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一、为做好进口药品的抽样管理工作,保证口岸检验抽样的代表性和科学性,保证检验结果的准确性,特制订本规定。二、进口药品抽样由承担该品种检验的口岸药品检验所负责进行。报验单位应当负责抽样所需工具和场地的准备,以及抽样时的搬移、倒垛、开拆和恢复包装等事项。三、同一合同,药品名称、生产国家、厂商、包装、批号、剂型、规格、唛头标记以及合同编号均相同者,方可作为同批药品进行抽样;同一合同进口的药品分次到货者,分次抽样。四、供国内分包装的进口药品制剂的抽样,进口单位应当提供大包装《进口药品注册证》及进口药品分
First, in order to do a good job in the sampling of imported drugs management, port inspection to ensure that the representativeness of the sampling and scientific, to ensure the accuracy of the test results, especially the provisions of this provision. Second, the sampling of imported drugs by the variety of species to undertake the inspection of the port drug inspection office. The inspection unit shall be responsible for the preparation of the tools and sites required for the sampling, as well as handling, unstacking, unpacking and recovery of packages during sampling. Third, the same contract, the name of the drug, the country of manufacture, the manufacturer, the packaging, the batch number, the dosage form, the specification, the mark and the contract number are the same before sampling as the same batch of drugs; Sub-sampling. 4. For the sampling of imported pharmaceutical preparations for domestic subcontracting, the importing unit shall provide the packaging with the “Imported Drug Registration Certificate” and the imported medicines