European Council Directive 2004/24/EC provides for a system of registration for herbal medicinal products and includes a mechanism by which the conditions of use, dosage, labelling, etc. of these products can be taken into consideration in the course of their registration. This will ensure that these products are of an appropriate quality and safe for use. The new system will require that all known adverse effects should be mentioned in the package leaflet. Directive 2004/24/EC is part of a package of European pharmaceutical legislation which will be implemented in Ireland in 2006.
The Irish Medicines Board is the statutory body responsible for regulating medicinal products in Ireland. It will administer the system of registration provided for in the directive and will ensure that the appropriate information is included when these products are registered.