Herbal medicinal products in the European Union - AESGP

Austria
According to Section 17a of the Medicines Law, for a simplified registration procedure
neither efficacy nor safety must be demonstrated in detail. Documents on safety and
efficacy do not need to be submitted if the active ingredient(s) is/are included in a specific
list. These active ingredients are non-prescription-bound substances whose quality and
safety are regarded to be proven without any detailed assessment for marketing
authorisation. The list of active substances and their permitted indications qualifying for
the abridged procedure was published in 1989 [AT 2] and last amended in 1992 [AT 3]. If
quality complies with the specifications in the list, e.g. Flos Arnicae ÖAB (Austrian
Pharmacopoeia), no individual specification needs to be submitted. This procedure is applied
exclusively to medicines and indications included in the specific list (see above).
The list includes approximately five hundred substances, medicinal plants, parts of plants,
essential oils, etc. for which a simplified registration procedure can be used. According to
Section 17a of the Medicines Law, this procedure applies not only to herbal medicinal
products but more generally to those substances that are considered by the Federal Ministry
of Labour, Health and Social Affairs to be suitable, well known and safe. The following
examples of plant drugs are included in the table:
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