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
In other sections
Marketing authorisation holders should also consider the regulatory information in the sections below:
- Patient registries
- Pharmacovigilance fees
- Pharmacovigilance inspections
- Post-authorisation safety studies: questions and answers
- Risk management
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