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HONG KONG DRUG LICENSING

As a pharmaceutical licence holder, what specific requirements apply to retaining records of medicine purchases and sales?

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.

Drug Office, Department of Health Chinese Medicines Board

Q31 · Category A: Licensing system and regulatory fundamentals (Q1–Q50)
Yes. Keeping detailed and accurate purchase and sales records is a basic legal responsibility of a licence holder and a core requirement of GDP and GSP. These records form the basis of medicine traceability. For wholesalers, each purchase record should include the supplier's name and address, the medicine name, dosage form, strength, quantity, batch number, and manufacturing/expiry dates. Each sales record should include the customer's name and address, details of the medicine and the dispatch date. For retail pharmacies, in addition to purchase records, records of sales of all prescription medicines must be kept, including the prescription date, patient's name, prescribing doctor's name, medicine name and quantity, and the name of the pharmacist responsible for dispensing. All these records must be properly maintained in written or electronic form for at least two years from the date of the transaction. They must be available for inspection at all times, and Department of Health inspectors are entitled to examine them during inspections.

📘 Regulatory basis

Section 28 of the Pharmacy and Poisons Regulations expressly sets out licence holders’ record-keeping requirements and a two-year retention period. The various Codes of Practice provide more detailed guidance on the specific content of records.

📗 Drew Tang's recommendations

We strongly recommend that clients use a reliable electronic inventory management system (ERP). A good system not only generates all compliance records efficiently and accurately, but also offers value-added functions such as stock alerts and batch tracking, greatly improving management efficiency and compliance.

📕 Risk notice

Incomplete records or an inability to produce them is a very serious breach identified during inspections. This means not only possible fines; more importantly, if a medicine recall occurs, the inability to provide accurate sales records may prevent the medicines from being traced, putting public health at risk and potentially resulting in grave consequences.

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