The Role and Requirements of the Wholesale Dealer Licence (WDL) in Hong Kong

The Wholesale Dealer Licence (WDL): Gateway to HK Pharmaceutical Distribution

The Wholesale Dealer Licence (WDL) is a foundational requirement under Hong Kong's regulatory framework for any company that intends to introduce, import, or distribute pharmaceutical products within the market. It is issued by the Department of Health (DoH) under the Pharmacy and Poisons Ordinance.

Scope of Distribution

The WDL is mandatory for any entity involved in the local distribution of pharmaceutical products. The term "distribution" is defined broadly to encompass a wide array of activities, including procuring and purchasing, holding and storing, selling and supplying, importing and exporting, and the delivery of products from the WDL premises to other locations. It's important to note that this licence specifically excludes dispensing or supplying pharmaceutical products directly to a patient or their agent.

Responsibility for Product Registration

A crucial role of the WDL holder is its direct involvement in the mandatory registration of pharmaceutical products with the Pharmacy and Poisons Board. For Locally Manufactured Products, either the licensed manufacturer or the licensed WDL holder can apply for registration. However, for Imported Products (Non-local Manufacture), the WDL holder is typically the required applicant, acting as the product's direct importer, or the local branch, agent, representative, or distributor of the overseas manufacturer.

Key Operational and Facility Requirements

To obtain and maintain a WDL, stringent operational and facility requirements must be met to ensure the integrity and quality of the pharmaceutical supply chain. The holder must provide designated storage facilities for the products, and it is permissible to lease these facilities, provided all regulatory conditions are satisfied. These Storage Conditions mean facilities must be fit for purpose and are subject to inspection by a pharmacist inspector. General requirements include appropriate control of temperature and humidity, adequate lighting and ventilation, ensuring products are stored away from direct sunlight and suitably spaced, and the installation of an alarm system for temperature-sensitive products.

Additional Licensing for Controlled Substances

Possession of a WDL may not be sufficient for all product types, as dealing in certain controlled substances requires supplementary licensing. If the pharmaceutical product contains ingredients classified as "dangerous drugs" under the Dangerous Drugs Ordinance, an additional Wholesale Dealer's Licence to Supply Dangerous Drugs must be obtained. Separately, regarding Import/Export Formalities, an Import Licence or Export Licence must be applied for from the Trade and Industry Department for every single instance of importation or exportation, regardless of the WDL.