Pharmaceutical products (also called drugs, medicines, or medicinal products) are used to diagnose, cure, treat, or prevent diseases by means of a pharmacological way of action. Pharmaceutical products in Europe must comply with the European Directive 2001/83/EG. The registration of pharmaceutical products can usually be done via national or MRP/DCP procedures. After finalization of a registration procedure the pharmaceutical dossier must be maintained and kept up-to-date according to the applicable rules.

Medical devices are used to diagnose, prevent, monitor, treat or alleviate a disease by means of a physiological way of action. Medical devices in Europe must comply with Regulation 2017/745 (MDR) or the European Directive Directive 93/42/EC (MDD). The certification procedure of a medical device is dependent on the classification of the involved product and usually (except for class I medical devices) a Notified Body approves the application.

YES Pharma Consultancy B.V. is specialized in questions coming up from the OTC market. We are experienced in the legislation for pharmaceuticals, medical devices, cosmetics, and foods. We have participated in borderline discussions concerning the classification of OTC products, since it is not always obviously clear which legislation (pharmaceutical, medical device, cosmetic or food) applies to an OTC product.