Regulating Herbal Medicines in Europe Heribert PITTNER Federal Ministry of Health and Women, Vienna, Austria 8th European Health Forum Gastein 7 October 2005

Regulating Herbal Medicines in Europe Until 2004: Different national regulations 31 March 2004: Directive 2004/24/EC as regards traditional herbal medicinal products

Traditional herbal medicinal product: Criteria (1) Indications without prescription Specified strength and dosage Oral, external and/or inhalation preparation Period of traditional use has elapsed: - at least 30 years, including at least 15 years within the European Union

Traditional herbal medicinal product: Criteria (2) Data are sufficient: - Not harmful in the specified conditions of use - Pharmacological effects or efficacy are plausible on the basis of long-standing use and experience

Directive 2004/24/EC Vitamins and minerals are allowed in traditional herbal medicinal products, provided that their action is ancillary to that of the herbal medicinal product

Documents for the application of traditional herbal medicinal products Results of pharmaceutical tests Summary of Product Characteristics Information relating to combinations Registrations in other countries Evidence to the medicinal use of at least 30 / 15 years

Labelling / Package Leaflet / Advertisement "Traditional herbal medicinal product for use in specified indication(s) exclusively based upon long-standing use"

Scientific Committees at EMEA (European Medicines Agency) CHMP (formerly CPMP): Human Medicines CVMP: Veterinary Medicines COMP: Orphan Products HMPC: Herbal Medicinal Products

HMPC (Committee for Herbal Medicinal Products) First Meeting on September 23, 2004: Chair elected: Konstantin Keller (Germany) Vice chair elected: Heribert Pittner (Austria) Meetings at EMEA every other month for 2 to 3 days

HMPC (Committee for Herbal Medicinal Products) 25 delegates and 25 alternates (1 per each EU Member State) Members from Norway and Iceland (with separate counting of votes) + up to 5 additional co-opted members

Tasks of the HMPC Check evidence of long-term medicinal use of a traditional herbal medicinal product Prepare lists of herbal substances for registration as traditional herbal medicinal products Establish community monographs for traditional and other herbal medicinal products Referral procedures for traditional herbal medicinal products Opinions on herbal substances in other medicinal products Any other task due to Community Law

Community herbal monographs (1) HMPC shall establish monographs for Herbal medicinal products with well- established medicinal use (= more than 10 years) Traditional herbal medicinal products

Community herbal monographs (2) Definition: Document the purpose of which is to provide a scientific summary of all data available on the safety and efficacy of a herbal substance / herbal preparation intended for medicinal use

Community herbal monograph: Sources ESCOP Monographs (European Scientific Cooperative on Phytotherapy) WHO Monographs European Pharmacopoeia Other Pharmacopoeias Any Published Literature

Goals of Regulation of Herbal Medicinal Products in the European Union Harmonisation of requirements on quality, safety and efficacy for herbal medicinal products Pharmacovigilance for herbal medicinal products Facilitation of free movement of safe herbal medicinal products within the European Union

Crucial issues to HMPC Setting the borderline between well-established use and traditional use Setting the borderline between traditional herbal medicinal products and food supplements