As a general rule, a licensed wholesaler should not split or repackage medicines without authorisation, as this constitutes a manufacturing activity and requires a Manufacturer of Pharmaceutical Products licence. You should distribute medicines in the smallest sales unit approved at the time of product registration. Any change to medicine packaging, including opening a bulk pack and repacking it into smaller bottles or boxes, may introduce risks such as cross-contamination, labelling errors and loss of batch number and expiry-date information, thereby compromising the integrity and traceability of the medicines. If you have a genuine business need to carry out such activities, you must apply for a Manufacturer of Pharmaceutical Products licence (secondary packaging) and comply strictly with GMP requirements, carrying out the work in a controlled clean environment and maintaining complete batch packaging records.
HONG KONG DRUG LICENSING
As a wholesale dealer, may we break bulk packs of medicines into smaller packs for sale to downstream customers?
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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