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

I plan to establish a company that will trade in medicine imports and exports only, with no physical sales in Hong Kong. Do I still need to arrange an interview for the RP?

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

Q119 · Category C: Applicant eligibility and personnel requirements (Q101–Q150)
Yes, this is absolutely required. If you are applying for a Wholesale Dealer Licence, you must nominate a qualified Responsible Person (RP), regardless of whether your business model is purely import/export trading (so-called “trans-shipment trade”) or includes local distribution. The RP must also pass an interview with the Pharmacy and Poisons Board (PPB). This is because, even when medicines are not physically sold in Hong Kong, their storage, trans-shipment and documentation in Hong Kong are still strictly regulated under Hong Kong's medicines legislation. The RP is responsible for ensuring that these activities fully comply with the requirements and for preventing counterfeit or substandard medicines from entering global markets through Hong Kong's trading system. The PPB therefore uses the interview to confirm that the RP has the knowledge and ability required to supervise these activities.

📘 Regulatory basis

The licence conditions for any entity holding a Wholesale Dealer Licence require an RP accepted by the PPB. The business scope (local distribution or import/export) may affect the emphasis of the interview, but does not exempt the applicant from the interview itself.

📗 Drew Tang's recommendations

For clients specialising in import and export, our RP interview coaching places particular emphasis on relevant laws and operational practices, such as the application process for import and export licences, requirements for the transit and storage of medicines in Hong Kong, the application of Good Distribution Practice (GDP) to trading activities, and handling customs inspections. This helps RPs give more focused and professional answers in interviews.

📕 Risk notice

Do not assume that “trading only, with no involvement in the local market” means you can apply lower compliance standards. As a free port, Hong Kong also strictly regulates the re-export trade in medicines. If the RP demonstrates ignorance of import and export regulations at an interview, the PPB may consider that the company cannot effectively manage supply-chain risks and refuse its licence application.

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