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

 
• By Ian Schofield

Updated guidance issued by the EU regulator explains how to comply with the provisions of the amended Variations Regulation, which will apply to new submissions from January 2025 and is intended to make lifecycle management “more efficient and future-proof.”

Updating on computer screen
EU guidance on changes to marketing authorizations is being updated (Shutterstock)

The European Medicines Agency has updated its guidance documents for companies on the submission of variations to marketing authorizations (MAs) in preparation for 1 January 2025, when the provisions of the amended EU Variations Regulation are due to apply.

Among the areas addressed by the updated guidance are minor Type IA variation procedures, the Article 5 procedure for classifying “unforeseen” variations, grouping and

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