How to identify a reclassification candidate and prepare for the early stages of the reclassification procedure

This guidance provides an overview of what companies should consider when evaluating a potential switch candidate and how to scope and prepare for the early stages of reclassification process, including how to prepare and engage with MHRA via scientific advice meetings.

The guidance covers:

• Company requirements
• Selection and assessment of potential reclassification candidates
• Building your product profile
• Liaison with MHRA