Outcome of the public consultation on the review of Regulation (EC) 1234/2008 article 4: variations guidelines

 A summary and all contributions received from stakeholders regarding the above mentioned public consultation can be found below.

 

List of all contributors to the public consultation (comments on Review of the Variations Guidelines EC 1234/2008)

Total:n 40 contributions

Industry (n 28 contributions):

Associations (n 14 contributions)

  1. AESGP – Association of the European Self-Medication Industrypdf(145 KB)
  2. APIC – Active Pharmaceutical Ingredients Committeepdf(109 KB)
  3. BPI – German Pharmaceutical Industry Associationpdf(144 KB)
  4. ECHAMP – European Coalition on Homeopathic and Antroposophic Medicinal Productspdf(99 KB)
  5. EFPIA – European Federation of Pharmaceutical Industries and Associations; EBE – European biopharmaceutical enterprises; EVM – European Vaccine Manufacturers : [1]pdf(414 KB) - [2]pdf(70 KB)
  6. EGGVP – European Group for Generic Veterinary Productspdf(352 KB)
  7. EUROPABIO – European Association for Bioindustriespdf(295 KB)
  8. IFAH-Europe – International Federation for Animal Health – Europe : [1]pdf(84 KB) - [2]pdf(138 KB)
  9. I.P.F.A – International Plasma Fractionation associationpdf(55 KB)
  10. PHARMIG – Austrian Association of the Pharmaceutical Industrypdf(42 KB)
  11. PPTA – Plasma Protein Therapeutics Association : [1]pdf(74 KB) - [2]pdf(129 KB) - [3]pdf(95 KB)
  12. SFSTP - French Society of Pharmaceutical Science and Technology)pdf(78 KB)
  13. VFA – Research-Based Pharmaceutical Companies, Germanypdf(111 KB)
  14. EGA – European Generic Medicines Associationpdf(702 KB)

Individual companies (n 14 contributions)

  1. Biocon, India : [1]pdf(146 KB) - [2]pdf(2 MB)
  2. Mundipharma Researchpdf(108 KB)

National authorities (n 5 contributions):

  1. Denmark – Danish Health and Medicines Authoritypdf(45 KB)
  2. BfArM– German Federal Institute for Drugs and Medical Devicespdf(70 KB)
  3. France – French authoritiespdf(13 KB)
  4. Norwaypdf(398 KB)
  5. Spain – Spanish Agency for Medicines and Medical Devicespdf(179 KB)

Other stakeholders (5 contributions):

  1. Nilesh Sheth - MRPharmS – Member of the Royal Pharmaceutical Society : [1]pdf(22 KB) - [2]pdf(10 KB)
  2. Leempdf(150 KB)
  3. Kinapse Ltd, UK – Life Sciences Consulting and Outsourcingpdf(91 KB)
  4. Selvaraj.J. – Dr.Reddys laboratories Ltd, Indiapdf(45 KB)
  5. Diamond BioPharm Limitedpdf(69 KB)

Not to be published (2 contributions):

  1. DSM Sinochem Pharmaceuticals
  2. TEVA Pharmaceutical Industries

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