Regulation of the medicine industry involves multiple agencies. In addition to the main regulators, the Drug Office, Department of Health and the Chinese Medicine Council of Hong Kong, you may also deal with other bodies. For example, Hong Kong Customs regulates medicine imports and exports to ensure that all medicines in transit have valid licences and documentation. The Consumer Council has no enforcement powers, but it receives and handles consumer complaints about medicine sales and may publicly name and criticise traders for poor business practices. The Hong Kong Police Force may investigate serious criminal offences, such as selling counterfeit medicines. The Labour Department also oversees occupational safety and health in the workplace, particularly in medicine manufacturing and storage environments.
HONG KONG DRUG LICENSING
Apart from the Department of Health and the Chinese Medicine Council, which other government agencies might regulate my pharmaceutical business?
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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