The marketing authorisation holder shall, based on the assessment of the pharmacovigilance data, and where necessary, submit without undue delay an application for a variation to the terms of a marketing authorisation in accordance with Article 62.
I gcás inar gá agus bunaithe ar an measúnú ar na sonraí faireachais cógas, tíolacfaidh sealbhóir an údaraithe margaíochta, gan moill mhíchuí, iarratas ar mhodhnú ar théarmaí údaraithe margaíochta i gcomhréir le hAirteagal 62.