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Fighting Falsified Medicines with Paperwork – A Historic Review of Danish Legislation Governing Distribution of Medicines

Borup, Rasmus ; Kaae, Susanne ; Minssen, Timo LU and Traulsen, Janine Marie (2016) In Journal of Pharmaceutical Policy and Practice 30(9). p.1-8
Abstract
Many areas of pharmaceutical legislation in the European Union (EU) are harmonised in order to promote the internal market and protect public health. Ideally, harmonisation leads to less fragmented regulation and cross-border complexities. This study, however, focuses on an increasingly harmonised legislative area that is subject to increases in requirements and complexities: the distribution of medicines. This study compared Danish legislation governing the distribution of medicines before and after Denmark joined the EU in order to assess the impact of EU harmonisation, as well as to evaluate whether the drastic increases in requirements mandated by the Falsified Medicines Directive of 2011 correspond to a new approach to governing the... (More)
Many areas of pharmaceutical legislation in the European Union (EU) are harmonised in order to promote the internal market and protect public health. Ideally, harmonisation leads to less fragmented regulation and cross-border complexities. This study, however, focuses on an increasingly harmonised legislative area that is subject to increases in requirements and complexities: the distribution of medicines. This study compared Danish legislation governing the distribution of medicines before and after Denmark joined the EU in order to assess the impact of EU harmonisation, as well as to evaluate whether the drastic increases in requirements mandated by the Falsified Medicines Directive of 2011 correspond to a new approach to governing the pharmaceutical supply chain. (Less)
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author
; ; and
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Faculty of Law, Pharmaceutical policy, risk management, regulation, legislation, Europe, Falsified Medicines Directive
in
Journal of Pharmaceutical Policy and Practice
volume
30
issue
9
pages
8 pages
publisher
BioMed Central (BMC)
external identifiers
  • scopus:84991585252
ISSN
2052-3211
DOI
10.1186/s40545-016-0078-2
language
English
LU publication?
no
id
b19dee38-362b-49d6-98d4-f323615fdaa1
date added to LUP
2020-12-16 14:23:28
date last changed
2022-04-19 03:01:34
@article{b19dee38-362b-49d6-98d4-f323615fdaa1,
  abstract     = {{Many areas of pharmaceutical legislation in the European Union (EU) are harmonised in order to promote the internal market and protect public health. Ideally, harmonisation leads to less fragmented regulation and cross-border complexities. This study, however, focuses on an increasingly harmonised legislative area that is subject to increases in requirements and complexities: the distribution of medicines. This study compared Danish legislation governing the distribution of medicines before and after Denmark joined the EU in order to assess the impact of EU harmonisation, as well as to evaluate whether the drastic increases in requirements mandated by the Falsified Medicines Directive of 2011 correspond to a new approach to governing the pharmaceutical supply chain.}},
  author       = {{Borup, Rasmus and Kaae, Susanne and Minssen, Timo and Traulsen, Janine Marie}},
  issn         = {{2052-3211}},
  keywords     = {{Faculty of Law; Pharmaceutical policy; risk management; regulation; legislation; Europe; Falsified Medicines Directive}},
  language     = {{eng}},
  month        = {{10}},
  number       = {{9}},
  pages        = {{1--8}},
  publisher    = {{BioMed Central (BMC)}},
  series       = {{Journal of Pharmaceutical Policy and Practice}},
  title        = {{Fighting Falsified Medicines with Paperwork – A Historic Review of Danish Legislation Governing Distribution of Medicines}},
  url          = {{http://dx.doi.org/10.1186/s40545-016-0078-2}},
  doi          = {{10.1186/s40545-016-0078-2}},
  volume       = {{30}},
  year         = {{2016}},
}