内蒙古出新规严管自助售药机和自动售械机

Core Viewpoint - The Inner Mongolia Autonomous Region has issued regulations for the management of self-service medicine and medical device vending machines to ensure the safety, effectiveness, and accessibility of medications and medical devices for the public [1][2]. Group 1: Regulations for Self-Service Medicine Vending Machines - The regulations define the qualifications for setting up self-service medicine vending machines, allowing only retail pharmacies with a valid drug business license to operate them [1]. - The sales range for self-service medicine vending machines is limited to Class B non-prescription drugs, explicitly prohibiting the sale of prescription drugs and Class A non-prescription drugs [1]. - The vending machines must be equipped with features such as automatic temperature and humidity monitoring, remote alarms, safety monitoring, drug traceability, and online pharmaceutical services [1]. Group 2: Regulations for Automatic Medical Device Vending Machines - The regulations stipulate that the storage and sales processes for automatic medical device vending machines must comply with quality management standards for medical device operations, limited to devices for personal use [2]. - The vending machines must meet strict conditions, including temperature and humidity monitoring, full video surveillance, issuance of sales receipts, and information traceability [2]. - Companies operating these machines are required to have dedicated personnel for daily maintenance and quality management to ensure the entire process of storage, sales, and traceability is controllable [2]. Group 3: Regulatory Oversight and Collaboration - The regulations clarify the local regulatory responsibilities of drug supervision departments and establish a collaborative regulatory mechanism across regions and departments [2]. - There is an emphasis on building a system for information sharing, joint inspections, and mutual recognition of results to create a coordinated regulatory environment [2].