Spring Intro 2023

Grouping of variations

= same Product* several related changes

Vertical

= several Products same Change

Horizontal

Also combination of vertical/horizontal possible

*All strengths/forms of the same product

Change 2 (Type IB)

Change 1 (Type IA)

Change 3 (Type II)

Change 1 (Type IA)

Single Filing for Product A

Product B

Product A

Single Filing

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What can be Grouped?

 Variations can be grouped together into bundles ● There are no conditions for the grouping of Type IA or IA IN variations (but need to consider if immediate notification) ● Groups containing Type IB or higher (Type II or extensions) need to be justified (see Annex III of Regulation 1234/2008) – Must be related changes, e.g. change to a method that affects the release specification – OR Needs to be confirmed by Agency; present justification for grouping in correspondence for agreement/confirmation ● CMDh guidance on “Examples for acceptable and not acceptable groupings for MRP/DCP products (CMDh/173/2010/Rev.20) ● Will follow the review timelines of the highest category change ● Check with agency in advance if grouping not specified in guidance. For EMA: Potential to use enquiry emails – EMA Service Desk Tickets (e.g. see for Type IAs see Q15 and response - https://www.ema.europa.eu/en/human-regulatory/post-authorisation/variations/type-ia-variations-questions answers )

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