Requirements and Role of the Wholesale Dealer Licence in Hong Kong

Legal Framework for the Wholesale Dealer Licence (WDL)

The Wholesale Dealer Licence (WDL) is a mandatory authorization under the Pharmacy and Poisons Ordinance (Cap. 138) for any person or entity engaging in the wholesale, import, and export of pharmaceutical products and/or poisons in Hong Kong. This license serves as the foundation for regulatory compliance and ensures the integrity of the drug supply chain.

Central Role in Drug Registration

The WDL holder plays a critical and legally defined role in the mandatory registration of pharmaceutical products with the Pharmacy and Poisons Board before they can be legally sold or supplied.

Locally Manufactured Products: The WDL holder may assume responsibility for obtaining registration by contracting with a licensed local manufacturer.

Imported Products (Non-local Manufacture): The WDL holder is typically the person responsible for obtaining registration, acting either as the direct importer or as the Hong Kong branch, agent, representative, or distributor of the overseas manufacturer.

Furthermore, possession of a WDL is a prerequisite when applying for an Import Licence (Form 3) to import an unregistered drug for the treatment of a specific patient, a process considered strictly on a case-by-case basis.

Specific Requirements for Controlled Substances

While the WDL grants the authority to deal in general pharmaceutical products, additional licenses, permits, and personnel are required when dealing with controlled substances:

Non-poison & Poisons (e.g., Part 1, Part 2, First/Third Schedule): Requires a WDL plus relevant record keeping under the Pharmacy and Poisons Ordinance (Cap. 138). No specific key personnel are mandated beyond WDL requirements.

Antibiotics: Requires a WDL plus an Antibiotics Permit under the Antibiotics Ordinance (Cap. 137).

Dangerous Drugs (DDO Part II Schedule 1 preparations): Requires a WDL plus a Wholesale Dealer’s Licence to Supply Dangerous Drugs under the Dangerous Drugs Ordinance (Cap. 134). Crucially, the dealer must employ a registered pharmacist to handle all transactions and record-keeping.

Advanced Therapy Products (ATPs): Requires a WDL under the Pharmacy and Poisons Ordinance (Cap. 138). The application is assessed case-by-case, and additional requirements (e.g., Antibiotics Permit) may apply based on the product's nature.

Entities dealing in wholesale of specific poisons, such as Gold Potassium Cyanide and Silver Potassium Cyanide, must also hold a WDL. Application for any required license or permit must be made in the specified form and accompanied by the prescribed fee, with registration approval contingent on meeting criteria for safety, efficacy, and quality.