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What specific responsibilities does the “Responsible Person” (Responsible Person, RP) of a licensed “wholesaler” have?

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

Q84 · Category B: Licence types and scope of application (Q51-Q100)
For a licensed medicine wholesaler, the “Responsible Person” (RP) is a key management role. Although its statutory requirements are not as strict as those for a manufacturer's Authorised Person (AP), the responsibilities remain significant. The RP's main duty is to ensure that the company's day-to-day operations, particularly activities relating to medicine quality, fully comply with the Code of Practice for Wholesale Dealers in Medicines and relevant legislation. Specifically, the RP is responsible for managing and overseeing the effective operation of the company's Quality Management System (QMS), including approving and managing Standard Operating Procedures (SOPs), ensuring that all staff receive appropriate training, overseeing the procurement, storage, sale and transport of medicines, handling customer complaints and product recalls, and ensuring that all records are accurate and complete. The RP is the company's main contact with the Department of Health and has primary responsibility for the company's compliance.

📘 Regulatory basis

The Code of Practice for Licensed Wholesale Dealers describes in detail the expectations and responsibilities of management and the “person-in-charge”, emphasising their central role in maintaining the quality of the medicine supply chain.

📗 Drew Tang's recommendations

Although the regulations do not prescribe formal academic qualifications for an RP, we strongly recommend appointing a senior manager with a background in pharmacy or life sciences, or extensive experience in the pharmaceutical industry. A competent RP can not only ensure the company’s compliance but also improve operational efficiency and market reputation by establishing an effective quality system. We can help train your RP to ensure that they fully understand their responsibilities.

📕 Risk notice

The RP cannot be a nominal appointee. During a Drug Office inspection, inspectors will interview the RP directly to assess their understanding and control of the company's quality system. If the RP cannot answer questions or the quality system has serious deficiencies, the Drug Office may consider the company to lack effective management. This may hinder licence renewal or even lead to suspension.

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