On 9 April 2003 the Commission adopted a new position on this Directive, extending the simplified registration procedure to medicinal products containing non-herbal ingredients.
The European Parliament’s first reading and vote on Commission’s original proposal was finalised in November 2002 and the new Commission position takes account of some of the Parliament’s 24 amendments.
The changes are:
broadened 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;
extended simplified registration procedure to include medicinal products containing non-herbal ingredients (such as vitamins and minerals);
required 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.
The European Council is expected to come to a common position on this proposal in June 2003.
