#591684
Córas Rialúcháin Iomaíoch Feithicleach don 21ú hAois", ("CARS 21").
A Competitive Automotive Regulatory System for the 21st century" ("CARS 21").
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#1629475
an córas rialúcháin don iompar
regulatory system for transport
#1638273
cur chun feidhme na bhforálacha maidir le prionsabail an chórais rialúchaín don iompar
the application of provisions concerning the principles of the regulatory system for transport
#1638274
cur chun feidhme na bhforálacha maidir le prionsabail an chórais rialúcháin don iompar
the application of provisions concerning the principles of the regulatory system for transport
#1647390
i gcás ina bhféadfaidh cur chun feidhme na bhforálacha maidir le prionsabail an chórais rialúcháin don iompar
where the application of provisions concerning the principles of the regulatory system for transport
#591728
Mar thoradh ar fheidhmiú an chórais rialúcháin nua atá leagtha síos leis an Rialachán seo, ba cheart na Treoracha seo a leanas a aisghairm:
As a consequence of the application of the new regulatory system set in place by this Regulation, the following Directives should be repealed:
#592764
Córas Rialúcháin Iomaíoch Feithicleach don 21ú hAois", is iomchuí gach Treoir ar leithligh a aisghairm ach gan an leibhéal cosanta a laghdú.
A Competitive Automotive Regulatory System for the 21st century", it is appropriate to repeal all separate Directives without reducing the level of protection.
#641552
an n-áirithíonn an córas rialála is infheidhme maidir le trialacha cliniciúla a dhéantar a stiúradh lasmuigh den Aontas go gcomhlíontar Airteagal 25(5) den Rialachán seo.
whether the regulatory system applicable to clinical trials conducted outside the Union ensures that Article 25(5) of this Regulation is complied with.
#1647389
i gcás ina bhféadfaidh cur chun feidhme na bhforálacha maidir le prionsabail an chórais rialúcháin don iompar éifeacht thromchúiseach a bheith aige
where the application of provisions concerning the principles of the regulatory system for transport would be liable to have a serious effect
#1962094
ciallaíonn ‘onnmhairiú’ an próiseas trína scaoiltear táirge aerloingseoireachta sibhialta ó chóras rialála le haghaidh sábháilteachta eitlíochta sibhialta Páirtí amháin go dtí córas an Pháirtí eile;
"export" means the process by which a civil aeronautical product is released from the regulatory system for civil aviation safety of a Party to that of the other Party;
#1962096
ciallaíonn ‘Páirtí onnmhairiúcháin’ an Páirtí a ndéantar táirge aerloingseoireachta sibhialta a scaoileadh óna chóras rialála le haghaidh sábháilteachta eitlíochta sibhialta;
"exporting Party" means the Party from whose regulatory system for civil aviation safety a civil aeronautical product is released;
#1962097
ciallaíonn ‘allmhairiú’ an próiseas trína ndéantar táirge aerloingseoireachta sibhialta atá onnmhairithe ó chóras rialála Páirtí le haghaidh sábháilteachta eitlíochta sibhialta, a thabhairt isteach i gcóras an Pháirtí eile;
"import" means the process by which an exported civil aeronautical product from the regulatory system for civil aviation safety of a Party is introduced into that of the other Party;
#1962098
ciallaíonn ‘Páirtí allmhairiúcháin’ an Páirtí a ndéantar táirge aerloingseoireachta sibhialta a thabhairt isteach ina chóras rialála le haghaidh sábháilteachta eitlíochta sibhialta;
"importing Party" means the Party into whose regulatory system for civil aviation safety a civil aeronautical product is introduced;
#1962276
creat dlíthiúil agus rialála, lena n-áirithítear go háirithe cumhachtaí rialála ar eintitis arna rialú faoi chóras rialála an Pháirtí maidir le sábháilteacht eitlíochta sibhialta;
a legal and regulatory framework, ensuring in particular regulatory powers over entities regulated under the regulatory system for civil aviation safety of the Party;
#2151723
“Agus aerárthach á allmhairiú isteach i gclár Ballstáit ó thríú tír nó ó chóras rialála nach bhfuil feidhm ag Rialachán (AE) 2018/1139 ann, déanfaidh an t-iarratasóir na nithe seo a leanas:”.
‘When importing an aircraft into a Member State’s register from a third country or from a regulatory system where Regulation (EU) 2018/1139 does not apply, the applicant shall:’.
#2240803
Chun an taraif stórála a shocrú, ghlac CRE córas rialála bunaithe ar chostais a chumhdach má mheastar iad a bheith ina gcostais éifeachtúla arna n-íoc ag oibreoirí.
In order to set the storage tariff, the CRE has adopted a regulatory system based on covering what are deemed to be efficient costs borne by operators.
#2637539
Leis an gcóras rialála nua agus leis an ardán, cuirtear feabhas ar chomhroinnt faisnéise agus ar chomhchinnteoireacht maidir le trialacha cliniciúla.
The new regulatory system and the platform improve information-sharing and collective decision-making on clinical trials.
#2735199
cumas infhíoraithe na n-údarás atá freagrach as formhaoirseacht rialála an aeriompróra córas rialála fónta a fhorfheidhmiú;
verifiable capability of the authorities responsible for regulatory oversight of the air carrier to enforce a sound regulatory system;
#3063913
fóram a sholáthar chun faisnéis a mhalartú faoi chóras rialála gach Páirtí, lena n-áirítear an bonn eolaíoch agus measúnaithe riosca dá chuid bearta SPS;
provide a forum to exchange information on each Party’s regulatory system, including the scientific and risk assessment basis for its SPS measures;
#288612
(16) Chun "cultúr sábháilteachta" agus feidhmiú ceart córais rialúcháin sna réimsí a chumhdaítear faoin Rialachán seo a chur chun cinn, daoine ar finnéithe iad ar theagmhais agus ar tharluithe, caithfidh siad na teagmhais agus na tarluithe sin a thuairisciú go spontáineach.
(16) The promotion of a "culture of safety" and the proper functioning of a regulatory system in the fields covered by this Regulation require that incidents and occurrences be spontaneously reported by the witnesses thereto.
#640153
Ba cheart, dá bhrí sin, córas rialála a bheadh fabhrach d'fhorbairt dhigiteach a chur chun cinn mar ghníomhaí a spreagfadh fás agus comhtháthú na hEorpa agus a dhéanfadh cothromú ar na héilimh maidir le hinfheistíocht, poist, iomaíochas gnó, nuálaíocht, meas ar shonraí pearsanta, cosaint tomhaltóirí, pleanáil spásúlachta, agus forbairt úsáid agus slándáil líonraí.
A regulatory system that is favourable to digital development should therefore be promoted as a driver for growth and European integration balancing the demands of investment, jobs, business competitiveness, innovation, respect for personal data, consumer protection, spatial planning, and development of use and security of networks.
#641551
an n-áirithíonn an córas rialála is infheidhme maidir le trialacha cliniciúla a dhéantar a stiúradh lasmuigh den Aontas go gcomhlíontar pointe 8 den Réamhrá agus prionsabail ghinearálta atá in Iarscríbhinn I a ghabhann le Treoir 2001/83/CE;
whether the regulatory system applicable to clinical trials conducted outside the Union ensures that point 8 of the Introduction and general principles contained in Annex I to Directive 2001/83/EC is complied with;
#741565
Tá géarghá le trédhearcacht agus le rochtain níos fearr ar fhaisnéis ar mhaithe leis an bpobal, curtha i láthair go cuí don úsáideoir ar dó a beartaíodh an fheiste, leis an tsláinte phoiblí a chosaint, chun cumhacht a thabhairt d'othair agus do ghairmithe cúraim sláinte agus chun a chur ar a gcumas cinntí eolacha a dhéanamh, chun bonn maith a chur faoin gcinnteoireacht rialála agus chun muinín sa chóras rialála a mhéadú.
Transparency and adequate access to information, appropriately presented for the intended user, are essential in the public interest, to protect public health, to empower patients and healthcare professionals and to enable them to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in the regulatory system.
#741653
Ba cheart don Choimisiún tacaíocht eolaíoch agus theicniúil agus an tacaíocht loighisticiúil a ghabhann leis sin a sholáthar d'údaráis náisiúnta chomhordúcháin agus a áirithiú go gcuirfear chun feidhme an córas rialála maidir le feistí go héifeachtach agus go haonfhoirmeach ar leibhéal an Aontais ar bhonn fianaise eolaíche iontaofa.
The Commission should provide scientific, technical and corresponding logistical support to coordinating national authorities and ensure that the regulatory system for devices is effectively and uniformly implemented at Union level based on sound scientific evidence.
#745416
Tá géarghá le trédhearcacht agus le rochtain níos fearr ar fhaisnéis, ar faisnéis í atá curtha i láthair go cuí don úsáideoir ar dó nó di a beartaíodh an fheiste, ar mhaithe leis an leas poiblí, chun an tsláinte phoiblí a chosaint, chun cumhacht a thabhairt d'othair agus do ghairmithe cúraim sláinte agus chun a chur ar a gcumas cinntí eolacha a dhéanamh, chun bonn maith a chur faoin gcinnteoireacht rialála agus chun muinín sa chóras rialála a mhéadú.
Transparency and adequate access to information, appropriately presented for the intended user, are essential in the public interest, to protect public health, to empower patients and healthcare professionals and to enable them to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in the regulatory system.
#745505
Ba cheart don Choimisiún tacaíocht eolaíoch agus theicniúil agus an tacaíocht lóistíochta a ghabhann leis sin a sholáthar d'údaráis náisiúnta comhordaithe chun a áirithiú go gcuirfear chun feidhme an córas rialála maidir le feistí go héifeachtach agus go haonfhoirmeach ar leibhéal an Aontais ar bhonn fianaise eolaíche iontaofa.
The Commission should provide scientific, technical and corresponding logistical support to coordinating national authorities and ensure that the regulatory system for devices is effectively and uniformly implemented at Union level based on sound scientific evidence.
#1741701
Is é is aidhm don athbhreithniú seo na laigí agus na heaspaí sin a shárú agus muinín na saoránach i gcumas an chórais rialála a athbhunú chun a áirithiú go ndéanfar cosaint leordhóthanach ar an tsláinte agus ar an gcomhshaol.
This revision aims to overcome these flaws and gaps and to restore the citizen's trust in the capability of the regulatory system to ensure an adequate level of protection of health and the environment.
#1958282
Beidh gach Páirtí in ann a sheasamh i leith dea-chleachtas rialála a chinneadh faoin gComhaontú ar bhealach a bheidh ag luí lena chreat dlíthiúil, cleachtas agus nósanna imeachta agus prionsabail bhunúsacha, is bunús lena chóras rialála féin.
Each Party shall be free to determine its approach to good regulatory practices under this Agreement in a manner consistent with its own legal framework, practice, procedures and fundamental principles underlying its regulatory system.
#1962101
ciallaíonn ‘sonraí maidir le hoiriúnacht oibríochtúil’ an tacar sonraí is gá chun tacú leis na gnéithe oibríochtúla a bhaineann go sonrach le cineálacha áirithe aerárthaí agus chun na gnéithe oibríochtúla sin a cheadú, ar gnéithe iad a rialáiltear faoin gcóras rialála maidir le sábháilteacht eitlíochta sibhialta an Aontais nó an Aontais Eorpaigh.
"operational suitability data" means the required set of data to support and allow the type specific operational aspects of certain types of aircraft that are regulated under the regulatory system for civil aviation safety of the Union or of the United Kingdom.
#1962103
Faoin gcóras rialála maidir le sábháilteacht eitlíochta sibhialta de chuid an Aontais nó na Ríochta Aontaithe, áireofar an t-iarratas ar cheadú ar shonraí na hoiriúnachta oibríochtúla, de réir mar is infheidhme maidir leis an gcineál aerárthaigh, san iarratas tosaigh ar dheimhniú cineáil nó ar dheimhniú srianta ar chineál, nó déanfar an t-iarratas ar cheadú ar shonraí na hoiriúnachta oibríochtúla a fhorlíonadh ina dhiaidh sin.
Under the regulatory system for civil aviation safety of the Union or of the United Kingdom, an initial application for a type certificate or restricted type certificate shall include, or be subsequently supplemented by, the application for approval of operational suitability data, as applicable to the aircraft type;
#1962146
Chun an Iarscríbhinn seo a chur chun feidhme, áiritheoidh gach Páirtí, ina chóras rialála maidir le sábháilteacht eitlíochta sibhialta, go mbeidh rialú leordhóthanach ar chumas aon eagraíochta deartha a cuid freagrachtaí a ghlacadh uirthi féin trí chóras deimhniúcháin d’eagraíochtaí deartha.
For the implementation of this Annex, each Party shall ensure that, in its regulatory system for civil aviation safety, the capability of any design organisation to assume its responsibilities is sufficiently controlled through a system of certification for design organisations.
#1962222
Arna iarraidh sin air, cabhróidh údarás inniúil Páirtí, i ndáil le táirgí aerloingseoireachta sibhialta a dheartar nó a mhonaraítear faoina chóras rialála, le húdarás inniúil an Pháirtí eile cinneadh a dhéanamh faoi aon ghníomh a mheastar a bheith riachtanach d’aeracmhainneacht leanúnach na dtáirgí aerloingseoireachta sibhialta.
Upon request, a competent authority of a Party shall, in respect of civil aeronautical products designed or manufactured under its regulatory system, assist the competent authority of the other Party in determining any action considered to be necessary for the continued airworthiness of the civil aeronautical products.
#1962283
D’fhonn muinín fhrithpháirteach a choinneáil ar bun i gcórais rialála a chéile maidir le cur chun feidhme na hIarscríbhinne seo ionas go n-áiritheofar leibhéal sábháilteachta atá coibhéiseach go leor, déanfaidh gníomhaire teicniúil gach Páirtí measúnú rialta ar chomhlíonadh údaráis inniúla an Pháirtí eile leis na ceanglais cháilíochta dá dtagraítear in Airteagal 28.
In order to maintain mutual confidence in each Party's regulatory system concerning the implementation of this Annex so that they ensure a sufficiently equivalent level of safety, the technical agent of each Party shall regularly assess the other Party's competent authorities' compliance with the qualification requirements referred to in Article 28.
#2151030
Rinneadh pointe M.A.904 d’Iarscríbhinn I a ghabhann le Rialachán (AE) Uimh. 1321/2014 a leasú le Rialachán Cur Chun Feidhme (AE) 2019/1383 chun na forálacha allmhairiúcháin a leathnú go haerárthaí a thagann as córas rialúcháin nach bhfuil feidhm ag Rialachán (AE) 2018/1139 ann.
Point M.A.904 of Annex I (Part-M) to Regulation (EU) No 1321/2014 was amended by Implementing Regulation (EU) 2019/1383 to extend the import provisions to aircraft that come from a regulatory system where Regulation (EU) 2018/1139 does not apply.
#2161501
Ba é conclúid na foirne go bhfuil sé de chumas ag CAAM formhaoirseacht a dhéanamh ar na gníomhaíochtaí eitlíochta sa Mholdáiv, córas rialála fónta a choinneáil ar bun, agus na rialacháin eitlíochta atá ann cheana a chur chun feidhme agus a fhorfheidhmiú chun aghaidh a thabhairt ar easnaimh sábháilteachta a thagann chun cinn.
The team concluded that CAAM has the capabilities to oversee the aviation activities in Moldova, maintain a sound regulatory system, implement and enforce the existing aviation regulations in order to address arising safety deficiencies.
#2202044
Ar an taobh eile, cuirtear i bhfeidhm leis córas comhréireach rialála atá dírithe ar chur chuige dea-shainithe rialála rioscabhunaithe nach gcruthaíonn srianta neamhriachtanacha maidir le trádáil, sa chaoi go ndéantar idirghabháil dhlíthiúil a shaincheapadh le haghaidh na gcásanna coincréiteacha sin lena bhfuil cúis imní chuí nó lena bhféadfaí a bheith ag súil le réasún leis an gcúis imní go luath amach anseo.
On the other hand, it puts in place a proportionate regulatory system centred on a well-defined risk-based regulatory approach that does not create unnecessary restrictions to trade, whereby legal intervention is tailored to those concrete situations where there is a justified cause for concern or where such concern can reasonably be anticipated in the near future.
#2291844
Ba cheart leis an Rialachán seo foráil a dhéanamh maidir le ról a thabhairt don Ghníomhaireacht i ndáil le tacaíocht a thabhairt do na painéil saineolaithe maidir le feistí leighis arna n-ainmniú i gcomhréir le hAirteagal 106(1) de Rialachán (AE) 2017/745 (“na painéil saineolaithe”) chun cúnamh neamhspleách eolaíochta agus teicniúil a sholáthar do na Ballstáit, don Choimisiún, do MDCG, do chomhlachtaí faoina dtugtar fógra agus do mhonaróirí, agus an trédhearcacht is mó is féidir a urramú mar choinníoll chun iontaoibh agus muinín i gcóras rialála an Aontais a chothú.
This Regulation should provide the Agency with a role in supporting the expert panels on medical devices designated in accordance with Article 106(1) of Regulation (EU) 2017/745 (the ‘expert panels’) in providing independent scientific and technical assistance to the Member States, the Commission, the MDCG, notified bodies and manufacturers, while upholding maximum transparency as a condition for fostering trust and confidence in the Union regulatory system.
#2291848
Leis na struchtúir sin, ní athrófaí an córas rialála ná na nósanna imeachta cinnteoireachta i réimse na bhfeistí leighis atá ann cheana san Aontas ar bhealach ar bith, nósanna imeachta ba cheart fanacht ar leithligh go soiléir ó na táirgí íocshláinte sin.
Those structures would in no way change the regulatory system or decision-making procedures in the area of medical devices that are already in place in the Union, which should remain clearly distinct from those for medicinal products.
#2646581
In ainneoin na rialacha atá sainithe gomaith, tá scór íseal ag an gcóras rialála mar gheall ar easpa comhordaithe lárnaigh ar na measúnuithe tionchair agus ar na meastóireachtaí beartais, is beag an mhaoirseacht a dhéantar ar úsáid chórasach nan‑uirlisí rialála agus níl ach trédhearcacht theoranta sna comhairliúcháin phoiblí.
Despite the well-defined rules, the regulatory system scores low due to the lack of centralcoordination of the impact assessments and policy evaluations, relatively low oversight of the systemic use of the regulatory tools and limited transparency of the public consultations.
#2678617
Rinne an Coimisiún measúnú ar an iarraidh trí athbhreithniú a dhéanamh ar an doiciméadú ábhartha agus trí athbhreithniú ar an láthair a dhéanamh ar chóras rialála Cheanada agus ar chigireacht bhreathnaithe agus trí aird chuí a thabhairt ar an bplean gníomhaíochta a mhol údarás inniúil Cheanada, Health Canada/Santé Canada, an 23 Meán Fómhair 2022.
The Commission has assessed the request by carrying on a review of the relevant documentation and an on-site review of Canada’s regulatory system and an observed inspection and taking due account of the action plan proposed on 23 September 2022, by the Canadian competent authority, Health Canada/Santé Canada.
#2812256
Mar ionstraim chun sceitheadh carbóin a chosc agus astaíochtaí gás ceaptha teasa a laghdú, ba cheart a áirithiú le SCCT go mbeidh táirgí allmhairithe faoi réir córas rialála lena gcuirtear i bhfeidhm costais charbóin atá coibhéiseach leo sin a ghearrtar faoi CTA AE, rud a d’fhágfadh go mbeadh praghas carbóin coibhéiseach ann le haghaidh táirgí allmhairithe agus táirgí intíre.
As an instrument to prevent carbon leakage and reduce greenhouse gas emissions, the CBAM should ensure that imported products are subject to a regulatory system that applies carbon costs equivalent to those borne under the EU ETS, resulting in a carbon price that is equivalent for imports and domestic products.
#2812302
Ba cheart na hearraí nó na táirgí próiseáilte a chumhdaítear le SCCT na gníomhaíochtaí a chumhdaítear le CTA AE a léiriú ós rud é go bhfuil an córas sin bunaithe ar chritéir chainníochtúla agus cháilíochtúla atá nasctha le cuspóir comhshaoil Threoir 2003/87/CE agus gurb é an córas rialála astaíochtaí gás ceaptha teasa is cuimsithí san Aontas é.
The goods or processed products covered by the CBAM should reflect the activities covered by the EU ETS as that system is based on quantitative and qualitative criteria linked to the environmental objective of Directive 2003/87/EC and is the most comprehensive greenhouse gas emissions regulatory system in the Union.
#2922374
Rinne an Coimisiún measúnú ar an iarraidh trí athbhreithniú a dhéanamh ar an doiciméadacht ábhartha agus trí athbhreithniú ar an láthair a dhéanamh ar chóras rialála na Téaváine ón 20 go dtí an 27 Aibreán 2023 lena n-áirítear cigireacht bhreathnaithe agus aird chuí á tabhairt ar na freagairtí, ar an bhfaisnéis agus ar an doiciméadacht a thug údarás inniúil na Téaváine, Riarachán Bia agus Drugaí na Téaváine (TFDA) laistigh den Aireacht Sláinte agus Leasa le linn an iniúchta.
The Commission has assessed the request by carrying on a review of the relevant documentation and an on-site review of Taiwan’s regulatory system from 20 to 27 April 2023 including an observed inspection and taking due account of the responses, information and documentation provided during the audit by the Taiwanese competent authority, Taiwan Food and Drug Administration (TFDA) within the Ministry of Health and Welfare.
#3161657
Faoin am a bheidh an Fhéile curtha i gcrích, ba cheart go mbeadh an tAcht Eorpach um Shaoirse na Meán i bhfeidhm. Dá bhrí sin, is í an Fhéile an chéad uair a bheidh ann chun plé a dhéanamh ar éifeachtaí an phíosa reachtaíochta shonraigh sin, mar aon le hionadaíocht leathan ar ghníomhaithe éagsúla a bhfuil tionchar ag an gcóras rialála orthu.
By the time the Festival will have taken place, the European Media Freedom Act should enter into force, therefore the Festival would be the first occasion to discuss the effects of this specific piece of legislation, together with a broad representation of different actors affected by the regulatory system in place.