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)
Writer:
Dr Günter Brendelberger,
CONCEPT HEIDELBERG
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