By derogation from paragraph 3 of this Article, if the competent authority in an additional Member State concerned has reasons for refusing the marketing authorisation on the ground that the veterinary medicinal product would pose a potential serious risk to human or animal health or to the environment, it shall, at the latest within a period of 60 days of receipt of both the data and information referred to in paragraph 1 and updated assessment report referred to in paragraph 2 of this Article raise its objections and provide a detailed statement of the reasons to the competent authority in the reference Member State referred to in Article 49 or 52, as applicable, and to the competent authorities in the Member States concerned, referred to in those Articles, and to the applicant.
De mhaolú ar mhír 3 den Airteagal seo, má tá cúiseanna ag an údarás inniúil i mBallstát eile lena mbaineann maidir le húdarú margaíochta a dhiúltú ar an bhforas go bhféadfadh an táirge íocshláinte tréidliachta a bheith ina riosca tromchúiseach féideartha do shláinte an duine nó do shláinte ainmhithe nó don chomhshaol, déanfaidh sé a chuid agóidí, ar a dhéanaí laistigh de thréimhse 60 lá tar éis na sonraí agus an fhaisnéis dá dtagraítear i mír 1 agus an tuarascáil mheasúnaithe nuashonraithe dá dtagraítear i mír 2 den Airteagal seo a fháil, agus déanfaidh sé ráiteas mionsonraithe de na cúiseanna a chur ar fáil don údarás inniúil sa Bhallstát tagartha dá dtagraítear in Airteagal 49 nó 52, de réir mar is infheidhme, agus do na húdaráis inniúla sna Ballstáit lena mbaineann, dá dtagraítear sna hAirteagail sin, agus don iarratasóir.