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【分享】Outcome of the public consultation on the review of Regulation (EC) 1234/2008

发布于 2013-01-16 · 浏览 819 · IP 上海上海
这个帖子发布于 12 年零 117 天前,其中的信息可能已发生改变或有所发展。
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 Industry
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    (145 KB)
  2. APIC – Active Pharmaceutical Ingredients Committee
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    (109 KB)
  3. BPI – German Pharmaceutical Industry Association
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    (144 KB)
  4. ECHAMP – European Coalition on Homeopathic and Antroposophic Medicinal Products
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    (99 KB)
  5. EFPIA – European Federation of Pharmaceutical Industries and Associations; EBE – European biopharmaceutical enterprises; EVM – European Vaccine Manufacturers : [1]
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    (414 KB)
    -[2]
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    (70 KB)
  6. EGGVP – European Group for Generic Veterinary Products
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    (352 KB)
  7. EUROPABIO – European Association for Bioindustries
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    (295 KB)
  8. IFAH-Europe – International Federation for Animal Health – Europe : [1]
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    (84 KB)
    - [2]
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    (138 KB)
  9. I.P.F.A – International Plasma Fractionation association
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    (55 KB)
  10. PHARMIG – Austrian Association of the Pharmaceutical Industry
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    (42 KB)
  11. PPTA – Plasma Protein Therapeutics Association : [1]
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    (74 KB)
    - [2]
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    (129 KB)
    - [3]
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    (95 KB)
  12. SFSTP - French Society of Pharmaceutical Science and Technology)
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    (78 KB)
  13. VFA – Research-Based Pharmaceutical Companies, Germany
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    (111 KB)
  14. EGA – European Generic Medicines Association
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    (702 KB)


  15. Individual companies (n 14 contributions)


    1. Alcon Laboratories
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      (238 KB)




    2. Astron Research Limited, India
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      (52 KB)




    3. Baush+Lomb – Healthcare US
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      (225 KB)




    4. Biocon, India : [1]
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      (146 KB)
      - [2]
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      (2 MB)




    5. Ecupharma, Italy
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      (2 MB)




    6. Focus Pharmaceuticals Ltd
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      (54 KB)




    7. LEO Pharma, Denmark
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      (91 KB)




    8. MedImmune
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      (110 KB)




    9. Mithra pharmaceuticals
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      (21 KB)



    10. Mundipharma Research
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      (108 KB)

    11. Ranbaxy, India
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      (37 KB)




    12. Regiomedica gmbh
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      (12 KB)




    13. Shire, Switzerland
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      (45 KB)




    14. Vetoquinol, UK
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      (64 KB)





    15. National authorities (n 5 contributions):

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


      6. Other stakeholders (5 contributions):

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


        6. Not to be published (2 contributions):

          1. DSM Sinochem Pharmaceuticals
          2. TEVA Pharmaceutical Industries( you can publish the comment without the name)
































最后编辑于 2022-10-09 · 浏览 819

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