Diapharm Consolidates its Top Herbal Registration Position

The decision by the British regulatory agency, MHRA, on “RelaxHerb,” in early March 2009, was double cause for celebration in Marlow (UK) and Oldenburg (Germany): first by registration holder, Schwabe Pharma (UK) Ltd, which, with the traditional herbal medicinal product, now has a product for alleviating symptoms associated with stress. And, secondly, by regulatory service provider, Diapharm, who prepared the quality dossier and evidence of traditional use.

RelaxHerb is the thirteenth UK registration managed by Diapharm. “Every second traditional herbal medicinal product in the UK is registered on the basis of dossiers from our company,” emphasized Diapharm General Manager, Dr Rainer Kolkmann.

Apart from the UK, Diapharm is also active in traditional-use registrations on the basis of EU Directive 2004/24/EC in Austria, the Czech Republic, Germany, Hungary, Lithuania, Poland, Portugal and Spain. The company’s main area of activity is in regulatory, medical and pharmaceutical consultancy and the management of medicinal product marketing authorizations and OTC products.

RelaxHerb contains 425 mg of passiflora extract per tablet. The indication registered by the MHRA is “for the temporary relief of symptoms associated with stress, such as mild anxiety”. The UK has so far registered a total of 26 traditional herbal medicinal products — more than any other country in Europe.

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