Article 8 — European Central Repository
Regulation (EU) No 376/2014
1. The Commission shall manage a European Central Repository to store all occurrence reports collected in the Union.
2. Each Member State shall, in agreement with the Commission, update the European Central Repository by transferring to it all information relating to safety stored in the national databases referred to in Article 6(6).
3. The Agency shall agree with the Commission the technical protocols for transferring to the European Central Repository all occurrence reports collected by the Agency under Regulation (EC) No 216/2008 and its implementing rules, particularly for occurrences stored in the Internal Occurrence Reporting System (IORS), as well as the information collected pursuant to Articles 4(9) and 5(5).
4. The Commission shall, by means of implementing acts, adopt the arrangements for the management of the European Central Repository as referred to in paragraph 1 and 2. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 19(2).
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