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 European Medicines Agency 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 below.
Effective date: The legal date that the document is effective from.
|Document(s)||Language||Status||First published||Last updated||Effective Date|
|Questions and answers on the procedure of paediatric-investigation-plan compliance verification at the European Medicines Agency, and paediatric rewards||(English only)||adopted||08/03/2011||21/01/2015||08/06/2011|
|European Medicines Agency policy on changes in scope of paediatric-investigation-plan decisions||(English only)||27/07/2012||08/05/2013|
|Standard operating procedure for handling of the compliance check with an agreed paediatric investigation plan||(English only)||adopted||26/05/2010||25/05/2010|
|Request for compliance check on an agreed paediatric-investigation-plan form - (PED3) certified||(English only)||14/06/2010||21/01/2015|
|Submission deadlines for 2014-2015 for submitting request for compliance check||(English only)||23/01/2013||14/04/2015|