopharmaceutical enterprises; EVM – European Vaccine Manufacturers : [1] - [2]
- EGGVP – European Group for Generic Veterinary Products
- EUROPABIO – European Association for Bioindustries
- IFAH-Europe – International Federation for Animal Health – Europe : [1] - [2]
- I.P.F.A – International Plasma Fractionation association
- PHARMIG – Austrian Association of the Pharmaceutical Industry
- PPTA – Plasma Protein Therapeutics Association : [1] - [2] - [3]
- SFSTP - French Society of Pharmaceutical Science and Technology
- VFA – Research-Based Pharmaceutical Companies (Germany)
- EGA – European Generic Medicines Association
Individual companies (14 contributions)
- Alcon Laboratories
- Astron Research Limited (India)
- Baush+Lomb – Healthcare US
- Biocon (India) : [1] - [2]
- Ecupharma (Italy)
- Focus Pharmaceuticals Ltd.
- LEO Pharma (Denmark)
- MedImmune
- Mithra pharmaceuticals
- Mundipharma Research
- Ranbaxy (India)
- Regiomedica gmbh
- Shire (Switzerland)
- Vetoquinol (UK)
National authorities (5 contributions)
- Danish Health and Medicines Authority (Denmark)
- BfArM – German Federal Institute for Drugs and Medical Devices
- French authorities (France)
- Norway
- Spanish Agency for Medicines and Medical Devices (Spain)
Other stakeholders (5 contributions)
- Nilesh Sheth - MRPharmS – Member of the Royal Pharmaceutical Society : [1] - [2]
- Leem
- Kinapse Ltd. – Life Sciences Consulting and Outsourcing (UK)
- Selvaraj.J. – Dr.Reddys laboratories Ltd. (India)
- Diamond BioPharm Limited