conduct surveillance audits of the manufacturer on at least an annual basis which shall be planned and conducted in line with the relevant requirements in Section 4.5.,
iniúchtaí faireachais a dhéanamh ar an monaróir ar bhonn bliantúil ar a laghad a bheartófar agus a chuirfear i gcrích i gcomhréir leis na ceanglais ábhartha i Roinn 4.5.,