《兽药管理条例》英译本
学新娘化妆盘头作者：中国兽药信息网 发表时间：2006.08.01
Regulations on Administration of Veterinary Drugs
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(Adopted at the 45th Executive Meeting of the State Council on March 24, 2004, promulgated by Decree No. 404 of the State Council of the People’s Republic of China on April 9, 2004, and effective as of November 1, 2004)
Chapter I General Provisions
martini Article 1 The Regulations are formulated for the purpo of strengthening the administration of veterinary drugs, ensuring the quality of such drugs, preventing and controlling animal dias, promoting the development of breeding industry, and safeguar
旌旗ding human health.英语培训机构迈格森
Article 2 Any entity engaged in rearch and development, manufacture, distribution, import and export, u, supervision and administration of veterinary drugs within the territory of the People’s Republic of China shall comply with the Regulations.
Article 3 The administrative department for veterinary medicine of the State Council is responsible for the supervision and administration of veterinary drugs nationwide.
The administrative departments for veterinary medicine of the local people’s governments at or above the county level are responsible for the supervision and administration of veterinary drugs within their respective administrative areas.
Article 4 The State adopts an administration system for classifying veterinary drugs into prescription and non-prescription ones. The measures and the specific implementation procedures of the administration system for classifying veterinary drugs into prescription and non-prescription ones shall be formulated by the administrative department for veterinary medicine of the State Council.
Article 5 The State adopts a system for rerve of veterinary drugs.
雅思口语机经
In the event of a rious epizootic dia, calamity or other emergency, the administrative department for veterinary medicine of the State Council may, for purpos of first aid, transfer veterinary drugs from the national rerve and, when necessary, may also transfer veterinary drugs from the rerve of other quarters.
Chapter II Rearch and Development of New Veterinary Drugs
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Article 6 The State encourages rearch and development of new veterinary drugs and protects the legitimate rights and interests of rearchers and developers according to law.
Article 7 For rearch and development of a new veterinary drug, there shall be premi
s, instruments and equipment, professional technicians, standards and measures for safety control commensurate with the rearch and development work.
For rearch and development of a new veterinary drug, safety evaluation shall be conducted. Any institution to be engaged in safety evaluation of veterinary drugs shall be subject to accreditation by the administrative department for veterinary medicine of the State Council, and shall comply with the Good Laboratory Practice for Non-clinical Laboratory Studies and the Good Clinical Practice in respect of veterinary drugs.
Article 8 For rearch and development of a new veterinary drug, an application attached with a report of safety evaluation made at the laboratory stage and other pre-clinical study data on the drug shall, before clinical trials are conducted, be submitted to the administrative department for veterinary medicine of the people’s government of the province, autonomous region or municipality directly under the Central Government, which shall notify the applicant of the result of examination in writing within 60 working days from the date it receives the application.
Where the new veterinary drug being rearched and developed is a biological product, an application shall, before clinical trials are conducted, be submitted to the administrative department for veterinary medicine of the State Council, which shall notify the applicant of the result of examination in writing within 60 working days from the date it receives the application.在线英汉互译
Where pathogenic microorganisms of Class I are necessary to be ud in the rearch and development of a new veterinary drug, conditions laid down by the administrative department for veterinary medicine of the State Council are, in addition, required to be met, and the matter shall, prior to the laboratory stage, be reported to the administrative department for veterinary medicine of the State Council for approval.
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