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How are medicines classified in Hong Kong, and how are “prescription-only medicines” and “over-the-counter medicines” defined?

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

Q4 · Category A: Licensing system and regulatory fundamentals (Q1–Q50)
Medicines in Hong Kong are classified mainly according to their safety risks and whether they contain ingredients listed in the Poisons List. Broadly, they fall into three categories. The first is “prescription-only medicines”, which may be purchased only on a prescription issued by a Hong Kong-registered doctor and under the supervision of a registered pharmacist at a registered pharmacy. They are usually Part I poisons in Substance A of the Poisons List, used to treat more serious conditions and carrying a high risk of misuse. The second is “medicines that may be sold under the supervision of a pharmacist”. These do not require a prescription but must be purchased at a pharmacy under the supervision of a registered pharmacist. They usually comprise Part I poisons in Substance B of the Poisons List. The third is “non-prescription medicines”, also known as proprietary medicines or over-the-counter (OTC) medicines. These may be purchased freely at pharmacies, medicine shops and even some supermarkets and convenience stores. They can be further divided into “Part II poisons” and “non-poison” medicines. This classification system seeks to balance convenient access to medicines with safety, ensuring that higher-risk medicines are used with professional guidance.

📘 Regulatory basis

Medicines are classified mainly under the Schedules of poisons in the Pharmacy and Poisons Regulations (Cap. 138A) and the medicine classification framework introduced by the Pharmacy and Poisons (Amendment) Ordinance. The definition of prescription medicines is closely linked to Part IA of the Poisons List.

📗 Drew Tang's recommendations

As a pharmaceutical operator, you must clearly segregate different categories of medicines in your shop and provide rigorous staff training to ensure that they understand the conditions for selling each category. For example, prescription medicines must be kept locked in an area accessible only to pharmacists.

📕 Risk notice

Illegal sale of prescription medicines is one of the most common forms of non-compliance in the industry. Even a seemingly harmless medicine is unlawful to sell without a prescription if it belongs to a prescription-only category, and may result in criminal prosecution of the licence holder and revocation of the licence.

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