European Medicines Agency - Human Medicines - Medicines for children - Compliance

Medicines for children
Guidance for applicants
Compliance
According to the Paediatric Regulation, if the Paediatric Committee has decided on a paediatric investigation plan for a medicine intended for children, the pharmaceutical company will have to follow that plan exactly. Once the plan is complete, the EMEA or the medicines authorities in the Member States will check that all studies and measures required have been performed.

This compliance check is necessary before an application for marketing authorisation can be considered valid. Further information on the compliance check can be found:

•Procedural advice for: validation of new marketing authorisation application – extension/validation application and compliance check with an agreed PIP
•Compliance check request form Updated on lunes, 14 de junio de 2010
•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 criteria for assessing significant studies
•Submission deadlines for 2012 and 2013 for submitting request for compliance check
•Submission deadlines 2010-2011 for compliance check

open here to download the documents:
European Medicines Agency - Human Medicines - Medicines for children - Compliance