Julia Coombes

I am the Unit Manager of the Product Information Quality Unit. I have worked in the area of label and leaflet regulation since joining the MHRA - assessing submissions, handling packaging complaints and responding to enquiries from healthcare professionals, patients and the pharmaceutical industry.

Help with Type 1B variations

The Product Information Quality Unit (PIQU) team often gets asked for help during a Type 1B variation procedure. This ranges from providing advice on missing documents to explaining why the proposed changes are not acceptable first time around.