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