第五十三条违反本法关于药品生产、药品经营的管理的其他规定的，处以警告或者罚款。

[Article 53] A violation of any other provision of this law in relation to the administration of drug production or handling will be punished by a caution or by a fine.

第五十四条本法规定的行政处罚，由县级以上卫生行政部门决定。违反本法第十五条规定、第八章有关广告管理的规定的行政处罚，由工商行政管理部门决定。

[Article 54] Any decision relating to the imposition of an administrative penalty pursuant to this law shall be made by the department administering health at above the county level. Any decision relating to the imposition of a penalty for and offence against Article 15 of this law or the provisions of Chapter VIII of this law with respect to the advertising of drugs, shall be made by the department administering industry and commerce. In relation to the penalty of ordering a drug-producing enterprise or drug-handling enterprise which is directly under the management of the Central Government or the People's Government of a province, autonomous region or municipality directly under the control of the Central Government to stop production or stop its operations for more than seven days, or of revoking its "Drug-production Enterprise Licence", or "Drug-handling Enterprise Licence", the department of the province, autonomous region or municipality under the direct control of the Central Government administering health shall submit it to the People's Government at the same level for decision.

对中央或者省、自治区、直辖市人民政府直接管辖的药品生产企业、药品经营企业处以停产、停业整顿7天以上或者吊销《药品生产企业许可证》、 《药品经营企业许可证》处罚的，由省、自治区、直辖市卫生行政部门报同级人民政府决定。对市、县或者市、县以下人民政府管辖的药品生产企业、药品经营企业处以停产，停业整顿 7天以上或者吊销《药品生产企业许可证》、《药品经营企业许可证》处罚的，由市、县人民政府卫生行政部门报同级人民政府决定。

In relation to a penalty ordering a drug-producing enterprise or drug-handling enterprise under the direct management of the People's Government at or below the city or county level to stop production or stop operations for more than seven days or of revoking its "Drug-production Enterprise Licence" or its "Drug-handling Enterprise Licence", the department of the city or county People's Government administering health shall submit the matter to the People's Government of the same level for decision.

没收的药品由卫生行政部门监督处理。

Confiscated drugs shall be disposed of under the supervision of the department responsible for health administration.

第五十五条当事人对行政处罚决定不服的，可以在接到处罚通知之日起 15 天内向人民法院起诉。

[Article 55] If a party objects to the decision to impose a penalty on him, he may, within 15 days from the date of receipt of notification of the penalty, bring an action in the People's Court. H

但是，对卫生行政部门作出的药品控制的决定，当事人必须立即执行。对处罚决定不履行逾期又不起诉的，由作出行政处罚决定的机关申请人民法院强制执行。

owever, in the case of a decision relating to drug control taken by the department responsible for health administration, the party shall immediately comply. Where the decision has not been complied with within the time limit and no action has been brought, the People's Court shall compulsorily enforce compliance upon application by the organ which made the decision.

第五十六条违反本法，造成药品中毒事故的，致害单位或者个人应当负损害赔偿责任。受害人可以请求县级以上卫生行政部门处理；当事人不服的，可以向人民法院起诉。受害人也可以直接向人民法院起诉。

[Article 56] In case of drug poisoning caused by a breach of this law, the unit or person who caused it shall be liable to pay compensation. The person suffering harm may request a department administering health at above county level to handle the matter; if the party who caused the harm objects, he or it may bring an action in the People's Court. The person suffering harm may also sue directly in the People's Court.

损害赔偿要求，应当从受害人或者其代理人知道或者应当知道之日起 1年内提出；超过期限的，不予受理。

A demand to be compensated for damage shall be submitted within a period of one year from the date on which the victim or his representative became aware or ought to have become aware of it. When this period has expired, the claim will not be entertained.

第五十七条本法下列用语的含义是：

[Article 57] The expressions used in this law are defined as follows:

药品：指用于预防、治疗、诊断人的疾病，有目的地调节人的生理机能并规定有适应症、用法和用量的物质，

"Drug" refers to a substance used for the prevention, treatment and diagnosis of human diseases, and with the object of regulating human physiological functions, with stipulated indications, usage and dosage.

包括中药材、中药饮片、中成药、化学原料药及其制剂、抗生素、生化药品、放射性药品、血清疫苗、血液制品和诊断药品等。

It includes Chinese medicinal materials and Chinese medicines sliced and prepared for decoction, prepared Chinese medicines, chemical raw material drugs and their components, antibiotics, biochemical drugs, radioactive drugs, blood serums and vaccines, blood products, diagnostic drugs and so on.

新药指我国未生产过的药品。

"New drugs" refers to those drugs which have never been produced in this country.

辅料指生产药品和调配处方时所用的赋形剂和附加剂。

"Supplementary materials" refers to excipients and additives used in the production and making up of drugs.

药品生产企业指生产药品的专营企业或者兼营企业。

"Drug-producing enterprise" refers to those enterprises exclusively or partially engaged in the production of drugs.

药品经营企业指经营药品的专营企业或者兼营企业。

"Drug-handling enterprise" refers to those enterprises exclusively or partially engaged in the handling of drugs.

第五十八条本法所说的药品生产，不包括中药材的种植、采集和饲养。

[Article 58] The production of drugs referred to in this law does not include the cultivation and collection of raw materials for Chinese medicines or the raising of animals in relation to Chinese medicines.

第五十九条国务院卫生行政部门根据本法制定实施办法报国务院批准施行。

[Article 59] Measures for the implementation of this law will be set down by the State Council department responsible for health administration and submitted to the State Council for approval and implementation.

中国人民解放军特需药品的管理办法由国家军事主管部门制定。

Special provisions for the management of drugs in the People's Liberation Army will be laid down by the department in charge of national military affairs.

第六十条本法自一九八五年七月一日起施行。

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