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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) (Text with EEA relevance) article 4 CELEX: 32020R1043 1. This Regulation shall apply as long as WHO has declared COVID-19 to be a pandemic or as long as an implementing act by which the Commission recognises a situation of public health emergency due to COVID-19 in accordance with Article 12 of Decision No 1082/2013/EU of the European Parliament and of the Council applies. 2. The Commission shall, when the conditions for the application of this Regulation referred to in paragraph 1 are no longer fulfilled, publish a notice in the Official Journal of the European Union to that effect. 3. Clinical trials within the scope of Article 2 of this Regulation that have been authorised under Directive 2001/20/EC prior to the publication of the notice referred to in paragraph 2 of this Article may validly continue and be used in support of an application for marketing authorisation in the absence of an 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. |