Pharmacovigilance

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The pharmacovigilance system in the European Union (EU) operates between the regulatory authorities in Member States, the European Commission and the European Medicines Agency. In some Member States, regional centres are in place under the coordination of the national competent authority.

The Agency's role is to coordinate the EU pharmacovigilance system and to operate specific systems, services and processes as laid down in the EU legislation.

The EMA pharmacovigilance system is described in the EMA pharmacovigilance system manual.

Pharmacovigilance in the product lifecycle

Research and developmentMarketing authorisationPost-authorisation
EudraVigilance
                      Patient registries
                      Pharmacovigilance fees
                      Risk management
  Good pharmacovigilance practices (GVP)
  Incident management plan
  Medication errors
  Medicines under additional monitoring
  Periodic safety update reports
  Post-authorisation safety studies
  Regulatory and procedural guidance
  Signal management

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