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HONG KONG DRUG LICENSING

How are Hong Kong pharmaceutical licence (HK-XXXXX) numbers allocated and managed?

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.

Drug Office, Department of Health Chinese Medicines Board

Q462 · Category J: Cross-border pharmaceuticals and industry practice (Q451-Q500)
The Drug Office, Department of Health, allocates Hong Kong pharmaceutical licence numbers centrally. Each approved registered medicine receives a unique number to identify it and regulate its sale on the market. The “HK-” prefix denotes Hong Kong, and the following digits are generated in registration date order. The licence number must be clearly displayed on the medicine packaging and package insert to enable tracking and verification. This numbering system helps regulators monitor the distribution and safety of medicines.

📘 Regulatory basis

Section 24 of the Pharmacy and Poisons Ordinance (Cap.138), Department of Health Drug Office administrative procedures

📗 Drew Tang's recommendations

Ensure that medicine packaging and package inserts display the medicine licence number accurately to avoid administrative penalties due to incorrect labelling. Rengangyongsheng (Hong Kong) Limited can assist with packaging reviews.

📕 Risk notice

Failure to display the pharmaceutical licence number as required may result in products being withdrawn from sale, fines or even legal proceedings.

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