- 中国医疗行业法律法规中英数据库 A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
中国医疗行业法律法规中英数据库
- （一）具有依法经过资格认定的药学技术人员； (1) 1 It shall be staffed with legally certified pharmaceutical technical personnel.
- （一）从事进口医疗器械业务不满3年的进口单位； (1) Importers that have been engaged in the import business of medical instrument for less than three years;
- （一）对不符合《药品生产质量管理规范》、《药品经营质量管理规范》的企业发给符合有关规范的认证证书的，或者对取得认证证书的企业未按照规定履行跟踪检查的职责，对不符合认证条件的企业未依法责令其改正或者撤销其认证证书的； (1) issue a certificate of qualification to an enterprise which does not meet the requirements of the ""Quality Control Standard of Pharmaceutical Production"" and the ""Quality Control Standard of Pharmaceutical Trading,"" fail to conduct inspections according to relevant regulations on the enterprises which have already obtained certificates, or fail to order the unqualified enterprises to amend themselves or revoke their certificates according to relevant regulations; or
- （一）具有与所经营药品相适应的药学技术人员。 (1) It must employ pharmaceutical technicians appropriate to the medicines handled.
- （一）具有与所生产药品相适应的药师或者助理工程师以上技术人员及技术工人。 (1) It must employ pharmacists, technical personnel above the rank of assistant engineer and technical workers appropriate to the drug production carried out by the enterprise.
- （一）严格遵守商检法及其实施条例、国家其他有关法律法规以及国家质检总局的相关规定，诚信度较高，连续3年无不良记录； (1) It shall be in strict accordance with the Inspection Law and its implementation rules, other relevant laws and regulations of the state and the relevant provisions of the GAQSIQ, have a relatively high credibility, and without any bad record for three successive years;
- （一）具有依法经过资格认定的药学技术人员、工程技术人员及相应的技术工人； (1) It shall be staffed with legally certified pharmaceutical technical personnel, engineering technical personnel, as well as corresponding skilled workers.
- （一）严格遵守商检法及其实施条例、国家其他有关法律法规以及国家质检总局的相关规定，诚信度高，连续5年无不良记录； (1) It shall severely observe the Inspection Law and its implementing regulation, other relevant laws and administrative regulations of the state as well as the relevant provisions of the GAQSIQ, shall have high credibility without any bad record for five successive years;
- （一）药品所含成份与国家药品标准规定的成份不符的； (1) Its components are different from those prescribed by state pharmaceutical standards.
- （一）非法采集血液的； (1)illegal collection of blood;?
- （十）具备与进口医疗器械产品范围与规模相适应的、相对独立的经营场所和仓储条件。 (10) It shall have relatively independent business premises and storage conditions that is appropriate for the scope and scale of the imported medical instruments.
- （十）具备与进口医疗器械产品范围与规模相适应的、相对独立的经营场所。 (10) It shall have relatively independent business premises that are appropriate for the scope and scale of the imported medical instruments.
- （二）从事进口医疗器械业务已满3年，但未提出分类管理申请的进口单位； (2) Importers that have been engaged in the import business of the medical instrument for three years but fails to bring an application for the classified management; and
- （二）对进口医疗器械实施检验监管； (2) inspection surveillance of the imported medical instruments; and
- （二）对不符合法定条件的单位发给《药品生产许可证》、《药品经营许可证》或者《医疗机构制剂许可证》的； (2) issue a Pharmaceutical Production License, a Pharmaceutical Trading License or a Dispensing Permit of Medical Organizations to a unit which does not meet legal requirements;
- （二）具有与所生产药品相适应的厂房、设施和卫生环境。 (2) It must have a factory building, facilities and a hygienic environment appropriate to its production of drugs.
- （二）具有与所经营药品相适应的营业场所、设备、仓储设施和卫生环境。 (2) It must have business premises, equipment, storage facilities and a hygienic environment appropriate to the drugs handled.
- （二）具有健全的质量管理体系，获得ISO9000质量体系认证，具备健全的质量管理制度，包括进口报检、进货验收、仓储保管、质量跟踪和缺陷报告等制度； (2) It shall have a sound management system quality, have already obtained a certification for the ISO9000 quality system, and have sound quality management system including the import declaration, inspection and acceptance of import goods, storage, quality follow-up, defect report, etc.;
- （二）具有健全的质量管理体系，具备健全的质量管理制度，包括进口报检、进货验收、仓储保管、质量跟踪和缺陷报告等制度； (2) It shall have a sound quality management system and sound quality management system including the import declaration, inspection and acceptance of import goods, storage, quality follow-up, defect report, and etc.;
- （二）具有与所经营药品相适应的营业场所、设备、仓储设施、卫生环境； (2) It shall have business premises, equipment, storage facilities and a sanitary environment suitable for the pharmaceuticals in which it trades.
- （二）具有与其药品生产相适应的厂房、设施和卫生环境； (2) It shall have factory premises, facilities and a sanitary environment suitable for the medicines produced.
- （二）未取得批准文号生产的； (2) It was produced without first obtaining an approval number;
- （二）超过有效期的； (2) Its period of efficacy has expired;
- （三）提出分类申请，经考核不符合一、二类进口单位条件，未列入一、二类分类管理的进口单位。 (3) Importers that have brought an application for the classified management but not listed in the Category A or B management because of failing to satisfy the requirements for the importers in Category A or B upon examination.
- （三）动产和不动产的收入； (3) incomes derived from movable and immovable property; and
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