Under a pharmaceutical products wholesaler licence, **any form of secondary processing is strictly prohibited**, including breaking down bulk packs of pharmaceutical products into smaller packs. Such repackaging is regarded as part of the “manufacturing” process because it changes the original packaging and labelling of the pharmaceutical products and introduces a very high risk of contamination and errors. To carry out such operations, you must apply separately for a Manufacturer’s Licence, and the operations must take place in a cleanroom that complies with Good Manufacturing Practice (GMP) standards. Even a well-managed ordinary pharmaceutical warehouse falls far short of the cleanliness, temperature and humidity, and air quality standards required for open handling of pharmaceutical products.
HONG KONG DRUG LICENSING
Is secondary processing of medicines, such as breaking down bulk packs into smaller packs, permitted in the warehouse?
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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