Herbal medicinal products

Amended by Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products. Directive 2001 /83/EC on the Community code relating to medicinal products for human use Amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use... 

They have indications exclusively appropriate to traditional herbal medicinal products which, by virtue of their composition and purpose, are intended and designed for use without the supervision of a medical practitioner for diagnostic purposes or for prescription or monitoring of treatment. 

All other homeopathic and herbal medicines that do not qualify for simplified registration procedures will have to go through the standard authorisation procedure with supporting technical dossiers. The Committee for Herbal Medicinal Products has been charged with preparing monographs on herbal products so as to further facilitate the registration of traditional and well-established use herbal products. 

Lang F, Keller K, Ihrig M, Oudtshoorn-Eckard J, Moller H, Srinivasan VS. Yu He-ci in FIP recommendations for biopharamceutical characterization of herbal medicinal products. Pharmacopeial Forum 2002 28(1) 173—181. 

Blume HH, Schug BS. Biopharmaceutical characterization of herbal medicinal products are in vivo studies necessary Eur J Drug Metabol Pharmacokinet 2000 25 41—48. 

Bhattaram VA, Graefe U, Kohlert C, Veit M, Derendorf H. (2002) Pharmacokinetics and bioavailability of herbal medicinal products. Phytomedicine 9 1-23. 

In view of the increasing profile and use of herbal medicines, the European union has established a Committee for Herbal Medicinal Products (see chapter 17). The MHRA consulted and has also established a Herbal Medicines... 

Advisory Committee (HMAC). This Committee would advise Ministers directly on areas for which the Committee is responsible. The remit of HMAC would be the registration scheme to be introduced under the Directive 2004/24/EC on Traditional Herbal Medicinal Products and unlicensed herbal medicines. However, CHM will be responsible for advice in relation to marketing authorizations for herbal medicines. Professor Philip Routledge has been appointed the first Chairman of HMAC, for a term of 4 years effective from 30 October 2005. 

A herbal medicinal product is defined as any medicinal product, exclusively containing as active ingredients one or more herbal substances or... 

Starting as an Ad Hoc Working Group on Herbal Medicinal Products in May 1997, there evolved a Herbal Medicinal Products Working Party (HMPWP) which had been operational as regards traditional herbal medicinal products imtil August 2004. However, Article 16h of Directive 2004/24/EC of 31 March 2004 formally established the Committee for Herbal Medicinal Products (HMPC). 

Article 16a provides for a simplified registration procedure for herbal medicinal products which fulfQl all of the following criteria ... 

However, this simplified procedure should be used only where no marketing authorisation can be obtained through procedures for t)q)ical medicinal products. In order to promote harmonisation, Member States are expected to recognise registrations of traditional herbal medicinal products granted by another Member State based... 

The HMPC is expected to establish community herbal monographs for herbal medicinal products. These herbal remedies have their product particulars and literature. Apart from other controls, any advertisement for a medicinal product registered is required to contain the following statement Traditional herbal medicinal product for use in specified indication(s) exclusively based upon long-standing use. ... 

Anon. Good Manufacturing Practices Supplementary Guidelines for the Manufacture of Herbal Medicinal Products. WHO Technical Report Series No. 863. Geneva, Switzerland World Health Organization, 1996 109-113. 

A general disillusionment with conventional medicines, coupled with the desire for a natural lifestyle has resulted in an increasing utilization of herbal medicinal products (HMPs) across the developed world. Sales of botanical products in the United States have increased sharply in recent years, according to industry reports. An estimated 4 billion was spent in health food stores in 2000 for botanical products in bulk, as well as capsules, tablets, extracts, and teas (1 ). A similar trend is noted for European countries (5). 

Nahrstedt A. Antidepressant constituents of Hypericum perforatum. In Chrubasik S, Roufogalis BD, eds. Herbal Medicinal Products for the Treatment of Pain. Lismore Southern Cross University Press, 2000 144—153. 

EMEA Comparative table of current and proposed specifications. Batch analysis data on two production batches for all tests in the new specification. Where appropriate, comparative dissolution profile data for the finished product on at least one pilot batch containing the excipient complying with the current and proposed specification. For herbal medicinal products, comparative disintegration data may be acceptable. Minor change type IB requires approval... 

Manufacture of immunological veterinary medical products Manufacture of medicinal gases Manufacture of herbal medicinal products Sampling of starting and packaging materials Manufacture of liquids, creams, and ointments Manufacture of pressurized metered-dose aerosol preparations for inhalation... 

Grzanna R, Lindmark L, Frondoza CG. Ginger— an herbal medicinal product with broad antiinflammatory actions. J Med Food. 2005 8 125-132. 

Huntley AL, Thompson Coon J, Ernst E. The safety of herbal medicinal products derived from Echinacea species a systematic review. Drug Saf. 2005 28 387-400. 

Rttler, M.H., Ernst, E. Systematic review Hepatotoxic events associated with herbal medicinal products. Alim. Pharm. Ther. 2003 18 451-471... 

The CPMP and CVMP each have four working parties, as well as a joint CPMP/CVMP Quality Working Party. There is also an EMEA working party on Herbal Medicinal Products. 

Artiges, A. Pharmaeopeial Standards for Herbal Medicinal Products in Europe, Proceedings of the 5th ESCOP International Symposium. 

Ernst E, Pittler MH. Risks associated with herbal medicinal products Wien Med Wochenschr 2002 152(7-8) 183-9. 

Ernst E. Herbal medicinal products during pregnancy are they safe BJOG 2002 109(3) 227-35. 

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