an ethics committee in that Member State has issued a negative opinion in relation to the substantial modification to the clinical investigation, which, in accordance with national law, is valid for that entire Member State.
má tá tuairim dhiúltach maidir leis an modhnú substaintiúil ar an imscrúdú cliniciúil eisithe ag coiste eitice sa Bhallstát sin, atá bailí, i gcomhréir leis an dlí náisiúnta, don Bhallstát ina iomláine.