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Directory on examination and approval on regional test on new biological products for animal use
(06/01/2005)

Transaction department: Office of Pharmaceutical Administration for Animal Remedy of Shanghai
Application formalities: to apply for regional testing on new biological products for animal use, applicants must submit the following materials:
1. Application official letter, including name of the new product, unit doing research work, applicant units, catalogue of application materials;
2. Draft of regulations on manufacturing and inspection of the new product;
3. Specifications of the new product;
4. Descriptions on quality standard;
5. Concluding report on testing of the new product;
6. Conclusion on field testing and on semi commercial production of the new product;
7. Plans on regional test.   

Transaction procedures:
1. Office of Pharmaceutical Administration for Animal Remedy of Shanghai is to do preliminary examination work on application materials and made a decision on whether to accept the application or not within 10 days;
2. Office of Pharmaceutical Administration for Animal Remedy of Shanghai is to organize experts to do appraisal work on application materials of the applicants passing the preliminary examination; institute of supervision on animal remedy and feeds of Shanghai is to do supervision work on proof test of technique and quality of the product from semi commercial production if necessary.
3. Those meeting prescriptions are to be approved by Office of Pharmaceutical Administration for Animal Remedy of Shanghai to do regional test within designated area. 
Charging standard and its basis: no standard or basis for fee collection
Submit to:
Address: F7, No.42 Xinfu Road, Fuyuan Mansion

audituser £º
The transaction is based on: "Regulations on Animal Remedy Management" (G.F.[1987], No.48), "Detailed Rules on Implementing Regulations on Animal Remedy Management" (issued by Ministry of Agriculture on June 30th, 1988, and amended and issued by Decree 28 from Ministry of Agriculture in 1988), "Methods of Management on Biological Products for Animal Use" (Decree 2 from the Ministry of Agriculture issued in 2002) and "Methods of Management on New Biological Products for Animal Use" (Decree 5 from the Ministry of Agriculture issued in1989).

Tel.: 62948495
Website:
Time for transaction: Monday-Friday
9£º00£­11£º30   l3£º00-17£º00 
Time limit for transaction: Decision on whether to accept the application or not is to be made within10 days. Decision on whether to approve or not within 30 days after accepting the application.
Applicant qualifications: Applicants can be units doing research work on new biological products for animal use.
Conditions for application: Applicants have obtained complete data after going through research process of lab testing, field testing and testing in semi commercial production, and have worked out draft of regulations on product manufacturing and inspection, having finalized production technique as well.