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Pharmacovigilance – a Science in its Own Right?
Pharmacovigilance deals with identifying, assessing, understanding and preventing adverse effects. Herbal medicinal products are also subject to the European pharmacovigilance guidelines. Requirements here are continual searches of the international literature for case reports, the MedDRA coding of adverse effects, sound scientific evaluation, electronic reporting of serious adverse events to national authorities and the EMA, as well as the regular risk / benefit assessment through periodic safety update reports (PSUR).
What we can do for you:
PSURsEvaluation of adverse drug effect notifications
Electronic reportingPharmacovigilance system
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