Intended for healthcare professionals


New European rules require all herbal medicines to be registered

BMJ 2011; 342 doi: (Published 06 May 2011) Cite this as: BMJ 2011;342:d2815
  1. Rory Watson
  1. 1Brussels

Since 1 May all traditional herbal medicines available in health food shops, pharmacies, and other outlets in the European Union must be formally registered and approved before they can be sold. The new rules mean that only products whose use is “plausible on the basis of longstanding use and experience” and whose quality and safety are guaranteed will be licensed.

The new requirements are set out in the EU’s Traditional Herbal Products Directive. Agreed in 2004, the directive gave manufacturers of traditional herbal remedies a seven year transitional period to register their products already on sale in the EU with the relevant national authorities.

John Dalli, the EU health …

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