中华人民共和国药品管理法(双语)(21)

作者:admin

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2014-3-11 09:16

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。
However, 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.