This is the text of the European Directive on food supplements:
http://eur-lex.europa.eu/LexUriServ/LexU...46:EN:HTML
The ban on megadose vitamin supplements is in Article 5.
This is the European Directive on traditional herbal medicinal products:
http://eur-lex.europa.eu/LexUriServ/LexU...24:EN:HTML
The criteria for a simplified registration procedure (referred to as 'traditional-use registration') are listed in article 16a. The procedure is simplified in comparison with the procedure for pharmaceuticals. The simplification is basically an exemption from the requirement for clinical trials. The exemption is only intended for use in those cases where clinical trials do not prove the effectiveness of a product. The exemption is only granted if the efficacy of the medicinal product is plausible on the basis of long-standing use and experience.
So the principle is still that an effective herbal medicinal product should go for full registration as a pharmaceutical product. It looks like the main goal of the exemption is to save the homeopathic industry in Europe the trouble of having to prove that their products actually work. An added benefit is that people can still sell hops without proving that it grows breasts.
There is a list of herbs, which is regularly updated. PM is not on it yet, hops is.
This is the website of the Committee on Herbal Medicinal Products (HMPC):
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000264.jsp&mid=WC0b01ac0580028e7c&jsenabled=true
and this is the list:
http://www.ema.europa.eu/ema/index.jsp?curl=%2Fpages%2Fmedicines%2Flanding%2Fherbal_search.jsp&mid=WC0b01ac058001fa1d&searchkwByEnter=false&alreadyLoaded=true&isNewQuery=true&startLetter=H&keyword=Enter+keywords&searchType=Latin+name+of+the+genus&taxonomyPath=&treeNumber=
http://eur-lex.europa.eu/LexUriServ/LexU...46:EN:HTML
The ban on megadose vitamin supplements is in Article 5.
This is the European Directive on traditional herbal medicinal products:
http://eur-lex.europa.eu/LexUriServ/LexU...24:EN:HTML
The criteria for a simplified registration procedure (referred to as 'traditional-use registration') are listed in article 16a. The procedure is simplified in comparison with the procedure for pharmaceuticals. The simplification is basically an exemption from the requirement for clinical trials. The exemption is only intended for use in those cases where clinical trials do not prove the effectiveness of a product. The exemption is only granted if the efficacy of the medicinal product is plausible on the basis of long-standing use and experience.
So the principle is still that an effective herbal medicinal product should go for full registration as a pharmaceutical product. It looks like the main goal of the exemption is to save the homeopathic industry in Europe the trouble of having to prove that their products actually work. An added benefit is that people can still sell hops without proving that it grows breasts.
There is a list of herbs, which is regularly updated. PM is not on it yet, hops is.
This is the website of the Committee on Herbal Medicinal Products (HMPC):
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000264.jsp&mid=WC0b01ac0580028e7c&jsenabled=true
and this is the list:
http://www.ema.europa.eu/ema/index.jsp?curl=%2Fpages%2Fmedicines%2Flanding%2Fherbal_search.jsp&mid=WC0b01ac058001fa1d&searchkwByEnter=false&alreadyLoaded=true&isNewQuery=true&startLetter=H&keyword=Enter+keywords&searchType=Latin+name+of+the+genus&taxonomyPath=&treeNumber=