Announcement No. 583 of the Ministry of agriculture and rural affairs of the people’s Republic of China
By: Date: 2022-07-28 Categories: authoritativerelease Tags: ,
According to the regulations on the administration of veterinary drugs and the measures for the registration of veterinary drugs, after examination, four veterinary drugs, including nitenpyram tablets, produced by three companies including France Lilan Co., Ltd., were approved to be re registered in China, the registration certificate of imported veterinary drugs was issued, and the revised quality standards, process procedures, instructions and labels were issued, which shall be implemented as of the date of entry into force of the newly issued registration certificate of imported veterinary drugs, The quality standards, instructions and labels of the four veterinary drugs previously issued shall be abolished at the same time.
 
Approve the re registration of porcine reproductive and respiratory syndrome virus (American type) indirect ELISA antibody detection kit produced by Spain Highbury biopharmaceutical factory in China, issue the registration certificate of imported veterinary drugs, and issue the revised quality standards, instructions and labels, which shall be implemented from the date of entry into force of the newly issued registration certificate of imported veterinary drugs, and the previously issued quality standards, instructions and labels of veterinary drugs shall be abolished at the same time.
 
Approve the registration change of meloxicam oral suspension (for cats) produced by the Mexican factory of Boehringer Ingelheim animal health Co., Ltd. in Germany, and issue the revised quality standards, process procedures, instructions and labels, which shall be implemented from the date of issuance. The previously issued quality standards, instructions and labels of the veterinary drug shall be abolished at the same time.
 
Two kinds of veterinary drugs produced by Boehringer Ingelheim animal health (USA) Co., Ltd. (Gainesville factory) and other two companies, such as chicken Marek’s disease type I and type III bivalent live vaccines, were approved to change the registration in China.
 
It is hereby announced.
 
Annex:1. Registration catalogue of imported veterinary drugs
 
2. Quality standards
 
3. Process specification
 
4. Instructions and labels
 
Ministry of agriculture and rural areas
 
July 24, 2022
 


附件1 

Registration catalogue of imported veterinary drugs
Veterinary drug name
Production plant
name
country other
Imported veterinary drugs
register
Certificate No
Term of validity
remarks
Nitenpyram tablets
(11.4mg)
Nitenpyram Tablets
法country礼蓝
Joint stock company Elanco France
法country
(2022)
Foreign Veterinary Drug Certificate
No. 67
2022.10.16  
2027.10.15
再register
Nitenpyram tablets
(57mg)
Nitenpyram Tablets
(2022)
Foreign Veterinary Drug Certificate
No. 68
Allyl pregnen oral solution
Altrenogest Oral Solution
法country诗华动物保健公司
CEVA SANTE ANIMALE S.A.
法country
(2022)
Foreign Veterinary Drug Certificate
No. 69
2023.06.11
2028.06.10
再register
Tylosin tartrate soluble powder
Tylosin Tartrate Soluble Powder
Bulgarian biaovite Co., Ltd
Biovet Joint Stock Company
Bulgaria
(2022)
Foreign Veterinary Drug Certificate
No. 70
2022.12.27
2027.12.26
再register
Tylosin Phosphate Premix
Tylosin Phosphate Premix
Bulgarian biaovite Co., Ltd
Biovet Joint Stock Company
Bulgaria
(2022)
Foreign Veterinary Drug Certificate
No. 71
2022.12.27
2027.12.26
再register
Porcine reproductive and respiratory syndrome virus (American type) indirect ELISA antibody detection kit
Detection and Quantification of Antibodies Against American Strains of Porcine Reproductive and Respiratory Syndrome Virus, by Indirect ELISA
Laboratorios hipra, S.A
Spain
(2022)
Foreign Veterinary Drug Certificate
No. 72
2022.10.24
2027.10.23
再register
Meloxicam oral
Suspension
(for cats)
(3ml∶1.5mg)
Meloxicam Oral Suspension
(for Cats)
德country勃林格殷格翰动物保健有限公司MexicoProduction plant
Boehringer Ingelheim Promeco, S.A. de C.V.
Mexico
(2021)
Foreign Veterinary Drug Certificate
No. 28
2021.04.27
2026.04.26
变更register:修改适用对象、质量标准、说明书和标签
Meloxicam oral
Suspension
(for cats)
(15ml∶7.5mg)
Meloxicam Oral Suspension
(for Cats)
(2021)
Foreign Veterinary Drug Certificate
No. 29
Meloxicam oral
Suspension
(for cats)
(30ml∶15mg)
Meloxicam Oral Suspension
(for Cats)
(2021)
Foreign Veterinary Drug Certificate
No. 30
Bivalent Live Vaccine of Marek’s disease type I and III in chicken
Marek’s Disease (SerotypeⅠ, Ⅲ)Bivalent Vaccine, Live
勃林格殷格翰动物保健(美country)有限公司(GainesvilleProduction plant)
Boehringer Ingelheim Animal Health USA Inc.
美country
(2021)
Foreign Veterinary Drug Certificate
No. 79
2022.02.13
2027.02.12
变更register:说明书注意事项中增加“疫苗中含有硫酸链霉素、青霉素和两性霉素B作为抑菌剂”
Porcine circovirus type 2
Baculovirus vector
Inactivated vaccine
Porcine Circovirus Type 2 Baculovirus Vector Vaccine, Inactivated
勃林格殷格翰动物保健(美country)有限公司(St.JosephProduction plant)Boehringer Ingelheim Animal Health USA Inc.
美country
(2018)
Foreign Veterinary Drug Certificate
No. 42
2018.10.18
2023.10.17
变更register:说明书注意事项中增加“本品含有新霉素作为防腐剂”


        Announcement No. 583 of the Ministry of agriculture and rural affairs of the people’s Republic of Chinaimage 中华人民共和country农业农村部公告 第583号.ofd