FrancophonIA/Publications_Medical_Domain_UE huggingface dataset:
English: It is for this reason appropriate that the relevant provision of Regulation (EU) 2017/745 applies at the earliest date possible and that the corresponding provisions of Directives 90/385/EEC and 93/42/EEC are repealed from that same date.
Slovenian: Zato je primerno, da se ustrezna določba Uredbe (EU) 2017/745 začne uporabljati na najzgodnejši možni datum in da se ustrezne določbe direktiv 90/385/EGS in 93/42/EGS razveljavijo z istim datumom.
English: Devices lawfully placed on the market pursuant to Directives 90/385/EEC and 93/42/EEC prior to 26 May 2021, and devices placed on the market from 26 May 2021 pursuant to paragraph 3 of this Article, may continue to be made available on the market or put into service until 26 May 2025.
Slovenian: Pripomočki, ki so bili zakonito dani na trg v skladu z direktivama 90/385/EGS in 93/42/EGS pred 26. majem 2021, in pripomočki, ki so bili dani na trg od 26. maja 2021 v skladu z odstavkom 3 tega člena, so lahko še naprej dostopni na trgu ali dani v uporabo do 26. maja 2025.
English: "- Article 11(13) of Directive 93/42/EEC and Article 9(9) of Directive 90/385/EEC which are repealed with effect from [insert date - date of entry into force of this Regulation]";
Slovenian: „- člena 11(13) Direktive 93/42/EGS in člena 9(9) Direktive 90/385/EGS, ki se razveljavita z učinkom od [vstaviti datum - datum začetka veljavnosti te uredbe]";
English: ][3: Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p.
Slovenian: ][3: Direktiva Sveta 93/42/EGS z dne 14. junija 1993 o medicinskih pripomočkih (UL L 169, 12.7.1993, str.
English: At the same time, it is necessary to defer the date of repeal of Directives 90/385/EEC and 93/42/EEC.
Slovenian: Hkrati je treba odložiti tudi datum razveljavitve direktiv 90/385/EGS in 93/42/EGS.
English: Regulation (EU) 2017/745 significantly reinforces key elements of the existing regulatory approach in Council Directive 90/385/EEC and Council Directive 93/42/EEC, such as the supervision of notified bodies, conformity assessment procedures, clinical investigations and clinical evaluation, vigilance and market surveillance, whilst introducing provisions ensuring transparency and traceability regarding medical devices, to improve health and safety.
Slovenian: Uredba (EU) 2017/745 znatno krepi ključne elemente obstoječega regulativnega pristopa iz Direktive Sveta 90/385/EGS in Direktive Sveta 93/42/EGS, kot so nadzor priglašenih organov, postopki ugotavljanja skladnosti, klinične raziskave in klinične ocene, vigilanca in nadzor trga, hkrati pa uvaja določbe, ki zagotavljajo preglednost in sledljivost medicinskih pripomočkov, z namenom izboljšanja zdravja in varnosti.
English: Taking into account the COVID-19 outbreak and the associated public health crisis, the Commission should be able to adopt Union-wide derogations in response to national derogations in order to address potential shortages Union wide of vitally important medical devices in an effective manner.
Slovenian: Ob upoštevanju izbruha COVID-19 in z njim povezane krize na področju javnega zdravja bi bilo treba Komisiji omogočiti, da sprejme odstopanja na ravni Unije kot odziv na nacionalna odstopanja, da bi učinkovito obravnavala morebitno pomanjkanje nujnih medicinskih pripomočkov v Uniji.
English: In order to take account of the fact that the possibility to adopt Union-wide derogations must, for a transitional period, be given to the Commission in relation to national derogations from Directives 90/385/EEC and 93/42/EEC, certain amendments to the relevant provisions of Regulation (EU) 2017/745 are necessary.
Slovenian: Da bi se upoštevalo dejstvo, da mora imeti Komisija v prehodnem obdobju možnost, da sprejme odstopanja na ravni Unije v zvezi z nacionalnimi odstopanji od direktiv 90/385/EGS in 93/42/EGS, so potrebne nekatere spremembe ustreznih določb Uredbe (EU) 2017/745.
English: The COVID-19 crisis has created extraordinary circumstances that demand substantial additional resources, as well as an increased availability of vitally important medical devices, that could not reasonably have been anticipated at the time of adoption of Regulation (EU) 2017/745.
Slovenian: Kriza zaradi COVID-19 je ustvarila izredne razmere, zaradi katerih so potrebni precejšnji dodatni viri in tudi večja razpoložljivost nujnih medicinskih pripomočkov, česar ob sprejetju Uredbe (EU) 2017/745 ni bilo mogoče razumno predvideti.
English: (8) In order to cover any national derogations granted by the Member States in accordance with Directives 90/385/EEC or 93/42/EEC in the context of the COVID-19 outbreak before the entry into force of this Regulation, it is also necessary to provide for the possibility for the Member States to notify those national derogations and for the Commission to extend their validity to the territory of the Union.
Slovenian: (8) Da se zajamejo vsa nacionalna odstopanja, ki so jih države članice odobrile v skladu z Direktivo 90/385/EGS ali Direktivo 93/42/EGS v okviru izbruha COVID-19 pred začetkom veljavnosti te uredbe, je treba zagotoviti tudi možnost, da države članice priglasijo navedena nacionalna odstopanja in da Komisija razširi njihovo veljavnost na ozemlje Unije.
English: ][2: Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (OJ L 189, 20.7.1990, p.
Slovenian: ][2: Direktiva Sveta 90/385/EGS z dne 20. junija 1990 o približevanju zakonodaje držav članic o aktivnih medicinskih pripomočkih za vsaditev (UL L 189, 20.7.1990, str.
English: To ensure the continuous availability of medical devices on the Union market, including medical devices that are vitally important in the context of the COVID-19 outbreak and the associated public health crisis, it is also necessary to adapt certain transitional provisions of Regulation (EU) 2017/745 that would otherwise no longer apply as from the date of application of those provisions.
Slovenian: Za zagotovitev neprekinjene razpoložljivosti medicinskih pripomočkov na trgu Unije, vključno z medicinskimi pripomočki, ki so nujno potrebni v okviru izbruha COVID-19 in z njim povezane krize na področju javnega zdravja, je treba tudi prilagoditi nekatere prehodne določbe Uredbe (EU) 2017/745, ki se sicer od datuma začetka uporabe navedenih določb ne bi več uporabljale.
English: The proposed amendment aims to ensure that the intended purpose of Regulation (EU) 2017/745, that is, to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices, which guarantees a high level of protection of public health and patient safety and the smooth functioning of the internal market for such devices, can be attained.
Slovenian: Namen predlagane spremembe je zagotoviti, da je mogoče doseči predvideni namen Uredbe (EU) 2017/745, tj. vzpostavitev trdnega, preglednega, predvidljivega in trajnostnega regulativnega okvira za medicinske pripomočke, ki zagotavlja visoko raven varovanja javnega zdravja in varnosti pacientov ter nemoteno delovanje notranjega trga za take pripomočke.
English: Those extraordinary circumstances have a significant impact on various areas covered by Regulation (EU) 2017/745, such as the designation and work of notified bodies and the placing on the market and making available on the market of medical devices in the Union.
Slovenian: Navedene izredne razmere pomembno vplivajo na različna področja, ki jih zajema Uredba (EU) 2017/745, kot so imenovanje in delo priglašenih organov ter dajanje medicinskih pripomočkov na trg in omogočanje njihove dostopnosti na trgu Unije.
English: (v) the following point (j) is added:
Slovenian: (v) doda se naslednja točka (j):
English: (11) Since the objectives of this Regulation, namely to defer the application of certain provisions of Regulation (EU) 2017/745 and to allow for the extension of the validity of national derogations, authorised under Directives 90/385/EEC or 93/42/EEC, to the territory of the Union, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union.
Slovenian: (11) Ker ciljev te uredbe, tj. odložiti začetek uporabe nekaterih določb Uredbe (EU) 2017/745 in omogočiti razširitev veljavnosti nacionalnih odstopanj, odobrenih v skladu z Direktivo 90/385/EGS ali Direktivo 93/42/EGS, na ozemlje Unije, države članice ne morejo zadovoljivo doseči, temveč se zaradi obsega in učinkov lažje dosežeta na ravni Unije, lahko Unija sprejme ukrepe v skladu z načelom subsidiarnosti iz člena 5 Pogodbe o Evropski uniji.
English: Taking into account the COVID-19 outbreak and the associated public health crisis, its epidemiological development, as well as the additional resources required in the Member States, health institutions, economic operators and other relevant parties, it is appropriate to defer the application of the relevant provisions of Regulation (EU) 2017/745 by one year.
Slovenian: Ob upoštevanju izbruha COVID-19 in z njim povezane krize na področju javnega zdravja, epidemiološkega razvoja ter dodatnih virov, ki jih potrebujejo države članice, zdravstvene ustanove, gospodarski subjekti in druge zadevne strani, je primerno, da se začetek uporabe ustreznih določb Uredbe (EU) 2017/745 odloži za eno leto.
English: At the same time, Regulation (EU) 2017/745 sets high standards of quality and safety for medical devices in order to meet common safety concerns as regards such devices.
Slovenian: Uredba (EU) 2017/745 določa tudi visoke standarde kakovosti in varnosti medicinskih pripomočkov, da bi upoštevali skupno skrb za varnost takih pripomočkov.
English: ‘The Member State may inform the Commission and the other Member States of any authorisation granted in accordance with Article 9(9) of Directive 90/385/EEC or Article 11(13) of Directive 93/42/EEC before [insert date - date of entry into force of this Regulation].
Slovenian: „Država članica lahko obvesti Komisijo in druge države članice o vseh odobritvah v skladu s členom 9(9) Direktive 90/385/EGS ali členom 11(13) Direktive 93/42/EGS pred [vstaviti datum - datum začetka veljavnosti te uredbe].
English: The COVID-19 outbreak and the associated public health crisis presents an unprecedented challenge to the Member States and is a high burden for national authorities, health institutions, EU citizens and economic operators.
Slovenian: Izbruh COVID-19 in z njim povezana kriza na področju javnega zdravja za države članice pomenita izziv brez primere in sta veliko breme za nacionalne organe, zdravstvene ustanove, državljane EU in gospodarske subjekte.
English: (2) The COVID-19 outbreak and the associated public health crisis presents an unprecedented challenge to the Member States and is a high burden for national authorities, health institutions, EU citizens, and economic operators.
Slovenian: (2) Izbruh COVID-19 in z njim povezana kriza na področju javnega zdravja za države članice pomenita izziv brez primere in sta veliko breme za nacionalne organe, zdravstvene ustanove, državljane EU in gospodarske subjekte.
English: (7) Both Directives 90/385/EEC and 93/42/EEC, as well as Regulation (EU) 2017/745, empower national competent authorities, on a duly justified request, to authorise the placing on the market of medical devices for which the relevant conformity assessment procedures have not been carried out, but the use of which is in the interest of protection of health, or in the interest of public health or patient safety or health respectively (‘national derogation').
Slovenian: (7) Direktivi 90/385/EGS in 93/42/EGS ter Uredba (EU) 2017/745 nacionalne pristojne organe pooblaščajo, da na podlagi ustrezno utemeljene zahteve odobrijo dajanje na trg medicinskih pripomočkov, za katere niso bili opravljeni ustrezni postopki ugotavljanja skladnosti, vendar je njihova uporaba v interesu varovanja zdravja ali v interesu javnega zdravja ali pa varnosti ali zdravja pacientov (v nadaljnjem besedilu: nacionalno odstopanje).
English: ‘Following a notification pursuant to paragraph 2 of this Article, the Commission, in exceptional cases relating to public health or patient safety or health, may, by means of implementing acts, extend for a limited period of time the validity of an authorisation granted by a Member State in accordance with paragraph 1 of this Article or, when granted before [insert date - date of entry into force of this Regulation], in accordance with Article 9(9) of Directive 90/385/EEC or Article 11(13) of Directive 93/42/EEC to the territory of the Union and set the conditions under which the device may be placed on the market or put into service.
Slovenian: „Po obvestilu iz odstavka 2 tega člena lahko Komisija v izjemnih primerih, povezanih z javnim zdravjem ali pa varnostjo ali zdravjem pacientov, z izvedbenimi akti za omejen čas razširi veljavnost odobritve, ki jo je dala država članica v skladu z odstavkom 1 tega člena ali, v primeru odobritve pred [vstaviti datum - datum začetka veljavnosti te uredbe], v skladu s členom 9(9) Direktive 90/385/EGS ali členom 11(13) Direktive 93/42/EGS, na ozemlje Unije in določi pogoje, pod katerimi se lahko pripomoček daje na trg ali v uporabo.
English: Those extraordinary circumstances have a significant impact on various areas covered by Regulation (EU) 2017/745 and therefore it is very likely that Member States, health institutions, economic operators and other relevant parties will not be in a position to ensure the proper implementation and application of that Regulation from 26 May 2020 as it provides for.
Slovenian: Navedene izredne razmere pomembno vplivajo na različna področja, ki jih zajema Uredba (EU) 2017/745, zato je zelo verjetno, da države članice, zdravstvene ustanove, gospodarski subjekti in druge zadevne strani ne bodo mogli zagotoviti ustreznega izvajanja in uporabe navedene uredbe od 26. maja 2020, kakor je določeno.
English: By way of derogation from Article 52 of this Regulation or, for the period from [insert date - date of entry into force of this Regulation] to 25 May 2021, by way of derogation from Article 9(1) and (2) of Directive 90/385/EEC or from Article 11(1) to (6) of Directive 93/42/EEC, any competent authority may authorise, on a duly justified request, the placing on the market or putting into service within the territory of the Member State concerned, of a specific device for which the applicable procedures referred to in those Articles have not been carried out but use of which is in the interest of public health or patient safety or health.
Slovenian: Z odstopanjem od člena 52 te uredbe ali, v primeru obdobja od [vstaviti datum - datum začetka veljavnosti te uredbe] do 25. maja 2021, z odstopanjem od člena 9(1) in (2) Direktive 90/385/EGS ali člena 11(1) do (6) Direktive 93/42/EGS lahko vsak pristojni organ na podlagi ustrezno utemeljene zahteve na ozemlju zadevne države članice odobri dajanje določenega pripomočka, za katerega niso bili opravljeni ustrezni postopki iz navedenih členov, vendar je njegova uporaba v interesu javnega zdravja ali pa varnosti ali zdravja pacientov, na trg ali v uporabo.
English: (7) in Article 122, the first paragraph is amended as follows:
Slovenian: (7) v členu 122 se prvi odstavek spremeni:
English: (9) in point (h) of point 5.1 of Annex IX,'26 May 2020' is replaced by '26 May 2021'.
Slovenian: (9) v točki (h) točke 5.1 Priloge IX se datum „26.
English: ‘(f) Article 27(4) shall apply to class IIa and class IIb devices from 26 May 2023 and to class I devices from 26 May 2025;',
Slovenian: „(f) se za pripomočke razredov IIa in IIb člen 27(4) uporablja od 26. maja 2023, za pripomočke razreda I pa od 26. maja 2025;";
English: (4) Given the unprecedented magnitude of the current challenges, and taking into account the complexity of Regulation (EU) 2017/745, it is very likely that Member States, health institutions, economic operators and other relevant parties will not be in a position to ensure the proper implementation and application of that Regulation from 26 May 2020 as it provides for.
Slovenian: (4) Glede na to, da se zdaj soočamo z izzivi, katerih razsežnost še nikoli ni bila tako velika, in ob upoštevanju kompleksnosti Uredbe (EU) 2017/745 je zelo verjetno, da države članice, zdravstvene ustanove, gospodarski subjekti in druge zadevne strani ne bodo mogle zagotoviti ustreznega izvajanja in uporabe navedene uredbe od 26. maja 2020, kakor je določeno.
English: (b) in paragraph 2, the following subparagraph is added:
Slovenian: (b) v odstavku 2 se doda naslednji pododstavek:
English: (5) In order to ensure the smooth functioning of the internal market, a high level of protection of public health and patient safety, to provide legal certainty, and to avoid potential market disruption, it is necessary to defer the application of certain provisions of Regulation (EU) 2017/745.
Slovenian: (5) Da bi zagotovili nemoteno delovanje notranjega trga, visoko raven varovanja javnega zdravja in varnosti pacientov ter pravno varnost in se izognili morebitnim motnjam na trgu, je treba odložiti začetek uporabe nekaterih določb Uredbe (EU) 2017/745.
English: Regulation (EU) 2017/745 of the European Parliament and of the Council, adopted on 5 April 2017, establishes a new regulatory framework to ensure the smooth functioning of the internal market as regards medical devices covered by that Regulation, taking as a base a high level of protection of health for patients and users, and taking into account the small- and medium-sized enterprises that are active in this sector.
Slovenian: Uredba (EU) 2017/745 Evropskega parlamenta in Sveta, sprejeta 5. aprila 2017, vzpostavlja nov regulativni okvir za zagotovitev nemotenega delovanja notranjega trga v zvezi z medicinskimi pripomočki, zajetimi v navedeni uredbi, pri čemer je izhodišče visoka raven varovanja zdravja pacientov in uporabnikov, ob upoštevanju malih in srednjih podjetij, ki delujejo v tem sektorju.
English: (iii) class I devices from 26 May 2027;',
Slovenian: (iii) za pripomočke razreda I od 26. maja 2027;";
English: (1) Regulation (EU) 2017/745 of the European Parliament and of the Council establishes a new regulatory framework to ensure the smooth functioning of the internal market as regards medical devices covered by that Regulation, taking as a base a high level of protection of health for patients and users, and taking into account the small- and medium-sized enterprises that are active in this sector.
Slovenian: (1) Uredba (EU) 2017/745 Evropskega parlamenta in Sveta vzpostavlja nov regulativni okvir za zagotovitev nemotenega delovanja notranjega trga v zvezi z medicinskimi pripomočki, zajetimi v navedeni uredbi, pri čemer je izhodišče visoka raven varovanja zdravja pacientov in uporabnikov, ob upoštevanju malih in srednjih podjetij, ki delujejo v tem sektorju.
English: In order to ensure the smooth functioning of the internal market, a high level of protection of public health and patient safety, to provide legal certainty, and to avoid potential market disruption, it is necessary to defer the application of certain provisions of Regulation (EU) 2017/745 by one year.
Slovenian: Da bi zagotovili nemoteno delovanje notranjega trga, visoko raven varovanja javnega zdravja in varnosti pacientov, pravno varnost in se izognili morebitnim motnjam na trgu, je treba odložiti začetek uporabe nekaterih določb Uredbe (EU) 2017/745 za eno leto.
English: (ii) class IIa and class IIb devices from 26 May 2025;
Slovenian: (ii) za pripomočke razredov IIa in IIb od 26. maja 2025;
English: (8) Article 123 is amended as follows:
Slovenian: (8) člen 123 se spremeni:
English: (2) Article 17 is amended as follows:
Slovenian: (2) člen 17 se spremeni:
English: (c) in paragraph 3, the first subparagraph is replaced by the following:
Slovenian: (c) v odstavku 3 se prvi pododstavek nadomesti z naslednjim:
English: (4) Article 59 is amended as follows:
Slovenian: (4) člen 59 se spremeni:
English: (6) Article 120 is amended as follows:
Slovenian: (6) člen 120 se spremeni:
English: (1) in Article 1(2), the second subparagraph is amended as follows:
Slovenian: (1) v členu 1(2) se drugi pododstavek spremeni:
English: (iv) point (g) is replaced by the following:
Slovenian: (iv) točka (g) se nadomesti z naslednjim:
English: (i) implantable devices and class III devices from 26 May 2023;
Slovenian: (i) za pripomočke za vsaditev in pripomočke razreda III od 26. maja 2023;
English: (f) paragraph 11 is amended as follows:
Slovenian: (f) odstavek 11 se spremeni:
English: (5) in Article 113, '25 February 2020' is replaced by '25 February 2021';
Slovenian: (5) v členu 113 se datum „25.
English: (a) paragraph 1 is replaced by the following:
Slovenian: (a) odstavek 1 se nadomesti z naslednjim:
English: (iii) point (f) is replaced by the following:
Slovenian: (iii) točka (f) se nadomesti z naslednjim:
English: (3) in Article 34(1), ‘25 March 2020' is replaced by '25 March 2021';
Slovenian: (3) v členu 34(1) se datum „25.
English: (b) paragraph 4 is replaced by the following:
Slovenian: (b) odstavek 4 se nadomesti z naslednjim:
English: Such eligible expenditure shall not exceed EUR 200 000.
Slovenian: Taki upravičeni izdatki ne presegajo 200 000 EUR.
English: 13 Regional and Urban Policy
Slovenian: 13 Regionalna in mestna politika
English: [XX.YY.YY.YY] NO NO NO NO
Slovenian: [XX YY YY YY] NE NE NE NE
English: There was no consultation of external stakeholders.
Slovenian: Posvetovanja z zunanjimi zainteresiranimi stranmi ni bilo.
English: These current limited and targeted changes do not require a separate impact assessment.
Slovenian: Te trenutno omejene in ciljno usmerjene spremembe ne zahtevajo ločene ocene učinka.
English: 4 Employment, Social affairs and Inclusion
Slovenian: 4 Zaposlovanje, socialne zadeve in vključevanje
English: from candidate countries[13: Candidate countries and, where applicable, potential candidate countries from the Western Balkans.]
Slovenian: držav kandidatk[13: Države kandidatke in po potrebi potencialne države kandidatke z Zahodnega Balkana.]
English: These measures are complementary and additional to the legislative modifications proposed on 13 March 2020.
Slovenian: Ti ukrepi dopolnjujejo zakonodajne spremembe, predlagane 13. marca 2020.
English: The first package of measures proposed by the Commission on 13 March 2020 introduced a number of important changes that allow for a more effective response in the current situation.
Slovenian: S prvim svežnjem ukrepov, ki ga je Komisija predlagala 13. marca 2020, je bilo uvedenih več pomembnih sprememb, ki omogočajo učinkovitejši odziv na trenutne razmere.
English: Equally, the Commission will display the same flexibility in assessing the compliance of Member States with their obligations.
Slovenian: Prav tako bo Komisija pokazala enako prožnost pri ocenjevanju izpolnjevanja obveznosti s strani držav članic.
English: Furthermore, certain procedural requirements linked to audits and financial instruments will be simplified.
Slovenian: Poenostavljene bodo tudi nekatere postopkovne zahteve v povezavi z revizijami in finančnimi instrumenti.
English: (3) However, the serious negative effects on EU economies and societies are becoming worse.
Slovenian: (3) Vendar postajajo resni negativni učinki na gospodarstva in družbe EU vedno hujši.
English: In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary to achieve those objectives.
Slovenian: V skladu z načelom sorazmernosti iz navedenega člena ta uredba ne presega tistega, kar je potrebno za doseganje navedenega cilja.
English: [10: Details of management modes and references to the Financial Regulation may be found on the BudgWeb site: http://www.cc.cec/budg/man/budgmanag/budgmanag_en.html]
Slovenian: [10: Pojasnila o načinih upravljanja in sklici na finančno uredbo so na voljo na spletišču BudgWeb: http://www.cc.cec/budg/man/budgmanag/budgmanag_en.html]
English: Such operations may be selected even before the necessary programme amendment is approved by the Commission.
Slovenian: Take operacije se lahko izberejo, še preden Komisija odobri potrebne spremembe programa.
English: The direct and indirect effects of the COVID-19 outbreak continue to increase in all Member States.
Slovenian: Neposredni in posredni učinki izbruha COVID-19 se v vseh državah članicah še naprej povečujejo.
English: In order to contribute to an effective response to the current crisis, the scope of support from the ERDF was considerably expanded.
Slovenian: Da bi prispevali k učinkovitemu odzivu na sedanjo krizo, je bil obseg podpore iz ESRR precej razširjen.
English: from EFTA countries[12: EFTA: European Free Trade Association. ]
Slovenian: držav Efte[12: Efta: Evropsko združenje za prosto trgovino. ]
English: DG: EMPL, REGIO 2020 2021 2022 2023 2024 2025 TOTAL
Slovenian: GD: EMPL, REGIO 2020 2021 2022 2023 2024 2025 SKUPAJ
English: In the meantime, the effects on our economies and societies become ever more serious.
Slovenian: Medtem pa se posledice za naša gospodarstva in družbe še zaostrujejo.
English: This has created an exceptional situation which needs to be addressed with specific measures.
Slovenian: Zaradi tega so nastale izredne razmere, ki jih je treba reševati s specifičnimi ukrepi.
English: Financial impact in 2020 - 2025
Slovenian: finančne posledice med letoma 2020 in 2025
English: Based on an assessment of the application of this exceptional co-financing rate, the Commission may propose an extension of this measure.
Slovenian: Na podlagi ocene uporabe te izredne stopnje sofinanciranja lahko Komisija predlaga razširitev tega ukrepa.
English: The proposal is based on Articles 177, 178 and 322 of the Treaty on the Functioning of the European Union.
Slovenian: Predlog temelji na členih 177, 178 in 322 Pogodbe o delovanju Evropske unije.
English: Payments =5+ 6
Slovenian: plačila = 5 + 6
English: The Commission will assess and may propose on that basis an extension of this measure.
Slovenian: Komisija bo izvedla oceno in lahko na tej podlagi predlaga razširitev tega ukrepa.
English: The Commission will carefully monitor the impact of the proposed modification on payment appropriations in 2020 taking into account both the implementation of the budget and revised Member States forecasts.
Slovenian: Komisija bo skrbno spremljala učinek predlagane spremembe na odobritve plačil v letu 2020, pri čemer bo upoštevala tako izvrševanje proračuna kot tudi popravljene napovedi držav članic.
English: The COVID-19 outbreak is also likely to have serious impacts on the implementation of ongoing operations.
Slovenian: Izbruh COVID-19 bo verjetno imel resne posledice tudi za izvajanje tekočih operacij.
English: SPECIFIC OBJECTIVE No 1…[17: As described in point 1.4.2.
Slovenian: SPECIFIČNI CILJ št. 1 …[17: Kakor je opisan v točki 1.4.2 „Specifični cilji …". ]
English: National authorities could also consider the possibility to select new operations or to launch new or additional calls for proposals if necessary.
Slovenian: Nacionalni organi bi lahko po potrebi razmislili tudi o možnosti izbire novih operacij ali uvedbi novih ali dodatnih razpisov za zbiranje predlogov.
English: [8: ABM: activity-based management; ABB: activity-based budgeting.]
Slovenian: [8: ABM: upravljanje po dejavnostih, ABB: oblikovanje proračuna po dejavnostih.]
English: 1b Smart and Inclusive Growth: European Regional Development Fund, the European Social Fund, the Cohesion Fund 4 Employment, social affairs and inclusion 13 Regional and Urban Policy Diff. NO NO NO NO
Slovenian: 1b Pametna in vključujoča rast: Evropski sklad za regionalni razvoj, Evropski socialni sklad, Kohezijski sklad 4 Zaposlovanje, socialne zadeve in vključevanje 13 Regionalna in mestna politika dif. NE NE NE NE
English: The transmission of the summary report prepared by the Commission in 2020, in accordance with Article 53(1), may be postponed accordingly.
Slovenian: Predložitev zbirnega poročila, ki ga je leta 2020 pripravila Komisija v skladu s členom 53(1), se lahko v skladu s tem preloži na pozneje.
English: Furthermore, it is also proposed to allow for additional flexibility at the closure of programmes to ensure that available resources are used to the largest extent (Article 1(3)).
Slovenian: Predlaga se tudi, da se ob zaključku programov omogoči dodatna prožnost, da se zagotovi čim večja uporaba razpoložljivih virov (člen 1(3)).
English: It provides clarity on the eligibility of expenditure affected by the measures put in place as a response to the public health crisis.
Slovenian: Zagotavlja jasnost glede upravičenosti izdatkov, na katere vplivajo ukrepi, ki se izvajajo v odziv na javnozdravstveno krizo.
English: The total annual breakdown of commitment appropriations for the European Regional Development Fund, the European Social Fund and the Cohesion Fund remains unchanged.
Slovenian: Skupna letna razdelitev odobritev za prevzem obveznosti za Evropski sklad za regionalni razvoj, Evropski socialni sklad in Kohezijski sklad ostaja nespremenjena.
English: "Article [25a]
Slovenian: Člen [25a]
English: However, the proposal follows extensive consultations with Member States and the European Parliament over recent weeks, and takes account of the more than 200 clarification and advice questions received from national authorities concerning their handling of crisis response measures through the Coronavirus Response Investment Initiative Task Force.
Slovenian: Vendar predlog temelji na obsežnih posvetovanjih z državami članicami in Evropskim parlamentom v zadnjih tednih ter upošteva več kot 200 pojasnjevalnih vprašanj in vprašanj glede nasvetov, ki jih je prejela od nacionalnih organov v zvezi z njihovim ravnanjem pri ukrepih za odzivanje na krizo prek delovne skupine v okviru naložbene pobude v odziv na koronavirus.
English: A Regulation is the appropriate instrument to introduce the additional flexibilities needed to address these unprecedented circumstances.
Slovenian: Uredba je ustrezen instrument za uvedbo dodatne prožnosti, ki je potrebna za obravnavo teh okoliščin brez primere.
English: Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 177, 178 and 322(1)(a) thereof,
Slovenian: ob upoštevanju Pogodbe o delovanju Evropske unije ter zlasti členov 177, 178 in 322(1)(a) Pogodbe,
English: They result from the close cooperation with Member States through the Coronavirus Response Investment Initiative Task Force where over 200 questions have already been addressed.
Slovenian: Izhajajo iz tesnega sodelovanja z državami članicami prek delovne skupine v okviru naložbene pobude v odziv na koronavirus, ki je obravnavala že več kot 200 vprašanj.
English: The deadline for the submission of the annual implementation reports for the year 2019 should be postponed, as should be the transmission of the Commission's summary report based on those annual implementation reports.
Slovenian: Rok za predložitev letnih poročil o izvajanju za leto 2019 bi bilo treba preložiti na pozneje, tako kot tudi predložitev zbirnega poročila Komisije na podlagi teh letnih poročil o izvajanju.
English: [4: OJ C 91 I, 20.3.2020, p.
Slovenian: [4: UL C 91 I, 20.3.2020, str.
English: Proposal/initiative in effect from 1/7/2020 to 30/6/2021
Slovenian: trajanje predloga/pobude od 1. 7. 2020 do 30. 6. 2021
English: The Commission considers that all necessary flexibility should be deployed in dealing with failure by beneficiaries to fulfil obligations in a timely manner for reasons related to the COVID-19 outbreak (for example, the unavailability of staff).
Slovenian: Komisija meni, da bi bilo treba uporabiti vso potrebno prožnost pri obravnavanju nepravočasnega izpolnjevanja obveznosti s strani upravičencev iz razlogov, povezanih z izbruhom COVID-19 (npr. zaradi nerazpoložljivosti osebja).
English: By way of derogation from Article 125(3)(b), such operations may be selected for support by the ERDF or the ESF prior to the approval of the amended programme.
Slovenian: Z odstopanjem od člena 125(3)(b) se lahko take operacije izberejo za podporo iz ESRR ali ESS pred odobritvijo spremenjenega programa.
English: (2) in Article 130, the following paragraph 3 is added:
Slovenian: (2) v členu 130 se doda naslednji odstavek 3:
English: It finally alleviates some requirements for Member States where these create administrative burdens that could delay implementation of measures to respond to the COVID-19 outbreak.
Slovenian: Nazadnje odpravlja nekatere zahteve za države članice, če te ustvarjajo upravna bremena, ki bi lahko povzročila zamudo pri izvajanju ukrepov za odziv na izbruh COVID-19.
English: [9: As referred to in Article 54(2)(a) or (b) of the Financial Regulation.]
Slovenian: [9: Po členu 54(2)(a) oz. (b) finančne uredbe.]
English: Additionally, it is proposed to exempt Member States from the need to comply with thematic concentration requirements, to enable a redirection of resources to the areas most impacted by the current crisis.
Slovenian: Predlaga se tudi, da se države članice izvzamejo iz obveznosti izpolnjevanja zahtev glede tematske osredotočenosti, da se omogoči preusmeritev virov na območja, ki so najbolj prizadeta zaradi trenutne krize.
English: (1) the following new Chapter is added in Title II of Part Two:
Slovenian: (1) v naslovu II drugega dela se doda naslednje novo poglavje:
English: (15) Given the urgency of the situation related to the COVID-19 outbreak, it is appropriate that this Regulation enters into force on the date of its publication in the Official Journal of the European Union.
Slovenian: (15) Zaradi resnosti razmer v povezavi z izbruhom COVID-19 je primerno, da začne ta uredba veljati na dan objave v Uradnem listu Evropske unije.
English: It is necessary therefore to provide exceptional additional flexibility to Member States to enable them to respond to this unprecedented crisis by enhancing the possibility to mobilise all non-utilised support from the Funds.
Slovenian: Zato je treba državam članicam zagotoviti izredno dodatno prožnost, da se bodo lahko odzvale na to krizo brez primere, in sicer z razširitvijo možnosti uporabe celotne neporabljene podpore iz skladov.
English: These exceptional changes shall be without prejudice to the rules that should apply under regular circumstances.
Slovenian: Te izredne spremembe ne posegajo v pravila, ki bi se morala uporabljati v običajnih okoliščinah.
English: The implementation of the measures will be monitored and reported upon in the framework of the general reporting mechanisms established in Regulation (EU) No 1303/2013.
Slovenian: Spremljanje izvajanja ukrepov in poročanje o tem bosta potekala v okviru splošnih mehanizmov poročanja, določenih v Uredbi (EU) št. 1303/2013.
English: Member States and regions will be able to mobilise more resources for scaling up and extending short-time work schemes, for support to SMEs working capital and for immediate expenditure in the healthcare sector.
Slovenian: Države članice in regije bodo lahko mobilizirale več sredstev za okrepitev in razširitev shem skrajšanega delovnega časa, podporo MSP v obliki obratnega kapitala in takojšnje izdatke v zdravstvenem sektorju.
English: In order to ensure continued focus on less developed regions, the Member States should first examine other possibilities for transferring funding before considering transfers from the budget for the less developed regions given the potential negative implications of such transfers for the essential investments in the region of origin or for the completion of operations selected prior to the request for transfer (Article 25a(3) and (4)).
Slovenian: Da se zagotovi nadaljnja osredotočenost na manj razvite regije, bi morale države članice najprej proučiti druge možnosti za prenos finančnih sredstev, preden uporabijo sredstva iz proračuna za manj razvite regije, saj bi taki prenosi lahko imeli negativne posledice za bistvene naložbe v regiji izvora ali za dokončanje operacij, izbranih pred zahtevkom za prenos (člen 25a(3) in (4)).
English: The proposal complements the Commission's proposal COM(2020) 113 of 13 March 2020 as regards specific measures to mobilise investments in the health care systems of the Member States and in other sectors of their economies in response to the COVID-19 outbreak (Coronavirus Response Investment Initiative) as well as all other measures aimed at addressing the current unprecedented situation.
Slovenian: Dopolnjuje predlog Komisije COM(2020) 113 z dne 13. marca 2020 glede posebnih ukrepov za mobilizacijo naložb v zdravstvenih sistemih držav članic in v drugih sektorjih njihovih gospodarstev v odziv na izbruh COVID-19 (Naložbena pobuda v odziv na koronavirus) ter vse druge ukrepe za reševanje trenutnih razmer brez primere.
English: N [18: Year N is the year in which implementation of the proposal/initiative starts.]
Slovenian: N [18: Leto N je leto začetka izvajanja predloga/pobude.]
English: By way of derogation from Articles 26(1), 27(1), 30(1) and 30(2), as from [date of entry into force of this Regulation] the consistency of programmes and of their implementation with the Partnership Agreement shall not be verified.
Slovenian: Z odstopanjem od členov 26(1), 27(1), 30(1) in 30(2) se od [datum začetka veljavnosti te uredbe] ne preverja skladnost programov in njihovega izvajanja s sporazumom o partnerstvu.
English: The crisis hampers growth in Member States, which in turn aggravates the serious liquidity shortages due to the sudden and important increase in public investments needed in their health care systems and other sectors of their economies.
Slovenian: Kriza ovira rast v državah članicah, kar še poslabšuje resne težave s pomanjkanjem likvidnosti zaradi nenadnega velikega povečanja javnih naložb, ki so potrebne v zdravstvenih sistemih in drugih sektorjih gospodarstev.
English: In particular, Partnership Agreements should no longer be amended until the end of the programming period neither to reflect prior changes in operational programmes nor to introduce any other changes.
Slovenian: Sporazumi o partnerstvu se do konca programskega obdobja ne bi smeli več spreminjati niti zaradi upoštevanja predhodnih sprememb operativnih programov niti zaradi uvajanja kakršnih koli drugih sprememb.
English: The proposal is a limited and targeted change not going beyond what is necessary to achieve the objective of providing additional flexibility and legal certainty to mobilise investments in response to the widespread public health crises affecting the growth potential of regions and enterprises and the well-being of the general public.
Slovenian: Predlog pomeni omejeno in usmerjeno spremembo, ki ne presega tistega, kar je potrebno za zagotovitev dodatne prožnosti in pravne varnosti za mobilizacijo naložb v odziv na obsežno javnozdravstveno krizo, ki vpliva na potencial regij in podjetij za rast ter blaginjo širše javnosti.
English: National authorities may thus consider adjusting operations (e.g. deliverables, time limit for execution, etc.) in accordance with their national rules where necessary and justified, in a way to minimise the impact of the COVID-19 outbreak on the programmes.
Slovenian: Nacionalni organi lahko zato razmislijo o prilagoditvi operacij (npr. rezultatov, rokov za izvršitev itd.) v skladu s svojimi nacionalnimi pravili, če je to potrebno in upravičeno, in sicer tako, da se čim bolj zmanjša vpliv izbruha COVID-19 na programe.
English: Type[16: Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, etc.).]
Slovenian: vrsta[16: Realizacije so dobavljeni proizvodi in opravljene storitve (npr. število financiranih izmenjav študentov, število kilometrov novozgrajenih cest …).]
English: For the purpose of these transfers, the requirements laid down in Article 92(4) shall not apply.
Slovenian: Za namen teh prenosov se zahteve iz člena 92(4) ne uporabljajo.
English: This derogation will allow all available resources from the ERDF, the Cohesion Fund and the ESF to be mobilised to overcome the unprecedented challenges the Member States are facing because of the COVID-19 outbreak.
Slovenian: To odstopanje bo omogočilo uporabo vseh razpoložljivih sredstev iz ESRR, Kohezijskega sklada in ESS za premagovanje izzivov brez primere, s katerimi se države članice spoprijemajo zaradi izbruha COVID-19.
English: N[15: Year N is the year in which implementation of the proposal/initiative starts.]
Slovenian: N[15: Leto N je leto začetka izvajanja predloga/pobude.]
English: "Undertakings in difficulty as defined in Union State aid rules; undertakings receiving support complying with the State aid Temporary Framework or Commission Regulations (EU) No 1407/2013, (EU) No 1408/2013 and (EU) No 717/2014 shall not be regarded as undertakings in difficulty for the purposes of this point.
Slovenian: „podjetij v težavah, kot je določeno v pravilih Unije o državnih pomočeh; podjetja, ki prejemajo podporo v skladu z začasnim okvirom za ukrepe državne pomoči ali uredbami Komisije (EU) št. 1407/2013, (EU) št. 1408/2013 in (EU) št. 717/2014, se za namene te točke ne obravnavajo kot podjetja v težavah;";
English: Resources transferred between the ERDF, the ESF and the Cohesion Fund under this paragraph shall be implemented in accordance with the rules of the Fund to which the resources are transferred.
Slovenian: Sredstva, ki se v skladu s tem odstavkom prenesejo med ESRR, ESS in Kohezijskim skladom, se izvršujejo v skladu s pravili sklada, v katerega se sredstva prerazporedijo.
English: "CHAPTER V
Slovenian: „POGLAVJE V
English: (16) In view of the COVID-19 outbreak and the urgency to address the associated public health crisis, it is considered necessary to use the exception to the eight-week period referred to in Article 4 of Protocol No 1 on the role of national Parliaments in the European Union, annexed to the Treaty on European Union, to the Treaty on the Functioning of the European Union and to the Treaty establishing the European Atomic Energy Community,
Slovenian: (16) Zaradi izbruha COVID-19 in nujnosti reševanja s tem povezane javnozdravstvene krize je primerno določiti izjemo od roka osmih tednov iz člena 4 Protokola št. 1 o vlogi nacionalnih parlamentov v Evropski uniji, ki je priložen Pogodbi o Evropski uniji, Pogodbi o delovanju Evropske unije in Pogodbi o ustanovitvi Evropske skupnosti za atomsko energijo -
English: 1b: Economic, social and territorial cohesion European Regional Development Fund, the European Social Fund, the Cohesion Fund Commitments (1) 0,000 0,000 0,000 0,000 0,000 0,000 0,000
Slovenian: 1b: Ekonomska, socialna in teritorialna kohezija Evropski sklad za regionalni razvoj, Evropski socialni sklad, Kohezijski sklad obveznosti (1) 0,000 0,000 0,000 0,000 0,000 0,000 0,000
English: Given the current limitations to perform necessary audit work, in the case of ERDF, ESF, EMFF and the Cohesion Fund, the extension of the possibility to make use of a non-statistical sampling method should be explicitly provided for.
Slovenian: Glede na trenutne omejitve pri izvajanju potrebnih revizij bi bilo treba v primeru ESRR, ESS, ESPR in Kohezijskega sklada izrecno določiti razširitev možnosti uporabe nestatistične metode vzorčenja.
English: The proposal/initiative requires the use of existing operational appropriations (no changes):
Slovenian: Za predlog/pobudo so potrebne obstoječe odobritve za poslovanje (brez sprememb):
English: Budget revenue line: Appropriations available for the current financial year Impact of the proposal/initiative[22: As regards traditional own resources (customs duties, sugar levies), the amounts indicated must be net amounts, i.e. gross amounts after deduction of 25 % for collection costs.]
Slovenian: Prihodkovna proračunska vrstica Odobritve na voljo za tekoče proračunsko leto Posledice predloga/pobude[22: Pri tradicionalnih lastnih sredstvih (carine, prelevmani na sladkor) se navedejo neto zneski, tj. bruto zneski po odbitku 25 % stroškov pobiranja.]
English: By way of derogation from Article 37(2)(g), no review or update of the ex-ante assessments shall be required where changes in financial instruments are necessary to provide an effective response to the COVID-19 outbreak.
Slovenian: Z odstopanjem od člena 37(2)(g) se ne zahteva pregled ali posodobitev predhodnih ocen, če so spremembe finančnih instrumentov nujne za zagotovitev učinkovitega odziva na izbruh COVID-19.
English: For operations fostering crisis response capacities in the context of the COVID-19 outbreak as referred to in the second sub-paragraph of Article 65(10), Article 65(6) shall not apply.
Slovenian: Za operacije, ki spodbujajo zmogljivosti za odzivanje na krizne razmere v okviru izbruha COVID-19 iz drugega pododstavka člena 65(10), se člen 65(6) ne uporablja.
English: There may be instances in which circumstances resulting from the COVID-19 outbreak qualify as a force majeure event under national law and thus constitute a valid justification for the incapacity to comply with an obligation.
Slovenian: V nekaterih primerih se lahko okoliščine, ki so posledica izbruha COVID-19, v skladu z nacionalno zakonodajo štejejo za višjo silo in tako ustrezno utemeljujejo nezmožnost izpolnjevanja obveznosti.
English: It is therefore necessary - as part of the second set of measures - to go beyond what is already possible and provide exceptional additional flexibility to respond to the current unprecedented situation, which led to activating the general escape clause under the Stability and Growth Pact.
Slovenian: Zato je treba - z drugim sklopom ukrepov - preseči to, kar je že mogoče, in zagotoviti izredno dodatno prožnost v odgovor na trenutne razmere, ki so brez primere in so privedle do aktivacije splošne odstopne klavzule v okviru Pakta za stabilnost in rast.
English: External staff (in Full Time Equivalent unit: FTE)[20: AC= Contract Staff; AL = Local Staff; END= Seconded National Expert; INT = agency staff; JED= Junior Experts in Delegations. ]
Slovenian: Zunanji sodelavci (v ekvivalentu polnega delovnega časa:: EPDČ)[20: PU = pogodbeni uslužbenec; LU = lokalni uslužbenec; NNS = napoteni nacionalni strokovnjak; ZU = začasni uslužbenec; MSD = mladi strokovnjak na delegaciji. ]
English: The proposed modification does not imply any changes in the Multiannual Financial Framework annual ceilings for commitments and payments as per Annex I to Regulation (EU) No 1311/2013.
Slovenian: Predlagana sprememba ne pomeni nobene spremembe letnih zgornjih mej prevzemanja obveznosti in plačil v večletnem finančnem okviru, kar je v skladu s Prilogo I k Uredbi (EU) št. 1311/2013.
English: Furthermore, in order to eliminate administrative burden, unnecessary under the present circumstances, on national and European public administrations stemming from the modification of programmes, it is also necessary to refrain from amending Partnership Agreements and to postpone the deadline for the submission of annual implementation reports in 2020 as well as the deadline for Commission reports based on those.
Slovenian: Da bi odpravili upravno breme za nacionalne in evropske javne uprave, ki v sedanjih okoliščinah ni potrebno in ki izhaja iz sprememb programov, je treba tudi prenehati spreminjati sporazume o partnerstvu ter rok za predložitev letnih poročil o izvajanju za leto 2020 in rok za poročila Komisije, ki temeljijo na njih, preložiti na pozneje.
English: To accommodate Member States' needs to tackle the current specific challenges, Member States should be able to request a transfer from their allocations for the year 2020 between categories of regions.
Slovenian: Da bi se upoštevale potrebe držav članic pri reševanju trenutnih posebnih izzivov, bi morale države članice imeti možnost, da zaprosijo za prenos sredstev za leto 2020 med kategorijami regij.
English: The proposal aims to allow for derogations from certain limitations pursuant to currently applicable Union provisions in order to allow for the widest possible flexibility to mobilise existing investment resources to address the direct and indirect effects stemming from the unprecedented public health crisis in the context of the COVID-19 outbreak.
Slovenian: Namen predloga je omogočiti odstopanja od nekaterih omejitev v skladu s trenutno veljavnimi določbami Unije, da se omogoči kar največja prožnost za mobilizacijo obstoječih naložbenih virov za obravnavo neposrednih in posrednih posledic, ki izhajajo iz javnozdravstvene krize brez primere zaradi izbruha bolezni COVID-19.