Q230 · In the application documents, apart from the…

Q230 · Category E: Application Process and Approval Procedures (Q201-Q250)

Appointing a Responsible Person (RP) is a mandatory legal requirement when applying for a pharmaceutical licence in Hong Kong. However, the regulations do not require the appointment of a Deputy RP. Whether to appoint one is a business decision for the company. Nevertheless, from the perspective of sound operations and risk management, we strongly recommend nominating one or two deputy Responsible Persons at the time of application. Their main role is to take over immediately if the RP is on leave, travelling or otherwise unable to fulfil their duties, ensuring that there is no “compliance gap” in the company’s operations. Demonstrating during a site inspection or when communicating with the regulatory authorities that you have a clear contingency plan and succession arrangements will make a professional and well-considered impression.

📘 Regulatory basis

The Code of Practice for Wholesale Dealers emphasises that licence holders need sufficient qualified personnel to perform the various tasks. Although it does not expressly require a “deputy person-in-charge”, appointing a deputy is fully consistent with the legislative intent of “ensuring the quality of medicines and business continuity”.

📗 Drew Tang's recommendations

We will clearly include the deputy RP’s role and responsibilities in the organisation chart and SOPs prepared for you. The deputy may be another member of the company’s management team with a relevant background. We will provide them with the same training to ensure that they clearly understand their responsibilities when the RP is absent. This seemingly small measure sends a strong message to the PPB Committee: your company has a mature and resilient management team.

📕 Risk notice

The risk of not having a deputy responsible person is operational vulnerability. Imagine that your company has only one RP and they suddenly need to take long-term sick leave. Your entire licensed business may come to a standstill because there is no second person who can lawfully oversee the release of medicines. This “single point of failure” is a risk that both mature businesses and prudent regulatory authorities seek to avoid.

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang

Business Manager Tang Shangyong (Drew Tang) will review your products, operating model, licence type and preparation requirements with you one-to-one. The precise service scope is confirmed in writing; pharmaceutical duties are carried out by legally qualified personnel, and approvals are determined by the competent authorities.

In the application documents, apart from the RP, do I also need to appoint a ‘Deputy RP’?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang