the performance study is the subject of an authorisation by the Member State(s) in which the performance study is to be conducted, in accordance with this Regulation, unless otherwise stated;
tá an staidéar feidhmíochta faoi réir údarú a thug an Ballstát nó na Ballstáit ina mbeidh an staidéar feidhmíochta le déanamh, i gcomhréir leis an Rialachán seo, mura rud é go sonraítear a mhalairt;