The sponsor shall also report to the Member States in which the performance study is being conducted any event referred to in paragraph 2 of this Article that occurred in third countries in which a performance study is performed under the same clinical performance study plan as the one applying to a performance study covered by this Regulation by means of the electronic system referred to in Article 69.
Déanfaidh an t-urraitheoir aon tarlú dá dtagraítear i mír 2 den Airteagal seo a thuairisciú do na Ballstáit ina bhfuil an staidéar feidhmíochta á dhéanamh, ar tarlú é a tharla i dtríú tíortha ina ndéantar staidéar feidhmíochta faoin bplean céanna don staidéar ar fheidhmíocht chliniciúil arb ionann é agus an ceann atá i bhfeidhm i leith staidéar feidhmíochta a chumhdaítear faoin Rialachán seo tríd an gcóras leictreonach dá dtagraítear in Airteagal 69.