The application process and procedures for veterinary drug approval number are as follows:

1. The applicant submits the application materials to the Ministry of Agriculture and should submit the following information:

( 1) "Veterinary Drug Product Approval Number Application Form" in duplicate;

(2) "Veterinary Drug Production License" in duplicate;

(3) "Veterinary Drug GMP" One copy of the "New Veterinary Drug Registration Certificate";

(4) One copy of the "New Veterinary Drug Registration Certificate";

(5) One copy of the review inspection report;< /p>

(6) Label and instruction manual samples in duplicate;

(7) Product production process, formula and other information in duplicate.

2. The Ministry of Agriculture will send the application materials to the China Veterinary Drug Supervision Institute for expert review within 5 working days from the date of acceptance, and make an approval within 15 working days from the date of receipt of the review opinions. Decide.

3. If the regulations are met, the veterinary drug product approval number, approved label and instructions will be issued.

Extended information:

"Measures for the Administration of Veterinary Drug Product Approval Numbers"

Article 3 Veterinary drug manufacturing enterprises that produce veterinary drugs must obtain veterinary drug products issued by the Ministry of Agriculture Approval number.

The veterinary drug product approval number is a veterinary drug approval document issued by the Ministry of Agriculture when it approves a specific veterinary drug manufacturer to produce specific veterinary drug products based on the national veterinary drug standards, production processes and production conditions.

Article 4 The Ministry of Agriculture is responsible for the issuance, supervision and management of national veterinary drug product approval numbers.

The veterinary administrative departments of local people’s governments at or above the county level are responsible for the supervision and management of veterinary drug product approval numbers within their respective administrative regions.

Chapter 2 Application and Issuance of Veterinary Drug Product Approval Number

Article 5 Veterinary drugs applying for veterinary drug product approval number shall meet the following conditions:

(1) Within the production scope specified in the "Veterinary Drug Production License";

(2) There is no record of the product approval number being revoked in the three years before application.

If the application for a veterinary drug product approval number is not in compliance with the regulations after two consecutive rechecks, the application for the veterinary drug product approval number will no longer be accepted within one year.

Baidu Encyclopedia-Veterinary Drug Product Approval Number Management Measures