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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

Substantial Amendment (SA)

A substantial amendment (SA) is a change to the conduct of the clinical trial that…

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S

Serious (Public) Health Threat

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

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