EMA assesses active substance safety

Published: 15-Apr-2013
Regulatory

For nationally approved medicines


The European Medicines Agency (EMA) is expanding its retroactive safety reviews of active substances in medicines legally sold in the European Union (EU).

Until now EMA only assessed those substances with EU-wide market approvals. Next year it will assess substances in medicines with approvals from more than one EU national regulator, but no pan-EU sales rights.

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