European Directive on Traditional Herbal Medicinal Products

The Directive on Traditional Herbal Medicinal Products, or more precisely, 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 is a European Union directive that was agreed in April 2004 and came into force on 30th October 2005.

The Directive requires traditional, over-the-counter herbal remedies to be made to assured standards of safety and quality and for regulations to be standardised throughout the European Union. There will be a transitional period for products legally on the market on 30 April, 2004, giving them protection until 2011update after|2011|1|1.

The Directive demands that a traditional herbal medicinal product must be shown to have been in use for 30 years in the EU (or at least 15 years in the EU and 15 years elsewhere) for it to be licensed and obtainable over the counter. There is concern that some herbal remedies of 30 years ago, which are no longer in widespread use, could still be sold but that valid new herbs which cannot meet the 30 year rule may require to be withdrawn from sale. The rule could also mean that it may not be possible to licence some traditional herbal medicines which were in common use more than 30 years ago, but have since fallen into disuse.

External links and references

* [http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32004L0024:EN:NOT Text of the Directive] ]
* [http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32001L0083:EN:NOT Text of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use] ]
* [http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=95 UK MHRA Traditional Herbal Medicines Registration Scheme]
* [http://www.herbsociety.org.uk/legislation.htm Herb Society Comment on Directive]