Module232025

07/05/2025

Other selected highlights

Article 42 • Member states to collect available paediatric use data and submit to EMA by January 2009

•

Expired

Article 43 • PDCO to establish an inventory of paediatric therapeutic needs

•

This happened…

…but seems no longer active

Article 45 • Existing paediatric data to be submitted to EMA by January 2008

•

Expired

The Organisation for Professionals in Regulatory Affairs

39

Article 46

Other selected highlights

This remains relevant and important if you are an MAH

The Organisation for Professionals in Regulatory Affairs

40