#641739
B.LITIR CHUMHDAIGH
B.COVER LETTER
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#641930
Sa chás sin, is leor nasc ar an doiciméadacht sin sa litir chumhdaigh (féach roinn B).
In the latter case, a link to this documentation in the cover letter is sufficient (see section B).
#641970
Litir chumhdaigh leis an bhfaisnéis seo a leanas:
A cover letter with the following information:
#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.
#254026
(b) cóip dheimhnithe den litir chumhdaigh ón gCoimisinéir nó ón mBinse arna heisiúint chuig an iarratasóir leis an mbreith réamhluaite sin ón gCoimisinéir nó leis an gcinneadh réamhluaite sin ón mBinse;
(b) a certified copy of the covering letter from the Commissioner or the Tribunal issued to the applicant with the aforementioned decision of the Commissioner or determination of the Tribunal;
#254069
(b) cóip dheimhnithe den litir chumhdaigh ón gCoimisinéir nó ón mBinse a eisíodh chuig an Iarratasóir leis an mbreith réamhluaite sin ón gCoimisinéir nó leis an gcinneadh réamhluaite sin ón mBinse;
(b) a certified copy of the covering letter from the Commissioner or the Tribunal issued to the Applicant with the aforementioned decision of the Commissioner or determination of the Tribunal;
#641740
Déanfaidh an litir chumhdaigh uimhir trialach AE agus an uimhir trialach uilíoch a shonrú agus aird a tarraingt ar aon ghnéithe atá sonrach don triail chliniciúil.
The cover letter shall specify the EU trial number and the universal trial number and shall draw attention to any features which are particular to the clinical trial.
#641741
Ní gá, áfach, an fhaisnéis atá i bhfoirm iarratais AE cheana féin a thabhairt arís sa litir chumhdaigh, taobh amuigh de na heisceachtaí seo a leanas:
However, in the cover letter it is not necessary to reproduce information already contained in the EU application form, with the following exceptions:
#641751
Léireofar sa litir chumhdaigh cá bhfuil an fhaisnéis a liostaítear i mír 7 le fáil sainchomhad an iarratais.
The cover letter shall indicate where the information listed in paragraph 7 is contained in the application dossier.
#641752
Cuirfidh an litir chumhdaigh in iúl má mheasann an t-urraitheoir gur triail chliniciúil idirghabhála ísle í an triail chliniciúil agus beidh bonn cirt mionsonraithe de sin inti.
The cover letter shall indicate if the clinical trial is considered by the sponsor to be a low-intervention clinical trial and shall contain a detailed justification thereof.
#641745
an cuid í an triail chliniciúil, nó an mbeartaítear go mbeidh sí ina cuid, den Phlean um Imscrúdú Péidiatraiceach (PIP) dá dtagraítear i dTeideal II de Chaibidil 3 de Rialachán (CE) Uimh.1901/2006 (má tá cinneadh eisithe cheana féin ag an nGníomhaireacht maidir leis an PIP, beidh nasc sa litir chumhdaigh chuig cinneadh na Gníomhaireachta ar a láithreán gréasáin);
whether the clinical trial is part or is intended to be part of a Paediatric Investigation Plan (PIP) as referred to in Title II, Chapter 3, of Regulation (EC) No 1901/2006 (if the Agency has already issued a decision on the PIP, the cover letter contains the link to the decision of the Agency on its website);
#641753
Cuirfidh an litir chumhdaigh in iúl má éilíonn modheolaíocht na trialach cliniciúla go gur grúpaí de dhaoine is ábhar seachas daoine aonair is ábhar atá ceaptha táirgí íocshláinte imscrúdaitheacha éagsúla a fháil i dtriail chliniciúil, agus mar thoradh air sin gheofar toiliú feasach ar bhealach simplithe.
The cover letter shall indicate if the methodology of the clinical trial requires that groups of subjects rather than individual subjects are allocated to receive different investigational medicinal products in a clinical trial, and as a consequence whether informed consent will be obtained by simplified means.
#641754
Léireofar sa litir chumhdaigh cén áit i sainchomhad an iarratais a bhfuil an fhaisnéis is gá chun measúnú a dhéanamh an frithghníomh díobhálach tromchúiseach neamhthuartha amhrasta é frithghníomh díobhálach is é sin an fhaisnéis thagartha maidir le sábháilteacht.
The cover letter shall indicate the location in the application dossier of the information necessary for assessing whether an adverse reaction is a suspected unexpected serious adverse reaction, that is the reference safety information.
#641755
I gcás iarratais a chuirtear isteach an athuair, sonrófar sa litir chumhdaigh uimhir thrialach AE d'iarratas roimhe sin ar thriail chliniciúil, leagfar béim inti ar na hathruithe ar an iarratas sin i gcomparáid leis an iarratas a cuireadh isteach roimhe sin agus, más infheidhme, sonrófar inti conas a tugadh aghaidh ar aon saincheisteanna gan réiteach sa chéad iarratas a cuireadh isteach.
In the case of a resubmission, the cover letter shall specify the EU trial number for the previous clinical trial application, highlight the changes as compared to the previous submission and, if applicable, specify how any unresolved issues in the first submission have been addressed.
#641967
Beidh liosta sa litir chumhdaigh de na trialacha cliniciúla ar fad lena mbaineann an t-iarratas ar mhodhnú substaintiúil, in éineacht lena n-uimhreacha aitheantais oifigiúla agus le huimhreacha trialacha AE modhnuithe ábhartha gach ceann de na trialacha cliniciúla sin.
The cover letter shall contain a list of all clinical trials to which the application for substantial modification relates, with the EU trial numbers and respective modification code numbers of each of those clinical trials.
#2650523
Comhdaíodh an litir chumhdaigh agus na ceangaltáin a ghabh léi mar Dhoiciméid Uimh. 1194243, 1194249, 1194179, 1194189, 1194181, 1194183, 1194199, 1194185, 1194187, 1194217, 1194191, 1194193, 1194197, 1194195, 1194255, 1194253, 1194205, 1194201, 1194203, 1194209, 1194207, 1194211, 1194213, 1194223, 1194215, 1194229, 1194219, 1194221, 1194225, 1194233, 1194227, 1194235, 1194231, 1194239, 1194251, 1194237, 1194245, 1194241, agus 1194247.
The cover letter with attachments are filed as Document Nos 1194243, 1194249, 1194179, 1194189, 1194181, 1194183, 1194199, 1194185, 1194187, 1194217, 1194191, 1194193, 1194197, 1194195, 1194255, 1194253, 1194205, 1194201, 1194203, 1194209, 1194207, 1194211, 1194213, 1194223, 1194215, 1194229, 1194219, 1194221, 1194225, 1194233, 1194227, 1194235, 1194231, 1194239, 1194251, 1194237, 1194245, 1194241, and 1194247.
#3093290
Cuirfidh na Páirtithe Conarthacha leagan den Chomhaontú ábhartha arna thabhairt i gcrích idir na Páirtithe Conarthacha i mBéarla nó i bhFraincis ar fáil don Chomhchoiste, comhaontú ina gcuimsítear na forálacha dá dtagraítear i bpointe (a) mar aon le litir chumhdaigh i mBéarla nó i bhFraincis ina gcuirtear in iúl na forálacha den Choinbhinsiún sin a ndéanann an Comhaontú ábhartha sin maolú ina leith;
Contracting Parties shall provide the chairperson of the Joint Committee with a version of the relevant Agreement concluded between the Contracting Parties in English or in French that contains the provisions referred to in point (a) and an accompanying letter in English or in French indicating the provisions of this Convention from which that relevant Agreement derogates;
#3241101
Ní mór a mheabhrú, mar a luaitear sa litir chumhdaigh an 17 Feabhra 2023 (t23.000887) a seoladh chuig na páirtithe leasmhara a d’fhéadfadh a bheith ann, gurb é an cuspóir a bhí ag an gCoimisiún an botún a d’aimsigh an Chúirt Ghinearálta a cheartú (gan ach muilleoirí ríse Indica meilte nó leathmheilte a próiseáladh ó rís gan scilleagadh a fásadh nó a baineadh san Aontas a chumhdach i raon feidhme an imscrúdaithe) agus, ar an mbealach sin, sampla tháirgeoirí an Aontais a mhéadú, agus ní díreach cuideachtaí nua a chur in ionad na gcuideachtaí sampláilte a roghnaíodh cheana san imscrúdú bunaidh.
It has to be recalled, as mentioned in the cover letter of 17 February 2023 (t23.000887) sent to the potentially interested parties, that the purpose of the Commission was to correct the mistake found by the General Court (limiting the scope of the investigation solely to millers of milled or semi-milled Indica rice processed from paddy rice grown or harvested in the EU) and thus enlarge the sample of the Union producers, and not to just replace the sampled companies that had already been selected in the original investigation.