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Registrations for four new traditional herbal medicinal products for the treatment of sleep disturbances have just been granted to the pharma service provider Diapharm by the British regulatory agency MHRA. The registrations for DiaNight, DiaNight Plus, DiaSleep and DiaSleep Plus are to be offered for sale.
DiaNight and DiaSleep are single-substance preparations in which one sugar-coated tablet contains 150 milligrams of valerian root extract. DiaNight Plus and DiaSleep Plus are combination preparations, each sugar-coated tablet containing 125 milligrams of valerian root extract and 250 milligrams of passiflora extract. According to the MHRA the products are indicated “for the temporary relief of sleep disturbances due to symptoms of mild anxiety, based on traditional use only”. Registration was granted on the basis of EU Directive 2004/24/EC.
Regulatory services for medicinal products are one of Diapharm’s main areas of activity. In particular, Diapharm collaborates with manufacturers of traditional herbal medicinal products: “Our company has been successfully involved in more than one third of all registrations by the MHRA”, stresses Diapharm General Manager Dr. Rainer Kolkmann.
About Diapharm
Diapharm (diapharm.com) 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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christian.rieke[.]diapharm.com 
