Herbal medicinal products in the European Union - AESGP

Ireland
The Irish Medicines Board (IMB) considers that ESCOP and WHO monographs and W H O
Guidelines have a supporting role.
Italy
The Ministry of Health has so far not considered ESCOP and WHO monographs and W H O
Guidelines as reference tools for medicinal products. It is awaiting the results of the Ad Hoc
Working Group on Herbal Medicinal Products. It would not oppose the development of
European core-SPCs.
Luxembourg
ESCOP and WHO monographs would in theory be acceptable as references, but at present
there is no assessment specific to herbal medicinal products.
The Netherlands
Monographs on indications or clinical use are at present not used.
Portugal
All this material is regarded as useful, but has not yet had any impact on the current
assessment process.
Spain
ESCOP and WHO monographs are used as bibliographic references.
Sweden
ESCOP monographs may be used along with other documents, but are not alone accepted as
sufficient support for approval (i.e., they cannot be the sole source). WHO monographs are
accepted as contributing support in the assessment process, but so far there has been no
experience with these monographs. The monographs are considered as not being complete
enough. The “WHO Guidelines on the Assessment of Herbal Medicines” have been partially
implemented.
United Kingdom
ESCOP and WHO monographs are regarded as a useful summary, but the original
references are needed.
Summary
ESCOP as well as WHO monographs are regarded as useful summaries of bibliographic
data in many countries. Other sources such as European Core-SPCs as well as further results
of the EMEA Ad hoc Working Group on Herbal Medicinal Products are considered desirable
by many health authorities for the assessment of herbal medicinal products.
VII.2.6 Existence of a Category for Well-Known Plants
The authorities were asked whether there is a specific category in which herbal medicinal
products containing well-known plants can be classified.
In the following countries, well-known plants can be included in the following categories:
Country Categories
Austria List according to Section 17a of the Medicines Law [AT 2,3]
Belgium Lists of the Ministerial Circular (“Circulaire ministérielle”) [B 2]
France Agency Instructions (“Cahiers de l’Agence No.3”) [F 4]
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