Seven EU member states have approved a new traditional herbal medicinal product (THMP) containing Hypericum (St John’s Wort) and Cimicifuga racemosa (Black Cohosh).
Czech Republic based women’s health specialist Idelyn will be marketing the THMP “for the relief of symptoms of the menopause, including hot flushes, night sweats, also profuse sweats, slightly low mood and mild anxiety based on traditional use only”, which was developed by pharmaceutical services provider Diapharm, in Hungary, Bulgaria, Estonia, Lithuania, Romania, Slovakia and the Czech Republic. These seven countries opted for registration in what is known as a voluntary decentralised procedure (DCP). Diapharm has also prepared further national authorisation applications on behalf of Idelyn.
“We are delighted to see more regulatory authorities using the voluntary DCP process,” explained Dr Rainer Kolkmann, head of product development at Diapharm: “This common procedure is still rarely used in the case of traditional herbal medical products. It can significantly reduce the bureaucratic complexity, both for the authorities and pharmaceutical companies.” The common authorisation process is also a testament to the fact that the EU directive on traditional herbal medicinal products is now accepted throughout Europe. Diapharm has helped manage over 500 product authorisations and approvals for phytopharmaceuticals in 23 European countries.