Herbal medicinal products in the European Union - AESGP

Summary
It can be demonstrated that Council Directive 92/27/EEC on the labelling has been
implemented by all Member States.
VII.6.2 Application of Council Directive 92/27/EEC to Herbal Medicinal
Products
National authorities were asked if Council Directive 92/27/EEC also applies to herbal
medicinal products. Their replies are summarised below.
Austria
The Medicines Law also applies to herbal medicinal products.
Belgium
As under the terms of the abridged licensing procedure the indication should be introduced
by the statement “This herbal medicinal product is indicated in ….”, the medicinal product
is always identified as a herbal medicinal product. Under the full application procedure,
there is no specific requirement for herbal medicinal products. The labelling of herbal (nonmedicinal)
products should be reported to the Ministry of Public Health.
Denmark
The national legislation implementing Council Directive 92/27/EEC also applies to natural
remedies [DK 3]. Natural medicinal products must have the supplementary labelling
“Natural Medicinal Product”. The labelling of natural remedies does not have to be reported
to the Danish Medicines Agency.
No specific rules apply to laxatives with plant ingredients apart from the fact that they must
be labelled with a statement that they should not be used for more than one week.
Finland
Administrative Regulation 5/93 entered into force on 1 January 1994, as part of the European
Economic Area (EEA) harmonisation process. Applications for marketing authorisations
submitted after that date had to include proposals for label and package leaflet texts. The
package leaflet should be in Finnish and Swedish. It should be written using clear language
that is understandable to the consumer. Its information should be based on the approved
summary of product characteristics. The outer package of a medicinal product must bear the
indication(s) and normal dosage as well as any other necessary information. If the
medicinal product is indicated for children, the dosage for children should also be shown.
Products that have not been approved for use by children should be marked “Not for
children”.
Regarding “old” herbal medicinal products, the implications of Council Directive 92/27/EEC
will be taken into consideration at the time of renewal of the marketing authorisation. This
process started in 1995 and is scheduled to be finished by 1999.
The text “Rohdosvalmiste - Naturmedel” (“natural remedy”) must always be included i n
labelling for herbal medicinal products.
There are no specific labelling requirements for certain products such as laxatives.
France
The package leaflet mentions the therapeutic class of the product. Herbal medicinal products
mention the herbal origin of the products or the fact that they belong to phytotherapy, although
this is not mandatory.
Germany
Council Directive 92/27/EC is applicable to all medicinal products, including herbal
medicinal products. Patient information leaflets are compulsory for newly registered
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