Q193 · If my business only involves pharmaceutical…

Q193 · Category D: Premises and Storage Requirements (Q151-Q200)

This is a very common and important question. The answer is: quite possibly. According to Department of Health guidance, if one legal entity (for example, the holding company of your clinic group) centralises procurement for multiple separate legal entities (for example, each clinic is a separate limited company) and then “distributes” or “resells” the pharmaceutical products to those clinics, the holding company’s activities constitute “wholesale”. The holding company would therefore need to apply for a wholesaler licence and establish a central pharmaceutical products warehouse that meets GDP standards. However, if all the clinics belong to the same legal entity (that is, they are branches rather than separate subsidiaries), the transfer of pharmaceutical products between different locations within the same entity may not be regarded as wholesale. The key factors are the legal structure and the transfer of ownership of the pharmaceutical products. Even internal transfers must ensure that transport and storage meet pharmaceutical product quality requirements.

📘 Regulatory basis

The Import and Export Ordinance (Cap. 60) and the Pharmacy and Poisons Ordinance (Cap. 138) jointly define the regulatory scope for the import, export and possession of medicines. Pure trans-shipment cargo may be exempt from import licensing under specific conditions.

📗 Drew Tang's recommendations

Even if you are engaged in re-export trade, we recommend establishing a documented Quality Management System to record and demonstrate that your medicines are handled appropriately throughout the supply chain. This includes selecting compliant transport and warehousing partners and retaining all relevant temperature records and transport documents. This is not only good business practice; it can also demonstrate your professionalism when overseas partners or regulatory authorities make enquiries.

📕 Risk notice

“Transhipment” and “import followed by re-export” must be clearly distinguished. If medicines have at any point left the customs-controlled area and entered any warehouse in Hong Kong (even temporarily), this constitutes “import”. Once an import has taken place, you must hold a Wholesale Dealer Licence, and the warehouse must also be licensed premises that comply with GDP. Confusing the two may lead to you unknowingly breaching the law by dealing in medicines without a licence.

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 only involves pharmaceutical entrepôt trade and the goods do not enter Hong Kong, do I still need to establish a Hong Kong warehouse that meets GDP requirements?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang