Abstract
In the European Union (EU) herbal medicinal products have become increasingly important.
This is, for instance, underlined by the recent introduction of a simplified procedure
in the Member States of the EU allowing the registration of herbal medicinal products
which fulfill the criteria of a traditional herbal medicinal product, i.e., sufficient
evidence of its medicinal use throughout a period of at least 30 years for products
in the EU and at least 15 years within the EU and 15 years elsewhere for products
outside the EU. With regard to the manufacturing of these products and their quality,
applications of traditional herbal medicinal products have to fulfil the same requirements
as applications for a marketing authorization. The quality of herbal substances as
well as herbal preparations will be determined by the availabilty of modern science-based
public monographs in the European Pharmacopoeia and their equivalents developed by
the pharmaceutical industry. The standards put forward in these monographs must allow
us not only to define the quality of these products, but also to eliminate dangerous
counterfeit, substandard, adulterated and contaminated (traditional) herbal medicinal
products. The usefulness of these monographs to implement the criteria on quality
and specifications put forward for these products in the different guidelines of the
European Medicines Agency (EMEA) is discussed.
Key words
herbal substance - herbal preparation - herbal medicinal product - quality - European
Pharmacopoeia - European Medicines Agency - Committee on Herbal Medicinal Products
References
http://eur-lex.europa.eu/en/index.htm . Accessed September 5, 2008.
1
History: This article is based on a plenary lecture, presented by A. J. Vlietinck, as recipient
of the Phytochemical Society of Europe Silver Medal at the 7th Joint Meeting of AFERP,
ASP, GA, PSA and SIF in Athens on August 4, 2008.
arnold.vlietinck@ua.ac.be
