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Glossary

Emerging Safety Issue

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A safety issue considered by a marketing authorization holder to require urgent attention by the competent authority because of the potentially major impact on the risk-benefit balance of the medicinal product and/or on patients’ or public health and the potential need for prompt regulatory action and communication to patients and healthcare professionals.

Other glossary definitions

D

Device Deficiency

Inadequacy of an investigational medical device related to its identity, quality, durability, reliability, safety, or…

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E

EudraCT Form

A harmonized application form is used for clinical trial applications across the European Union. EudraCT…

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