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Announcement No. 463 of the Ministry of Agriculture and Rural Affairs of the People's Republic of China

 Last Update: 2021-09-11
 Source: Internet
 Author: User

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According to the " Regulations on Administration of Veterinary Drugs " and "Regulations on Veterinary Drug Registration", after review, 3 veterinary products including the African swine fever virus ELISA antibody detection kit declared by 10 units including Beijing Jinnuo Biotech Co.
, Ltd.
are approved as new veterinary drugs , Issue the "New Veterinary Drug Registration Certificate", and publish the product trial procedures, quality standards, instructions and inner packaging labels, which will be implemented from the date of issuance .

Approval of the change registration of the allergestin oral solution declared by Ningbo Sansheng Biotechnology Co.
, Ltd.
shall be implemented from the date of issuance
.
The quality standards, instructions and labels shall be implemented in accordance with the same varieties as the Announcement No.
2653 of the Ministry of Agriculture and Rural Affairs
.

Approval of the change registration of glucose injection declared by Heilongjiang Qitai Animal Health Products Co.
, Ltd.
shall be implemented from the date of issuance .
The quality standards, instructions and labels are implemented in accordance with the "Chinese Veterinary Pharmacopoeia" (2020 edition) of the same species .

Hereby announce
.

　　Attachment: 1.
New veterinary drug registration catalog

　　2.
List of veterinary drugs change registration

　　3.
Trial procedures for manufacturing and inspection

　　4.
Quality standards

　　5.
Instructions and inner packaging label

　　Ministry of Agriculture and Rural Affairs

　　August 29, 2021

　　attachment1

　　New veterinary drug registration catalog

New veterinary drug name	Development unit	category	New veterinary drug registration certificate number	Monitoring period	Remark
African swine fever virus ELISA antibody detection kit	Beijing Jinnuo Biotech Co. , Ltd. , China Agricultural University	Second category	(2021) New Veterinary Drug Certificate No. 53	4 years	register
Newcastle disease, avian influenza (H9 subtype), avian adenovirus disease (group I type 4) triple inactivated vaccine (La Sota strain + YT strain + QD strain)	Shandong Bolaiwei Biotechnology Research Institute, Shandong Binzhou Wohua Biological Engineering Co. , Ltd. , Zhaofenghua Biological Technology (Nanjing) Co. , Ltd. , Jiujiang Bomeilai Biological Products Co. , Ltd.	Three categories	(2021) New Veterinary Medicine Syndrome No. 54	3 years	register
Chlorine dioxide solution	Feed Research Institute of Chinese Academy of Agricultural Sciences, Guangdong Wen's Dahuanong Biotechnology Co. , Ltd. , China Animal Husbandry Industry Co. , Ltd. Huanggang Animal Medicine Factory, Hunan Aidi Biotechnology Co. , Ltd.	Second category	(2021) New Veterinary Medicine Certificate No. 55	4 years	register

　　Annex 2

　　Veterinary Drug Change Registration List

Name of veterinary drug	Development unit	Changes
Allergen Oral Solution	Ningbo Sansheng Biotechnology Co. , Ltd.	The packaging was changed from "Medicinal Aluminum Bottle" to "Medicinal High Density Polyethylene Bottle"
Glucose injection	Heilongjiang Qitai Animal Health Products Co. , Ltd.	Increase specification 100ml: 25g

　　Appendix:

　　 Instructions and labels.
doc

Veterinary Medicine Beijing Bio- African Swine Fever Virus Detection Kit

Ningbo

Animal health products glucose

　　Hereby announce
.

　　Attachment: 1.
New veterinary drug registration catalog

　　2.
List of veterinary drugs change registration

　　3.
Trial procedures for manufacturing and inspection

　　4.
Quality standards

　　5.
Instructions and inner packaging label

　　Ministry of Agriculture and Rural Affairs

　　August 29, 2021

　　attachment1

　　New veterinary drug registration catalog

New veterinary drug name	Development unit	category	New veterinary drug registration certificate number	Monitoring period	Remark
African swine fever virus ELISA antibody detection kit	Beijing Jinnuo Biotech Co. , Ltd. , China Agricultural University	Second category	(2021) New Veterinary Drug Certificate No. 53	4 years	register
Newcastle disease, avian influenza (H9 subtype), avian adenovirus disease (group I type 4) triple inactivated vaccine (La Sota strain + YT strain + QD strain)	Shandong Bolaiwei Biotechnology Research Institute, Shandong Binzhou Wohua Biological Engineering Co. , Ltd. , Zhaofenghua Biological Technology (Nanjing) Co. , Ltd. , Jiujiang Bomeilai Biological Products Co. , Ltd.	Three categories	(2021) New Veterinary Medicine Syndrome No. 54	3 years	register
Chlorine dioxide solution	Feed Research Institute of Chinese Academy of Agricultural Sciences, Guangdong Wen's Dahuanong Biotechnology Co. , Ltd. , China Animal Husbandry Industry Co. , Ltd. Huanggang Animal Medicine Factory, Hunan Aidi Biotechnology Co. , Ltd.	Second category	(2021) New Veterinary Medicine Certificate No. 55	4 years	register

　　Annex 2

　　Veterinary Drug Change Registration List

New veterinary drug name	Development unit	category	New veterinary drug registration certificate number	Monitoring period	Remark
African swine fever virus ELISA antibody detection kit	Beijing Jinnuo Biotech Co. , Ltd. , China Agricultural University	Second category	(2021) New Veterinary Drug Certificate No. 53	4 years	register
Newcastle disease, avian influenza (H9 subtype), avian adenovirus disease (group I type 4) triple inactivated vaccine (La Sota strain + YT strain + QD strain)	Shandong Bolaiwei Biotechnology Research Institute, Shandong Binzhou Wohua Biological Engineering Co. , Ltd. , Zhaofenghua Biological Technology (Nanjing) Co. , Ltd. , Jiujiang Bomeilai Biological Products Co. , Ltd.	Three categories	(2021) New Veterinary Medicine Syndrome No. 54	3 years	register
Chlorine dioxide solution	Feed Research Institute of Chinese Academy of Agricultural Sciences, Guangdong Wen's Dahuanong Biotechnology Co. , Ltd. , China Animal Husbandry Industry Co. , Ltd. Huanggang Animal Medicine Factory, Hunan Aidi Biotechnology Co. , Ltd.	Second category	(2021) New Veterinary Medicine Certificate No. 55	4 years	register

New veterinary drug name

Development unit

category

New veterinary drug registration certificate number

Monitoring period

Remark

African swine fever virus ELISA antibody detection kit

Beijing Jinnuo Biotech Co.
, Ltd.
, China Agricultural University

Second category

(2021)

New Veterinary Drug Certificate No.
53

4 years

Newcastle disease, avian influenza (H9 subtype), avian adenovirus disease (group I type 4) triple inactivated vaccine (La Sota strain + YT strain + QD strain)

Shandong Bolaiwei Biotechnology Research Institute, Shandong Binzhou Wohua Biological Engineering Co.
, Ltd.
, Zhaofenghua Biological Technology (Nanjing) Co.
, Ltd.
, Jiujiang Bomeilai Biological Products Co.
, Ltd.

Three categories

(2021)

New Veterinary Medicine Syndrome No.
54

3 years

Chlorine dioxide solution

Feed Research Institute of Chinese Academy of Agricultural Sciences, Guangdong Wen's Dahuanong Biotechnology Co.
, Ltd.
, China Animal Husbandry Industry Co.
, Ltd.
Huanggang Animal Medicine Factory, Hunan Aidi Biotechnology Co.
, Ltd.

Second category

(2021)

New Veterinary Medicine Certificate No.
55

4 years

New veterinary drug name

Development unit

category

New veterinary drug registration certificate number

Monitoring period

Remark

New veterinary drug name

Development unit

category

New veterinary drug registration certificate number

Monitoring period

Remark

African swine fever virus ELISA antibody detection kit

Beijing Jinnuo Biotech Co.
, Ltd.
, China Agricultural University

Second category

(2021)

New Veterinary Drug Certificate No.
53

4 years

African swine fever virus ELISA antibody detection kit

Beijing Jinnuo Biotech Co.
, Ltd.
, China Agricultural University

Second category

(2021)

New Veterinary Drug Certificate No.
53

(2021)

New Veterinary Drug Certificate No.
53

4 years

Newcastle disease, avian influenza (H9 subtype), avian adenovirus disease (group I type 4) triple inactivated vaccine (La Sota strain + YT strain + QD strain)

Three categories

(2021)

New Veterinary Medicine Syndrome No.
54

3 years

Newcastle disease, avian influenza (H9 subtype), avian adenovirus disease (group I type 4) triple inactivated vaccine (La Sota strain + YT strain + QD strain)

Three categories

(2021)

New Veterinary Medicine Syndrome No.
54

(2021)

New Veterinary Medicine Syndrome No.
54

3 years

Chlorine dioxide solution

Second category

(2021)

New Veterinary Medicine Certificate No.
55

4 years

Chlorine dioxide solution

Second category

(2021)

New Veterinary Medicine Certificate No.
55

(2021)

New Veterinary Medicine Certificate No.
55

4 years

　　Annex 2

　　Veterinary Drug Change Registration List

Name of veterinary drug	Development unit	Changes
Allergen Oral Solution	Ningbo Sansheng Biotechnology Co. , Ltd.	The packaging was changed from "Medicinal Aluminum Bottle" to "Medicinal High Density Polyethylene Bottle"
Glucose injection	Heilongjiang Qitai Animal Health Products Co. , Ltd.	Increase specification 100ml: 25g

Name of veterinary drug

Development unit

Changes

Allergen Oral Solution

Ningbo Sansheng Biotechnology Co.
, Ltd.

The packaging was changed from "Medicinal Aluminum Bottle" to "Medicinal High Density Polyethylene Bottle"

Glucose injection

Heilongjiang Qitai Animal Health Products Co.
, Ltd.

Increase specification 100ml: 25g

Name of veterinary drug

Development unit

Changes

Name of veterinary drug

Development unit

Changes

Allergen Oral Solution

Ningbo Sansheng Biotechnology Co.
, Ltd.

The packaging was changed from "Medicinal Aluminum Bottle" to "Medicinal High Density Polyethylene Bottle"

Allergen Oral Solution

Ningbo Sansheng Biotechnology Co.
, Ltd.

The packaging was changed from "Medicinal Aluminum Bottle" to "Medicinal High Density Polyethylene Bottle"

Glucose injection

Heilongjiang Qitai Animal Health Products Co.
, Ltd.

Increase specification 100ml: 25g

Glucose injection

Heilongjiang Qitai Animal Health Products Co.
, Ltd.

Increase specification 100ml: 25g

　　Appendix:

　　 Instructions and labels.
doc

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