Scientific advice and Paediatric Investigational Plan (PIP)
If available, a copy of the summary of scientific advice of the Agency, or of any Member State or third country, with regard to the clinical trial shall be submitted.
If the clinical trial is part of or is intended to be part of a Paediatric Investigation Plan (PIP) as referred to in Title II, Chapter 3, of Regulation (EC) No 1901/2006, a copy of the summary of scientific advice of the Agency, or of any Member State or third country, with regard to the clinical trial must be submitted (if available).
If the clinical trial is part of an agreed PIP, a copy of the Agency’s decision on the agreement on the PIP, and the opinion of the Paediatric committee must be submitted, unless fully accessible via the internet as indicated in the cover letter.