ABSTRACT
Products that affect human health are heavily regulated to guarantee the quality of their production, as well as their safety and efficacy, which must be demonstrated in non-clinical and clinical studies, prior to their authorization and marketing.
Regulations and standards are set by individual governments and the regulatory agencies and/or other competent authorities are responsible for oversight to ensure that health risks are minimized, and compliance is achieved in each territory.
The legislation in force in each territory will define the requirements to be met by products used for human or animal health, food, or hygiene. However, this classification is not entirely obvious, and it is not uncommon to find borderline products that are difficult to classify under a single regulatory framework. This is more complex in the case of products containing components classified as different from a regulatory point of view, known as combined products.
