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The precautionary principle and the authorisation of Covid-19 vaccines under EU
DONATI, Alessandra
2021
 

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Keywords :
vaccination; Covid-19; conditional marketing authorisation; precautionary principle; europe
Abstract :
[en] The decision of the EU Commission, based on positive advice from the European Medicines Agency, to grant conditional marketing authorisation to Covid-19 vaccines should be qualified as a precautionary measure. Under the established case law of the CJEU, the conditions for the application of this principle are met. Such conditions are the existence of a risk to the environment and public health and uncertainty. Given this qualification as a precautionary measure, whether the Commission had complied with the procedural obligations that surround the implementation of this principle under EU law was assessed. Some shortcomings are identified concerning the risk assessment conducted by the European Medicines Agency and the risk management carried out by the Commission.
Disciplines :
European & international law
Author, co-author :
DONATI, Alessandra ;  University of Luxembourg > Faculty of Law, Economics and Finance (FDEF) > Department of Law (DL)
Language :
English
Title :
The precautionary principle and the authorisation of Covid-19 vaccines under EU
Publication date :
02 December 2021
Publisher :
blogdroiteuropéen
Focus Area :
Law / European Law
Available on ORBilu :
since 10 December 2021

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