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Glossary

Pharmacovigilance

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Science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.

Other glossary definitions

E

European Union (EU) Legal Representative

Sponsors who are not based in the EU/EEA must appoint a legal representative based in…

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M

Marketing Authorization Application (MAA)

The marketing of medicinal products is conditioned by regulators’ approval, in order to ensure that…

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