CRED Managing Variations Effectively

Can submit these changes as a type-IB ‘unforeseen’: ● When the change is not specifically classified as a major variation of Type II or an Extension (and not covered by an Article 5 recommendation) (submit using as “z” – other variation category e.g. B.I.a.2.z ) - TIP: tick “Type IB” Unforeseen in application form ● These are often changes not precisely covered by the guidance but that require a modest technical and risk assessment (largely quality changes) ● The agency may re-classify to a Type II unforeseen (or even a Type IA) during validation of a Type IB What is an Unforeseen Variation? Despite >90 variations being defined in Guidance, there are still many changes being identified that don’t ‘fit’ within the current categories Other uncategorised Type-IB ‘default’ variations: ● When one or more of the conditions established in the Classification Guideline for a Type IA variation are not met (use Type IA category number, e.g. B.I.a.2.a , but note exception to conditions) - TIP: tick “Type IB” in application form