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.

Welcome to the MedRegs Blog

If you’re working to develop and submit applications to MHRA for marketing authorisations and clinical trial authorisations, then you need to keep up to date with the latest regulatory thinking and be able to easily find tips and tricks to avoid common pitfalls.