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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Autores principales:	Drenska M., Getov I.
Formato:	article
Lenguaje:	EN
Publicado:	Sciendo 2017
Materias:	off-label use drug legislation drug regulation off-label regulation Medicine R
Acceso en línea:	https://doaj.org/article/b42bba9c6cf34f679dee54c7a912cad4
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spelling	oai:doaj.org-article:b42bba9c6cf34f679dee54c7a912cad42021-12-02T16:42:08ZResearch on Approaches for Regulation of the “Off-label” use of Medicinal Products in the European Union0324-175010.1515/amb-2017-0003https://doaj.org/article/b42bba9c6cf34f679dee54c7a912cad42017-05-01T00:00:00Zhttps://doi.org/10.1515/amb-2017-0003https://doaj.org/toc/0324-1750Despite 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 of practice. In recent years, through guidance and legal changes in some countries were defined the conditions and responsibilities, but in the most European countries still lack rules for off-label prescribing. The purpose of this study was to identify and analyse different approaches to regulation, adopted by some member states as well as to summarize the efforts in demand of common harmonized approach to solve this problem within the European Union. In the study, we used the available regulatory information in different electronic resources associated with the off-label drug use in selected European countries without limited time range. The results show that decisions taken to regulate the issue have significant differences and specific approach, while none of them is enough satisfactory and comprehensive. In conclusion, it can be claimed that the existing regulatory rules in various countries require significant improvement and update.Drenska M.Getov I.Sciendoarticleoff-label usedrug legislationdrug regulationoff-label regulationMedicineRENActa Medica Bulgarica, Vol 44, Iss 1, Pp 17-21 (2017)
institution	DOAJ
collection	DOAJ
language	EN
topic	off-label use drug legislation drug regulation off-label regulation Medicine R
spellingShingle	off-label use drug legislation drug regulation off-label regulation Medicine R Drenska M. Getov I. Research on Approaches for Regulation of the “Off-label” use of Medicinal Products in the European Union
description	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 of practice. In recent years, through guidance and legal changes in some countries were defined the conditions and responsibilities, but in the most European countries still lack rules for off-label prescribing. The purpose of this study was to identify and analyse different approaches to regulation, adopted by some member states as well as to summarize the efforts in demand of common harmonized approach to solve this problem within the European Union. In the study, we used the available regulatory information in different electronic resources associated with the off-label drug use in selected European countries without limited time range. The results show that decisions taken to regulate the issue have significant differences and specific approach, while none of them is enough satisfactory and comprehensive. In conclusion, it can be claimed that the existing regulatory rules in various countries require significant improvement and update.
format	article
author	Drenska M. Getov I.
author_facet	Drenska M. Getov I.
author_sort	Drenska M.
title	Research on Approaches for Regulation of the “Off-label” use of Medicinal Products in the European Union
title_short	Research on Approaches for Regulation of the “Off-label” use of Medicinal Products in the European Union
title_full	Research on Approaches for Regulation of the “Off-label” use of Medicinal Products in the European Union
title_fullStr	Research on Approaches for Regulation of the “Off-label” use of Medicinal Products in the European Union
title_full_unstemmed	Research on Approaches for Regulation of the “Off-label” use of Medicinal Products in the European Union
title_sort	research on approaches for regulation of the “off-label” use of medicinal products in the european union
publisher	Sciendo
publishDate	2017
url	https://doaj.org/article/b42bba9c6cf34f679dee54c7a912cad4
work_keys_str_mv	AT drenskam researchonapproachesforregulationoftheofflabeluseofmedicinalproductsintheeuropeanunion AT getovi researchonapproachesforregulationoftheofflabeluseofmedicinalproductsintheeuropeanunion
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Research on Approaches for Regulation of the “Off-label” use of Medicinal Products in the European Union

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