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Glossary

MA (Marketing Authorisation)

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Marketing authorisation is the process of reviewing and assessing the evidence to support a medicinal product, such as a drug, in relation to its marketing, finalised by granting of a licence to be sold. 

Other glossary definitions

S

Serious (Public) Health Threat

Any event type, which results in an imminent risk to the study population of death,…

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I

Integrated summary of efficacy (or effectiveness) (ISE)

Comprehensive integrated analysis of the effectiveness of a study drug, recommended to be submitted to…

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