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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
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 "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.
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