#1977117
Cód eagraíochta ó EMA (córas SPOR le haghaidh ISO IDMP)
Organisation code from EMA (SPOR system for ISO IDMP)
Scag na torthaí
Bailiúcháin
119 toradh in 42 doiciméad
#1992462
Cód eagraíochta ó EMA (córas SPOR le haghaidh ISO IDMP);
Organisation code from EMA (SPOR system for ISO IDMP);
#2160199
EMA CVMP (An Coiste um Tháirgí Íocshláinte d’Úsáid Tréidliachta de chuid na Gníomhaireachta Leigheasra Eorpaí), 2001.
EMA CVMP (European Medicines Agency Committee for Medicinal Products for Veterinary Use), 2001.
#2212235
An Ghníomhaireacht Leigheasra Eorpach (EMA)
European Medicines Agency (EMA)
#2387588
maidir le dúnadh chuntais na Gníomhaireachta Leigheasra Eorpaí (EMA) don bhliain airgeadais 2020
on the closure of the accounts of the European Medicines Agency (EMA) for the financial year 2020
#2570641
arna iarraidh sin don Choimisiún, do CSS nó do EMA; agus
at the request of the Commission, the HSC or EMA; and
#2664271
An Ghníomhaireacht Leigheasra Eorpach (EMA)
European Medicines Agency (EMA)
#2899939
maidir le dúnadh chuntais na Gníomhaireachta Leigheasra Eorpaí (EMA) don bhliain airgeadais 2021
on the closure of the accounts of the European Medicines Agency (EMA) for the financial year 2021
#2994619
Measúnú Riosca na Gníomhaireachta Leigheasra Eorpaí (EMA)
Risk Assessment of the European Medicines Agency (EMA)
#3032472
Tá meitibilítí den sórt sin le sainaithint de réir EMA/CPMP/ICH/286/1995, leathanach 8.
Such metabolites are to be identified according to EMA/CPMP/ICH/286/1995, page 8.
#3152716
An Ghníomhaireacht Leigheasra Eorpach (EMA)
European Medicines Agency (EMA)
#746775
I gcás feiste dhiagnóiseach choimhdeachta, tabharfaidh údarás inniúil na meastóireachta nó an t-údarás inniúil comhordúcháin dá dtagraítear i mír 9 den Airteagal seo an t-údarás inniúil náisiúnta sin nó EMA ar an eolas, de réir mar is iomchuí, ag brath ar cibé an ndeachaigh an comhlacht dá dtugtar fógra i gcomhairle le húdarás inniúil ábhartha an Bhallstáit a thug údarú do na táirgí míochaine nó le EMA, i gcomhréir leis na nósanna imeachta a leagtar amach i Roinn 5.2 d'Iarscríbhinn IX agus i Roinn 3.11 d'Iarscríbhinn X de réir mar is infheidhme.
In the case of companion diagnostic, the evaluating competent authority or the coordinating competent authority referred to in paragraph 9 of this Article shall, depending on whether the relevant competent authority of the Member State that authorised the medicinal products or the EMA was consulted by the notified body in accordance with the procedures set out in Section 5.2 of Annex IX and Section 3.11 of Annex X, inform that national competent authority or the EMA, as appropriate.
#2571686
I bhfianaise shainordú na Gníomhaireachta Leigheasra Eorpaí (EMA) agus i bhfianaise a róil a mhéid a bhaineann le faireachán agus maolú a dhéanamh ar ghanntanais fhéideartha nó iarbhír maidir le táirgí íocshláinte, feistí leighis agus feistí leighis diagnóiseacha in vitro, lena n-áirítear liostaí de tháirgí íocshláinte criticiúla agus d’fheistí leighis criticiúla a bhunú, faoi Rialachán (AE) 2022/123 ó Pharlaimint na hEorpa agus ón gComhairle, i bhfianaise na nithe sin ba cheart dlúthchomhar agus comhordú idir an Coimisiún agus EMA a áirithiú chun na bearta dá bhforáiltear sa Rialachán seo a chur chun feidhme.
In view of the mandate of the European Medicines Agency (EMA) and its role as regards monitoring and mitigating potential and actual shortages of medicinal products, medical devices and in vitro diagnostic medical devices, including establishing lists of critical medicinal products and critical medical devices, under Regulation (EU) 2022/123 of the European Parliament and of the Council, close cooperation and coordination between the Commission and EMA should be ensured to implement the measures provided for in this Regulation.
#3156178
Le Rialachán (AE) 2022/123, treisíodh ról an EMA maidir le hullmhacht agus bainistiú géarchéimeanna do tháirgí íocshláinte agus d’fheistí leighis, rud a chuir ar a chumas do EMA dlúthfhaireachán a dhéanamh ar na ganntanais táirgí leighis agus iad a mhaolú, agus éascú a dhéanamh ar fhormheas níos tapa ar na cógais a d’fhéadfadh galar a chóireáil nó a chosc, ar galar é is cúis le géarchéim sláinte poiblí.
Regulation (EU) 2022/123 strengthened the role of the EMA in crisis preparedness and the management of medicinal products and medical devices, allowing the EMA to closely monitor and mitigate shortages of medicines and facilitate the faster approval of medicines that could treat or prevent a disease causing a public health crisis.
#327624
- na roghanna seo a leanas a scrúdú i ndlúthchomhar le ECDC agus EMA agus WHO agus an obair atá déanta ag WHO go dtí seo á cur san áireamh:
- examine with the ECDC and the EMA in close cooperation with and taking into account the work done so far by the WHO, the options to
#748341
Áireofar i ndoiciméadacht an chomhlachta dá dtugtar fógra maidir leis an bhfeiste tuairim údarás na dtáirgí íocshláinte nó EMA, chomh maith le haon nuashonrú a d'fhéadfadh a bheith ann.
The opinion of the medicinal products authority consulted and any possible update shall be included in the documentation of the notified body concerning the device.
#1982150
https://www.ema.europa.eu/en/documents/other/functional-specifications-european-union-eu-portal-eu-database-be-audited_en.pdf
https://www.ema.europa.eu/documents/other/functional-specifications-european-union-eu-portal-eu-database-be-audited_en.pdf
#2160138
Tá meastóireacht déanta cheana féin ag an gCoiste um Tháirgí Íocshláinte d’Úsáid Tréidliachta de chuid na Gníomhaireachta Leigheasra Eorpaí (EMA CVMP) ar hidreaclóiríd ampróiliam.
Amprolium hydrochloride has already been evaluated by the European Medicines Agency Committee for Medicinal Products for Veterinary Use (EMA CVMP).
#2160139
Sa tuarascáil uaidh mí Eanáir 2001, chinn EMA CVMP nach bhfuil gá ar bith le huasteorainn iarmhar (MRL) a leagan síos i gcás ampróiliam.
In its report from January 2001, EMA CVMP concluded that there is no need to establish a maximum residue limit (MRL) for amprolium.
#2160200
Eanáir 2001. https://www.ema.europa.eu/en/documents/mrl-report/amprolium-summary-report-2-committee-veterinary-medicinal-products_en.pdf
January 2001. https://www.ema.europa.eu/en/documents/mrl-report/amprolium-summary-report-2-committee-veterinary-medicinal-products_en.pdf
#2281149
Sna conclúidí, chuir EMA in iúl gur i dtáirgí íocshláinte a úsáidtear dé-ocsaíd tíotáiniam go príomha mar dhath agus mar theimhneoir, fiú má tá feidhmeanna iomadúla eile aici.
In its conclusions, EMA indicated that titanium dioxide is mainly used in medicinal products as a colour and opacifier, even if it has multiple functions.
#2281153
Chuir EMA i dtábhacht an gá atá le measúnú cúramach ar roghanna eile, go háirithe chun a gcomhoiriúnacht le comhábhair éagsúla de tháirgí aonair cógaisíochta a áirithiú.
EMA highlighted the need to carefully assess alternatives, notably to ensure their compatibility with the various components of individual pharmaceutical products.
#2281207
Ba cheart an t-athbhreithniú sin a bhunú ar mheasúnú cothrom le dáta le EMA atá le déanamh roimh an 1 Aibreán 2024.
This review should be based on an updated assessment of the EMA to be performed before 1 April 2024.
#2342241
Tacaíonn an tuairim ó EMA leis na feachtais náisiúnta vacsaínithe sna Ballstáit sin a dhéanann cinneadh maidir le teanndáileoga a thairiscint do dhéagóirí.
The opinion from EMA supports the national vaccination campaigns in those Member States that decide to offer booster vaccinations to adolescents.
#2387563
maidir le hurscaoileadh i ndáil le cur chun feidhme bhuiséad na Gníomhaireachta Leigheasra Eorpaí (EMA) don bhliain airgeadais 2020
on discharge in respect of the implementation of the budget of the European Medicines Agency (EMA) for the financial year 2020
#2570885
Déanfar an obair sin go comhpháirteach le EMA agus go háirithe trí ardán nua um fhaireachán vacsaíní.”
That work shall be conducted jointly with EMA and in particular through a new vaccine monitoring platform.’
#2571655
Ba cheart ionadaithe na mBallstát, ionadaithe ECDC, ionadaithe EMA agus ionadaithe ghníomhaireachtaí nó chomhlachtaí eile de chuid an Aontais nó ionadaithe EDS, a bheith in ann a bheith rannpháirteach mar bhreathnóirí.
Representatives of the Member States, of the ECDC, of EMA, and of other Union agencies or bodies or of the WHO, should be able to participate as observers.
#2571687
Agus na cúraimí a leagtar amach in Airteagail 7 go 13 den Rialachán seo á ndéanamh aige, ba cheart don Choimisiún, lena n-áirítear HERA, freagrachtaí EMA a urramú ina n-iomláine.
When carrying out the tasks set out in Articles 7 to 13 of this Regulation, the Commission, including HERA, should fully respect EMA’s responsibilities.
#2571825
Áiritheoidh an Coimisiún idir-inoibritheacht an chórais TF leis na córais leictreonacha faireacháin agus tuairiscithe arna bhforbairt ag EMA de bhun Airteagal 9(1), pointe (c), de Rialachán (AE) 2022/123.
The Commission shall ensure the interoperability of the IT system with the electronic monitoring and reporting systems developed by EMA pursuant to Article 9(1), point (c), of Regulation (EU) 2022/123.
#2627793
ina bhfuil barúlacha atá in gcuid dhílis den chinneadh maidir le hurscaoileadh i ndáil le cur chun feidhme bhuiséad na Gníomhaireachta Leigheasra Eorpaí (EMA) don bhliain airgeadais 2020
with observations forming an integral part of the decision on discharge in respect of the implementation of the budget of the European Medicines Agency (EMA) for the financial year 2020
#2628674
ag tabhairt dá haire gur thuairiscigh formhór na ngníomhaireachtaí nach ndearna siad cásanna coinbhleachta leasa a imscrúdú agus/nó a thabhairt i gcrích in 2020; ag tabhairt dá haire gur tuairiscíodh cás amháin i gcás Frontex inar thángthas ar an gconclúid nach raibh aon choinbhleacht leasa ann; ag tabhairt dá haire, áfach, go bhfuil an cás sin fós á fhiosrú ag an Oifig Eorpach Frith-Chalaoise (OLAF); ag tabhairt dá haire freisin, i gcás EMA, gur chuir seisear saineolaí in iúl don Ghníomhaireacht go raibh sé beartaithe acu a bheith fostaithe i gcuideachta chógaisíochta; ag tabhairt dá haire, tar éis a mbeartais maidir le coinbhleachtaí leasa a chosc agus a bhainistiú, gur chuir EMA na bearta riachtanacha i bhfeidhm chun an baol a bhaineann le haon chásanna ina bhféadfadh coinbhleachtaí leasa teacht chun cinn a mhaolú;
Notes that most of the agencies reported that they have not investigated and/or concluded cases of conflict of interests in 2020; notes that for Frontex there was one case reported which concluded that no conflict of interest existed; notes, however, that the European Anti-Fraud Office (OLAF) is still investigating this case; further notes that for the EMA six experts informed the Agency of their intention to become employees in a pharmaceutical company; notes that following their policy on prevention and management of conflicts of interest, EMA applied the necessary measures to mitigate the risk of any cases of potential conflicts of interest arising;
#2899914
maidir le hurscaoileadh i ndáil le cur chun feidhme bhuiséad na Gníomhaireachta Leigheasra Eorpaí (EMA) don bhliain airgeadais 2021
on discharge in respect of the implementation of the budget of the European Medicines Agency (EMA) for the financial year 2021
#3032285
I gcomhréir le treoirlínte EMA ERA, cóimheas PEC/PNEC le haghaidh an táirge íocshláinte a fhaightear sa Mheasúnú Riosca Comhshaoil, tá sé faoi bhun 1.
In line with the EMA ERA guidelines, the PEC/PNEC ratio for the medicinal product obtained in the Environmental Risk Assessment is below 1.
#3032483
Céim 5, 2022, leagan 27.6.2023 le fáil aghttps://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use_en-33.pdf.
Step 5, 2022, version of 27.6.2023 available at: https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use_en-33.pdf.
#3032491
Céim 5, 2022, leagan 27.6.2023 le fáil aghttps://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use_en-33.pdf.
Step 5, 2022 (version of 27.6.2023 available at: https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use_en-33.pdf).
#3049210
ina bhfuil barúlacha atá in gcuid dhílis den chinneadh maidir le hurscaoileadh i ndáil le cur chun feidhme bhuiséad na Gníomhaireachta Leigheasra Eorpaí (EMA) don bhliain airgeadais 2021
with observations forming an integral part of the decision on discharge in respect of the implementation of the budget of the European Medicines Agency (EMA) for the financial year 2021
#3050243
ag tabhairt dá haire, maidir le hiontaofacht na gcuntas, gur eisigh an Chúirt mír maidir le ‘béim ar ábhar’ don Ghníomhaireacht Leigheasra Eorpach (EMA), don Ghníomhaireacht Eorpach um an nGarda Teorann agus Cósta (Frontex) agus don Institiúid Eorpach um Chomhionannas Inscne (EIGE); ag tabhairt dá haire go raibh baint ag an mír ‘béim ar ábhar’ do EMA leis an tsaincheist leanúnach maidir leis an gcomhaontú léasa dá áitribh roimhe sin i Londain a mhaireann go dtí 2039, gan aon fhoráil a dhéanamh maidir le luathfhoirceannadh agus dliteanais fhéideartha a mheastar a bheith cothrom le EUR 383 milliún an 31 Nollaig 2021; ag tabhairt dá haire go raibh baint ag an mír ‘béim ar ábhar’ do Frontex le ríomh mícheart na ranníocaíochtaí ó thíortha nach bhfuil i limistéar Schengen neamh-AE a bhfuil EUR 2,6 milliún níos lú ná mar ba cheart a bheith íoctha acu le buiséad Frontex in 2021; ag tabhairt dá haire go raibh an mhír ‘béim ar ábhar’ do EIGE bainteach le dliteanas teagmhasach (EUR 22000) ina chuntais a d’fhéadfaí a thabhú i gcás cúirte leanúnach a bhaineann le hoibrithe gníomhaireachta sealadacha;
Notes that, as regards the reliability of accounts, the Court issued an ‘emphasis of matter’ paragraph for the European Medicines Agency (EMA), the European Border and Coast Guard Agency (Frontex) and the European Institute for Gender Equality (EIGE); notes that the ‘emphasis of matter’ paragraph for EMA was related to the ongoing issue regarding the lease agreement for its previous premises in London that lasts until 2039, with no provision for early termination and potential liabilities estimated at EUR 383 million on 31 December 2021; notes that the ‘emphasis of matter’ paragraph for Frontex was related to the incorrect calculation of the contributions from non-EU Schengen area countries with EUR 2,6 million less than they should have paid to the budget of Frontex in 2021; notes that the ‘emphasis of matter’ paragraph for EIGE was related to a contingent liability (EUR 22000) in its accounts which could be incurred in an ongoing court case concerning temporary agency workers;
#3050291
ag tabhairt dá haire go bhfuil beartas sceithirí i bhfeidhm ag na gníomhaireachtaí uile, agus go bhfuil cuid acu (EMA, EU-LISA) tar éis é a nuashonrú in 2021; ag iarraidh ar CEPOL bealaí tuairiscithe sonracha sábháilte a chur i bhfeidhm i gcomhréir le ceanglais ábhartha Threoir (AE) 2019/1937 an 23 Deireadh Fómhair 2019 maidir le sceithireacht; ag tabhairt faoi deara gur tuairiscíodh cásanna sceithireachta in 2021 ag ÚBE (1 chás dúnta), ag Frontex (3 chás: dúnadh ceann amháin agus cuireadh in iúl é do OLAF agus dhá chás atá fós ar siúl) agus ag EUSPA (cás amháin atá fós ar siúl); ag tabhairt dá haire, thairis sin, nach ndearna EMA tuairisciú ar aon chás sceithireachta inmheánacha, ach fuarthas 29 dtuarascáil ar chásanna sceithireachta seachtracha, agus dúnadh 23 chás díobh sin agus tá 6 chás fós ar siúl; ag iarraidh ar na gníomhaireachtaí lena mbaineann tuairisciú don údarás um urscaoileadh maidir leis an dul chun cinn atá déanta sna cásanna atá fós ar siúl; ag iarraidh ar gach gníomhaireacht seisiúin oiliúna athnuachana maidir le beartas sceithireachta a thairiscint go rialta dá bhfoireann uile, an topaic sin a chur san áireamh sna cláir ionduchtúcháin do nuatheachtaithe agus faisnéis maidir le sceithireacht a fhoilsiú ar leathanaigh gréasáin inlín na ngníomhaireachtaí;
Notes that all agencies have a whistleblower policy in place, with some of them (EMA, eu-LISA) having updated it in 2021; calls on CEPOL to put specific, safe reporting channels in place in line with the relevant requirements of Directive (EU) 2019/1937 of the European Parliament and of the Council on whistleblowing; observes that in 2021, whistleblowing cases were reported at the EBA (1 case closed), at Frontex (3 cases: one closed and notified to OLAF and two cases ongoing) and at the EUSPA (1 case ongoing); further notes that the EMA did not report any internal whistleblowing cases, however, 29 reports of external whistleblowing cases were received, of which 23 cases were closed and 6 cases are still ongoing; calls on the agencies concerned to report to the discharge authority on the progress made in the ongoing cases; calls on all agencies to offer regular refresher training courses on whistleblowing policy to all their staff, to include this topic in the induction programmes for newcomers and to publish information on whistleblowing on the agencies’ intranet webpages;
#3156179
Tar éis idirthréimhse tosaigh, déanfaidh EMA comhordú freisin ar fhreagairtí na mBallstát ar ghanntanais feistí leighis criticiúla i gcás géarchéime.
After an initial transition period, the EMA will also coordinate responses of the Member States on shortages of critical medical devices in the event of a crisis.
#3245993
Comhoibriú, i gcomhar le ECDC, le saotharlanna i dtríú tíortha agus leis an Údarás Eorpach um Shábháilteacht Bia (EFSA) agus/nó leis an nGníomhaireacht Leigheasra Eorpach (EMA), de réir mar is ábhartha;
collaborating, in cooperation with the ECDC, with laboratories in third countries and with the European Food Safety Authority (EFSA) and/or the European Medicines Agency (EMA), as relevant;
#3246069
Comhoibriú, i gcomhar le ECDC, le saotharlanna i dtríú tíortha agus leis an nGníomhaireacht Eorpach Comhshaoil (EEA) agus leis an nGníomhaireacht Leigheasra Eorpach (EMA), de réir mar is ábhartha;
collaborating, in cooperation with ECDC, with laboratories in third countries and with the European Environmental Agency (EEA) and the European Medicines Agency (EMA), as relevant;
#3246088
Comhoibriú, i gcomhar le ECDC, le saotharlanna i dtríú tíortha agus leis an nGníomhaireacht Leigheasra Eorpach (EMA), de réir mar is ábhartha;
collaborating, in cooperation with the ECDC, with laboratories in third countries and the European Medicines Agency (EMA), as relevant;
#327619
- chun malartú faisnéise idir na soláthróirí seirbhísí vacsaíne a éascú agus chun liosta neamh-uileghabhálach na ngnéithe a mholtar a áireamh i gcártaí imdhíonta nó leabhráin sláinte náisiúnta agus fo-náisiúnta a shainaithint le tacaíocht ón Lárionad Eorpach um Ghalair a Chosc agus a Rialú (ECDC) agus ón nGníomhaireacht Leigheasra Eorpaí (EMA).
- in order to facilitate the exchange of information between vaccine service providers, to identify with the support of the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA) a non-exhaustive list of elements suggested for inclusion in national, sub-national immunisation cards or health booklets.
#739692
comhoibriú laistigh dá raon feidhme le saotharlanna i dtríú tíortha agus leis an Údarás Eorpach um Shábháilteacht Bia (ECDC), leis an nGníomhaireacht Leigheasra Eorpach (EMA) agus leis an Lárionad Eorpach um Ghalair a Chosc agus a Rialú (ECDC);
collaborating within the scope of their mission with laboratories in third countries and with the European Food Safety Authority (EFSA), the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC);
#741851
Nuair a dhéanfaidh an Coimisiún plé ar stádas rialála ionchasach mar fheiste i gcás táirgí lena mbaineann táirgí íocshláinte, fíocháin agus cealla daonna, bithicídí nó táirgí bia, áiritheoidh sé leibhéal iomchuí comhairliúcháin leis an nGníomhaireacht Leigheasra Eorpach (EMA), leis an nGníomhaireacht Eorpach Ceimiceán (ECHA) agus leis an Údarás Eorpach um Shábháilteacht Bia (EFSA), de réir mar is ábhartha.
When deliberating on the possible regulatory status as a device of products involving medicinal products, human tissues and cells, biocides or food products, the Commission shall ensure an appropriate level of consultation of the European Medicines Agency (EMA), the European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA), as relevant.
#743059
I gcás feistí dá dtagraítear sa chéad fhomhír d'Airteagal 1(8) agus ina bhféadfadh an teagmhas tromchúiseach nó an gníomh ceartaitheach um shábháilteacht allamuigh a bheith bainteach le substaint a measfaí gur táirge íocshláinte í dá mbeadh sí in úsáid ar leithligh, déanfaidh údarás inniúil na meastóireachta nó an t-údarás inniúil comhordúcháin dá dtagraítear i mír 9 den Airteagal seo an t-údarás inniúil sin nó EMA a chur ar an eolas, de réir mar is iomchuí, ag brath ar cé acu a thug an tuairim eolaíoch faoi Airteagal 52(9) aidir leis an substaint sin i dtaca leis an teagmhas sin tromchúiseach sin nó an an ghníomhaíocht cheartaitheach allamuigh.
In the case of devices referred to in the first subparagraph of Article 1(8) and where the serious incident or field safety corrective action may be related to a substance which, if used separately, would be considered to be a medicinal product, the evaluating competent authority or the coordinating competent authority referred to in paragraph 9 of this Article shall, inform the national competent authority or the EMA, depending on which issued the scientific opinion on that substance under Article 52(9), of that serious incident or field safety corrective action.
#744794
Sula ndéanfaidh an comhlacht dá dtugtar fógra deimhniú AE do mheasúnú ar dhoiciméadacht theicniúil a eisiúint, agus úsáideacht na substainte mar chuid den fheiste deimhnithe aige agus an chríoch a beartaíodh don fheiste á cur san áireamh, iarrfaidh sé tuairim eolaíoch ó cheann de na húdaráis inniúla a ainmneoidh na Ballstáit i gcomhréir le Treoir 2001/83/CE nó ó EMA, a ngairfear “an t-údarás um tháirgí íocshláinte a ndeachthas i gcomhairle leis” ar cheachtar acu sa Roinn seo, ag brath ar cé acu a ndeachthas i gcomhairle leis faoin bpointe seo, maidir le cáilíocht agus sábháilteacht na substainte lena n-áirítear tairbhe nó riosca ionchorprú na substainte san fheiste.
Before issuing an EU technical documentation assessment certificate, the notified body shall, having verified the usefulness of the substance as part of the device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or from the EMA, either of which to be referred to in this Section as ‘the medicinal products authority consulted’ depending on which has been consulted under this point, on the quality and safety of the substance including the benefit or risk of the incorporation of the substance into the device.
#744795
I gcás ina mbeidh díorthach ó fhuil dhaonna nó ó phlasma daonna nó substaint ionchorpraithe san fheiste,, a fhéadfar a mheas gur táirge íocshláinte í a thagann faoi raon eisiach na hIarscríbhinne a ghabhann le Rialachán (CE) Uimh. 726/2004, má tá sí in úsáid ar leithligh, iarrfaidh an comhlacht dá dtugtar fógra tuairim EMA.
Where the device incorporates a human blood or plasma derivative or a substance that, if used separately, may be considered to be a medicinal product falling exclusively within the scope of the Annex to Regulation (EC) No 726/2004, the notified body shall seek the opinion of the EMA.
#744827
Chomh maith leis sin, i gcás feistí, nó a dtáirgí meitibileachta a ionsúnn corp an duine go córasach ionas go mbainfear amach an críoch a beartaíodh dóibh, lorgóidh an comhlacht dá dtugtar fógra tuairim eolaíoch ó cheann de na húdaráis inniúla a ainmneoidh na Ballstáit i gcomhréir le Treoir 2001/83/CE nó ó EMA, dá ngairfear sa Roinn seo “an t-údarás um tháirgí íocshláinte a ndeachthas i gcomhairle leis” ag brath ar cé acu a ndeachthas i gcomhairle leis faoin bpointe seo, maidir le comhréireacht na feiste leis na ceanglais ábhartha a leagtar síos in Iarscríbhinn I a ghabhann le Treoir 2001/83/CE.
In addition, for devices, or their products of metabolism, that are systemically absorbed by the human body in order to achieve their intended purpose, the notified body shall seek a scientific opinion from one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or from the EMA, either of which to be referred to in this Section as ‘the medicinal products authority consulted’ depending on which has been consulted under this point, on the compliance of the device with the relevant requirements laid down in Annex I to Directive 2001/83/EC.
#745676
Nuair a dhéanfaidh an Coimisiún plé ar stádas rialála féideartha mar fheiste táirgí a bhaineann le táirgí íocshláinte, fíocháin agus cealla daonna, bithicídí nó táirgí bia, áiritheoidh sé leibhéal iomchuí comhairliúchán leis an nGníomhaireacht Leigheasra Eorpach (EMA), leis an nGníomhaireacht Eorpach Ceimiceán agus leis an Údarás Eorpach um Shábháilteacht Bia a áirithiú, de réir mar is ábhartha.
When deliberating on the possible regulatory status as a device of products involving medicinal products, human tissues and cells, biocides or food products, the Commission shall ensure an appropriate level of consultation of the European Medicines Agency (EMA), the European Chemicals Agency and the European Food Safety Authority, as relevant.