The Commission has adopted a modified proposal for an herbal medicines Directive, extending the simplified registration procedure to medicinal products containing non-herbal ingredients. The Council is expected to come to a common position on this proposal in June.
The Commission accepted some of the 24 amendments proposed by the Parliament. In particular, the modified proposal:
- broadens the responsibilities of the new Committee for Herbal Medicinal Products of the European Agency for the Evaluation of Medicinal Products (EMEA) to comprise arbitration procedures in case of disagreements between Member States;
- extends the simplified registration procedure to include medicinal products containing non-herbal ingredients (such as vitamins and minerals);
- requires labels and leaflets to state that the safety and efficacy of the product are based on information on the long-term traditional use and not regular scientific data.