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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. |