Announcement No. 580 of the Ministry of agriculture and rural affairs of the people’s Republic of China
By: Date: 2022-07-14 Categories: authoritativerelease Tags: ,
According to the regulations on the administration of veterinary drugs and the measures for the registration of veterinary drugs, after examination, letilana chewable tablets (for dogs) produced by France Lilan Co., Ltd. were approved to be registered in China, the registration certificate of imported veterinary drugs was issued, and the quality standards, instructions, labels and process procedures were issued, which shall be implemented from the date of issuance.
 
Approve the re registration of enrofloxacin injection and other four kinds of veterinary drugs produced by kVp Kiel Co., Ltd. and other four companies in China, issue the registration certificate of imported veterinary drugs, and issue the revised quality standards, instructions, labels and process procedures, which will be implemented from the date when the newly issued registration certificate of imported veterinary drugs takes effect. The previously issued quality standards, instructions and labels of these four kinds of veterinary drugs will be abolished at the same time.
 
Approve the re registration of IBDV live vaccine (D22 strain) produced by Indonesia Madian Co., Ltd. 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 the veterinary drugs shall be abolished at the same time.
 
The live vaccine of IBDV turkey herpesvirus vector (vhvt-013-69 strain) produced by Boehringer Ingelheim animal health (USA) Co., Ltd. (Gainesville factory) was approved to change the registration in China.
 
It is hereby announced.
 
Attachment:1 Registration catalogue of imported veterinary drugs
 
  2. quality standard
 
  3. Instructions and labels
 
  4. Process specification
 
Ministry of agriculture and rural areas
 
July 12, 2022
 
Attachment 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
Letilana chewable tablets
(for dogs)
(56.25mg)
Lotilaner Chewable Tablets for Dogs
法country礼蓝
Joint stock company Elanco France
法country
(2022)
Foreign Veterinary Drug Certificate
No. 53
2022.07.12    
2027.07.11
register
Letilana chewable tablets
(for dogs)
(112.5mg)
Lotilaner Chewable Tablets for Dogs
(2022)
Foreign Veterinary Drug Certificate
No. 54
Letilana chewable tablets
(for dogs)
(225mg)
Lotilaner Chewable Tablets for Dogs
(2022)
Foreign Veterinary Drug Certificate
No. 55
Letilana chewable tablets
(for dogs)
(450mg)
Lotilaner Chewable Tablets for Dogs
(2022)
Foreign Veterinary Drug Certificate
No. 56
Letilana chewable tablets
(for dogs)
(900mg)
Lotilaner Chewable Tablets for Dogs
(2022)
Foreign Veterinary Drug Certificate
No. 57
Enrofloxacin Injection
(50ml∶1.25g)
Enrofloxacin Injection
KVP Kiel
Limited liability
company
KVP Pharma+Veterinär Produkte GmbH
德country
(2022)
Foreign Veterinary Drug Certificate
No. 58
2022.07.12   
2027.07.11
再register
Enrofloxacin Injection
(100ml∶2.5g)
Enrofloxacin Injection
(2022)
Foreign Veterinary Drug Certificate
No. 59
Malic acid citrate powder
Citric Acid and Malic Acid Powder
韩countryRNL
科技company
RNL Animal Health Co., Ltd.
韩country
(2022)
Foreign Veterinary Drug Certificate
No. 60
2022.07.12   
2027.07.11
再register
Hydrocortisone propyl acetate spray
Hydrocortisone Aceponate Spray
法country维克
有限companyVirbac S.A.
法country
(2022)
Foreign Veterinary Drug Certificate
No. 61
2022.11.21  
2027.11.20
再register
Meloxicam oral suspension
(10ml∶15mg)Meloxicam Oral Suspension
德country勃林格殷格翰动物保健有限companyMexicoProduction plantBoehringer Ingelheim Promeco, S.A. de C.V.
Mexico
(2022)
Foreign Veterinary Drug Certificate
No. 62
2022.10.24  
2027.10.23
再register
Meloxicam oral suspension
(32ml∶48mg)Meloxicam Oral Suspension
(2022)
Foreign Veterinary Drug Certificate
No. 63
Meloxicam oral suspension
(100ml∶150mg)Meloxicam Oral Suspension
(2022)
Foreign Veterinary Drug Certificate
No. 64
Meloxicam oral suspension
(180ml∶270mg)Meloxicam Oral Suspension
(2022)
Foreign Veterinary Drug Certificate
No. 65
Live vaccine of infectious bursal disease of chicken
(D22 strains)
Infectious Bursal Disease Vaccine, Live
(Strain D22)
Indonesia美迪安有限company
PT MEDION FARMA JAYA
Indonesia
(2022)
Foreign Veterinary Drug Certificate
No. 66
2022.07.12   
2027.07.11
再register
Live vaccine of avian infectious bursal disease virus and turkey herpesvirus vector (vhvt-013-69 strain)
Bursal Disease – Marek’s Disease Vaccine,Serotype 3,Live Marek’s Disease Vector
勃林格殷格翰动物保健(美country)有限company(GainesvilleProduction plant)
Boehringer Ingelheim Animal Health USA Inc.
美country
(2019)
Foreign Veterinary Drug Certificate
No. 62
2019.08.21  
2024.08.20
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”
Attachment: