You may set up a laboratory, but doing so is not straightforward. If the results of tests conducted by the laboratory will be used to decide whether a batch of medicines may be released for sale, the laboratory itself must be treated as part of the medicine manufacturing process and must comply with GMP standards. Your company may also need to apply for an additional Manufacturer of Pharmaceutical Products licence, at least for the testing activities. If the laboratory is used only for internal monitoring, preliminary screening or non-decisive testing (such as checking the appearance of packaging), and is not used as the formal basis for quality release, operations may be more flexible. Even so, you must ensure that laboratory operations do not cause contamination or mix-ups involving stored medicines, and that clear procedures are included in your Quality Management System (QMS).
HONG KONG DRUG LICENSING
As a licensed “wholesale dealer”, may I set up a small laboratory in my warehouse to conduct quality spot checks on medicines?
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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