Q323 · What are the qualification and duty…

Q323 · Category G: Quality management and compliance systems (Q301–Q350)

Under GDP requirements, licensed wholesalers must appoint a sufficient number of key personnel with appropriate competence and experience to carry out their duties. The Responsible Person (RP) is a core role and bears personal responsibility for ensuring that the company’s operations continue to comply with GDP requirements. The RP is generally required to be a registered pharmacist or to hold a relevant degree and have sufficient practical experience. Core duties include ensuring that an effective QMS is implemented and maintained; overseeing initial and continuing staff training; coordinating and carrying out medicine recalls; ensuring that customers and suppliers are qualified; and approving the final disposition of returned medicines. The RP must have sufficient authority and resources to perform these duties and should make quality decisions independently of commercial pressure.

📘 Regulatory basis

Chapter 2, “Personnel”, of the Good Distribution Practice (GDP) for Medicinal Products describes in detail the requirements for key personnel, particularly the person-in-charge. The licensee is responsible for ensuring that the RP has the authority and resources needed to fulfil their duties. The RP’s name and qualifications must be submitted with a licence application or change notification.

📗 Drew Tang's recommendations

Choosing the RP is one of the key factors in whether a licence application succeeds. We recommend that clients assess not only the candidate's academic qualifications and certificates when appointing an RP, but also their practical experience and leadership in pharmaceutical quality management. The RP's responsibilities should be clearly defined in the documents. If the RP is part-time, you must ensure they have sufficient time and capacity to perform the role and can respond to emergencies at any time.

📕 Risk notice

A nominal RP without real authority or sufficient capability is a major deficiency in the eyes of the regulator. If the RP knows nothing about the company’s quality operations, or if the sales department can easily override the RP’s quality decisions, the entire QMS will be regarded as ineffective. In the event of a serious quality incident, the RP may bear personal legal liability.

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.

What are the qualification and duty requirements for “Key Personnel” under a wholesale dealer licence, such as the “Responsible Person” (RP)?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang