Borderline products

Although it may be immediately obvious that a product is a medicine and should be regulated as such, some products are more difficult to distinguish from medicines or medical devices and may function for a medicinal purpose and another purpose, such as a cosmetic purpose. For these products, the classification is not immediately clear and multiple regulatory frameworks may apply. For example, it may be uncertain whether a more complex healthcare product might be viewed as a medical device, cosmetic, food, dietary supplement, herbal medicine or biocidal product. Sometimes it is certain circumstances or if certain criteria are met or even claims made about the product’s use that might cause it to be classified as a medicinal product, so it can be unclear which regulatory framework one should comply with for an effective regulatory strategy. These products are called borderline products until their status has been decided.

The regulatory classification of a product can have important ramifications, for example, on how the product is regulated (and by whom), how long it will take before such product can be commercialised (especially if pre-market approval is required), how the