Q58 · If my business involves wholesale of both…

Q58 · Category B: Licence types and scope of application (Q51-Q100)

Yes, you need to apply for two entirely separate licences. Western medicines and Chinese medicines are governed in Hong Kong by two different legal frameworks and regulatory authorities. Wholesale dealing in western medicines is regulated by the Pharmacy and Poisons Ordinance (Cap. 138), with applications reviewed and regulated by the Drug Office, Department of Health; you need to apply for a “Wholesale Dealer Licence”. Wholesale dealing in proprietary Chinese medicines is regulated by the Chinese Medicine Ordinance (Cap. 549), with the Chinese Medicine Regulatory Office (CMRO) under the Department of Health responsible; you need to apply for a “Wholesale Dealer Licence for Proprietary Chinese Medicines”. The application requirements, assessment criteria and requirements for personnel and facilities differ, and the licences are not interchangeable.

📘 Regulatory basis

The Pharmacy and Poisons Ordinance (Cap. 138) and the Chinese Medicine Ordinance (Cap. 549) are two parallel legal regimes that separately regulate businesses dealing in Western medicines and Chinese medicines. Applicants must meet the requirements of both regimes to lawfully deal in both types of products.

📗 Drew Tang's recommendations

If your warehouse is intended to store both Western medicines and proprietary Chinese medicines, you must establish clearly separated areas to prevent cross-contamination and mix-ups. Applications for the two licences can be made at the same time, but two separate sets of application documents must be prepared. We will assist you in ensuring that the warehouse layout, Quality Management System and staffing arrangements meet the dual review standards of the Drug Office and the Chinese Medicines Regulatory Office.

📕 Risk notice

You absolutely cannot use a Wholesale Dealer Licence to conduct wholesale business in proprietary Chinese medicines, or vice versa. If this commingling of business activities is discovered, severe penalties may follow. In addition, purchase, sales and stock records for the two product categories must be strictly segregated for inspection by the respective regulatory authorities.

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.

If my business involves wholesale of both Western medicines and proprietary Chinese medicines, do I need to apply for two separate licences?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang