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

Can I engage a third-party logistics company (3PL) to store and transport my medicines? If so, how does the application process differ?

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

Q231 · Category E: Application Process and Approval Procedures (Q201-Q250)
Yes, you may outsource medicine storage and/or transport to a suitably qualified third-party logistics provider (3PL). This is a very common business model in the industry, particularly for companies seeking to operate an asset-light business. If you choose this approach, your application process will change significantly. You will no longer need to lease and fit out a medicine warehouse yourself. Instead, you will need to enter into a detailed service contract with a 3PL company that already holds a valid Wholesale Dealer Licence for medicines. You must submit this contract with your licence application and clearly define the responsibilities of your company and the 3PL. You will still need to establish a Hong Kong company and appoint an RP, but the RP's main responsibility will shift from managing a physical warehouse to overseeing and auditing the 3PL's service quality, ensuring that its operations comply with GSDP requirements and your company's SOPs. The Department of Health may conduct on-site inspections at your office and the 3PL's warehouse, either at the same time or separately.

📘 Regulatory basis

The Code of Practice for Wholesale Dealers has a dedicated section on “Outsourced Activities”. It expressly provides that the licence holder (that is, you) retains ultimate responsibility for any outsourced activity, must ensure that the contractor (3PL) is capable of providing compliant services, and must effectively oversee it.

📗 Drew Tang's recommendations

Choosing a reliable 3PL partner is crucial. RGYS may assist with document preparation and project coordination within the written scope of services; the respective responsible parties must verify personnel qualifications and statutory roles and take responsibility for professional judgements, while approval is determined independently by the competent authority. We will assist you in conducting due diligence, selecting the partner best suited to your business needs, and drafting a Technical Agreement that clearly defines rights and responsibilities and meets regulatory requirements. This agreement will be one of the key documents for the success of your application.

📕 Risk notice

The greatest risk is thinking that outsourcing everything will solve the problem. If you believe you can relax once logistics have been outsourced, you are seriously mistaken. If your 3PL partner is found to have committed serious breaches during a subsequent inspection, you, as the commissioning party and licence holder, may also be legally liable, and your licence may likewise be suspended or revoked. Ongoing supplier audits and quality oversight are therefore essential.

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