Phytotherapy is different from the classic pharmacotherapy, since herbal medicinal products can have a simplified registration procedure.
The studens will learn about the Community Herbal Monographs developed by the Committee on Herbal Medicinal Products (HMPC) of the EMA. These monographs are intended to help pharmaceutical companies to obtain easier a marketing authorisation (MA) or registration of well-established or traditional herbal medicinal products. The monographs contain data on subsequently the qualitative and quantitative composition, pharmaceutical form, clinical particulars (therapeutic indications, posology and method of administration, contra-indications, special warnings and precautions for use, interactions, pregnancy and lactation, effects on ability to drive and use machines, undesirable effects, overdose) and pharmacological properties (pharmacodynamic, pharmacokinetic, and preclinical safety data). The students will learn how to use these information sources for the evaluation of selected herbal medicinal products.