Research on Approaches for Regulation of the “Off-label” use of Medicinal Products in the European Union

Despite the increasingly strict legislation on medicinal products, the „off-label use“ or „use of medicinal product outside the approved summary of product characteristics (SmPC)“ is a weak point of today’s drug regulation and raises many questions about the risk, ethics, and legality of this type o...

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Bibliographic Details
Main Authors: Drenska M., Getov I.
Format: Article
Language:English
Published: Sciendo 2017-05-01
Series:Acta Medica Bulgarica
Subjects:
Online Access:https://doi.org/10.1515/amb-2017-0003