Quaity and Manufacturing

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Vlietinck A, Pieters L, Apers S

Legal Requirements for the Quality of Herbal Substances and Herbal Preparations

for the Manufacturing of Herbal Medicinal Products in the European Union*

[JOURNAL ARTICLE]

Planta Med 2009 Feb 9.

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.