Pharmaceutical service provider Diapharm (www.diapharm.com) is planning to raise the profile of traditional herbal medicinal products which have to date only been used in individual EU countries. For this reason, Diapharm has now applied in several European countries for registration of a product for migraine prophylaxis containing the active ingredient feverfew (lat.: tanacetum parthenium). “In the United Kingdom, feverfew has been used for more than 30 years for the prevention of migraine-type headaches and has since become firmly established on the market as a traditional medicine. However, it is practically unknown in countries like Spain, Sweden and German-speaking countries,” says Dr. Rainer Kolkmann at Diapharm. The objective of the THMP Directive from 2004 was precisely to harmonise long-established traditional medicines throughout Europe. Diapharm currently has more than 20 dossiers and registrations for traditional herbal medicinal products in its portfolio and transfers marketing rights and approvals to medicinal product manufacturers across Europe.
Diapharm’s decision to apply for these registrations for feverfew has been supported by a recently published HMPC monograph (EMA/HMPC/587578/2009). This monograph attributes a strong indication to Tanacetum parthenium, an established herbal medicine in the UK: “Traditional herbal medicinal product for the prophylaxis of migraine headaches after serious conditions have been excluded by a medical doctor”. However, Dr. Rainer Kolkmann also sees opportunities to identify new traditional medicines in Eastern and Southern Europe and then to introduce them into other EU countries. In addition to Germany, the United Kingdom and Austria, Diapharm is also already active in Lithuania, Portugal, Spain, Poland, Czech Republic, Hungary, Netherlands, Belgium, France and Rumania. The focus of the company’s service is to provide regulatory, medical and pharmaceutical advice and to manage medicinal product approvals and OTC products.
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