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滋补保健类中药材经营监管法律规制研究

The Research on Supervision Regulation of Traditional Chinese Herbal Medicine Management

【作者】 张琳

【导师】 林彦;

【作者基本信息】 上海交通大学 , 法律硕士·宪法与行政法学(专业学位), 2015, 硕士

【摘要】 中药材的经营管理对保障中药材在流通过程中的质量安全具有重要意义,对中药材经营行为实施有效监管,直接关系到公众生命健康权益的维护和保障。近年来,随着经济发展和公众保健意识的提升,滋补保健类中药材的市场需求不断增长,除了城乡集贸市场以外,城市中经营此类中药材的经营者也在逐渐增多。《药品管理法》及相关法律规范将滋补保健类中药材的经营主体分为“药品经营企业”和“非药品经营单位”两类,对于前者实行严格的市场准入制度和药品经营质量管理规范制度,而对于后者则无需取得《药品经营许可证》即可经营滋补保健类中药材。本文通过实证调研,归纳分析了目前滋补保健类中药材经营监管中存在的法律依据不足、标准缺失、监管方式落后等问题,并对如何进一步完善滋补保健类中药材经营监管法律制度提出相关建议。

【Abstract】 The management of Chinese herbal medicines business is critical for assuring its quality in the process of the circulation. Regulatory towards herbal medicines business is linked with the maintenance and assurance of the well being and health of the public. Nowadays, the market needs of the herbal tonic have risen as the development of social economy and public health care awareness. Other than in the bazaars of countryside, the number of business persons in the city has also increased. In line with The Medication Administration Law of PRC and relevant legal code, Herbal tonic business entity can be categorized as medication sale enterprise and the seller who doesn’t acquire the medication sale license. The front one is demanded to strictly follow the market access system, however, the latter one is not necessarily subject to the system.This essay concludes and analyses the defects within the supervision of herbal tonic business such as lack of legal basis and criteria as well as the original supervision. At the same point, the essay brings up some suggestion in terms of how to improve the law of the supervision of the Chinese herbal medicines.

【关键词】 中药材经营监管法律规制
【Key words】 Chinese herbal medicinemanagementsupervisionregulation
  • 【分类号】D922.16
  • 【被引频次】1
  • 【下载频次】126
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