The Legal and Regulatory Framework of Herbal Medicinal Products in the European Union: A Focus on the Traditional Herbal Medicines Category

Directive 2004/24/EC harmonized the definition of traditional herbal medicinal products (THMPs) in the European Union and established a simplified licensing system for these medicines. THMPs are defined in the European legislation by a number of criteria, including their type of indication, route of administration, and long-standing experience. The Directive sets up a registration system specific to THMPs and creates a new fully fledged scientific committee, the Herbal Medicinal Products Committee, within the European Medicines Agency. One of the main roles of the committee is to develop Community monographs and list entries that aim at facilitating the authorization or registration of herbal medicines. Five years after the issuance of the Directive, the number of registrations is slowly picking up in a couple of EU countries. A brisk increase is expected when the deadline for registering existing products on the market approaches. The Commission report proposed to extend the scope to other traditional products of nonherbal origin, which would further contribute to harmonizing the market.