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第一条:为促进广东省药品批发、零售连锁企业(以下简称企业)落实药品经营质量管理主体责任,更好地发挥质量负责人在企业药品质量管理体系中的关键作用,根据《药品管理法》、《药品经营许可证管理办法》、《药品经营质量管理规范》等法律法规,制定本办法。第二条:本办法所称质量负责人,是指由企业任命,并经食品药品监督管理部门核准,在企业《药品经营许可证》“质量负责人”项登记的企业高层管理人员。第三条:本规定适用于广东省内药品批发企业和药品零售连
Article 1 In order to promote the responsibility of the pharmaceutical wholesale and retail chain enterprises (hereinafter referred to as the “enterprises”) in Guangdong Province for the implementation of the main responsibility for the quality management of pharmaceuticals and give better play to the key role of quality managers in the quality control system for pharmaceuticals of enterprises, “”, “Drug business license management approach”, “drug quality management practices” and other laws and regulations, the development of this approach. Article 2: The term “person in charge of quality” as mentioned in the present Measures refers to the top management of an enterprise appointed by the enterprise and approved by the food and drug supervision and administration department and registered in the enterprise’s “Drug Administration License” and “Quality Manager”. Article 3: These Provisions shall apply to drug wholesalers and drug retailers in Guangdong Province