This guideline replaces ‘Guideline on pharmaceutical aspects of the product information for human vaccines’ (EMEA/CPMP/BWP/2758/02).

This guideline describes the information on the quality aspects to be included in the Product Information (PI) of vaccines for human use.

Introduction (background)

The purpose of this document is to provide applicants and regulators with harmonized guidance on the quality aspects to be considered in the Summary of Product Characteristics (SmPC), Package Leaflet (PL) and labelling for vaccines for human use. This guideline should be read in conjunction with other guidelines/documents which are referenced in this document. Applicants are advised to take this guideline into account when submitting applications for Marketing Authorization (MA) for new vaccines,  and may consider it on the occasion of applying for renewals or updates of the product information of

already approved vaccines for human use.