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

 

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”