Moisturizers as cosmetics, medicines, or medical device? the regulatory demands in the european union

Abstract

The majority of moisturizing creams on the market are regulated as cosmetics. However, moisturizing creams may also be classified as pharmaceuticals (equivalent to medicinal products) or as medical devices within the European Member States. During recent years, there has been an increase in topically applied semi-solid formulations certified as medical devices. The regulatory demands and the approval process differ between the three regulatory categories. The present chapter gives a brief overview of the differences and similarities between the categories, where the topics such as efficacy, safety, labeling, manufacturing, vigilance, post-marketing surveillance, qualified and responsible persons are addressed.