ARO.GEN.135 Immediate reaction to a safety problem

(a)Without prejudice to Regulation (EU) No 376/2014 of the European Parliament and of the Council, 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, appliances, persons or organisations subject to Regulation (EC) No 216/2008 and its Implementing Rules.

(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 (c) shall immediately be notified to all persons or organisations which need to comply with them under Regulation (EC) No 216/2008 and its Implementing Rules. The competent authority shall also notify those measures to the Agency and, when combined action is required, the other Member States concerned.