中国医疗行业法律法规中英数据库
第十七条医疗单位配制制剂必须经所在省、自治区、直辖市卫生行政部门审查批准，并发给《制剂许可证》。 [Article 17] The making up of drugs by medical treatment units must be examined and approved by the department in charge of health administration in the province, autonomous region or municipality under the direct control of the Central Government where the unit is situated, which will issue a ""Dispensing Licence"".第十八条医疗单位配制制剂必须具有能够保证制剂质量的设施、检验仪器和卫生条件。 [Article 18] A medical treatment unit which makes up drugs must have adequate facilities, instruments for examination and hygienic conditions to ensure the quality of the drugs prepared.第十九条医疗单位配制的制剂，必须根据临床需要并按照规定进行质量检验；合格的，凭医生处方使用。 [Article 19] The drugs made up by medical treatment units must comply with clinical requirements and, in accordance with regulations, quality examinations must be conducted. They are only to be used if up to quality and on a doctor's prescription.第一条为加强药品监督管理，保证药品质量，增进药品疗效，保障人民用药安全，维护人民身体健康，特制定本法。 [Article 1] This law has been drawn up in order to strengthen drug control and administration, ensure the quality of drugs, enhance the efficacy of drugs, guarantee safe drug use and safeguard the physical health of the people.第二十条医疗单位购进药品，必须执行质量验收制度。 [Article 20] When a medical treatment unit purchases drugs, it must implement a system of checking the quality on delivery.第二十一条国家鼓励研究、创制新药。 [Article 21] The State encourages research into and development of new drugs.第二十二条生产新药，必须经国务院卫生行政部门批准，并发给批准文号。但是，生产中药饮片除外。 [Article 22] The production of new drugs must be approved by the department of the State Council administering health which will issue an approval number. However, the production of Chinese medicines sliced and prepared for decoction is excepted.第二十三条药品必须符合国家药品标准或者省、自治区、直辖市药品标准。 [Article 23] Drugs must comply with the national drug standard, or with the drug standard of the province, autonomous region or municipality under the direct control of the Central Government.第二十四条国务院卫生行政部门和省、自治区、直辖市卫生行政部门可以成立药品审评委员会，对新药进行审评，对已经生产的药品进行再评价。 [Article 24] The State Council department responsible for health administration and the departments of the provinces, autonomous regions and municipalities under the direct control of the Central Government administering health may establish a Drug Evaluation Committee to evaluate new drugs and re-evaluate drugs already being produced.第二十五条国务院卫生行政部门对已经批准生产的药品，应当组织调查；对疗效不确、不良反应大或者其他原因危害人民健康的药品，应当撤销其批准文号。 [Article 25] The department of the State Council responsible for administering health shall organise investigation into drugs already approved for production; where the efficacy of a drug is not reliable, the side-effects to a drug are great, or a drug is for any other reason harmful to people's health, the approval number shall be revoked.第二十六条禁止进口疗效不确、不良反应大或者其他原因危害人民健康的药品。 [Article 26] It is forbidden to import a drug if its efficacy is not reliable, if its side-effects are great, or it is for any other reason harmful to people's health.第二十七条首次进口的药品，进口单位必须提供该药品的说明书、质量标准、检验方法等有关资料和样品以及出口国（地区）批准生产的证明文件，经国务院卫生行政部门批准，方可签订进口合同。 [Article 27] Where a drug is being imported for the first time, the importing unit must submit a written description of the drug, details of its quality standards, testing and other relevant data, samples, and documentation proving that the exporting country (place) has approved production. Only when the approval of the department of the State Council administering health has been obtained may the import contract be signed.第二十八条进口的药品，必须经国务院卫生行政部门授权的药品检验机构检验；检验合格的，方准进口。 [Article 28] Imported drugs must be examined by a drug examination body so authorised by the State Council department responsible for health administration. Only when a drug passes examination will importation be permitted.第二十九条对国内供应不足的中药材、中成药，国务院卫生行政部门有权限制或者禁止出口。 [Article 29] Where the supply of Chinese medicinal materials or prepared Chinese medicine is not sufficient for the Chinese domestic market, the State Council department responsible for health administration has the power to restrict or prohibit its export.第二条国务院卫生行政部门主管全国药品监督管理工作。 [Article 2] The State Council department responsible for health administration is the body in charge of national drug control and administration.第三十条进口、出口麻醉药品和国务院卫生行政部门规定范围内的精神药品，必须持有国务院卫生行政部门发给的《进口准许证》、《出口准许证》。 [Article 30] In order to import or export narcotic drugs or psychotropic drugs which come within the scope laid down by the department of the State Council administering health, it is necessary to hold an ""Import Licence"" or ""Export Licence"" issued by the department of the State Council administering health.第三十一条新发现和从国外引种的药材，经省、自治区、直辖市卫生行政部门审核批准后，方可销售。 [Article 31] Medicinal materials which have been newly discovered or introduced from abroad may only be sold where they have been examined and approved by the department of the province, autonomous region or municipality under the direct control of the Central Government administering health.第三十二条地区性民间习用药材的具体管理办法，由国务院卫生行政部门制定。 [Article 32] Detailed provisions for the administration of local customarily used folk medicines will be laid down by the State Council department responsible for health administration.第三十三条禁止生产、销售假药。有下列情形之一的为假药： [Article 33] The production and sale of spurious drugs is prohibited. A drug is spurious if any one of the following circumstances exists:第三十四条禁止生产、销售劣药。有下列情形之一的药品为劣药： [Article 34] It is forbidden to produce or sell inferior drugs. A drug is inferior if one of the following circumstances exists:第三十五条药品生产企业、药品经营企业和医疗单位直接接触药品的工作人员，必须每年进行健康检查。患有传染病或者其他可能污染药品的疾病的患者，不得从事直接接触药品的工作。 [Article 35] Personnel of drug-producing enterprises, drug-handling enterprises and medical treatment units who come into direct contact with drugs must undergo a medical examination annually. Persons suffering from contagious diseases or any other disease that could contaminate drugs may not engage in work involving direct contact with drugs.第三十六条药品包装必须适合药品质量的要求，方便储存、运输和医疗使用。规定有效期的药品，必须在包装上注明有效期。 [Article 36] The packaging of drugs must be appropriate to the requirements of the quality of the drug and must facilitate their storage, transportation and use. Where a period of efficacy for a drug has been fixed, the period of efficacy must be clearly indicated on the package.第三十七条药品包装必须按照规定贴有标签并附有说明书。 [Article 37] Drug packages must, in accordance with regulations, be labelled and have an instruction booklet attached.第三十八条药品经营企业分装药品，必须具有与所分装药品相适应的设施和卫生条件，由药学技术人员负责，分装记录必须完整准确。 [Article 38] A drug-handling enterprise engaged in the repackaging of drugs must have equipment and hygienic conditions appropriate for the quantity of drugs repackaged. It must be under the charge of pharmaceutical technicians; records of the repackaging must be complete and precise.第三十九条国家对麻醉药品、精神药品、毒性药品、放射性药品，实行特殊的管理办法。管理办法由国务院制定。 [Article 39] The State imposes special controls on narcotic drugs, psychotropic drugs, poisons and radioactive drugs. The controls will be stipulated by the State Council.
