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HONG KONG DRUG LICENSING

If my company only holds a licence but does not currently conduct any actual pharmaceutical import or export business, do I still need to maintain a qualified Responsible Person (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

Q136 · Category C: Eligibility and Personnel Requirements (Q101-Q150)
Yes, this must be maintained. A core and ongoing condition of a pharmaceutical wholesaler licence is that there must always be a Responsible Person (RP) accepted by the Pharmacy and Poisons Board (PPB). This requirement is unrelated to whether the company has any actual business volume. Even if your company has no imports or exports of medicines for a period, it remains a licensed entity under the law and must remain in a state of compliance readiness at all times. The presence of an RP is a key indicator of this readiness. The regulatory authority considers that, while the licence remains valid, the company may resume operations at any time and must therefore have a qualified professional to ensure that any potential activities are conducted within a compliant framework. The RP is also responsible for handling any legacy issues that may arise, such as enquiries or complaints concerning products sold in the past.

📘 Regulatory basis

The Conditions of Licence for a wholesaler’s licence expressly require the licence holder to continue meeting all requirements that applied when the licence was issued, including having a qualified RP. This is a basic prerequisite for the licence to remain valid.

📗 Drew Tang's recommendations

If the company plans to suspend its business for a period, we recommend agreeing a reasonable part-time or consultancy arrangement with the RP to maintain the statutory position at lower cost. You should also ensure the RP can be contacted at all times and continues to perform their minimum statutory duties (such as receiving regulatory notices). Do not leave the RP position vacant to save costs.

📕 Risk notice

Allowing the RP position to remain vacant during the licence validity period is a serious breach. If the Drug Office finds during a renewal review or surprise inspection that the company has no qualified RP, it may not only refuse renewal but also immediately initiate proceedings to revoke the licence. This is an absolute red line that must not be crossed.

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