Herbal medicinal products in the European Union - AESGP

Ireland
The case has not been encountered but, in order to get a marketing authorisation, a
medicinal product based on a plant non native to Europe would require a dossier as
prescribed in the Notice to Applicants (The Rules Governing Medicinal Products in the
European Union).
Italy
Regarding the registration of herbal medicinal products, it is necessary to submit a n
application with a full dossier (including Parts III and IV). Therefore, results of
pharmacological, toxicological and clinical studies (in accordance with the general rules
for medicinal products) should be included.
For herbal (non-medicinal) products (i.e. health products without therapeutic indications), the
responsibility for marketing authorisation lies with the importer and/or the manufacturer.
At the time of importation of a pre-finished product or its herbal ingredient(s), the Ministry
of Health requests documents that certify the absence of chemical contaminant residues
(e.g., heavy metals, pesticides and mycotoxins) and microbiological and biological
contaminants. As far as Central and East European countries are involved, the Ministry
also requests a document certifying the absence of radioactivity. If it appears that the
products or materials are contaminated, the product may be refused or destroyed at the
expense of the importer and/or manufacturer.
Luxembourg
The case of plants non-native to Europe is handled on a case-by-case basis.
The Netherlands
The situation would depend on how herbal products based on plants non-native to Europe
enter the market. If they do so as a foodstuff without medicinal claims, safety and efficacy
are not assessed. If an application for marketing authorisation as a medicinal product is
submitted, then safety and efficacy are assessed in accordance with Council Directives
65/65/EEC, 75/318/EEC and 75/319/EEC.
Oriental herbs (e.g., from India) present a problem of control. The Medicines Evaluation
Board (MEB) intends to establish a list of herbs with forbidden substances.
Portugal
There is no defined policy as the health authority does for the moment not think these
products are of major relevance. Currently there is a debate on regulating products
originating in Macão.
Spain
Plants that are not known to Spain or Europe must be registered as with a full dossier. After
five years on the market and once safety has been proven, they can be switched to nonprescription
status. It is supposed that in the future they will become phytotraditional products
if they are added to the Annex to the draft Royal Decree of 1997 [SP 1] described in point
VII.1.2.b above.
Sweden
Either full or abridged applications may be used for plants traditionally used in the occident.
For plants traditionally used in other parts of the world, the requirements are the same as
for ordinary medicinal products (i.e., full application needed). This does not prevent
Ginseng from being sold in Sweden based on extensive use in Europe. However, products
containing Ginseng have not yet been revised under the 1993 Medicinal Products Act.
United Kingdom
Plants non-native to Europe are considered as new chemical entities.
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