The following guidance outlines the main steps to take to prepare for submission, and a list of documents required for the main1 types of paediatric submissions.
This document should be read in conjunction with other relevant guidance on content available on the EMA website, such as the European Commission Guideline on the Format and Content of PIP applications; Paediatric Medicines; Paediatric investigation plans: questions and answers; and the Paediatric Regulation…
