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中华人民共和国药品管理法(双语)(7)

2014-02-28    来源:网络    【      美国外教 在线口语培训

城乡集市贸易市场不得出售中药材以外的药品持有《药品经营企业许可证》的除外。
Drugs other than Chinese medicinal materials may not be sold in the trading markets of country towns, unless a "Drug-handling Enterprise Licence" is held.

第四章医疗单位的药剂管理
CHAPTER IV ADMINISTRATION OF DRUGS IN MEDICAL TREATMENT UNITS

第十六条医疗单位必须配备与其医疗任务相适应的药学技术人员,非药学技术人员不得直接从事药剂技术工作。
[Article 16] Medical treatment units must be staffed with the number of pharmaceutical technicians appropriate to their medical treatment responsibilities. Personnel who are not pharmaceutical technicians may not be engaged directly in pharmaceutical technical work.

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".

《制剂许可证》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。
A "Dispensing 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 laid down by the department of the State Council administering health.

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.



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