Handling drugs requiring cold-chain management (such as vaccines and biologics) imposes far stricter requirements on warehouse facilities and operating procedures than handling ambient-temperature drugs. When applying for a licence, you must demonstrate to the Department of Health that you have full cold-chain management capabilities. For the warehouse, you must have dedicated, validated refrigeration equipment (usually refrigerators or cold rooms maintained at 2–8°C). This equipment must have an independent, continuous temperature and humidity monitoring and recording system with an alarm function. Your SOPs must contain dedicated sections describing in detail the entire process for receiving, storing, picking, packing and transporting cold-chain products. You must use validated refrigerated transport containers and data loggers, and ensure that the temperature remains within the required range at every stage from your warehouse to the customer. During an on-site inspection, inspectors will examine your cold-chain facilities and procedures in great detail.
HONG KONG DRUG LICENSING
For medicines requiring cold chain transport, what special requirements apply to the warehouse and processes when applying for a licence?
A complete explanation of the regulatory basis, Drew Tang’s recommendations and risk alerts. The original material dates from 2025; read it alongside the latest official requirements.
Original guide, 2025 edition: These FAQs are provided for topic-based reference and have not all been individually checked against current rules. Please confirm fees, personnel, renewal, changes and product requirements against the professional in-depth guide for the relevant licence type and the official requirements in force at the time.
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