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Definition of Herbal Medicinal Products: Iarc Monographs Volume 82 52

Herbal medicinal products in the EU require marketing approval and are generally classified as medicinal if they make therapeutic claims. Non-medicinal products may fall under food or cosmetic categories, and specific definitions vary by Member State. Combination products are assessed under strict guidelines, and marketing authorization necessitates comprehensive documentation of quality, safety, and efficacy.

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Definition of Herbal Medicinal Products: Iarc Monographs Volume 82 52

Herbal medicinal products in the EU require marketing approval and are generally classified as medicinal if they make therapeutic claims. Non-medicinal products may fall under food or cosmetic categories, and specific definitions vary by Member State. Combination products are assessed under strict guidelines, and marketing authorization necessitates comprehensive documentation of quality, safety, and efficacy.

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52 IARC MONOGRAPHS VOLUME 82

3.2.1 Definition of herbal medicinal products


According to Council Directive 65/65/EEC (European Commission, 1965), which
has been implemented in national law in all Member States, medicinal products require
prior marketing approval before gaining access to the market. In almost all Member
States, herbal medicinal products are considered as medicinal products, and are, in
principle, subject to the general regulations for medicines as laid down in the various
national medicine laws. In many cases, a specific definition of herbal medicinal products
is available, which is in line with the EU Guideline ‘Quality of Herbal Medicinal
Products’. This includes plants, parts of plants and their preparations, mostly presented
with therapeutic or prophylactic claims. Different categories of medicinal products
containing plant preparations exist or are in the process of being created. For instance,
draft legislation in Spain includes the definitions ‘herbal medicinal products’ and
‘phytotraditional products’. The latter are not considered as ‘pharmaceutical specialties’
and are therefore not classified as herbal medicinal products.

3.2.2 Classification of herbal products


Generally, herbal products are classified as medicinal products if they claim thera-
peutic or prophylactic indication, and are not considered as medicinal products when
they do not make these claims. Products not classified as medicinal in most cases belong
to the food or cosmetic areas, although they sometimes contain plants which have
pharmacological properties. For example, senna pods (from Cassia plants, used as
laxatives) (see General Remarks and monograph on Rubia tinctorum, Morinda officinalis
and anthraquinones in this volume) can be marketed as food in Belgium. Specific cate-
gories of non-medicinal products exist in some Member States, such as the so-called
‘therapeutic supplement products’ in Austria. In Ireland, Spain and the United Kingdom,
there exist preparations defined as medicinal products, which are under specific condi-
tions exempt from licensing requirements.

3.2.3 Combination products


Herbal ingredients used in combination are widely used in Europe, and their
assessment is often performed according to specific guidelines. Combinations of herbal
and homeopathic ingredients exist in a few countries. Their assessment follows rather
strict criteria, usually those of a ‘full’ application procedure. Combinations of herbal
ingredients and vitamins are available in many countries.

3.2.4 Documentation of quality, safety and efficacy


A marketing authorization for a herbal medicinal product is, in principle, granted
based on an extensive dossier in terms of proof of quality, safety and efficacy in all
Member States, with the exception of Denmark and Finland, where it is possible to use

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