Market authorisation, safety notices, report incidents
Clinical trials, GLP, GMP, GDP, GVP and report quality defects
We promote public health, effective enforcement, prevention measures
How do we preserve what is good as well as develop moving forward? We have set out our direction of travel for the coming years.
The IGJ inspected 24 authorised representatives acting on behalf of more than 3 manufacturers in relation to specified tasks with regard to the latter’s obligations under the MDR/IVDR. The IGJ outlines specific actions for improvement.
European rules apply to the manufacture of medicinal products entering the European market. These products may be manufactured in factories outside the European Economic Area (EEA), but European rules still apply. That is why the IGJ conducts inspections of factories outside the EEA.
