Announcement No. 404 of the Ministry of Agriculture and Rural Affairs of the People’s Republic of China
By: Date: 2021-03-10 Categories: authoritativerelease Tags: ,
  According to the”Regulations on Administration of Veterinary Drugs” and”Regulations on Veterinary Drug Registration”, after review, the inactivated vaccines for porcine circovirus type 1-2 chimera and mycoplasma pneumonia produced by Shuo Teng’s Charlessburg production plant in the United States are approved To register in my country, issue the”Imported Veterinary Drug Registration Certificate”, and issue product quality standards, instructions and labels, which shall be implemented from the date of issuance.
   approved Boehringer Ingelheim Animal Health (U.S.) Co., Ltd. St. Joseph production plant and other two companies to produce porcine pseudorabies live vaccine (K-61 strain) and other two veterinary drug products to be re-registered in my country, and issued the”Import Veterinary Drug Registration Certificate”, and release product quality standards, instructions and labels, which shall be implemented from the date of release The previously issued product quality standards, instructions and labels shall be repealed at the same time.
   Approved the alteration of registration of the live fowlpox vaccine (M-92 strain) produced by Indonesia Median Co., Ltd. in my country, and issued the revised product quality standards, instructions and labels, which will be implemented from the date of release. The previously issued product quality standards, instructions and labels shall be repealed at the same time.
   hereby announces.
  Annex:1. Imported veterinary drug registration catalog
  2. Quality standard
  3. Manual and label
   Ministry of Agriculture and Rural Affairs
  March 4, 2021
  Attachment 1
Imported veterinary drug registration catalog
Name of veterinary drug
Production plant
Name
CountryDon’t
Imported veterinary drugs
Register
Certificate number
Valid period
Remarks
Porcine Circovirus Type 1-2 Chimera, Mycoplasma Pneumonia Duo
Inactivated vaccine
Porcine Circovirus Vaccine, Type 1-Type 2 Chimera, Killed Virus,
Mycoplasma Hyopneumoniae Bacterin
Zoetis Inc., Charlessburg production plant of Zoetis, USA
United States
(2021)
Foreign veterinary drug certificate
12th
2021.03.04
2026.03.03
Register
Pseudorabies in pigs
Live vaccine
(K-61 strain)
Swine Pseudorabies Vaccine, Live
(Strain K-61)
Boehringer Ingelheim Animal Health (United States)
Limited company
St. Joseph
Production plant Boehringer Ingelheim Animal Health USA Inc.
United States
(2021)
Foreign veterinary drug certificate
13th
2021.03.04
2026.03.03
Registration again
D-chloroprostol sodium
Injection
D-Cloprostenol Sodium Injection
Spain Haibolai Biology
LABORATORIOS HIPRA S.A.
Spain
(2021)
Foreign veterinary drug certificate
No. 14
2021.03.04
2026.03.03
Registration again
Live fowlpox vaccine (M-92 strain)
Avian Pox Vaccine, Live
(Strain M-92)
Midean, Indonesia
Limited company
PT Medion Farma Jaya
Indonesia
(2018)
Foreign veterinary drug certificate
No. 31
2018.07.17
2023.07.16
Change registration:change the character, the virus content determination method in the efficacy test, the quality standard of the fowlpox live vaccine diluent
  Attachment: