Variations

Variation applications

• Cover letter for Variation Applications in the Mutual Recognition Procedure (October 2024) [Track version]

Worksharing procedure to RMS according to Article 20 of Commission Regulation (EC) No 1234/2008

• Template of letter of intent for the submission of a worksharing procedure (June 2019)

• Link to EMA website for Template for letter of intent for worksharing including CAPs and MRPs

Grouping of type IA variations according to Article 7a of Commission Regulation (EC) No 1234/2008 
 

• Template Letter of Intent for the submission of a type IA super-grouped procedure  (October 2024) [Track version]

Recommendation on the classification of an unforeseen on variation under Article 5 of Commission Regulation (EC) No 1234/2008

• Template Recommendation form - Article 5 (April 2022)

• Template Request form for recommendation - Article 5 (October 2024) [Track version]

Template for MAHs to provide their responses during type II variations or variation worksharing procedures
 

• Template for MAHs response during type II variations (September 2022)