Such implementing acts may also set out the procedures and timescales for coordinated assessment in the case of substantial modifications pursuant to paragraph 12 of this Article and in the case of reporting of adverse events pursuant to Article 76(4) and in the case of performance studies involving companion diagnostics, where the medicinal products are under a concurrent coordinated assessment of a clinical trial under Regulation (EU) No 536/2014.
Féadfaidh na gníomhartha cur chun feidhme sin na nósanna imeachta agus na scálaí ama maidir le measúnú comhordaithe i gcás modhnuithe substaintiúla de bhun mír 12 den Airteagal seo a leagan amach, freisin, agus i gcás tarluithe díobhálacha a thuairisciú de bhun Airteagal 76(4) agus i gcás staidéir feidhmíochta lena mbaineann feistí diagnóiseacha coimhdeachta, i gcás ina mbíonn na táirgí míochaine faoi mheasúnú comhordaithe, comhreathach ar thriail chliniciúil faoi Rialachán (AE) Uimh. 536/2014.