Regulation (EU) 2020/1043 of the European Parliament and of the Council of 15 July 2020

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In the unprecedented situation of public health emergency created by the COVID-19 pandemic, it is necessary that the protection of public health prevails. Therefore, it is necessary to grant a temporary derogation from the requirements concerning a prior environmental risk assessment and consent under Directives 2001/18/EC and 2009/41/EC for the duration of the COVID-19 pandemic or as long as COVID-19 is a public health emergency. The derogation should be limited to clinical trials with investigational medicinal products containing or consisting of GMOs intended to treat or prevent COVID-19. During the period in which the temporary derogation applies, the environmental risk assessment and consent under Directives 2001/18/EC and 2009/41/EC should not be a prerequisite for the conduct of those clinical trials.

 

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