#641304
Coinneoidh an t-urraitheoir taifid mhionsonraithe de gach teagmhas díobhálach a thuairisceoidh an t-imscrúdaitheoir dó.
The sponsor shall keep detailed records of all adverse events reported to it by the investigator.
Scag na torthaí
Bailiúcháin
90 toradh in 24 doiciméad
#642085
Teagmhas díobhálach tromchúiseach;
Serious adverse event;
#642086
Teagmhas díobhálach neamh-thromchúiseach;
Non-serious adverse event.
#729608
☐ an áit ar tharla an teagmhas díobhálach
☐ place where the harmful event occurred
#2116412
an chéad taifead d’aon teagmhas díobhálach amhrasta;
initial recording of any suspected adverse event;
#2116418
taifead a dhéanamh d’aon teagmhas díobhálach i mbunachar sonraí faireachais cógas an Aontais;
recording of any adverse event in the Union pharmacovigilance database;
#2116479
Taifeadadh teagmhas díobhálach
Recording of adverse events
#2116491
Taifeadadh teagmhas díobhálach i mbunachar sonraí faireachais cógas an Aontais
Adverse event recording in the Union pharmacovigilance database
#2579946
teagmhas díobhálach aeráide atá inchurtha le tubaistí nádúrtha agus teagmhais dhíobhálacha aeráide eile;
an adverse climatic event which can be assimilated to a natural disaster and other adverse climatic events;
#1734524
Déanfaidh údaráis inniúla taifead sa bhunachar sonraí faireachais cógas ar gach teagmhas díobhálach amhrasta a thuairiscíodh dóibh agus a tharla i gcríoch a mBallstáit, laistigh de 30 lá ón lá a fuarthas an tuairisc maidir leis an teagmhas díobhálach amhrasta.
Competent authorities shall record in the pharmacovigilance database all suspected adverse events which were reported to them and that occurred in the territory of their Member State, within 30 days of receipt of the suspected adverse event report.
#1734525
Déanfaidh sealbhóirí údaruithe margaíochta taifead sa bhunachar sonraí faireachais cógas ar gach teagmhas díobhálach amhrasta a tuairiscíodh dóibh agus a tharla san Aontas nó i dtríú tír nó a foilsíodh sa litríocht eolaíoch maidir lena dtáirgí íocshláinte tréidliachta údaraithe, gan mhoill agus tráth nach déanaí ná 30 lá ón lá a fuarthas an tuairisc maidir leis an teagmhas díobhálach amhrasta.
Marketing authorisation holders shall record in the pharmacovigilance database all suspected adverse events which were reported to them and that occurred within the Union or in a third country or that have been published in the scientific literature with regard to their authorised veterinary medicinal products, without delay and no later than within 30 days of receipt of the suspected adverse event report.
#1880860
I gcás a bhaineann le tort, de bharr na hoibleagáide sin, ba ghá, leis an oibleagáid sin, cúirt nó údarás riaracháin na háite inar tharla an teagmhas díobhálach a rinne difear do na tomhaltóirí nó ina bhféadfadh an teagmhas díobhálach sin tarlú, a chur ar an eolas faoin méid sin.
In a case related to tort, this obligation would involve informing the court or administrative authority of the place where the harmful event affecting the consumers occurred or may occur.
#2116380
ciallaíonn “comhartha” faisnéis a thagann ó fhoinse amháin nó ó roinnt foinsí, lena n-áirítear barúlacha nó turgnaimh, ar faisnéis í a thugann baint chúisíoch nua le fios nó gné nua de bhaint chúisíoch aitheanta idir idirghabháil agus teagmhas díobhálach nó sraith teagmhas díobhálach gaolmhar, rud a mheastar go dtabharfaidh sé údar le tuilleadh imscrúdaithe ar chúisíocht a d’fhéadfadh a bheith ann.
‘signal’ means information that arises from one or multiple sources, including observations and experiments, which suggests a potentially new causal association, or a new aspect of a known causal association between an intervention and an adverse event or a set of related adverse events, that is judged likely to justify further investigation of possible causality.
#2116544
An tionchar a d’fhéadfadh a bheith ag gach teagmhas díobhálach ar an gcothromaíocht sochair-riosca atá ag a dtáirgí, déanfaidh sealbhóirí an údaraithe margaíochta é sin a mheas mura rud é nach bhfuil aon nasc cúisíoch ann idir a dtáirgí agus an teagmhas díobhálach.
Marketing authorisation holders shall consider the potential impact of each adverse event on the benefit-risk balance of their products, unless there is no causal link between their products and the adverse event.
#2579851
Scéimeanna cabhrach a bhaineann le teagmhas díobhálach atá inchurtha le tubaistí nádúrtha, bunófar iad laistigh de 3 bliana agus íocfar an chabhair 4 bliana ón dáta a tharlaíonn an teagmhas díobhálach aeráide atá inchurtha le tubaistí nádúrtha.
Aid schemes related to an adverse climatic event which can be assimilated to a natural disaster shall be established within three years and the aid paid out four years from the date of the occurrence of the adverse climatic event which can be assimilated to a natural disaster.
#2579859
an toradh atá ar mheánchainníocht bhliantúil na dtáirgí talmhaíochta a táirgeadh sa tréimhse 3 bliana roimh an teagmhas díobhálach aeráide atá inchurtha le tubaistí nádúrtha, nó ar mheán 3 bliana bunaithe ar an tréimhse 5 bliana roimh an teagmhas díobhálach aeráide atá inchurtha le tubaistí nádúrtha, an toradh atá ar an méid sin, cé is moite den iontráil is airde agus is ísle, a iolrú faoin meánphraghas díola a fuarthas.
the result of multiplying the average annual quantity of agricultural products produced in the three-year period preceding the adverse climatic event which can be assimilated to a natural disaster, or a three-year average based on the five-year period preceding the adverse climatic event which can be assimilated to a natural disaster, excluding the highest and lowest entry by the average selling price obtained.
#2579860
I gcás inar bunaíodh FBM níos lú ná 3 bliana ón dáta a tharla an teagmhas díobhálach aeráide atá inchurtha le tubaistí nádúrtha, déanfar an tagairt don tréimhse 3 bliana i mír 8, pointe (b) a thuiscint mar thagairt don chainníocht a tháirg agus a dhíol meánghnóthas den mhéid céanna den iarratasóir, eadhon micrifhiontar nó fiontar beag nó fiontar meánmhéide, faoi seach, san earnáil náisiúnta nó réigiúnach a ndearnadh an teagmhas díobhálach aeráide atá inchurtha le tubaistí nádúrtha difear di.
Where an SME was set up less than three years from the date of the occurrence of the adverse climatic event which can be assimilated to a natural disaster, the reference to the three-year period in paragraph 8, point (b) shall be understood as referring to the quantity produced and sold by an average undertaking of the same size as the applicant, namely a micro enterprise or a small enterprise or a medium enterprise, respectively, in the national or regional sector affected by the adverse climatic event which can be assimilated to a natural disaster.
#2580257
aitheantas foirmiúil ag údaráis inniúla an Bhallstáit lena mbaineann gur tharla an dóiteán, an tubaiste nádúrtha, an teagmhas díobhálach aeráide atá inchurtha le tubaistí nádúrtha, teagmhas díobhálach aeráide eile, lotnaidí plandaí, teagmhas turraingeach nó teagmhas a bhaineann leis an athrú aeráide, agus beidh an chabhair faoi réir cruthúnas a bheith curtha isteach ag na tairbhithe ar uirlisí bainistíochta riosca ábhartha iomchuí chun dul i ngleic le tarlú féideartha an teagmhais is cúis leis an damáiste amach anseo, i gcás inarb iomchuí;
the formal recognition by the competent authorities of the Member State concerned that the fire, natural disaster, adverse climatic event which can be assimilated to a natural disaster, other adverse climatic event, plant pest, catastrophic event or climate change related event has occurred and to the submission by the beneficiaries of proof of appropriate risk management tools to address the potential occurrence of the damaging event in the future where appropriate;
#2580943
Ba cheart na coinníollacha sin a bheith bainteach le haitheantas foirmiúil ag údaráis inniúla na mBallstát, go háirithe, do nádúr an imeachta mar thubaiste nádúrtha nó teagmhas díobhálach aeráide atá inchurtha le tubaiste nádúrtha agus do nasc cúisíoch díreach idir an tubaiste nádúrtha nó an teagmhas díobhálach aeráide agus na damáistí don ghnóthas is tairbhí, gnóthas is féidir a bheith ina ghnóthas atá i gcruachás, agus ba cheart a áirithiú leis na coinníollacha sin go ndéanfar róchúiteamh a sheachaint.
Those conditions should relate, in particular, to the formal recognition by the competent Member States’ authorities of the character of the event as a natural disaster or adverse climatic event that can be assimilated to a natural disaster and to a direct causal link between the natural disaster or adverse climatic event and the damages suffered by the beneficiary undertaking, which may include undertakings in difficulty, and should ensure that overcompensation is avoided.
#2581782
Ní sháróidh sé an costas deisiúcháin ná an laghdú ar an margadhluach cothrom arbh é an teagmhas díobhálach aeráide atá inchurtha le tubaiste nádúrtha ba chúis leis, is é sin an difríocht idir luach na sócmhainne go díreach roimh an teagmhas díobhálach aeráide atá inchurtha le tubaiste nádúrtha agus go díreach ina dhiaidh.
It shall not exceed the repair cost or the decrease in fair market value caused by the adverse climatic event which can be assimilated to a natural disaster, namely the difference between the asset’s value immediately before and immediately after the adverse climatic event which can be assimilated to a natural disaster.
#332682
in ábhair a bhaineann le tort, míghníomh nó samhail mhíghnímh, sna cúirteanna don áit inar tharla an teagmhas díobhálach, nó ina bhféadfaidh sé tarlú;
in matters relating to tort, delict or quasi-delict, in the courts for the place where the harmful event occurred or may occur;
#332708
Féadfar fairis sin an t-árachóir a agairt sna cúirteanna don áit inar tharla an teagmhas díobhálach más é a bhíonn i gceist árachas i leith dliteanais nó árachas ar mhaoin dhochorraithe.
In respect of liability insurance or insurance of immovable property, the insurer may in addition be sued in the courts for the place where the harmful event occurred.
#533266
in ábhair a bhaineann le tort, míghníomh nó samhail mhíghnímh, sna cúirteanna don áit inar tharla an teagmhas díobhálach, nó ina bhféadfaidh sé tarlú;
in matters relating to tort, delict or quasi-delict, in the courts for the place where the harmful event occurred or may occur;
#533294
I ndáil le hárachas dliteanais nó árachas ar mhaoin dhochorraithe, féadfar fairis sin an dlí a agairt ar an árachóir sna cúirteanna don áit inar tharla an teagmhas díobhálach.
In respect of liability insurance or insurance of immovable property, the insurer may in addition be sued in the courts for the place where the harmful event occurred.
#640833
Ciallaíonn “teagmhas díobhálach” aon tarlú íocshláinte atá díobhálach i gcás duine is ábhar ar tugadh táirge íocshláinte dó agus nach gá go mbeadh gaolmhaireacht chúise aige leis an gcóireáil sin;
‘Adverse event’ means any untoward medical occurrence in a subject to whom a medicinal product is administered and which does not necessarily have a causal relationship with this treatment;
#640835
Ciallaíonn “teagmhas díobhálach tromchúiseach neamhthuartha” frithghníomh díobhálach tromchúiseach nach bhfuil an cineál, an déine ná an toradh ag luí leis an bhfaisnéis thagartha faoi shábháilteacht;
‘Unexpected serious adverse reaction’ means a serious adverse reaction, the nature, severity or outcome of which is not consistent with the reference safety information;
#650718
ciallaíonn "teagmhas díobhálach aeráide" an aimsir, amhail sioc, stoirmeacha agus clocha sneachta, oighear, báisteach throm nó triomach dian a d'fheadfadh a bheith ina cuid de thubaiste nádúrtha;
"adverse climatic event" means weather conditions, such as frost, storms and hail, ice, heavy rain or severe drought, which can be assimilated to a natural disaster;
#650964
infheistíochtaí le haghaidh athchóiriú talamh talmhaíochta agus acmhainneacht táirgeachta a ndearnadh damáiste dóibh de bharr tubaistí nádúrtha, teagmhas díobhálach aeráide agus teagmhas turraingeach.
investments for the restoration of agricultural land and production potential damaged by natural disasters, adverse climatic events and catastrophic events.
#651260
Cistí frithpháirteacha le haghaidh teagmhas díobhálach aeráide, galar ainmhithe agus plandaí, foirgeachta le lotnaidí agus teagmhas comhshaoil
Mutual funds for adverse climatic events, animal and plant diseases, pest infestations and environmental incidents
#655964
Cabhróidh tacaíocht i gcomhair árachais bhuainte le hioncam táirgeoirí a chosaint nuair a bhíonn caillteanais de dheasca tubaistí nádúrtha, teagmhas díobhálach aeráide, galair nó inmhíolú lotnaidí.
Support for harvest insurance shall contribute to safeguarding producers' incomes where there are losses as a consequence of natural disasters, adverse climatic events, diseases or pest infestations.
#656160
80 % de chostas na bpréimheanna árachais íoctha ag na táirgeoirí i gcomhair árachais in aghaidh caillteanas de bharr teagmhas díobhálach aeráide atá inchurtha le tubaistí nádúrtha;
80 % of the cost of the insurance premiums paid for by producers for insurance against losses resulting from adverse climatic events which can be assimilated to natural disasters;
#1457007
3. in ábhair a bhaineann le tort, míghníomh nó samhail mhíghnímh, sna cúirteanna don áit inar tharla an teagmhas díobhálach;
3. in matters relating to tort, delict or quasi-delict, in the courts for the place where the harmful event occurred;
#1457052
Féadfar fairis sin an t-árachóir a agairt sna cúirteanna don áit inar tharla an teagmhas díobhálach más é a bhíonn i gceist árachas i leith dliteanais nó árachas ar mhaoin dhochorraithe.
In respect of liability insurance or insurance of immovable property, the insurer may in addition be sued in the courts for the place where the harmful event occurred.
#1675477
Cistí frithpháirteacha le haghaidh teagmhas díobhálach aeráide, galar ainmhithe agus plandaí, foirgeachta le lotnaidí agus teagmhas comhshaoil
Mutual funds for adverse climatic events, animal and plant diseases, pest infestations and environmental incidents
#1734028
ceanglas maidir le fógra a thabhairt do na húdaráis inniúla nó don Ghníomhaireacht, de réir mar is infheidhme, i leith aon teagmhas díobhálach a bhaineann le húsáid an táirge íocshláinte tréidliachta;
a requirement to notify to the competent authorities or the Agency, as applicable, of any adverse event relating to the use of the veterinary medicinal product;
#1842979
Cabhróidh tacaíocht i gcomhair árachais bhuainte le hioncam táirgeoirí a chosaint nuair a bhíonn caillteanais de dheasca tubaistí nádúrtha, teagmhas díobhálach aeráide, galair nó inmhíolú lotnaidí.
Support for harvest insurance shall contribute to safeguarding producers' incomes where there are losses as a consequence of natural disasters, adverse climatic events, diseases or pest infestations.
#1843007
80 % de chostas na bpréimheanna árachais íoctha ag na táirgeoirí i gcomhair árachais in aghaidh caillteanas de bharr teagmhas díobhálach aeráide atá inchurtha le tubaistí nádúrtha;
80 % of the cost of the insurance premiums paid for by producers for insurance against losses resulting from adverse climatic events which can be assimilated to natural disasters;
#1863909
in ábhair a bhaineann le tort, míghníomh nó samhail mhíghnímh, sna cúirteanna don áit inar tharla an teagmhas díobhálach, nó ina bhféadfaidh sé tarlú;
in matters relating to tort, delict or quasi-delict, in the courts for the place where the harmful event occurred or may occur;
#1863935
Féadfar fairis sin an t-árachóir a agairt sna cúirteanna don áit inar tharla an teagmhas díobhálach más é a bhíonn i gceist árachas i leith dliteanais nó árachas ar mhaoin dhochorraithe.
In respect of liability insurance or insurance of immovable property, the insurer may in addition be sued in the courts for the place where the harmful event occurred.
#2579338
chun an damáiste a tharlaíonn de bharr teagmhas díobhálach aeráide atá inchurtha le tubaistí nádúrtha a shlánú i gcomhréir le hAirteagal 25;
to make good the damage caused by an adverse climatic event which can be assimilated to a natural disaster in accordance with Article 25;
#2579490
cabhair chun cúiteamh a dhéanamh as caillteanais a tharla de bharr teagmhas díobhálach aeráide atá inchurtha le tubaistí nádúrtha i gcás ina gcomhlíontar na coinníollacha a leagtar síos in Airteagal 25;
aid to compensate for losses caused by adverse climatic event which can be assimilated to a natural disaster where the conditions laid down in Article 25 are fulfilled;
#2579845
Cabhair chun damáiste a tharlaíonn de bharr teagmhas díobhálach aeráide atá inchurtha le tubaistí nádúrtha a shlánú, beidh an chabhair sin faoi réir na gcoinníollacha carnacha a leanas:
Aid to make good damage caused by an adverse climatic event which can be assimilated to a natural disaster, shall be subject to the following cumulative conditions:
#2579846
d’aithin údarás inniúil an Bhallstáit go hoifigiúil go bhfuil tréithe ag roinnt leis an teagmhas gur teagmhas díobhálach aeráide atá inchurtha le tubaistí nádúrtha atá ann;
the competent authority of the Member State has formally recognised the character of the event as an adverse climatic event which can be assimilated to a natural disaster;
#2579847
tá nasc cúisíoch díreach ann idir an teagmhas díobhálach aeráide atá inchurtha le tubaistí nádúrtha agus an damáiste a rinneadh don ghnóthas.
there is a direct causal link between the adverse climatic event which can be assimilated to a natural disaster and the damage suffered by the undertaking.
#2580974
chun an damáiste a tharlaíonn de dheasca teagmhas díobhálach aeráide atá inchurtha le tubaistí nádúrtha a shlánú;
to make good the damage caused by adverse climatic event which can be assimilated to a natural disaster;
#2581774
d’aithin údarás inniúil an Bhallstáit go foirmiúil go bhfuil tréithe ag roinnt leis an teagmhas díobhálach aeráide atá inchurtha le tubaiste nádúrtha; agus
the competent authority of the Member State has formally recognised the character of the adverse climatic event which can be assimilated to a natural disaster; and
#2581775
beidh nasc cúisíoch díreach ann idir an teagmhas díobhálach aeráide atá inchurtha le tubaiste nádúrtha agus an damáiste a rinneadh don ghnóthas.
there is a direct causal link between the adverse climatic event which can be assimilated to a natural disaster and the damage suffered by the undertaking.
#2581778
Bunófar scéimeanna cabhrach laistigh de thrí bliana ón dáta a tharlaíonn an teagmhas díobhálach aeráide atá inchurtha le tubaistí nádúrtha.
Aid schemes shall be established within three years from the date of the occurrence of the adverse climatic event which can be assimilated to a natural disaster.
#2581781
Beidh ríomh an damáiste ábhartha bunaithe ar chostas deisiúcháin na sócmhainne dá ndéantar dochar nó ar luach eacnamaíoch na sócmhainne sin roimh an teagmhas díobhálach aeráide atá inchurtha le tubaiste nádúrtha.
The calculation of the material damage shall be based on the repair cost or economic value of the affected asset before the adverse climatic event which can be assimilated to a natural disaster.
#2870131
rianú teagmhas díobhálach, amhail líon na dteagmhas de dhíluchtú domhain, an t-am a chaitear i dteochtaí foircneacha, an t-am a chaitear ag luchtú i dteochtaí foircneacha;
the tracking of harmful events, such as the number of deep discharge events, time spent in extreme temperatures, time spent charging in extreme temperatures;