Hong Kong Drug Licence Applications and Acquisitions · RGYS|Global Licensing and Compliance Service Provider
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HONG KONG DRUG LICENSING

Apart from the Department of Health, do drug licence applications also involve dealing with other Hong Kong government departments?

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

Q238 · Category E: Application Process and Approval Procedures (Q201-Q250)
In the main pharmaceutical licence application process, your primary and most direct contacts are the Department of Health (including its Drug Office or Chinese Medicine Regulatory Office) and the Pharmacy and Poisons Board (PPB). However, during the preparation and operation of your business, you may need to interact with other government departments. First, you must register the company with the Companies Registry and obtain a Business Registration certificate from the Business Registration Office of the Inland Revenue Department. Your business premises must also comply with the fire safety requirements of the Fire Services Department and the building safety standards of the Buildings Department. Although you will not normally need to apply directly to these two departments when applying for a pharmaceutical licence, Department of Health inspectors will check during their inspection that your premises have basic fire safety facilities, such as fire extinguishers and emergency exit signs, and are structurally safe. If your business involves imports or exports, you will also need to deal with Hong Kong Customs and may need to apply for relevant import or export licences.

📘 Regulatory basis

The Companies Ordinance, Business Registration Ordinance, Fire Safety (Buildings) Ordinance, Buildings Ordinance and Import and Export Ordinance, among others, are basic laws that businesses in Hong Kong must comply with and are closely related to your drug licence application and operations.

📗 Drew Tang's recommendations

We provide an integrated solution. When assessing and designing a warehouse for you, we consider not only the Department of Health's requirements, but also basic fire safety and building safety requirements, conducting a comprehensive compliance review. If your business requires it, we can also help you with customs-related import and export licensing matters to ensure that your business is lawful and compliant in all respects in Hong Kong.

📕 Risk notice

The risk lies in overlooking these “peripheral” but equally important compliance requirements. For example, your warehouse may pass inspection by the Department of Health, but if a routine inspection by the Fire Services Department finds blocked fire escape routes or expired fire equipment, you may still face a fine or an order to suspend operations for remedial work. A successful business must establish a comprehensive culture of compliance, rather than meeting the requirements of only one regulator.

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