Herbal medicinal products in the European Union - AESGP

Ireland Yes Normal procedure
Italy Yes Food supplements
Luxembourg - -
The Netherlands Yes Food
Portugal - -
Spain Yes Dietary supplement
Sweden Yes *5) As Herbal Medicinal Products
United Kingdom Yes As Food or following CPMP
Guidelines
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Table 5: Combination of herbal ingredients with vitamins and food
supplements
Notes:
1) Belgium:
In general, the Ministry of Public Health does not easily accept combinations of plants and
foods. However, prior to the publication of the Royal Decree (“Arrêté Royal”) of 29 August
1997 [B 1], it was not unusual for the Ministry of Public Health to designate products as
“food” if they contained plants as the applicant seeking to put such products on the market
was often looking for some type of legal recognition. This situation was acknowledged i n
the Royal Decree by the double classification of “food/plant”.
2) Finland:
There are herbal medicinal products on the market that are combinations of herbs and
vitamins, and herbs and homeopathics, but not combinations of herbs and amino acids.
Vitamins and homeopathics in these products are classified as non-active ingredients, and
the amount of vitamin in the daily dose must be less than the Recommended Daily
Allowance (RDA) level of the vitamin in question. Quality assessment of these combination
product vitamins is performed according to the same guidelines as active ingredients. Some
combination products are sold without any medicinal claims under the Food Act.
3) France:
There are no registered combinations of herbals and homeopathics. The current legal
framework for abridged procedures does not permit the registration of combinations of
medicinal plants (either homeopathic or not), vitamins and oligo elements. Such
combinations (some exist in the market e.g. “aspirin, caffeine and meadowsweet”) require a
completely new registration. Normally speaking Community legislation would apply but the
current legal framework for abridged procedures in France does not permit the registration
of such combinations.
4) Germany:
For these products, the Federal Institute for Drugs and Medical Devices (BfArM) requires a
justification of the combination according to Section 22 paragraph 3a (see Point VII.2.7.).
This requirement might prevent some products from receiving a positive decision on their
application for registration renewal. Combinations of products with different legal status
(e.g., medicinal products combined with foodstuffs or cosmetics) are not allowed.
5) Sweden:
There are combination products containing herbs plus vitamins and mineral substances on
the market. The assessment procedures for combinations are the same as those applied to
herbal medicinal products. For herbs, there is an efficacy and safety requirement. For
vitamins and minerals, there is only a safety evaluation (and they must not be alleged to
have any efficacy). With regard to combination substances that are not herbs, there is a
requirement that these substances must not be active substances. No specific guidelines exist
with regard to “combination products”.
Summary
Combinations of herbal ingredients are widely used in Europe. Their specific
assessment criteria will be treated in a separate chapter (point VII.3.1.).
Combinations of herbal and homeopathic ingredients are only available in a few
countries (Austria, Finland, Germany, Ireland and the Netherlands), and these
combinations are mostly assessed by rather strict criteria, i.e. those of a “full”
application procedure. Combinations of herbal ingredients and vitamins are