Where a Member State, the Commission or the marketing authorisation holder considers that there are reasons to believe that a veterinary medicinal product could present a potential serious risk to human or animal health or to the environment, a scientific evaluation of the product should be undertaken at Union level, leading to a single decision on the area of disagreement, binding on the relevant Member States, and taken on the basis of an overall benefit-risk assessment.
I gcás ina measann Ballstát, an Coimisiún nó sealbhóir an údaraithe margaíochta go bhfuil cúiseanna ann lena chreidiúint go bhféadfadh riosca tromchúiseach féideartha a bheith i dtáirge íocshláinte tréidliachta do shláinte an duine nó do shláinte ainmhithe nó don chomhshaol, ba cheart measúnú eolaíochta a dhéanamh ar leibhéal an Aontais, agus ba cheart cinneadh aonair faoin ábhar easaontais a bheith mar thoradh air, a bheidh ina cheangal ar na Ballstáit ábhartha, agus ba cheart é a ghlacadh bunaithe ar mheasúnú foriomlán tairbhe agus riosca.