EU legislation on pharmaceutical products for human use also applies to traditional herbal medicines. Herbal medicinal products are defined as any medicinal product, exclusively containing as active ingredients one or more herbal substances, one or more herbal preparations, or a combination of the two.
Legal Framework
A simplified registration procedure was introduced by Directive 2004/24/EC.
The simplified registration procedure clarifies differences and uncertainties in the status of traditional herbal medicinal products and facilitates the free movement of these products through harmonised rules.
The registration procedure is intended for herbal medicinal products with a long tradition of medicinal use (at least 30 years, including 15 in the EU), which do not fulfil the "well established use" requirements for marketing authorisation, i.e. published scientific literature on recognised efficacy and safety.
With regard to the manufacturing and quality of traditional herbal medicines, applications for registration of these products have to fulfil the same requirements as applications for a marketing authorisation.
List of approved substances, preparations and combinations
Given the particularities of herbal medicinal products, a Committee for Herbal Medicinal Products (HMPC) was established at the European Medicines Agency (EMA).
The HMPC has been tasked with establishing monographs for traditional herbal medicinal products and proposing a list of herbal substances which have been in medicinal use for more than 30 years and are, therefore, not considered to be harmful under normal conditions of use.
On the basis of the scientific opinion of the HMPC, a list of herbal substances, preparations, and combinations for use in certain traditional herbal medicinal products has been established by Commission Decision 2008/911/EC.
Applicants can refer to this list in relation to safety and efficacy when registering a traditional herbal medicine. The quality of the medicinal products still needs to be verified prior to approval.
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