#746545
gur sainchomhad iarratais atá neamhchomhlánaithe fós an sainchomhad iarratais a tíolacadh de bhun Airteagal 66(3);
the application dossier submitted pursuant to Article 66(3) remains incomplete;
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72 toradh in 12 doiciméad
#596856
Beidh na sonraí seo a leanas sa sainchomhad iarratais dá dtagraítear in Airteagal 49(4):
An application dossier referred to in Article 49(4) shall comprise:
#596923
Tabharfar na hidirthréimhsí sin le fios sa sainchomhad iarratais dá dtagraítear in Airteagal 8(2).
Such transitional periods shall be indicated in the application dossier referred to in Article 8(2).
#640631
Ba cheart é a fhágáil faoi na Ballstáit na ceanglais teanga don sainchomhad iarratais a shuíomh.
It should be left to Member States to establish the language requirements for the application dossier.
#640863
cibé an bhfuil an sainchomhad iarratais iomlán i gcomhréir le hIarscríbhinn I.
whether the application dossier is complete in accordance with Annex I;
#641024
an bhfuil an sainchomhad iarratais iomlán i gcomhréir le hIarscríbhinn II.
the application dossier is complete in accordance with Annex II.
#641067
cibé an bhfuil an sainchomhad iarratais iomlán i gcomhréir le hIarscríbhinn II.
whether the application dossier is complete in accordance with Annex II.
#641109
SAINCHOMHAD IARRATAIS
APPLICATION DOSSIER
#641111
Sonraí arna gcur isteach sa sainchomhad iarratais
Data submitted in the application dossier
#641726
SAINCHOMHAD IARRATAIS DON IARRATAS TOSAIGH
APPLICATION DOSSIER FOR THE INITIAL APPLICATION
#641965
SAINCHOMHAD IARRATAIS LE HAGHAIDH MODHNAITHE SHUBSTAINTIÚIL
APPLICATION DOSSIER FOR SUBSTANTIAL MODIFICATION
#642012
Déanfar tagairt sa litir chumhdaigh don áit a bhfuil an RSI le fáil sa sainchomhad iarratais.
The covering letter shall refer to the location of the RSI in the application dossier.
#1789517
Beidh an méid seo a leanas i sainchomhad iarratais dá dtagraítear in Airteagal 24(7):
An application dossier as referred to in Article 24(7) shall include:
#641069
I gcás ina gcinnfidh an Ballstát lena mbaineann nach mbaineann an modhnú substaintiúil le gné atá cumhdaithe ag Cuid II den tuarascáil mheasúnaithe nó nach bhfuil an sainchomhad iarratais iomlán, cuirfidh sé an t-urraitheoir ar an eolas faoi sin trí thairseach AE agus leagfaidh sé deich lá síos ar a mhéad don urraitheoir chun barúlacha a thabhairt maidir leis an iarratas nó chun an sainchomhad iarratais a chomhlánú trí thairseach AE.
Where the Member State concerned finds that the substantial modification does not concern an aspect covered by Part II of the assessment report or that the application dossier is not complete, it shall inform the sponsor thereof through the EU portal and shall set a maximum of 10days for the sponsor to comment on the application or to complete the application dossier through the EU portal.
#640853
Chun údarú a fháil, cuirfidh an t-urraitheoir sainchomhad iarratais faoi bhráid na mBallstát lena mbaineann ina mbeartaítear triail a dhéanamh trí bhíthin na tairsí dá dtagraítear in Airteagal 80 (“tairseach AE”).
In order to obtain an authorisation, the sponsor shall submit an application dossier to the intended Member States concerned through the portal referred to in Article 80 (the ‘EU portal’).
#640864
Féadfaidh Ballstáit lena mbaineann aon bhreithnithe atá ábhartha do bhailíochtú an iarratais a chur in iúl don Bhallstát tuairiscithe laistigh de sheacht lá ón sainchomhad iarratais a thíolacadh.
Member States concerned may communicate to the reporting Member State any considerations relevant to the validation of the application within seven days from the submission of the application dossier.
#640985
Ní fhéadfar an sainchomhad iarratais a thíolacadh ach amháin tar éis an dáta ar a dtugtar an fógra i leith an chinnidh údaraithe tosaigh.
The application dossier may be submitted only after the notification date of the initial authorisation decision.
#640986
Is é an Ballstát tuairiscithe le haghaidh an sainchomhad iarratais dá dtagraítear i mír 1 a bheidh mar Bhallstát tuairiscithe le haghaidh an nós imeachta um údarú tosaigh.
The reporting Member State for the application dossier referred to in paragraph 1 shall be the reporting Member State for the initial authorisation procedure.
#641017
Chun údarú a fháil, cuirfidh an t-urraitheoir sainchomhad iarratais faoi bhráid na mBallstát lena mbaineann tríd an tairseach AE.
In order to obtain an authorisation, the sponsor shall submit an application dossier to the Member States concerned through the EU portal.
#641021
Féadfaidh Ballstáit lena mbaineann aon bhreithnithe atá ábhartha do bhailíochtú an iarratais ar mhodhnú substaintiúil a chur in iúl don Bhallstát tuairiscithe laistigh de chúig lá ón sainchomhad iarratais a thíolacadh.
Member States concerned may communicate to the reporting Member State any considerations relevant to the validation of the application of a substantial modification within five days from the submission of the application dossier.
#641065
Laistigh de shé lá ón sainchomhad iarratais a thíolacadh, tabharfaidh an Ballstát lena mbaineann fógra don urraitheoir trí thairseach AE maidir leis an méid seo a leanas:
Within six days from the submission of the application dossier, the Member State concerned shall notify the sponsor through the EU portal of the following:
#641372
An fhaisnéis ábhartha maidir le hinrianaitheacht, stóráil, tabhairt ar ais agus scriosadh táirgí íocshláinte dá dtagraítear i mír 1, beidh sí sa sainchomhad iarratais.
The relevant information regarding the traceability, storage, return and destruction of medicinal products referred to in paragraph 1 shall be contained in the application dossier.
#641730
I gcás ina mbeidh níos mó ná urraitheoir amháin ag triail chliniciúil, cuirfear faisnéis mhionsonraithe ar fhreagrachtaí gach ceann de na n-urraitheoirí isteach sa sainchomhad iarratais.
Where a clinical trial has more than one sponsor, detailed information of the responsibilities of each of the sponsors shall be submitted in the application dossier.
#641974
béim ar aon saincheisteanna speisialta a bhaineann leis an modhnú agus tagairt don áit ina bhfuil an fhaisnéis ábhartha nó an téacs ábhartha le fáil sa bhun-sainchomhad iarratais;
a highlighted indication of any special issues relating to the modification and an indication as to where the relevant information or text is located in the original application dossier;
#1789526
I gcás den sórt sin, sonrófar na cúiseanna sin sa sainchomhad iarratais dá dtagraítear in Airteagal 23(2).
In such case, the application dossier referred to in Article 23(2) shall state those reasons.
#2049483
Beidh na codanna seo a leanas in aon sainchomhad iarratais i ndáil le húdarú margaíochta le haghaidh táirge íocshláinte tréidliachta:
Any dossier for an application for marketing authorisation for a veterinary medicinal product shall consist of the following parts:
#2110506
Ar na nithe a bheidh ina gcuid den sainchomhad iarratais, beidh an tagairt leictreonach d’fhoilsiú na sonraíochta táirge.
The application dossier shall include the electronic reference of the publication of the product specification.
#2110515
Is ar an dáta a chuirfear an sainchomhad iarratais faoi bhráid an Choimisiúin a thosóidh an idirthréimhse agus beidh sí chomh gearr agus is féidir.
The transitional period shall start from the date on which the application dossier is submitted to the Commission and shall be as short as possible.
#2277442
ciallaíonn “triail chliniciúil ilnáisiúnta” triail chliniciúil ar chuir an t-urraitheoir sainchomhad iarratais faoi bhráid níos mó ná Ballstát amháin ina leith trí thairseach an Aontas.
‘Multi-national clinical trial’ means a clinical trial for which the sponsor submitted an application dossier to more than one Member State through the EU portal.
#2521439
Sonrófar sa treoir an fhaisnéis is gá a bheith i sainchomhad iarratais maidir le húdarú a thabhairt do phróiseas athchúrsála a chuireann an teicneolaíocht shonrach sin i bhfeidhm.
The guidance shall specify the information required to be included in an application dossier for the authorisation of a recycling process applying that specific technology.
#2723268
Dá bhrí sin, mheas an tÚdarás nach mbeidh 1-meitil-2-pioróladón ann sna tuaslagóirí a úsáidtear sa phróiseas monaraíochta a thuairiscítear sa sainchomhad iarratais.
Therefore, the Authority considered that 1-methyl-2-pyrrolidone is not expected to be present in the solvents used in the manufacturing process described in the application dossier.
#597141
Más rud é, i ndiaidh measúnú a dhéanamh ar aon fhreasúra a fhaightear, go measann an Ballstát gur comhlíonadh ceanglais an Rialacháin seo, féadfaidh sé cinneadh fabhrach a dhéanamh agus sainchomhad iarratais a thaisceadh leis an gCoimisiún.
If, after assessment of any opposition received, the Member State considers that the requirements of this Regulation are met, it may take a favourable decision and lodge an application dossier with the Commission.
#640576
Dá bhrí sin, ar mhaithe leis na nósanna imeachta a shimpliú maidir le tíolacadh sainchomhaid iarratais i dtaca le húdarú do thriail chliniciúil, ba cheart go seachnófaí faisnéis atá mar an gcéanna den chuid is mó a chur isteach arís agus arís eile agus ina ionad sin ba cheart aon sainchomhad iarratais amháin a chur isteach chuig na Ballstáit uile lena mbaineann trí thairseach tíolactha iarratais.
Therefore, in order to simplify the procedures for the submission of an application dossier for the authorisation of a clinical trial, the multiple submission of largely identical information should be avoided and replaced by the submission of one application dossier to all the Member States concerned through a single submission portal.
#640577
I bhfianaise go bhfuil an tábhacht chéanna do thaighde cliniciúil Eorpach ag baint le trialacha cliniciúla a dhéantar i mBallstát aonair, ba cheart go ndéanfaí an sainchomhad iarratais do na trialacha cliniciúla sin a chur isteach freisin tríd an tairseach aonair sin.
Given that clinical trials carried out in a single Member State are equally important to European clinical research, the application dossier for such clinical trials should also be submitted through that single portal.
#640583
Ba cheart go mbeadh na hamlínte chun sainchomhad iarratais ar thrialacha cliniciúla a mheasúnú fada go leor le gur féidir an comhad a mheasúnú, ach rochtain mhear ar chóireálacha nuálaíocha nua a áirithiú ag an am céanna, agus ba cheart go n-áiritheofaí gur áit tharraingteach é an tAontas i gcónaí chun trialacha cliniciúla a stiúradh.
The timelines for assessing an application dossier for clinical trials should be sufficient to assess the file while, at the same time, ensuring quick access to new, innovative treatments and ensuring that the Union remains an attractive place for conducting clinical trials.
#640605
Ba cheart a fhoráil sa nós imeachta um údarú gur féidir na hamlínte don mheasúnú a fhadú chun ligean don urraitheoir díriú ar cheisteanna nó barúlacha a ardaítear le linn an mheasúnaithe ar an sainchomhad iarratais.
The authorisation procedure should provide for the possibility to extend the timelines for the assessment in order to allow the sponsor to address questions or comments raised during the assessment of the application dossier.
#640859
Déanfaidh an Ballstát tuairiscithe, tríd an tairseach AE, agus laistigh de sé lá ón sainchomhad iarratais a thíolacadh, fógra a thabhairt don urraitheoir agus do na Bhallstát eile lena mbaineann gurb é féin an Ballstát tuairiscithe.
The reporting Member State shall notify the sponsor and the other Member States concerned that it is the reporting Member State, through the EU portal, within six days from the submission of the application dossier.
#640860
I gcás gur le haghaidh trialach cliniciúla idirghabhála ísle atá an sainchomhad iarratais agus gur triail í nach mbaintear úsáid as táirge íocshláinte imscrúdaitheach inti i gcomhréir le téarmaí an údaraithe margaíochta ach gur cóireáil fhianaise-bhunaithe atá in úsáid an táirge sin agus go bhfuil an méid sin tacaithe le fianaise eolaíoch fhoilsithe maidir le sábháilteacht agus éifeachtúlacht an táirge sin, déanfaidh an t-urraitheoir ceann de na Ballstáit lena mbaineann a mholadh mar Bhallstát tuairiscithe i gcás inar cóireáil fhianaise-bhunaithe atá i gceist leis an úsáid.
The sponsor shall, when applying for a low-intervention clinical trial, where the investigational medicinal product is not used in accordance with the terms of the marketing authorisation but the use of that product is evidence-based and supported by published scientific evidence on the safety and efficacy of that product, propose one of the Member States concerned where the use is evidence-based, as reporting Member State.
#640861
Laistigh de dheich lá ón sainchomhad iarratais a thíolacadh, déanfaidh an Ballstát tuairiscithe an t-iarratas a bhailíochtú á chur san áireamh dó na breithnithe a bheidh léirithe ag na Ballstáit eile lena mbaineann agus tabharfaidh sé fógra don urraitheoir, tríd an tairseach AE, maidir leis an méid seo a leanas:
Within 10days from the submission of the application dossier, the reporting Member State shall validate the application taking into account considerations expressed by the other Member States concerned and notify the sponsor, through the EU portal, of the following:
#640865
I gcás nach bhfuil fógra tugtha ag an mBallstát tuairiscithe don urraitheoir laistigh den tréimhse dá dtagraítear sa chéad fhomhír de mhír 3, measfar go dtagann an triail chliniciúil a gcuirtear isteach uirthi faoi raon feidhme an Rialacháin seo, agus measfar an sainchomhad iarratais a bheith iomlán.
Where the reporting Member State has not notified the sponsor within the period referred to in the first subparagraph of paragraph 3, the clinical trial applied for shall be deemed to fall within the scope of this Regulation and the application dossier shall be considered complete.
#640866
I gcás ina bhfaigheann an Ballstát tuairiscithe, agus na breithnithe a bheidh léirithe ag na Ballstáit eile lena mbaineann á gcur san áireamh aige, nach bhfuil an t-iarratas iomlán nó nach dtagann an triail chliniciúil ar cuireadh isteach uirthi faoi raon feidhme an Rialacháin seo, cuirfidh sé an méid sin in iúl don urraitheoir trí thairseach AE agus socróidh sé tréimhse deich lá ar a mhéad don urraitheoir chun barúil a thabhairt ar an iarratas nó chun an sainchomhad iarratais a thabhairt chun iomláine trí thairseach AE.
Where the reporting Member State, taking into account considerations expressed by the other Member States concerned, finds that the application dossier is not complete, or that the clinical trial applied for does not fall within the scope of this Regulation, it shall inform the sponsor thereof through the EU portal and shall set a maximum of 10days for the sponsor to comment on the application or to complete the application dossier through the EU portal.
#640867
Laistigh de chúig lá tar éis na barúlacha nó an sainchomhad iarratais iomlán a fháil, tabharfaidh an Ballstát tuairiscithe fógra don urraitheoir maidir le cé acu an chomhlíonann an t-iarratas na ceanglais a leagtar amach i bpointe (a) agus i bpointe (b) den chéad fhomhír de mhír 3.
Within five days from receipt of the comments or the completed application dossier, the reporting Member State shall notify the sponsor as to whether or not the application complies with the requirements set out in points (a) and (b) of the first subparagraph of paragraph 3.
#640869
I gcás nach bhfuil barúlacha soláthraithe ag an urraitheoir nó nach bhfuil an sainchomhad iarratais tugtha chun iomláine aige laistigh den tréimhse dá dtagraítear sa chéad fhomhír, measfar an t-iarratas bheith imithe i léig sna Ballstáit uile lena mbaineann.
Where the sponsor has not provided comments or completed the application dossier within the period referred to in the first subparagraph, the application shall be deemed to have lapsed in all Member States concerned.
#640984
I gcás inar mian leis an urraitheoir triail chliniciúil údaraithe a leathnú amach chuig Ballstát eile (“Ballstát breise lena mbaineann”), cuirfidh an t-urraitheoir an sainchomhad iarratais faoi bhráid an Bhallstáit sin tríd an tairseach AE.
Where the sponsor wishes to extend an authorised clinical trial to another Member State (‘additional Member State concerned’), the sponsor shall submit an application dossier to that Member State through the EU portal.
#640992
Idir an dáta a gcuirtear an sainchomhad iarratais dá dtagraítear i mír 1 isteach agus cúig lá roimh dhul in éag na tréimhse dá dtagraítear i mír 3, féadfaidh an Ballstát breise lena mbaineann, tríd an tairseach AE, aon bhreithnithe is ábhartha don iarratas a chur in iúl don Bhallstát tuairiscithe agus do na Ballstáit eile lena mbaineann.
Between the date of submission of the application dossier referred to in paragraph 1 and five days before the expiry of the period referred to in paragraph 3, the additional Member State concerned may communicate to the reporting Member State and the other Member States concerned any considerations relevant to the application through the EU portal.
#641022
Laistigh de shé lá ón sainchomhad iarratais a thíolacadh, déanfaidh an Ballstát tuairiscthe an t-iarratas a bhailíochtú, á chur san áireamh dó na breithnithe a bheidh léirithe ag na Ballstáit eile lena mbaineann, agus tabharfaidh sé fógra don urraitheoir trí thairseach AE maidir leis an méid seo a leanas:
Within six days from the submission of the application dossier, the reporting Member State shall validate the application taking into account considerations expressed by the other Member States concerned and notify the sponsor through the EU portal as to whether:
#641025
Más rud é nach mbeidh fógra tugtha don urraitheoir ag an mBallstát tuairiscithe laistigh den tréimhse dá dtagraítear sa chéad fhomhír de mhír 2, measfar go mbaineann an modhnú substaintiúil a ndearnadh iarratas ina leith le gné atá cumhdaithe ag Cuid I den tuarascáil measúnaithe agus measfar go bhfuil an sainchomhad iarratais iomlán.
Where the reporting Member State has not notified the sponsor within the period referred to in paragraph 2, the substantial modification applied for shall be deemed to concern an aspect covered by Part I of the assessment report and the application dossier shall be deemed to be complete.
#641028
Más rud é nach mbeidh fógra tugtha don urraitheoir ag an mBallstát tuairiscithe laistigh den tréimhse dá dtagraítear sa dara fomhír, measfar go mbaineann an modhnú substaintiúil a ndearnadh iarratas ina leith le gné atá cumhdaithe ag Cuid I den tuarascáil measúnaithe agus measfar go bhfuil an sainchomhad iarratais iomlán.
Where the reporting Member State has not notified the sponsor within the period referred to in the second subparagraph, the substantial modification applied for shall be deemed to concern an aspect covered by Part I of the assessment report and the application dossier shall be deemed to be complete.
#641068
I gcás nach mbeidh fógra tugtha ag an mBallstát lena mbaineann don urraitheoir laistigh den tréimhse dá dtagraítear i mír 1, measfar go mbaineann an modhnú substaintiúil a ndearnadh iarratas ina leith le gné atá cumhdaithe ag Cuid II den tuarascáil mheasúnaithe agus measfar go bhfuil an sainchomhad iarratais iomlán.
Where the Member State concerned has not notified the sponsor within the period referred to in paragraph 1, the substantial modification applied for shall be deemed to concern an aspect covered by Part II of the assessment report and the application dossier shall be deemed to be complete.
#641070
Laistigh de chúig lá ó na barúlacha nó ón sainchomhad iarratais iomlán a fháil, tabharfaidh an Ballstát tuairiscithe fógra don urraitheoir maidir le cé acu an chomhlíonann nó nach gcomhlíonann an t-iarratas na ceanglais a leagtar amach i bpointe (a) agus i bpointe (b) de mhír 1.
Within five days from receipt of the comments or the completed application dossier, the reporting Member State shall notify the sponsor as to whether or not the application complies with the requirements set out in points (a) and (b) of paragraph 1.