Are you working on a PIP?
Please note that paediatric submissions must be submitted via the IRIS platform from 4 June 2024.
The following submission types are affected:
• Initial paediatric investigation plan (PIP)
• Modification of PIP
• Product-specific waiver
• Compliance check
• Annual report
• Confirmation on class waiver, or inclusion of an indication
• Discontinuation of paediatric development.
Not familiar with IRIS? We are. Please reach out at info@regfile.se
RegFile AB
Eklundshovsvägen 1G,
752 37 Uppsala, Sweden
info@regfile.se
