Derogation procedure for GMO containing COVID-19 medicinal products has ended

Derogation procedure for GMO containing COVID-19 medicinal products has ended

The derogation from the authorisation procedure for GMO medicines intended for the treatment or prevention of coronavirus disease that was in force during the COVID-19 pandemic has ended in the EU on March 3rd 2024 (Notice from the Commission). In future, the normal notification and application procedures in accordance with the gene technology regulation will apply for COVID-19 medicinal and vaccine products.

During the pandemic, the EU complied with Commission Regulation (EU) 2020/1043 concerning clinical trials with medicinal products containing GMOs for the treatment or prevention of coronavirus disease. For these products, the Regulation provided for a temporary derogation from certain authorisation requirements of the Gene Technology Directives 2001/18/EC and 2009/41/EC, such as environmental risk assessment. The exceptional procedure was applied to clinical trials approved in accordance with Directive 2001/20/EC for the treatment or prevention of COVID-19 and to the treatment of seriously ill patients in a situation where the GMO medicinal product did not yet have a marketing authorisation.