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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

L

Lay Person Summary (of a clinical trial)

The EU Clinical Trials Regulation 536/2014 (Article 37) requires sponsors to provide summary results of…

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O

Orphan Drug Designation (ODD)

Most health authorities promote the development of orphan drugs, by offering a series of incentives…

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