Variations

Variation applications
 

• Cover letter for Variation Applications in the Mutual Recognition Procedure (December 2022)

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 7 of Commission Regulation (EC) No 1234/2008

• Template of letter of intent for the submission of a type IA grouped procedures ("Supergroup") (July 2013)

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 (April 2012) 

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)