Those procedures shall include arrangements for unannounced on-site audits of manufacturers and, where applicable, subcontractors and suppliers carrying out product tests and the monitoring of compliance with any conditions binding manufacturers and associated with certification decisions, such as updates to clinical data at defined intervals,
Áireofar ar na nósanna imeachta sin socruithe maidir le hiniúchtaí ar an láthair, gan réamhfhógra, ar mhonaróirí, agus, i gcás inarb infheidhme, ar fhochonraitheoirí agus ar sholáthraithe, tástálacha ar tháirgí a dhéanamh agus faireachán ar chomhlíonadh aon choinníollacha lena gceanglaítear monaróirí agus a bhaineann le cinntí deimhniúcháin, amhail nuashonruithe ar shonraí cliniciúla ag eatraimh shainithe,