The budget for implementing an electronic pharmaceutical track-and-trace system varies greatly, depending on the system’s complexity and the scale of your business. A basic system may simply add batch management and serial number scanning to your existing inventory management (ERP) software; this software upgrade may cost tens of thousands of Hong Kong dollars. A more comprehensive system, if it needs to comply with the international GS1 standard, use two-dimensional barcodes (Data Matrix) and establish a data exchange platform with upstream and downstream partners, may involve initial software development, hardware purchases (such as high-speed scanners and servers) and systems integration costing hundreds of thousands or even over a million Hong Kong dollars.
HONG KONG DRUG LICENSING
As regulators have tightened requirements for pharmaceutical “traceability” in recent years, how much budget is generally needed to implement an electronic traceability system?
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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