#1883849
Tar éis dul i gcomhairle le Coiste Foirne Chomhghnóthas IMI 2 JU,
After having consulted the IMI 2 JU Staff Committee,
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#1883852
Tugann an Comhghnóthas IMI 2 JU faoina ghníomhaíochtaí i gcomhréir le Rialachán (AE) Uimh. 557/2014.
The IMI 2 JU carries out its activities in accordance with Regulation (EU) No 557/2014.
#1883897
Ní chuirfidh Comhghnóthas IMI 2 JU aon srian i bhfeidhm ach amháin chun coimirciú a dhéanamh in aghaidh an méid seo a leanas:
Any restriction shall only be applied by the IMI 2 JU to safeguard:
#1883968
Do Bhord Rialaithe an IMI 2 JU
For the Governing Board of the IMI 2 JU
#1883858
Feidhmíonn Comhghnóthas S2R, agus é á ionadú ag a Stiúrthóir Feidhmiúcháin, mar rialaitheoir sonraí gan beann ar thoscaireachtaí eile ag a bhfuil ról rialtóra laistigh den Chomhghnóthas IMI 2 JU chun freagrachtaí oibriúcháin a léiriú maidir le hoibríochtaí um próiseáil sonraí pearsanta áirithe.
The IMI 2 JU, represented by its Executive Director, acts as the data controller irrespective of further delegations of the controller role within the IMI 2 JU to reflect operational responsibilities for specific personal data processing operations.
#1883914
Sula gcuirfidh sí srianta i bhfeidhm ar na cúiseanna dá dtagraítear i bpointe (a) agus i bpointe (b) den chéad fhomhír, rachaidh Comhghnóthas IMI 2 JU i gcomhairle le seirbhísí ábhartha an Choimisiúin, le hinstitiúidí an Aontais, le comhlachtaí, le gníomhaireachtaí, le hoifigí nó le húdaráis inniúla na mBallstát murar léir go bhfuil sé soiléir don Chomhghnóthas IMI 2 JU go bhforáiltear do chur i bhfeidhm srianta i gceann de na gníomhartha dá dtagraítear sna pointí sin.
Before applying restrictions in the circumstances referred to in points (a) and (b) of the first subparagraph, the IMI 2 JU shall consult the relevant Commission services, Union institutions, bodies, agencies, offices or the competent authorities of Member States unless it is clear to the IMI 2 JU that the application of a restriction is provided for by one of the acts referred to in those points.
#1883958
Cuirfidh Comhghnóthas IMI 2 JU, gan moill mhíchuí, in iúl d’Oifigeach Cosanta Sonraí Chomhghnóthas IMI 2 JU (“an OCS”) aon uair a shrianfaidh an rialaitheoir feidhmiú chearta na ndaoine is ábhar do na sonraí, nó nuair a shínfidh sé an srianadh, i gcomhréir leis an gCinneadh seo.
The IMI 2 JU shall, without undue delay, inform the Data Protection Officer of the IMI 2 JU (‘the DPO’) whenever the controller restricts the application of data subjects’ rights, or extends the restriction, in accordance with this Decision.
#1883843
lena leagtar síos rialacha inmheánacha maidir le srianta le cearta áirithe de dhaoine is ábhar do na sonraí i ndáil le sonraí pearsanta a phróiseáil faoi chuimsiú fheidhmiú IMI 2 JU
laying down internal rules concerning restrictions of certain rights of data subjects in relation to processing of personal data in the framework of the functioning of the IMI 2 JU
#1883844
BORD RIALAITHE CHOMHGHNÓTHAS AN TIONSCNAIMH UM MÍOCHAINE NUÁLAÍOCH 2 (dá ngairtear “Comhghnóthas IMI 2 JU” anseo feasta),
THE GOVERNING BOARD OF THE INNOVATIVE MEDICINES INITIATIVE 2 JOINT UNDERTAKING (hereafter referred to as ‘the IMI 2 JU’),
#1883863
Ba cheart cúnamh agus comhar a bheith san áireamh ann a chur Comhghnóthas IMI 2 JU ar fáil d’údaráis náisiúnta agus d’eagraíochtaí idirnáisiúnta lasmuigh dá imscrúduithe riaracháin.
It should also include assistance and cooperation provided by the IMI 2 JU to national authorities and international organisations outside of its administrative investigations.
#1883867
Ar an ábhar sin féadfaidh Comhghnóthas IMI 2 JU srian a chur leis an bhfaisnéis chun cosaint a dhéanamh ar an imscrúdú mar aon le cearta bunúsacha agus saoirsí bunúsacha ábhar sonraí eile.
The IMI 2 JU may thus restrict the information for the purposes of protecting the investigation, and the fundamental rights and freedoms of other data subjects.
#1883868
Ba cheart do Chomhghnóthas IMI 2 JU faireachán a dhéanamh ó am go chéile ar na coinníollacha a thugann údar maith don srian lena áirithiú go mbeidh feidhm fós leis agus deireadh a chur leis an srian mura mbeidh feidhm leis.
The IMI 2 JU should periodically monitor that the conditions justifying the restriction apply, and lift the restriction as far as they no longer apply.
#1883879
Is é Comhghnóthas IMI 2 JU rialaitheoir na n‐oibríochtaí próiseála, a ndéanann a Stiúrthóir Feidhmiúcháin ionadaíocht dó agus a bhféadfaidh an Stiúrthóir feidhm an rialaitheora a tharmligean.
The controller of the processing operations is the IMI 2 JU, represented by its Executive Director, who may delegate the function of the controller.
#1883880
Cuirfear daoine is ábhar do na sonraí ar an eolas faoin rialaitheoir tarmligthe trí na fógraí nó na taifid chosanta sonraí a fhoilsítear ar shuíomh gréasáin agus/nó inlíon Chomhghnóthas IMI 2 JU.
Data subjects shall be informed of the delegated controller by way of the data protection notices or records published on the website and/or the intranet of the IMI 2 JU.
#1883883
Cuirfidh Comhghnóthas IMI 2 JU i bhfeidhm na coimircí seo a leanas atá dírithe ar chosc a chur ar mhí-úsáid nó ar rochtain neamhdhleathach ar shonraí pearsanta nó a n‐aistriú neamhdhleathach:
The IMI 2 JU shall put in place the following safeguards aimed at preventing abuse or unlawful access or transfer of personal data:
#1883906
Mar fheidhmiú áirithe na gcríoch a mhínítear i mír 1 thuas, féadfaidh Comhghnóthas IMI 2 JU srianta a chur i bhfeidhm, sna cúinsí seo a leanas:
As a specific application of the purposes described in paragraph 1 above, the IMI 2 JU may apply restrictions in the following circumstances:
#1883912
i gcás ina gcuirfear cuspóir a leithéide de shrian atá ag an údarás inniúil sin i mbaol mura gcuirfidh Comhghnóthas IMI 2 JU srian coibhéiseach i bhfeidhm maidir leis na sonraí pearsanta céanna.
where the purpose of such a restriction by that competent authority would be jeopardised were the IMI 2 JU not to apply an equivalent restriction in respect of the same personal data;
#1883944
Déanfaidh Comhghnóthas IMI 2 JU athbhreithniú ar chur i bhfeidhm an tsriain gach 6 mhí tar éis é a ghlacadh agus ar dhúnadh an fhiosrúcháin, an nós imeachta nó an imscrúdaithe ábhartha.
The IMI 2 JU shall review the application of the restriction every six months from its adoption and at the closure of the relevant inquiry, procedure or investigation.
#1883853
De réir Airteagal 25(1) de Rialachán (AE) 2018/1725, ba cheart srianta le feidhmiú Airteagail 14 go 22, 35 agus 36, chomh maith le hAirteagal 4 den Rialachán sin, sa mhéid go dtagann a fhorálacha leis na cearta agus na dualgais a fhoráiltear in Airteagail 14 go 22, a bhunú ar rialacha inmheánacha a bheidh le glacadh ag Comhghnóthas IMI 2 JU, i gcás nach bhfuil siad sin bunaithe ar ghníomhartha dlíthiúla arna nglacadh ar bhonn na gConarthaí.
In accordance with Article 25(1) of Regulation (EU) 2018/1725 restrictions of the application of Articles 14 to 22, 35 and 36, as well as Article 4 of that Regulation in so far as its provisions correspond to the rights and obligations provided for in Articles 14 to 22 should be based on internal rules to be adopted by the IMI 2 JU, where these are not based on legal acts adopted on the basis of the Treaties.
#1883855
Agus Comhghnóthas IMI 2 JU ag déanamh a dhualgas maidir le cearta an duine is ábhar do na sonraí faoi Rialachán (AE) 2018/1725, déanfar machnamh ar aon díolúintí a leagtar síos sa Rialachán sin a fheidhmiú.
Where the IMI 2 JU performs its duties with respect to data subject’s rights under Regulation (EU) 2018/1725, it shall consider whether any of the exemptions laid down in that Regulation apply.
#1883856
Faoi chuimsiú a fheidhmithe riaracháin, féadfaidh Comhghnóthas IMI 2 JU fiosrúcháin riaracháin agus imeachtaí araíonachta a dhéanamh, réamhghníomhaíochtaí a dhéanamh a bhaineann le cásanna neamhrialtachtaí a thuairiscítear do OLAF, cásanna sceithireachta a phróiseáil, nósanna imeachta (foirmiúla agus neamhfhoirmiúla) ciaptha a phróiseáil, gearáin inmheánacha agus sheachtracha a phróiseáil, iniúchtaí inmheánacha a dhéanamh, imscrúduithe a dhéanamh tríd an Oifigeach Cosanta Sonraí i gcomhréir le hAirteagal 45(2) de Rialachán (AE) 2018/1725 agus imscrúduithe slándála inmheánacha (TF) a dhéanamh.
Within the framework of its administrative functioning, the IMI 2 JU may conduct administrative inquiries, disciplinary proceedings, carry out preliminary activities related to cases of potential irregularities reported to OLAF, process whistleblowing cases, process (formal and informal) procedures of harassment, process internal and external complaints, conduct internal audits, carry out investigations by the Data Protection Officer in line with Article 45(2) of Regulation (EU) 2018/1725 and internal (IT) security investigations.
#1883857
Déanann Comhghnóthas IMI 2 JU próiseáil ar roinnt catagóirí sonraí pearsanta, lena n‐áirítear sonraí crua (sonraí “oibiachtúla” ar nós sonraí aitheantais, sonraí teagmhála, sonraí gairmiúla, sonraí riaracháin, sonraí a fhaightear as foinsí faoi leith, sonraí cumarsáide leictreonaí agus sonraí tráchta) agus sonraí boga (sonraí “suibiachtúla” a bhaineann leis an gcás ar nós na réasúnaíochta, sonraí iompraíochta, breithmheasanna, sonraí feidhmíochta agus iompair, agus sonraí a bhaineann le hábhar an nós imeachta nó na gníomhaíochta nó a thagann chun cinn maidir leis).
The IMI 2 JU processes several categories of personal data, including hard data (‘objective’ data such as identification data, contact data, professional data, administrative details, data received from specific sources, electronic communications and traffic data) and soft data (‘subjective’ data related to the case such as reasoning, behavioural data, appraisals, performance and conduct data and data related to or brought forward in connection with the subject matter of the procedure or activity).
#1883860
Ní choimeádtar na sonraí pearsanta a phróiseáiltear níos faide ná mar is gá agus mar is cuí chun na críocha lena ndéantar próiseáil na sonraí don tréimhse a shonraítear sna fógraí cosanta sonraí, ráitis phríobháideachta nó taifid de chuid Chomhghnóthas IMI 2 JU.
The personal data processed are retained for no longer than necessary and appropriate for the purposes for which the data are processed for the period specified in the data protection notices, privacy statements or records of the IMI 2 JU.
#1883861
Ba cheart feidhm a bheith ag na rialacha inmheánacha maidir leis na hoibríochtaí próiseála go léir a dhéanann Comhghnóthas IMI 2 JU i bhfeidhmiú fiosrúchán riaracháin, imeachtaí araíonachta, réamhghníomhaíochtaí a bhaineann le cásanna neamhrialtachtaí ionchasacha a thuairiscítear do OLAF, nósanna imeachta sceithireachta, nósanna imeachta (foirmiúla agus neamhfhoirmiúla) maidir le cásanna ciaptha, próiseáil gearán inmheánach agus seachtrach, iniúchtaí inmheánacha, leis na himscrúduithe a dhéanann an tOifigeach Cosanta Sonraí i gcomhréir le hAirteagal 45(2) de Rialachán (AE) 2018/1725, imscrúduithe slándála (TF) arna láimhseáladh go hinmheánach nó le rannpháirtíocht sheachtrach (e.g. CERT‐AE).
The internal rules should apply to all processing operations carried out by the IMI 2 JU in the performance of administrative inquiries, disciplinary proceedings, preliminary activities related to cases of potential irregularities reported to OLAF, whistleblowing procedures, (formal and informal) procedures for cases of harassment, processing internal and external complaints, internal audits, the investigations carried out by the Data Protection Officer in line with Article 45(2) of Regulation (EU) 2018/1725, (IT) security investigations handled internally or with external involvement (e.g. CERT-EU).
#1883864
I gcásanna ina bhfuil feidhm ag na rialacha inmheánacha sin, ní mór do Chomhghnóthas IMI 2 JU údar a thabhairt lena mínítear cén fáth a bhfuil na srianta fíor-riachtanach agus comhréireach i sochaí dhaonlathach agus bunbhrí na gceart agus na saoirsí bunúsacha a urramú.
In cases where these internal rules apply, the IMI 2 JU must provide justifications explaining why the restrictions are strictly necessary and proportionate in a democratic society and respect the essence of the fundamental rights and freedoms.
#1883865
Laistigh den chreat sin, ní mór do Chomhghnóthas IMI 2 JU géilleadh, chomh fada agus is féidir, do chearta bunúsacha na n‐ábhar sonraí le linn na nósanna imeachta thuasluaite, go háirithe, do na cearta a bhaineann leis an gceart chun faisnéise, an ceart rochtana agus an ceart go ndéanfaí ceartúcháin, an ceart go ndéanfaí léirscriosadh, an ceart go gcuirfí srian le próiseáil, le ceart an ábhair sonraí teachtaireacht a fháil má sháraítear a shonraí pearsanta nó a rúndacht cumarsáide mar a chumhdaítear i Rialachán (AE) 2018/1725.
Within this framework the IMI 2 JU is bound to respect, to the maximum extent possible, the fundamental rights of the data subjects during the above procedures, in particular, those relating to the right of provision of information, access and rectification, right to erasure, restriction of processing, right of communication of a personal data breach to the data subject or confidentiality of communication as enshrined in Regulation (EU) 2018/1725.
#1883866
D’fhéadfadh sé a bheith d’oibleagáid ar Chomhghnóthas IMI 2 JU, áfach, srian a chur le rochtain ar fhaisnéis agus cearta eile de chuid an duine is ábhar do na sonraí, go háirithe chun cosaint a dhéanamh ar a imscrúduithe féin, imscrúduithe agus imeachtaí údarás poiblí eile agus cearta daoine eile a bhaineann lena imscrúduithe nó lena nósanna imeachta eile.
However, the IMI 2 JU may be obliged to restrict the information to data subject and other data subject’s rights to protect, in particular, its own investigations, the investigations and proceedings of other public authorities, as well as the rights of other persons related to its investigations or other procedures.
#1883873
Leagtar síos sa Chinneadh seo rialacha a bhaineann leis na coinníollacha faoina bhféadfaidh Comhghnóthas IMI 2 JU, faoi chuimsiú a nósanna imeachta a leagtar amach i mír 2, srian a chur le feidhmiú na gceart atá cumhdaithe in Airteagail 14 go 22, Airteagail 35 agus 36, chomh maith le hAirteagal 4 de, i gcomhréir le hAirteagal 25 de Rialachán (AE) 2018/1725.
This Decision lays down rules relating to the conditions under which the IMI 2 JU in the framework of its procedures set out paragraph 2 may restrict the application of the rights enshrined in Articles 14 to 22, 35 and 36, as well as Article 4 thereof, following Article 25 of Regulation (EU) 2018/1725.
#1883874
Faoi chuimsiú fheidhmiú riaracháin Chomhghnóthas IMI 2 JU, tá feidhm ag an gcinneadh seo maidir leis na hoibríochtaí próiseála ar shonraí pearsanta atá déanta ag Oifig an Chláir chun na gcríoch seo: fiosrúcháin riaracháin a dhéanamh, imeachtaí araíonachta a chur i gcrích, réamhghníomhaíochtaí a bhaineann le cásanna neamhrialtachtaí ionchasacha a thuairiscítear do OLAF a dhéanamh, cásanna sceithireachta a phróiseáil, nósanna imeachta (foirmiúla agus neamhfhoirmiúla) ciaptha a chur i gcrích, gearáin inmheánacha agus seachtracha a phróiseáil, imscrúduithe arna ndéanamh ag an Oifigeach Cosanta Sonraí i gcomhréir le hAirteagal 45(2) de Rialachán (AE) 2018/1725 agus imscrúduithe slándála (FT) arna láimhseáil go hinmheánach nó le rannpháirtíocht sheachtrach (e.g. CERT‐AE).
Within the framework of the administrative functioning of the IMI 2 JU, this Decision applies to the processing operations on personal data by the Programme Office for the purposes of conducting administrative inquiries, disciplinary proceedings, preliminary activities related to cases of potential irregularities reported to OLAF, processing whistleblowing cases, (formal and informal) procedures of harassment, processing internal and external complaints, conducting internal audits, investigations carried out by the Data Protection Officer in line with Article 45(2) of Regulation (EU) 2018/1725 and (IT) security investigations handled internally or with external involvement (e.g. CERT-EU).
#1883893
I gcás ina smaoineoidh Comhghnóthas IMI 2 JU ar shrian a chur i bhfeidhm, déanfar an riosca do chearta agus do shaoirsí an duine is ábhar do na sonraí a mheas, go háirithe, an riosca do chearta agus do shaoirsí na ndaoine eile is ábhar do na sonraí agus an baol go gcuirfear éifeacht imscrúduithe nó nósanna imeachta Chomhghnóthas IMI 2 JU ar ceal, mar shampla, trí fhianaise a bheith scriosta.
Where the IMI 2 JU considers to apply a restriction, the risk to the rights and freedoms of the data subject shall be weighed, in particular, against the risk to the rights and freedoms of other data subjects and the risk of cancelling the effect of the IMI 2 JU’s investigations or procedures for example by destroying evidence.
#1883909
i gcás ina gcuirfear cuspóir a leithéide de shrian atá ag an tseirbhís Choimisiúin, ag institiúid, comhlacht nó gníomhaireacht an Aontais sin i mbaol mura gcuirfidh Comhghnóthas IMI 2 JU srian coibhéiseach i bhfeidhm maidir leis na sonraí pearsanta céanna.
where the purpose of such a restriction by that Commission service, Union institution, body or agency would be jeopardised were the IMI 2 JU not to apply an equivalent restriction in respect of the same personal data;
#1883934
I gcás ina gcuirfidh Comhghnóthas IMI 2 JU srian, go hiomlán nó go páirteach, ar chur i bhfeidhm na gceart i mír 1 thuas, déanfaidh sé na bearta atá leagtha amach in Airteagail 6 agus 7 den Chinneadh seo.
Where the IMI 2 JU restricts, wholly or partly, the application of the rights in paragraph 1 above, it shall take the steps set out in Articles 6 and 7 of this Decision.
#1883935
I gcás ina n‐iarrfaidh daoine is ábhar do na sonraí rochtain ar a gcuid sonraí pearsanta a próiseáladh i gcomhthéacs cás sonrach amháin nó níos mó nó ar oibríocht phróiseála ar leith, i gcomhréir le hAirteagal 17 de Rialachán (AE) 2018/1725, is ar an iarratas sonraí pearsanta sin amháin a dhéanfaidh Comhghnóthas IMI 2 JU measúnú.
Where data subjects request access to their personal data processed in the context of one or more specific cases or to a particular processing operation, in accordance with Article 17 of Regulation (EU) 2018/1725, the IMI 2 JU shall limit its assessment of the request to such personal data only.
#1883946
I gcás ina bhfeidhmeoidh Comhghnóthas IMI 2 JU, go hiomlán nó go páirteach, na srianta a leagtar amach in Airteagal 5 den Chinneadh seo, taifeadfaidh sé na cúiseanna leis an srian, an bunús dlí de réir mhír 1 thuas, lena n‐áirítear measúnú ar riachtanas agus comhréireacht an tsriain.
Where the IMI 2 JU applies, wholly or partly, the restrictions outlined in Article 5 of this Decision, it shall record the reasons for the restriction, the legal ground in accordance with paragraph 1 above, including an assessment of the necessity and proportionality of the restriction.
#1883951
Áireoidh Comhghnóthas IMI 2 JU sna fógraí cosanta sonraí, sna ráitis phríobháideachta nó sna taifid i gcomhréir le hAirteagal 31 de Rialachán (AE) 2018/1725 a fhoilseofar ar a shuíomh gréasáin agus/nó ar an inlíon lena gcuirfear daoine is ábhar do na sonraí ar an eolas faoina gcearta i gcomhthéacs nós imeachta ar leith, eolas a bhaineann le srianadh féideartha na gceart seo.
The IMI 2 JU shall include in the data protection notices, privacy statements or records in the sense of Article 31 of Regulation (EU) 2018/1725, published on its website and/or on the intranet informing data subjects of their rights in the framework of a given procedure, information relating to the potential restriction of these rights.
#1883953
Gan dochar d’fhorálacha Airteagail 6(4), cuirfidh Comhghnóthas IMI 2 JU, i gcás ina mbeidh sé comhréireach, na daoine go léir is ábhar do na sonraí, a meastar go bhfuil siad bainteach leis an oibríocht phróiseála ar leith, ar an eolas, duine ar dhuine, faoina gcearta maidir le srianta reatha nó srianta le teacht sa todhchaí, gan moill mhíchuí agus i bhfoirm scríofa.
Without prejudice to the provisions of Article 6(4), the IMI 2 JU, where proportionate, shall also inform individually all data subjects, which are considered persons concerned in the specific processing operation, of their rights concerning present or future restrictions without undue delay and in a written form.
#1883954
I gcás ina gcuirfidh Comhghnóthas IMI 2 JU srian, go hiomlán nó go páirteach, leis na cearta atá leagtha amach in Airteagal 5, cuirfidh sé in iúl don duine is ábhar do na sonraí lena mbaineann go bhfuil feidhm leis an srian agus na príomhchúiseanna a bhaineann leis, agus gur féidir gearán a sheoladh chuig an Maoirseoir Eorpach um Chosaint Sonraí nó leigheas breithiúnach a lorg i gCúirt Bhreithiúnais an Aontais Eorpaigh.
Where the IMI 2 JU restricts, wholly or partly, the rights laid out in Article 5, it shall inform the data subject concerned of the restriction applied and of the principal reasons thereof, and of the possibility of lodging a complaint with the European Data Protection Supervisor or of seeking a judicial remedy in the Court of Justice of the European Union.