Commission reviews proposal on herbal medicines

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.


"Through this new legislation, herbal medicinal products will become far more easily available to the citizens all over Europe and this to the benefit of users as well as for the numerous small, mid-sized and larger European companies operating in this sector," said Dr Hubertus Cranz, Director-General of theAssociation of the European Self-Medication Industry.


The Commission adopted the amended proposal for a Directive on traditional herbal medicinal products on 9 April 2003, which will be considered by the Council in its June meeting. The European Parliament established a position on the legislative proposal on 21 November 2002 (see alsoEURACTIV, 22 November 2002).


The proposal will be discussed by the Health Council in June 2003.


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