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
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.