Development of Dossier for Herbal Pharmaceutical Product Project Details
Product is made in form of hard gelatin capsules filled with dry herbal extracts of two herbs. Product is currently sold as food supplement. Required is upgrade of Dossier from food supplement to herbal pharmaceutical product. Beside compilation of documentation work may also include sourcing of suitable manufacturers and obtaining of product documentation from them.
Dosser should be compiled in compliance with European Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use.