A variation is a change to the dossier of an authorized product. In terms of Marketing Authorizations (MAs) a Variation is: “an amendment to the contents of the documents referred to in Articles 8 to 12 of Directive 2001/83/EC” Once an MA has been granted, the Marketing Authorization Holder (MAH) has a legal obligation to … Read more
This guidance provides recommendations to sponsors of new drug applications (NDA’s), abbreviated new drug applications (ANDA’s), and abbreviated antibiotic applications (AADA’s) who intend, during the post approval period, to change: SU: Scale-up during original dossier assessment. Note that this is not SU during development. Consider changes made after the Biobatch PAC: Post-PQ/post-approval, i.e. Variations. … Read more
