Pharmacovigilance: post-authorisation
European Union (EU) legislation requires marketing authorisation holders, national competent authorities and the European Medicines Agency (EMA) to follow a number of pharmacovigilance processes after a product has been authorised.
Monitoring the safety of a medicine once it is on the market is the cornerstone of pharmacovigilance. The Agency provides extensive guidance to enable all stakeholders to meet their legal pharmacovigilance obligations.
In this section
- European Risk Management Strategy (ERMS)
- Good pharmacovigilance practices (GVP)
- Incident management plan
- Medical literature monitoring
- Medication errors
- Medicines under additional monitoring
- Periodic safety update reports (PSURs)
- Pharmacovigilance systems
- Post-authorisation safety studies (PASS)
- Regulatory and procedural guidance
- Risk management plan (RMP)
- Signal management
In other sections
Marketing authorisation holders should also consider the regulatory information in the sections below: