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Approval Code of Veterinary Medicine Products
(06/21/2005)

Responsible Department: Shanghai Municipal Veterinary Medicine Administration Office
Procedure: Veterinary Medicine production enterprises shall apply for production approval code from Shanghai Municipal Veterinary Medicine Administration Office. Two copies of the following materials shall be submitted.
1. Application report for Veterinary Medicine product manufacturing.
2. Prescription and production procedure.
3. Quality standards or technical standards.
4. Package, tab, and production description sample.
5. Sample inspection report.
6. Production cost calculating.

Handling Procedure:
(I) Shanghai Municipal Veterinary Medicine Administration Office will carry out preliminary inspection. If necessary, production equipment and quality assurance equipments of the enterprise will be checked. Approved application will be submitted to Shanghai Veterinary Medicine Feed Inspection and Supervision Institution for re-check.
(II) After receiving the application, Shanghai Veterinary Medicine Feed Inspection and Supervision Institution will check the product sample according to standards and submit the inspection report back to Shanghai Municipal Veterinary Medicine Administration Office. If approved, Shanghai Municipal Veterinary Medicine Administration Office will issue approval code.
The approval code is valid for five years. Six months before its expiry, the Veterinary Medicine production enterprise shall submit the new application. For medicines that haven't been manufactured for three consecutive years, the approval code is expired automatically.
Fee and Collection Standards: The checking free for medicines in "Dictionary of China on Veterinary Medicine" and "Regulation on Veterinary Medicine" and other standard medicine" RMB 250/each kind. Fee for products manufactured according to local standards: RMB 500/each kind.
According to "Circular on Publishing Administrative Charging Items and Standards within Agricultural Industry", State Pricing Bureau, Ministry of Finance (1992) J.F.Z.No.452, (1992) N.M.W.No.245)
Submitted to:
Address: Xin Fu Road No. 42 (Fu Yuan Building) Floor 7

audituser:
According to: "Regulations on the Administration of Veterinary Medicines" (G.F. (1987) No.48), "Detailed Regulation on the Implementation of Veterinary Medicine Administration", (Published by the Ministry of Agriculture on June 30th, 1988, Decree No.28 of Ministry of Agriculture). "Measures on the Administration of New Veterinary Medicines and New Preparation", (published by the Ministry of Agriculture on September 2, 1989). "Measures on the Administration of Veterinary Medicine Administration and Inspection", (published by the Ministry of Agriculture on September 2, 2989), "Regulations on the Administration of Veterinary Medicine Approval Code", (N.M.F. (1998) No.4)
Telephone: 62948495

Web-site:
Working Hours: Monday to Friday 9:00-11:30 a.m. 1:00-5:00 p.m.
Duration of Handling: Shanghai Municipal Veterinary Medicine Administration Office will make its decision within fifteen working days after the receipt of the application. Shanghai Municipal Pharmaceutical Medicine and Feed Inspection and Supervision Institution will finish its re-check within sixty days after receiving the application report and product sample. Shanghai Municipal Veterinary Medicine Administration Office will then make its decision within fifteen working days after receiving the re-check report.

Qualification of Applicants: (I) Applicant" Pharmaceutical enterprises registered within Shanghai. (II) Requirement: The enterprise has to be a Veterinary Medicine production enterprise that meet state, professional and local standards.