EMA: Draft reflection paper on microbiological aspects of herbal medicinal products and traditional herbal medicinal products

Directive 2001/83/EC as amended and Directive 2001/82/EC as amended provide definitions for herbal substances, herbal preparations, and herbal medicinal products (HMPs). The basic legislation applies to both HMPs for human and veterinary use. An additional simplified registration procedure has been established for traditional herbal medicinal products (THMPs) for human use under Directive 2004/24/EC. The principles of this reflection paper apply equally to such THMPs.