natgillin/translations-raw huggingface dataset:
(9)In view of the COVID-19 outbreak and the urgency to address the associated public health crisis, it was considered appropriate to provide for an 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.
(9)Zaradi izbruha COVID-19 in nujnosti reševanja s tem povezane javnozdravstvene krize je bilo ocenjeno, da 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.
-⌧ Financial impact in 2020 - 2024
-⌧ finančne posledice med letoma 2020 in 2024.
-⌧ Proposal/initiative in effect from 01/07/2020 to 30/06/2021
-⌧ trajanje predloga/pobude od 1. 7. 2020 do 30. 6. 2021
(5)In order to ensure that the most deprived can continue to receive assistance by the Fund in a safe environment, it is necessary to provide for sufficient flexibility for Member States to adjust the schemes of support to the current context, including by allowing alternative schemes of delivery through electronic vouchers and by allowing Member States to amend certain elements of the operational programme without requiring an adoption by Commission decision.
(5)Da bi lahko najbolj ogroženi pomoč iz sklada še naprej prejemali v varnem okolju, je treba državam članicam zagotoviti zadostno prožnost, da sheme podpore prilagodijo trenutnim razmeram, med drugim z omogočanjem alternativnih shem dostave prek elektronskih kuponov in tako, da se državam članicam omogoči, da spremenijo nekatere elemente operativnega programa, ne da bi bilo treba sprejeti sklep Komisije.
1.2.Policy area(s) concerned in the ABM/ABB structure 4
1.2.Zadevna področja v strukturi ABM/ABB 4
(7)In order to enable Member States to concentrate on introducing measures to respond to the crisis and avoid the disruption of the delivery of support to the most deprived due to risks of contamination, it is appropriate to provide for specific measures that reduce administrative burden for authorities and provide flexibility for compliance with certain legislative requirements, in particular on monitoring and on control and audit.
(7)Da bi se države članice lahko osredotočile na uvajanje ukrepov za odziv na krizo in da bi se preprečile motnje dostave podpore najbolj ogroženim zaradi tveganja okužbe, je primerno, da se določijo posebni ukrepi, ki zmanjšujejo upravno breme za organe in omogočajo prožnost pri izpolnjevanju nekaterih zakonodajnih zahtev, zlasti glede spremljanja ter nadzora in revizije.
(10)Regulation (EU) No 223/2014 should therefore be amended accordingly,
(10)Uredbo (EU) št. 223/2014 bi bilo zato treba ustrezno spremeniti -
◻ The proposal/initiative relates to a new action following a pilot project/preparatory action 5
◻ Predlog/pobuda se nanaša na nov ukrep na podlagi pilotnega projekta / pripravljalnega ukrepa 5 .
(4)With a view to alleviating the burden on public budgets responding to the crisis situation, Member States should be given the exceptional possibility to request for a co-financing rate of 100% to be applied for the accounting year 2020-2021, in accordance with budget appropriations and subject to available funding.
(4)Da bi zmanjšali breme za javne proračune pri odzivanju na krizne razmere, bi bilo treba državam članicam dati izredno možnost, da zaprosijo za stopnjo sofinanciranja v višini 100 %, ki se uporabi za obračunsko leto 2020-2021, in sicer v skladu s proračunskimi odobritvami in glede na razpoložljiva sredstva.
(2)Member States have been affected by the COVID-19 outbreak in an unprecedented manner.
(2)Izbruh COVID-19 je države članice prizadel na način, kakršnega še ni bilo.
(6)It is appropriate to establish specific rules for determining the eligible costs borne by beneficiaries in the case where certain operations are delayed, suspended or not fully implemented due to the COVID-19 outbreak.
(6)Primerno je določiti posebna pravila za določanje upravičenih stroškov, ki jih imajo upravičenci, kadar se nekatere dejavnosti zaradi izbruha COVID-19 odložijo, začasno ustavijo ali se ne izvedejo v celoti.
(1)In Article 9 paragraph 4 is replaced by the following:
(1)V členu 9 se odstavek 4 nadomesti z naslednjim:
(2)Point (c) is replaced by the following:
(2)točka (c) se nadomesti z naslednjim:
(3)In order to provide for an immediate response to the impact of the crisis on the most deprived, expenditure for operations for fostering crisis response capacities to the COVID-19 outbreak should be eligible as of 1 February 2020.
(3)Da se zagotovi takojšen odziv na posledice krize za najbolj ogrožene, bi morali biti odhodki za dejavnosti za krepitev zmogljivosti za odzivanje na krizo zaradi izbruha COVID-19 upravičeni od 1. februarja 2020.
(2)In Article 13(1) the following subparagraph is added:
(2)V členu 13(1) se doda naslednji pododstavek:
(1)Point (a) is replaced by the following:
(1)točka (a) se nadomesti z naslednjim:
(6)In Article 26 paragraph 2 is amended as follows:
(6)V členu 26 se odstavek 2 spremeni:
(8)In Article 30 the following paragraph is inserted:
(8)V členu 30 se vstavi naslednji odstavek:
(4)In Article 22(4) the following subparagraph is inserted:
(4)V členu 22(4) se vstavi naslednji pododstavek:
(5)In Article 23 the following paragraph is inserted:
(5)V členu 23 se vstavi naslednji odstavek:
(3)In Article 20 the following paragraph is inserted:
(3)V členu 20 se vstavi naslednji odstavek:
(11)Given the urgency of the support needed, this Regulation should enter into force as soon as possible.
(11)Glede na nujnost potrebne podpore bi morala ta uredba začeti veljati čim prej.
(b)EUR 8 700 000 for the Canary Islands;
(b)8 700 000 EUR za Kanarske otoke;
-enable resort to the storage mechanism if Member States have not set and published trigger prices,
-omogoči uporaba mehanizma za skladiščenje, če države članice niso določile in objavile sprožitvenih cen,
1.The resources available for commitments from the EMFF for the period from 2014 to 2020 under shared management shall be EUR 5 749 331 600 in current prices in accordance with the annual breakdown set out in Annex II.
1.Razpoložljiva sredstva za prevzem obveznosti iz ESPR za obdobje od 2014 do 2020 v okviru deljenega upravljanja znašajo 5 749 331 600 EUR v trenutnih cenah v skladu z letno razdelitvijo iz Priloge II.
(c)EUR 12 350 000 for the French outermost regions referred to in Article 349 TFEU.
(c)12 350 000 EUR za francoske najbolj oddaljene regije iz člena 349 PDEU.
-allow aquaculture producer organisations to benefit from the storage mechanism.
-organizacijam proizvajalcev v sektorju akvakulture omogoči, da izkoristijo mehanizem skladiščenja.
-a deletion of the ring-fenced amounts in Article 13, with the exception of those for fisheries control, collection of scientific data and compensation of additional costs in the outermost regions,
-črtanje posebnih sredstev v členu 13, z izjemo tistih za nadzor ribištva, zbiranje znanstvenih podatkov in nadomestilo za dodatne stroške v najbolj oddaljenih regijah,
2.Support under paragraph 1(a) may only be granted where the suspension of harvesting due to the contamination of molluscs is the result of the proliferation of toxin-producing plankton or the presence of plankton containing biotoxins, and provided that:
2.Podpora iz odstavka 1(a) se lahko dodeli le, kadar je začasna ustavitev pridobivanja gojenih mehkužcev zaradi okuženosti posledica širjenja planktona, ki proizvaja toksine, ali prisotnosti planktona, ki vsebuje biotoksine, in pod pogojem, da:
1.The EMFF may support the following compensation schemes:
1.ESPR lahko podpira naslednje sheme nadomestil:
3.The duration for which compensation under paragraph 1(a) may be granted shall be a maximum of 12 months over the entire programming period.
3.Obdobje, za katero se lahko dodeli nadomestilo iz odstavka 1(a), znaša v celotnem programskem obdobju največ 12 mesecev.
5.Member States shall have the possibility to use interchangeably the resources available under paragraphs 2 and 3.
5.Države članice imajo možnost izmenljivosti pri uporabi sredstev, ki so na voljo v skladu z odstavkoma 2 oziroma 3 tega člena.
(3)The resources available for commitments from the EMFF under shared management should be broken down in a way that ensures that fixed amounts are established for fisheries control, the collection of scientific data and the compensation of additional costs in the outermost regions.
(3)Razpoložljiva sredstva za prevzem obveznosti iz ESPR v okviru deljenega upravljanja bi morala biti razčlenjena na način, ki zagotavlja, da se določijo fiksni zneski za nadzor ribištva, zbiranje znanstvenih podatkov in nadomestilo za dodatne stroške v najbolj oddaljenih regijah.
-support to producer organisations and associations of producer organisations for the storage of fishery and aquaculture products, in accordance with the Common Market Organisation.
-podporo organizacijam proizvajalcev in združenjem organizacij proizvajalcev za skladiščenje ribiških proizvodov in proizvodov iz akvakulture v skladu s skupno ureditvijo trgov.
(10)To enable Member States to react promptly to the suddenness and unpredictability of the COVID-19 outbreak, they should be entitled to set trigger prices for their producer organisations to trigger the storage mechanism.
(10)Da bi se države članice lahko hitro odzvale na nenadnost in nepredvidljivost izbruha COVID-19, bi morale imeti pravico, da za svoje organizacije proizvajalcev določijo sprožitvene cene za sprožitev mehanizma skladiščenja.
(7)Given the key role played by producer organisations in the management of the crisis, the ceiling for support to production and marketing plans should be increased to 12 % of the average annual value of the production placed on the market.
(7)Glede na ključno vlogo, ki jo imajo organizacije proizvajalcev pri obvladovanju krize, je treba zgornjo mejo za podporo za načrte proizvodnje in trženja povečati na 12 % povprečne letne vrednosti proizvodnje, dane na trg.
(8)The sudden disruptions of fishery and aquaculture activities ensuing from the COVID-19 outbreak, and the resulting risk of jeopardising markets of fishery and aquaculture products, make it appropriate to set up a mechanism for storing fishery and aquaculture products for human consumption.
(8)Zaradi nenadnih motenj v dejavnostih ribištva in akvakulture, ki so posledica izbruha COVID-19, in posledičnega tveganja ogroženosti trgov ribiških proizvodov in proizvodov iz akvakulture je primerno, da se vzpostavi mehanizem za skladiščenje ribiških proizvodov in proizvodov iz akvakulture za prehrano ljudi.
(12)Regulation (EU) No 1379/2013 and Regulation (EU) No 508/2014 should therefore be amended accordingly,
(12)Uredbo (EU) št. 1379/2013 in Uredbo (EU) št. 508/2014 bi bilo zato treba ustrezno spremeniti -
(6)Given the urgency of the support needed, it should be possible to extend the scope of the simplified procedure to include amendments to operational programmes related to the specific measures and the reallocation of financial resources thereto to address the consequences of the COVID-19 outbreak.
(6)Glede na nujnost potrebne podpore bi bilo treba omogočiti, da se področje uporabe poenostavljenega postopka razširi na spremembe operativnih programov, ki se nanašajo na posebne ukrepe, in na prerazporeditev finančnih sredstev v ta namen, da bi se odpravile posledice izbruha COVID-19.
(5)Given the need for flexibility in the reallocation of financial resources to address the consequences of the COVID-19 outbreak, support for the temporary cessation of fishing activities caused by this outbreak should not be subject to a financial capping.
(5)Glede na potrebo po prožnosti pri prerazporeditvi finančnih sredstev za obravnavanje posledic izbruha COVID-19 podpora za začasno prenehanje ribolovnih dejavnosti, ki je posledica tega izbruha, ne bi smela biti predmet finančnega omejevanja.
(4)Given the significant socio-economic consequences of the COVID-19 outbreak and the need for liquidity in the economy, it should be possible to support the temporary cessation of fishing activities caused by the COVID-19 outbreak crisis with a maximum co-financing rate of 75 % of eligible public expenditure.
(4)Zaradi znatnih družbeno-gospodarskih posledic izbruha COVID-19 in potrebe po likvidnosti v gospodarstvu bi moralo biti mogoče podpreti začasno prenehanje ribolovnih dejavnosti, ki ga je povzročila kriza zaradi izbruha COVID-19, z najvišjo stopnjo sofinanciranja v višini 75 % upravičene javne porabe.
-a modification of the simplified procedure for amending operational programmes, in view of the introduction of the specific measures and the reallocation of financial resources thereto.
-sprememba poenostavljenega postopka za spremembo operativnih programov zaradi uvedbe posebnih ukrepov in prerazporeditve finančnih sredstev v ta namen.
(9)Given the suddenness and magnitude of the contraction of demand for fishery and aquaculture products resulting from the COVID-19 outbreak, it should be possible to increase the quantities eligible for storage aid to 25 % of the annual quantities of the products concerned put up for sale by the producer organisation concerned.
(9)Glede na nenadnost in obseg zmanjšanja povpraševanja po ribiških proizvodih in proizvodih iz akvakulture, ki je posledica izbruha COVID-19, je treba omogočiti povečanje količin, upravičenih do pomoči za skladiščenje, na 25 % letnih količin zadevnih proizvodov, ki jih je zadevna organizacija proizvajalcev dala v prodajo.
These specific measures should also comprise support to producer organisations and associations of producer organisations for the storage of fishery and aquaculture products in accordance with Regulation (EU) No 1379/2013 3 .
Navedeni ukrepi bi morali vključevati tudi podporo organizacijam proizvajalcev in združenjem organizacij proizvajalcev za skladiščenje ribiških proizvodov in proizvodov iz akvakulture v skladu z Uredbo (EU) št. 1379/2013 3 .
(2)It should be possible for the European Maritime and Fisheries Fund (EMFF) established by Regulation (EU) No 508/2014 2 to support specific measures until 31 December 2020 to mitigate the impact of the COVID-19 outbreak in the fishery and aquaculture sector.
(2)Treba bi bilo omogočiti, da se v okviru Evropskega sklada za pomorstvo in ribištvo (ESPR), ustanovljenega z Uredbo (EU) št. 508/2014 2 , do 31. decembra 2020 podpirajo posebni ukrepi za ublažitev posledic izbruha COVID-19 v sektorju ribištva in akvakulture.
2.EUR 580 000 000 of the budgetary resources referred to in paragraph 1 shall be allocated to the control and enforcement measures referred to in Article 76.
2.Ukrepom nadzora in izvrševanja iz člena 76 se dodeli 580 000 000 EUR proračunskih sredstev iz odstavka 1.
-support to fishermen for the temporary cessation of fishing activities caused by the COVID-19 outbreak,
-podporo ribičem za začasno prenehanje ribolovnih dejavnosti, ga je povzročil izbruh COVID-19,
3.EUR 520 000 000 of the budgetary resources referred to in paragraph 1 shall be allocated to the measures on data collection referred to in Article 77.
3.Ukrepom za zbiranje podatkov iz člena 77 se dodeli 520 000 000 EUR proračunskih sredstev iz odstavka 1.
-support to aquaculture farmers for the temporary suspension or the reduction of production caused by the COVID-19 outbreak,
-podporo gojiteljem vodnih organizmov za začasno ustavitev ali zmanjšanje proizvodnje, ki ju je povzročil izbruh COVID-19,
(1)Article 13 is replaced by the following:
(1)člen 13 se nadomesti z naslednjim:
4.EUR 192 500 000 of the budgetary resources referred to in paragraph 1 shall be allocated to the compensation of outermost regions under Chapter V of Title V. That compensation shall not exceed, per year:
4.Za nadomestilo za najbolj oddaljene regije na podlagi poglavja V naslova V se dodeli 192 500 000 EUR proračunskih sredstev iz odstavka 1.
(2)Article 16(1) is amended as follows:
(2)člen 16(1) se spremeni:
(6)Article 33(1) and (2) are amended as follows:
(6)člen 33(1) in (2) se spremeni:
(1)The fishery and aquaculture sector has been particularly hard hit by the market disruption generated by a significant drop in demand ensuing from the COVID-19 outbreak.
(1)Motnje na trgu, ki jih povzroča znatno upadanje povpraševanja zaradi izbruha COVID-19, so še posebej močno prizadele sektor ribištva in akvakulture.
(5)Article 25(3) is amended as follows:
(5)člen 25(3) se spremeni:
"(j)Article 59 shall apply from [insert date - date of entry into force of this Regulation]';
„(j)se člen 59 uporablja od [vstaviti datum - datum začetka veljavnosti te uredbe].
(12)The adoption of this Regulation takes place under exceptional circumstances arising from the COVID-19 outbreak and the associated public health crisis.
(12)Sprejetje te uredbe poteka v izjemnih okoliščinah, ki so posledica izbruha COVID-19 in z njim povezane krize na področju javnega zdravja.
(13)In light of the overriding need to immediately address the public health crisis associated with the COVID-19 outbreak, this Regulation should enter into force as a matter of urgency,
(13)Glede na nujno potrebo po takojšnji obravnavi krize na področju javnega zdravja, povezane z izbruhom COVID-19, bi morala ta uredba začeti veljati čim prej -
(10)Regulation (EU) 2017/745 should therefore be amended accordingly.
(10)Uredbo (EU) 2017/745 bi bilo zato treba ustrezno spremeniti.
(3)Medical devices, such as medical gloves, surgical masks, equipment for intensive care and other medical equipment, play a crucial role in the context of the COVID-19 outbreak and the associated public health crisis to ensure the health and safety of Union citizens and to enable Member States to give patients urgently in need the necessary medical treatment.
(3)Medicinski pripomočki, kot so medicinske rokavice, kirurške maske, oprema za intenzivno nego in druga medicinska oprema, imajo v okviru izbruha COVID-19 in z njim povezane krize na področju javnega zdravja ključno vlogo pri zagotavljanju zdravja in varnosti državljanov Unije ter omogočanju državam članicam, da se pacienti, ki to nujno potrebujejo, ustrezno zdravijo.
(9)To ensure the continuous presence of a functioning and effective regulatory framework for medical devices it is necessary to also defer the application of the provision repealing Directives 90/385/EEC and 93/42/EEC.
(9)Za zagotovitev stalnega obstoja delujočega in učinkovitega regulativnega okvira za medicinske pripomočke je treba prav tako odložiti začetek uporabe določbe o razveljavitvi direktiv 90/385/EGS in 93/42/EGS.
‘(g)with regard to reusable devices that are required to bear the UDI carrier on the device itself, Article 27(4) shall apply to:
„(g)se za pripomočke za večkratno uporabo, za katere se zahteva, da je zapis UDI naveden na samem pripomočku, člen 27(4) uporablja:
(6)The application should be deferred for provisions of Regulation (EU) 2017/745 that would otherwise start to apply from 26 May 2020.
(6)Začetek uporabe bi bilo treba odložiti za določbe Uredbe (EU) 2017/745, ki bi se sicer začele uporabljati 26. maja 2020.
‘4.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.
„4.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.
Regulation (EU) 2017/745 significantly reinforces key elements of the existing regulatory approach in Council Directive 90/385/EEC 2 and Council Directive 93/42/EEC 3 , 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.
Uredba (EU) 2017/745 znatno krepi ključne elemente obstoječega regulativnega pristopa iz Direktive Sveta 90/385/EGS 2 in Direktive Sveta 93/42/EGS 3 , 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.
(v)the following point (j) is added:
(v)doda se naslednja točka (j):
(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.
(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.
(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.
(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.
(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.
(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.
(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').
(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).