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How EMA monitors medicines once they are on the market

After its authorisation a medicine is used by many patients, often together with other medicines. Over time, certain side effects may emerge that have not previously been identified. It is therefore essential that the safety of all medicines is continuously monitored throughout their use in healthcare practice.

The European Medicines Agency (EMA) protects public and animal health in the European Union and the European Economic Area by analysing information on possible side effects from new clinical studies, scientific publications and reports from doctors, pharmacists and patients.

To address new or increased risks linked to a specific medicine, EMA can recommend a range of actions to protect public and animal health - ranging from restricting the medicine’s use to taking it off the market.

For an easy introduction to how the Agency monitors medicines, watch this video.
 

For further information, consult our webpage on pharmacovigilance.