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HONG KONG DRUG LICENSING

Does Hong Kong’s pharmaceutical licensing system apply to veterinary medicines?

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

Q39 · Category A: Licensing system and regulatory fundamentals (Q1–Q50)
Yes, Hong Kong's pharmaceutical licensing system also applies to veterinary medicines, although the regulatory framework differs slightly from that for medicines for human use. Under the Pharmacy and Poisons Ordinance, veterinary medicines containing scheduled poisons are also regarded as “pharmaceutical products”, and their manufacture, wholesale and retail require the relevant licences. For example, a company wholesaling veterinary medicines must hold a Wholesale Dealer Licence. At retail level, however, registered veterinarians are also entitled to certain exemptions when dispensing medicines to animals under their care. Hong Kong currently has no separate veterinary medicine registration system. However, under the Public Health (Animals and Birds) (Chemical Residues) Regulation, certain medicines used in food-producing animals are strictly regulated. Overall, veterinary medicines are regulated jointly by the Department of Health and the Agriculture, Fisheries and Conservation Department, but core licensing remains within the framework of the Pharmacy and Poisons Ordinance.

📘 Regulatory basis

The definition of “pharmaceutical product” in the Pharmacy and Poisons Ordinance does not distinguish between products for human and veterinary use. Accordingly, veterinary medicines are regulated if their ingredients and effects meet the definition. The Veterinary Surgeons Registration Ordinance (Cap. 529) also governs the scope of veterinary practice.

📗 Drew Tang's recommendations

For companies seeking to enter Hong Kong’s veterinary medicine market, clarifying the legal status of the products is the first step. We can help clients analyse product ingredients, determine whether they are controlled pharmaceutical products, and plan compliant import and distribution routes, whether through traditional wholesale channels or direct supply to veterinary clinics.

📕 Risk notice

Do not assume that veterinary medicines are less strictly regulated than medicines for human use. The illegal import or sale of unlicensed veterinary antibiotics or hormone medicines is also a serious offence, particularly where these medicines may enter the human body through the food chain. Regulatory authorities will pay especially close attention to this.

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