Q124 · For an application for a wholesale…

Q124 · Category C: Applicant eligibility and personnel requirements (Q101–Q150)

The qualification requirements for the Responsible Person (RP) under a wholesale licence for proprietary Chinese medicines are more specific to the Chinese medicine sector than those for Western medicine wholesalers. Although both require the RP to have knowledge and experience in supervising the handling of medicines, the RP for proprietary Chinese medicines needs a deeper understanding of Chinese medicines. According to the guidance of the Chinese Medicines Board, the RP of a wholesaler of proprietary Chinese medicines would generally need to meet one of the following qualifications: 1) be a registered or listed Chinese medicine practitioner; 2) have completed a recognised course in Chinese materia medica or a related field; or 3) have at least 5 years’ experience in wholesale of proprietary Chinese medicines or related business. By comparison, the background requirements for an RP for Western medicines tend to be more focused on Western pharmacy or related sciences. An RP for proprietary Chinese medicines needs a sound understanding of their sources and authenticity, storage conditions (such as protection from damp and mould), and Hong Kong’s specific labelling and registration requirements for proprietary Chinese medicines.

📘 Regulatory basis

The Chinese Medicine Ordinance (Cap. 549) and the Practice Guidelines for Wholesalers of Chinese Herbal Medicines and Proprietary Chinese Medicines provide a framework for the qualifications of an RP for proprietary Chinese medicines. In assessing an application, the Chinese Medicines Board will evaluate the nominee’s practical understanding of the proprietary Chinese medicine business.

📗 Drew Tang's recommendations

When nominating an RP for a wholesale proprietary Chinese medicine business, give priority to candidates with practical experience in the Chinese medicine industry. In preparing their CV and for interview, highlight their experience in identifying Chinese herbal medicines, the registration system for proprietary Chinese medicines, and handling quality issues specific to Chinese medicines (such as aflatoxin and excessive heavy metals).

📕 Risk notice

It is almost impossible for a nominee with experience only in Western medicines to pass the review as the RP for proprietary Chinese medicines. The regulatory authorities may consider that the nominee lacks the expertise needed to supervise the quality and safety of proprietary Chinese medicines—for example, the ability to distinguish between similar or counterfeit products or knowledge of the storage restrictions for particular herbal medicines.

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.

For an application for a wholesale proprietary Chinese medicines licence, what are the qualification requirements for the Responsible Person (RP), and how do they differ from those for a Western medicine wholesaler?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang