Variations: guidance under Regulation (EC) No 1234/2008 and Regulation (EU) No 712/2012

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 submitted on or before 27 January 2022 to be concluded in accordance with Regulation (EC) No 1234/2008 and Regulation (EU) No 712/2012.

This guidance only applies to procedures initiated under Regulation (EC) No 1234/2008 and Regulation (EU) No 712/2012. before 28 January 2022.

For variation procedures submitted on or after 28 January 2022, see Variations: guidance under the Veterinary Medicinal Products Regulation.

In this section

• Type IA variations
• Type IB variations
• Type II variations
• Grouping of variations
• Worksharing of variations
• Classification of changes