Yes, this is absolutely required. Throughout the licence application process, you have an ongoing responsibility to ensure that all information submitted to the Department of Health is up to date and accurate. The company's director and shareholder structure is an important factor in the regulatory authority's assessment of whether the applicant is “fit and proper”. Therefore, as soon as there is any appointment or resignation of a director, or a significant change in the shareholding structure (for example, a change of controlling shareholder), you must proactively notify the Drug Office, Department of Health, in writing. You will need to submit the relevant company resolutions, the latest forms filed with the Companies Registry (such as ND2A and NSC1), and identity documents and CVs of newly appointed directors. The regulatory authority needs to carry out the same background checks on new directors or shareholders.
HONG KONG DRUG LICENSING
During the licence application process, if there is a change of director or shareholder in my company, do I need to notify the Department of Health?
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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