Data requirements for vaccine platform technology master files (PTMF) - Scientific guideline

The main aim of the guideline is to address the type of data to be included in a vaccine platform technology master file (vPTMF). Furthermore, the guideline addresses the omission of information and /or possible reductions on data requirements for subsequent dossier submissions for marketing authorisations (MA) based on a vPTMF after its first evaluation and certification.

Keywords: Vaccine, platform technology, master files, veterinary vaccines, IWP