#641349
Comhlíonadh an phrótacail agus an dea-chleachtais chliniciúil
Compliance with the protocol and good clinical practice
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#1969909
Imscrúdú cliniciúil ar fheistí leighis le haghaidh daoine - Dea-chleachtas cliniciúil (SO 14155:2020)”;
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)’
#1969977
Imscrúdú cliniciúil ar fheistí leighis le haghaidh daoine - Dea-chleachtas cliniciúil (ISO 14155:2020)”;
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)’
#2050380
ráiteas comhlíontachta i leith an dea-chleachtais chliniciúil;
a statement of compliance with good clinical practice;
#3221429
Le haghaidh aon chigireacht shainiúil maidir le Dea-chleachtas Cliniciúil laistigh den Aontas, beidh feidhm ag táille EUR 45600.
For any distinct Good Clinical Practice inspection within the Union a fee of EUR 45600 shall apply.
#3221431
Le haghaidh aon chigireacht shainiúil maidir le Dea-chleachtas Cliniciúil lasmuigh den Aontas, beidh feidhm ag táille EUR 57000.
For any distinct Good Clinical Practice inspection outside the Union a fee of EUR 57000 shall apply.
#284934
2. Déanfaidh an Coimisiún, tar éis dul i gcomhairle leis an nGníomhaireacht, treoirlínte mionsonraithe a tharraingt suas maidir leis an dea-chleachtas cliniciúil a bhainfidh go sonrach le táirgí íocshláinte ardteiripe.
2. The Commission shall, after consulting the Agency, draw up detailed guidelines on good clinical practice specific to advanced therapy medicinal products.
#641350
Áiritheoidh urraitheoir na trialach cliniciúla agus an t-urraitheoir go ndéanfar an triail chliniciúil a stiúradh i gcomhréir leis an bprótacal agus le prionsabail an dea-chleachtais chliniciúil.
The sponsor of a clinical trial and the investigator shall ensure that the clinical trial is conducted in accordance with the protocol and with the principles of good clinical practice.
#641352
Cuirfidh an Coimisiún ar fáil don phobal na treoirlínte mionsonraithe ICH le dea-chleachtas cliniciúil dá dtagraítear sa dara fomhír.
The Commission shall make publicly available the detailed ICH guidelines on good clinical practice referred to in the second paragraph.
#641769
ráiteas go bhfuil an triail chliniciúil le stiúradh i gcomhréir leis an bprótacal, leis an Rialachán seo agus leis na prionsabail dea-chleachtais chliniciúil;
a statement that the clinical trial is to be conducted in compliance with the protocol, with this Regulation and with the principles of good clinical practice;
#641950
Tabharfar tuairisc ar aon oiliúint a fuarthas roimhe sin i bprionsabail an dea-chleachtais chliniciúil nó ar aon taithí a fuarthas ó obair i mbun trialacha cliniciúla agus ar chúram othar.
Any previous training in the principles of good clinical practice or experience obtained from work with clinical trials and patient care shall be described.
#745148
Déanfaidh an tUrraitheoir fianaise a chur ar fáil lena léireofar go bhfuil an t-imscrúdú á dhéanamh i gcomhréir le dea-chleachtas cliniciúil, mar shampla trí chigireacht inmheánach nó sheachtrach.
The Sponsor shall provide evidence that the investigation is being conducted in line with good clinical practice, for instance through internal or external inspection.
#1735994
Déanfar trialacha cliniciúla allamuigh i gcomhréir le prionsabail sheanbhunaithe dea-chleachtais chliniciúla, ach amháin má tá údar maith gan sin a dhéanamh.
Clinical field trials shall be conducted in accordance with established principles of good clinical practice, unless otherwise justified.
#1736274
Déanfar trialacha cliniciúla i gcomhréir le prionsabail sheanbhunaithe dea-chleachtais, ach amháin mura bhfuil údar leo.
Field trials shall be conducted in accordance with established principles of good clinical practice, unless otherwise justified.
#2049537
Déanfar trialacha cliniciúla (trialacha allamuigh) i gcomhréir le prionsabail sheanbhunaithe an dea-chleachtais chliniciúil, ach amháin mura bhfuil údar leis.
Clinical trials (field trials) shall be conducted in accordance with established principles of good clinical practice, unless otherwise justified.
#2049884
Tabharfar aird iomchuí ar threoirlínte idirnáisiúnta dhea-chleachtais VICH agus ar threoraíocht ábhartha arna foilsiú ag an nGníomhaireacht agus trialacha cliniciúla á ndearadh, á ndéanamh agus á dtuairisciú.
Clinical trials shall be designed, carried out and reported taking due account of the international guidelines on good clinical practice of the VICH and relevant guidance published by the Agency.
#2050243
Déanfar trialacha cliniciúla (trialacha allamuigh) i gcomhréir le prionsabail sheanbhunaithe an dea-chleachtais chliniciúil (DCC).
Clinical trials (field trials) shall be conducted in compliance with established principles of good clinical practice (GCP).
#284857
(16) Ba chóir trialacha cliniciúla ar tháirgí íocshláinte ardteiripe a reáchtáil i gcomhréir leis na prionsabail uileghabhálacha agus leis na ceanglais eiticiúla a leagtar síos le Treoir 2001/20/CE ó Pharlaimint na hEorpa agus ón gComhairle an 4 Aibreán 2001 maidir le comhfhogasú dhlíthe, rialacháin agus fhorálacha riaracháin na mBallstát maidir le cur chun feidhme an dea-chleachtais chliniciúil i reáchtáil trialacha cliniciúla ar tháirgí íocshláinte lena n-úsáid ag an duine [6].
(16) Clinical trials on advanced therapy medicinal products should be conducted in accordance with the overarching principles and the ethical requirements laid down in Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use [6].
#284858
Ba chóir oiriúnú a dhéanamh, áfach, ar Threoir 2005/28/CE ón gCoimisiún an 8 Aibreán 2005 lena leagtar síos prionsabail agus treoirlínte mionsonraithe do dhea-chleachtas cliniciúil maidir le táirgí íocshláinte imscrúdaitheacha lena n-úsáid ag an duine, mar aon leis na ceanglais údaraithe chun táirgí den sórt sin a dhéanamh nó a allmhairiú [7], trí rialacha a leagan síos a saincheapadh chun go gcuirfí san áireamh go hiomlán na tréithe teicniúla sonracha a bhaineann le táirgí íocshláinte ardteiripe.
However, Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products [7] should be adapted by laying down rules tailored to fully take into account the specific technical characteristics of advanced therapy medicinal products.
#284871
Ba chóir na treoirlínte maidir le dea-chleachtas cliniciúil agus dea-chleachtas déantúsaíochta a leagan síos a luaithe agus is féidir, agus b’fhearr go ndéanfaí é sin i rith na chéad bhliana tar éis don Rialachán seo teacht i bhfeidhm agus roimh an dáta a gcuirfear i bhfeidhm é.
The guidelines on good clinical practice and good manufacturing practice should be laid down as soon as possible, preferably during the first year after entry into force and before the date of application of this Regulation.
#348054
Treoir 2001/20/CE ó Pharlaimint na hEorpa agus ón gComhairle an 4 Aibreán 2001 maidir le comhfhogasú dhlíthe, rialacháin agus fhorálacha riaracháin na mBallstát maidir le dea-chleachtas cliniciúil a chur chun feidhme i stiúradh trialacha cliniciúla ar tháirgí íocshláinte lena n-úsáid ag an duine.
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.
#349195
Déanfaidh an Coimisiún na prionsabail a ghlacadh a bhaineann leis an dea-chleachtas cliniciúil mar aon le rialacha mionsonraithe a bheidh ag teacht leis na prionsabail sin agus, más gá, déanfaidh sé athbhreithniú ar na prionsabail agus ar na rialacha mionsonraithe sin chun aird a thabhairt ar ascnamh teicniúil agus eolaíoch.
The Commission shall adopt the principles relating to good clinical practice and detailed rules in line with those principles and shall, if necessary, revise those principles and detailed rules to take account of technical and scientific progress.
#349199
Maidir le Treoir 2001/20/CE, ba cheart, go háirithe, go dtabharfaí de chumhacht don Choimisiún, prionsabail a bhaineann leis an dea-chleachtas cliniciúil mar aon le rialacha mionsonraithe a bheidh ag teacht leis na prionsabail sin a ghlacadh, ceanglais shonracha a leagan síos agus forálacha áirithe a oiriúnú.
As regards Directive 2001/20/EC, the Commission should be empowered in particular to adopt principles relating to good clinical practice and detailed rules in line with those principles, to lay down specific requirements and to adapt certain provisions.
#349200
Treoir 2001/20/CE ó Pharlaimint na hEorpa agus ón gComhairle an 4 Aibreán 2001 maidir le comhfhogasú dhlíthe, rialacháin agus fhorálacha riaracháin na mBallstát maidir le dea-chleachtas cliniciúil a chur chun feidhme i stiúradh trialacha cliniciúla ar tháirgí íocshláinte lena n-úsáid ag an duine [8]
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use [8]
#640673
Comhaltaí na Comhdhála Idirnáisiúnta ar Chomhchuibhiú Ceanglas Teicniúil do Chlárú Cógaisíochta lena nÚsáid ag an Duine (ICH), tá siad tar éis comhaontú ar shraith mhionsonraithe treoirlínte maidir le dea-chleachtas cliniciúil arb ionann í anois agus caighdeán a nglactar go hidirnáisiúnta leis maidir le dearadh, stiúradh, taifeadadh agus tuairisciú trialacha cliniciúla, atá comhsheasmhach le prionsabail a bhfuil a mbunús i nDearbhú Heilsincí de chuid Chomhlachas Domhanda na Lianna Míochaine.
The members of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) have agreed on a detailed set of guidelines on good clinical practice which is an internationally accepted standard for designing, conducting, recording and reporting clinical trials, consistent with principles that have their origin in the World Medical Association's Declaration of Helsinki.
#640675
I gcás den sórt sin, ba cheart treoirlínte ICH maidir le dea-chleachtas cliniciúil a chur i gcuntas go hiomchuí maidir le cur chun feidhme na rialacha a leagtar amach sa Rialachán seo, ar choinníoll nach bhfuil aon treoraíocht shonrach eile eisithe ag an gCoimisiún agus go bhfuil na treoirlínte sin comhsheasmhach leis an Rialachán seo.
In such a case, the ICH guidelines on good clinical practice should be taken appropriately into account for the application of the rules set out in this Regulation, provided that there is no other specific guidance issued by the Commission and that those guidelines are compatible with this Regulation.
#640760
Tá an Rialachán seo ag luí leis na príomhdhoiciméid treoraíochta idirnáisiúnta maidir le trialacha cliniciúla, amhail leagan 2008 de Dhearbhú Heilsincí ón gComhlachas Domhanda na Lianna Míochaine agus an dea-chleachtas cliniciúil atá bunaithe ar Dhearbhú Heilsincí.
This Regulation is in line with the major international guidance documents on clinical trials, such as the 2008 version of the World Medical Association's Declaration of Helsinki and good clinical practice, which has its origins in the Declaration of Helsinki.
#640831
Ciallaíonn “dea-chleachtas cliniciúil” sraith ceanglas mionsonraithe maidir le cáilíocht eiticiúil agus eolaíoch do dhearadh, stiúradh, déanamh, faireachán, iniúchadh, taifeadadh, anailísiú agus tuairisciú trialacha cliniciúla lena n-áiritheofar go ndéantar cearta, sábháilteacht agus dea-bhail na ndaoine is ábhar, agus go mbeidh na sonraí a ghintear sa triail chliniciúil iontaofa agus stóinseach;
‘Good clinical practice’ means a set of detailed ethical and scientific quality requirements for designing, conducting, performing, monitoring, auditing, recording, analysing and reporting clinical trials ensuring that the rights, safety and well-being of subjects are protected, and that the data generated in the clinical trial are reliable and robust;
#641351
Gan dochar do reachtaíocht ná d'aon fhoráil eile de dhlí an Aontais ná do threoirlínte sonracha an Choimisiúin, déanfaidh an t-urraitheoir agus an t-imscrúdaitheoir, agus an prótacal á tharraingt suas acu agus an Rialachán seo agus an prótacal á gcur i bhfeidhm acu, aird iomchuí a thabhairt freisin ar na caighdeáin cháilíochta agus i dtreoirlínte ICH maidir le dea-chleachtas cliniciúil.
Without prejudice to any other provision of Union law or Commission guidelines, the sponsor and the investigator, when drawing up the protocol and when applying this Regulation and the protocol, shall also take appropriate account of the quality standards and the ICH guidelines on good clinical practice.
#641709
Treoir 2001/20/CE ó Pharlaimint na hEorpa agus ón gComhairle an 4 Aibreán 2001 maidir le comhfhogasú dhlíthe, rialacháin agus fhorálacha riaracháin na mBallstát maidir le dea-chleachtas cliniciúil a chur chun feidhme i stiúradh trialacha cliniciúla ar tháirgí íocshláinte lena n-úsáid ag an duine (IO L 121, 1.5.2001, lch. 34).
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L121, 1.5.2001, p.34).
#641875
Beidh ráiteas ann freisin maidir le comhlíonadh an dea-chleachtais chliniciúil ag na trialacha cliniciúla roimhe sin, chomh maith le tagairt don iontráil phoiblí dá dtagraítear in Airteagal 25(6).
It shall also contain a statement of the compliance with good clinical practice of those previous clinical trials, as well as a reference to the public entry referred to in Article 25(6).
#741606
Ba cheart na rialacha maidir le himscrúduithe cliniciúla a bheith i gcomhréir leis an treoir idirnáisiúnta sheanbhunaithe sa réimse sin, amhail Caighdeán Idirnáisiúnta ISO 14155:2011 maidir le dea-chleachtas cliniciúil i gcás imscrúduithe cliniciúla ar fheistí leighis lena n-úsáid ag daoine, le gur fusa a bheidh sé lasmuigh den Aontas glacadh leis na torthaí ó imscrúduithe cliniciúla a dhéantar san Aontas mar dhoiciméadacht agus le gur fusa a bheidh sé laistigh den Aontas glacadh leis na torthaí ó imscrúduithe cliniciúla a dhéantar lasmuigh den Aontas i gcomhréir le treoirlínte idirnáisiúnta.
The rules on clinical investigations should be in line with well-established international guidance in this field, such as the international standard ISO 14155:2011 on good clinical practice for clinical investigations of medical devices for human subjects, so as to make it easier for the results of clinical investigations conducted in the Union to be accepted as documentation outside the Union and to make it easier for the results of clinical investigations conducted outside the Union in accordance with international guidelines to be accepted within the Union.
#745054
Tabharfar treoracha leordhóthanacha don phearsanra a bheidh páirteach san imscrúdú agus cuirfear oiliúint leordhóthanach orthu ó thaobh na feiste imscrúdaithí a úsáid go cuí, agus maidir leis an bplean don imscrúdú cliniciúil agus dea-chleachtas cliniciúil.
Personnel involved in the conduct of an investigation shall be adequately instructed and trained in the proper use of the investigational device, and as regards the clinical investigation plan and good clinical practice.
#745120
Ráiteas lena gcuirtear in iúl go gcomhlíontar na prionsabail aitheanta eiticiúla i ndáil le taighde leighis a bhaineann le daoine agus na prionsabail i ndáil le dea-chleachtais chliniciúla ó thaobh imscrúduithe cliniciúla ar fheistí chomh maith leis na ceanglais rialála is infheidhme.
Statement of compliance with the recognised ethical principles for medical research involving humans, and the principles of good clinical practice in the field of clinical investigations of devices, as well as with the applicable regulatory requirements.
#745146
Ceapfaidh an tUrraitheoir monatóir a bheidh neamhspleách ar an láthair imscrúdaithe chun a áirithiú go ndéanfar an t-imscrúdú a chur i gcrích i gcomhréir leis an PIC, le prionsabail an dea-chleachtais chliniciúil agus leis an Rialachán seo.
The Sponsor shall appoint a monitor that is independent from the investigational site to ensure that the investigation is conducted in accordance with the CIP, the principles of good clinical practice and this Regulation.
#745461
Ba cheart na rialacha maidir le staidéir feidhmíochta a bheith i gcomhréir leis an treoir idirnáisiúnta seanbhunaithe sa réimse seo, amhail caighdeán idirnáisiúnta ISO 14155:2011 maidir le dea-chleachtas cliniciúil i gcás imscrúduithe cliniciúla ar fheistí leighis lena n-úsáid ag an duine, le gur fusa a bheidh sé na torthaí ar staidéir feidhmíochta a dhéanfar san Aontas a ghlacadh mar dhoiciméadacht lasmuigh den Aontas agus le gur fusa a bheidh sé torthaí na staidéar feidhmíochta sin a dhéanfar lasmuigh den Aontas i gcomhréir le treoirlínte idirnáisiúnta a ghlacadh laistigh den Aontas.
The rules on performance studies should be in line with well-established international guidance in this field, such as the international standard ISO 14155:2011 on good clinical practice for clinical investigations of medical devices for human subjects, so as to make it easier for the results of performance studies conducted in the Union to be accepted as documentation outside the Union and to make it easier for the results of performance studies conducted outside the Union in accordance with international guidelines to be accepted within the Union.
#748526
ráiteas lena gcuirtear in iúl go gcomhlíontar na prionsabail aitheanta eiticiúla i ndáil le taighde leighis a bhaineann le daoine agus na prionsabail i ndáil le dea-chleachtas cliniciúil i réimse na staidéar ar fheidhmíocht chliniciúil chomh maith le comhlíonadh na gceanglas rialála is infheidhme;
statement of compliance with the recognised ethical principles for medical research involving humans and the principles of good clinical practice in the field of clinical performance studies as well as with the applicable regulatory requirements;
#748624
Ceapfaidh an t-urraitheoir monatóir a bheidh neamhspleách ar an láthair imscrúdaithe chun a áirithiú go ndéanfar an staidéar ar fheidhmíocht chliniciúil a chur i gcrích i gcomhréir leis an bPlean don Staidéar ar Fheidhmíocht Chliniciúil, le prionsabail an dea-chleachtais chliniciúil agus leis an Rialachán seo.
The sponsor shall appoint a monitor that is independent of the investigation site to ensure that the clinical performance study is conducted in accordance with the Clinical Performance Study Plan, the principles of good clinical practice and this Regulation.
#1671672
Treoir 2001/20/CE ó Pharlaimint na hEorpa agus ón gComhairle an 4 Aibreán 2001 maidir le comhfhogasú dhlíthe, rialacháin agus fhorálacha riaracháin na mBallstát maidir le dea-chleachtas cliniciúil a chur chun feidhme i stiúradh trialacha cliniciúla ar tháirgí íocshláinte lena n-úsáid ag an duine (IO L 121, 1.5.2001, lch. 34).”.
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p. 34).’;
#1733211
comhordú a dhéanamh, a mhéid a bhaineann le táirgí íocshláinte lena n-úsáid ag an duine agus táirgí íocshláinte tréidliachta, ar a fhíorú an bhfuil prionsabail an dea-chleachtais monaraíochta, an dea-chleachtais saotharlainne agus an dea-chleachtais chliniciúil á gcomhlíonadh agus, a mhéid a bhaineann le táirgí íocshláinte lena n-úsáid ag an duine, ar a fhíorú an bhfuil oibleagáidí cógas-aireachais á gcomhlíonadh;
coordinating, as regards medicinal products for human use and veterinary medicinal products, the verification of compliance with the principles of good manufacturing practice, good laboratory practice, good clinical practice and, as regards medicinal products for human use, the verification of compliance with pharmacovigilance obligations;
#1733882
Déanfar na trialacha cliniciúla agus aird chuí á tabhairt ar threoirlínte idirnáisiúnta maidir le dea-chleachtas cliniciúil an Chomhair Idirnáisiúnta um Chomhchuibhiú Ceanglas Teicniúil do Chlárú Táirgí Íocshláinte Tréidliachta (“VICH”).
The clinical trials shall be carried out taking due account of the international guidelines on good clinical practice of the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (‘VICH’).
#1733884
Ní fhéadfar sonraí a thagann ó thrialacha cliniciúla arna ndéanamh lasmuigh den Aontas a chur san áireamh chun measúnú a dhéanamh ar iarratas ar údarú margaíochta ach amháin i gcás ina ndearnadh na trialacha sin a dhearadh, a chur chun feidhme agus a thuairisciú i gcomhréir le treoirlínte idirnáisiúnta VICH maidir le dea-chleachtas cliniciúil.
Data stemming from clinical trials conducted outside the Union may be taken into consideration for the assessment of an application for a marketing authorisation only if those trials were designed, implemented and reported in accordance with the international guidelines on good clinical practice of the VICH.
#1747963
Treoir 2001/82/CE ó Pharlaimint na hEorpa agus ón gComhairle an 6 Samhain 2001 maidir leis an gcód Comhphobail a bhaineann le táirgí íocshláinte tréidliachta (IO L 311, 28.11.2001, lch. 1). (19) Treoir 2001/20/CE ó Pharlaimint na hEorpa agus ón gComhairle an 4 Aibreán 2001 maidir le comhfhogasú dhlíthe, rialacháin agus fhorálacha riaracháin na mBallstát maidir le dea-chleachtas cliniciúil a chur chun feidhme i stiúradh trialacha cliniciúla ar tháirgí íocshláinte lena n-úsáid ag an duine (IO L 121, 1.5.2001, lch. 34).
Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1) (19) Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p. 34).
#1890904
Ceanglais eiticiúla agus dea-chleachtas cliniciúil a chomhlíonadh le linn do thrialacha cliniciúla a bheith á stiúradh, leanann siad de bheith éigeantach fós chomh maith le dea-chleachtas monaraíochta a chomhlíonadh i monarú nó in allmhairiú táirgí íocshláinte imscrúdaitheacha ina bhfuil OGManna nó atá comhdhéanta díobh.
Compliance with ethical requirements and good clinical practice in the conduct of clinical trials continues to be mandatory as well as compliance with good manufacturing practice in the manufacture or importation of investigational medicinal products containing or consisting of GMOs.
#1890948
Treoir 2001/20/CE ó Pharlaimint na hEorpa agus ón gComhairle an 4 Aibreán 2001 maidir le comhfhogasú fhorálacha reachtaíochta, rialúcháin agus riaracháin na mBallstát maidir le dea-chleachtas cliniciúil a chur chun feidhme i stiúradh trialacha cliniciúla ar tháirgí íocshláinte lena n‐úsáid ag an duine (IO L 121, 1.5.2001, lch. 34).
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p. 34).
#1952122
Treoir 2001/20/CE ó Pharlaimint na hEorpa agus ón gComhairle an 4 Aibreán 2001 maidir le comhfhogasú dhlíthe, rialacháin agus fhorálacha riaracháin na mBallstát maidir le dea-chleachtas cliniciúil a chur chun feidhme i stiúradh trialacha cliniciúla ar tháirgí íocshláinte lena n-úsáid ag an duine;
Directive 2001/20/EC of European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use;
#2162798
Tá sé fíor-riachtanach go bhfuil na gníomhaíochtaí a chistíonn Comhghnóthas Shláinte Dhomhanda EDCTP3 nó a chumhdaítear faoina chlár oibre, i gcomhréir iomlán le Cairt um Chearta Bunúsacha an Aontais Eorpaigh, an Coinbhinsiún Eorpach um Chearta an Duine agus a Phrótacail Fhorlíontacha, na prionsabail eiticiúla i nDearbhú Heilsincí de chuid Chomhlachas Domhanda na Lianna Míochaine, 2008, na caighdeáin dea-chleachtas a ghlac an Chomhdháil Idirnáisiúnta um Chomhchuibhiú Ceanglas Teicniúil i ndáil le Clárú Earraí Cógaisíochta atá le hÚsáid ag an Duine, reachtaíocht ábhartha an Aontais agus riachtanais eiticiúla áitiúla na dtíortha ina dtabharfar faoi na gníomhaíochtaí taighde.
It is essential that the research activities funded by Global Health EDCTP3 Joint Undertaking, or otherwise covered by its work programme, are in full compliance with the Charter of Fundamental Rights of the European Union, the European Convention on Human Rights and its Supplementary Protocols, ethical principles included in the World Medical Association’s Declaration of Helsinki of 2008, the standards of good clinical practice adopted by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, relevant Union legislation and local ethics requirements of the countries where the research activities are to be conducted.
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Treoir 2001/20/CE ó Pharlaimint na hEorpa agus ón gComhairle an 4 Aibreán 2001 maidir le comhfhogasú fhorálacha reachtaíochta, rialúcháin agus riaracháin na mBallstát maidir le dea-chleachtas cliniciúil a chur chun feidhme i stiúradh trialacha cliniciúla ar tháirgí íocshláinte lena n-úsáid ag an duine (IO L 121, 1.5.2001, lch. 34).
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p. 34).
#2277584
Treoir 2001/20/CE ó Pharlaimint na hEorpa agus ón gComhairle an 4 Aibreán 2001 maidir le comhfhogasú fhorálacha reachtaíochta, rialúcháin agus riaracháin na mBallstát maidir le dea-chleachtas cliniciúil a chur chun feidhme i stiúradh trialacha cliniciúla ar tháirgí íocshláinte lena n-úsáid ag an duine (IO L 121, 1.5.2001, lch. 34).
Directive 2001/20/EC of 4 April 2001 of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p. 34).
#2854603
Treoir 2001/20/CE ó Pharlaimint na hEorpa agus ón gComhairle an 4 Aibreán 2001 maidir le comhfhogasú fhorálacha reachtaíochta, rialúcháin agus riaracháin na mBallstát maidir le dea-chleachtas cliniciúil a chur chun feidhme i stiúradh trialacha cliniciúla ar tháirgí íocshláinte lena n-úsáid ag an duine (IO L 121, 1.5.2001, lch. 34).
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p. 34).