After a medicine is registered in Hong Kong, if there are significant changes to its ingredients, manufacturing process, packaging or labelling, the applicant must submit a change application to the Drug Office, Department of Health, and obtain approval before implementing the changes. The change submission must include an explanation of the changes and relevant supporting information to ensure that they do not affect the medicine’s quality or safety. Minor changes should also be recorded and documented. Failure to notify changes as required may be regarded as an offence.
HONG KONG DRUG LICENSING
What are the requirements for change notifications or applications for medicines after registration in Hong Kong?
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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