Article 2

Article 1 shall be without prejudice to cooperative arrangements on individual quality assurance reviews between the competent authorities of a Member State and the competent authorities of the United States of America, provided that such an arrangement meets the criteria set out in Article 2 of Commission Implementing Decision 2013/280/EU ³ and does not pre-empt any Decision to be taken in accordance with Article 47(3) of Directive 2006/43/EC.