Articles
LAWS AND REGULATION ON MEDICINAL AND AROMATIC PLANTS IN EUROPE
Article number
678_1
Pages
13 – 22
Language
English
Abstract
Medicinal and aromatic plants and their preparations are used by human beings all over the world.
With respect to their legal status, these products are either medicines or foodstuffs, depending on their use and the legal situation in each country.
According to the basic European Directives in the pharmaceutical area, medicinal products require pre-marketing approval before gaining access to the market.
Documentation of quality, safety, and efficacy as well as respective expert reports are required.
Quality requirements for herbal medicinal products include appropriate quality of the raw material (e.g.
European Pharmacopoeia, Good Agricultural and Collection Practice), Good Manufacturing Practice and testing on potential contamination (e.g. microbiological purity, heavy metals, aflatoxins, pesticides). Regarding safety and efficacy assessment, in principle for all medicinal products pharmacological and toxicological examinations are requested, and efficacy has to be proven by clinical studies.
For products with well-known active ingredients and a well-established medicinal use, an option for a so-called bibliographic application is provided by Article 10.1 a (ii) of Directive 2001/83/EC. One of ESCOPs main objectives is to establish harmonized criteria for the assessment of herbal medicinal products.
Sixty proposals for monographs on medicinal plants and their medicinal use have been published taking into consideration all the relevant scientific literature.
The Herbal Medicinal Products Working Party (HMPWP) proposed common criteria for the evaluation of quality, safety and efficacy of herbal medicinal products.
In particular, the group started assessing the monographs published by ESCOP and drafted so-called Core SPCs/Core data based on these monographs.
A Directive on traditionally used medicinal products is designed to amend the existing legal framework and will offer Member States the option to establish their own system of registration of products which are traditionally used, of sufficient quality and without any demonstrated harm.
With respect to their legal status, these products are either medicines or foodstuffs, depending on their use and the legal situation in each country.
According to the basic European Directives in the pharmaceutical area, medicinal products require pre-marketing approval before gaining access to the market.
Documentation of quality, safety, and efficacy as well as respective expert reports are required.
Quality requirements for herbal medicinal products include appropriate quality of the raw material (e.g.
European Pharmacopoeia, Good Agricultural and Collection Practice), Good Manufacturing Practice and testing on potential contamination (e.g. microbiological purity, heavy metals, aflatoxins, pesticides). Regarding safety and efficacy assessment, in principle for all medicinal products pharmacological and toxicological examinations are requested, and efficacy has to be proven by clinical studies.
For products with well-known active ingredients and a well-established medicinal use, an option for a so-called bibliographic application is provided by Article 10.1 a (ii) of Directive 2001/83/EC. One of ESCOPs main objectives is to establish harmonized criteria for the assessment of herbal medicinal products.
Sixty proposals for monographs on medicinal plants and their medicinal use have been published taking into consideration all the relevant scientific literature.
The Herbal Medicinal Products Working Party (HMPWP) proposed common criteria for the evaluation of quality, safety and efficacy of herbal medicinal products.
In particular, the group started assessing the monographs published by ESCOP and drafted so-called Core SPCs/Core data based on these monographs.
A Directive on traditionally used medicinal products is designed to amend the existing legal framework and will offer Member States the option to establish their own system of registration of products which are traditionally used, of sufficient quality and without any demonstrated harm.
Authors
B. Steinhoff
Keywords
marketing authorisation, European Pharmacopoeia, well-established medicinal use, scientific monographs, traditional herbal medicinal products
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