Validation checklist for initial marketing authorisation applications - biologicals other than immunologicals (applicable to submissions under Regulation (EU) 2019/6)

June 20, 2022

3D rendering of a checkmark in a checkbox.

JUNE 2022

EMA/278419/2022-Rev.1

This validation checklist is used by the Agency to validate initial marketing authorization applications for pharmaceuticals and applicants should use it as a means to review in advance of their submission that standard requirements are fulfilled.

Download the Checklist

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TAGS: EMA Europe Agency Alerts Regulatory Sciences

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