Q234 · If my application is approved, will the…

Q234 · Category E: Application Process and Approval Procedures (Q201-Q250)

No. In most cases, a Hong Kong Wholesale Dealer Licence is a “general” authorisation permitting wholesale dealing in pharmaceutical products and/or poisons. The licence itself does not list the specific medicine names or therapeutic categories you may deal in. This means that, in theory, once you obtain a Wholesale Dealer Licence, you may wholesale any medicines registered in Hong Kong, whether prescription medicines, medicines subject to supervision in sale or non-prescription medicines, and regardless of their therapeutic area. However, note that if you plan to handle medicines subject to special regulatory requirements, such as Dangerous Drugs or Antibiotics, you may need to meet additional storage and record-keeping requirements and obtain a specific endorsement on the licence. For the vast majority of ordinary medicines, however, the scope of the licence is broad.

📘 Regulatory basis

The format and scope of authorisation of a licence are prescribed by the Pharmacy and Poisons Regulations. Additional controls for special medicines such as dangerous drugs derive from other relevant legislation, including the Dangerous Drugs Ordinance (Cap. 134).

📗 Drew Tang's recommendations

Although the licence authorises a broad scope of activities, we recommend focusing in the early stages of operations on the product areas with which you are familiar and which are clearly specified in your business plan. We will ensure that your SOPs and facilities fully support the types of products you currently handle and plan to handle in the near future. If you later plan to expand into new product areas with special requirements, such as cold-chain products, we will help you update your SOPs and assess whether your existing facilities need to be upgraded, so that your business expansion remains compliant.

📕 Risk notice

The risk lies in misunderstanding “general authorisation” and assuming that all medicines can be handled without distinction. If you start wholesaling vaccines without the appropriate cold-chain facilities and procedures, even with a valid Wholesale Dealer Licence, this would be a serious breach because you have failed to meet the GSDP requirements specific to those products. A licence authorises eligibility, but actual operations must be suited to the characteristics of the products.

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 application is approved, will the licence specify the types of medicines I am permitted to wholesale?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang