Herbal medicinal products in the European Union

Herbal medicinal products exist in all Member States of the European Union (EU), although their importance varies considerably from o­ne country to another. They do not represent a homogeneous group. Generally speaking, there are either fully licensed medicinal products with efficacy proven by clinical studies or by bibliography (in accordance with Article 4.8 a (ii) of Council Directive 65/65/EEC) or products with a more or less simplified proof of efficacy according to their national use. Although these two categories exist in many Member States, there are major discrepancies between the Member States in the classification of individual herbal drug preparations and products into o­ne of these categories as well as in the requirements for obtaining a marketing authorisation.

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