+Artikolu 8 Repożitorju Ċentrali Ewropew
---+Article 8 1.
---+Article 8 2.
---+Article 8 3.
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Artikolu 8 Repożitorju Ċentrali Ewropew

Artikolu 8

Repożitorju Ċentrali Ewropew

1. Il-Kummissjoni għandu jkollha l-ġestjoni ta' Repożitorju Ċentrali Ewropew biex jaħżen ir-rapporti kollha ta' okkorrenza miġbura fl-Unjoni.

2. Kull Stat Membru, bi qbil mal-Kummissjoni, għandu jaġġorna r-Repożitorju Ċentrali Ewropew permezz tat-trasferiment fih tal-informazzjoni kollha relatata mas-sikurezza maħżuna fil-bażijiet tad-data data nazzjonali msemmija fl-Artikolu 6(6).

3. L-Aġenzija għandha tiftiehem mal-Kummissjoni dwar il-protokolli tekniċi għat-trasferiment fir-Repożitorju Ċentrali Ewropew tar-rapporti kollha dwar l-okkorrenzi miġbura mill-Aġenzija skont ir-Regolament (KE) Nru 216/2008 u r-regoli ta' implimentazzjoni tiegħu, b'mod partikolari għall-okkorrenzi maħżuna fis-Sistema Interna ta' Rrappurtar tal-Okkorrenzi (IORS), kif ukoll l-informazzjoni miġbura skont l-Artikoli 4(9) u 5(5).

4. Il-Kummissjoni għandha tadotta, permezz ta' atti ta' implimentazzjoni, l-arranġamenti għall-ġestjoni tar-Repożitorju Ċentrali Ewropew kif imsemmi fil-paragrafi 1 u 2. Tali atti ta' implimentazzjoni għandhom jiġu adottati f'konformità mal-proċedura ta' eżami msemmija fl-Artikolu 19(2).

1. Ħarsa ġenerali

Titlu	Regolamentazzjoni
Article 8 1.	The Commission shall manage a European Central Repository to store all occurrence reports collected in the Union.
Article 8 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).
Article 8 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).
Article 8 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).

1.1 Referenzi

1.2 Rekwiżiti identifikati

1.3 Standards relatati

2. Rekwiżiti identifikati

Rekwiżiti
Sors	Rekwiżit

3. Standards relatati

Standards
Sors	Rekwiżit

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