Regulation (EU) No 1178/2011
(a) Without prejudice to Regulation (EU) No 376/2014 and the delegated and implementing acts adopted on the basis thereof, the competent authority 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 to Member States and the Commission any information, including recommendations or corrective actions to be taken, necessary for them to react in a timely manner to a safety problem involving products, parts, non-installed equipment, persons or organisations 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 (a) and (b), the competent authority shall take adequate measures to address the safety problem.
(d) Measures taken under point (c) 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 shall also notify those measures to the Agency and, when combined action is required, the other Member States concerned.
Competent authorities must collect, analyse, and disseminate safety information, take adequate measures to address safety problems, and notify affected parties, the Agency, and other Member States as required.
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