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 legislation
- Pharmacovigilance fees
- Good pharmacovigilance practices
- Risk-management plans
- Medication errors
- Signal management
- Post-authorisation safety studies
- Medicines under additional monitoring
- Periodic safety update reports
- European Risk Management Strategy
- Incident management plan
- Patient registries
- Regulatory and procedural guidance
- Public hearings
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- European Medicines Agency pharmacovigilance system manual (29/07/2014)
- Pharmacovigilance (18/05/2015)