Instructions for reporting variations in the documentation for medicine resulting from PRAC recommendations based on the safety signals assessment
The European Medicines Agency (EMA) monthly publishes recommendations of the Pharmacovigilance Risk Assessment Committee adopted based on the safety signal assessment.
EC marketing authorisation holders for medicines containing active substances that are subject to adopted recommendations are required to undertake respective measures in accordance with these recommendations. In cases where PRAC recommendations include a regulatory procedure, like introducing new information in the summary of product characteristics (SPC) and package leaflet (PIL), marketing authorisation holders are required to submit an application for variation.
Detailed information is accessible under the link below.