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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

P

Pharmacovigilance System Master File (PSMF)

A Pharmacovigilance System Master File is a document describing the pharmacovigilance system used by the…

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A

Assay

(For Small Molecule and Synthetic Low Molecular Weight Peptide Drug Substances) A specific, stability-indicating procedure…

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