中华人民共和国药品管理法(双语)(15)

作者:admin

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2014-3-6 10:20

麻醉药品、精神药品、毒性药品、放射性药品和外用药品的标签必须印有规定标志。
The labels of narcotic drugs, psychotropic drugs, poisonous drugs, radioactive drugs and drugs for external use only must bear the prescribed mark.

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.

分装药品必须附有说明书,在包装上注明品名、规格、生产企业和产品批号、分装单位和分装批号。规定有效期的药品,分装后必须注明有效期。
An instruction booklet must be attached to a repackaged drug. The product name, specifications, name of the production unit and product batch number and of the repackaging unit and repackaging batch number shall be set out clearly on the package. Where a period of efficacy has been set for the drug, when it has been repackaged, the period of efficacy must be clearly indicated.

第七章特殊管理的药品
CHAPTER VII DRUGS UNDER SPECIAL CONTROL

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.