Variations and Extensions Form HMV4 - Sequence of Variations

Different variations of the same type (e.g., multiple marketing authorization extensions) or of different types (IA, IB, II, and marketing authorization extension) may be submitted together as a multiple application, provided that all variations involve the same drug product. To improve orientation and clarity, in the context of a complex multiple application with different variation types, the order of the individual variations in the form "Variations and extensions HMV4" can be changed to reflect the order of the variations in the dossier. It is recommended to note this accordingly in the cover letter.