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

Can my existing drug licence continue to be used if my business changes from a sole proprietorship to a limited company?

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

Q435 · Category I: Renewals, changes and penalties for non-compliance (Q401-Q450)
No. A licence is granted to a specific legal entity. When your business changes from a sole proprietorship to a limited company, a new and separate legal entity is created in law. Therefore, you cannot directly “continue” or “transfer” the licence held by the sole proprietorship for use by the new limited company. The new limited company must submit a completely new licence application to the regulatory authority in its own name and go through the full approval process, including submitting all documents and undergoing an on-site inspection.

📘 Regulatory basis

The principle that a licence is strictly tied to the licensed legal entity is fundamental to all licensing systems. A change of legal entity is equivalent to a change of licence holder.

📗 Drew Tang's recommendations

Before proceeding with a corporate restructuring, a new licence application must be treated as a key element of the timetable and budget. We recommend starting the application for the new licence immediately after the limited company is incorporated, to minimise any gap in operations during the handover.

📕 Risk notice

Starting a medicines business in the name of a limited company without first obtaining a new licence will be regarded as operating without a licence. This is a very serious mistake: do not confuse an individual sole proprietor with a limited company as a separate legal entity.

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