Standard operating procedure for paediatric investigation plan or a waiver from pre-submission to start of procedure
English (EN) (150.19 KB - PDF)
Standard operating procedure for Paediatric investigation plan or a waiver from start of procedure to clock-stop or PDCO opinion
English (EN) (137.46 KB - PDF)
Standard operating procedure for paediatric investigation plan from re-start of procedure (after clock-stop) to PDCO opinion
English (EN) (132.31 KB - PDF)
Standard operating procedure for re-examination of Paediatric Committee opinions
English (EN) (157.71 KB - PDF)
Standard operating procedure for European Medicines Agency decision-making process for decisions on Paediatric Committee opinions
Standard operating procedure for European Medicines Agency decision-making process for decisions on Paediatric Committee opinions
English (EN) (143.66 KB - PDF)
Standard operating procedure for compliance check of an agreed paediatric investigation plan
English (EN) (155.37 KB - PDF)
Standard operating procedure for modification of an agreed paediatric investigation plan
This SOP describes the handling of an application for modification of an agreed PIP from receipt of the
letter of intent to adoption of the PDCO opinion.
English (EN) (138.21 KB - PDF)
Work instructions for paediatric core master files and numbering
English (EN) (103.74 KB - PDF)
Standard operating procedure for rectifying errors in PDCO opinions and European Medicines Agency decisions
English (EN) (145.34 KB - PDF)
Work instructions for review of granted paediatric product-specific and class waivers
English (EN) (96.02 KB - PDF)