浅析药品批发企业资质证明资料的风险管控.pdfVIP

浅析药品批发企业资质证明资料的风险管控 ＊ 陈 悦 （浙江丰元医药有限公司，杭州 310009） 中图分类号 R95 文献标志码 C 文章编号 1001-0408（2013）29-2695-03 DOI 10.6039/j.issn. 1001-0408.2013.29.03 摘 要 目的：为药品批发企业资质证明资料的日常控制性管理及规避失控风险提供参考。方法：依据相关药事法规和规范性文 件的要求，对药品批发企业在药品购销过程中发放企业资质证明资料的内容进行细化，并对失控现象及原因进行分析，提出管控 措施。结果与结论：药品批发企业提供给销售客户的资料应包括本企业证照资料和销售人员个人资质证明资料；作为供货企业的 销售客户，药品批发企业提供给供货企业的应包括加盖企业公章的药品经营许可证、营业执照等。失控现象有对本企业的资料未 采取严格的控制性管理、企业印章样式备案无管控措施等。药品批发企业应对发放的资料做到规范管理、流向清晰。具体措施有 严格做好药品采购、销售人员的授权管理及必要的限定和防伪工作；提供给销售客户留存的销售凭证样张和印章样式，必须限定 使用、逐一登记，以有效管控等。 关键词 药品批发企业；资质证明资料；风险；失控；管控 On Risk Management and Control of Qualification Proof Materials for Medicine Wholesale Enterprises CHEN Yue（Zhejiang Fengyuan Medicine Co. ，Ltd. ，Hangzhou 310009，China ） ABSTRACT OBJECTIVE ：To provide reference for daily controlling management of qualification proof materials for medicine wholesale enterprises ，and to avoid risk of out of control. METHODS ：According to the requirements of pharmaceutical laws and regulatory documents ，the qualification proof materials for medicine wholesale enterprises should be refined during medicine pur- chase and sale process. The phenomenon of out of control for qualification proof materials was analyzed ，management and control measures were put forward. RESULTS CONCLUSIONS ：The information provided by medicine wholesale enterprises for custom- ers include license and information of the enterprise ，the qualification certification material of salesman ；the information provided by medicine wholesale enterprise for suppliers include license for pharmaceutical trading with the enterprise seal ，business licence ， etc. The phenomenon of out of control include strict controlling management of enterprise information is absent ；there was no con- trolling measure for pattern of enterprise seal as a record. Medicine wholesale enterprises should conduct standardized man