Variations including extensions of marketing authorisations

A variation is a change to the terms of a marketing authorisation. This section provides guidance for marketing authorisation holders on the regulatory requirements and procedures for the different types of variations.

In this section

• Article 5 procedure: Regulatory and procedural guidance
• Grouping of variations: questions and answers
• Variations regulation: regulatory and procedural guidance
• Type-IA variations: questions and answers
• Type-IB variations: questions and answers
• Type-II variations: questions and answers
• Extensions of marketing authorisations: questions and answers
• Worksharing: questions and answers
• Guidance on the application of the amended Variations Regulation from 1 January 2025

Using the IRIS platform

From January 2025, marketing authorisation holders should use the IRIS platform when managing variations including extensions of marketing authorisations after the original submission.

Further guidance on the use of the IRIS platform and how to prepare submissions is available on the dedicated IRIS website:

• IRIS: A secure online platform for handling product-related scientific and regulatory procedures with EMA

IRIS does not replace the current submission gateway; they coexist serving different functions.