Updated guidance on requirements for paediatric 'compliance checks' during validation

We have previously published guidance on how the MHRA will handle the impact of the requirements of the Paediatric Regulation on the validation of applications for marketing authorisations (MAs). The guidance has been updated to reflect the need for compliance checks on certain line extensions and variations as well as initial applications for new medicinal products.
The same principles apply in these cases and the MHRA will continue to request an opinion from the European Paediatric Committee where one has not already been obtained by the applicant. The document has also been updated to refer to the final European Commission guideline on the content of applications for paediatric investigation plans and the operation of the compliance check and also to other European Medicines Agency (EMA) and Co-ordination Group for Mutual Recognition and Decentralised Procedures (CMDh) guidance.
Guidance on the MHRA’s Handling Of The Requirement in the Paediatric Regulation to Undertake a ‘Compliance Check’ During Validation (85Kb)