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Variations

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

Related content

  • Post-authorisation

Related EU legislation

  • Commission Regulation (EC) No 1234/2008 ('the Variations Regulation')
  • Commission Regulation (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products
  • Rules governing medicinal products in the European Union, volume 6, Notice to Applicants

Related documents

  • Procedural guidance on the handling of variations and on worksharing

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