FORTÉ PHARMA, Monaco, received a registration by the French regulatory authority ANSM for a traditional herbal medicine containing Valerian, Passionflower and Melissa with the indication “for the relief of mild nervous tension and sleep disorders”. The coated tablets were developed by Diapharm.
FORTÉ PHARMA managed the application with the French authorities in accordance with the relevant regulations for implementing a Traditional Herbal Medicinal Product (THMP) in France. Dr. Rainer Kolkmann, responsible for product development at Diapharm, reported with appreciation, “This registration, eight years following the coming into force of the European THMP Directive 2004/24/EC, is a milestone for the medicinal market in Europe. It is a clear sign that traditional plant-based medication for self-medication has, in the meantime, received recognition across Europe. Countries that previously hesitated, such as France and Portugal are now proceeding along this path.”
Mid-year, the pharmaceuticals provider had, for the first time, achieved registration for a THMP in Portugal. Almost every fifth registration for traditional plant-based medications in the EU can be directly attributed to the efforts of Diapharm. The main focus of the company, which has offices in Germany, the UK and Austria, is regulatory, medical and pharmaceutical advisory and support for marketing authorization applications.