The Conditional Marketing Authorisation of Covid-19 Vaccines: A Critical Assessment under EU Law.

ABSTRACT

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.