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From Integration to Exclusion: EU composite administration and gaps in judicial accountability in the authorisation of pharmaceuticals

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Abstract

In the EU, pharmaceuticals are subject to a marketing authorisation requirement that, depending on the type of product concerned, can be obtained either centrally through a Commission decision with EU-wide effects or in the Member States, potentially subject to mutual recognition in composite authorisation procedures. These composite decision-making processes can nowadays be considered a standard way of administrative decision-making in the EU internal market. Yet, judicial supervision remains anchored in the separation of jurisdictions between the national and the EU level, and between national levels. This article explores the challenges posed to judicial review in the case of pharmaceutical marketing authorisations when European administrative composite structures are used.
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Details

Original languageEnglish
Article numberPII S1867299X19000321
Pages (from-to)393-411
Number of pages19
JournalEuropean Journal of Risk Regulation
Volume10
Issue number2
DOIs
Publication statusPublished - Jun 2019