translation: An application for the approval of an active substance or for an amendment to the conditions of an approval shall be submitted by the producer of the active substance to a Member State, (the rapporteur Member State), together with a summary and a complete dossier as provided for in Article 8(1) and (2) of this Regulation or a scientifically reasoned justification for not providing certain parts of those dossiers, demonstrating that the active substance fulfils the approval criteria provided for in Article 4 of this Regulation.
translation: L-applikazzjoni għall-approvazzjoni ta' sustanza attiva jew għal emenda għall-kundizzjonijiet ta' approvazzjoni għandha titressaq mill-produttur tas-sustanza attiva lill-Istat Membru, (l-Istat Membru relatur), flimkien ma' sommarju u ma' dossier komplet kif previst fl-Artikolu 8(1) u (2) ta' dan ir-Regolament jew flimkien ma' ġustifikazzjoni motivata xjentifikament għalfejn ma ġewx previsti ċerti partijiet minn dawk id-dossiers, fejn jintwera li s-sustanza attiva tissodisfa l-kriterji ta' approvazzjoni previsti fl-Artikolu 4 dan ir-Regolament.