中国医疗行业法律法规中英数据库
第九条 各级红十字会理事会由会员代表大会民主选举产生。理事会民主选举产生会长和副会长。 Article 9 The Councils of the Red Cross Societies at various levels shall be democratically elected by respective congresses of members. The Councils shall democratically elect their Presidents and Vice- Presidents.第九条 精神药品的原料和第一类精神药品制剂的供应计划，由卫生部会同国家医药管理局，根据省、自治区、直辖市医药管理部门提出的计划，综合平衡后与生产计划一并下达。 Article 9 The plan for the supply of raw materials of psychotropic drugs and for the supply of psychotropic drugs of category I shall be made jointly by the Ministry of Public Health and the State Administration for Medicine after balancing the plans made by the administration department for medicine of each province, autonomous region or municipality directly under the Central Government and shall be assigned together with the production plan by the Ministry of Public Health and the State Administration for Medicine.第九条 各级政府应当开展预防传染病的卫生健康教育，组织力量消除鼠害和蚊、蝇等病媒昆虫以及其他传播传染病的或者患有人畜共患传染病的动物的危害。 Article 9. Governments at various levels shall carry out health education on the prevention of infectious diseases and organize people for the elimination of the hazards of rodents and vector insects like mosquitoes and flies as well as other animals that transmit infectious diseases or suffer from infectious diseases common to human beings and animals.第九十条 药品的生产企业、经营企业、医疗机构在药品购销中暗中给予、收受回扣或者其他利益的，药品的生产企业、经营企业或者其代理人给予使用其药品的医疗机构的负责人、药品采购人员、医师等有关人员以财物或者其他利益的，由工商行政管理部门处一万元以上二十万元以下的罚款，有违法所得的，予以没收； Article 90 If pharmaceutical producing enterprises, trading enterprises and medical organizations give or receive commissions or other interests in secret during the purchase or sale of pharmaceuticals; and if pharmaceutical producing enterprises, trading enterprises or their agents give any property or other interests to the directors, buyers, physicians and other relevant persons in the medical organizations where their medicines are used, a fine of more than 10,000 but less than 200,000 RMB shall be imposed and the unlawful income shall be confiscated by the government body of industry and commerce administration第九十一条 药品的生产企业、经营企业的负责人、采购人员等有关人员在药品购销中收受其他生产企业、经营企业或者其代理人给予的财物或者其他利益的，依法给予处分，没收违法所得；构成犯罪的，依法追究刑事责任。 Article 91 If directors or buyers of pharmaceutical producing enterprises or trading enterprises receive any property or other interests from other producing enterprises, trading enterprises or their agents during the purchase or sale of medicines, they shall be punished according to relevant regulations and shall have their unlawful income confiscated. If a crime is constituted, an investigation shall be made for criminal liabilities.第九十二条 违反本法有关药品广告的管理规定的，依照《中华人民共和国广告法》的规定处罚，并由发给广告批准文号的药品监督管理部门撤销广告批准文号，一年内不受理该品种的广告审批申请；构成犯罪的，依法追究刑事责任。 Article 92 Those who act against the administrative regulations concerning pharmaceutical advertisement as provided in this Law shall be sanctioned in conformity with the Advertisement Law of the PRC, have its advertisement registration number revoked by the pharmaceutical supervisory and administrative departments from which the registration number has been issued, and its application for the approval of the advertisement regarding this variety of medicines shall not be accepted for one year. If a crime is constituted, an investigation of criminal liabilities shall be made in conformity with relevant laws and regulations.第九十三条 药品的生产企业、经营企业、医疗机构违反本法规定，给药品使用者造成损害的，依法承担赔偿责任。 Article 93 If pharmaceutical producing enterprises, trading enterprises or medical organizations act against this law which results in damages to the users of pharmaceuticals, they shall bear liabilities of compensation in conformity with relevant regulations.第九十四条 药品监督管理部门违反本法规定，有下列行为之一的，由其上级主管机关或者监察机关责令收回违法发给的证书、撤销药品批准证明文件，对直接负责的主管人员和其他直接责任人员依法给予行政处分；构成犯罪的，依法追究刑事责任： Article 94 If a pharmaceutical supervisory and administrative department violates this law with one of the following acts, a competent authority of a higher level or a supervisory organization shall order it to withdraw the unlawfully issued certificates, revoke the pharmaceutical approval certificates, and render administrative sanctions against the directly liable person in charge and other responsible personnel. If their acts constitute a crime, they shall be investigated for criminal liabilities.第九十五条 药品监督管理部门或者其设置的药品检验机构或者其确定的专业从事药品检验的机构参与药品生产经营活动的，由其上级机关或者监察机关责令改正，有违法收入的予以没收；情节严重的，对直接负责的主管人员和其他直接责任人员依法给予行政处分。 Article 95 If a pharmaceutical supervisory and administrative department, or an inspection institution it has established, or an organization exclusively engaged in pharmaceutical inspection it has appointed, participates in the production and trade of pharmaceuticals, the responsible authority of a higher level or a supervisory organization shall order it to amend itself and have its unlawful income confiscated. If the circumstances are serious, the directly liable person in charge and other responsible personnel shall be subject to administrative sanctions.第九十六条 药品监督管理部门或者其设置、确定的药品检验机构在药品监督检验中违法收取检验费用的，由政府有关部门责令退还，对直接负责的主管人员和其他直接责任人员依法给予行政处分。对违法收取检验费用情节严重的药品检验机构，撤销其检验资格。 Article 96 If a pharmaceutical supervisory and administrative department or a pharmaceutical inspection institution it has established or appointed unlawfully collects inspection fees during a pharmaceutical supervision and inspection, it shall be ordered by the government bodies concerned to make reimbursements, and the directly liable person and other responsible personnel shall be subject to administrative sanctions. If the circumstances are serious, the certificate of qualification of the inspection institution which has unlawfully collected inspection fees shall be revoked.第九十七条 药品监督管理部门应当依法履行监督检查职责，监督已取得《药品生产许可证》、《药品经营许可证》的企业依照本法规定从事药品生产、经营活动。 Article 97 A pharmaceutical supervisory and administrative department shall perform its duty of supervision and inspection according to laws and regulations, and shall supervise the production and trade of the enterprises which have obtained a Pharmaceutical Production License or a Pharmaceutical Trade License according to the regulations of this Law.第九十八条 药品监督管理部门对下级药品监督管理部门违反本法的行政行为，责令限期改正；逾期不改正的，有权予以改变或者撤销。 Article 98 A pharmaceutical supervisory and administrative department shall, within a prescribed time limit, order a pharmaceutical supervisory and administrative department of a lower level to correct an administrative act which is not in conformity with this Law. If the administrative act is not corrected within the prescribed time limit, the department shall have the power to change or repeal it.第九十九条 药品监督管理人员滥用职权、徇私舞弊、玩忽职守，构成犯罪的，依法追究刑事责任；尚不构成犯罪的，依法给予行政处分。 Article 99 If the personnel of the pharmaceutical supervision and administration misuse their authority, engage in irregular practices due to favoritism, or neglect their duties to such an extent that a crime is constituted, they shall be investigated for criminal liabilities. If their acts have not constituted a crime, they shall be subject to administrative sanctions.申请一类进口单位的，直属检验检疫局应当在完成书面审核后组织现场考核，考核合格的，将考核结果和相关材料报国家质检总局。 As for an application for a Category A importer, the administration of inspection and quarantine directly under the GAQSIQ shall arrange the spot assessment after completing the assessment on written application, and shall submit the result of assessment and relevant materials to the GAQSIQ if the assessment is passed.申请二类进口单位的，直属检验检疫局完成书面审核后，可以自行或者委托进口单位所在地检验检疫机构组织现场考核。 As for an application for a Category B importer, the administration of inspection and quarantine directly under the GAQSIQ may arrange the spot assessment by itself or entrusting the IQ organ at the place where the importer is situated after completing the assessment of written application.列明于承保表内 As stated in Policy Schedule在乡、民族乡、镇的医疗、预防、保健机构中工作的执业助理医师，可以根据医疗诊治的情况和需要，独立从事一般的执业活动。 Assistant medical practitioners who work in institutions of medical treatment, prevention or health care of townships, nationality townships or towns may, in the light of the conditions and needs of medical treatment, engage in general practice of medicine on their own.授权签署 Authorized Signature第十条开办药品经营企业必须由所在地药品生产经营主管部门审查同意，经县级以上卫生行政部门审核批准，并发给《药品经营企业许可证》。无《药品经营企业许可证》的，工商行政管理部门不得发给《营业执照》。 [Article 10] The establishment of a drug-handling enterprise must be examined and agreed to by the department responsible for drug production and handling in the place where the enterprise is situated, and must be examined and approved by a health department at county level or above, which will issue a ""Drug-handling Enterprise Licence"", without which the department administering industry and commerce may not issue a ""Business Licence"".第十一条开办药品经营企业必须具备以下条件： [Article 11] The establishment of a drug-handling enterprise must satisfy the following conditions:第十二条收购药品，必须进行质量验收；不合格的，不得收购。 [Article 12] On purchasing drugs, quality examinations must be carried out; if the drugs do not come up to standard, they may not be purchased.第十三条销售药品必须准确无误，并正确说明用法、用量和注意事项； [Article 13] In selling drugs, it is necessary to be exact and accurate; the method of use, dosage and points to note must be explained precisely.第十四条药品仓库必须制定和执行药品保管制度，采取必要的冷藏、防潮、防虫、防鼠等措施。 [Article 14] Drug warehouses shall lay down and implement a system of rules and regulations for the storage of drugs and take measures necessary in relation to cold storage, protection against damp, and protection from insects, rodents, etc.第十五条城乡集市贸易市场可以出售中药材，国家另有规定的除外。 [Article 15] Chinese medicinal materials may be sold in town and country trading markets except where otherwise stipulated by the State.第十六条医疗单位必须配备与其医疗任务相适应的药学技术人员，非药学技术人员不得直接从事药剂技术工作。 [Article 16] Medical treatment units must be staffed with the number of pharmaceutical technicians appropriate to their medical treatment responsibilities. Personnel who are not pharmaceutical technicians may not be engaged directly in pharmaceutical technical work.
