European Union herbal monographs

The monographs are established by the European Medicines Agency’s Committee on Herbal Medicinal Products (HMPC).

European Union Monographs

EU herbal monographs are established for certain herbal substances and preparations. In each monograph, the Committee evaluate and specify information about the preparation, use and safety, which can be used to define individual herbal medicinal products. The information is divided into two columns, one for approval based on well established medicinal use and one for registration based on traditional use.

The monographs are aimed to facilitate an application, and may substitute all or parts of the efficacy and safety documentation in module 4 and 5 (non-clinical and clinical documentation). In some cases the monograph needs to be supplemented by additional product specific studies.

Current final monographs are taken into account by the national competent authority when examining an application, and any deviation from the monograph as adopted by the HMPC should be duly justified by the applicant. The monographs are thus not legally binding.

European Union list entries

The European Commission adopts, on the proposal of HMPC, a list of herbal substances and preparations which may be part of traditional herbal medicinal products. The list contains, for each substance / preparation, the indication, strength, dosage, route of administration, and the scientific name of the relevant plant.

For substances / preparations listed in the EU list it is considered that traditional use and safety has been demonstrated and reference to the list may substitute efficacy and safety documentation. The list is binding, national authorities may not derogate from the Commission's decision.

HMPC – The Committee on Herbal Medicinal Products

The European Medicines Agency (EMA) has a Committee on Herbal Medicinal Products (HMPC). One of its aims is to facilitate the processes of approval and registration for (traditional) herbal medicinal products in the EU, to support the harmonisation of the European market.