Brussels, 29 April 2011
Traditional herbal medicines: more safety for products put on EU market
From tomorrow, EU citizens can be reassured that the traditional herbal medicines they buy in the EU are safe and effective. The expiry of the 7 year transition period set out in the 2004 Herbal Directive (2004/24/EC) means that only medicinal products which have been registered or authorised can remain on the EU market after 1 May 2011. The Herbal Directive introduces a simpler registration procedure than for other medicinal products, in respect of the long history of use of traditional herbal medicinal products. At the same time, the Directive provides the necessary guarantees of their quality, safety and efficacy.
John Dalli, European Commissioner for Health and Consumer Policy, said, "We have now reached the end of a long transition period which has given producers and importers of traditional herbal medicinal products the necessary time to show that their products have an acceptable level of safety and efficacy. Patients can now be confident about the traditional herbal medicinal products they buy in the EU."
In order to protect public health, all medicinal products, including traditional herbal medicinal products, need a marketing authorisation to be placed on the EU market. The simplified procedure introduced by the Herbal Directive allows these products to be registered without the safety tests and clinical trials that a full marketing authorisation procedure would involve.
Instead, an applicant who wishes to register a traditional herbal medicinal product must provide documentation showing that the product in question is not harmful in the specified conditions of use. They must also provide evidence that the product has a proven track record, ie. that it has been used safely for at least 30 years – 15 of these in the EU.
Seven years to register
The Herbal Directive was adopted by the European Parliament and the Council on 31 March 2004. It gave an exceptionally long transition period of 7 years for manufacturers to register their traditional herbal products already on the EU market when the Directive entered into force.
Applicants have had 7 years to apply to the competent authority in the Member States(s) where they wanted to market their product. If, by 30 April 2011, a herbal medicinal product is not registered or authorised, then it may not be on the EU market after 1 May 2011. After this date, producers of traditional herbal medicines can still apply for a registration through the simplified registration procedure.
The Herbals Directive:
Some plants contain substances that may be used to treat diseases. Medicinal products that are made from these substances are known as "Herbal Medicinal Products". Even though they are natural, a number of these products may be harmful to health. Therefore, these products are covered by pharmaceutical legislation, which aims to protect public health by ensuring the safety, efficacy and quality of medicinal products.
"Traditional" herbal medicinal products are a sub group of herbal medicinal products that have been in use for at least 30 years, including at least 15 years in the EU, and that are intended to be used without the supervision of a medical practitioner and are not administered by injection. This category is not limited to European traditional herbal medicinal products; it can also include Chinese and Ayurdevic medicinal products.
The Herbals Directive updated the 2001 Directive on the Community code for medicinal products for human use (Directive 2001/83/EC) by introducing a simplified procedure specifically for traditional herbal medicinal products.
Link to MEMO/11/71