in the case of performance studies carried out pursuant to points (b) and (c) of Article 58(1) and Article 58(2) or performance studies other than those referred to in point (a) of this paragraph, as soon as the Member State concerned has notified the sponsor of its authorisation and 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 phointe (b) agus phointe (c) d'Airteagal 58(1) agus de bhun Airteagal 58(2) nó staidéir feidhmíochta seachas iad siúd dá dtagraítear i bpointe (a) den mhír seo, a luaithe a bheidh fógra tugtha ag an mBallstát lena mbaineann don urraitheoir faoina údarú 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.