Module 12 2019

Tips and tricks

• Non-compliant submissions are rejected and resubmission is requested

• Do not print and scan the eAF!

• Submit the PDF, not the XML

• Make sure that you save a version of the eAF before signing the eAF (signing the form will lock it for further editing. In case of updates for validation issues, you have to re-do the eAF – export/import–) • Manufacturing site in eAF is called: “Processing of medicinal product“

The Organisation for Professionals in Regulatory Affairs