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21L.B.13 Information to the Agency

Regulation (EU) 2022/1361

(a) The competent authority of the Member State shall notify the Agency in case of any significant problems with the implementation of Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof, within 30 days from the manifestation of such problems.

(b) Without prejudice to Regulation (EU) No 376/2014 and its delegated and implementing acts, the competent authority of the Member State shall provide the Agency as soon as possible with any safety-significant information stemming from the occurrence reports stored in the national database as specified in Article 6(6) of Regulation No (EU) 376/2014.