Good Distribution Practice (GDP) is a set of quality management standards for the wholesale and distribution of medicines. It aims to ensure that the quality and integrity of medicines are maintained throughout the supply chain, from the manufacturer to the final retail outlet. GDP covers every aspect of medicine distribution, including establishing a quality management system; personnel qualifications and training; premises and equipment requirements, particularly storage conditions such as temperature and humidity control; order processing; receipt; storage; picking; dispatch; handling returns; and monitoring transport. For holders of a “wholesale dealer licence” in Hong Kong, compliance with GDP is not optional but a mandatory legal requirement. The Drug Office, Department of Health, conducts regular inspections of licensed wholesalers against GDP standards. Any serious GDP breach may result in the licence being suspended or revoked. GDP is therefore the fundamental operating standard for every wholesale medicines business.
HONG KONG DRUG LICENSING
What is “Good Distribution Practice” (GDP)? What does it mean for pharmaceutical licence holders?
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.
Back to Category A: Licence System and Regulatory Basics (Q1-Q50) Search more questions