EN PL

EMA; Regulatory and procedural guideline: Procedure for calls for scientific data for use in HMPC assessment work

05.01.2011
In accordance with Directive 2004/24/EC (1), amending as regards traditional herbal medicinal products, Directive 2001/83/EC, it is the task of the Committee on Herbal Medicinal Products (HMPC) to establish a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (Article 16f). Furthermore, the HMPC shall establish Community herbal monographs for herbal medicinal products (Article 16h(3)).