The legal framework of our pharmacovigilance services for medicines marketed within the EU is provided in Regulation (EU) No 1235/2010 amending Regulation (EC) No 726/2004, in Directive 2010/84/EU amending Directive 2001/83/EC and in Implementing Regulation (EU) 520/2012 as amended by Implementing Regulation (EU) 2025/1466. Furthermore, the national legislation and the guidance on good pharmacovigilance practices (GVP) as well as pertinent ICH and CIOMS guidelines build up the framework for the conduct of our pharmacovigilance business.
