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. 2020 Jan 31;10:1664. doi: 10.3389/fphar.2019.01664

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Copyright © 2020 Verbaanderd, Rooman, Meheus and Huys

This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

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Regulatory frameworks for on- and off-label use of new therapeutic indications in Europe. Marketing authorization (MA), well-established use (WEU), commission regulation (Reg).