2020-11-27 13:57

Qlife will not respond to preliminary rejection by the Danish Medicines Agency for COVID-19 test – focus on receiving CE-marking by year-end

On November 13, Qlife was informed that the Danish Medicines Agency (Lægemiddelstyrelsen) had rejected the application for temporay approval in Denmark “in the interest of health protection” for the company’s COVID-19 test. The company has since had 14 days to respond to the preliminary announcement and now the company has decided to waive this. Instead, Qlife will focus on completing the documentation for CE-marking in accordance with the timeline previously communicated. Qlife expects CE-marking at the turn of the year 2020/2021.