the Member State in which the performance study is being or is to be conducted has notified the sponsor of its refusal based on the grounds referred to in Article 67(4) or on considerations of public health, of subject and user safety or health, or of public policy; or
má tá fógra tugtha ag an mBallstát ina ndéantar an staidéar feidhmíochta nó ina mbeidh an staidéar le déanamh don urraitheoir go bhfuil sé ag diúltú ar bhonn na bhforas dá dtagraítear in Airteagal 67(4) nó ar bhonn foras a bhaineann le sláinte an phobail, le sábháilteacht nó le sláinte an ábhair nó an úsáideora, nó leis an mbeartas poiblí; nó