Guidance on the MHRA’s handling of the requirement in the Paediatric Regulation to undertake a ‘compliance check’ during validation

This guidance outlines to companies how the MHRA intends to handle the impact of the requirements of the Paediatric Regulation on the validation of applications for marketing authorisations (MAs). In summary, where an application is submitted to the MHRA and no previous compliance check has been undertaken by the Paediatric Committee, the MHRA will, in all cases which are purely national applications or where we are Reference Member State, request an opinion from the Paediatric Committee as to whether the studies conducted by an applicant are in compliance with the agreed Paediatric Investigation Plan (PIP).

Page last modified: 30 July 2008