Q443 · Can I operate a wholesale business in…

Q443 · Category I: Renewals, changes and penalties for non-compliance (Q401-Q450)

Yes, but you must apply for and hold two different licences for the premises: a Wholesale Dealer Licence issued by the Department of Health and a wholesaler’s licence for proprietary Chinese medicines issued by the Chinese Medicine Council of Hong Kong. In addition, you must establish clearly segregated physical areas within the premises for storing Western medicines and proprietary Chinese medicines separately, to prevent cross-contamination and confusion. Two separate Quality Management Systems and record-keeping systems are also essential, each meeting the GDP requirements for Western medicines and the relevant requirements for proprietary Chinese medicines. During inspections, the regulatory authorities will independently inspect each area and system.

📘 Regulatory basis

Western medicines and proprietary Chinese medicines are regulated under different legislation and by different regulatory authorities. They therefore require separate licences and compliance systems, even when operated at the same physical address.

📗 Drew Tang's recommendations

RGYS may assist with document preparation and project coordination within the written scope of services; the respective responsible parties must verify personnel qualifications and statutory roles and take responsibility for professional judgements, while approval is determined independently by the competent authority. The key is careful planning at an early stage to ensure that the warehouse layout, workflows and document systems are clearly separated and independently compliant from the outset, avoiding confusion in subsequent operations.

📕 Risk notice

If Western medicines and proprietary Chinese medicines are treated as one in management, for example by sharing stock areas or combining records, this will constitute a serious non-compliance in the assessment of both licences and may put both licences at risk.

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.

Can I operate a wholesale business in Western medicines and a wholesale business in proprietary Chinese medicines at the same licensed premises?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang