On the request of the competent authority in the reference Member State referred to in paragraph 3 of this Article, the marketing authorisation holder shall provide the coordination group with a summary that specifies the differences between the summaries of product characteristics, its proposal for a harmonised summary of product characteristics, package leaflet and labelling in accordance with Article 7, supported by the appropriate existing data submitted in accordance with Article 8 and which are relevant to the proposal for harmonisation concerned.
Arna iarraidh sin don údarás inniúil sa Bhallstát tagartha dá dtagraítear i mír 3 den Airteagal seo, déanfaidh sealbhóir an údaraithe margaíochta achoimre a chur ar fáil don ghrúpa comhordúcháin ina sonraítear na difríochtaí idir na hachoimrí ar shaintréithe an táirge, a mholadh le haghaidh achoimre chomhchuibhithe ar shaintréithe an táirge, ar an mbileog phacáiste agus an lipéadú i gcomhréir le hAirteagal 7, agus beidh na sonraí iomchuí atá ann cheana, arna gcur isteach i gcomhréir le hAirteagal 8 agus a bhaineann leis an moladh le haghaidh comhchuibhithe lena mbaineann mar thaca leo.