The guideline discusses the use of existing tools and processes to address the specific needs and challenges of safety monitoring of medicines used in children; give information about how to adapt regulatory requirements to the pediatric population in the European Union; and discusses more specific topics as off-label use, medication errors, risk management plans and periodic safety update reports.
The guideline applies to approved drugs with a pediatric indication or ongoing pediatric development, and to approved drugs with adults indication that are used to treat children.
