HMPC - Community herbal monographs – deviating
In accordance with Directive 2001/83/Econ the Community code relating to medicinal products for human use as amended by Directive 2004/27/EC and Directive 2004/24/EC, the Committee on Herbal Medicinal Products (HMPC) is responsible for establishing Community herbal monographs.
A community herbal monograph comprises the Committee’s scientific opinion on the concerned product, based on its evaluation of available scientific data (well-established use) or on the historic use of that product in the European Community (traditional use).
For some herbal medicinal products, the Community monograph covers both well-established use and traditional use.
The Community herbal monographs provide a harmonised approach to the scientific assessment of herbal medicinal products in the EU.
However, taking into account their own assessment within the framework of the establishing of monograph and the traditions or national positions , the health authorities of member states of the European Union may decide to deviate from the contents of a monograph in the evaluation of the authorisation / registration requests referring to this .
In Belgium, the Committee for Herbal Medicinal Products, based on the evaluation of scientific data, has decided to deviate from the contents of the monograph
- Hypericum perforatum L. (Well-established medicinal use): "Deviation from the community herbal monograph on Hypericum perforatum L, herba as accepted or required by the Belgian Commission for Herbal Medicinal products for human use". This deviation is based on the evaluation of scientific data published on the St. John's Wort and the EMA guidelines on the clinical assessment of efficacy of the medicines in the treatment of depression.