Variation Classification Lookup

The Variation Classification Lookup is a helpful tool to search or browse variation codes from the EU Variation Classification Guideline C/2025/5045. Pick a matching entry to see the conditions, required documentation and resulting procedure type. A summary of the selected variations can be downloaded for use in cover letter or eAF.

Variation Fee Calculator — companion tool

Variation Classification Lookup

© Dr. Tom Deutschle

Search or browse variation codes from the EU Variation Classification Guideline. Pick a matching entry to see the conditions, required documentation and resulting procedure type. Guideline , applicable from .

Select an entry from the list to see its conditions, required documentation and procedure type. Tick off conditions as you confirm them to see whether the change qualifies for the listed type.

If you have any comments or suggestions for improvement, please let me know:

info@pharmazulassung.de

CMDh recommendations for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008 will be included soon. As of today, the Excel list published by CMDh is still empty.