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);
Nuair a dhéanfaidh an Coimisiún plé ar stádas rialála na dtáirgí i gcásanna teorannacha a bhaineann le táirgí íocshláinte, fíocháin agus cealla daonna, táirgí bithicíde nó táirgí bia, ba cheart dó leibhéal iomchuí comhairliúchán leis an nGníomhaireacht Leigheasra Eorpach, leis an nGníomhaireacht Eorpach Ceimiceán agus leis an Údarás Eorpach um Shábháilteacht Bia a áirithiú, de réir mar is ábhartha.
When deliberating on the regulatory status of products in borderline cases involving medicinal products, human tissues and cells, biocidal products or food products, the Commission should ensure an appropriate level of consultation of the European Medicines Agency (EMA), the European Chemicals Agency and the European Food Safety Authority, as relevant.
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.
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.
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.
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.
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.
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.
Sa bhreis ar na nósanna imeachta dá dtagraítear sa chéad fhomhír agus sa dara fomhír, i gcás feistí diagnóiseacha coimhdeachta, rachaidh an comhlacht dá dtugtar fógra i gcomhairle le húdarás inniúil, arna ainmniú ag na Ballstáit i gcomhréir le Treoir 2001/83/CE ó Pharlaimint na hEorpa agus ón gComhairle [25], nó leis an EMA, de réir mar is infheidhme, i gcomhréir leis an nós imeachta a leagtar amach i Roinn 5.2 d'Iarscríbhinn IX.
In addition to the procedures referred to in the first and second subparagraphs, for companion diagnostics, the notified body shall consult a competent authority designated by the Member States in accordance with Directive 2001/83/EC of the European Parliament and of the Council [25] or the EMA, as applicable, in accordance with the procedure set out in Section 5.2 of Annex IX.
I gcás feistí diagnóiseacha coimhdeachta, rachaidh an comhlacht dá dtugtar fógra, go háirithe, i gcomhairle le húdarás inniúil, arna ainmniú ag na Ballstáit i gcomhréir le Treoir 2001/83/CE nó leis an EMA, de réir mar is infheidhme, i gcomhréir leis an nós imeachta a leagtar amach i bpointe (k) de Roinn 3 d'Iarscríbhinn X.
For companion diagnostics, the notified body shall in particular consult a competent authority designated by the Member States in accordance with Directive 2001/83/EC or the EMA, as applicable, in accordance with the procedure set out in point (k) of Section 3 of Annex X.
Sa bhreis ar na nósanna imeachta dá dtagraítear sa chéad fhomhír agus sa dara fomhír, i gcás feistí diagnóiseacha coimhdeachta, leanfaidh an comhlacht dá dtugtar fógra, i gcás gach feiste, an nós imeachta don mheasúnú ar dhoiciméadacht theicniúil a leagtar síos i Roinn 5.2 d'Iarscríbhinn IX agus déanfaidh sé an nós imeachta don mheasúnú ar dhoiciméadacht theicniúil a leagtar síos i Roinn 4.1 go Roinn 4.8 d'Iarscríbhinn IX a chur i bhfeidhm agus rachaidh sé i gcomhairle le húdarás inniúil, arna ainmniú ag na Ballstáit i gcomhréir le Treoir 2001/83/CE nó leis an EMA, de réir mar is infheidhme, i gcomhréir leis an nós imeachta a leagtar amach i Roinn 5.2 d'Iarscríbhinn IX.
In addition to the procedures referred to in the first and second subparagraphs, for companion diagnostics the notified body shall for every device follow the procedure for technical documentation assessment laid down in Section 5.2 of Annex IX, and shall apply the procedure for technical documentation assessment laid down in Sections 4.1 to 4.8 of Annex IX and shall consult the competent authority designated by the Member States in accordance with Directive 2001/83/EC or the EMA, as applicable, in accordance with the procedure set out in Section 5.2 of Annex IX.
I gcás feistí diagnóiseacha coimhdeachta, rachaidh an comhlacht dá dtugtar fógra, go háirithe i gcás gach feiste, i gcomhairle le húdarás inniúil, arna ainmniú ag na Ballstáit i gcomhréir le Treoir 2001/83/CE nó leis an EMA, de réir mar is infheidhme, i gcomhréir leis an nós imeachta a leagtar amach i bpointe (k) de Roinn 3 d'Iarscríbhinn X.
For companion diagnostics the notified body shall in particular for every device consult a competent authority designated by the Member States in accordance with Directive 2001/83/EC or the EMA, as applicable, in accordance with the procedure set out in point (k) of Section 3 of Annex X.
I gcás feistí diagnóiseacha coimhdeachta, beidh nósanna imeachta doiciméadaithe ar bun ag an gcomhlacht dá dtugtar fógra arb é is aidhm dóibh ceanglais an Rialacháin seo a chomhlíonadh maidir le dul i gcomhairle le EMA nó le húdarás inniúil táirgí íocshláinte agus measúnú á dhéanamh acu ar na cineálacha sin feistí.
In the case of companion diagnostics, the notified body shall have documented procedures in place that aim to fulfil the requirements of this Regulation in relation to consultation of the EMA or a medicinal products competent authority during its assessment of such types of device.
Sula ndéanfaidh an comhlacht dá dtugtar fógra deimhniú AE maidir le measúnú ar dhoiciméadacht theicniúil d'fheiste dhiagnóiseach choimhdeachta a eisiúint agus ar bhonn na dréacht-achoimre ar shábháilteacht agus ar fheidhmíocht agus na ndréacht-treoracha úsáide, iarrfaidh sé tuairim eolaíoch ar cheann de na húdaráis inniúla arna n-ainmniú ag na Ballstáit i gcomhréir le Treoir 2001/83/CE nó ar EMA, (a ngairtear “údarás inniúil na dtáirgí íocshláinte a ndeachthas i gcomhairle leis” ar cheachtar acu sa Roinn seo feasta) ag brath ar cé acu a ndeachthas i gcomhairle leo faoin bpointe seo, maidir lena oiriúnaí atá an fheiste i ndáil leis an táirge íocshláinte lena mbaineann.
The notified body shall, before issuing an EU technical documentation assessment certificate for the companion diagnostic and on the basis of the draft summary of safety and performance and the draft instructions for use, 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, regarding the suitability of the device in relation to the medicinal product concerned.
I gcás ina dtagann an táirge íocshláinte faoi raon feidhme eisiach na hIarscríbhinne a ghabhann le Rialachán (CE) Uimh. 726/2004 [1], iarrfaidh an comhlacht dá dtugtar fógra tuairim EMA.
Where the medicinal product falls exclusively within the scope of the Annex to Regulation (EC) No 726/2004 of the European Parliament and of the Council [1], the notified body shall seek the opinion of the EMA.
Más rud é go bhfuil an táirge íocshláinte lena mbaineann údaraithe cheana, nó má tíolacadh iarratas dá údarú, rachaidh an comhlacht dá dtugtar fógra i gcomhairle leis an údarás táirgí íocshláinte, nó le EMA, atá freagrach as an údarú.
If the medicinal product concerned is already authorised, or if an application for its authorisation has been submitted, the notified body shall consult the medicinal products authority, or the EMA, that is responsible for the authorisation.
I gcás feistí diagnóiseacha coimhdeachta, déanfaidh an comhlacht dá dtugtar fógra, ar bhonn na dréacht-achoimre ar shábháilteacht agus ar fheidhmíocht agus na ndréacht-treoracha úsáide, tuairim a iarraidh ar cheann de na húdaráis inniúla arna n-ainmniú ag na Ballstáit i gcomhréir le Treoir 2001/83/CE nó ó EMA (a ngairtear “údarás inniúil na dtáirgí íocshláinte a ndeachthas i gcomhairle leis” ar cheachtar acu sa Roinn seo feasta) ag brath ar cé acu a ndeachthas i gcomhairle leis maidir lena oiriúnaí atá an fheiste i ndáil leis an táirge íocshláinte lena mbaineann.
for companion diagnostics, seek the opinion, on the basis of the draft summary of safety and performance and the draft instructions for use, of one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMA (either of which to be hereinafter referred to as ‘the medicinal products authority consulted’ depending on which has been consulted under this point) on the suitability of the device in relation to the medicinal product concerned.
Más rud é go bhfuil an táirge íocshláinte lean mbaineann údaraithe, nó má tíolacadh iarratas dá údarú, rachaidh an comhlacht dá dtugtar fógra i gcomhairle le húdarás inniúil na dtáirgí íocshláinte, nó le EMA, cibé acu atá freagrach as an údarú.
If the medicinal product concerned is already authorised, or if an application for its authorisation has been submitted, the notified body shall consult the medicinal products competent authority, or the EMA, that is responsible for the authorisation.
I gcás ina ndéanfaidh na hathruithe difear d'fheidhmíocht feiste diagnóisí coimhdeachta nó don úsáid a beartaíodh di a fhormheastar leis an deimhniú ar scrúdú cineáil AE nó maidir lena oiriúnaí atá sí i ndáil le táirge íocshláinte, rachaidh an comhlacht dá dtugtar fógra i gcomhairle le húdarás inniúil na dtáirgí íocshláinte a bhí bainteach leis an gcomhairliúchán tosaigh nó rachaidh sé i gcomhairle le EMA.
Where the changes affect the performance or the intended use of a companion diagnostic approved through the EU type-examination certificate or its suitability in relation to a medicinal product, the notified body shall consult the medicinal products competent authority that was involved in the initial consultation or the EMA.
Maidir leis an gCoimisiún, agus maidir le roinnt comhlachtaí, oifigí agus gníomhaireachtaí de chuid an Aontais, amhail an Oifig Eorpach Frith-Chalaoise (OLAF), an Ghníomhaireacht Eorpach um Shábháilteacht Mhuirí (EMSA), Gníomhaireacht Sábháilteachta Eitlíochta na hEorpa (EASA), an tÚdarás Eorpach um Urrúis agus Margaí (ESMA) agus an Ghníomhaireacht Leigheasra Eorpach (EMA), tá bealaí tuairiscithe seachtracha agus nósanna imeachta tuairiscithe seachtracha chun tuairiscí a fháil ar sháruithe a thagann faoi raon feidhme na Treorach seo i bhfeidhm acu, ar bealaí agus nósanna imeachta iad a dhéanann foráil go príomha do rúndacht chéannacht na ndaoine tuairiscithe.
The Commission, as well as some bodies, offices and agencies of the Union, such as the European Anti-Fraud Office (OLAF), the European Maritime Safety Agency (EMSA), the European Aviation Safety Agency (EASA), the European Security and Markets Authority (ESMA) and the European Medicines Agency (EMA), have in place external reporting channels and procedures for receiving reports of breaches falling within the scope of this Directive, which mainly provide for confidentiality of the identity of the reporting persons.
Breathnóidh na Páirtithe freisin ar chomhar idir údaráis na Ríochta Aontaithe agus gníomhaíochtaí an Aontais amhail an Ghníomhaireacht Leigheasra Eorpach (EMA), an Ghníomhaireacht Eorpach Ceimiceán (ECHA), agus an Ghníomhaireacht Eorpach um Shábháilteacht Eitlíochta (EASA).
The Parties will also explore the possibility of cooperation of United Kingdom authorities with Union agencies such as the European Medicines Agency (EMA), the European Chemicals Agency (ECHA), and the European Aviation Safety Agency (EASA).
Chun an cuspóir a ghnóthú, mar atá táirgí íocshláinte sábháilte éifeachtúla a chur ar fáil, ar táirgí iad atá beartaithe COVID-19 a chóireáil nó a chosc, ghlac an Ghníomhaireacht Leigheasra Eorpach (EMA) agus líonra na n‐údarás inniúil náisiúnta raon beart ar leibhéal an Aontais chun forbairt agus údarú margaíochta cóireálacha agus vacsaíní a éascú, tacaíocht a thabhairt dóibh agus dlús a chur leo.
To achieve the objective of making available safe and efficacious medicinal products intended to treat or prevent COVID-19, a range of measures have been taken at Union level by the European Medicines Agency (EMA) and by the network of national competent authorities to facilitate, support and speed up the development and marketing authorisation of treatments and vaccines.
Mar a fhoráiltear i Rialachán (CE) Uimh. 726/2004, leanfaidh EMA de mheasúnú a dhéanamh ar an tionchar ar an gcomhshaol atá ag táirgí íocshláinte ina bhfuil OGManna atá beartaithe COVID-19 a chóireáil nó a chosc nó atá comhdhéanta díobh i gcomhthráth le meastóireacht a dhéanamh ar cháilíocht, sábháilteacht agus éifeachtúlacht an táirge íocshláinte lena mbaineann, agus na ceanglais sábháilteachta comhshaoil a leagtar amach i dTreoir 2001/18/CE á n‐urramú.
As provided in Regulation (EC) No 726/2004, the environmental impact of medicinal products containing or consisting of GMOs intended to treat or prevent COVID-19 will continue to be assessed by the EMA in parallel with the evaluation of the quality, safety and efficacy of the medicinal product concerned, respecting the environmental safety requirements set out in Directive 2001/18/EC.
Dá bhrí sin, ba cheart, trí bhíthin an Chláir, tacú le forbairt, cur chun feidhme agus forfheidhmiú reachtaíocht sláinte an Aontais agus, i gcomhar le comhlachtaí ábhartha amhail EMA agus ECDC, ba cheart dó sonraí ardcháilíochta, neamhchlaonta, inchomparáide agus iontaofa a sholáthar, lena n-áirítear sonraí cúraim sláinte san fhíorshaol, chun tacú le ceapadh beartas agus faireachán, spriocanna a leagan síos agus uirlisí a fhorbairt chun dul chun cinn a thomhas.
The Programme therefore should support the development, implementation and enforcement of Union health legislation and, in conjunction with relevant bodies such as EMA and ECDC, should provide high-quality, comparable and reliable data, including real-world healthcare data, to support policymaking and monitoring, set targets and develop tools to measure progress.
Chun an tsaorghluaiseacht a éascú, agus chun a áirithiú gur féidir deireadh a chur leis na srianta ar an tsaorghluaiseacht atá i bhfeidhm faoi láthair le linn phaindéim COVID-19 ar mhodh comhordaithe, bunaithe ar an bhfianaise eolaíoch agus an treoir is déanaí a chuireann an Coiste Slándála Sláinte a bunaíodh le hAirteagal 17 de Chinneadh Uimh. 1082/2013/AE ó Pharlaimint na hEorpa agus ón gComhairle, ECDC agus an Ghníomhaireacht Leigheasra Eorpach (EMA) ar fáil, ba cheart deimhniú vacsaínithe idir-inoibritheach a bhunú.
For the purpose of facilitating free movement, and to ensure that restrictions to free movement currently in place during the COVID-19 pandemic can be lifted in a coordinated manner based on the latest scientific evidence and guidance made available by the Health Security Committee established by Article 17 of Decision No 1082/2013/EU of the European Parliament and of the Council, ECDC and the European Medicines Agency (EMA), an interoperable vaccination certificate should be established.
Chun go mbeidh sé ar chumas an Choimisiúin teacht ar chomhsheasamh go mear, ba cheart dó a bheith in ann a iarraidh ar an gCoiste Slándála Sláinte, ar ECDC nó ar EMA treoir a eisiúint maidir leis an bhfianaise eolaíoch atá ar fáil maidir le hiarmhairtí teagmhas leighis a dhoiciméadaítear i ndeimhnithe arna mbunú i gcomhréir leis an Rialachán seo, lena n-áirítear éifeachtacht agus fad thréimhse na himdhíonachta arna tabhairt le vacsaíní in aghaidh COVID-19, cibé acu a chuireann nó nach gcuireann vacsaíní cosc ar ionfhabhtú aisiomptómach agus tras-seoladh SARS-CoV-2, staid na ndaoine atá téarnaithe ó COVID-19, agus an tionchar atá ag athraithigh SARS-CoV-2 nua ar dhaoine atá vacsaínithe nó ionfhabhtaithe cheana.
To be able to obtain a common position quickly, the Commission should be able to ask the Health Security Committee, the ECDC or EMA to issue guidance on the available scientific evidence on the effects of medical events documented in the certificates established in accordance with this Regulation, including the effectiveness and duration of the immunity conferred by COVID-19 vaccines, whether vaccines prevent asymptomatic infection and SARS-CoV-2 transmission, the situation of people having recovered from COVID-19, and the impacts of the new SARS-CoV-2 variants on people who have been vaccinated or already infected.
I gcás inar gá, iarrfaidh an Coimisiún ar an gCoiste Slándála Sláinte, ar ECDC nó ar EMA treoir a eisiúint maidir leis an bhfianaise eolaíoch atá ar fáil i ndáil leis na hiarmhairtí teagmhas leighis a dhoiciméadaítear sna deimhnithe dá dtagraítear i mír 1, go háirithe a mhéid a bhaineann le hathraitheacha nua SARS-CoV-2 is ábhar imní.
Where necessary, the Commission shall ask the Health Security Committee, the ECDC or EMA to issue guidance on the available scientific evidence on the effects of medical events documented in the certificates referred to in paragraph 1, in particular with regard to new SARS-CoV-2 variants of concern.
Comhairle maidir le bearta cur chun feidhme faoi Airteagal 37(4) de Rialachán (AE) 2019/6 maidir le táirgí íocshláinte tréidliachta – Critéir maidir le hainmniú ábhar frithmhiocróbach atá le forchoimeád chun ionfhabhtuithe áirithe i ndaoine a chóireáil (EMA/CVMP/158366/2019)
Advice on implementing measures under Article 37(4) of Regulation (EU) 2019/6 on veterinary medicinal products – Criteria for the designation of antimicrobials to be reserved for treatment of certain infections in humans (EMA/CVMP/158366/2019).
Mar fhreagra ar an iarraidh ón gCoimisiún, an 8 Meán Fómhair 2021, sholáthar an Ghníomhaireacht Leigheasra Eorpach (EMA) anailís eolaíoch ar chuspóir theicniúil úsáid dé-ocsaíde tíotáiniam (E 171) i dtáirgí íocshláinte, ar indéantacht an ionadaithe, agus ar thréimhsí féideartha i gcás roghanna eile.
In response to a request from the Commission, the European Medicines Agency (EMA) provided on 8 September 2021 a scientific analysis on the technical purpose of the use of titanium dioxide (E 171) in medicinal products, the feasibility of replacement and possible timeframes for alternatives.
Thairis sin, tháinig EMA ar an gconclúid gur deacair faoi láthair idirthréimhse bheacht a mholadh maidir le dé-ocsaíd tíotáiniam (E 171) a úsáidtear i dtáirgí íocshláinte a ionadú, toisc go bhféadfadh roinnt blianta a bheith de dhíth chun gach táirge aonair a athfhoirmliú, ag brath ar chastacht an athfhoirmlithe agus ar na staidéir a mbeadh gá leo.
Furthermore, EMA concluded that it is difficult at this stage to recommend a precise transition period timeframe for the replacement of titanium dioxide (E 171) used in medicinal products, as the time needed to reformulate each individual product could take several years, depending on the complexity of reformulation and studies required.
Ar deireadh, i bhfianaise scála úsáide an támháin seo agus líon na dtáirgí a mbeadh tionchar aige orthu, agus slabhraí soláthair domhanda san áireamh, chuir EMA i dtábhacht gur chinnte go gcruthódh ceanglas chun dé-ocsaíd tíotáiniam (E 171) a ionadú ganntanais shuntasacha cógais ar mhargadh an Aontais.
Finally, considering the scale of the use of this excipient and the volume of products impacted, and taking into account global supply chains, EMA stressed that a requirement to replace titanium dioxide (E 171) would almost certainly cause significant medicines shortages on the Union market.
Ar bhonn anailís eolaíoch EMA, agus chun ganntanais táirgí íocshláinte a d’fhéadfadh tionchair a bheith acu ar shláinte phoiblí a sheachaint, ba cheart dé-ocsaíd tíotáiniam (E 171) a fhágáil ar liosta na mbreiseán údaraithe go sealadach ionas go bhféadfaí í a úsáid le dath a chur ar tháirgí íocshláinte, go dtí go bhforbrófar roghanna eile oiriúnacha lena gcur ina ionad agus cáilíocht, sábháilteacht agus éifeachtúlacht na dtáirgí íocshláinte lena mbaineann á n-áirithiú.
On the basis of the EMA scientific analysis, and in order to avoid shortages of medicinal products that could have impacts on public health, titanium dioxide (E 171) should remain provisionally on the list of authorised additives to allow its use in medicinal products as a colour, pending the development of adequate alternatives to replace it while ensuring the quality, safety and efficacy of the medicinal products concerned.
An 24 Feabhra 2022, d’fhógair an Ghníomhaireacht Leigheasra Eorpach (“EMA”) gur mhol an Coiste um Tháirgí Íocshláinte lena nÚsáid ag an Duine go bhféadfaí teanndáileog den vacsaín Comirnaty COVID-19 a thabhairt do dhéagóirí atá 12 bhliain d’aois i gcás inarb iomchuí.
On 24 February 2022, the European Medicines Agency (‘EMA’) announced that its Committee for Medicinal Products for Human Use had recommended that a booster dose of the COVID-19 vaccine Comirnaty may be given where appropriate to adolescents from 12 years of age.
An tráth céanna, mar a thug EMA faoi deara, ní mór a chur san áireamh sa chinneadh an dtairgfidh siad teanndáileoga don aoisghrúpa seo agus cathain a thairgfidh siad iad, imthosca amhail leathadh an ghalair agus chomh dian is dócha a bheidh an galar i ndaoine óga, go háirithe mar gheall ar athraitheach Omicron, an riosca aitheanta fo-iarmhairtí, go háirithe aimhréidh an-annamh ach tromchúiseach de mhiócairdíteas, agus bearta agus srianta cosanta eile a bheith ann.
At the same time, as noted by EMA, the decision on whether and when to offer boosters in this age group will need to take into account such factors as the spread and likely severity of the disease in younger persons, especially with the Omicron variant, the known risk of side effects, particularly the very rare but serious complication of myocarditis, and the existence of other protective measures and restrictions.
Nuair a chuaigh an Coimisiún i gcomhairle leis, mheas líon mór saineolaithe de chuid na mBallstát sa Choiste Slándála Sláinte a bunaíodh le hAirteagal 17 de Chinneadh Uimh. 1082/2013/AE ó Pharlaimint na hEorpa agus ón gComhairle, fiú dá gcinnfeadh roinnt Ballstát teanndáileog a thairiscint do mhionaoisigh, bunaithe ar na cúinsí éagsúla a ndearna EMA tuairisc orthu, go mbeadh sé iomchuí mionaoisigh a dhíolmhú ón tréimhse inghlacthachta chaighdeánach a bunaíodh le Rialachán Tarmligthe (AE) 2021/2288.
When consulted by the Commission, a large number of Member States’ experts in the Health Security Committee established by Article 17 of Decision No 1082/2013/EU of the European Parliament and of the Council considered that, even if some Member States might decide, based on the different considerations outlined by EMA, to offer booster vaccinations to minors, it is appropriate to exempt minors from the standard acceptance period established by Delegated Regulation (EU) 2021/2288.
De bhun Airteagal 3(11) de Rialachán (AE) 2021/953, i gcás inar gá, iarrfaidh an Coimisiún ar an gCoiste Slándála Sláinte, ar ECDC nó ar EMA treoir a eisiúint maidir le glacadh le vacsaíní in aghaidh COVID-19 atá ag dul faoi thrialacha cliniciúla sna Ballstáit.
Pursuant to Article 3(11) of Regulation (EU) 2021/953, where necessary, the Commission is to ask the Health Security Committee, ECDC or EMA to issue guidance on the acceptance of COVID-19 vaccines undergoing clinical trials in the Member States.
I gcás ina mbeidh treoir faighte ag an gCoimisiún ón gCoiste Slándála Sláinte, ón Lárionad Eorpach um Ghalair a Chosc agus a Rialú (ECDC) nó ón nGníomhaireacht Leigheasra Eorpach (EMA) maidir le glacadh le deimhnithe arna n-eisiúint le haghaidh vacsaín in aghaidh COVID-19 atá ag dul faoi thrialacha cliniciúla, foilseofar an treoir mar chuid de dhoiciméad na dtacar luacha nó foilseofar ar leithligh í.”;
Where the Commission has received guidance from the Health Security Committee, the European Centre for Disease Prevention and Control (ECDC) or the European Medicines Agency (EMA) with regard to the acceptance of certificates issued for a COVID-19 vaccine undergoing clinical trials, the guidance shall be published either as part of the value sets document or separately.’;
Chun cur chuige comhleanúnach a áirithiú, ba cheart cumhacht a thabhairt don Choimisiún a iarraidh ar an gCoiste Slándála Sláinte, ar an Lárionad Eorpach um Ghalair a Chosc agus a Rialú (ECDC) nó ar an nGníomhaireacht Leigheasra Eorpach (EMA) treoir a eisiúint maidir le glacadh le deimhnithe a eisítear le haghaidh vacsaín in aghaidh COVID-19 atá ag dul faoi thrialacha cliniciúla ach nach bhfuil údarú margaíochta deonaithe aici go fóill de bhun Rialachán (CE) Uimh. 726/2004, treoir lenar cheart go gcuirfí san áireamh na critéir eiticiúla agus eolaíocha is gá chun trialacha cliniciúla a dhéanamh.
To ensure a coherent approach, the Commission should be empowered to ask the Health Security Committee, the European Centre for Disease Prevention and Control (ECDC) or the European Medicines Agency (EMA) to issue guidance with regard to the acceptance of certificates issued for a COVID-19 vaccine undergoing clinical trials that has not yet been granted a marketing authorisation pursuant to Regulation (EC) No 726/2004, which should take into account the ethical and scientific criteria necessary for carrying out clinical trials.
I gcás inar gá, iarrfaidh an Coimisiún ar an gCoiste Slándála Sláinte, ar ECDC nó ar EMA treoir a eisiúint maidir leis an bhfianaise eolaíoch atá ar fáil i ndáil le héifeachtaí na dteagmhas leighis a dhoiciméadaítear sna deimhnithe dá dtagraítear i mír 1, go háirithe a mhéid a bhaineann le hathraithigh nua SARS-CoV-2 ar díol imní iad, agus maidir le vacsaíní in aghaidh COVID-19 atá ag dul faoi thrialacha cliniciúla sna Ballstáit”;
Where necessary, the Commission shall ask the Health Security Committee, the ECDC or EMA to issue guidance on the available scientific evidence on the effects of medical events documented in the certificates referred to in paragraph 1, in particular with regard to new SARS-CoV-2 variants of concern, and on the acceptance of COVID-19 vaccines undergoing clinical trials in the Member States.’;
Comhairle maidir le hainmniú ábhar frithmhiocróbach nó grúpaí frithmhiocróbacha arna bhforchoimeád chun ionfhabhtuithe áirithe i ndaoine a chóireáil - i ndáil le bearta cur chun feidhme faoi Airteagal 37(5) de Rialachán (AE) 2019/6 maidir le táirgí íocshláinte tréidliachta (EMA/CVMP/678496/2021), 16 Feabhra 2022).
Advice on the designation of antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans – in relation to implementing measures under Article 37(5) of Regulation (EU) 2019/6 on veterinary medicinal products (EMA/CVMP/678496/2021, 16 February 2022).
Is éard is ‘táirgí leighis’ ann: (1) 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.
‘Medical products’ are: (1) 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.
I ndlúth-chomhoibriú leis na Ballstáit, leis an nGníomhaireacht Leigheasra Eorpach (EMA) agus le comhlachtaí agus gníomhaireachtaí ábhartha eile de chuid an Aontais, chomh maith le heagraíochtaí idirnáisiúnta, forbróidh an Lárionad creat maidir le galair theagmhálacha agus saincheisteanna sláinte speisialta lena mbaineann a chosc, lena n-áirítear tosca riosca socheacnamaíocha, galair atá inchoiscthe trí vacsaíniú, an fhrithsheasmhacht in aghaidh ábhair fhrithmhiocróbacha, cur chun cinn na sláinte, oideachas sláinte, litearthacht sláinte agus athrú iompraíochta.
In close collaboration with Member States, the European Medicines Agency (EMA) and other relevant Union bodies and agencies, as well as with international organisations, the Centre shall develop a framework for the prevention of communicable diseases and related special health issues, including socio-economic risk factors, vaccine preventable diseases, antimicrobial resistance, health promotion, health education, health literacy and behaviour change.
I gcásanna práinneacha a bhaineann le déine nó le húrnuacht bagartha tromchúisí trasteorann ar an tsláinte nó le luas a leata i measc na mBallstát, cuirfidh an Lárionad réamhaisnéisí eipidéimeolaíocha dá dtagraítear in Airteagal 5(3), pointe (h), ar fáil, arna iarraidh sin don Choimisiún, do CSS, do EMA, do na Ballstáit nó ar a thionscnamh féin.
In situations of urgency related to the severity or novelty of a serious cross-border threat to health or to the rapidity of its spread among the Member States, at the request of the Commission, the HSC, EMA, the Member States or on its own initiative, the Centre shall make available epidemiological forecasts as referred to in Article 5(3), point (h).
Chun éifeachtacht na hullmhachta agus na freagartha i leith bagairtí tromchúiseacha trasteorann ar an tsláinte a mhéadú, ba cheart don Choimisiún, lena n-áirítear, i gcás inarb ábhartha, an tÚdarás Eorpach um Ullmhacht agus Freagairt i dtaca le hÉigeandáilí Sláinte (HERA) a bunaíodh mar sheirbhís de chuid an Choimisiúin le Cinneadh ón gCoimisiún an 16 Meán Fómhair 2021, agus an Coiste Slándála Sláinte, ECDC, EMA agus gníomhaireachtaí agus comhlachtaí ábhartha eile de chuid an Aontais, comhordú agus comhoibriú a dhéanamh i ndáil leis an ullmhacht agus an fhreagairt sin.
In order to increase the effectiveness of the preparedness for and response to serious cross-border threats to health, the Commission including, where relevant, the Health Emergency Preparedness and Response Authority (HERA) established as a Commission service by Commission Decision of 16 September 2021, and the HSC, the ECDC, EMA and other relevant Union agencies and bodies should coordinate and cooperate in relation to such preparedness and response.
Ba cheart don Choimisiún an comhar agus gníomhaíochtaí a neartú idir na Ballstáit, ECDC, EMA, agus gníomhaireachtaí nó comhlachtaí eile de chuid an Aontais, bonneagair thaighde agus an Eagraíocht Dhomhanda Sláinte, tríd an gcur chuige Aon Sláinte Amháin, chun an cosc ar ghalair theagmhálacha, amhail galair atá inchoiscthe le vacsaín, chomh maith le saincheisteanna sláinte eile, amhail frithsheasmhacht in aghaidh ábhair fhrithmhiocróbacha, a fheabhsú.
The Commission should strengthen cooperation and activities with the Member States, the ECDC, EMA, other Union agencies or bodies, research infrastructures and the WHO to improve, through the One Health approach, the prevention of communicable diseases, such as vaccine preventable diseases, as well as other health issues, such as antimicrobial resistance.
An Ghníomhaireacht Leigheasra Eorpach (EMA), i gcomhréir le hAirteagal 1 de Rialachán (AE) 2022/123 ó Pharlaimint na hEorpa agus ón gComhairle, i gcás ina bhfuil an bhagairt thromchúiseach trasteorann ar an tsláinte nasctha le táirgí íocshláinte agus le feistí leighis;
the European Medicines Agency (EMA), in accordance with Article 1 of Regulation (EU) 2022/123 of the European Parliament and of the Council, where the serious cross-border threat to health is linked to medicinal products and medical devices;
Déanfar an measúnú riosca i gcás bagairt dá dtagraítear in Airteagal 2(1) den Rialachán seo i gcomhar le Gníomhaireacht an Aontais Eorpaigh i ndáil le Comhar i bhForfheidhmiú an Dlí (Europol) i gcás ina n-eascraíonn an bhagairt thromchúiseach trasteorann ar an tsláinte ó ghníomhaíocht sceimhlitheoireachta nó ó ghníomhaíocht choiriúil dá dtagraítear in Airteagal 3 de Rialachán (AE) 2016/794 ó Pharlaimint na hEorpa agus ón gComhairle; agus i gcomhar le EMA, i gcás ina bhfuil an bhagairt thromchúiseach trasteorann ar an tsláinte nasctha le táirgí íocshláinte.
The risk assessment shall be carried out in the case of a threat referred to in Article 2(1) of this Regulation in cooperation with the European Union Agency for Law Enforcement Cooperation (Europol) where the serious cross-border threat to health emanates from terrorist or criminal activity referred to in Article 3 of Regulation (EU) 2016/794 of the European Parliament and of the Council; and in cooperation with EMA, where the serious cross-border threat to health is linked to medicinal products.
Beidh an Coiste Comhairleach comhdhéanta de shaineolaithe neamhspleácha, a bhféadfaidh ionadaithe oibrithe cúraim sláinte agus cúraim shóisialta agus ionadaithe ón tsochaí shibhialta a bheith ar áireamh ann, arna roghnú ag an gCoimisiún de réir réimsí saineolais agus taithí na n na n-ionadaithe sin, arb iad na réimsí saineolais agus taithí is ábhartha don bhagairt shonrach atá ag tarlú, agus lena n-áirítear ionadaithe ECDC agus EMA mar bhreathnóirí buana.
The Advisory Committee shall be composed of independent experts, who may include representatives of healthcare and social care workers and civil society representatives, selected by the Commission according to the fields of expertise and experience of those representatives, which are the most relevant to the specific threat that is occurring, and including representatives of the ECDC and EMA as permanent observers.
Ba cheart a áirithiú go ndéanann an Coimisiún dlúthchomhar le ECDC agus EMA, toisc gurb é an ghníomhaireacht atá freagrach as comhairle eolaíoch agus measúnú eolaíoch ar tháirgí íocshláinte nua nó athphróifílithe, ba cheart sin a áirithiú maidir leis na hábhair sin, agus maidir leis na hábhair a bhaineann le gnéithe rialála i dtaobh údarú táirgí íocshláinte, lena n-áirítear suíomhanna nua monaraíochta a bhunú le haghaidh táirgí íocshláinte údaraithe agus chun a ráthú go mbeidh na trialacha cliniciúla, agus an fhianaise a ghineann siad le haghaidh údarú táirgí íocshláinte nua nó athphróifílithe, inghlactha.
Close coordination of the Commission with the ECDC and the EMA, as the Agency responsible for scientific advice and scientific assessment of new and repurposed medicinal products, should be ensured for those matters, as well as for those related to regulatory aspects concerning the authorisation of medicinal products, including for the establishment of new manufacturing sites for authorised medicinal products, and to guarantee the acceptability of the clinical trials and the evidence they generate for the authorisation of new or repurposed medicinal products.
Áiritheoidh an Bord um Ghéarchéimeanna Sláinte go mbeidh institiúidí, comhlachtaí, oifigí agus gníomhaireachtaí ábhartha uile an Aontais, lena n-áirítear an Ghníomhaireacht Leigheasra Eorpach (EMA), an Lárionad Eorpach um Ghalair a Chosc agus a Rialú (ECDC), agus an Coiste Comhairleach um éigeandálaí sláinte poiblí rannpháirteach mar bhreathnóirí.
The Health Crisis Board shall ensure the participation of all relevant Union institutions, bodies, offices and agencies, including the European Medicines Agency (EMA), the European Centre for Disease Prevention and Control (ECDC), and the Advisory Committee on public health emergencies, as observers.