145.B.135 Immediate reaction to a
safety problem
Regulation
(EU) 2021/1963
(a) Without prejudice to Regulation (EU) No
376/2014 and its delegated and implementing acts, 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 the relevant authority
of the 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,
appliances, persons or organisations that are subject to Regulation (EU)
2018/1139 and its delegated and implementing acts.
(c) Upon receiving the information referred to in points (a) and (b), the competent authority shall take adequate measures to address the safety problem.
(d) The competent
authority shall immediately notify measures taken under point (c) to all
persons or organisations which need to comply with them under Regulation (EU)
2018/1139 and its delegated and implementing acts. The competent authority
shall also notify those measures to the Agency and, when combined action is
required, to the other Member States concerned.
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