Amendment to a European Directive Concerning Traditional Herbal Medicinal Products

GMP News No. 175

GMP News
28 February 2002


Amendment to a European Directive Concerning 
Traditional Herbal Medicinal Products

On 17 January 2002 the Commission of the European Communities adopted the proposal for a Directive of the European Parliament and of the Council amending the Directive 2001/83/EC as regards traditional herbal medicinal products.

It is the proposal's objective to simplify the registration procedure for herbal medicinal products with a traditional medicinal use of at least 30 years. The quality standards are the same as in the regular authorisation procedure. However, the tests and trials on safety and efficacy of the products can be replaced by information on the traditional use of the product provided that there is a sufficient basis for its assessment. For example, if it can be demonstrated by detailed references to published scientific literature that the product has a well-established medicinal use. This new procedure, too, is to guarantee that only such medicinal products may be marketed in the EU as comply with the requirements of quality, efficacy and safety.

The proposal also provides for the foundation of a scientific committee within the EMEA that is to establish above all "Community herbal monographs relevant for the registration as well as the authorisation of herbal medicinal products."

You can download the unabridged document in several languages from the news page of the EC DG III commission. (Download link for the English version)

Dr Günter Brendelberger,


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