the Member State in which the clinical investigation is being or is to be conducted has notified the sponsor of its refusal based on the grounds referred to in Article 71(4) or on considerations of public health, subject and user safety or health, of public policy, or
má tá fógra tugtha ag an mBallstát ina bhfuil an t-imscrúdú cliniciúil á dhéanamh nó le déanamh don urraitheoir go bhfuil sé ag diúltú ar bhonn na bhforás dá dtagraítear in Airteagal 71(4) nó ar bhonn forais a bhaineann leis an tsláinte phoiblí, sábháilteacht nó sláinte an ábhair nó an úsáideora, leis an mbeartas poiblí, nó