All operations related to the conduct of clinical trials, including packaging and labelling, storage, transport, destruction, disposal, distribution, supply, administration or use of investigational medicinal products for human use containing or consisting of GMOs intended to treat or prevent COVID-19, with the exception of the manufacturing of the investigational medicinal products, shall not require a prior environmental risk assessment or consent in accordance with Articles 6 to 11 of Directive 2001/18/EC or Articles 4 to 13 of Directive 2009/41/EC when these operations relate to the conduct of a clinical trial authorised in accordance with Directive 2001/20/EC.

Sponsors shall implement appropriate measures to minimise foreseeable negative environmental impacts resulting from the intended or unintended release of the investigational medicinal product into the environment.

By way of derogation from point (a) of Article 6(2) of Regulation (EC) No 726/2004 and from the second indent of the fourth paragraph of point 1.6 of Part I of Annex I to Directive 2001/83/EC, 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 in accordance with Part B of Directive 2001/18/EC.