As part of the specific obligations referred to in paragraph 4, the holder of a marketing authorisation granted pursuant to this Article shall be required to complete ongoing studies, or to conduct new studies, with a view to confirming that the risk-benefit balance is favourable.
Mar chuid de na hoibleagáidí sonracha dá dtagraítear i mír 4, beidh de cheangal ar shealbhóir an údaraithe margaíochta a dheonaítear de bhun an Airteagail seo staidéir leanúnacha a thabhairt i gcrích, nó staidéir nua a sheoladh, d’fhonn a dheimhniú go bhfuil an chothromaíocht idir rioscaí agus tairbhí fabhrach.