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Diapharm Obtains Europe’s First Traditional Herbal Registration with Minerals - Pharmaceutical services provider Diapharm has registered a new product to support cardiovascular function and protect against climatic stress which will be marketed by its pooling partners
Diapharm Obtains Europe’s First Traditional Herbal Registration with Minerals

 

NewswireToday - /newswire/ - Muenster, North Rhine-Westfalia, Germany, 2010/10/04 - Pharmaceutical services provider Diapharm has registered a new product to support cardiovascular function and protect against climatic stress which will be marketed by its pooling partners.

   
 
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The product contains 40mg hawthorn extract and 150mg of both potassium and magnesium salts, making it Europe’s first traditional herbal medicinal product to be combined with minerals. Following successful registration by the German Federal Institute for Drugs and Medical Devices (BfArM) by the end of September 2010, Diapharm is also seeking to register the product in more EU countries, including Austria and the United Kingdom.

"We are particularly proud to have obtained the first registration for our hawthorn combination product in Germany,” says Dr. Rainer Kolkmann at Diapharm. "The German Drug Authorities are very strict in their regulation of traditional herbal medicinal products in line with EU directive 2004/24/EC. But in this case, BfArM is leading the way."

However, it is not Diapharm who will be marketing the new hawthorn product in Germany. This task will instead be performed by pooling partners. The same is true in other countries where registration applications are submitted: Diapharm will perform the regulatory duties and then transfer the dossiers and registrations to other pharmaceutical companies for sales and marketing. Approximately one quarter of all traditional herbal medicinal products in the European Union originate from Diapharm in this way.

Diapharm (diapharm.de) is a full-service provider to the healthcare industry. Founded in 1988, Diapharm supports pharmaceutical companies in all questions concerning regulatory affairs, medical & clinical development, quality management and business development. Its activities focus on the sectors of medicinal products, food supplements and dietetic food, medical devices and cosmetics. With about 100 employees, Diapharm is at the service of multinational companies as well as of recent start-ups and small to mid-sized businesses.

 
 
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Diapharm Obtains Europe’s First Traditional Herbal Registration with Minerals

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