Q95 · I have seen some convenience stores and…

Q95 · Category B: Licence types and scope of application (Q51-Q100)

The ‘medicines’ you see in convenience stores or supermarkets are generally not ‘poisons’ as defined under the Pharmacy and Poisons Ordinance (that is, Part I and Part II poisons). In law, these products are known as ‘non-pharmaceutical products’ or medicines that are exempt because they pose very low risks. Examples include certain throat lozenges, medicated shampoos and topical disinfectants at very low concentrations. Their sale does not require a pharmacy or medicine shop licence. In addition, the law provides for a very short Exempted Medicines List. Aspirin, for example, may be sold in any retail shop when sold in specified packaging and dosage. These large chains can therefore lawfully sell these particular goods, which are not subject to medicine licensing controls, under their ordinary retail licences.

📘 Regulatory basis

Schedule 2 to the Pharmacy and Poisons Regulations lists “exempted poisons”. In addition, the final classification of a product depends on the Department of Health’s determination of its ingredients and claims. Products that do not contain any controlled “poison” ingredients are not regulated by these Regulations.

📗 Drew Tang's recommendations

This situation demonstrates the importance of “product classification”. Where a product can be sold depends entirely on its legal classification. For pharmaceutical manufacturers or brand owners, if the product can legally be classified as a “non-pharmaceutical product” or an “exempt drug” through changes to its formulation or the management of its claims, this can greatly broaden its distribution channels and open up the wider fast-moving consumer goods market. We can provide advice on regulatory strategy in this area.

📕 Risk notice

As a retailer, even a large supermarket, you must ensure that the “health products” you sell are not in fact regulated pharmaceutical products. If a supplier has misclassified a product or a product is found to contain undeclared medicinal ingredients, the retailer may also be held legally liable. Supplier checks and requests for evidence of compliance are therefore very important.

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.

I have seen some convenience stores and supermarkets selling medicines. What licences do they hold?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang