Q：
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What conditions do enterprises engaged in drug wholesale activities need to meet?
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A：
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Enterprises engaged in drug wholesale activities shall meet the following conditions:
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Having quality management organization and personnel suitable for its business scope; The legal representative, main person in charge, quality manager, quality management department head of the enterprise etc. meet the prescribed conditions;
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Having pharmacists or other pharmaceutical technicians who have been certified according to law;
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Having self-operated warehouses, business sites and facilities and equipment suitable for its business variety and scale, and it has modern logistics facilities and equipment for the warehousing, transmission, sorting, shelving and discharging of drugs;
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Having quality management system to ensure the quality of drugs and an information management system covering the whole process of drug management, quality control and traceability, and meets the requirements of drug trading quality management standards.
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Q：
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What conditions do enterprises engaged in drug retail activities need to meet?
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A：
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Enterprises engaged in drug retail activities shall meet the following conditions:
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Those engaged in the operation of prescription drugs or Class A over-the-counter drugs shall be equipped with legally qualified pharmacists or other pharmaceutical technicians who are suitable for the scope and variety of business in accordance with regulations. Those who only operate Class B over-the-counter drugs may be equipped with drug sales personnel who have passed the examination organized by the drug regulatory department of the city divided into districts;
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Having business sites, equipment, display, storage facilities and a hygienic environment suitable for the drugs business; Where other commodities (non-drugs) are business at the same time, display and storage facilities shall be set up separately from drugs; Those engaged in drug retail activities in supermarkets and other places shall have an independent business area;
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Having quality management organization and personnel suitable for the drugs business; The legal representative, main person in charge, quality manager, quality management department head of the enterprise etc. meet the prescribed conditions;
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Having quality management system that ensures the quality of drugs, an information management system that meets the requirements of quality management and traceability, and meets the requirements of drug trading quality management standards.
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Q：
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What materials are required to apply for the Drug Business License?
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A：
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To establish a drug business enterprise, it shall apply to the local drug regulatory department at or above the county level for a drug trading License after obtaining a business license and submit the following materials:
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Application Form for Drug Business License;
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The quality management organization and the main person in charge, quality person in charge, quality management department in charge of education, work experience related materials;
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Qualification certificates and employment documents of pharmacists or other pharmaceutical technicians;
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Materials related to the mode and scope of drug business;
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Drug quality management rules and regulations, as well as a list of key facilities and equipment such as display and warehousing;
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Information on the business sites, equipment, storage facilities, and surrounding sanitary environment, as well as the layout plan of the business premises and warehouse and materials related to property rights or usage rights;
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Other materials required by laws and regulations.
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Q：
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What are the items specified in the Drug Business License?
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A：
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The items specified in the Drug Distribution License are divided into licensing items and registration items. License items refer to business address, business scope, business mode, and warehouse address. The registered items refer to the name of the enterprise, the unified social credit code, the legal representative, the main person in charge, the quality person in charge, etc.
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Q：
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What should enterprises do when the validity period of the Drug Business License expires?
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A：
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If the validity period of the Drug Business License expires and it is necessary to continue operating drugs, the drug business enterprise shall submit a re-examination and issuance application to the issuing authority between six months and two months before the expiration of the validity period.
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FAQ
