Submissions

Behind the scenes of: Submissions

Posted by: Rachel Hyde, Posted on: 3 July 2017 - Categories: Behind the Scenes

The Information Processing Unit (IPU) is a part of the Information Management Division at MHRA. As the main submission hub for the Agency, in IPU we are responsible for making sure regulatory applications relating to Marketing Authorisations and Clinical Trial …

Help with Type 1B variations

Posted by: Julia Coombes, Posted on: 10 January 2017 - Categories: 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.