The EMA pharmacovigilance system is described in this manual, which covers the EMA organisational structure, responsibilities, procedures, processes and resources, appropriate resource management, compliance management and record management. This manual does not cover pharmacovigilance aspects related to veterinary medicines.
The detailed operational requirements of all EMA pharmacovigilance tasks that constitute the EMA pharmacovigilance system are set out in the Agency’s policies, standard operating procedures (SOPs) and work instructions (WINs), which are part of the EMA’s integrated quality management system and can be found on the Agency’s website.
The EMA pharmacovigilance system is embedded in the Agency’s overall quality system, and takes account of key corporate governance structure requirements outlined in the Agency’s mission and policies, such as transparency and data protection.