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