Spring Intro 2023

Type IB Variations: Procedure

 Type IB “Tell, wait and do” 1. MAH to notify Authorities prior to making the change (TELL) 2. Wait a minimum of 30 days after validation of the variation application by the Agency before implementing the change (WAIT) 3. MAH to implement the change (DO) • If Agency wants more information, procedure may be extended and change should not be implemented until receiving approval from the regulators. • Can be grouped with other variations but grouping needs to be justified. • Many changes to biologics manufacturing processes are classed as Type IB by default, as they are outside of the conditions of the guidelines.

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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

 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  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

The Organisation for Professionals in Regulatory Affairs

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