CRED Managing Variations Effectively

VALIDATION CORRECTION REQUEST (VCR)  new process

0%

• Application on hold to resolve technical validation issues

VCR

REJECTION

HOLD

E I Y

VALID

APP REC’D

CASE CREATION

TECHNICAL VALIDATION

BUSINESS VALIDATION

• MAH instructed to resubmit • Case withdrawn • 10% fee

Benefits: • One step validation process • Reduction in rejection letters • Less rework for MHRA • Better customer service

INVALID

10%