Before deciding to start the application process for a Hong Kong Wholesale Dealer Licence, you must make thorough preparations to ensure a smooth application. First, you need to establish a Hong Kong limited company and determine an organisational structure that complies with the Companies Ordinance. Second, and crucially, you must identify and lease commercial premises that meet the strict requirements of the Drug Office, Department of Health (DPO). The premises must satisfy specific physical requirements for the storage, management and distribution of medicines, such as temperature and humidity control, security and adequate space. You must also appoint a qualified Responsible Person (RP) with a relevant pharmaceutical background or experience in the pharmaceutical industry. In addition, it is essential to establish an initial set of Quality Management System (QMS) documents, including Standard Operating Procedures (SOPs). These preparations form the foundation for the subsequent application.
HONG KONG DRUG LICENSING
What key preparations should I complete before formally submitting an application for a pharmaceutical products wholesaler 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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