Pharmacovigilance: post-authorisation

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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.

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Marketing authorisation holders should also consider the regulatory information in the sections below:

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