Arna iarraidh sin don Choimisiún, lena n-áirítear thar ceann an Bhoird um Ghéarchéimeanna Sláinte, soláthróidh EMA faisnéis dó maidir le faireachán ar tháirgí íocshláinte, agus ar fheistí leighis, lena n-áirítear a n-éileamh agus a soláthar, i gcomhréir le hAirteagail 9(2), pointí (c) agus (d), agus Airteagal 25(2), pointí (c) agus (d), de Rialachán (AE) 2022/123.
Upon request of the Commission, including on behalf of the Health Crisis Board, EMA shall provide it with information with regard to monitoring of medicinal products and medical devices, including their demand and supply, in accordance with Article 9(2), points (c) and (d), and Article 25(2), points (c) and (d), of Regulation (EU) 2022/123.
#2571868
Agus gníomhaíochtaí maidir le trialacha cliniciúla á gcur ar bun aige, déanfaidh an Coimisiún Tascfhórsa Éigeandála na Gníomhaireachta Leigheasra Eorpaí arna bhunú le Rialachán (AE) 2022/123 mar aon le líonraí atá ann cheana, amhail an Gréasán Bonneagair um Thaighde Cliniciúil Eorpach, a rannpháirtiú, agus áiritheoidh sé san am céanna go gcomhlíonfar Rialachán (AE) Uimh. 536/2014 ó Pharlaimint na hEorpa agus ón gComhairle, agus go ndéanfar comhordú leis an Lárionad Eorpach um Ghalair a Chosc agus a Rialú freisin.
In setting up actions on clinical trials, the Commission shall involve the EMA Emergency Task force established by Regulation (EU) 2022/123 as well as existing networks, such as the European Clinical Research Infrastructure Network, while ensuring compliance with Regulation (EU) No 536/2014 of the European Parliament and of the Council as well as coordination with ECDC.
#2571886
leathnú acmhainneachtaí atá ann cheana nó bunú acmhainneachtaí nua a bhaineann le gníomhaíochtaí a éascú agus bearta lena n-áiritheofar solúbthacht rialála a thabhairt isteach, chun tacú le frithbhearta leighis atá ábhartha i gcás géarchéime a tháirgeadh agus a chur ar an margadh ach, san am céanna, freagrachtaí na Gníomhaireachta Leigheasra Eorpaí agus údarás náisiúnta cógas maidir le meastóireacht agus maoirseacht ar tháirgí íocshláinte a urramú;
facilitating the expansion of existing, or the establishment of new, capacities related to activities and the introduction of measures ensuring regulatory flexibility, in order to support the production and placing on the market of crisis-relevant medical countermeasures, while respecting the responsibilities of EMA and national medicines authorities with regard to the evaluation and supervision of medicinal products;
#2628650
ag tabhairt dá haire gur chinn an Chúirt go bhfuil méadú tagtha ar laigí maidir le bainistiú acmhainní daonna, go háirithe maidir le nósanna imeachta earcaíochta inar shainaithin an Chúirt cineálacha éagsúla easnamh i sé cinn de na 22 ghníomhaireacht a ndearnadh iniúchadh orthu, amhail céimeanna neamhleora chun teidlíochtaí ar liúntais a fhíorú do bhaill foirne atá i mbun dualgas mar ghníomhairí sealadacha (EMSA), folúntais bhainistíochta ar feadh tréimhse iomarcaí (EASO, EFSA), mainneachtain rialuithe inmheánacha éifeachtacha a chur i bhfeidhm le linn na nósanna imeachta earcaíochta (ACER), laigí i gceapadh painéal roghnúcháin le haghaidh nósanna imeachta earcaíochta (EMA), agus laigí i mbainistiú grád ball foirne nua (Frontex);
Notes that the Court found an increase in weaknesses concerning human resources management, in particular relating to recruitment procedures where the Court identified different types of shortcomings in six of the 22 audited agencies, such as insufficient steps to verify entitlements to allowances for staff taking up duties as a temporary agents (EMSA), vacant managerial posts for an excessive period (EASO, EFSA), a failure to apply effective internal controls during the recruitment procedures (ACER), weaknesses in appointment of selection panels for recruitment procedures (EMA), and weaknesses in management of grades of new staff members (Frontex);
#2628678
ag tabhairt dá haire gur eisigh an Chúirt míreanna “ábhar eile” do ACER agus ENISA agus aird á tarraingt aici ar an bhfíoras nár ghlac siad rialacha inmheánacha chun aghaidh a thabhairt ar leanúnachas na dtoscaireachtaí i gcásanna ina bhfágann oifigigh údarúcháin tharmligthe nó arna dtarmligean, a bpost; ag iarraidh ar gach gníomhaireacht aird a thabhairt ar an tsaincheist áirithe seo i gcoitinne, agus ar bhonn níos sonraí nuair a bheidh stiúrthóir (feidhmiúcháin) nua i gceannas ar an ngníomhaireacht; á athdhearbhú gur mhol an Chúirt gur cheart do na gníomhaireachtaí rialacha inmheánacha a ghlacadh a chuideoidh go fónta leis na córais rialaithe bainistíochta, le trédhearcacht agus le cuntasacht; á chur i bhfios sampla EMA arna sholáthar ag an gCúirt mar thagairt do na rialacha inmheánacha sin;
Notes that the Court issued ‘other matter’ paragraphs for ACER and ENISA drawing attention to the fact that they did not adopt internal rules to address the continuity of delegations in cases where delegating or delegated authorising officers leave their post; calls on all agencies to pay attention to this particular issue in general, and more specifically when a new (executive) director takes charge of the agency; reiterates the Court’s recommendation that the agencies should adopt internal rules that provide a sound contribution to the management control systems, to transparency and accountability; points to the example of the EMA provided by the Court as a reference for these internal rules;
#2637384
D’fhormheas an Ghníomhaireacht Leigheasra Eorpach (EMA) leaganacha oiriúnaithe de vacsaíní Comirnaty agus Spikevax, ar vacsaíní iad atá dírithe ar an víreas bunaidh SARS-CoV-2 agus ar an bhfo-athraitheach BA.1 Omicron agus údaraíodh san Aontas iad ag tús mhí Mheán Fómhair, faoi phróiseas brostaithe a ndearna an Coimisiún foráil ina leith in 2021.
Adapted versions of the Comirnaty and Spikevax vaccines, targeting the original SARS-CoV-2 virus as well as the BA.1 Omicron subvariant were approved by the European Medicines Agency (EMA) and authorised in the EU at the beginning of September, under an accelerated process provided for by the Commission in 2021.
#2637385
Chuir EMA tús freisin le hathbhreithniú leanúnach ar leagan de Comirnaty a cuireadh in oiriúint don víreas bunaidh SARS-CoV-2 agus dá fho-athraithigh Omicron BA.4 agus BA.5, maidir le húdarú brostaithe féideartha san fhómhar.
The EMA has also started a rolling review for a version of Comirnaty adapted to the original SARS-CoV-2 virus and to its Omicron subvariants BA.4 and BA.5, for a potential accelerated authorisation in the autumn.
#2637652
Cuireann na moltaí sin leis an ráiteas comhpháirteach ó ECDC agus ón nGníomhaireacht Leigheasra Eorpach (EMA) maidir leis an gceathrú dáileog de vacsaíní mRNA a thabhairt an 6 Aibreán 2022 agus maidir le Preliminary public health considerations for COVID-19 vaccination strategies in the second half of 2022 [Réamhbhreithnithe sláinte poiblí maidir le straitéisí vacsaínithe COVID-19 sa dara leath de 2022], a d’fhoilsigh ECDC an 18 Iúil 2022.
These recommendations build on the joint statement from the ECDC and the European Medicines Agency (EMA) on the administration of a fourth dose of mRNA vaccines of 6 April 2022 as well as Preliminary public health considerations for COVID-19 vaccination strategies in the second half of 2022, published by the ECDC on 18 July 2022.
#3028106
IMP 5.1.: An líon Ballstát a chistítear agus a rinne sonraí a bhailiú agus a thuairisciú go tráthúil don Ghníomhaireacht Leigheasra Eorpach (EMA) maidir le díolacháin táirgí íocshláinte tréidliachta frithmhiocróbacha agus maidir le húsáid táirge míochaine tréidliachta frithmhiocróbacha in ainmhithe
IMP 5.1.: Number of the Member States funded which collected and timely reported to the European Medicines Agency (EMA) data on the sales of antimicrobial veterinary medicines and use in animals of the antimicrobial medicinal products
#3032223
tá API ina shubstaint a fhaightear go nádúrtha, amhail vitimíní, leictrilítí, aimíonaigéid, peiptídí, próitéiní, núicléitídí, carbaihiodráití agus lipidí agus, i gcomhréir le Treoirlíne na Gníomhaireachta Leigheasra Eorpaí maidir le measúnú riosca comhshaoil ar tháirgí íocshláinte lena n-úsáid ag an duine (treoirlínte EMA ERA), meastar go ginearálta go bhfuil sé in-díghrádaithe sa chomhshaol;
the API is a naturally occurring substance, such as vitamins, electrolytes, amino acids, peptides, proteins, nucleotides, carbohydrates and lipids, and, in line with the European Medicines Agency Guideline on the environmental risk assessment of medicinal products for human use (EMA ERA guideline), is generally considered to be degradable in the environment;
#3032226
is féidir teacht ar an gconclúid go mianraítear iad bunaithe ar an Tástáil shonrach Uimh. 308: Trasfhoirmiú Aeróbach agus Anaeróbach i gCórais Dríodair Uiscigh (ECFE 308) de Threoirlíne ECFE maidir le Ceimiceáin a Thástáil i gcomparáid le critéir mharthanachta mar a shainmhínítear i dtreoirlíne EMA ERA.
can be concluded to be mineralised based on a specific Test No 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems (OECD 308) of the OECD Guidelines for the Testing of Chemicals compared to persistence criteria as defined in the EMA ERA guideline.
#3032278
na comhábhair arb é atá iontu foirmliú an táirge íocshláinte, is substaintí iad a fhaightear go nádúrtha, amhail vitimíní, leictrilítí, aimíonaigéid, peiptídí, próitéiní, núicléitídí, carbaihiodráití agus lipidí agus, i gcomhréir le Treoirlíne na Gníomhaireachta Leigheasra Eorpaí maidir le measúnú riosca comhshaoil ar tháirgí íocshláinte lena n-úsáid ag an duine (treoirlínte EMA ERA), meastar go ginearálta go bhfuil siad in-díghrádaithe sa chomhshaol;
the ingredients that constitute the formulation of the medicinal product are naturally occurring substances such as vitamins, electrolytes, amino acids, peptides, proteins, nucleotides, carbohydrates and lipids, and, in line with European Medicines Agency Guideline on the environmental risk assessment of medicinal products for human use (EMA ERA guideline), are generally considered to be degradable in the environment;
#3032280
is féidir teacht ar an gconclúid go mianraítear iad bunaithe ar an Tástáil shonrach Uimh. 308: Trasfhoirmiú Aeróbach agus Anaeróbach i gCórais Dríodair Uiscigh (ECFE 308) de Threoirlíne ECFE maidir le Ceimiceáin a Thástáil i gcomparáid le critéir mharthanachta mar a shainmhínítear i dtreoirlíne EMA ERA.
can be concluded to be mineralised based on a specific Test No 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems (OECD 308) of OECD Guidelines for the Testing of Chemicals compared to persistence criteria as defined in the EMA ERA guideline.
#3032469
Treoirlínte na Gníomhaireachta Leigheasra Eorpaí maidir le measúnú riosca comhshaoil ar tháirgí íocshláinte lena n-úsáid ag an duine, leagan 27.6.2023 le fáil ag https://www.ema.europa.eu/en/environmental-risk-assessment-medicinal-products-human-use-scientific-guideline.
European Medicines Agency Guidelines on the environmental risk assessment of medicinal products for human use, version of 27.6.2023 available at: https://www.ema.europa.eu/en/environmental-risk-assessment-medicinal-products-human-use-scientific-guideline.
#3048708
Á chur in iúl gur geal léi comhoibriú an Lárionaid le gníomhaireachtaí eile an Aontais, amhail an comhar leis an Údarás Leigheasra Eorpach (EMA) chun ardán nua um fhaireachán vacsaíní a bhunú; ag tabhairt dá haire gur chuir an Lárionad síneadh leis an sprioc atá aige slándáil sláinte san Aontas a mhéadú chun comhar agus comhordú idir an Lárionad agus comhpháirtithe i dtíortha nach bhfuil san Aontas a neartú;
Welcomes the collaboration of the Centre with other Union agencies, such as the collaboration with the European Medicines Authority (EMA) to establish a new vaccine monitoring platform; notes that the Centre has extended its goal of increasing health security in the Union to strengthen cooperation and coordination between the Centre and partners in non-Union countries;
#3048709
Á chur in iúl gur geal léi go leanann an Lárionad de dhea-chleachtais a chomhroinnt agus go mbíonn sé ag obair go rialta le gníomhaireachtaí eile an Aontais, go háirithe an tÚdarás Eorpach um Shábháilteacht Bia, EMA agus an Lárionad Faireacháin Eorpach um Dhrugaí agus um Andúil i nDrugaí; ag aithint, thairis sin, go bhfuil an Lárionad rannpháirteach i nósanna imeachta soláthair idirinstitiúideacha arna n-eagrú ag gníomhaireachtaí eile an Aontais; ag moladh don Lárionad comhar breise agus comhar níos fairsinge a lorg go gníomhach le heagraíochtaí agus comhlachais ábhartha, le comhlachtaí inniúla náisiúnta agus le heagraíochtaí idirnáisiúnta amhail an Eagraíocht Dhomhanda Sláinte, agus dúbláil na dtreoirlínte atá ann cheana féin á seachaint ag an am céanna;
Welcomes the fact that the Centre continues to share best practices and regularly works with other Union agencies, most notably the European Food Safety Authority, EMA and the European Monitoring Centre for Drugs and Drug Addiction; acknowledges, furthermore, that the Centre participates in interinstitutional procurement procedures organised by other Union agencies; encourages the Centre to actively seek further and broader cooperation with relevant organisations and associations, national competent bodies and international organisations such as the World Health Organization, while avoiding any duplication of existing guidelines;
#3118358
foirmlithe cógaisíochta atá deartha le haghaidh tástáil agus riar daoine (nó tréidliachta) i gcóireáil fadhbanna sláinte, (2) réamhphacáistithe lena ndáileadh mar tháirgí cliniciúla nó leighis, agus (3) arna bhformheas ag an nGníomhaireacht Leigheasra Eorpach (EMA) lena gcur ar an margadh mar tháirgí cliniciúla nó leighis nó lena n-úsáid mar thaighde ar dhrugaí nua.
pharmaceutical formulations designed for testing and human (or veterinary) administration in the treatment of medical conditions, (2) prepackaged for distribution as clinical or medical products, and (3) approved by the European Medicines Agency (EMA) either to be marketed as clinical or medical products or for use as research new drug.
#3156177
D’fhonn cosaint sláinte daoine agus ainmhithe agus tomhaltóirí táirgí íocshláinte a chur chun cinn ar fud an Aontais, agus d’fhonn comhlánú an mhargaidh inmheánaigh a chur chun cinn trí chinntí rialála aonfhoirmeacha a ghlacadh bunaithe ar na critéir eolaíochta a bhaineann le táirgí íocshláinte a chur ar an margadh agus a úsáid, is é an cuspóir atá ag an nGníomhaireacht Leigheasra Eorpach (EMA) an chomhairle eolaíochta is fearr agus is féidir a sholáthar do na Ballstáit agus d’institiúidí an Aontais ar aon cheist maidir le meastóireacht ar cháilíocht, sábháilteacht, agus éifeachtúlacht táirgí íocshláinte lena n-úsáid ag an duine agus le haghaidh úsáid tréidliachta, i gcomhréir le forálacha reachtaíocht an Aontais a bhaineann le táirgí íocshláinte.
In order to promote the protection of human and animal health and of consumers of medicinal products throughout the Union, and in order to promote the completion of the internal market through the adoption of uniform regulatory decisions based on scientific criteria concerning the placing on the market and the use of medicinal products, the objective of the European Medicines Agency (EMA) is to provide the Member States and the institutions of the Union with the best possible scientific advice on any question relating to the evaluation of the quality, the safety, and the efficacy of medicinal products for human and veterinary use, in accordance with the provisions of the Union legislation relating to medicinal products.
#3221121
Tá na táillí a bhaineann leis an gcomhairle a sholáthraíonn painéil saineolaithe iníoctha le EMA de bhun Airteagal 30, pointe (f), de Rialachán (AE) 2022/123 ó Pharlaimint na hEorpa agus ón gComhairle.
The fees related to the advice provided by expert panels are payable to EMA pursuant to Article 30, point (f), of Regulation (EU) 2022/123 of the European Parliament and of the Council.
#1943350
D’fhonn cur leis an gcumas san Aontas chun ullmhú d’aon ghéarchéimeanna sláinte a bheidh ann amach anseo, freagairt orthu agus iad a bhainistiú, ba cheart, trí bhíthin an Chláir, tacaíocht a sholáthar do na gníomhaíochtaí arna ndéanamh faoi chuimsiú na sásraí agus na struchtúr a bhunaítear faoi Chinneadh Uimh. 1082/2013/AE ó Pharlaimint na hEorpa agus ón gComhairle agus do shásraí agus do struchtúir ábhartha eile dá dtagraítear i dteachtaireacht ón gCoimisiún an 11 Samhain 2020 dar teideal “Aontas Sláinte de chuid na hEorpa a chur ar bun: Athléimneacht an Aontais a threisiú i leith bagairtí sláinte trasteorann”, lena n-áirítear na gníomhaíochtaí sin atá dírithe ar phleanáil ullmhachta agus cumas freagartha a neartú ar an leibhéal náisiúnta agus ar leibhéal an Aontais, ar ról an Lárionaid Eorpaigh um Ghalair a Chosc agus a Rialú (ECDC) agus na Gníomhaireacht Leigheasra Eorpaí (EMA) a threisiú, agus ar udarás um ullmhacht agus fhreagairt d’éigeandáil sláinte a bhunú.
With a view to strengthening the capability in the Union to prepare for, respond to and manage any future health crises, the Programme should provide support to actions taken in the framework of the mechanisms and structures established under Decision No 1082/2013/EU of the European Parliament and of the Council and other relevant mechanisms and structures referred to in the communication of the Commission of 11 November 2020 entitled ‘Building a European Health Union: Reinforcing the EU’s resilience for cross-border health threats’, including actions directed at strengthening preparedness planning and response capacity at national and Union level, at reinforcing the role of the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA), and at establishing a health emergency preparedness and response authority.
#2570918
I bhfianaise na ceachtanna a foghlaimíodh le linn phaindéim leanúnach COVID-19 agus chun ullmhacht agus freagairt leormhaith a éascú ar fud an Aontais i ndáil le gach bagairt trasteorann ar an tsláinte, is gá an creat dlíthiúil le haghaidh faireachas eipidéimeolaíoch, faireacháin a dhéanamh ar bhagairtí tromchúiseacha trasteorann ar an tsláinte, lena n-áirítear bagairtí zónóiseacha, luathrabhadh a thabhairt ina leith agus iad a chomhrac, dá bhforáiltear i gCinneadh Uimh. 1082/2013/AE, a leathnú maidir le ceanglais tuairiscithe bhreise agus anailís a mhéid a bhaineann le táscairí córas sláinte, agus i ndáil le comhar idir na Ballstáit agus gníomhaireachtaí agus comhlachtaí an Aontais, go háirithe an Lárionad Eorpach um Ghalair a Chosc agus a Rialú (ECDC), an Ghníomhaireacht Leigheasra Eorpach (EMA), agus eagraíochtaí idirnáisiúnta, go háirithe an Eagraíocht Dhomhanda Sláinte (EDS), agus an t-ualach a bhíonn ar údaráis náisiúnta inniúla á chur san áireamh, ag brath ar an staid iarbhír sláinte poiblí.
In light of the lessons learnt during the ongoing COVID-19 pandemic and in order to facilitate adequate Union-wide preparedness for and response to all cross-border threats to health, the legal framework for epidemiological surveillance, monitoring, early warning of, and combatting serious cross-border threats to health, including zoonotic-related threats, as provided for in Decision No 1082/2013/EU, needs to be broadened with regard to additional reporting requirements and analysis regarding health systems indicators, and with regard to cooperation between Member States and Union agencies and bodies, particularly the European Centre for Disease Prevention and Control (ECDC), the European Medicines Agency (EMA), and international organisations, in particular the World Health Organization (WHO), while taking into account the burden faced by national competent authorities depending on the actual public health situation.
#2628637
ag tabhairt dá haire, d’ainneoin chonclúid na Cúirte gur dheimhnigh a torthaí iniúchóireachta le haghaidh 2020 na torthaí dearfacha a tuairiscíodh sna blianta roimhe sin, nach raibh 2020 mar a bheadh aon bhliain eile de bharr phaindéim COVID-19; ag tabhairt dá haire, sa chomhthéacs sin, gur chinn an Chúirt freisin, maidir le cláir oibre agus gníomhaíochtaí, gur spreag paindéim COVID-19 athbheartú tosaíochta suntasacha acmhainní agus gníomhaíochtaí pleanáilte, agus go bhfuil na samplaí is suntasaí le fáil i réimse beartais na Sláinte (an Lárionad Eorpach um Ghalair a Chosc agus a Rialú (ECDC) agus an Ghníomhaireacht Leigheasra Eorpach (EMA)); ag tabhairt dá haire go ndearnadh difear do réimsí eile freisin, mar shampla, ní raibh Frontex in ann gníomhaíochtaí a bhí beartaithe a chur chun feidhme mar gheall ar shrianta taistil ar fud an domhain agus tháinig athruithe suntasacha ar an obair allamuigh a bhí beartaithe ag an bhForas Eorpach chun Dálaí Maireachtála agus Oibre a Fheabhsú (Eurofound) dá 7ú Suirbhé ar Dhálaí Oibre san Eoraip, lena n-áirítear gur cuireadh isteach ar anailís treochtaí ar dhálaí oibre a bhaineann le tréimhse níos mó ná 20 bliain; ag tabhairt dá haire gur fhreagair na gníomhaireachtaí do na dúshláin sin trí ghníomhaíochtaí ábhartha agus trí obair a oiriúnú trí bhíthin dlús a chur le bearta digitithe, le comhoibriú níos fearr agus le malartú feabhsaithe faisnéise;
Notes that, despite the conclusion of the Court that its audit findings for 2020 confirmed the positive results reported in previous years, as a result of the COVID-19 pandemic, 2020 was not just another year; notes with that in mind that the Court also concluded that, with respect to work programmes and activities, the COVID-19 pandemic triggered significant reprioritisation of resources and planned activities, with the most notable examples to be found in the policy area of Health (the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA)); notes that other areas were also affected, for example Frontex was unable to implement planned activities due to travel restrictions worldwide and fieldwork planned by the European Foundation for the Improvement of Living and Working Conditions (Eurofound) for its 7th European Working Conditions Survey significantly changed, including the disruption of a trend analysis on working conditions spanning more than 20 years; notes that the agencies responded to those challenges through relevant actions and adaptations of work by accelerating digitalisation measures, better collaboration and improved exchange of information;
#2628639
ag tabhairt dá haire ón staidéar Cost of Non-EU Agencies Focusing on the Health and Safety Cluster of the EU Decentralised Agencies [Costas Gníomhaireachtaí Neamh-AE a Dhíríonn ar Chnuasach Sláinte agus Sábháilteachta Ghníomhaireachtaí Díláraithe AE] gur léirigh seacht ngníomhaireacht an Aontais i réimse na sláinte agus na sábháilteachta breisluach láidir Eorpach agus go bhfuil sé sin aitheanta go forleathan ag na Ballstáit agus ag geallsealbhóirí eile lena n-áirítear geallsealbhóirí gnó; ag tabhairt dá haire go háirithe go raibh ról tábhachtach ag na gníomhaireachtaí sa bhraisle sláinte agus sábháilteachta i bhfreagairt an Aontais ar phaindéim COVID-19; ag tabhairt dá haire go raibh baint dhíreach ag ECDC agus EMA le dul i ngleic leis na dúshláin a d’eascair as an ngéarchéim, trí fhaireachán a dhéanamh ar shonraí eipidéimeolaíocha agus trí vacsaíní a fhormheas, agus gur chuir gníomhaireachtaí eile treoir ar fáil maidir leis na rioscaí a bhaineann leis an víreas a tholg in earnálacha áirithe a laghdú, amhail an Prótacal Sábháilteachta Sláinte Eitlíochta COVID-19 ó EASA, ráitis an Údaráis Eorpaigh um Shábháilteacht Bia (EFSA) maidir leis an mbaol go bhféadfaí víreas COVID-19 a tholg trí bhia, agus tuarascálacha na Gníomhaireachta Eorpaí um Shábháilteacht Mhuirí (EMSA) maidir le tionchar phaindéim COVID-19 ar loingseoireacht; ag tabhairt dá haire gur leag paindéim COVID-19 béim ar mhéid an chomhoibrithe idir na Gníomhaireachtaí;
Notes from the study ‘Cost of Non-EU Agencies Focusing on the Health and Safety Cluster of the EU Decentralised Agencies’ that the seven Union agencies in the health and safety field demonstrated strong European added value and that this is widely recognised by Member States and other stakeholders including business stakeholders; notes, in particular, that the agencies in the health and safety cluster have played an important role in the Union’s response to the COVID-19 pandemic; notes that the ECDC and the EMA have been directly involved in tackling challenges arising from the crisis, by monitoring epidemiological data and through the approval of vaccines, while other agencies produced guidance on reducing the risk of contracting the virus in particular sectors, such as the EASA’s COVID-19 Aviation Health Safety Protocol, the European Food Safety Authority’s (EFSA) statements on risk of contracting the COVID-19 virus through food, and the European Maritime Safety Agency’s (EMSA) reports on the impact of the COVID-19 pandemic on shipping; notes that the COVID-19 pandemic highlighted the extent of collaboration between the Agencies;
#3050288
á aithint nach bhfuil feidhm ag na rialacha maidir le cásanna a d’fhéadfadh a bheith ann maidir le ‘doras imrothlach’ agus an riosca coinbhleachtaí leasa a bhaineann leo maidir le comhaltaí de bhoird gníomhaireachtaí, coistí eolaíocha, grúpaí saineolaithe agus comhlachtaí comhchosúla eile; ag tabhairt dá haire i dtuarascáil na Cúirte nach ndearna ach ceithre ghníomhaireacht measúnú, le linn na tréimhse iniúchta (2019-2021), ar aon chásanna a bhain le comhaltaí dá mboird, a ghlac le post nua nó le gníomhaíocht sheachtrach; á chur in iúl gur saoth léi nach ndearnadh measúnú ach ar 25 chás (i.e. 3,8 %) as 659 imeacht a bhain le comhaltaí de bhoird na ngníomhaireachtaí; ag moladh ÚBE, ÚEÁPC, an Gníomhaireacht Iarnróid an Aontais Eorpaigh (EIT), EMA, ESMA, Europol agus FRA) as forálacha sonracha a bheith i bhfeidhm lena gcumhdaítear an riosca go mbeadh ‘doras imrothlach’ ann i ndáil le comhaltaí dá mbord, in ainneoin an fholúis dhlíthiúil atá ann cheana;
Acknowledges that the rules on handling potential ‘revolving door’ situations and the associated risk of conflicts of interest do not apply to the members of agencies’ boards, scientific committees, expert groups and other similar bodies; notes from the Court’s report that during the audited period (2019-2021), only four agencies assessed any cases related to members of their boards taking up a new job or an outside activity; deplores that only 25 cases (i.e. 3,8 %) out of 659 departures related to members of agencies’ boards were assessed; commends EBA, EIOPA, the European Institute of Innovation and Technology (EIT), EMA, ESMA, Europol and FRA) for having specific provisions in place covering the risk of ‘revolving door’ situations in relation to members of their boards, despite the existing legal vacuum;