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      Causes of drug shortages in the legal pharmaceutical framework.

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          Abstract

          Different causes of drug shortages can be linked to the pharmaceutical legal framework, such as: parallel trade, quality requirements, economic decisions to suspend or cease production, etc. However until now no in-depth study of the different regulations affecting drug shortages is available. The aim of this paper is to provide an analysis of relevant legal and regulatory measures in the European pharmaceutical framework which influence drug shortages.

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          Author and article information

          Journal
          Regul. Toxicol. Pharmacol.
          Regulatory toxicology and pharmacology : RTP
          1096-0295
          0273-2300
          Mar 2015
          : 71
          : 2
          Affiliations
          [1 ] KU Leuven Department of Pharmaceutical and Pharmacological Sciences, Herestraat 49, PO Box 521, 3000 Leuven, Belgium. Electronic address: elfi.deweerdt@pharm.kuleuven.be.
          [2 ] KU Leuven Department of Pharmaceutical and Pharmacological Sciences, Herestraat 49, PO Box 521, 3000 Leuven, Belgium. Electronic address: steven.simoens@pharm.kuleuven.be.
          [3 ] KU Leuven Department of Pharmaceutical and Pharmacological Sciences, Herestraat 49, PO Box 420, 3000 Leuven, Belgium. Electronic address: luc.hombroeckx@pharm.kuleuven.be.
          [4 ] KU Leuven Department of Pharmaceutical and Pharmacological Sciences, Herestraat 49, PO Box 521, 3000 Leuven, Belgium. Electronic address: minne.casteels@kuleuven.be.
          [5 ] KU Leuven Department of Pharmaceutical and Pharmacological Sciences, Herestraat 49, PO Box 521, 3000 Leuven, Belgium. Electronic address: Isabelle.huys@pharm.kuleuven.be.
          Article
          S0273-2300(15)00006-9
          10.1016/j.yrtph.2015.01.005
          25591547
          9b663e58-5ef6-4979-9ed6-01fd88ed39ea
          Copyright © 2015 Elsevier Inc. All rights reserved.
          History

          Drug shortages,Legal framework,Market authorization,Parallel trade,Pricing,Quality requirements,Quota

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