Where a variation is included in the list established in accordance with Article 60(1), the marketing authorisation holder shall record the change including, as applicable, the summary of product characteristics, labelling or package leaflet in languages referred to in Article 7, in the product database within 30 days following the implementation of that variation.
I gcás ina gcuirtear modhnú ar an liosta a bunaíodh i gcomhréir le hAirteagal 60(1), déanfaidh sealbhóir an údaraithe margaíochta an t-athrú a thaifeadadh agus áireoidh sé, de réir mar is infheidhme, an achoimre ar shaintréithe an táirge, an lipéadú nó an bhileog phacáiste i dteangacha dá dtagraítear in Airteagal 7, sa bhunachar sonraí táirgí laistigh de 30 lá tar éis chur chun feidhme an mhodhnaithe sin.