中华人民共和国药品管理法(双语)(2)

作者:admin

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2014-2-25 11:02

无《药品生产企业许可证》的工商行政管理部门不得发给《营业执照》。
Without a "Drug-production Enterprise Licence", the department administering industry and commerce may not issue a "Business Licence".

《药品生产企业许可证》应当规定有效期,到期重新审查发证。具体办法由国务院卫生行政部门规定。
The "Drug-production Enterprise Licence" shall stipulate its period of validity, and at the expiry of the period the issue of the licence shall be examined afresh. Specific procedures will be determined by the State Council department responsible for health administration.

第五条开办药品生产企业必须具备以下条件:
[Article 5] The establishment of an enterprise to produce drugs must satisfy the following conditions:

(一)具有与所生产药品相适应的药师或者助理工程师以上技术人员及技术工人。
(1) It must employ pharmacists, technical personnel above the rank of assistant engineer and technical workers appropriate to the drug production carried out by the enterprise.

中药饮片加工企业没有药师或者助理工程师以上技术人员,配备熟悉药性并经县级以上卫生行政部门审查登记的药工人员。
Where an enterprise engaged in the processing of traditional Chinese medicine does not have a pharmacist or technical personnel of a rank above that of assistant engineer, it may use drug industry personnel with an intimate knowledge of drugs who have been examined and registered by a department of health administration above the county level.

(二)具有与所生产药品相适应的厂房、设施和卫生环境。
(2) It must have a factory building, facilities and a hygienic environment appropriate to its production of drugs.