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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

Data Protection Impact Assessment (DPIA)

A Data Protection Impact Assessment (DPIA) is a process to help identify and minimize the…

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G

GMDN – Global Medical Device Nomenclature.

GMDN is a comprehensive set of terms that provides generic descriptors for the identification of…

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