Data recommendations for herbal medicinal products and traditional herbal medicinal products used in paediatric patients - Scientific guideline
HumanHerbalScientific guidelines
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This document aims to provide basic recommendations for establishment of European Union herbal monographs with a paediatric indication. These recommendations can be applied by the national competent authorities, by analogy, in the assessment of applications for (traditional) herbal medicinal products or by applicants preparing application dossiers.
Keywords: Herbal medicinal products; traditional herbal medicinal products; well-established use; traditional use; paediatric population