Herbal medicinal products in the European Union - AESGP

18 February 1997, No.44 [I 7] and through a Ministerial Decree (“Decreto Ministeriale”) of
10 March 1998 [I 8].
7) Spain:
Council Directive 65/65/EEC was implemented into Spanish legislation in 1990 by the
Medicines Law (“Ley del Medicamento”) [SP 2].
8) Sweden:
The basis for marketing authorisations is the Medicinal Products Act (SFS 1992:859).
9) United Kingdom:
Council Directives 65/65/EEC, 75/318/EEC and 75/319/EEC have been implemented by SI
1994/3144, the Medicines for Human Use (Marketing Authorisations etc.) Regulations.
VII.1.2 Definition of Herbal Medicinal Products
According to Council Directive 65/65/EEC, a medicinal product is defined as “any substance
or combination of substances presented for treating or preventing disease in human beings
or animals.” The Directive further states that “any substance or combination of substances
which may be administered to human beings or animals with a view to making a medical
diagnosis or to restoring, correcting or modifying physiological functions in human beings
or in animals is likewise considered a medicinal product.” In this study, Member States
were asked whether herbal medicinal products are considered as medicinal products and
how herbal medicinal products are defined in their country. In several cases, different
categories of herbal medicinal products exist and are listed below.
a) Herbal Medicinal Products Considered As Medicinal Products
In all Member States, herbal medicinal products are considered as medicinal products,
except in Portugal where (with a few exceptions of fully authorised products) herbal products
in general have not yet entered the legislative framework on medicinal products. At present,
these products are covered by the 1993 Portuguese legislation on health products covering
cosmetics, medicinal plants, dietetic products with therapeutic use and homeopathics [P 1].
The following additional information is available:
Austria
The Austrian Medicines Law [AT 1] does not distinguish between medicinal products made
from chemical substances and those made from plants or natural substances. Herbal
medicinal products are regulated by the same rules as all other medicinal products.
Registration requirements are the same concerning production, over-the-counter (OTC) and
prescription-only status, labelling, advertising and selling for both chemical and herbal
medicinal products. According to the Austrian Medicines Law, both herbal and homeopathic
medicinal products belong to the category of medicinal products.
France
Article L.511 of the Public Health Code (“Code de la Santé Publique”), which defines
medicinal products, does not distinguish between medicinal products made from chemical
substances and those made from plants or natural substances. Herbal medicinal products
fall under the definition of Article L.511 of the Public Health Code and are thus subject to the
general regulations for medicinal products.
Germany
Herbal medicinal products are fully considered as medicinal products. There is no
distinction between medicinal products made from chemical substances and those made
from plants or natural substances.
Spain
Article 42 of the Spanish Medicines Law [SP 2] states that “the plants and the mixtures thereof
as well as the preparations obtained from plants in the form of extracts, lyophilised, distilled,
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