A company applying for a pharmaceutical product wholesale dealer licence in Hong Kong must be a limited company duly incorporated under Hong Kong's Companies Ordinance (Cap. 622). This is the basic requirement for the applicant entity. In addition, the company must have a fixed, lawful business address in Hong Kong to serve as its registered office and actual place of business. The premises must meet the standards for medicine storage, management and distribution under the Pharmacy and Poisons Ordinance and its subsidiary regulations. Before issuing a licence, inspectors from the Drug Office, Department of Health will conduct an on-site inspection to ensure that the facilities, security system, temperature controls and Quality Management System meet statutory requirements. The company must also demonstrate a sound financial position sufficient to support the normal operation of its licensed pharmaceutical business.
HONG KONG DRUG LICENSING
What are the basic eligibility requirements for a company applying for a pharmaceutical wholesale dealer licence in Hong Kong?
A complete explanation of the regulatory basis, Drew Tang’s recommendations and risk alerts. The original material dates from 2025; read it alongside the latest official requirements.
Original guide, 2025 edition: These FAQs are provided for topic-based reference and have not all been individually checked against current rules. Please confirm fees, personnel, renewal, changes and product requirements against the professional in-depth guide for the relevant licence type and the official requirements in force at the time.
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