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EU: Derogation for Covid-19 clinical trials of medicinal products containing or consisting of genetically modified organisms
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In the context of the Covid-19 coronavirus pandemic, the European Union has adopted a Regulation providing for a temporary exemption from European legislation on genetically modified organisms (Regulation (EU) 2020/1043 of the European Parliament and of the Council of 15 July 2020 on the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease (Covid-19).).
The objective of this Regulation is twofold: (1) To support the development of safe and effective products for the treatment or prevention of Covid-19 by enabling clinical trials to be carried out, as soon as possible, on medicinal products containing or consisting of GMOs; and (2) To ensure rapid availability of vaccines and treatments for Covid-19 in the event of an emergency.
This Regulation foresees that operations related to the conduct of clinical trials of ‘investigational medicinal products for human use containing or consisting of GMOs intended to treat or prevent Covid-19’, shall not require a prior environmental risk assessment. Furthermore, in applications for marketing authorisation for ‘medicinal products containing or consisting of GMOs intended to treat or prevent Covid-19’, the applicant shall not be required to include a copy of the competent authority’s written consent to the deliberate release into the environment of GMOs for research and development purposes.
This Regulation is temporary: it applies as long as WHO declares Covid-19 to be a pandemic or as long as an implementing act by which the EU Commission recognises a situation of public health emergency due to Covid-19 remains applicable.