Safer herbal medicinal products

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The Directive 2001/83/CE of 6th November 2001, on the Community code relating to medicinal products for human use, demands that all marketing authorization requests for a medicinal product must be accompanied by a dossier containing information and documents demonstrating the quality, safety and efficacy of the product.

However, a significant number of traditional medicinal products, the vast majority of which being based on herbal substances, despite their long tradition, did not fulfill the requirements of the above directive.

To regulate this situation, Directive 2004/24/EC of the European Parliament and of the Council of 31st March 2004 was created. This new directive institutes a simplified registration procedure for that kind of medicinal products (oral, external and/or inhalation preparations).

The simplified registration can only be used when the herbal medicinal product relies on a sufficiently long medicinal use (at least 30 years, including at least 15 years within the Community).

The need to perform clinical trials, where proof of a long standing use and experience can be proven, may be reduced. Pre-clinical tests are not necessary in cases where the medicinal product, on the basis of the information on its traditional use, proves not to be harmful in the specified conditions of use.
Nevertheless, data for assessing the safety is necessary and products should comply with quality standards in the relevant Pharmacopoeia monographs.

With Directive 2004/24/EC, producers already having these products on the market had a period of seven years to register their products. Now, from May the 1st 2011, only authorized or registered herbal medicinal products can be marketed on the UE.

Herbal medicinal product:

Any medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations. (Directive 2004/24/CE of the European Parliament and of the Council of 31 March 2004).

Source : Europa Gateway to the European Union.