Herbal medicinal products in the European Union - AESGP

According to the Agency Instructions No. 3, there should be only two possibilities:
— The drug is included in the positive list. An abridged application may be submitted
with the therapeutic indication “Traditionally used in …”. However, there is an
exemption for laxatives, for which the laxative nature of the medicinal product and its
indication, i.e. constipation, must be clearly stated. Indications such as “purgative” or
“for slimming purposes” etc. are not accepted.
— The drug is not included in the positive list. There is no simplification in the
requirements for proof of efficacy (and therefore no option to use an abridged
procedure).
Traditional therapeutic indications for herbal drugs reported in Annex II to Agency
Instructions No. 3 have been selected based on a careful review of all available literature,
including chemical composition and pharmacological, toxicological and clinical data. The
number of therapeutic indications allowed for a herbal medicinal product has usually been
limited to two; they are chosen by the applicant from the list of indications for the active
principle. When two indications are chosen for a combination of several active principles,
they should belong to the same therapeutic category.
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