The next formal meeting of the EEA Joint Committee is foreseen on 25 September. In view of the importance and urgency nof the two acts during the ongoing pandemic, the EEA Joint Committee adopted the two JCDs by written procedure*.
The first adpoted JCD incorporates 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 (GMOs) intended to treat or prevent coronavirus disease (COVID-19).
The objective of the Regulation is to ensure that clinical trials with medicinal products for human use that contain or consist of GMOs and are intended to treat or prevent COVID-19 can start swiftly and without a prior environmental risk assessment and/or consent in so far as there is a valid declaration of pandemic by the World Health Organization, or if COVID-19 is declared an emergency situation in accordance with Decision No 1082/2013/EU and remains so. The suggested amendments are important for the development of vaccines and medicinal products and against COVID-19 in the EEA. The act will give patients in the EEA EFTA countries access to medicinal products on equal terms as patients in the EU.
The second adopted JCD incorporates Commission Regulation (EU) 2020/972 of 2 July 2020 amending Regulation (EU) No 1407/2013 amending Regulation (EU) No 651/2014 as regards its prolongation and relevant adjustments (the de minimis Regulation and the General Block Exemption Regulation). The act provides that undertakings as a consequence of the COVID-19 outbreak should remain eligible under the General Block Exemption Regulation for a limited period of time. It was considered necessary to swiftly incorporate the act to ensure that the same State aid rules apply within the whole EEA.
*Written procedure is used in exceptional circumstances that require swift incorporation of acts into the EEA Agreement.
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