Hong Kong Drug Licence Applications and Acquisitions · RGYS|Global Licensing and Compliance Service Provider
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HONG KONG DRUG LICENSING

Can the same company apply for both a Hong Kong pharmaceutical licence and an import and export 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.

Drug Office, Department of Health Chinese Medicines Board

Q488 · Category J: Cross-border pharmaceuticals and industry practice (Q451-Q500)
Yes. Under the Pharmacy and Poisons Ordinance (Cap. 138), the pharmaceutical licence and import/export licences may be applied for and held by the same corporate entity. The licence holder must meet the relevant requirements for facilities, personnel qualifications and management, and ensure that the storage, transport and sale of medicines comply with the law. Rengangyongsheng (Hong Kong) Limited recommends that businesses consolidate their application processes and manage compliance centrally, which can help improve operational efficiency and reduce regulatory risks.

📘 Regulatory basis

Sections 17 and 20 of the Pharmacy and Poisons Ordinance (Cap.138)

📗 Drew Tang's recommendations

Holding two licences in the same company can simplify management; business structures should be planned appropriately.

📕 Risk notice

Misuse of a licence or operating beyond its scope may lead to enforcement risks

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