Herbal medicinal products in the European Union - AESGP

a product as a medicinal product, both by function and by presentation. The term “medicinal
purposes” is applied on a case-by-case basis taking into account all properties of a certain
herbal medicinal product.
In this context, the term “traditionally” means traditionally used in the proposed indication
in Europe or in countries that are close to Europe with regard to their healthcare traditions.
Use for 20 years can be regarded as traditional use. A shorter period cannot be acceptable i n
the case of herbal medicinal products.
The administrative regulation 9/93 [FIN 1] of the National Agency for Medicines
(“Lääkelaitos” or “NAM”) regulates the status of herbal medicinal products in Finland.
According to this regulation, herbal products contain plants or parts of plants that are
traditionally used (in Europe or similar countries with the same therapeutic culture), i n
dried form, extracts or tinctures prepared from them, or traditionally used essential or fatty
oils.
France
There is no legal definition of herbal medicinal products. In the Agency Instructions No. 3
(“Cahiers de l’Agence N° 3”) [F 4], the French Medicines Agency (“Agence du Médicament” or
“AdM”) considers that herbal medicinal products are medicinal products containing as
active ingredients exclusively herbal drugs and/or herbal drug preparations. Herbal drugs
are substances used for medicinal purposes and derived from either fresh or dried plants.
Herbal drugs can be the whole plant, plant parts (cut or whole) or unprocessed plant exudates
(e.g., gums, latex, etc.). Active ingredients are herbal drugs or herbal drug preparations
whether or not the active constituents are known. Isolated chemical constituents extracted
from a herbal drug are not considered herbal products. The list of poisonous substances and
narcotic substances (which is fixed by Decrees published in the Official Journal of the
French Republic) indicates some materials of plant origin (e.g. belladonna) which are for
prescription-only use.
Germany
Herbal medicinal products are medicinal products containing as active ingredients only
plants, parts of plants or plant materials, or combinations thereof, whether in crude or
processed form. Chemically defined, isolated constituents of herbal origin (such as menthol,
cineol, or digitoxin) are not classified as herbal medicinal products. Most herbal medicinal
products are available for self-medication without a prescription.
Greece
According to a Ministerial Decree on herbal medicinal products of 1 April 1994 [GR 1],
herbal medicinal products are medicinal products that contain as active ingredients only
plants or preparations of plants. The regulation is not applicable to plant products that are
used as food supplements, beverages or for other purposes which are regulated as food.
Ireland
There is no legal definition of herbal medicinal products.
Italy
For the definition of medicinal products, the Community definition applies, according to
Council Directive 65/65/EEC. There is also a proposal for a definition of herbal products
[I 18]. Therefore, those herbal products that make therapeutic claims or have a particular
pharmaceutical activity are considered as herbal medicinal products.
There is no specific framework for isolated chemical compounds or highly purified extracts
of herbal drugs. They can be included in medicinal or non-medicinal products. They should
not be considered as herbal medicinal products but rather constituents of regular medicinal
products, in agreement with the definition of the Ad Hoc Working Group on Herbal
Medicinal Products. Table III of the Italian pharmacopoeia (“FU”): “Substances registered i n
the FU to be kept in locked cabinet” (which is commonly considered as a table of poisonous
substances registered in the FU) and the list of narcotic substances include some materials
of plant origin (e.g. belladonna) for prescription-only use.
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