Hong Kong Drug Licence Applications and Acquisitions · RGYS|Global Licensing and Compliance Service Provider
Hong Kong pharmaceutical compliance · applications / acquisitions / ongoing maintenance Independent Third-Party Service Provider
HONG KONG DRUG LICENSING

To ensure effective product traceability, what key data points does my records system need to capture?

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

Q328 · Category G: Quality management and compliance systems (Q301–Q350)
Product traceability is a core GDP requirement and the basis for a rapid recall. An effective traceability system must work in both directions: forward traceability (knowing who each batch was sold to) and backward traceability (knowing where each batch came from). Your record system, whether paper-based or electronic, must therefore capture key data at every stage. On receipt, record the date received, product name, supplier name, quantity, batch number and expiry date. On sale and dispatch, record the dispatch date, product name, customer name and address, quantity, batch number and expiry date. Linking the “batch number” in the receipt records with that in the dispatch records establishes a complete traceability chain.

📘 Regulatory basis

The Good Distribution Practice (GDP) for Medicinal Products requires wholesalers to maintain a system that can quickly identify the source and destination of any medicine. Records must make the distribution route of every batch traceable.

📗 Drew Tang's recommendations

We strongly recommend using a computerised inventory management system with batch management functions, such as a WMS or ERP. This can greatly improve traceability efficiency and accuracy and prevent errors in manual records. Conduct regular “mock traceability exercises”; for example, select a batch at random and see how long your team takes to provide accurate, complete information on its source and destination. This is a key indicator of the effectiveness of your traceability system.

📕 Risk notice

A system that cannot provide fast and accurate batch traceability is completely unacceptable to the regulator. If your system cannot produce an accurate distribution list within a few hours when an urgent recall is required, you may be regarded as posing a direct threat to public health. This could warrant the most severe regulatory action, including immediate suspension of your licence.

Back to Category G: Quality Management and Compliance Systems (Q301-Q350) Search more questions

YOUR NEXT STEP

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang

Business Manager Tang Shangyong (Drew Tang) will review your products, operating model, licence type and preparation requirements with you one-to-one. The precise service scope is confirmed in writing; pharmaceutical duties are carried out by legally qualified personnel, and approvals are determined by the competent authorities.

Book a Project Assessment ↗