By way of derogation from paragraph 1, in the case of a marketing authorisation for a hybrid veterinary medicinal product supported by additional pre-clinical studies or clinical trials, the relevant sections of the summary of product characteristics referred to in paragraph 1 shall not be considered to be subject to harmonisation.
De mhaolú ar mhír 1, i gcás údarú margaíochta le haghaidh táirge íocshláinte tréidliachta hibrideach arna thacú le staidéir bhreise réamhchliniciúla nó trialacha cliniciúla, ní mheasfar na ranna ábhartha den achoimre ar shaintréithe an táirge dá dtagraítear i mír 1 a bheith faoi réir comhchuibhiú.