Well-established use

Last updated on: 23.10.2023

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Term used in phytotherapy. The Herbal Medicinal Product Committee(HMPC) of the EMA = European Medicines Agency, divides plants/drugs into well-established use and traditional-use.

Well-established use" is defined as a label whose prerequisite is at least ten years of medical use as a medicinal product in a country of the EU with sufficient bibliographic documentation as well as accepted and professionally recognized data. From the point of view of the HMPC, at least one good clinical study is required for assignment to this category. In case of heterogeneous data, the available evidence has to be considered in its entirety.

Well-established use means:

recognized medicinal effect and accepted safety, well-established use (marketing authorization, WEU): sufficient data on safety and efficacy demonstrated.

The following plants/drugs and their indications count as well-established:

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  1. https://www.ema.europa.eu/en/documents/other/hmpc-monographs-overview-recommendations-uses-herbal-medicinal-products-paediatric-population_en.pdf

Last updated on: 23.10.2023