These two Ordinances are complementary parts of Hong Kong’s pharmaceutical control system, but they regulate different subjects and serve different purposes. The Pharmacy and Poisons Ordinance (Cap. 138) provides a broad framework for regulating the quality, safety and distribution of all “pharmaceutical products” to protect public health. It establishes the pharmaceutical licensing and product registration systems. The Dangerous Drugs Ordinance (Cap. 134), by contrast, is a more specifically targeted criminal law aimed at combating the illegal trafficking, manufacture and abuse of dangerous drugs. “Dangerous drugs” controlled under it are substances with a high potential for addiction and abuse, such as morphine, cocaine and ketamine (“K”). Many dangerous drugs are also legitimate medicines for medical use, such as morphine for pain relief, and are then subject to both Ordinances. For example, a company wishing to deal lawfully in morphine needs a wholesaler licence under Cap. 138 and a separate dangerous drugs licence from the Department of Health under Cap. 134; its storage and record-keeping must also comply with more stringent requirements.
HONG KONG DRUG LICENSING
What are the differences and links between the Dangerous Drugs Ordinance (Cap. 134) and the Pharmacy and Poisons Ordinance?
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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