The summary of product characteristics and the package leaflet shall clearly mention that the marketing authorisation for the medicinal product has been granted subject to specific obligations as referred to in paragraph 4.
Luafar go soiléir san achoimre ar shaintréithe an táirge agus ar bhileog an phacáiste gur deonaíodh an t-údarú margaíochta don táirge íocshláinte faoi réir na n-oibleagáidí sonracha sin dá dtagraítear i mír 4.