#2277556
faisnéis a sholáthar maidir leis an uair a bheidh tuarascáil sábháilteachta bhliantúil thar téarma;
provide information on when an annual safety report is overdue;
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Bailiúcháin
7 dtoradh in 2 dhoiciméad
#2277513
an tuarascáil mheasúnaithe dheireanach a chur isteach sna córais faisnéise dá dtagraítear in Airteagal 11 laistigh de 42 lá tar éis an tuarascáil sábháilteachta bhliantúil is déanaí a chur isteach nó laistigh de 84 lá ar a mhéad ón dáta a chuirfear isteach an tuarascáil sábháilteachta bhliantúil is déanaí má iarrtar faisnéis bhreise de bhun phointe (b);
submit the final assessment report in the information systems referred to in Article 11 within 42 days after the submission of the latest annual safety report or within a maximum of 84 days from the submission of the latest annual safety report if additional information is requested pursuant to point (b);
#2277517
De mhaolú ar mhír 1, i gcás ina gcuireann an t-urraitheoir isteach tuarascáil sábháilteachta bhliantúil aonair a bhaineann go sonrach le triail chliniciúil aonair lena mbaineann roinnt táirgí íocshláinte imscrúdaitheacha de bhun Airteagal 43(2) de Rialachán (CE) Uimh. 536/2014, déanfaidh Ballstát tuairiscithe na trialach cliniciúla áirithe sin measúnú ar an tuarascáil sábháilteachta bhliantúil sin.
By way of derogation from paragraph 1, when the sponsor submits a single annual safety report specific to a single clinical trial involving several investigational medicinal products pursuant to Article 43(2) of Regulation (EU) No 536/2014, this annual safety report shall be assessed by the reporting Member State of this particular clinical trial.
#642054
Má tharlaíonn athruithe suntasacha ar an FTS le linn na tréimhse tuairiscithe, liostófar iad sa tuarascáil sábháilteachta bhliantúil.
If there are significant changes to the RSI during the reporting period they shall be listed in the annual safety report.
#2277474
Más féidir, seolfar an nós imeachta sin tar éis don Bhallstát measúnaithe sábháilteachta an tuarascáil mheasúnaithe deiridh ar an tuarascáil sábháilteachta bhliantúil a chur isteach.
That procedure shall, if possible, be launched after the submission by the safety assessing Member State of the final assessment report of the annual safety report.
#2277491
An tuarascáil mheasúnaithe dheireanach ar an tuarascáil sábháilteachta bhliantúil dheireanach maidir leis an tsubstainte gníomhach, cuirfidh sé í sin isteach gan moill mhíchuí..
It shall submit the final assessment report of the last annual safety report for the active substance without undue delay.
#2277478
Sna cásanna dá dtagraítear i míreanna 1 agus 2, leanfaidh an Ballstát measúnaithe sábháilteachta bunaidh de bheith ag comhlíonadh a chuid cúraimí go dtí go gcuirfear isteach na tuarascálacha agus na taifid mheasúnaithe dheireanacha, lena n-áirítear an tuarascáil mheasúnaithe ar an tuarascáil sábháilteachta bhliantúil dheireanach, agus go dtí go mbeidh taifead déanta ag an mBallstát measúnaithe sábháilteachta nua sna córais faisnéise dá dtagraítear in Airteagal 11 i gcomhréir le mír 3.
In the situations referred to in paragraphs 1 and 2, the original safety assessing Member State shall continue carrying out its tasks until all final safety assessment reports and records, including the assessment report of the last annual safety report, have been submitted and the new safety assessing Member State has been recorded in the information systems referred to in Article 11 in accordance with paragraph 3.