The tasks, set out in Article 78, of the qualified person responsible for pharmacovigilance referred to in paragraph 8 of this Article may be outsourced to a third party under the conditions set out in that paragraph.
Féadfar cúraimí an duine cháilithe, a leagtar amach in Airteagal 78, atá freagrach as faireachas cógas dá dtagraítear i mír 8 den Airteagal seo a sheachfhoinsiú do thriú páirtí faoi na coinníollacha a leagtar amach sa mhír sin.