(openPR) - Marlow (UK), Oldenburg (DE), 18 March 2009. The decision by the British regulatory agency MHRA on “RelaxHerb” in early March 2009 was double cause for celebration, in Marlow in the UK and in Oldenburg, Germany: firstly by registration holder Schwabe Pharma (UK) Ltd. which, with the traditional herbal medicinal product, now has in its portfolio a product for alleviating symptoms associated with stress. And secondly by regulatory service provider Diapharm (www.diapharm.com) which prepared the necessary quality dossier and evidence of traditional use for Schwabe. RelaxHerb is the thirteenth United Kingdom registration managed by Diapharm: “Every second traditional herbal medicinal product there is registered on the basis of dossiers from our company”, emphasises Diapharm General Manager Dr. Rainer Kolkmann.
Apart from the United Kingdom, 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 authorisations 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 United Kingdom has so far registered a total of 26 traditional herbal medicinal products – more than any other country in Europe.
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Background information: Diapharm
Diapharm supports companies in the medicinal and health products industry in all regulatory, medical and pharmaceutical matters to do with medicinal products, medical devices, food supplements, biocides and cosmetics. A team of approximately 90 employees in Münster, Bielefeld, Oldenburg and Lübeck (Germany) provides, inter alia, strategic advice, management and responsible care for trademarks and product portfolios. Diapharm is present throughout Europe with partners in France, Great Britain, Poland, Portugal, Slovenia, Spain, the Czech Republic and Hungary.
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