The European Medicines Agency has updated its guidance in line with the amended EU Variations Regulation, whose provisions will apply from 1 January 2025.
Among issues addressed in the updated guidance are Type IA variations, the classification of “unforeseen” variations, grouping and “super-grouping” of variations, and work-sharing procedures.
The European Commission is also updating its Variations Guidelines on categories and the operation of procedures, which should be ready sometime in 2025.

‘Unforeseen’ Variations & ‘Super-Grouping’ Addressed In New EU Guidance

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