Journal De Jure
“ST. CYRIL AND ST. METHODIUS” UNIVERSITY OF VELIKO TARNOVO - UNIVERSITY PRESS

A brief historical development and normative basis for the licensing of medicinal products in human medicine


Authors:
Ivelina Aleksandrova St. Cyril and St. Methodius University of Veliko Tarnovo, Bulgaria

Pages: 110-113

Abstract:

This article provides an overview of the historical developments of the BDA and addresses one of the major licensing regimes in human medicine directly related to its activities. An analysis of the procedure, the necessary documents and possible solutions are presented.

Keywords:

license, executive agency for medicines, individual administrative act.

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