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Do I need a pharmaceutical licence if I only want to sell first-aid kits containing disinfectant and bandages?

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

Q91 · Category B: Licence types and scope of application (Q51-Q100)
This depends on the specific contents of the first-aid kit. If it contains only non-medicated items, such as bandages, gauze, adhesive tape and scissors, as well as disinfectants that are not classified as “pharmaceutical products” (for example, low-concentration chlorhexidine or cetrimide disinfectant), a pharmaceutical licence is generally not required to sell the kit. However, if it contains any item classified as a Part I or Part II poison, such as an antibiotic ointment, a strong painkiller or a disinfectant at a specified concentration, the whole kit will be regarded as a combined medicinal pack and its sale will be regulated under the Pharmacy and Poisons Ordinance. You will need to hold at least a Listed Seller of Poisons (LSP) licence to sell it.

📘 Regulatory basis

The regulatory status of a product is determined by each of its ingredients. The Department of Health’s “Guidance Notes on the Differentiation between Pharmaceutical Products and Non-pharmaceutical Products” may be used to determine whether disinfectants or ointments in a first-aid kit are regulated pharmaceutical products.

📗 Drew Tang's recommendations

Before designing or purchasing first-aid kit products, we strongly recommend submitting the complete ingredient list to us for review. We can assess the regulatory classification of each ingredient to ensure that your product range complies with the regulations and avoid the unauthorised sale of controlled medicines. For corporate clients, we can also customise fully compliant first-aid kits for offices or factories.

📕 Risk notice

Do not underestimate the regulation of first-aid supplies. Some disinfectants or burn creams that appear commonplace may contain ingredients classified as “poisons” in Hong Kong. Selling first-aid kits containing such ingredients without a licence amounts to unlicensed sale of medicines and is a serious offence.

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