“Good Storage and Distribution Practices” (GSDP) is an internationally recognised quality management standard intended to ensure that medicines retain their quality, safety and efficacy throughout the distribution chain, from the manufacturer to the end user. It is not a specific law, but a set of guiding principles and a code of practice. In Hong Kong, the “Code of Practice for Licensed Wholesalers” issued by the PPB is based on GSDP principles. GSDP plays a central and decisive role in licence approval. The entire approval process, from document review to on-site inspection, is essentially an assessment of whether your company can meet GSDP requirements. Everything—including the design of your premises, staffing, SOPs and document-recording system—must be established around the principles of GSDP. GSDP is, in effect, the “rules of the game” for the pharmaceutical wholesale industry. If you cannot demonstrate that you can comply with these rules, you cannot obtain entry (that is, a Wholesale Dealer Licence).
HONG KONG DRUG LICENSING
What is “Good Storage and Distribution Practice” (GSDP)? What role does it play in licence approval?
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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