TY - JOUR
T1 - From Integration to Exclusion
T2 - EU composite administration and gaps in judicial accountability in the authorisation of pharmaceuticals
AU - Röttger-Wirtz, S.
AU - Eliantonio, Mariolina
N1 - Publisher Copyright:
© The Author(s) 2019.
PY - 2019/6
Y1 - 2019/6
N2 - 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.
AB - 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.
U2 - 10.1017/err.2019.32
DO - 10.1017/err.2019.32
M3 - Article
SN - 1867-299X
VL - 10
SP - 393
EP - 411
JO - European Journal of Risk Regulation
JF - European Journal of Risk Regulation
IS - 2
M1 - PII S1867299X19000321
ER -