DiapharmGruppe shares in Cimicifuga licensing approval success in the UK

London, Oldenburg, 18 July 2007 – For the first time British women are able to use a registered traditional herbal medicinal product (THMP) for the treatment of symptoms of the menopause such as hot flushes, night sweats or mood swings following the successful registration of a herbal product containing an extract of Black Cohosh (Cimicifuga racemosa). MH Pharma UK Ltd., supported by its German partner, the Dr. Kolkmann & Partner GmbH, DiapharmGruppe (www.diapharmgruppe.de), recently received UK registration approval for it’s Cimicifuga containing brand, Menoherb. The registration procedure for such products, approved through the European Traditional Herbal Medicinal Products Directive, is still in relatively early stages throughout Europe. In Great Britain, the Medicines and Healthcare Products Regulatory Agency (MHRA) has so far registered four traditional herbal medicinal products, three of which have used quality dossiers and herbal knowledge supplied by the DiapharmGruppe. In Germany the number of herbals having been registered by this procedure is four, in Austria two.

"We expect registered herbal medicinal products to play an increasingly prominent role in self-medication in the future", comments the Technical Director of MH Pharma UK Ltd, Dr. Dick Middleton. Out of the four traditional herbal medicinal products in UK, three have been registered by MH Pharma UK Ltd. "Creating an extensive range of registered products under the MedicHerb brand is key to our success in the future and this could not be achieved without the expertise, competency and skill of our colleagues and partners within the DiapharmGruppe. The knowledge and experience in creating quality dossiers, along with herbal knowledge gained from a heritage in herbal medicine over many years, has been instrumental in our success."
In the course of the implementation of the European Directive 2004/24/EC many herbal medicinal products will have to undergo registration in the next few years in order to remain on the market. This is particularly true in Great Britain where a large number of unlicensed herbal medicines must have gained approval by the end of March 2011, in order to remain on sale. The protracted approval process has led to the MHRA advising companies to apply as soon as possible in order to ensure continuity of supply as 2011 edges ever closer. The main prerequisites for a registration as traditional herbal medicinal product are the proof of the pharmaceutical quality and the evidence of the continuous use of the product over the last 30 years. The deadline for the registration of the traditional herbal medicinal products is the end of March 2011.

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Background information: DiapharmGruppe

The DiapharmGruppe offers comprehensive and individual regulatory services and pharmaceutical consulting to companies in the health product sector, for an optimal management of the portfolio of medicinal products and health products. The DiapharmGruppe, consisting of a team of more than 60 qualified staff members, performs the strategic planning, management and responsible maintenance of complete product portfolios. The business volume of the group amounts to 10 Mio Euro. The following corporations form the DiapharmGruppe: Dr. Stefan Sandner GmbH (Pharmaceutical Management & Portfolio Solutions), Dr. Kolkmann & Partner GmbH (Drug Registration & New Projects), Dr. Middeler et al. GmbH (Biotechnology & Medical Devices), Zentralinstitut Arzneimittelforschung GmbH (Analytics), Dr. Ebeling & Assoc. GmbH (Medical Affairs & Pharmacovigilance), Beate Beime & Team (Clinical Research Coordination) as well as HÄLSA Pharma GmbH (Responsible Manufacturer & Product Release).

Contact:
DiapharmGruppe
Press office
Lingener Str. 12
D-48155 Münster

Contact person:
Nicole Sibbing

Tel.: +49 (0)251 - 60935-17
nicole.sibbing@diapharmgruppe.de
www.diapharmgruppe.de


Agency contact:
co-operate Wegener & Rieke GmbH
Zumsandestraße 32
D-48145 Münster

Contact person:
Christian Rieke

Tel.: +49 (0)251 - 3222611
wort@co-operate.net
www.co-operate.net

This release was published on openPR.