Announcement of the Ministry of Agriculture [2005] No. 552
[2005] No. 552
In accordance with the Regulations on Administration of Veterinary Drugs and the Measures for Registering of Veterinary Drugs, and
upon deliberation, the Flunixin Meglumine Injection produced by the French manufacturing plant of Schering-Plough Animal Health Corporation
is approved to register in China (see Appendix 1), a Registration Certificate of Imported Veterinary Drugs is granted after check,
and its quality standards, label and drug directions (see Appendix 2) are released to the public hereby. These quality standards
shall come into effect as of the date of promulgation.
2 kinds of veterinary drugs of both Novrtis Animal Health Inc. and the other company are approved to undergo re-registration (see
Appendix 1) and modification registration (see Appendix 2) in China, and a Registration Certificate of Imported Veterinary Drugs
is granted to each of them after check. The supervision and inspection of products shall comply with quality standards of the imported
veterinary drugs which have been published by the Ministry and fall under the same category of such products.
All information above is hereby announced.
Appendices:
1.
Catalogues for Registration and Re-registration of Imported Veterinary Drugs
2.
Catalogue for Modification Registration of Imported Veterinary Drugs
3.
Quality Standards, Label and Drug Directions of Flunixin Meglumine Injection
Ministry of Agriculture
October 11, 2005 htm/e04454.htm
Appendix 1
Appendix 1
Catalogue for Registration and Re-registration of Imported Veterinary Drugs
Name of Veterinary Drug
Manufacturer
Certificate No.
Period of Validity
Remarks
Flunixin Meglumine Injection (5%)
Schering-Plough Animal Health Corporation (France)
Wai Shou Yao Zheng Zi (2005) No.40
October 2005 to September 2010
Registration
Marek’s Disease Vaccine,Live Virus (CV1988)
Fort Dodge Animal Health(Holland)
Wai Shou Yao Zheng Zi (2005) No.41
October 2005 to September 2010
Re-registration
Tiamulin Fumarate
Novartis Animal health Inc.Switzerland
Wai Shou Yao Zheng Zi (2005) No.42
October 2005 to September 2010
Re-registration
Appendix 2:
Catalogue for Modification to Registration of Imported Veterinary Drugs
Name of Veterinary Drug after Modification
Manufacturer after Modification
License No.
Period of Validity
Major Modified Contents
Marek’s Disease Vaccine,Live Virus (CV1988)
Fort Dodge Animal Health Holland
Wai Shou Yao Zheng Zi (2005) No.41
October 2005 to September 2010
Veterinary drug directions shall be revised in accordance with the State veterinary drug quality standards or requirements
of the Ministry of Agriculture.