Article 4

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^f1 applies.

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.

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.