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.
United Kingdom's (UK) withdrawal from the EU
EMA has published important information to help users of the centralised procedure prepare for the expected consequences of 'Brexit', including their obligations related to establishment within the European Economic Area (EEA). For more information, see UK's withdrawal from the EU.
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
- 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: