中国医疗行业法律法规中英数据库
第六十六条 国务院和省、自治区、直辖市人民政府的药品监督管理部门应当定期公告药品质量抽查检验的结果；公告不当的，必须在原公告范围内予以更正。 Article 66 The pharmaceutical supervisory and administrative departments under the State Council and of the provinces, autonomous regions and municipalities directly under the central government shall regularly promulgate the results of sampling examinations and inspections on the quality of pharmaceuticals, and shall, in the case of improperly published statements, amend such statements in the original published documents.第六十七条 当事人对药品检验机构的检验结果有异议的，可以自收到药品检验结果之日起七日内向原药品检验机构或者上一级药品监督管理部门设置或者确定的药品检验机构申请复验，也可以直接向国务院药品监督管理部门设置或者确定的药品检验机构申请复验。受理复验的药品检验机构必须在国务院药品监督管理部门规定的时间内作出复验结论。 Article 67 If a party concerned disagrees with the inspection decision made by the inspection institutions, it may apply for re-inspection to the original inspection institutions or ones established or appointed by the pharmaceutical supervisory and administrative departments of superior levels within seven days from the date of receiving the pharmaceutical inspection decision, and may directly apply for re-inspection to the inspection institutions established or appointed by the pharmaceutical supervisory and administrative department under the State Council. The inspection institutions which have accepted the re-inspections shall conclude the re-inspections within the time limit prescribed by the pharmaceutical supervisory and administrative department under the State Council.第六十九条 地方人民政府和药品监督管理部门不得以要求实施药品检验、审批等手段限制或者排斥非本地区药品生产企业依照本法规定生产的药品进入本地区。 Article 69 The local people's governments and pharmaceutical supervisory and administrative departments shall not restrict or exclude the entrance of pharmaceuticals produced according to this Law by pharmaceutical producing enterprises in other regions of the country through the excuse of conducting inspection , examination and approval of the pharmaceuticals.第七条（医疗机构评审制度） Article 7 (The Appraisal and Examination System for Medical Institutions)第七条符合下列条件之一的中药品种，可以申请二级保护：? Article 7 All varieties of traditional Chinese medicines conforming with 1 of the following requirements can apply for Grade 2 protection:第七条医师可以依法组织和参加医师协会。 Article 7 Doctors may organize and join the doctors’ association according to law.第七条医疗保健机构应当为公民提供婚前保健服务。 Article 7 Medical and health institutions shall provide citizens with pre-marital health-care services. 第七条 开办药品生产企业，须经企业所在地省、自治区、直辖市人民政府药品监督管理部门批准并发给《药品生产许可证》， Article 7 The establishment of a pharmaceutical producing enterprise must be approved by and issued a Pharmaceutical Production License by the pharmaceutical supervisory and administrative department of the province, autonomous region, or municipality directly under the Central government in which the enterprise is located.第七条三类进口单位包括： Article 7 The importers in Category C shall comprise:第七条 中国红十字会使用白底红十字标志。 Article 7 The Red Cross Society of China shall use the sign of the Red Cross against a white background.第七条国家鼓励国家工作人员、现役军人和高等学校在校学生率先献血，为树立社会新风尚作表率。 Article 7 The State encourages state functionaries, active-duty service personnel and students in institutions of higher learning to take the lead in blood donation to set a role model in new social tendency.第七条 精神药品的原料和制剂的生产单位必须建立严格的管理制度， Article 7 The units that produce raw materials of psychotropic drugs and the units that produce psychotropic drugs must establish a strict control system.第七条 在中华人民共和国领域内的一切单位和个人，必须接受医疗保健机构、卫生防疫机构有关传染病的查询、检验、调查取证以及预防、控制措施，并有权检举、控告违反本法的行为。 Article 7. Any unit or individual on the territory of the People's Republic of China must respond to inquiries by medical care and health institutions and anti-epidemic agencies on infectious diseases and accept their examinations and investigations for certification as well as their preventive and control measures, and shall have the right to inform the authorities or file charges against any violation of this Law.第七十条 药品监督管理部门及其设置的药品检验机构和确定的专业从事药品检验的机构不得参与药品生产经营活动，不得以其名义推荐或者监制、监销药品。 Article 70 Pharmaceutical supervisory and administrative departments and the pharmaceutical inspection institutions they have established, as well as the institutions exclusively engaged in pharmaceutical inspection they have appointed, shall not participate in pharmaceutical production and trade, and shall not endorse or supervise the production and sale of pharmaceuticals in their own names.第七十一条 国家实行药品不良反应报告制度。药品生产企业、药品经营企业和医疗机构必须经常考察本单位所生产、经营、使用的药品质量、疗效和反应。 Article 71 A reporting system over any adverse reactions of pharmaceuticals shall be practiced by Sstate. Pharmaceutical producing enterprises, pharmaceutical trading enterprises, and medical institutions shall conduct regular surveys on the quality, curative effects and adverse reactions of the pharmaceuticals they have produced, traded or used.第七十二条 药品生产企业、药品经营企业和医疗机构的药品检验机构或者人员，应当接受当地药品监督管理部门设置的药品检验机构的业务指导。 Article 72 The organs or personnel in charge of pharmaceutical inspection in pharmaceutical producing enterprises, pharmaceutical trading enterprises and medical organizations shall receive operational guidance from the pharmaceutical inspection institutions established by local pharmaceutical supervisory and administrative departments. 第七十三条 未取得《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》生产药品、经营药品的，依法予以取缔，没收违法生产、销售的药品和违法所得，并处违法生产、销售的药品（包括已售出的和未售出的药品，下同）货值金额二倍以上五倍以下的罚款；构成犯罪的，依法追究刑事责任。 Article 73 Those who produce or trade in medicines without obtaining a Pharmaceutical Production License, Pharmaceutical Trade License, or Dispensing Permit of Medical Organizations, shall be placed under ban, have the unlawfully produced and sold medicines and any unlawful income confiscated, and may concurrently be fined a sum of money more than two but less than five times the value of the medicines unlawfully made or sold (including both sold and unsold pharmaceuticals, which also applies below). Those whose acts constitute a crime shall be investigated for criminal liabilities.第七十四条 生产、销售假药的，没收违法生产、销售的药品和违法所得，并处违法生产、销售药品货值金额二倍以上五倍以下的罚款；有药品批准证明文件的予以撤销，并责令停产、停业整顿；情节严重的，吊销《药品生产许可证》、《药品经营许可证》或者《医疗机构制剂许可证》；构成犯罪的，依法追究刑事责任。 Article 74 Those who produce and sell fake medicines shall have his unlawfully produced or sold medicines and any unlawful income confiscated, and concurrently be fined a sum of money more than two but less than five times the value value of the medicines unlawfully produced and sold. Those who have an approval certificate of pharmaceuticals shall have the certificate revokeded, and be ordered to suspend production or business operations pending rectification; if the circumstances are serious, the party shall have Pharmaceutical Production License, or Pharmaceutical Trade License or Dispensing Permit of Medical Organizations revoked. Those whose acts constitute a第七十五条 生产、销售劣药的，没收违法生产、销售的药品和违法所得，并处违法生产、销售药品货值金额一倍以上三倍以下的罚款；情节严重的，责令停产、停业整顿或者撤销药品批准证明文件、吊销《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》；构成犯罪的，依法追究刑事责任。 Article 75 Those who produce and sell medicines of inferior quality shall have his unlawfully made and sold medicines and any unlawful income confiscated, and be concurrently fined the sum of money more than two but less than three times the value of the medicines unlawfully made or sold; if the circumstances are serious, the party shall be ordered to suspend production or business pending rectification, or have thepharmaceutical approval certificate revoked and his Pharmaceutical Production License, or Pharmaceutical Trade License or Dispensing Permit of Medical Organizations revoked. Those whose acts constitute a crime will be investigated for criminal liabilities.第七十六条 从事生产、销售假药及生产、销售劣药情节严重的企业或者其他单位，其直接负责的主管人员和其他直接责任人员十年内不得从事药品生产、经营活动。 Article 76 The person-in-charge or personnel directly liable in the enterprise or other unit which produces and sells fake medicines or produces and sells pharmaceuticals of inferior quality shall not be permitted to engage in the production and trade of pharmaceuticals for ten years, if the circumstances are serious.第七十七条 知道或者应当知道属于假劣药品而为其提供运输、保管、仓储等便利条件的，没收全部运输、保管、仓储的收入，并处违法收入百分之五十以上三倍以下的罚款；构成犯罪的，依法追究刑事责任。 Article 77 Those who provide facilities including transportation, preservation and storage that have been or should have been aware of the fakery or inferior quality of the pharmaceuticals, shall have the entirety of his income from such transportation, preservation and storage confiscated, and concurrently be fined a sum of money more than 50% but less than three times the value of the unlawful income. Those whose acts constitute a crime shall be investigated for criminal liabilities.第七十八条 对假药、劣药的处罚通知，必须载明药品检验机构的质量检验结果；但是，本法第四十八条第三款第（一）、（二）、（五）、（六）项和第四十九条第三款规定的情形除外。 Article 78 The notice of penalties on fake medicines and medicines of inferior quality shall indicate the inspection results of the inspection institution. However, this does not apply to the circumstances prescribed by Article 48(3)(a)(b)(e)(f) and Article 49 (3) of this Law.第七十九条 药品的生产企业、经营企业、药物非临床安全性评价研究机构、药物临床试验机构未按照规定实施《药品生产质量管理规范》、《药品经营质量管理规范》、药物非临床研究质量管理规范、药物临床试验质量管理规范的，给予警告，责令限期改正；逾期不改正的，责令停产、停业整顿，并处五千元以上二万元以下的罚款；情节严重的，吊销《药品生产许可证》、《药品经营许可证》和药物临床试验机构的资格。 Article 79 Pharmaceutical producing enterprises, trading enterprises, pharmaceutical non-clinical safety appraisal research institution, and pharmaceutical clinical testing institutions, shall be served a warning and be ordered to amend themselves within a prescribed time limit if they do not carry out the stipulations of the ""Quality Control Standard of Pharmaceutical Production,"" the ""Quality Control Standard of Pharmaceutical Trade,"" the quality control standard of pharmaceutical non-clinical research, and the quality control standard of pharmaceutical clinical testing. Those who do not rectify their mistakes within the prescribed time limit shall be ordered to suspend production and business operations pending rectification, and be concurrently fined more than 5000 but less than 20,000 RMB. If the circumstances are serious, they shall have their Pharmaceutical Production License, Pharmaceutical Trading License or Dispensing Permit of Medical Organizations revoked.第八条（设置规划） Article 8 (The Establishment Planning)第八条国务院卫生行政部门批准的新药，按照国务院卫生行政部门规定的保护期给予保护；其中，符合本条例第六条、第七条规定的，在国务院卫生行政部门批准的保护期限届满前六个月，可以重新依照本条例的规定申请保护。? Article 8 Any new variety of traditional Chinese medicines having been duly approved by health administrative departments under the State Council are subject to protection for a period as specified by the health administrative departments under the State Council, of which, if having been found conforming with the stipulations as set forth in Article 6 and/or Article 7, can apply, following the procedures as set forth in this Decree, for protection 6 months prior to the termination of the period for protection as approved specifically by health administrative departments under the State Council.
