Hong Kong requires medicine labels and package inserts to be presented bilingually in Chinese and English. They should include the medicine name, pharmaceutical product registration number (HK-XXXXX), ingredients, directions and dosage, indications, adverse reactions, storage conditions and manufacturer information, among other details. Labels must comply with the Department of Health’s format requirements to ensure that consumers can clearly understand the information. In addition, all promotional materials must not contain false or misleading statements and must comply with the relevant provisions of the Pharmacy and Poisons Ordinance.
HONG KONG DRUG LICENSING
What are the specific requirements for medicine labels and package inserts in Hong Kong pharmaceutical licence applications?
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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