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HONG KONG DRUG LICENSING

I am a logistics company providing storage and transport services to licensed pharmaceutical wholesalers. Does my company need to apply for a pharmaceutical 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

Q92 · Category B: Licence types and scope of application (Q51-Q100)
Generally, if your logistics company (a third-party logistics provider, or 3PL) only provides warehouse space and transport vehicles, while ownership of the medicines and ultimate responsibility for quality management remain with your client—the licensed medicines wholesaler—your logistics company does not itself need to apply for a wholesale licence. However, your facilities and services must meet the wholesaler’s compliance requirements and be subject to its supervision and audit. This means that your warehouse must comply with GDP principles, such as temperature and humidity control and monitoring, good security and clearly defined zones. You must operate strictly in accordance with the Quality Agreement signed with your client.

📘 Regulatory basis

The Code of Practice for Licensed Wholesale Dealers allows licensees to outsource some of their functions, such as storage and transportation. However, the code expressly states that the licensee (your client) remains ultimately responsible for the quality and safety of the medicines and is responsible for ensuring that its subcontractor (you) is qualified.

📗 Drew Tang's recommendations

As a 3PL company seeking to enter pharmaceutical logistics, we strongly recommend proactively designing and managing your warehouse in accordance with GDP standards. Independent GDP certification, for example from an organisation such as SGS, can significantly enhance your appeal and credibility among pharmaceutical clients. We can provide GDP compliance consultancy and certification preparation services to help you develop this specialist market.

📕 Risk notice

If an operational error in your storage or transport processes, such as a cold-chain interruption, damage to or loss of goods, causes a medicine quality issue, your customer (the licensed wholesaler) may pursue substantial financial and legal claims against you under your contract, even if you are unlicensed. Professional SOPs and staff training are therefore essential.

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