Data stemming from clinical trials shall be submitted with the application for a marketing authorisation for the purposes of providing the documentation referred to in point (b) of Article 8(1).
Déanfar sonraí arna n-eascairt as trialacha cliniciúla a chur isteach in éineacht leis an iarratas ar údarú margaíochta chun críocha an doiciméadacht dá dtagraítear i bpointe (b) d’Airteagal (8)(1) a sholáthar.