#284953
Luafaidh an dréacht-tuairim na seasaimh éagsúla agus na forais ar a mbeidh siad bunaithe.
The draft opinion shall mention the divergent positions and the grounds on which they are based.
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#2004979
Cuirfear an dréacht-tuairim faoi bhráid an chéad Seisiúin Iomlánaigh eile lena glacadh gan leasú.
The draft opinion shall be submitted to the following Plenary Session for adoption without amendment.
#2005250
Déanfar an vótáil ar na leasuithe in ord na bpointí sa dréacht-tuairim atá faoi chaibidil.
Voting on amendments shall follow the order of the points in the draft opinion under discussion.
#2270871
Cuirfear an dréacht-tuairim arna hullmhú ag an bhfaireachlann faoi bhráid na rannóige lena glacadh.
The draft opinion prepared by the observatory shall be submitted to the section for adoption.
#2271154
Féadfar leasuithe ar an dréacht-tuairim a chur síos le linn chruinnithe na rannóige.
Amendments to the draft opinions may be submitted in the section.
#2449971
Cuirfear an dréacht-tuairim arna hullmhú ag an bhfaireachlann faoi bhráid na rannóige lena glacadh.
The draft opinion prepared by the observatory shall be submitted to the section for adoption.
#2450254
Féadfar leasuithe ar an dréacht-tuairim a chur síos le linn chruinnithe na rannóige.
Amendments to the draft opinions may be submitted in the section.
#2805665
Cuirfear an dréacht-tuairim faoi bhráid an chéad Seisiúin Iomlánaigh eile lena glacadh gan leasú.
The draft opinion shall be submitted to the following Plenary Session for adoption without amendment.
#2805940
Déanfar an vótáil ar na leasuithe in ord na bpointí sa dréacht-tuairim atá faoi chaibidil.
Voting on amendments shall follow the order of the points in the draft opinion under discussion.
#1802886
I gcás go ndéanfar dréacht-tuairim, dréachtmholadh nó dréachtchinneadh a tharraingt siar, féadfaidh an Stiúrthóir dréacht-tuairim nua, dréachtmholadh nua nó dréachtchinneadh nua a éisiúint, ag cloí leis an nós imeachta a leagtar amach i bpointe (a) d'Airteagal 22(5) agus sa dara fomhír den mhír seo.Chun críocha phointe (a) den tríú fomhír den mhír seo, i gcás nach gcloífidh an Stiúrthóir leis na barúlacha agus na leasuithe a fuarthas ón mBord Rialálaithe nó go ndiúltóidh sé nó sí dóibh, déanfaidh an Stiúrthóir míniú a mbeidh údar cuí leo a thabhairt i scríbhinn.
In the case of a withdrawal of a draft opinion, recommendation or decision, the Director may issue a new draft opinion, recommendation or decision following the procedure set out in point (a) of Article 22(5) and in the second subparagraph of this paragraph. For the purposes of point (a) of the third subparagraph of this paragraph, where the Director deviates from or rejects the comments and amendments received from the Board of Regulators, the Director shall also provide a duly justified written explanation.
#2004789
Féadfaidh comhalta malartach a cheapfar mar rapóirtéir an dréacht-tuairim a bhfuil sé nó sí freagrach aisti a thíolacadh ag an Seisiún Iomlánach sin a bhfuil an dréacht-tuairim ar a chlár oibre.
An alternate who has been appointed rapporteur may present the draft opinion for which he or she is responsible at the Plenary Session at which the draft opinion is on the agenda.
#2005109
Mura féidir leis an gcoimisiún lena mbaineann, dréacht-tuairim a tharraingt suas faoin sprioc-am is gá, féadfaidh an Biúró a mholadh go gceapfaidh an Tionól Iomlánach rapóirtéir ginearálta, a chuirfidh dréacht-tuairim díreach faoi bhráid an Tionóil Iomlánaigh.
If the commission concerned cannot draw up a draft opinion by the required deadline the Bureau may propose that the Plenary Assembly appoint a rapporteur-general, who shall submit their draft opinion straight to the Plenary Assembly.
#2805475
Féadfaidh comhalta malartach a cheapfar mar rapóirtéir an dréacht-tuairim a bhfuil sé nó sí freagrach aisti a thíolacadh ag an Seisiún Iomlánach sin a bhfuil an dréacht-tuairim ar a chlár oibre.
An alternate who has been appointed rapporteur may present the draft opinion for which he or she is responsible at the Plenary Session at which the draft opinion is on the agenda.
#2805800
Mura féidir leis an gcoimisiún lena mbaineann, dréacht-tuairim a tharraingt suas faoin sprioc-am is gá, féadfaidh an Biúró a mholadh go gceapfaidh an Tionól Iomlánach rapóirtéir ginearálta, a chuirfidh dréacht-tuairim díreach faoi bhráid an Tionóil Iomlánaigh.
If the commission concerned cannot draw up a draft opinion by the required deadline the Bureau may propose that the Plenary Assembly appoint a rapporteur-general, who shall submit their draft opinion straight to the Plenary Assembly.
#2869785
Foilseoidh an Ghníomhaireacht an dréacht-tuairim ón gCoiste um Anailís Shocheacnamaíoch ar a suíomh gréasáin gan mhoill agus iarrfaidh sí ar pháirtithe leasmhara a mbarúlacha a sholáthar maidir leis an dréacht-tuairim tráth nach déanaí ná 60 lá ó fhoilsiú na dréacht-tuairime sin.
The Agency shall publish the draft opinion of the Committee for Socioeconomic Analysis on its website without delay and invite interested parties to provide their comments on the draft opinion no later than 60 days from the publication of that draft opinion.
#1802614
barúlacha agus leasuithe an Bhoird Rialálaithe a chur san áireamh agus an dréacht-tuairim, dréachtmholadh nó dréachtchinneadh athbhreithnithe a thíolacadh chuig an mBord Rialálaithe arís le haghaidh tuairimefábharaí;
shall take the comments and amendments of the Board of Regulators into account and shall resubmit the revised draft opinion, recommendation or decision to the Board of Regulators for a favourable opinion;
#1909928
Déanfar fochoiste a dhíscaoileadh a luaithe a dhéanfaidh an Coiste vótáil ar an dréacht-tuairim nó ar an tuarascáil faisnéise a bheidh ullmhaithe aige.
A subcommittee shall be automatically dissolved as soon as the draft opinion or information report which it has prepared is voted on by the Committee.
#2004790
Féadfaidh an comhalta a chearta vótála nó a cearta vótála a tharmligean chuig an gcomhalta malartach sin le linn don dréacht-tuairim i gceist a bheith á plé.
The member may delegate his or her vote to this alternate while the draft opinion in question is being discussed.
#2004969
Má chuirtear an dréacht-tuairim ar ais chuig an gcoimisiún inniúil, ní mór don choimisiún ceann de na trí rogha seo a chinneadh:
If the draft opinion is returned to the competent commission, the commission must decide either to:
#2004970
an dréacht-tuairim a chur isteach arís le haghaidh díospóireachta agus le glacadh, arna modhnú de réir na leasuithe sa Seisiún Iomlánach;
re-submit the draft opinion for debate and adoption, as modified by the amendments adopted in Plenary Session,
#2004984
Is é an rapóirtéir a thíolacfaidh an dréacht-tuairim nó an dréacht-tuarascáil ag an Seisiún Iomlánach agus féadfaidh sí a bheith ina hábhar díospóireachta.
The draft opinion or report shall be presented by the rapporteur at the Plenary Session and may be the subject of a debate.
#2005185
Ní bheidh gá le níos mó ná dhá chruinniú chun dréacht-tuairim a phlé, gan an chéad chruinniú ina n-eagrófar an obair a chur san áireamh.
The discussion of a draft opinion shall require no more than two meetings, not including the first meeting at which the work shall be organised.
#2005186
I gcásanna eisceachtúla, féadfaidh an Biúró tuilleadh cruinnithe a údarú chun dréacht-tuairim a phlé, nó féadfaidh sé an teorainn ama faoina ndéanfar an dréacht a thíolacadh a fhadú.
In exceptional cases the Bureau may authorise further meetings to discuss a draft opinion, or may extend the time limit for the presentation of the draft.
#2005200
Tiocfaidh an coimisiún i gceann a chéile, nuair is féidir, chun díospóireacht a dhéanamh agus an dréacht-tuairim a ghlacadh, agus cuirfear ar aghaidh chuig an gcéad Seisiún Iomlánach eile í.
The commission shall meet, where possible, to hold a debate and adopt the draft opinion, which shall be sent to the next Plenary Session.
#2005253
an dréacht-tuairim a chur isteach arís le haghaidh díospóireachta agus a glactha, mar atá sí modhnaithe ag na leasuithe a glacadh sa choimisiún, ag féachaint d’fhorálacha Riail 53;
re-submit the draft opinion for debate and adoption, as modified by the amendments adopted in commission, having regard to provisions of Rule 53,
#2005256
A luaithe agus a ghlacfaidh coimisiún dréacht-tuairim, cuirfidh cathaoirleach an choimisiúin ar aghaidh chuig Uachtarán an Choiste í.
Once a draft opinion has been adopted by a commission, it shall be forwarded by the commission chair to the President of the Committee.
#2270858
Déanfar fochoiste a dhíscaoileadh a luaithe a dhéanfaidh an Tionól vótáil ar an dréacht-tuairim a bheidh ullmhaithe aige.
A subcommittee shall be automatically dissolved as soon as the assembly votes on the draft opinion which it has prepared.
#2270872
I gcás ina nglacfaidh an rannóg an dréacht-tuairim, is í an rannóg a chuirfidh faoi bhráid an Tionóil í lena glacadh.
Where the section adopts the draft opinion, the section shall submit it to the assembly for adoption.
#2271244
Má chinneann an Biúró gan í a tharchur ar ais, cuirfear an dréacht-tuairim, i gcás inar féidir, leis an gclár oibre don lá deireanach den seisiún iomlánach.
If the bureau decides not to refer it back, the draft opinion shall, where possible, be added to the agenda for the last day of the plenary session.
#2271292
I gcás rapóirtéir aonair, oibreoidh sé nó sí ina aonar nó ina haonar, gan grúpa staidéir, chun dréacht-tuairim a ullmhú agus í a chur faoi bhráid na rannóige nó CCMI.
A rapporteur working alone shall work without a study group to prepare a draft opinion and submit it to the section or the CCMI.
#2271299
Daingneoidh an Tionól an ceapachán a dhéanfaidh Uachtarán an Choiste sula bpléifear an dréacht-tuairim lena mbaineann.
The appointment made by the Committee president shall be ratified by the assembly before the draft opinion concerned is discussed.
#2449958
Déanfar fochoiste a dhíscaoileadh a luaithe a dhéanfaidh an Tionól vótáil ar an dréacht-tuairim a bheidh ullmhaithe aige.
A subcommittee shall be automatically dissolved as soon as the assembly votes on the draft opinion which it has prepared.
#2449972
I gcás ina nglacfaidh an rannóg an dréacht-tuairim, is í an rannóg a chuirfidh faoi bhráid an Tionóil í lena glacadh.
Where the section adopts the draft opinion, the section shall submit it to the assembly for adoption.
#2450344
Má chinneann an Biúró gan í a tharchur ar ais, cuirfear an dréacht-tuairim, i gcás inar féidir, leis an gclár oibre don lá deireanach den seisiún iomlánach.
If the bureau decides not to refer it back, the draft opinion shall, where possible, be added to the agenda for the last day of the plenary session.
#2450392
I gcás rapóirtéir aonair, oibreoidh sé nó sí ina aonar nó ina haonar, gan grúpa staidéir, chun dréacht-tuairim a ullmhú agus í a chur faoi bhráid na rannóige nó CCMI.
A rapporteur working alone shall work without a study group to prepare a draft opinion and submit it to the section or the CCMI.
#2450399
Daingneoidh an Tionól an ceapachán a dhéanfaidh Uachtarán an Choiste sula bpléifear an dréacht-tuairim lena mbaineann.
The appointment made by the Committee president shall be ratified by the assembly before the draft opinion concerned is discussed.
#2631830
Moladh ón dréacht-tuairim ón Ardán don Todhchaí maidir le ‘Conas taobhú leis an idirnascacht idir an t-aistriú digiteach agus an t-aistriú glas, lena n-áirítear trí shimpliú’.
Recommendation of the Fit for Future Platform draft opinion on “How to favour interconnectivity between the digital and green transition, including through simplification”.
#2805476
Féadfaidh an comhalta a chearta vótála nó a cearta vótála a tharmligean chuig an gcomhalta malartach sin le linn don dréacht-tuairim i gceist a bheith á plé.
The member may delegate his or her vote to this alternate while the draft opinion in question is being discussed.
#2805655
Má chuirtear an dréacht-tuairim ar ais chuig an gcoimisiún inniúil, ní mór don choimisiún ceann de na trí rogha seo a chinneadh:
If the draft opinion is returned to the competent commission, the commission must decide either to:
#2805656
an dréacht-tuairim a chur isteach arís le haghaidh díospóireachta agus le glacadh, arna modhnú de réir na leasuithe sa Seisiún Iomlánach;
re-submit the draft opinion for debate and adoption, as modified by the amendments adopted in Plenary Session,
#2805670
Is é an rapóirtéir a thíolacfaidh an dréacht-tuairim nó an dréacht-tuarascáil ag an Seisiún Iomlánach agus féadfaidh sí a bheith ina hábhar díospóireachta.
The draft opinion or report shall be presented by the rapporteur at the Plenary Session and may be the subject of a debate.
#2805875
Ní bheidh gá le níos mó ná dhá chruinniú chun dréacht-tuairim a phlé, gan an chéad chruinniú ina n-eagrófar an obair a chur san áireamh.
The discussion of a draft opinion shall require no more than two meetings, not including the first meeting at which the work shall be organised.
#2805876
I gcásanna eisceachtúla, féadfaidh an Biúró tuilleadh cruinnithe a údarú chun dréacht-tuairim a phlé, nó féadfaidh sé an teorainn ama faoina ndéanfar an dréacht a thíolacadh a fhadú.
In exceptional cases the Bureau may authorise further meetings to discuss a draft opinion, or may extend the time limit for the presentation of the draft.
#2805890
Tiocfaidh an coimisiún i gceann a chéile, nuair is féidir, chun díospóireacht a dhéanamh agus an dréacht-tuairim a ghlacadh, agus cuirfear ar aghaidh chuig an gcéad Seisiún Iomlánach eile í.
The commission shall meet, where possible, to hold a debate and adopt the draft opinion, which shall be sent to the next Plenary Session.
#2805943
an dréacht-tuairim a chur isteach arís le haghaidh díospóireachta agus a glactha, mar atá sí modhnaithe ag na leasuithe a glacadh sa choimisiún, ag féachaint d’fhorálacha Riail 53;
re-submit the draft opinion for debate and adoption, as modified by the amendments adopted in commission, having regard to provisions of Rule 53,
#2805946
A luaithe agus a ghlacfaidh coimisiún dréacht-tuairim, cuirfidh cathaoirleach an choimisiúin ar aghaidh chuig Uachtarán an Choiste í.
Once a draft opinion has been adopted by a commission, it shall be forwarded by the commission chair to the President of the Committee.
#284841
Dá bhrí sin, is cuí go gcruthófaí, laistigh den Ghníomhaireacht, Coiste um Ardteiripí, ar chóir go mbeadh sé de fhreagracht air dréacht-tuairim a ullmhú ar cháilíocht, ar shábháilteacht agus ar éifeachtúlacht gach táirge íocshláinte ardteiripe chun go ndéanfadh Coiste na Gníomhaireachta um Tháirgí Íocshláinte lena nÚsáid ag an Duine formheas críochnaitheach orthu.
For this reason, it is appropriate to create, within the Agency, a Committee for Advanced Therapies, which should be responsible for preparing a draft opinion on the quality, safety and efficacy of each advanced therapy medicinal product for final approval by the Agency’s Committee for Medicinal Products for Human Use.
#284951
2. Nuair a bheidh dréacht-tuairim á hullmhú chun go ndéanfadh an Coiste um Tháirgí Íocshláinte lena nÚsáid ag an Duine formheas críochnaitheach uirthi, féachfaidh an Coiste um Ardteiripí le teacht ar chomhthuairim eolaíoch.
2. When preparing a draft opinion for final approval by the Committee for Medicinal Products for Human Use, the Committee for Advanced Therapies shall endeavour to reach a scientific consensus.
#284954
3. Déanfar an dréacht-tuairim a thabharfaidh an Coiste um Ardteiripí uaidh faoi mhír 1 a sheoladh go tráthúil chuig Cathaoirleach an Choiste um Tháirgí Íocshláinte lena nÚsáid ag an Duine chun a áirithiú go bhféadfar cloí leis an spriocdháta a leagtar síos in Airteagal 6(3) nó in Airteagal 9(2) de Rialachán (CE) Uimh. 726/2004.
3. The draft opinion given by the Committee for Advanced Therapies under paragraph 1 shall be sent to the Chairman of the Committee for Medicinal Products for Human Use in a timely manner so as to ensure that the deadline laid down in Article 6(3) or Article 9(2) of Regulation (EC) No 726/2004 can be met.
#284955
4. I gcás nach mbeidh an tuairim eolaíoch ar tháirge íocshláinte ardteiripe a tharraingeoidh an Coiste um Tháirgí Íocshláinte lena nÚsáid ag an Duine suas faoi Airteagal 5(2) agus (3) de Rialachán (CE) Uimh. 726/2004 i gcomhréir le dréacht-tuairim an Choiste um Ardteiripí, cuirfidh an Coiste um Tháirgí Íocshláinte lena nÚsáid ag an Duine míniúchán mionsonraithe ar fhorais eolaíocha na ndifríochtaí i gceangal lena thuairim.
4. Where the scientific opinion on an advanced therapy medicinal product drawn up by the Committee for Medicinal Products for Human Use under Article 5(2) and (3) of Regulation (EC) No 726/2004 is not in accordance with the draft opinion of the Committee for Advanced Therapies, the Committee for Medicinal Products for Human Use shall annex to its opinion a detailed explanation of the scientific grounds for the differences.