中国医疗行业法律法规中英数据库
第八条血站是采集、提供临床用血的机构，是不以营利为目的的公益性组织。 Article 8 Blood stations are institutions that collect and provide blood for clinical use and are nonprofit organizations not for the purpose of making profits.第八条 县级以上按行政区域建立地方各级红十字会，根据实际工作需要配备专职工作人员。 Article 8 Local Red Cross Societies at or above the county level shall be established according to the division of the administrative areas and manned with full-time staff members according to the actual need of work.第八条婚前医学检查包括对下列疾病的检查： Article 8 Pre-marital medical examination shall include the examination of the following diseases:第八条 精神药品的原料和第一类精神药品制剂，由卫生部会同国家医药管理局指定的经营单位统一调拨或者收购； Article 8 Raw materials of psychotropic drugs and psychotropic drugs of category I shall be allotted or purchased by the drug dealer units appointed jointly by the Ministry of Public Health and the State Administration for Medicine.第八条国家实行医师资格考试制度。 Article 8 The state practices an examination system for the qualifications of doctors.第八条 开办药品生产企业，必须具备以下条件： Article 8 To establish a pharmaceutical producing enterprise, the following requirements must be met:第八条申请一类进口单位或者二类进口单位的医疗器械进口单位（以下简称申请单位），应当向所在地直属检验检疫局提出申请，并提交以下材料： Article 8 Where a medical instrument importer applies for a Category A or B importer (hereinafter referred to as the applicant), it shall submit an application to the administration of inspection and quarantine directly under the GAQSIQ at the place where the applicant is situated, and submit the materials as follows:第八条 对预防、控制传染病做出显著成绩和贡献的单位和个人，给予奖励。 Article 8. Units and individuals who have made remarkable achievements in or contributions to the prevention and control of infectious diseases shall be awarded.第八十条 药品的生产企业、经营企业或者医疗机构违反本法第三十四条的规定，从无《药品生产许可证》、《药品经营许可证》的企业购进药品的，责令改正，没收违法购进的药品，并处违法购进药品货值金额二倍以上五倍以下的罚款；有违法所得的，没收违法所得；情节严重的，吊销《药品生产许可证、《药品经营许可证》或者医疗机构执业许可证书。 Article 80 If any pharmaceutical producing enterprises, pharmaceutical trading enterprises or medical organizations violate Article 34 of this Law and purchase medicines from enterprises without the Pharmaceutical Production License or Pharmaceutical Trade License, they shall be ordered to amend themselves, have their unlawfully purchased medicines confiscated, and be concurrently fined the sum of money more than two but less than five times the value of the unlawfully purchased medicines. If they have obtained any unlawful income, the unlawful income shall be confiscated; if the circumstances are serious, their Pharmaceutical Production License, Pharmaceutical Trading License or Practicing Permit of Medical Organizations shall be revoked.第八十一条 进口已获得药品进口注册证书的药品，未按照本法规定向允许药品进口的口岸所在地的药品监督管理部门登记备案的，给予警告，责令限期改正；逾期不改正的，撤销进口药品注册证书。 Article 81 Those who import pharmaceuticals with a pharmaceutical import registration document and fail to register according to this Law at the pharmaceutical supervisory and administrative department at the location of the port allowed for pharmaceutical import, shall be served a warning and be ordered to correct its mistakes within a prescribed time limit. Those who have not corrected its mistakes within the prescribed time limit shall have their registration document to import pharmaceuticals revoked.第八十二条 伪造、变造、买卖、出租、出借许可证或者药品批准证明文件的，没收违法所得，并处违法所得一倍以上三倍以下的罚款；没有违法所得的，处二万元以上十万元以下的罚款；情节严重的，并吊销卖方、出租方、出借方的《药品生产许可证》、《药品经营许可证》、《医疗机构制剂许可证》或者撤销药品批准证明文件；构成犯罪的，依法追究刑事责任。 Article 82 Those who forge, alter, trade, lease or lend licenses or pharmaceutical approval certificates, shall have their unlawful income confiscated and be concurrently fined the sum of money more than two but less than three times the amount of the unlawful income. If the party has not obtained unlawful income yet, it will be fined more than 20,000 but less than 100,000 RMB; if the circumstances are serious, the Pharmaceutical Production License, Pharmaceutical trading License or Dispensing Permit of Medical Organizations of the seller, lessor or lender shall be revoked, or the pharmaceutical approval certificate shall be recalled. Those whose acts constitute a crime shall be investigated for criminal liabilities.第八十三条 违反本法规定，提供虚假的证明、文件资料样品或者采取其他欺骗手段取得《药品生产许可证》、《药品经营许可证》、《医疗机构制剂许可证》或者药品批准证明文件的，吊销《药品生产许可证》、《药品经营许可证》、《医疗机构制剂许可证》或者撤销药品批准证明文件，五年内不受理其申请，并处一万元以上三万元以下的罚款。 Article 83 Those who violate this Law by providing false certificates or samples of documents, or obtaining the Pharmaceutical Production License, the Pharmaceutical Trading License, the Dispensing Permit of Medical Organizations or pharmaceutical approval certificates through cheating, shall have their Pharmaceutical Production License, Pharmaceutical Trade License, or Dispensing Permit of Medical Organizations revoked, have their pharmaceutical approval certificates revoked, have their application rejected for five years, and have a concurrent fine of more than 10,000 but less than 30,000 RMB be imposed upon them.第八十四条 医疗机构将其配制的制剂在市场销售的，责令改正，没收违法销售的制剂，并处违法销售制剂货值金额一倍以上三倍以下的罚款；有违法所得的，没收违法所得。 Article 84 If a medical organization sells its preparations on the market, it shall be ordered to correct its mistakes, have its unlawfully sold preparations confiscated and concurrently be fined a sum of money more than two but less than three times the value of the unlawfully sold preparations. If it has obtained any unlawful income, the unlawful income shall be confiscated.第八十五条 药品经营企业违反本法第十八条、第十九条规定的，责令改正，给予警告；情节严重的，吊销《药品经营许可证》。 Article 85 If a pharmaceutical trading enterprise violates Article 18 and Article 19 of this law, it shall be ordered to amend itself and be served a warning. If the circumstances are serious, its Pharmaceutical Trading License shall be revoked.第八十六条 药品标识不符合本法第五十四条规定的，除依法应当按照假药、劣药论处的外，责令改正，给予警告；情节严重的，撤销该药品的批准证明文件。 Article 86 A medicine whose mark is not in conformity with Article 54 of this Law shall be handled as fake medicine or medicine of inferior quality. In addition, a correction shall be made and a warning shall be served. If the circumstances are serious, the approval certificate of this medicine shall be revoked.第八十七条 药品检验机构出具虚假检验报告，构成犯罪的，依法追究刑事责任；不构成犯罪的，责令改正，给予警告，对单位并处三万元以上五万元以下的罚款；对直接负责的主管人员和其他直接责任人员依法给予降级、撤职、开除的处分，并处三万元以下的罚款； Article 87 A pharmaceutical inspection institution which produces false inspection reports, where the circumstances are so serious as to constitute a crime, shall be investigated for criminal liabilities; if a crime is not constituted, it shall be ordered to amend and be served a warning. The institution shall be concurrently imposed a fine of more than 30,000 but less than 50,000 RMB, and the person-in-charge and other personnel directly liable shall be demoted, dismissed from their posts, or expelled according to law, and shall be concurrently be fined less than 30,000RMB.第八十八条 本法第七十三条至第八十七条规定的行政处罚，由县级以上药品监督管理部门按照国务院药品监督管理部门规定的职责分工决定；吊销《药品生产许可证》、《药品经营许可证、《医疗机构制剂许可证》、医疗机构执业许可证书或者撤销药品批准证明文件的，由原发证、批准的部门决定。 Article 88 The decision to impose administrative sanctions stipulated from Article 73 to Article 87 by this Law shall be made by the pharmaceutical supervisory and administrative departments at or above the county level in conformity with the division of functions prescribed by the pharmaceutical supervisory and administrative department under the State Council. The original issue and approval departments shall decide regarding the revocation of the Pharmaceutical Production License, the Pharmaceutical Trading License, the Dispensing Permit of Medical Organizations, the practicing permit of medical organizations, and the pharmaceutical approval certificates.第八十九条 违反本法第五十五条、第五十六条、第五十七条关于药品价格管理的规定的，依照《中华人民共和国价格法》的规定处罚。 Article 89 Violations of Article 55, 56, 57 of this Law concerning the price control of pharmaceuticals shall be punished according to the Price Law of the People's Republic of China.第九条（设置申请） Article 9 (Application for Establishment)第九条具有下列条件之一的，可以参加执业医师资格考试： Article 9 Anyone who satisfies any of the following conditions may participate in the examination for the qualifications of medical practitioners:第九条血站对献血者必须免费进行必要的健康检查； Article 9 Blood stations must conduct necessary physical checkup of blood donors free of charge.第九条 药品生产企业必须按照国务院药品监督管理部门依据本法制定的《药品生产质量管理规范》组织生产。药品监督管理部门按照规定对药品生产企业是否符合《药品生产质量管理规范》的要求进行认证；对认证合格的，发给认证证书。 Article 9 Pharmaceutical producing enterprises must organize production in accordance with the ""Standards for Quality Control of Pharmaceutical Production"" formulated by the pharmaceutical supervisory and administrative departments under the State Council on the basis of this Law. Pharmaceutical supervisory and administrative departments shall confirm whether the pharmaceutical producing enterprises have met the requirements of the ""Standards,"" and shall issue certificates to those qualified ones.第九条经婚前医学检查，对患指定传染病在传染期内或者有关精神病在发病期内的，医师应当提出医学意见；准备结婚的男女双方应当暂缓结婚。 Article 9 Physicians shall, after pre-marital medical examination, give medical advice to those who are in the infective period of any target infectious disease or who are in the morbid period of any re-levant mental disease; both the male and female planning to be married shall postpone their marriage for the time being.第九条申请办理中药品种保护的程序：? Article 9 Procedures of application for protection of the variety of traditional Chinese medicines:第九条直属检验检疫局应当在5个工作日内完成对申请单位提交的申请的书面审核。申请材料不齐的，应当要求申请单位补正。 Article 9 The administration of inspection and quarantine directly under the GAQSIQ shall complete the assessment on written application as submitted by an applicant within five workdays; in case the application materials are incomplete, the applicant shall make supplement as required.
