5/2/11

Master of News

Hundreds of herbal medicines banned in Europe from May 1

Hundreds of traditional herbal medicinal plants are banned in Europe from May 1, while a directive requiring registration or authorization comes into force.Adopted in March 2004 by the European Parliament, Directive (2004/24/EC) on herbal medicines requires proof of medicinal use for at least 30 years, at least 15 years in the European Union. Directive granted a transition period of 7 years for the registration of products already on the market in 2004.
This is a "simplified" procedure, compared with the requirements vis-à-vis the pharmaceutical companies for the marketing of drugs. This exemption from registration for clinical trials demonstrating the efficacy and safety "since the efficiency is plausible because of the long-standing use and experience."

Manufacturers who can provide such evidence must comply with the same requirements that pharmaceutical companies for drugs, that is to say, demonstrate through clinical trials comparing the product to placebo, efficacy and safety.

In addition, manufacturers will have to prove that their products meet certain standards and contain a clear and constant dosage. The products will be approved now as for health problems "minor", such as colds, aches and pains and sleep problems. The product information should include the side effects and interactions with other drugs and to specify that they are approved on the basis of traditional use.

So far 211 applications for registration have been filed of which 105 were accepted. Recent concern with 36 plants wort, echinacea and black cohosh. Products already on sale will remain until the expiration date.

The measure was challenged by "small" manufacturers can not afford to meet these requirements. Others, however, would have wanted more protections for consumers.

According to China Radio International, no application for registration has been filed for traditional Chinese medicines. Some consider the directive, which the threshold is considered too high, as a protectionist die.

Some of these products may, however, remained on the market as a food or food supplements (if they comply with the relevant food legislation) without being presented as having properties for treating or preventing diseases or as having an pharmacological, immunological or metabolic action. Dietary supplements such as vitamins and minerals and fish oils, are not affected by the directive.
Homeopathy is also not affected by this new regulation, reports Europe1.