Only registered herbal medicines can remain on the EU market after May 1, 2011. Thanks to this, people who use them will be able to trust the safety of these drugs more, informed the European Commission.
At the same time, it will be easier to register them than other drugs.
May 1 marks the 7-year transition period for EU countries to apply the Directive on traditional herbal medicinal products. This means that they must be registered before placing them on the market.
We have now reached the end of a long transition period which has given producers and importers of traditional herbal medicinal products the time it takes to demonstrate that their products are safe and effective. Patients can now have confidence in the traditional herbal medicines they buy in the EU, EU Health Commissioner John Dalli said on Friday.
Commissioner spokesman Frederic Vincent added that this meant the withdrawal of some unregistered medicines on May 1. Consumers will be able to trust that the purchased herbal medicinal products are of good quality and safe, he emphasized. He added that the purpose of the directive was also to simplify the registration procedure for traditional herbal medicines.
The procedure will be simpler than for other medicinal products due to the long history of using traditional herbal medicines, the Commission explains. It will be possible to register herbal products without the safety and clinical trials that would be required for a full marketing authorization procedure.
Instead, an applicant wishing to register a traditional herbal medicinal product must provide documentation demonstrating that the product is not harmful. He must also provide evidence that the product has a proven history of use, i.e. that it has been used safely for at least 30 years – of which 15 years in the EU, the European Commission explains.
Julita Żylińska (PAP) from Brussels