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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.
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