WHO global benchmarking tool plus rev. VI+ ver. 1, Licensing Establishments (LI)

Overview

In order to protect public health, licensing activities are of outstanding importance and are considered fundamental, together with inspections activities, for guaranteeing the quality, safety and efficacy of medical products used within or exported out of the country. The National Regulatory Authority (NRA) is responsible for coordinating licensing activities and should be supported by published and readily available legal provisions, regulations and guidelines which ensure that licensing of facilities throughout the supply chain is based on compliance with Good Practices (GXP) and that the NRA is empowered to issue, suspend or revoke licenses for premises and establishments.