When assessing whether an applicant is ‘fit and proper’, certain types of criminal record are almost insurmountable obstacles and are highly likely to result in an automatic refusal. These records primarily relate to offences directly connected with integrity, professional conduct and public safety. They include: 1) offences involving dishonesty, such as theft, fraud, document forgery, corruption or bribery; 2) serious medicine-related offences, such as the illegal manufacture, trafficking or supply of dangerous drugs; 3) serious violent offences; and 4) convictions in Hong Kong or another jurisdiction for serious breaches of medicine manufacturing or distribution regulations. If a director or key manager of the applicant company has any of these convictions, the regulatory authorities are highly likely to consider that they lack the integrity and sense of responsibility required to operate a medicine business and refuse the licence application.
HONG KONG DRUG LICENSING
What types of criminal record may lead to an application for a pharmaceutical licence being “automatically rejected” during a background check?
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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