Herbal medicinal products in the European Union - AESGP

VII.2.5 ESCOP and WHO Monographs and WHO Guidelines
The utilisation of monographs can be useful for the assessment and review of herbal
medicinal products as stated by the Ad Hoc Working Group on Herbal Medicinal Products
in November 1997. National authorities were therefore asked whether the monographs of
ESCOP (European Scientific Co-operative on Phytotherapy) and/or WHO (World Health
Organisation) as well as the “WHO Guidelines on the Assessment of Herbal Medicines” are
already used or intended to be used.
Austria
ESCOP and WHO monographs may only be used as a source for bibliographic data. It seems
difficult for the Federal Ministry of Labour, Health and Social Affairs to use them as a basis
for marketing authorisation because they often contain bibliographic data themselves and
not original data from studies.
Experts from the Federal Ministry are not required to follow the monographs. However, it
seems possible that a European core-SPC could be used, if available.
Belgium
ESCOP and WHO monographs may be used, but references are not limited to these
monographs.
Denmark
ESCOP monographs may be used as part of the bibliographic documentation but are not
accepted automatically. WHO monographs are not used as they cannot be considered to keep
up with the required standards. Other references may be used but will have a supportive role.
The Danish Medicines Agency will follow the recommendations of the EMEA Ad hoc
Working Group on Herbal Medicinal Products.
Finland
ESCOP monographs and the “WHO Guidelines on the Assessment of Herbal Medicines”
may be used.
Other sources of literature may be used with a supportive purpose. The National Agency for
Medicines (NAM) intends to follow most of the recommendations of the Ad Hoc Working
group on Herbal Medicinal Products as they consider it lacks a lot of the expertise and
competence that is available in this Working Group.
France
The French Medicines Agency (AdM) uses ESCOP and WHO monographs as a summary of
the current literature. WHO Guidelines are not used.
Germany
The Federal Institute for Drugs and Medical Devices (BfArM) considers that ESCOP
monographs offer a valuable overview of the published literature. They are used, together
with the bibliography, in the assessment of dossiers. The WHO monographs are not yet
finally published; however, the drafts are used in the same way as ESCOP monographs.
Greece
ESCOP and WHO monographs and WHO Guidelines are taken into account although they
have no official status. The Greek Health Authority (EOF) is waiting for the outcome of the
assessment by the Ad Hoc Working Group before officially accepting the ESCOP and W H O
monographs.
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