Parliament restricts use of herbal medicines

On 21 November, MEPs voted in favour of creating a new registration system and labelling regime for traditional herbal medicinal products.

On 21 November, MEPs adopted a resolution in first reading under the codecision procedure, drafted byGiuseppe NISTICO (EPP-ED, I), with the aim of setting basic quality and safety standards for herbal medicinal products in the EU. The new rules supported by Parliament center around the following main issues:

  • Anew registration systemhas been proposed for traditional herbal medicines. These registered products will be subject to standards on the quantity and quality of their ingredients. The substances will have to prove their safety through “traditional use” which means that they must have been on the market for 30 years, of which, 15 years must have been in Europe.
  • A newlabellingregime is proposed to clearly state what the products are intended for and what conditions they can treat or cure.
  • A newCommittee on Herbal Medicinal Productsis to take over the tasks of the Committee for Human Medicinal Products with regard to the evaluation of the herbal medicinal products.
  • Astatement which accompanies the product informationis to describe in an appropriate way the product’s nature and main priorities. It is also important that the consumer be informed about the possible occurrence of adverse reactions or possible interactions with food and/or other drugs administered.
  • The Committee on Herbal Medicinal Products is to establish aclassificationof herbal medicinal products, taking into account their composition and their pharmacological and toxicological effects.

 

TheAssociation of the European Self-Medication Industry, representing the European manufacturers of non-prescription medicines, welcomed the outcome of the vote in Parliament. Director of AESGP Dr. Hubertus Cranz greeted the new rules as a "missing piece of legislation which will clarify the legal basis for traditional herbal medicinal products in the European Union."

TheAlliance for Natural Health, on the other hand, expressed disappointment with the vote. Dr. Rob Verkerk, speaking on behalf of the organisation that represents herbal medicine practitioners, said he feared some herbal medicines with a proven safety record would disappear off the shelves of health food stores.

 

In January 2002, the European Commission proposed a new directive to establish a harmonised legislative framework for traditional herbal medicinal products. The Commission's main objectives with the proposal were:

  • to guarantee a high level of health protection for European patients;
  • to promote the Single Market for herbal medicines: laying down harmonised rules and procedures will facilitate the cross-border trade in herbal medicines;
  • to create a clear and favourable environment for the mainly small and medium-sized companies working in this sector.

 

The proposal will be discussed by the Council in a next meeting.

 

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