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Administration on "Permit on Veterinary Medicine Production"
(06/01/2005)

Responsible Department: Shanghai Municipal Veterinary Medicine Administration Office
Procedure:  Applicants that want to establish veterinary medicine production factories shall proceed with the following procedure according to state regulation.
(I) The applicant or its supervising departments shall submit the application to district (county) level agriculture (animal farming) departments. After being approved, the application will be submitted to Shanghai Municipal Veterinary Pharmaceutical Administration Office for final approval.
(II) After being approved, "Permit on Veterinary Medicine Production" will be issued.
(III) The applicant shall register at local Industrial and Commercial Administration Bureau with its permit and other relevant documents. Business license will be issued if approved.
(IV) China-foreign joint equity ventures, contractual cooperative enterprises or foreign enterprises that want to apply for the production of veterinary medicines shall be carried out according to certain regulations.
(V) After being approved by the Ministry of Agriculture, the producer of veterinary biological products will receive a "Permit on the Production of Veterinary Medicines" from Shanghai Municipal Veterinary Pharmaceutical Administration Office.

Handling Procedure:
(I) Letter of Application and approval from district (county) level supervising authority will be checked. Approval from the Ministry of Agriculture is needed for the establishment of factories that product veterinary biological production.
(II) After the application is approved, factory design, workshop layout and equipment arrangement will be checked.
(III) After the factory is established, the enterprise shall apply for GMP inspection and acceptance from the Ministry of Agriculture. After the preliminary approval from Shanghai Municipal Veterinary Medicine Administration Office, the case will be submitted to the Ministry of Agriculture for approval.
(IV) Enterprises that pass GMP inspection of the Ministry of Agriculture shall fill out the "Application Form For the Production of Veterinary Medicines". Shanghai Municipal Veterinary Medicine Administration Office will issue "Permit on the Production of Veterinary Medicines" to approved enterprises.
   
Fee and Collection Standards:  (I) Charging standards: RMB 100 yuan for issuance of "Permit on the Production of Veterinary Medicines", RMB 15 yuan for the cost of the permit.
(II) 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

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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 "Permit on Veterinary Medicine Production", "Permit on Veterinary Buying and Selling of Veterinary Medicines" and "Permit on the Buying and Selling of Veterinary Preparation" (Decree No.2 of the Ministry of Agriculture published on July 10, 1989). "Regulations on the Administration of Veterinary Medicine Production Quality", "Measures on the Inspection and Administration of Veterinary Medicine Production Quality Administration"

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 one months after the receipt of all the documents.
Qualification of Applicants: (I) Applicant: Veterinary medicine production enterprises registered within Shanghai.
(II) Veterinary medicine production enterprises shall meet the following requirements.
1. Have assistant engineer, assistant veterinary or other technical staff to carry out production.
2. Have factory venue, facility and hygiene environment for the production.
3. Have security and hygiene equipments and conditions that meet state standards.
4. Have quality inspection institution, inspection staff and other necessary equipments and instrument.
5. Enterprises that are not specialized in veterinary medicines shall have specific production area.