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 is the difference between applying for a licence to wholesale veterinary medicines and one to wholesale medicines for human use?

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

Q77 · Category B: Licence types and scope of application (Q51-Q100)
In Hong Kong, whether you wholesale medicines for human use or veterinary drugs, you need to apply for a wholesale dealer licence issued by the Department of Health. The licence application process and the basic requirements for storage and the QMS are the same. However, the key difference is that you must demonstrate your ability to handle the specific requirements of veterinary drugs. For example, your staff need basic knowledge of veterinary medicines and must be able to understand the information on their labels. Your records system must be able to trace whether medicines were sold to veterinary clinics or ordinary pharmacies. In addition, if the veterinary drugs you wholesale contain antibiotics or certain controlled ingredients, you must also apply for additional permits, such as an antibiotic permit.

📘 Regulatory basis

The Pharmacy and Poisons Ordinance (Cap. 138) covers both human medicines and veterinary medicines. Wholesale dealing in veterinary medicines is therefore also regulated by the Ordinance. Veterinary surgeons’ prescribing rights and use of medicines are also subject to the Veterinary Surgeons Registration Ordinance (Cap. 529).

📗 Drew Tang's recommendations

If you plan to deal exclusively or mainly in veterinary medicine wholesale, we recommend making this clear in your application documents and highlighting your expertise in the veterinary field. For example, you could appoint someone with a veterinary background or relevant experience as your person responsible for quality, and establish sales and support procedures specifically for veterinary clients. This can help demonstrate your expertise to the Department of Health and expedite the approval process.

📕 Risk notice

Although they fall under the same licence, human medicines and veterinary medicines must never be confused in the supply chain. Selling veterinary medicines to human healthcare providers in error, or incorrectly recommending human medicines for animals, may create serious health risks and legal liabilities. Your inventory and sales records must clearly distinguish between these two product categories.

Back to Category B: Licence Types and Scope of Application (Q51-Q100) 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 ↗