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21L.B.15 Immediate reaction to a safety problem

Regulation (EU) 2022/1361

(a)     Without prejudice to Regulation (EU) No 376/2014 and its delegated and implementing acts, the competent authority of the Member State shall implement a system to appropriately collect, analyse, and disseminate safety information.

(b)     The Agency shall implement a system to appropriately analyse any relevant safety information received, and without undue delay, provide Member States and the Commission with any information, including recommendations or corrective actions to be taken, that is necessary for them to react in a timely manner to a safety problem involving products, parts, persons or organisations that are subject to Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof.

(c)      Upon receiving the information referred to in points (a) and (b), the competent authority of the Member State shall take adequate measures to address the safety problem.

(d)     Measures taken under point (c) of point 21L.B.15 shall immediately be notified to all persons or organisations that need to comply with them under Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof. The competent authority of the Member State shall also notify those measures to the Agency and, when combined action is required, to the other Member States concerned.