Medicinal products for human use

Medicines for children - PIP Guideline

Results of public consultation in preparation of the "Communication from the Commission - Guideline on the format and content of applications for agreement or modification of a paediatric investigation plan and requests for waivers or deferrals and concerning the operation of the compliance check and on the criteria for assessing significant studies" ("PIP Guideline").

A summary of the responses is available here.

Below are the public responses to the above-mentioned public consultation.

Additional information: