CRED Managing Variations Effectively

Work Flow for National and MR Type IAs

This is a 30 Day procedure  Scientific check ( no assessment)

 the outcome is either approve or reject  MHRA will not request clarification, additional information or documentation from the MAH  clock-off not possible, MHRA receives 15,000 Type IA variations per year

Focus on getting it right first time Resubmission of the variation as instructed

178