Europe – Guidance on paediatric submissions

A letter of intent to submit a paediatric investigation plan (PIP) or a product specific waiver is no longer required nor processed.
When creating a delivery file at the time of submission via eSubmission Gateway / Web Client, the following six-digit code is to be used:

• the six digits of the already assigned paediatric procedure number (e.g. 001234) – for any follow-up submissions, such as the second or further PIP/waiver submissions for identical active substances; for responses to PDCO requests for modifications; modifications on agreed PIPs, requests for compliance checks, re-examination grounds, withdrawal of procedure instructions, notifications of change; annual reports for deferrals; information on discontinuations;

or if no procedure number was ever assigned:

• 000000 – for first-time PIP and product specific waiver applications, PIP unrelated requests for confirmation of class-waiver decision applicability, and pre-submission interaction requests only. A procedure number to use in any further correspondence will be communicated to the applicant when the first-time submission has been processed…