Hong Kong Drug Licence Applications and Acquisitions · RGYS|Global Licensing and Compliance Service Provider
Hong Kong pharmaceutical compliance · applications / acquisitions / ongoing maintenance Independent Third-Party Service Provider
HONG KONG DRUG LICENSING

What are the specific legal requirements for medicine labelling and packaging 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.

Drug Office, Department of Health Chinese Medicines Board

Q13 · Category A: Pharmaceutical Licensing System and Regulatory Framework (Q1-Q50)
Hong Kong has very strict and detailed requirements for the labelling and packaging of medicines to ensure consumers receive accurate and important product information. Under the Pharmacy and Poisons Regulations, the labels of all registered pharmaceutical products sold in Hong Kong must clearly state the following information: the product name, active ingredients and their quantities, Hong Kong registration number (in the format HK-XXXXX), manufacturer name, batch number and expiry date. Certain medicines may be subject to additional labelling requirements, such as warning statements reading “Poison”, “Prescription Only” or “To be sold under the supervision of a pharmacist”. Packaging must also protect the medicines against contamination and damage under normal handling and storage conditions. In addition, all information provided to consumers, including labels and package inserts, must be available in both English and Traditional Chinese. These requirements help ensure that both professionals and members of the public can use medicines safely and correctly.

📘 Regulatory basis

Part III of the Pharmacy and Poisons Regulations (Cap. 138A) sets out detailed requirements for the labelling and packaging of pharmaceutical products and is a cardinal rule that the industry must strictly observe.

📗 Drew Tang's recommendations

Even if the original packaging of imported medicines meets the standards of the exporting country, the labels must be redesigned or supplemented to comply with Hong Kong regulations. We recommend submitting draft labels to us for review before the products are shipped to Hong Kong to avoid delays and additional costs if non-compliance is discovered after the goods arrive.

📕 Risk notice

Incorrect or missing label information is a common reason for medicines to be recalled. The Hong Kong registration number in particular must be accurate. Any non-compliant labelling may be regarded as unlawful sale and may be subject to penalties.

Back to Category A: Licence System and Regulatory Basics (Q1-Q50) Search more questions

YOUR NEXT STEP

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang

Business Manager Tang Shangyong (Drew Tang) will review your products, operating model, licence type and preparation requirements with you one-to-one. The precise service scope is confirmed in writing; pharmaceutical duties are carried out by legally qualified personnel, and approvals are determined by the competent authorities.

Book a Project Assessment ↗