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HONG KONG DRUG LICENSING

If my application requires an interview for the Responsible Person (RP), what topics are usually covered?

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

Q209 · Category E: Application Process and Approval Procedures (Q201-Q250)
Although not all applications require a formal interview for the Responsible Person (RP), an interview may be requested in certain circumstances, for example, if the PPB has doubts about the RP’s experience or understanding of the regulations. The main purpose is to assess whether the RP genuinely has the ability and knowledge needed to supervise the licensed business. The interview will generally cover the following areas. First, understanding of Hong Kong pharmaceutical legislation, particularly the Pharmacy and Poisons Ordinance and relevant codes of practice. Second, the RP’s role and responsibilities in the Quality Management System (QMS), such as handling product complaints and initiating and conducting medicine recalls. Third, scenario questions may be used to test the RP’s ability to respond and make decisions in unexpected situations, such as abnormal warehouse temperature or humidity or an accident during transport. The interviewer will want to confirm that the RP is not merely a nominal person in charge but a professional with practical management ability.

📘 Regulatory basis

The Code of Practice for Wholesale Dealers expressly requires a licence holder to appoint a person-in-charge with appropriate authority and resources to discharge their duties and ensure the quality of medicines. An interview is one way for the PPB to verify whether that person is “fit and proper”.

📗 Drew Tang's recommendations

If you receive an interview notice, we will immediately begin an intensive interview coaching programme for your RP. A senior consultant from Rengangyongsheng (Hong Kong) Limited will conduct a one-to-one mock interview, covering all questions that may be asked and refining the RP's answers to ensure they are clear, logical and confident, and demonstrate convincing professional competence to the Committee.

📕 Risk notice

Poor performance by the RP at interview is one of the direct reasons an application may fail. If the RP has only a superficial understanding of key regulations, or makes incorrect judgements in scenario-based questions, the Committee will have good reason to consider them incapable of fulfilling the role and reject the entire licence application. The interview must therefore be taken seriously and prepared for as the most critical stage.

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