Under the Good Distribution Practice (GDP) requirements for wholesale dealers in medicines, you must keep detailed records of the receipt and supply of all medicines to ensure complete traceability. Records should include, at a minimum: the name of the medicine, dosage form, strength, batch number, expiry date, transaction date, name and address of the supplier or recipient, and quantity involved. All records must be properly kept and made available for inspection by Department of Health inspectors at any time. The law requires these records to be retained for at least two years from the transaction date.
HONG KONG DRUG LICENSING
As a licensed Western medicine wholesale dealer, what transaction records must I keep, and for how long?
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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