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Approval to the Registration of Imported Veterinary Drugs (Registration of Veterinary Drugs)

DATE:2013-05-14       SOURCE:MOA
 

Item Name:

Approval to the Registration of Imported Veterinary Drugs

 

Handling approach:

Review and approval

 

Contents to be reviewed:

1. Whether the drug conforms with the regulations governing the use of veterinary drugs;

2. Whether the experimental data is authentic;

3. Whether the drug's quality is evaluated and whether it is up to the mandatory standard set down in relevant regulations;

4. Whether the drug is safe, effective and high-quality.

 

Legal basis:

1Regulations on Administration of Veterinary Drugs (Order No. 404 of the State Council)

2Measures for Registration of Veterinary Drugs (Order No. 44 of the Ministry of Agriculture of the People's Republic of China)

3.Announcement No. 442 of the Ministry of Agriculture of the People's Republic of China  

 

Submission requirements:

1. Two original copies of the Application Form for the Registration of Veterinary Drugs;

2. A document certifying that the manufacture and sale of the drug were approved by competent veterinary authority of the country or territory wherein the manufacturer is based (notarization and verification required);

3. GMP certificate issued by competent veterinary authority of the country or territory wherein the manufacturer is based (notarization and verification required);

4. Authorization Letter from the exporter to the importer, ID document or legal presence registration document of the applicant (photocopy);

5. Samples, inspection & test records, and test reports of three consecutive lots;

6. Materials of relevant seed bacteria (viruses, or insects) and cells, and their supporting documents, in case of application for licensing biological veterinary products;

7. Supporting documents required by Announcement No. 442 of the Ministry of Agriculture of China in light with categories of imported veterinary drugs;

 

8. Two sets of documents for submission in bound book of A4 double-sided copies with official seals of applicants (same applicants with the ones written in Application Form).

 

The documents shall be provided with complete information, table of contents, page number, original test reports (even in case of entrusted tests), original chromatograms and photos of test findings.

 

Procedure:

1. Acceptance of submitted documents.

Administrative Examination and Approval Office of MOA shall preliminarily examine the Application Form for the Registration of Veterinary Drugs and related documents submitted. It accepts the submission in accordance with guidance issued by MOA Veterinary Drug Evaluation Center if the application materials are complete.

2. Evaluation fee.

Upon acceptance, the applicant shall pay the evaluation fee to the MOA Department of Finance by the Note for Paying Administrative Fee issued by MOA Administrative Examination and Approval Office.

3. Technical evaluation.

An expert panel organized by MOA Veterinary Drug Evaluation Center shall conduct a technical evaluation on the application.

4. Experimental evaluation.

In light with the suggestions made upon technical evaluation, the applicant shall submit samples of the drug to designated quality testing agencies in veterinary medicine for experimental tests and evaluation.

5. Verification tests.

The applicant shall follow the advice made by the expert panel and conducts clinical trials and verification tests in designated agencies within territory of China.

6. On-site inspection.

MOA shall conduct on-site inspection when necessary.

7. Approval issuance.

According to conclusions reached during evaluation, MOA Bureau of Veterinary Service shall submit a proposal for approval to the Minister, and then shall give a written reply to the applicant upon the Minister's final approval.

 

Promised time frame:

60 workdays (a maximum of 120 workdays for technical evaluation or experimental evaluation; a maximum of 150 workdays for special testing)

 

Charge:

 RMB 6,000/product (Note: Fee collection is made by per product (per API or per formulated product), and is increased by 20% in case of one additional formulated product.)

--Article No. 53 under the Regulations on Administration of Veterinary Drugs and the Joint Circular on Releasing the Items and Standards of Administrative Fee in Agricultural Sector (No. 452 [1992])

 

Contact Information

Mail:  To: Veterinary Desk

Address: Administrative Examination and Approval Office

Ministry of Agriculture

No.11 Nongzhanguan Nanli, Chaoyang District, Beijing, China

Postcode: 100125  

 

(All information posted in this website is authentic in Chinese. English version is provided for reference only.)

 

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