Herbal medicinal products in the European Union - AESGP

VII.6.4 Application of Council Directive 92/28/EEC to Herbal Medicinal
Products
National authorities were asked whether Council Directive 92/28/EEC also applies to herbal
medicinal products. Their replies are summarised below.
Austria
The Medicines Law which also regulates pharmaceutical advertising is applied to herbal
medicinal products.
Belgium
The Royal Decree of 7 April 1995 explicitly forbids advertising that links the efficacy or
safety of a medicinal product to the fact that it is a natural substance. It is important to stress
that this limitation only pertains to medicinal products. Foodstuffs that are in accordance
with the Royal Decree (“Arrêté Royal”) of 29 August 1997 are not covered and are only
subject to the general rules of consumer protection.
Denmark
The Danish Ministry of Health Order No. 736 implementing Council Directive 92/28/EEC
also applies to natural remedies.
Finland
NAM’s Administrative Regulation 3/97 implementing Council Directive 92/28/EEC also
applies to herbal medicinal products.
France
The French pharmaceutical advertising regulations also apply to herbal medicinal products.
Advertising of medicinal products to the general public is allowed in all media after a visa
has been obtained from the French Medicines Agency (AdM). Reimbursable medicinal
products, regardless of their legal status (non-prescription or prescription only), may not be
advertised to the general public. Herbal medicinal products are usually not reimbursed,
although a few are.
Germany
Council Directive 92/28/EEC is applicable to all medicinal products, including herbal
medicinal products. OTC advertising to the general public is allowed for all nonprescription
medicinal products (including reimbursed medicinal products) in all media.
However, certain indications may not be advertised to the general public.
Greece
OTCs and herbal remedies may be advertised; however, the Greek Health Authority (EOF)
has the right to ban the advertising of reimbursable products (Law 1965 Section 17). All public
advertising must be submitted to EOF prior to publication. A post-publication monitoring
system has already been established by EOF and an industry pre-vetting system is also i n
force. Advertising through the mass media should comply with the SPC or the patient leaflet
regarding safety, quality and efficacy. No medical information should be provided through
advertising. According to the regulation of April 1994 [GR 1], the advertising of herbal
medicinal products is only allowed for non-prescription products using a text that has been
authorised by the EOF. Advertising statements must be restricted to the summary of product
characteristics that has been authorised by the EOF.
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