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.