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.
|Research and development||Marketing authorisation||Post-authorisation|
|Good pharmacovigilance practices (GVP)|
|Incident management plan|
|Periodic safety update reports|
|Post-authorisation safety studies|
|Medicines under additional monitoring|
|Regulatory and procedural guidance|
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- European Medicines Agency pharmacovigilance system manual (2016-10-14)
- Pharmacovigilance (2015-05-18)