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HERBS AND PHYTOMEDICINES IN THE EUROPEAN COMMUNITY

In Western Europe, the professional use of herbs and phytomedicines enjoys relatively strong integration with conventional medicine. In the countries of the European Union (formerly European Economic Community, EEC), herbal medicines are generally sold in pharmacies as licensed nonprescription or prescription medicines. According to EU directive 65/65/EEC, all phytomedicines are treated as drugs. Registrations based on quality, safety, and efficacy are required (Keller, 1994; Schilcher, 1991). Exceptions include the Netherlands and the United Kingdom, where botanicals are still sold as food supplements or dietary supplements (Gruenwald, 1998).

Definitions

According to European Union definitions, herbal medicinal products (medicines) are "medicinal products containing as active ingredients exclusively plant material and/or vegetable drug preparations." Vegetable drugs are "plant material used for a medicinal purpose. An herbal drug or a preparation thereof is regarded as one active ingredient in its entirety whether or not the constituents with therapeutic activity are known." Herbal medicinal preparations are "comminuted or powdered vegetable drugs, extracts, tinctures, fatty or essential oils, expressed plant juices, etc. prepared from herbal drugs, and preparations whose production involves a purification or concentration process. However, chemically defined isolated constituents or their mixtures are not considered herbal medicinal products. Other substances such as solvents, diluents, preservatives [or] may form part of vegetable drug preparations. These substances must be indicated." Constituents with known therapeutic activity "are chemically defined substances or groups of substances which are known to contribute to the therapeutic activity of a vegetable drug or of a preparation." (Commission of European Communities, 1989.) (This definition formerly contained the term "vegetable drug" when first published; .however, this term was replaced by "herbal medicinal product" by EU in November 1997 [Busse, 1997c]). Some scientists consider isolated plant substances used as conventional drugs in pharmacy and medicine (e.g., digitoxin, atropine, escin, etc.) as phytomedicines, but these are not regulated as phytomedicines under German or EU drug laws (Schilcher, 1997b). Table 3: Sales of OTC Herbal Remedies in the Euronean Union - 1996

Nation Annual Retail Sales in millions (US $)    % per capita
Germany $3,500 50.0 $42.9
France   1,800 25.7 31.2
Italy     700 10.0 12.2
United Kingdom     400 5.7 6.9
Spain 300 4.3 7.6
Netherlands 100 1.4 6.4
All others 130 2.9 4.5
Total $7,000 100.0 $19 1 (mean)

Estimation based on Institute for Medical Statistics (IMS) market analysis of 1994 plus average growth rates. Source: PhytoPharm Consulting Berlin (Gruenwald 1998).

 

 

 

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Norman@thehormoneshop.com
This page was last updated on 10/31/08

Please note that the sale of DHEA or Melatonin is not available, legally in Australia or any member nations of the
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Disclaimer: The Hormone Shop LLC assumes no liability, whether under a theory of contract, tort, negligence, product liability or otherwise. In no event shall The Hormone Shop LLC be liable for any direct or indirect, consequential, incidental, special, punitive or exemplary damages, or for any loss incurred due to results or comments that are reported or the use of collection materials that are supplied, or any prescriptions regardless of whether The Hormone Shop LLC knew or should have known of the possibility of such damages. Furthermore, in no event  shall The Hormone Shop LLC's total cumulative liability exceed The Hormone Shop LLC's net profit on any specific product, sample or  consultation giving rise to the liability.  The Hormone Shop LLC specifically assumes no liability incurred by any 3rd party associate and if you are reading this web site in a language other that English it has been machine translated by SYSTRAN who strives to achieve the highest possible accuracy, however no automated translation is perfect nor is it intended to replace human translators. Users should note that the quality of the source text significantly affects the translations and The Hormone Shop LLC assumes no liability for incorrect or misleading translations.  The questions and comments appearing in the "Discussion Group Forum" are strictly from unknown or unidentified sources and the reader/participant should be aware that credentials from any source are completely lacking and should be questioned.  The Hormone Shop LLC specifically assumes no liability for any comment or advice appearing in the "Discussion Forum".

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Notice: This information on anti-aging products  is provided for educational and nutritional purposes. Any medical procedures, dietary changes or the use of dietary supplements discussed herein should only be undertaken on the advice of a qualified medical doctor. Although listed and sold as dietary supplements these are not innocuous, inert substances; rather they can and do affect vital systems within the human body and it is for this reason that you are urged to find a medical doctor who will work with you in monitoring and maintaining your well being.

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