Herbal medicinal products in the European Union - AESGP

Ireland
No information available.
Italy
The Ministry of Health in a Decree dated 16 April 1998 [I 17] has approved a Guideline on the
advertising of laxative products (i.e., herbal and non-herbal medicinal products). There is a
requirement that explicitly forbids any advertising that would link the efficacy or safety of a
herbal-based laxative medicinal product to the fact that it is a “natural” substance.
Luxembourg
Council Directive 92/28/EEC is applied to herbal medicinal products.
The Netherlands
No information available.
Portugal
The Directive is only applicable to authorised herbal medicinal products.
Spain
The draft Royal Decree of 1997 [SP 1] also regulates the advertising of herbal medicinal
products.
Sweden
The Marketing Act and the Medicines Act, which cover the advertising of all medicinal
products, consequently also cover the advertising of natural remedies.
United Kingdom
The provisions of Council Directive 92/28/EEC are applied to herbal medicinal products
granted marketing authorisation.
Specific problems:
The following specific conditions apply concerning the advertising of herbal medicinal
products.
Austria
Health claims are permitted for “health products” after a licence has been granted by the
Federal Ministry of Labour, Health and Social Affairs.
Finland
Food supplements or health products are not allowed to make medical or medicinal claims.
Such advertising is regulated by the Food Act and controlled by the National Food
Administration. Controlling illegal medicinal advertising of food supplements is a big
problem for both the National Food Administration and National Agency for Medicines
(NAM). Most of these products contain herbs but are not classified as herbal medicinal
products because officially they are sold without medicinal claims. Most of them, however,
are marketed illegally with medicinal claims.
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