Gaois

Search direction

Search mode

Filter results

Collections

2,704 results in 411 documents

  1. #642096

    Sainaithint trialach cliniciúla (lena n-áirítear teideal na trialach, uimhir phrótacail, uimhir thrialach AE agus aitheantóirí eile);

    Clinical trial identification (including title of the trial, protocol number, EU trial number and other identifiers);

    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

  2. #2637670

    An triail REMAP-CAP, an triail EU-SolidAct agus an triail ECRAID-Prime.

    REMAP-CAP trial, EU SolidAct trial and ECRAID-Prime trial.

    COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS EU response to COVID-19: preparing for autumn and winter 2023

  3. #2691381

    Maidir le cearta nós imeachta daoine atá faoi dhrochamhras agus daoine atá cúisithe faoi réir coinneáil réamhthrialach, ba cheart go gcumhdófaí leis an treoir sa Mholadh seo príomhchaighdeáin maidir le coinneáil réamhthrialach a úsáid mar bheart de roghanna dheireanacha agus de roghanna eile maidir le choinneáil, forais le haghaidh coinneála réamhthrialach, ceanglais maidir le cinnteoireacht ag údaráis bhreithiúnacha, athbhreithniú tréimhsiúil ar choinneáil réamhthrialach, éisteacht daoine atá faoi dhrochamhras nó daoine atá cúisithe i leith cinntí maidir le coinneáil réamhthrialach, leigheasanna éifeachtacha agus an ceart achomharc a dhéanamh, fad na coinneála réamhthrialach agus aitheantas don am a chaitear i gcoinneáil réamhthrialach i dtéarmaí asbhainte ón bpianbhreith deiridh.

    With respect to procedural rights of suspects and accused persons subject to pre-trial detention, the guidance in this Recommendation should cover key standards on the use of pre-trial detention as a measure of last resort and alternatives to detention, grounds for pre-trial detention, requirements for decision-making by judicial authorities, periodic review of pre-trial detention, the hearing of suspect or accused persons for decisions on pre-trial detention, effective remedies and the right to appeal, the length of pre-trial detention and the recognition of time spent in pre-trial detention in terms of a deduction from the final sentence.

    Commission Recommendation (EU) 2023/681 of 8 December 2022 on procedural rights of suspects and accused persons subject to pre-trial detention and on material detention conditions

  4. #148033

    Tabharfar fógra trialach sula gcuirfear an chaingean síos i gcomhair trialach.

    Notice of trial shall be given before setting down the action for trial.

    Statutory Instruments: 1980

  5. #254376

    Fógra Trialach/Fógra chun dáta a shocrú le haghaidh Trialach

    Notice of Trial/Notice to fix a date for Trial

    S.I. No. 510 of 2001: The Circuit Court Rules

  6. #444461

    (C) i gcás gur ordaíodh atriail, i ndeireadh na hatrialach;”.

    (C) where a re-trial has been ordered, at the conclusion of the re-trial;”.

    CRIMINAL PROCEDURE ACT 2010

  7. #640797

    Ciallaíonn “triail chliniciúil idirghabhála ísle” staidéar cliniciúil a chomhlíonann gach ceann de na coinníollacha seo a leanas:

    ‘Low-intervention clinical trial’ means a clinical trial which fulfils all of the following conditions:

    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

  8. #640875

    Cibé an triail chliniciúil idirghabhála ísle í an triail chliniciúil, i gcás ina maíonn an t-urraitheoir amhlaidh.

    Whether the clinical trial is a low-intervention clinical trial, where claimed by the sponsor;

    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

  9. #641357

    an triail chliniciúil idirghabhála ísle í an triail chliniciúil;

    whether the clinical trial is a low-intervention clinical trial;

    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

  10. #641400

    Beidh sa mháistirchomhad trialach cliniciúla i gcónaí na doiciméid bunriachtanacha a bhaineann leis an triail chliniciúil a chuireann ar chumas fíorú a dhéanamh ar stiúradh na trialach cliniciúla agus ar chaighdeán na sonraí a ghintear, ag cur saintréithe ar fad na trialach cliniciúla san áireamh, lena n-áirítear go háirithe más triail chliniciúil idirghabhála ísle í an triail chliniciúil.

    The clinical trial master file shall at all times contain the essential documents relating to that clinical trial which allow verification of the conduct of a clinical trial and the quality of the data generated, taking into account all characteristics of the clinical trial, including in particular whether the clinical trial is a low-intervention clinical trial.

    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

  11. #641570

    Déanfaidh bunachar sonraí AE gach triail chliniciúil a shainaithint trí uimhir trialach uathúil AE.

    The EU database shall identify each clinical trial by a unique EU trial number.

    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

  12. #642061

    Sainaithint trialach cliniciúla (lena n-áirítear teideal na trialach agus uimhir prótacail);

    Clinical trial identification (including title of the trial and protocol number);

    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

  13. #642143

    cód tagartha na trialach cliniciúla lenar féidir láthair na trialach, an t-imscrúdaitheoir agus an duine is ábhar a aithint;

    clinical trial reference code allowing identification of the clinical trial site, investigator and subject;

    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

  14. #642147

    cód tagartha trialach cliniciúla lenar féidir láthair na trialach, an t-imscrúdaitheoir, an t-urraitheoir agus an duine is ábhar a aithint.

    clinical trial reference code allowing identification of the clinical trial site, investigator, sponsor and subject;

    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

  15. #775770

    Triail daoine a bheidh ag feitheamh le n-a dtriail i dtosach feidhm an Achta so.

    Trial of persons awaiting trial at commencement of Act.

    Number 10 of 1924: THE COURTS OF JUSTICE ACT, 1924

  16. #782786

    Orduithe chun an díotáil do leasú, chun triail fé leith do dhéanamh, agus chun an triail do chur ar athló.

    Orders for amendment of indictment, separate trial, and postponement of trial.

    Number 44 of 1924: CRIMINAL JUSTICE (ADMINISTRATION) ACT, 1924

  17. #795830

    Triail daoine atá anois ag feitheamh le n-a dtriail.

    Trial of persons now awaiting trial.

    Number 1 of 1926: COURTS OF JUSTICE ACT, 1926

  18. #824846

    —(1) Pé uair agus gach uair (ach ní níos mó ná dhá uair maidir le haon triail áirithe) is deimhin le Breitheamh i gceannas na Príomh-Chúirte Coiriúla no le Breitheamh den Chúirt Chuarda ina shuidhe chun ceisteanna coiriúla do thriail nár mhaith an rud, mar gheall ar eagla do bheith á cur no iarracht do bheith á tabhairt ar eagla do chur ar choisteoirí no ar fhínnithe maidir le triail cheisteanna coiriúla i gcoitinne no le triail aon tsaghas áirithe ceisteanna coiriúla no maidir le triail duine áirithe no mar gheall ar eagla do bheith á cur no iarracht do bheith á tabhairt ar eagla do chur ar choisteoirí no ar fhínnithe áirithe, nár mhaith an rud triail no trialacha duine no daoine cúisithe a bheidh ag feitheamh le n-a dtriail ina láthair do bheith ann ag an suidhe a bheidh ar siúl an uair sin ag an bPríomh-Chúirt Choiriúil no ag an gCúirt Chuarda (pe'ca aca é) féadfidh an Breitheamh san triail no trialacha an duine no na ndaoine cúisithe sin do chur ar athló go dtí an chéad shuidhe eile a bheidh ag an gCúirt sin no, i gcás na Cúirte Cuarda, go dtí an chéad shuidhe eile a bheidh ag an gCúirt sin chun ceisteanna coiriúla sa chontae no sa chontae-bhuirg sin do thriail.

    —(1) Whenever and as often (but not more than twice in respect of any one trial) as a Judge presiding in the Central Criminal Court or a Judge of the Circuit Court sitting for the trial of criminal issues is satisfied that, by reason of intimidation or attempted intimidation of jurors or witnesses either in relation to the trial of criminal issues generally or of any class of criminal issues or in relation to the trial of a particular person or the intimidation or attempted intimidation of particular jurors or witnesses it is not desirable that the trial or trials of one or more accused persons awaiting trial before him should be had at the sittings of the Central Criminal Court or the Circuit Court (as the case may be) then in progress, such Judge may adjourn the trial or trials of such accused person or persons until the next following sittings of such Court or, in the case of the Circuit Court, to the next following sittings of such Court for the trial of criminal issues in that county or county borough.

    Number 33 of 1929: JURIES (PROTECTION) ACT, 1929

  19. #1560531

    Socróidh an Dlísheomra Trialach dáta le haghaidh na trialach ansin.

    The Trial Chamber shall then set the date for trial.

    Number 40 of 1998: INTERNATIONAL WAR CRIMES TRIBUNALS ACT, 1998

  20. #1560942

    Socróidh an Dlísheomra Trialach dáta le haghaidh na trialach ansin.

    The Trial Chamber shall then set the date for trial.

    Number 40 of 1998: INTERNATIONAL WAR CRIMES TRIBUNALS ACT, 1998

  21. #1574297

    (a) freastal os comhair chúirt na trialach agus fianaise a thabhairt i dtriail an chúisí, agus

    (a) attend before the trial court and give evidence at the trial of the accused, and

    Number 10 of 1999: CRIMINAL JUSTICE ACT, 1999

  22. #1574307

    (a) freastal os comhair chúirt na trialach agus fianaise a thabhairt i dtriail an chúisí, agus

    (a) attend before the trial court and give evidence at the trial of the accused, and

    Number 10 of 1999: CRIMINAL JUSTICE ACT, 1999

  23. #1700704

    Déanfar fógra trialach a thabhairt sula gcuirfear an chaingean síos i gcomhair trialach.

    Notice of trial shall be given before setting down the action for trial.

    S.I. No. 15 of 1986: The Rules of the Superior Courts

  24. #1791174

    ciallaíonn “imeachtaí coiriúla” an chéim roimh an triail, céim na trialach agus forghníomhú an chiontaithe;

    ‘criminal proceedings’ means the pre-trial stage, the trial stage and the execution of the conviction;

    Regulation (EU) 2019/816 of the European Parliament and of the Council of 17 April 2019 establishing a centralised system for the identification of Member States holding conviction information on third-country nationals and stateless persons (ECRIS-TCN) to supplement the European Criminal Records Information System and amending Regulation (EU) 2018/1726

  25. #1960733

    ciallaíonn ‘imeachtaí coiriúla’ an chéim roimh an triail, céim na trialach agus forghníomhú an chiontaithe;

    "criminal proceedings" means the pre-trial stage, the trial stage and the execution of a conviction;

    Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part

  26. #640665

    Ionas go bhféadfadh othair measúnú a dhéanamh ar na féidearthachtaí i dtaca le bheith rannpháirteach i dtriail chliniciúil, agus chun go bhféadfadh an Ballstát lena mbaineann maoirseacht éifeachtach a dhéanamh ar thriail chliniciúil, ba cheart fógra a thabhairt i leith thús na trialach cliniciúla, dheireadh earcaíocht na ndaoine is ábhar agus dheireadh na trialach cliniciúla.

    In order to allow patients to assess possibilities to participate in a clinical trial, and to allow for effective supervision of a clinical trial by the Member State concerned, the start of the clinical trial, the end of the recruitment of subjects for the clinical trial and the end of the clinical trial should be notified.

    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

  27. #640733

    Sa bhreis air sin, níor cheart tríd is tríd go ndéanfaí príomh-shaintréithe na trialach cliniciúla, an chonclúid maidir le Cuid I den tuarascáil mheasúnaithe maidir le húdarú do thriail chliniciúil agus an cinneadh maidir le húdarú na trialach cliniciúla, an modhnú substaintiúil ar an triail chliniciúil agus torthaí na trialach cliniciúla, lena n-áirítear na cúiseanna lena stopadh go sealadach agus lena fhoirceannadh go luath, a mheas mar nithe rúnda.

    In addition, the main characteristics of a clinical trial, the conclusion on Part I of the assessment report for the authorisation of a clinical trial, the decision on the authorisation of a clinical trial, the substantial modification of a clinical trial, and the clinical trial results including reasons for temporary halt and early termination, in general, should not be considered confidential.

    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

  28. #642067

    Faisnéis ghinearálta faoin triail chliniciúil (lena n-áirítear faisnéis faoi phríomhchuspóirí na trialach, faoi dhearadh trialach, faoi chúlra eolaíoch agus faoi mhíniú na réasúnaíochta don triail; dáta thús na trialach, bearta arna nglacadh maidir le cosaint daoine is ábhar, teiripe cúlra; agus modhanna staidrimh a úsáidtear);

    General information about the clinical trial (including information about main objectives of the trial, trial design, scientific background and explanation of rationale for the trial; date of the start of the trial, measures of protection of subjects taken, background therapy; and statistical methods used);

    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

  29. #782794

    (4) Más rud é, roimh thriail no in aon chéim de thriail, gur dó leis an gcúirt gur rud oiriúnach le déanamh é triail duine a cúisíodh do chur ar athló de bharr feidhmiú bheith déanta ar aon chomhacht atá ag an gcúirt fén Acht so chun díotáil do leasú no chun a ordú go ndéanfí triail fé leith ar scór, déanfidh an chúirt pé ordú a dheabhróidh bheith riachtanach i dtaobh an triail do chur ar athló.

    (4) Where, before trial, or at any stage of a trial, the court is of opinion that the postponement of the trial of a person accused is expedient as a consequence of the exercise of any power of the court under this Act to amend an indictment or to order a separate trial of a count, the court shall make such order as to the postponement of the trial as appears necessary.

    Number 44 of 1924: CRIMINAL JUSTICE (ADMINISTRATION) ACT, 1924

  30. #812896

    —(1) Pé uair agus faid a bheidh an Chuid seo den Acht so i bhfeidhm, tuigfar gach éinne bheidh cúisithe in aon chionta dá luaidhtear sa Sceideal a ghabhann leis an Acht so do bheith curtha ar aghaidh chun a thrialta ag cúirt speisialta má dineadh, roimh thosach feidhme na Coda so den Acht so, é do chur ar aghaidh chun a thrialta ag aon Chúirt agus má bhíonn sé, le linn an tosaigh fheidhme sin, ag feitheamh le n-a thriail ag an gCúirt sin, agus, má cuirtar ar aghaidh chun a thrialta é le linn an Chuid seo den Acht so do bheith i bhfeidhm, cuirfar ar aghaidh chun a thrialta ag cúirt speisialta é d'ainneoin éinní atá in aon Acht eile.

    —(1) Whenever and so long as this Part of this Act is in force, every person charged with any of the offences mentioned in the Schedule to this Act shall, if he has before the commencement of this Part of this Act been sent forward for trial by any Court, and is at such commencement awaiting trial by such Court, be deemed to have been sent forward for trial by a special court, and, if he is sent forward for trial while this Part of this Act is in force, be sent forward notwithstanding anything contained in any other Act for trial by a special court.

    Number 31 of 1927: PUBLIC SAFETY ACT, 1927

  31. #824826

    (b) dul ar aghaidh le triail an duine sin, agus sa chás san fuilingeoidh an duine sin príosúntacht do réir an daortha san o dheire agus i dteanta pé pionós eile (más ann do) chun ar daoradh é ag an triail sin no, más rud é, ar aon réasún, nár daoradh é chun aon phionóis eile den tsórt san ag an triail sin, o dheire na trialach san, ach mara dtánathas ar aon bhreith-fhocal ag an triail sin ní chuirfidh an daora san cosc leis an duine sin do thriail arís, tar éis na príosúntachta san, sa chúis inar thárla an teip sin ar theacht ar bhreithfhocal ina taobh.

    ( b ) proceed with the trial of such person, in which case such person shall suffer imprisonment in accordance with such sentence as from the conclusion of and in addition to such other punishment (if any) as he may have been sentenced to at such trial or, where for any reason he was not sentenced to any such other punishment at such trial, as from the conclusion of such trial but where no verdict was found at such trial such sentence shall not prevent such person after he has suffered such imprisonment being again tried on the charge in respect of which such failure to find a verdict occurred.

    Number 33 of 1929: JURIES (PROTECTION) ACT, 1929

  32. #824850

    (3) An chomhacht a bronntar leis an alt so chun triail do chur ar athló beidh sí i dteanta agus ní hin ionad aon chomhachta eile a bheidh ann do réir dlí de thurus na huaire chun triail do chur ar athló, agus ní dhéanfidh triail do chur ar athló uair no dhó fén alt so cosc do chur leis an triail sin do chur ar athló ina dhiaidh sin fé aon chomhacht eile den tsórt san chun triail do chur ar athló, ná ní dhéanfidh triail do chur ar athló uair no dhó fé aon cheann de sna comhachta deiridh sin a luaidhtear cosc do chur leis an triail sin do chur ar athló ina dhiaidh sin fén alt so.

    (3) The power of adjourning a trial conferred by this section shall be in addition to and not in substitution for any other power of adjournment for the time being existing by law and one or two adjournments of a trial under this section shall not prevent a subsequent adjournment of such trial under any such other power of adjournment nor shall one or more adjournments of a trial under any of such last-mentioned powers prevent a subsequent adjournment of such trial under this section.

    Number 33 of 1929: JURIES (PROTECTION) ACT, 1929

  33. #1453473

    (2) Breithneoidh an coiste eitice do thriail chliniciúil bheartaithe ar cheart an triail bheartaithe a sheoladh agus na dálaí faoina mbeartaítear í a sheoladh agus, i gcás gur dóigh leis an gcoiste gur cheart an triail bheartaithe a sheoladh agus go mbeidh sé sásta leis na dálaí sin, formheasfaidh sé seoladh na trialach beartaithe agus déanfaidh an duine a bheidh ag déanamh comhshocruithe do sheoladh na trialach beartaithe an formheas sin a chur in iúl i scríbhinn don Aire.

    (2) The ethics committee for a proposed clinical trial shall consider the justification for conducting the proposed trial and the circumstances under which it is proposed to be conducted and, where the committee considers that the proposed trial is justified and it is satisfied with those circumstances, it shall give its approval to the conducting of the proposed trial and the person who is arranging for the conducting of the proposed trial shall communicate such approval to the Minister in writing.

    Number 28 of 1987: CONTROL OF CLINICAL TRIALS ACT, 1987

  34. #1703750

    folaíonn "foilseáin" gach leabhar, páipéar agus doiciméad, agus an mhaoin, na hábhair agus na nithe eile go léir d'aon sórt a bhainfidh leis na himeachtaí i gcoinne aon duine a bheidh i dteideal, nó a bhféadfar a údarú dó, achomharc a dhéanamh, más rud é go mbeidh siad curtha ar aghaidh chun na Cúirte trialach ar an duine cúisithe a chimiú chun a thrialach, nó go mbeifear tar éis iad a thabhairt ar aird agus a úsáid i bhfianaise le linn trialach duine, nó imeachtaí eile i ndáil le duine, a bheidh i dteideal nó a mbeidh údarás aige achomharc a dhéanamh, agus aon ráiteas i scríbhinn a bheidh sínte ag an duine sin isteach chun Breitheamh na Cúirte trialach, ach ní fholóidh sé teistíochtaí bunaidh finnéithe a bheifear tar éis a cheistiú os comhair an bhreithimh a mbeidh an cimiú déanta aige ná aon díotáil i gcoinne aon duine den sórt sin nó aon phléadáil a bheidh comhdaithe sa chúirt trialach;

    "exhibits" includes all books, papers and documents and all other property, matters and things whatsoever connected with the proceedings against any person who is entitled or may be authorised to appeal if the same have been forwarded to the Court of trial on the person accused being committed for trial, or having been produced and used in evidence during the trial of, or other proceedings in relation to a person entitled or authorised to appeal, and any written statement handed in to the Judge of the Court of trial by such person, but shall not include the original depositions of witnesses examined before the committing justice nor any indictment against any such person or any plea filed in the court of trial;

    S.I. No. 15 of 1986: The Rules of the Superior Courts

  35. #148034

    Mura mbeidh an triail curtha síos ag páirtí amháin nó ag an bpáirtí eile laistigh de shé lá tar éis fógra trialach a thabhairt, ní bheidh feidhm a thuilleadh ag an bhfógra trialach.

    Unless, within six days after notice of trial is given the trial shall be set down by one party or the other, the notice of trial shall be no longer in force.

    Statutory Instruments: 1980

  36. #640720

    Ba cheart an chumhacht a thabhairt don Bhallstát lena mbaineann an t-údarú do thriail chliniciúil a chúlghairm, triail chliniciúil a fhionraí nó a cheangal ar an urraitheoir triail chliniciúil a mhodhnú.

    The Member State concerned should be given the power to revoke the authorisation of a clinical trial, suspend a clinical trial or require the sponsor to modify a clinical trial.

    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

  37. #641120

    tagairt don triail chliniciúil nó do na trialacha cliniciúla atáthar a mhodhnú go substaintiúil ag úsáid uimhir trialach AE dá dtagraítear sa tríú fomhír d'Airteagal 81(1) (“uimhir trialach AE”);

    a reference to the clinical trial or clinical trials which are substantially modified using the EU trial number referred to in the third subparagraph of Article 81(1) (the ‘EU trial number’);

    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

  38. #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.

    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

  39. #641780

    tuairisc ar chineál na trialach cliniciúla atá le stiúradh agus plé ar dhearadh na trialach cliniciúla (lena n-áirítear scéimléaráid de dhearadh, nósanna imeachta agus céimeanna na trialach, más ábhartha);

    a description of the type of clinical trial to be conducted and a discussion of the trial design (including a schematic diagram of trial design, procedures and stages, if relevant);

    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

  40. #642098

    Faisnéis ghinearálta faoin triail chliniciúil (lena n-áirítear cá stiúradh an triail, cathain a rinneadh an triail chliniciúil, príomhchuspóirí na trialach agus míniú ar na cúiseanna le hé a stiúradh);

    General information about the clinical trial (including where and when the trial was conducted, the main objectives of the trial and an explanation of the reasons for conducting it);

    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

  41. #148037

    Muna gcuirfidh an páirtí a bheidh tar éis fógra trialach a thabhairt an triail síos an lá a tugadh an fógra trialach nó an lá dá éis sin, féadfaidh an páirtí dár tugadh an fógra, mura mbeidh an fógra curtha ar ceal faoi riail 20, an triail a chur síos laistigh de cheithre lá.

    If the party giving notice of trial omits to set down the trial on the day of or day after giving notice of trial, the party to whom notice has been given may, unless the notice has been countermanded under rule 20, within four days set down the trial.

    Statutory Instruments: 1980

  42. #163944

    Oibreoidh an fógra trialach sin agus a chomhdú chun an t-ábhar nó an chaingean (lena n-áiritear Frithéileamh más ann) a chur síos le haghaidh a éisteachta dáta na trialach a bheidh leagtha amach sa bhfógra trialach nó lá ar bith tar éis dul in éag don dáta a luafar san fhógra sin a thiocfaidh an triail ar aghaidh de réir a oird sa liosta.

    Such notice of trial and filing thereof shall operate to set down the action or matter (including a Counterclaim if any) for hearing upon the date of trial set out in the notice of trial or upon any day after the expiration of the date mentioned in such notice upon which the trial may come on in its order in the list.

    Statutory Instruments: 1978

  43. #253181

    Oibreoidh an fógra trialach sin agus a chomhdú chun an chaingean nó an t-ábhar (lena n-áirítear frithéileamh, más ann) a chur síos lena héisteacht nó lena éisteacht ar an dáta trialach a bheidh leagtha amach san fhógra trialach nó ar lá ar bith tar éis dul in éag don dáta a bheidh luaite san fhógra sin ar a bhféadfaidh an triail teacht ar aghaidh de réir a hoird sa liosta nó ar cibé dáta a shocróidh an Chúirt nó an Cláraitheoir Contae tar éis Fógra a sheirbheáil.

    Such notice of trial and filing thereof shall operate to set down the action or matter (including a counterclaim if any) for hearing upon the date of trial set out in the notice of trial or upon any day after the expiration of the date mentioned in such notice upon which the trial may come on in its order in the list or upon such date as may be fixed by the Court or the County Registrar following the service of a Notice.

    S.I. No. 510 of 2001: The Circuit Court Rules

  44. #640769

    Maidir le hAirteagal 114 CFAE, déantar, leis an Rialachán seo, comhchuibhiú ar na rialacha maidir le stiúradh trialacha cliniciúla san Aontas lena n-áirithítear, dá réir sin, feidhmiú an mhargaidh inmheánaigh d'fhonn triail chliniciúil a stiúradh i roinnt Ballstát éagsúil, inghlacthacht ar fud an Aontais sonraí arna nginiúint i dtriail chliniciúil agus arna gcur isteach san iarratas ar údarú trialach cliniciúla eile, nó táirge íocshláinte a chur ar an margadh, agus saorghluaiseacht táirgí íocshláinte i gcomhthéacs trialach cliniciúla.

    Regarding Article 114 TFEU, this Regulation harmonises the rules for the conduct of clinical trials in the Union, therefore ensuring the functioning of the internal market in view of the conduct of a clinical trial in several Member States, the acceptability throughout the Union of data generated in a clinical trial and submitted in the application for the authorisation of another clinical trial or of the placing on the market of a medicinal product, and the free movement of medicinal products used in the context of a clinical trial.

    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

  45. #641234

    De mhaolú ar phointe (b) agus ar phointe (c) d'Airteagal 28(1), ar phointe (a) agus ar phointe (b) d'Airteagal 31(1) agus ar phointe (a) agus (b) d'Airteagal 32(1), féadfar toiliú feasach a fháil páirt a ghlacadh i dtriail chliniciúil, agus féadfar faisnéis maidir leis an triail chliniciúil a thabhairt, tar éis an cinneadh an duine is ábhar a áireamh sa triail chliniciúil ar choinníoll go ndéanfar an cinneadh tráth na chéad idirghabhála maidir leis an duine is ábhar i gcomhréir leis an bprótacal don triail chliniciúil sin, agus go gcomhlíontar na coinníollacha seo a leanas ar fad:

    By way of derogation from points (b) and (c) of Article 28(1), from points (a) and (b) of Article 31(1) and from points (a) and (b) of Article 32(1), informed consent to participate in a clinical trial may be obtained, and information on the clinical trial may be given, after the decision to include the subject in the clinical trial, provided that this decision is taken at the time of the first intervention on the subject, in accordance with the protocol for that clinical trial" and that all of the following conditions are fulfilled:

    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

  46. #812900

    (3) Gach éinne a cuirfar ar aghaidh chun a thrialta ag cúirt speisialta agus a bheidh, nuair a scuirfidh an Chuid seo den Acht so de bheith i bhfeidhm, ag feitheamh le n-a thriail ag cúirt speisialta, tuigfar, nuair a thárlóidh an scur san, é do bheith curtha ar aghaidh chun a thrialta ag an bPríomh-Chúirt Choiriúil, agus tabharfar go dtí an Chúirt sin chun a thrialta agus trialfa sí é dá réir sin.

    (3) Every person sent forward for trial by a special court who is when this Part of this Act ceases to be in force awaiting trial by a special court shall on such cesser be deemed to have been sent forward for trial by the Central Criminal Court, and shall be brought for trial to and be tried by that Court accordingly.

    Number 31 of 1927: PUBLIC SAFETY ACT, 1927

  47. #824824

    (a) a ordú go bhfuilingeoidh an duine sin an phríosúntacht san láithreach agus sa chás san déanfar láithreach an duine sin do bhreith chun siúil i gcimeád agus do chur i bpríosún do réir an daortha san agus beidh triail an duine sin sa chúis ina raibh sé á thriail nuair a daoradh amhlaidh é ar athló go dtí an chéad shuidhe eile, tar éis a scaoilte ón bpríosúntacht san, a bheidh ag an gCúirt sin no, i gcás na Cúirte Cuarda, a bheidh ag an gCúirt sin chun ceisteanna coiriúla sa chontae no sa chontae-bhuirg sin do thriail, agus ar a scaoile amhlaidh coinneofar i gcimeád é fé is dá gcuirtí ar aghaidh é chun a thrialta ag an suidhe chun a mbeidh a thriail curtha ar athló amhlaidh, no

    ( a ) direct that such person shall suffer such imprisonment forthwith, in which case such person shall thereupon be removed in custody and imprisoned in accordance with such sentence, and the trial of such person on the charge on which he was being tried when he was so sentenced shall stand adjourned to the sittings of such Court or, in the case of the Circuit Court, to the sittings of such Court for the trial of criminal issues in that county or county borough, next after his release from such imprisonment, and upon such release he shall be detained in custody as if he had been returned for trial at the sittings to which his trial so stands adjourned, or

    Number 33 of 1929: JURIES (PROTECTION) ACT, 1929

  48. #824848

    (2) Pé uair a cuirfar triail duine chúisithe ar athló fén alt so tuigfar chun gach críche gur cuireadh an duine cúisithe sin ar aghaidh chun a thrialta ag an suidhe chun ar cuireadh a thriail ar athló amhlaidh agus féadfar dá réir sin, d'ainneoin éinní ina choinnibh sin in aon reacht a bheidh i bhfeidhm i Saorstát Éireann, é do choinneáil i gcimeád fé is dá gcuirtí é ar aghaidh chun a thrialta ag an suidhe sin.

    (2) Whenever the trial of an accused person is adjourned under this section such accused person shall for all purposes he deemed to have been returned for trial at the sittings to which his trial is so adjourned and may accordingly, notwithstanding anything to the contrary contained in any statute in force in Saorstát Eireann, be detained in custody as if he had been returned for trial at such sittings.

    Number 33 of 1929: JURIES (PROTECTION) ACT, 1929

  49. #937234

    (4) Fé réir forálacha an Achta so, an cleachtadh agus an nós imeachta bhaineann le duine do thriail ar a dhíotáil sa Phríomh-Chúirt Choiriúil bainfid, sa mhéid gur féidir é, le duine do thriail ag Cúirt Choiriúil Speisialta agus na rialacha i dtaobh fianaise is infheidhmithe le linn duine do thriail amhlaidh sa Phríomh-Chúirt Choiriúil bainfid le gach triail a dhéanfaidh Cúirt Choiriúil Speisialta.

    (4) Subject to the provisions of this Act, the practice and procedure applicable to the trial of a person on indictment in the Central Criminal Court shall, so far as practicable, apply to the trial of a person by a Special Criminal Court, and the rules of evidence applicable upon such trial in the Central Criminal Court shall apply to every trial by a Special Criminal Court.

    Number 13 of 1939: OFFENCES AGAINST THE STATE ACT, 1939

  50. #1453471

    —(1) Más rud é gur deimhin leis an Aire, maidir le coiste eitice beartaithe do thriail chliniciúil, go bhfuil an coiste sin inniúil chun a bhreithniú ar cheart an triail chliniciúil bheartaithe a sheoladh agus chun breithniú a dhéanamh ar na dálaí faoina seolfar í, formheasfaidh sé an coiste beartaithe agus air sin tiocfaidh an coiste sin chun bheith ina choiste eitice don triail chliniciúil bheartaithe agus, i gcás go dtabharfaidh an coiste eitice a fhormheas de réir fho-alt (2), don triail chliniciúil.

    — (1) Where the Minister is satisfied that a proposed ethics committee for a clinical trial is competent to consider the justification for conducting the proposed clinical trial and the circumstances under which it is to be conducted, he shall give his approval of the proposed committee, which shall thereupon become the ethics committee for the proposed clinical trial and, where the ethics committee gives its approval in accordance with subsection (2), for the clinical trial.

    Number 28 of 1987: CONTROL OF CLINICAL TRIALS ACT, 1987