in the case of performance studies carried out pursuant to point (a) of Article 58(1) and where the specimen collection does not represent a major clinical risk to the subject of the study, unless otherwise stated by national law, immediately after the validation date of application described in paragraph 5 of this Article, provided that a negative opinion which is valid for the entire Member State, under national law, has not been issued by an ethics committee in the Member State concerned in respect of the performance study;
i gcás staidéir feidhmíochta a dhéantar de bhun pointe (a) d'Airteagal 58(1) agus i gcás nach ionann an t-eiseamal a bhailiú agus riosca cliniciúil tromchúiseach don ábhar don staidéar, mura sonraítear a mhalairt leis an dlí náisiúnta díreach tar éis dháta bailíochtaithe an iarratais a ndéantar cur síos air i mír 5 den Airteagal seo, agus ar choinníoll nár eisigh coiste eitice sa Bhallstát lena mbaineann tuairim dhiúltach i ndáil leis an staidéar feidhmíochta, ar tuairim í atá bailí don Bhallstát sin ina iomláine, faoin dlí náisiúnta;