Legal aspects of marketing authorization for medicinal products in the territory of Poland

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Legal aspects of marketing authorization for medicinal products in the territory of Poland

Journal Title: Przegląd Prawno-Ekonomiczny - Year 2017, Vol 1, Issue 38

Abstract

Marketing authorisation procedure aims at ensuring that patients have access to medicinal products which meet scientifically proven quality, therapeutic efficacy and safety of use standards. Marketing authorisation constitutes a sine qua non condition for placing a medicinal product on a market. Only in extraordinary situations is trading in medicinal products which have not been granted marketing authorisation lawfully admissible. Producers of pharmaceuticals who have been granted marketing authorisation for a medicinal product, are obligated to develop a system supervising the safety of pharmacotherapy, the so called pharmacovigilance. The system collects and registers adverse reactions, which is of utmost importance as diligently performed assessment of the medicine safety profile allows providing full information on the medicine, which in turn facilitates the choice of appropriate medicinal product for a given patient. The above-mentioned process continues throughout the period of use of a medicinal product for, the moment new fact are reported, the efficacy assessment of the medicinal product in question is performed anew.

Authors and Affiliations

dr Katarzyna Syroka-Marczewska

Keywords

pharmaceutical law medicinal products procedures for marketing authorisation of medicinal products

EP ID EP221211
DOI -
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