The new European legislation on traditional herbal medicines: main features and perspectives.
Under the Italian Presidency of the Council of the European Union (July 2003-December 2003) an agreement has been reached by the European Parliament and the Council on the approval of the proposal of Directive of the European Parliament and the Council amending the Directive 2001/83/EC as regards traditional herbal medicinal products. Once implemented in the E.U. Member States, this new Directive will remove the constraints that have made it difficult granting marketing authorisations of herbal substances and preparations as traditional medicinal products under the pre-existing Community legislation. The main features (i.e. traditional herbal medicine definition, simplified registration procedure, provisions for Community herbal monographs and Community list of herbal substances and preparations and establishment of the Committee for Herbal Medicinal Products) of this new Community legislation are analysed and discussed in the present paper together with some expected positive public health impacts.
Silano
Marco
M
Department of Metabolism and Pathological Biochemistry, Istituto Superiore di Sanità, Rome, Italy. marco.silano@iss.it
De Vincenzi
Massimo
M
De Vincenzi
Alessandro
A
Silano
Vittorio
V
D005060:Europe; D029001:Herbal Medicine / Q000331:legislation & jurisprudence*; D006801:Humans; D007880:Legislation, Drug; D008517:Phytotherapy; D010946:Plants, Medicinal