Herbal medicinal products in the European Union - AESGP

VIII. CONCLUSIONS AND RECOMMENDATIONS
Council Directive 65/65/EEC defines the basic criteria for medicinal products. Herbal
preparations are considered as medicinal products if they meet the definition of this
Directive. Herbal medicinal products can be found in all Member States of the European
Union although the relative size of their markets varies considerably. According to Council
Directive 65/65/EEC, herbal medicinal products – like all other medicinal products – need to
obtain a marketing authorisation before they can be placed on the market. This guarantees a
high level of consumer protection through the fact that proof of quality, safety and efficacy
has to be provided.
The Ad hoc Working Group on Herbal Medicinal Products established in 1997 at the
European Agency for the Evaluation of Medicinal Products (EMEA) has carried out a
comprehensive review of existing guidelines and updated/adapted them to the particular
needs of herbal medicinal products. This work is highly appreciated by all parties involved
because it helps to provide specific guidance in the assessment of the quality, safety and
efficacy of herbal medicinal products. It is therefore recommended to strengthen the Ad hoc
Working Group. This should help to further develop and update guidelines to clarify the
situation for herbal medicinal products, with the final objective of allowing their free
circulation throughout the European Union. This work should also include the verification of
monographs proposed by the European Scientific Co-operative on Phytotherapy (ESCOP) and
the World Health Organisation (WHO) in order to come to generally accepted European
Summaries of Product Characteristics for widely used medicinal plants. To carry out this
work, it would seem appropriate to endow the Ad hoc Working Group on Herbal Medicinal
Products with an enlarged budget and an improved infrastructure. Consideration should
also be given to turning the Ad Hoc Working Group into a committee with a permanent
structure, and eventually into a Committee on Herbal Medicinal Products (CHMP) which
would co-ordinate the assessment of herbal medicinal products within the EMEA and
consequently for the European Union.
Although herbal medicinal products are covered by the requirements of Council Directive
65/65/EEC, several EU Member States seem to face problems in applying identical rules to
all medicinal products in a uniform manner. It is therefore recommended that some
clarification of Council Directive 75/318/EEC be incorporated into the existing EC legislation
on pharmaceuticals for those herbal medicinal products which are safe, of appropriate
quality and whose indications are exclusively based on adequate proof of efficacy through
documented traditional use. This might include the incorporation of a statement relating to
this traditional use in the approved indication, e.g. in the form of a prefix. In this way,
communication on such medicines would become identifiable, e.g. through the label/leaflet
and through advertising.
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