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HONG KONG DRUG LICENSING

How should we respond if a law enforcement agency, such as Hong Kong Customs or the police, asks to inspect our medicine distribution records?

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

Q389 · Category H: Licensed operations and routine regulatory oversight (Q351–Q400)
You must cooperate with lawful requests from law enforcement agencies, while also following procedures to protect the legitimate interests of the company and its customers. The appropriate steps are: 1. Verify identity and authority: Politely ask the officers to show their identification and search warrant or other relevant legal authorisation. You are entitled to verify that they have lawful authority. 2. Contact management and legal counsel: Immediately notify senior management and/or legal counsel so they are aware of the situation and can provide guidance. 3. Clarify the scope and accompany the officers: Establish clearly which records they wish to inspect (for example, for a specific medicine, period or customer). Assign a senior employee to accompany them throughout the inspection, without obstructing their work. 4. Provide copies, not originals: Where possible, provide copies rather than originals. If the officers insist on taking originals, require a detailed receipt listing all documents taken. 5. Record the process: Keep a detailed record of the incident, including the officers’ names and departments, their arrival and departure times, and a list of all documents inspected or taken.

📘 Regulatory basis

Although medicines legislation requires you to keep records, other laws, such as the Criminal Procedure Ordinance, empower law enforcement agencies to inspect and seize evidence in certain circumstances. At the same time, you are responsible for protecting customer information under the Personal Data (Privacy) Ordinance, unless disclosure is required by law.

📗 Drew Tang's recommendations

We recommend that the company prepare an SOP in advance for responding to enforcement inspections and train key staff. Keeping all distribution records complete, accurate and readily retrievable will enable the required information to be provided quickly and accurately in such circumstances, avoiding unnecessary suspicion caused by disorganisation. If you are unsure how to proceed, it is prudent to delay and seek advice from legal counsel.

📕 Risk notice

Obstructing enforcement officers in the execution of their duties is a criminal offence. However, handing over large volumes of records containing commercially sensitive information and customer privacy data to others without verifying their authority is also irresponsible. It is essential to strike a balance between cooperation and caution. An inappropriate response may expose the company to legal risks or reputational damage.

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