Standard No.:	T/SHSPTA 002-2023
English Name:	Specification for entrusted distribution management by drug market authorization holders
Chinese Name:	药品上市许可持有人委托销售管理规范
Chinese Classification:	C00    Standardization and quality management
Professional Classification:	T/    Social Organization Standard
ICS Classification:	03.120.10 03.120.10    Quality management and quality assurance 03.120.10
Source Content Issued by:	Shanghai Pharmaceutical Trade Association‌
Issued on:	2023-05-10
Implemented on:	2023-5-20
Status:	valid
Target Language:	English
File Format:	PDF

本文件规定了药品上市许可持有人委托销售活动中委托方、受托方及其他相关方的职责，明确了人员、过程管理、追溯体系、质量审核、药物警戒、售后管理、应急处置、变更控制、档案管理等方面的要求。
本文件适用于药品上市许可持有人委托销售过程中所涉及的经营管理活动。
本文件亦可作为中药饮片生产企业委托销售活动的执行参考依据。