Fighting falsified medicines with paperwork �? a historic review of Danish legislation governing distribution of medicines

Journal of Pharmaceutical Policy and Practice

Rasmus Borup¹  Janine Traulsen¹  Susanne Kaae¹  Timo Minssen¹ 

[1] 1Department of Pharmacy, University of Copenhagen, Universitetsparken 2, 2100 Copenhagen, Denmark

关键词: Harmonisation;    Legislation;    European Union;    Falsified Medicines Directive;    Enforcement;   

DOI  :  10.1186/s40545-016-0078-2

学科分类：药理学

来源: BioMed Central

【 摘 要 】

Background

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.

【 授权许可】

Unknown