Pharmaceuticals—regulatory framework

Introduction to the regulation of medicinal products

A medicinal product is defined as a substance that is either:

1. •

   presented as preventing or treating disease, or

2. •

   used to correct or modify a physiological function by pharmacological, immunological or metabolic action, or to make a medical diagnosis

It is often obvious whether a product should be classified as a medicinal product, medical device, cosmetic product, food, or a biocide. On the other hand, the regulatory status of so-called ‘borderline products’ is not immediately clear. 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 product can be marketed and what advertising claims can be made etc. For an analysis of the definition of medicinal product and the borderline between medicinal products and other products, see Practice Note: Introduction to borderline products.

The borderline between cosmetic products and those that are regulated as a medicinal product or medical device or have health claims