Guidance on Paediatric Submissions

On 18 March 2020 the EMA issued the new guidance on eSubmission Gateway and eSubmission web client for paediatric investigation.

It is mandatory for applicants to use the eSubmission Gateway / Web Client for all paediatric submissions to the Agency. A letter of intent to submit a paediatric investigation plan (PIP) or a product specific waiver is no longer required nor processed.

Detailed guidance on creating the delivery file is to be found in User Guidance for submissions via eSubmission Gateway / Web Client using xml delivery files. All documents and zip files should be sent in a single folder as paediatric applications do not follow eCTD standards.

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