The sponsor shall also report to the Member States in which the clinical investigation is being conducted any event referred to in paragraph 2 of this Article that occurred in third countries in which a clinical investigation is performed under the same clinical investigation plan as the one applying to a clinical investigation covered by this Regulation by means of the electronic system referred to in Article 73.
Tuairisceoidh an t-urraitheoir freisin do na Ballstáit lena mbaineann ina bhfuil an t-imscrúdú cliniciúil á dhéanamh, trí mheán an chórais leictreonaigh dá dtagraítear in Airteagal 73, aon tarlú dá dtagraítear i mír 2 den Airteagal seo a tharla i dtríú tíortha ina bhfuil imscrúdú cliniciúil á dhéanamh faoin bplean céanna don imscrúdú cliniciúil agus an ceann a bhfuil feidhm aige i leith imscrúdaithe chliniciúil a chumhdaítear faoin Rialachán seo.