New Polish law strengthens regulator and implements EU pharma legislation
This article was originally published in SRA
Executive Summary
The Polish government has adopted new legislation that enhances the role of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) by giving it an independent status as a government agency. The law, which entered into force on 1 May, transfers to the office certain responsibilities currently vested in the health ministry, most notably those related to marketing authorisations and clinical trials1.