" /> Marketing Authorization Procedure - CISMeF





Preferred Label : Marketing Authorization Procedure;

NCIt definition : A formal procedure by which a regulatory agency grants an applicant authorization for the marketing or free distribution of a product after evaluation for safety, efficacy and quality.;

Alternative definition : CDISC-GLOSS: Formal EU procedure applied by a medicines regulatory agency to grant a marketing authorization, to amend an existing one, to extend its duration or to revoke it. [After ISO 11615:2017, 3.1.43];

NCI Metathesaurus CUI : CL540565;

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