中国医疗行业法律法规中英数据库
第十七条 精神药品的经营单位和医疗单位应当建立精神药品收支帐目，按季度盘点，做到帐物相符，发现问题应当立即报告当地卫生行政部门，卫生行政部门应当及时查处。 Article 17 the drug dealer unit and the medical treatment unit are required to keep a balance account book of psychotropic drugs. An inventory of the drugs must be made every three months to ensure the stock conforms to the account book. Should anything suspicious is found, a report must be made promptly to the local health administrative department and the latter must make immediate investigation in the matter.第十七条被批准保护的中药品种，在保护期内限于由获得《中药保护品种证书》的企业生产；但是，本条例第十九条另有规定的除外。? Article 17 The preparation of varieties of traditional Chinese medicines granted with a protection shall be limited to enterprises issued with ""the Certificate of Variety of Traditional Chinese Medicines under Protection"" period. However, it does not include those as stipulated in Article 19 of this Decree.第十七条 因宗教信仰使用红新月标志的，其使用办法适用红十字标志的使用规定。 Article 17 Where the sign of the Red Crescent is used due to religious beliefs, the provisions on the use of the sign of the Red Cross shall apply.第十七条进口一般风险医疗器械的，实施现场检验与监督检验相结合的方式进行检验管理，其中年批次现场检验率分别为： Article 17 With respect to the import of ordinary risk medical instruments, the spot inspection shall be performed combining with surveillant inspection, and the annual rates of spot inspection of batches shall be as follows respectively:第十七条 被甲类传染病病原体污染的污水、污物、粪便，有关单位和个人必须在卫生防疫机构的指导监督下进行严密消毒后处理；拒绝消毒处理的， 当地政府可以采取强制措施。 Article 17. When the sewage, wastes and feces are contaminated with the pathogen of A Class infectious diseases, the unit or the individual concerned must carry out strict disinfection under the supervision and direction of an anti-epidemic agency; in cases of refusal to carry out disinfection, compulsory measures may be taken by the local government.第十八条（批准书有效期） Article 18 (The Validity Period of the Approval Certificate)第十八条国务院卫生行政部门批准保护的中药品种如果在批准前是由多家企业生产的，其中未申请《中药保护品种证书》的企业应当自公告发布之日起六个月内向国务院卫生行政部门申报，并依照本条例第十条的规定提供有关资料，由国务院卫生行政部门指定药品检验机构对该申报品种进行同品种的质量检验。国务院卫生行政部门根据检验结果，可以采取以下措施：? Article 18 If a given variety of traditional Chinese medicines granted with a protection by the health administrative departments under the State Council was prepared by more than 1 enterprise before its approval, those enterprises not having applied for ""the Certificate of Variety of Traditional Chinese Medicines under Protection"" shall submit its application, within 6 months as of its publication on designated specialized papers, to the health administrative departments under the State Council for issuance. The application shall be attached with reference material as stipulated in Article 10 of this Decree. The health administrative departments under the State Council shall designate a drug control institution to examine its quality, and shall take the following measures based on the results of the examination:第十八条经产前诊断，有下列情形之一的，医师应当向夫妻双方说明情况，并提出终止妊娠的医学意见： Article 18 If one of the following cases is detected in the pre-natal diagnosis, the physician shall explain the situations to the married couple and give them medical advice on a termination of gestation:第十八条 军队使用红十字标志，依照日内瓦公约及其附加议定书的有关规定执行。 Article 18 In case the armed forces use the sign of the Red Cross, the relevant provisions of the Geneva Conventions and their Additional Protocols shall apply.第十八条 药品经营企业购销药品，必须有真实完整的购销记录。购销记录必须注明药品的通用名称、剂型、规格、批号、有效期、生产厂商、购（销）货单位、购（销）货数量、购销价格、购（销）货日期及国务院药品监督管理部门规定的其他内容。 Article 18 Pharmaceutical trading enterprises shall keep accurate and complete records of purchased pharmaceuticals. Purchasing records must bear information on the pharmaceutical product's generic names, types, specifications, batches, valid periods, producing enterprises, purchasing (selling) units, purchasing (selling) quantity, purchasing and selling price, purchasing (selling) date and other contents required by the pharmaceutical supervisory and administrative department under the State Council.第十八条根据需要，国家质检总局对高风险的进口医疗器械可以按照对外贸易合同约定，组织实施监造、装运前检验和监装。 Article 18 The GAQSIQ may, as required, arrange the production supervision, pre-shipment inspection and installment surveillance over the imported high risk medical instruments as agreed in a foreign trade contract.第十八条 精神药品的进出口业务由对外经济贸易部指定的单位按照国家有关对外贸易的规定办理。 Article 18 the import and export of psychotropic drugs shall be handled by the units appointed by the Ministry of Foreign Economic Relations and Trade in accordance with the State provisions governing foreign trade.第十八条中止医师执业活动二年以上以及有本法第十五条规定情形消失的，申请重新执业，应当由本法第三十一条规定的机构考核合格，并依照本法第十三条的规定重新注册。 Article 18 Where anyone has ceased his practice of medicine for more than two years or the circumstance prescribed in Article 15 of this Law has disappeared, if he intends to apply for resumption of his practice, he should succeed in the evaluation by the institution prescribed in Article 31 of this Law and renew his registration according to the provisions of Article 13 of this Law.第十八条有下列行为之一的，由县级以上地方人民政府卫生行政部门予以取缔，没收违法所得，可以并处十万元以下的罚款；构成犯罪的，依法追究刑事责任： Article 18 Whoever commits any of the following acts shall be banned by the department of public health under the people’s government at or above the county level, the illegal gains shall be confisticated and may be concurrently imposed a fine of less than RMB 100,000 Yuan; where a crime has been constituted, criminal liability shall be investigated according to law:?第十八条 同人畜共患传染病有关的家畜家禽的传染病防治管理工作，由各级政府畜牧兽医部门负责。 Article 18. The animal husbandry and veterinary departments of governments at various levels shall be responsible for the prevention, treatment and management of infectious diseases of domestic animals and fowls related to infectious diseases common to human beings and animals.第十九条（变更、重新设置审批和分支机构的审批） Article 19 (Procedure for Examining and Approving the Alteration, Re-establishment, and for Examining and Approving the Establishment of Branches)第十九条血站违反有关操作规程和制度采集血液，由县级以上地方人民政府卫生行政部门责令改正； Article 19 A blood station that collects blood in contravention of the relevant operational procedures and rules shall be ordered by the department of public health under local people’s government at or above the county level to make a rectification;第十九条 禁止滥用红十字标志。 Article 19 Abuses of the sign of the Red Cross is prohibited.第十九条申请个体行医的执业医师，须经注册后在医疗、预防、保健机构中执业满五年，并按照国家有关规定办理审批手续；未经批准，不得行医。 Article 19 Any medical practitioner who intends to apply for opening his practice individually must, upon registration, practice medicine in an institution of medical treatment, prevention or health care for at least five years and go through examination and approval procedures according to relevant state provisions; without approval, no one may open his practice.第十九条 药品经营企业销售药品必须准确无误，并正确说明用法、用量和注意事项；调配处方必须经过核对，对处方所列药品不得擅自更改或者代用。对有配伍禁忌或者超剂量的处方，应当拒绝调配；必要时，经处方医师更正或者重新签字，方可调配。 Article 19 It is imperative for pharmaceutical trading enterprises, in the sale of pharmaceuticals, to be accurate and free of mistakes, and to provide correct directions for use, dosage and precautions. Prescriptions being dispensed must be checked. Pharmaceutical products listed in the prescription must not be presumptuously changed or substituted. Prescriptions containing incompatible substances or excessive dosages shall be rejected by the dispensary. If necessary, such prescriptions can be dispensed after they have been corrected or re-signed by the doctors who wrote them.第十九条 因医疗、教学和科研工作需要进口精神药品的，应报卫生部审查批准，发给《精神药品进口准许证》后，方可申请办理进口手续。 Article 19 Medical treatment units, medical colleges or medical science research institutions that are in need of imported psychotropic drugs must submit an application to the Ministry of Public Health for examination and approval. Only after a License for the Import of Psychotropic Drugs is issued to them can they go through import formalities.第十九条依照本法规定施行终止妊娠或者结扎手术，应当经本人同意，并签署意见。本人无行为能力的，应当经其监护人同意，并签署意见。 Article 19 Termination of gestation or performance of ligation operations practised in accordance with the provisions of this Law shall be subject to the consent and signing of the person per se. If the person per se has no capacity for civil conduct, it shall be subject to the consent and signing of the guardian of the person.第十九条对临床用药紧缺的中药保护品种，根据国家中药生产经营主管部门提出的仿制建议，经国务院卫生行政部门批准，由仿制企业所在地的省、自治区、直辖市卫生行政部门对生产同一中药保护品种的企业发放批准文号。 Article 19 Upon the proposal raised by the responsible departments at the state level in charge of the preparation and management of traditional Chinese medicines, and with the approval of health administrative departments under the State Council, relating to the replication preparation of the protected varieties of traditional Chinese medicines much in need of clinically, the health departments of the province/municipality/autonomous region, in which, the replicating enterprise is situated, may grant approval for replication preparation of the said protected variety.第十九条进口医疗器械进口时，进口医疗器械的收货人或者其代理人（以下简称报检人）应当向报关地检验检疫机构报检，并提供下列材料： Article 19 Where the medical instruments are imported, the consignee or its agent of the imported medial instruments (hereinafter referred to as the inspection applicants) shall apply for inspection to the IQ organ at the place where the customs declaration is made, and file the following materials as well:第十九条 在自然疫源地和可能是自然疫源地的地区兴办的大型建设项目开工前，建设单位应当申请当地卫生防疫机构对施工环境进行卫生调查，并根据卫生防疫机构的意见，采取必要的卫生防疫措施。 Article 19. Before a large construction project is started in an area which is a natural infection focus or a possible natural infection focus, the construction unit shall apply to the local anti-epidemic agency for a sanitary investigation of the construction environment and take necessary anti-epidemic measures according to the requirements of the anti-epidemic agency.
