Announcement No. 2117 of the Ministry of Agriculture of the People's Republic of China
In accordance with the provisions of the Regulations on the Administration of Veterinary Drugs and the Measures for the Registration of Veterinary Drugs, upon review, the registration in China of the Fowl Pox-Laryngotracheitis Vaccine, Live Fowl Pox Vector produced by Ceva Biomune Company of the United States is approved, the Import Veterinary Drug Registration Certificate is issued, and the product quality standards, instructions and labels are published, effective from the date of publication.
The re-registration in China of 6 veterinary drug products, including Tylosin Tartrate Soluble Powder, produced by 4 companies such as the UK manufacturing site of Eli Lilly and Company of the United States, is approved, the Import Veterinary Drug Registration Certificate is issued, and the revised product quality standards, instructions and labels are published, effective from the date of publication. The quality standards for the same veterinary drug products previously published are simultaneously repealed.
The modification registration of 2 veterinary drug products, including Enrofloxacin Injection, produced by 2 companies such as KVP Kiel GmbH, is approved, and the revised product quality standards, instructions and labels are published, effective from the date of publication. The quality standards for the same veterinary drug products previously published are simultaneously repealed.
The modification registration in China of 10 veterinary drug products, including the Canine Distemper, Adenovirus Type 2, Parainfluenza and Parvovirus Vaccine, Modified Live Virus, produced by 2 companies such as Zoetis Inc., is approved.
This announcement is hereby made.
Attachments: 1. Catalogue of Imported Veterinary Drug Registration
2. Quality Standards
3. Instructions and Labels
Ministry of Agriculture
June 24, 2014
Attachment 1
Catalogue of Imported Veterinary Drug Registration
|
Veterinary Drug Name |
Name of Manufacturer |
Certificate No. |
Validity Period |
Remarks |
|
Fowl Pox-Laryngotracheitis Vaccine, Live Fowl Pox Vector Fowl Pox-Laryngotracheitis Vaccine, Live Fowl Pox Vector |
Ceva Biomune Company, USA Biomune Company |
(2014) Foreign Veterinary Drug Certificate No. 22 |
2014.06 - 2019.05 |
Registration |
|
Tylosin Tartrate Soluble Powder Tylosin Tartrate Soluble Powder |
Eli Lilly and Company Limited, UK manufacturing site Eli Lilly and Company Limited |
(2014) Foreign Veterinary Drug Certificate No. 23 |
2014.06 - 2019.05 |
Re-registration |
|
Enrofloxacin Enrofloxacin |
KVP Kiel GmbH KVP Pharma + Veterinär Produkte GmbH |
(2014) Foreign Veterinary Drug Certificate No. 24 |
2014.06 - 2019.05 |
Re-registration |
|
Toltrazuril Toltrazuril |
(2014) Foreign Veterinary Drug Certificate No. 25 |
|||
|
Amoxicillin Soluble Powder Amoxicillin Soluble Powder |
Intervet International B.V., Italy manufacturing site Intervet Productions S.r.l. |
(2014) Foreign Veterinary Drug Certificate No. 26 |
2014.06 - 2019.05 |
Re-registration |
|
Porcine Circovirus Type 2 Baculovirus Vector Vaccine, Inactivated Porcine Circovirus Type 2 Baculovirus Vector Vaccine, Inactivated |
Boehringer Ingelheim Vetmedica, Inc. (USA) Boehringer Ingelheim Vetmedica, Inc. |
(2014) Foreign Veterinary Drug Certificate No. 27 |
2014.06 - 2019.05 |
Re-registration |
|
Porcine Reproductive and Respiratory Syndrome Vaccine, Live Porcine Reproductive and Respiratory Syndrome Vaccine, Live |
(2014) Foreign Veterinary Drug Certificate No. 28 |
2014.06 - 2019.05 |
Re-registration |
|
|
Enrofloxacin Injection (100ml:10g) Enrofloxacin Injection |
KVP Kiel GmbH KVP Pharma+Veterinar Produkte GmbH |
(2010) Foreign Veterinary Drug Certificate No. 17 |
2010.04 - 2015.03 |
Change of registration: addition of use for the treatment of bacterial and mycoplasma infections in cattle |
|
Serum Gonadotrophin and Chorionic Gonadotrophin for Injection Serum Gonadotrophin and Chorionic Gonadotrophin for Injection |
Intervet International B.V. Intervet International B.V. |
(2011) Foreign Veterinary Drug Certificate No. 17 |
2011.05 - 2016.04 |
Change of registration: change of storage conditions of the veterinary drug |
|
Bordeiella Bronchiseptica-Pasteurella Multocida Bacterin-Toxoid Bordeiella Bronchiseptica-Pasteurella Multocida Bacterin-Toxoid |
Zoetis Inc., Lincoln, USA manufacturing site Zoetis Inc.,Lincoln,USA |
(2013) Foreign Veterinary Drug Certificate No. 43 |
2013.08 - 2018.07 |
Change of registration: the name of the manufacturer is changed from “Pfizer Inc.” to “Zoetis Inc.”; the name of the manufacturing site is changed from “Pfizer Inc., Lincoln, USA manufacturing site” to “Zoetis Inc., Lincoln, USA manufacturing site” |
|
Pseudorabies Vaccine, Modified Live Virus (Bucharest Strain) Pseudorabies Vaccine, Modified Live Virus |
(2013) Foreign Veterinary Drug Certificate No. 44 |
2013.08 - 2018.07 |
||
|
Canine Distemper, Adenovirus Type 2, Parainfluenza and Parvovirus Vaccine, Modified Live Virus Canine Distemper, Adenovirus Type2, Parainfluenza and Parvovirus Vaccine, Modified Live Virus |
(2012) Foreign Veterinary Drug Certificate No. 03 |
2012.01 - 2016.12 |
||
|
Parvovirus Vaccine, Modified Live Virus Parvovirus Vaccine, Modified Live Virus |
(2011) Foreign Veterinary Drug Certificate No. 10 |
2011.04 - 2016.03 |
||
|
Canine Distemper-Adenovirus Type 2-Coronavirus-Parainfluenza-Parvovirus Vaccine, Modified Live and Killed Virus, Leptospira Canicola-Icterohaemorrhagiae Bacterin Canine Distemper-Adenovirus Type2-Coronavirus-Parainfluenza-Parvovirus Vaccine, Modified Live and Killed Virus, Leptospira Canicola-Icterohaemorrhagiae Bacterin |
(2011) Foreign Veterinary Drug Certificate No. 18 |
2011.05 - 2016.04 |
||
|
Clostridium Perfringens Type C and Escherichia Coli Vaccine, Inactivated Clostridium Perfringens Type C and Escherichia Coli Vaccine, Inactivated |
(2013) Foreign Veterinary Drug Certificate No. 33 |
2013.05 - 2018.04 |
||
|
Marek’s Disease Vaccine, Live (HVT FC-126 Strain) Marek’s Disease Vaccine, Live(HVT FC-126 Strain) |
Merial, Inc. (USA) Merial, Inc. |
(2013) Foreign Veterinary Drug Certificate No. 69 |
2013.12 - 2018.11 |
Change of registration: the name of the manufacturer is changed to “Merial, Inc.”; the registered address is changed to “1730 Olympic Drive Athens, GA30601” |
|
Marek’s Disease Turkey Herpesvirus Vaccine, Live (Strain FC126) Marek’s Disease Turkey Herpesvirus Vaccine, Live(Strain FC126) |
(2011) Foreign Veterinary Drug Certificate No. 02 |
2011.01 - 2015.12 |
||
|
Marek’s Disease Vaccine, Live (Strain CVI1988) Marek’s Disease Vaccine, Live(Strain CVI1988) |
(2011) Foreign Veterinary Drug Certificate No. 03 |
2011.02 - 2016.01 |
||
|
Marek’s Disease (Serotype I, III) Bivalent Vaccine, Live Marek’s Disease(SerotypeⅠ,Ⅲ)Bivalent Vaccine, Live |
(2012) Foreign Veterinary Drug Certificate No. 09 |
2012.02 - 2017.01 |
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