Last updated 12 February 2026
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Guidance for applicants for the preparation of the ‘precise scope’ section of the variation application form
This guidance (Rev 1.0 12 February 2026) aims at supporting applicants in completing the ‘Precise scope and Background for a change, and Justification for grouping, worksharing and classification for unforeseen changes (if applicable)’ section of the Application Form for Type I and Type II variations.
It provides guidance on the information to be included in this section and some examples of changes applied for each of the scopes listed in the Guidelines on the details of the various categories of variation, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use, and on the documentation to be submitted pursuant to those procedures (hereinafter called ‘the Variations Guidelines’).
Source: EMA
Updated PLM Portal eAF Release notes now available
An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.2.1.5 released to production on 02 February 2026 is now available on the eSubmission PLM Portal eAF web page.
Source: eSubmission
Validation checklist for Type II quality variations
Here, you can view the checklist which was last updated on 10 February 2026
Source: EMA
Validation checklist for Type II (non) clinical variations
Here, you can view the checklist which was last updated on 30 January 2026.
Source: EMA