CRED Managing Variations Effectively

Classification Decision tree for a specific change

Extension application

Is it an Extension?

Yes*

No

IA IN

– Immediate notification

Does it meet Type IA (cond.) requirements?

Yes

IA – notification ≤12 months Submit as a Type II

No

Is it listed as a Type II?

Yes

No

Submit as a Type IB

Type IB unforeseen? No Is it listed as a Type IB?

Yes

Submit as a Type IB or II

* Annex I of Variations regulation , EMA post-authorisation guidance on Extension applications , Guideline on the categorisation of new applications versus variation applications

39 Introduction to Classification of CMC (Quality) / Clinical / PhV Variations