top of page

EMA Checklist: Updated Validation checklist for Type II quality variations

Recently on 10th February 2023, the European Medicines Agency (EMA) updated and released their "Validation checklist for Type II quality variations".

The EMA defines variation as a change to the terms of a marketing authorisation. A variation regulation governs the procedures for amending the marketing authorisation and technical dossier following the decision.

The following categories of variations are defined in Article 2 of the Variations Regulation:

  • Minor variations of Type IA

  • Minor variations of Type IB

  • Major variations of Type II

  • Extensions

  • Urgent safety restriction

According to Commission Regulation (EC) No 1234/2008 (the Variations Regulation), a major variation of type II is a variation that does not extend the marketing authorisation (line extension) but may significantly affect the safety, quality, or efficacy of a medicinal product.

The newly updated checklist will help to scrutinize the validation, click this LINK to see validation checkpoints for identifying type II variations.


bottom of page