Where the medicinal products authority consulted obtains information on the ancillary substance, which could have an impact on the risk or benefit previously established concerning the incorporation of the substance into the device, it shall advise the notified body as to whether this information has an impact on the risk or benefit previously established concerning the incorporation of the substance into the device.
I gcás ina bhfaigheann an t-údarás um tháirgí íocshláinte a ndeachthas i gcomhairle leis faisnéis maidir leis an tsubstaint choimhdeach, a bhféadfadh tionchar a bheith aici ar an riosca nó ar an tairbhe a bunaíodh roimhe seo a bhaineann leis an tsubstaint a ionchorprú san fheiste, cuirfidh sé comhairle ar an gcomhlacht dá dtugtar fógra faoi cibé acu atá tionchar ag an bhfaisnéis sin ar an riosca nó ar an tairbhe a bunaíodh roimhe seo a bhaineann leis an tsubstaint a ionchorprú san fheiste.