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HONG KONG DRUG LICENSING

As the RP of a pharmaceutical wholesale dealer, am I legally responsible for the company's business decisions, such as pricing and marketing strategy?

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

Q132 · Category C: Eligibility and Personnel Requirements (Q101-Q150)
No. The legal responsibilities of an RP focus mainly on technical operations relating to medicine quality, safety and compliance. Your core responsibility is to ensure that the company strictly complies with the Pharmacy and Poisons Ordinance and GDP at every stage, including procurement, storage, distribution and documentation. You are responsible for matters such as the legality of medicine sources, compliance of storage conditions, completeness of distribution records and effectiveness of the pharmacovigilance system. Commercial decisions, such as medicine pricing, marketing activities and sales targets, are usually handled by the company’s management or business department. Provided these commercial activities do not breach relevant laws such as those on medicine advertising or competition, the RP is not legally responsible for their commercial success or failure.

📘 Regulatory basis

The Code of Practice for Holder of Wholesale Dealer Licence clearly defines the scope of the RP’s responsibilities, which centre mainly on the handling of medicines and quality assurance. The RP’s role is that of technical supervisor, not commercial decision-maker.

📗 Drew Tang's recommendations

We recommend clearly distinguishing the RP’s technical duties from their commercial duties in the appointment letter and job description. This helps the RP focus on their core compliance work and provides a clear framework for allocating responsibilities when responding to regulatory enquiries or conducting internal audits.

📕 Risk notice

Although the RP is not responsible for commercial decisions, if a commercial decision leads to non-compliant operations—for example, procuring medicines through illegal channels to reduce costs—the RP may still be liable for failing in their oversight duties if they knew about it but did not report it or effectively prevent it. The RP cannot evade their statutory compliance oversight responsibilities by saying, “It was the owner's decision”.

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