While demand for herbal medicines is growing across the EU, there is currently no legislation at EU level.
The Commission proposes:
- asimplified registration systemfor traditional herbal medicinal products:
- quality requirements will be identical to those for all medicinal products
- safety and efficacy will be assessed on the basis of information gathered on its traditional use (even partially outside the EU) over a period of min. 30 years (instead of new tests)
- anew scientific committee of herbal medicine expertswill be established within the European Agency for the Evaluation of Medicinal Products (London)
- its major task will be to establish monographs that further harmonise and facilitate registration applications