M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality

SCOPE AND ORGANISATION
The M4Q(R2) guideline establishes the location and structure of quality information for registration applications of all medicinal products for human use. It supports various submission types, including those referring to or consisting of master files, and applies to both initial marketing authorisation and post-approval submissions. This guideline is structured to be flexible to accommodate all types of medicinal products and their components.