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NewswireToday - /newswire/ -
Menster, North Rhine-Westfalia, Germany, 12/05/2007 - Europe is not likely to see harmonised claims for traditional herbal remedies for quite some time. This is the upshot of the conference on "Herbal Medicinal Products in Europe – Harmonisation Achieved?" in Berlin.
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Europe is not likely to see harmonised claims for traditional herbal remedies for quite some time. This is the upshot of the conference on "Herbal Medicinal Products in Europe – Harmonisation Achieved?" in Berlin. It brought together representatives from authorities and industry from 15 countries to discuss the different ways in which European Parliament directive 2004/24/EC has been transposed into national law. This directive is intended to harmonise the market for these Traditional Herbal Medicinal Products (THMP). It stipulates that medicinal products which have been used on the basis of years of experience can now be registered throughout the EU according to the same rules. "However, harmonising the national markets is still a long way off", points out Dr. Rainer Kolkmann from the DiapharmGruppe, Chairman of the Conference, summing up the outcome of the talks.
At the event, Dr. Linda Anderson from the MHRA licensing agency in the UK referred to the fact that the majority of herbal products in the UK have been able to be marketed completely unlicensed up to now. Therefore, the MHRA is facing the challenge of bringing UK products into effective regulation. The situation is different in Germany: many herbal remedies there have been subject to the German Drug Law for decades. Consequently, Dr. Werner Knöss from the German competent authority, the BfArM (Federal Institute for Drugs and Medical Devices), points out that his authority is concerned with guaranteeing the transition from 'traditional licensing' to 'traditional registration'.
The registration process still represents new ground right across Europe: whilst there have been six products registered so far in the UK and five in Germany, the figure for Austria is four, and two in Spain, Holland and Slovenia (as per October 2007). "The presumptive applicants appear hesitant", points out Dr. Per Claeson from the Swedish supervisory authority, Läkemedelsverket. So far, there have not even been ten applications for registration in Sweden.
Ursula Schäfer from the pharmaceutical service provider DiapharmGruppe has considered a possible reason for this: "Given the fact that, under certain preconditions, foodstuffs can also be advertised with health-related claims, European producers are also going down this route in order to avoid costly registration procedures for their herbal products." For example, Sabal Extract is approved in Germany as a medicinal product; it is registered as a traditional remedy in the UK, but freely sold as a food supplement in France.
Some 45 experts from authorities and industry attended the conference on 13 and 14 November 2007. The event was organised by the European Compliance Academy and Concept Heidelberg.
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