Pharmaceutical information: Does the Directive 2001/83/EC protect such a right for the end user?

<p>The right to information is of crucial importance for the end-user of pharmaceuticals to exercise their right of self-determination. In the Directive 2001/83/EC relating to pharmaceuticals for human use all the particulars that have to be on the labelling or in the package leaflet a...

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Autor principal: Andrea Faeh
Formato: article
Lenguaje:EN
Publicado: Amsterdam Law Forum 2011
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Acceso en línea:https://doaj.org/article/4ec4640311e140d7979b914e763413f4
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spelling oai:doaj.org-article:4ec4640311e140d7979b914e763413f42021-12-02T08:24:45ZPharmaceutical information: Does the Directive 2001/83/EC protect such a right for the end user?1876-8156https://doaj.org/article/4ec4640311e140d7979b914e763413f42011-02-01T00:00:00Zhttp://ojs.ubvu.vu.nl/alf/article/view/193https://doaj.org/toc/1876-8156<p>The right to information is of crucial importance for the end-user of pharmaceuticals to exercise their right of self-determination. In the Directive 2001/83/EC relating to pharmaceuticals for human use all the particulars that have to be on the labelling or in the package leaflet are stipulated and need to be transposed into national law.</p> <p>This contribution scrutinises first the implications that a correct implementation of the information rules entails for the legal position of the individual. Second, the conditions and consequences of a failed implementation will be equally assessed in order to evaluate the legal impact when the right to information is violated by the state or the marketing authorisation holder.</p>Andrea FaehAmsterdam Law Forumarticleright to informationpharmaceuticalslabellinglegal implications of Directive 2001/83/ECmarketing of medicinesLawKENAmsterdam Law Forum, Vol 3, Iss 1, Pp 30-41 (2011)
institution DOAJ
collection DOAJ
language EN
topic right to information
pharmaceuticals
labelling
legal implications of Directive 2001/83/EC
marketing of medicines
Law
K
spellingShingle right to information
pharmaceuticals
labelling
legal implications of Directive 2001/83/EC
marketing of medicines
Law
K
Andrea Faeh
Pharmaceutical information: Does the Directive 2001/83/EC protect such a right for the end user?
description <p>The right to information is of crucial importance for the end-user of pharmaceuticals to exercise their right of self-determination. In the Directive 2001/83/EC relating to pharmaceuticals for human use all the particulars that have to be on the labelling or in the package leaflet are stipulated and need to be transposed into national law.</p> <p>This contribution scrutinises first the implications that a correct implementation of the information rules entails for the legal position of the individual. Second, the conditions and consequences of a failed implementation will be equally assessed in order to evaluate the legal impact when the right to information is violated by the state or the marketing authorisation holder.</p>
format article
author Andrea Faeh
author_facet Andrea Faeh
author_sort Andrea Faeh
title Pharmaceutical information: Does the Directive 2001/83/EC protect such a right for the end user?
title_short Pharmaceutical information: Does the Directive 2001/83/EC protect such a right for the end user?
title_full Pharmaceutical information: Does the Directive 2001/83/EC protect such a right for the end user?
title_fullStr Pharmaceutical information: Does the Directive 2001/83/EC protect such a right for the end user?
title_full_unstemmed Pharmaceutical information: Does the Directive 2001/83/EC protect such a right for the end user?
title_sort pharmaceutical information: does the directive 2001/83/ec protect such a right for the end user?
publisher Amsterdam Law Forum
publishDate 2011
url https://doaj.org/article/4ec4640311e140d7979b914e763413f4
work_keys_str_mv AT andreafaeh pharmaceuticalinformationdoesthedirective200183ecprotectsucharightfortheenduser
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