EMA Updated the Pharmacovigilance System Manual

On 16 March 2021 the EMA updated the pharmacovigilance system manual version 1.3.

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.

The changes of the updated version include:

  • the insertion of updated organisational chart and updated references to Agency organisational entities
  • updated description of Divisions’ responsibilities
  • updated list of pharmacovigilance tasks
  • updated definition of Medicines Leadership Team
  • updated EMA leadership responsibility model to provide reference to task forces
  • updated Joint EU Telematics governance model
  • removal of reference to Impact Strategy and Work Plan under development
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