Affaires réglementaires pharmaceutiques : accès libre

Regulation of Herbal (Traditional) Medicinal Products in the European Union

Abstract

Ruiz-Poveda OMP

Legal framework for pharmaceutical legislation in the European Union is complex but clear in its principles, with the main objective of safeguarding public health. The regulation of (traditional) herbal medicinal products is covered by regulations, directives and scientific guidelines to ensure safety and efficacy. Pharmaceutical quality criteria for herbal medicinal products is defined in the amended Directive 2001/83/EC and Directive 2003/63/EC and complemented with several scientific guidelines which ensure that all herbal medicinal products in the European market are manufactured or imported only by authorized manufacturers which have also followed the Good Manufacturing Practices adopted by the Community. This will lead to high quality herbal substances, herbal preparations and herbal medicinal products which can be placed in the market through different types of application: full application, well-established use or traditional use marketing authorization, according to the efficacy data. This article provides an updated review on the specific characteristics of these groups of medicinal products before they are granted a marketing authorization.