FrancophonIA/Publications_Medical_Domain_UE huggingface dataset:
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.
Croatian: Kako bi se osigurala stalna dostupnost medicinskih proizvoda na tržištu Unije, uključujući medicinske proizvode koji su od životne važnosti u kontekstu pandemije bolesti COVID-19 i povezane javnozdravstvene krize, potrebno je prilagoditi i određene prijelazne odredbe Uredbe (EU) 2017/745 koje se inače više ne bi primjenjivale od datuma primjene tih odredaba.
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.
Croatian: Kako bi se u obzir uzela činjenica da se Komisiji za prijelazno razdoblje mora dati mogućnost donošenja odstupanja na razini Unije u vezi s nacionalnim odstupanjima od direktiva 90/385/EEZ i 93/42/EEZ, potrebne su određene izmjene odgovarajućih odredaba Uredbe (EU) 2017/745.
English: "- Article 11(13) of Directive 93/42/EEC and Article 9(9) of Directive 90/385/EEC which are repealed with effect from [insert date - date of entry into force of this Regulation]";
Croatian: „- članak 11. stavak 13. Direktive 93/42/EEZ i članak 9. stavak 9. Direktive 90/385/EEZ koji se stavljaju izvan snage s učinkom od [umetnuti datum - datum stupanja na snagu ove Uredbe]";
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.
Croatian: Istovremeno, Uredbom (EU) 2017/745 utvrđuju se visoki standardi kvalitete i sigurnosti za medicinske proizvode u svrhu rješavanja općih sigurnosnih problema povezanih s tim proizvodima.
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.
Croatian: Zbog krize uzrokovane bolešću COVID-19 došlo je do izvanrednih okolnosti koje zahtijevaju znatna dodatna sredstva i povećanu dostupnost životno važnih medicinskih proizvoda, a koje nisu bile razumno predvidljive u vrijeme donošenja Uredbe (EU) 2017/745.
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.
Croatian: Uzimajući u obzir pandemiju bolesti COVID-19 i s njom povezanu javnozdravstvenu krizu, njezin epidemiološki razvoj te dodatna sredstva koja su potrebna državama članicama, zdravstvenim institucijama, gospodarskim subjektima i drugim relevantnim stranama, primjereno je odgoditi primjenu relevantnih odredaba Uredbe (EU) 2017/745 za jednu godinu.
English: (v) the following point (j) is added:
Croatian: v. dodaje se sljedeća točka (j):
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].
Croatian: „Država članica može obavijestiti Komisiju i druge države članice o svakom odobrenju dodijeljenom u skladu s člankom 9. stavkom 9. Direktive 90/385/EEZ ili člankom 11. stavkom 13. Direktive 93/42/EEZ prije [umetnuti datum - datum stupanja na snagu ove Uredbe].",
English: [1: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p.
Croatian: [1: Uredba (EU) 2017/745 Europskog parlamenta i Vijeća od 5. travnja 2017. o medicinskim proizvodima, o izmjeni Direktive 2001/83/EZ, Uredbe (EZ) br. 178/2002 i Uredbe (EZ) br. 1223/2009 te o stavljanju izvan snage direktiva Vijeća 90/385/EEZ i 93/42/EEZ (SL L 117, 5.5.2017., str. 1.).][2: Direktiva Vijeća 90/385/EEZ od 20. lipnja 1990. o usklađivanju zakonodavstva država članica koja se odnose na aktivne medicinske proizvode za ugradnju (SL L 189, 20.7.1990., str. 17.).][3: Direktiva Vijeća 93/42/EEZ od 14. lipnja 1993. o medicinskim proizvodima (SL L 169, 12.7.1993., str. 1.).]
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').
Croatian: (7) Direktivama 90/385/EEZ i 93/42/EEZ te Uredbom (EU) 2017/745 ovlašćuju se nacionalna nadležna tijela da, na propisno utemeljen zahtjev, odobre stavljanje na tržište medicinskih proizvoda za koje nisu provedeni relevantni postupci ocjenjivanja sukladnosti, ali čija je uporaba u interesu zaštite zdravlja, od interesa za javno zdravlje ili sigurnost odnosno zdravlje pacijenata („nacionalno odstupanje").
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.
Croatian: Predloženom izmjenom nastoji se postići predviđeni cilj Uredbe (EU) 2017/745, odnosno uspostava čvrstog, transparentnog, predvidljivog i održivog regulatornog okvira za medicinske proizvode kojim se jamči visoka razina zaštite javnog zdravlja i sigurnosti pacijenata te neometano funkcioniranje unutarnjeg tržišta za te proizvode.
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.
Croatian: „Slijedom obavijesti u skladu sa stavkom 2. ovog članka, Komisija može, u iznimnim slučajevima u vezi s javnim zdravljem ili sigurnošću odnosno zdravljem pacijenata, provedbenim aktima na ograničeni rok proširiti valjanost odobrenja koje je dodijelila država članica u skladu sa stavkom 1. ovog članka ili, ako je dodijeljeno prije [umetnuti datum - datum stupanja na snagu ove Uredbe], u skladu s člankom 9. stavkom 9. Direktive 90/385/EEZ ili člankom 11. stavkom 13. Direktive 93/42/EEZ, na područje Unije i utvrditi uvjete pod kojima se proizvod može staviti na tržište ili u uporabu.
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.
Croatian: S obzirom na to da ciljeve ove Uredbe, odnosno odgodu primjene određenih odredaba Uredbe (EU) 2017/745 i dopuštanje proširenja valjanosti nacionalnih odstupanja odobrenih na temelju Direktive 90/385/EEZ ili Direktive 93/42/EEZ na područje Unije, ne mogu dostatno ostvariti države članice, nego se zbog svojeg opsega i učinaka oni na bolji način mogu ostvariti na razini Unije, Unija može donijeti mjere u skladu s načelom supsidijarnosti utvrđenim u članku 5. Ugovora o Europskoj uniji.
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.
Croatian: (2) Pandemija bolesti COVID-19 i s njom povezana javnozdravstvena kriza nezapamćeni je izazov za države članice i veliko opterećenje za nacionalna tijela, zdravstvene institucije, građane EU-a i gospodarske subjekte.
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.
Croatian: Pandemija bolesti COVID-19 i s njom povezana javnozdravstvena kriza nezapamćeni je izazov za države članice i veliko opterećenje za nacionalna tijela, zdravstvene institucije, građane EU-a i gospodarske subjekte.
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.
Croatian: Te izvanredne okolnosti imaju znatan utjecaj na različita područja obuhvaćena Uredbom (EU) 2017/745 te je stoga vrlo vjerojatno da države članice, zdravstvene ustanove, gospodarski subjekti i druge relevantne strane neće moći osigurati pravilnu provedbu i primjenu te uredbe od 26. svibnja 2020., datuma predviđenog za početak njezine primjene.
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.
Croatian: (4) S obzirom na aktualnu krizu neviđenih razmjera i uzimajući u obzir složenost Uredbe (EU) 2017/745 vrlo je vjerojatno da države članice, zdravstvene ustanove, gospodarski subjekti i druge relevantne strane neće moći osigurati pravilnu provedbu i primjenu te uredbe od 26. svibnja 2020., datuma predviđenog za početak njezine primjene.
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.
Croatian: (5) Kako bi se osiguralo neometano funkcioniranje unutarnjeg tržišta i visoka razina zaštite javnog zdravlja i sigurnosti pacijenata te pružila pravna sigurnost i izbjegli mogući poremećaji na tržištu, nužno je odgoditi primjenu određenih odredaba Uredbe (EU) 2017/745.
English: (5) in Article 113, '25 February 2020' is replaced by '25 February 2021';
Croatian: (5) u članku 113. datum „25. veljače 2020." zamjenjuje se datumom „25. veljače 2021.";
English: It primarily aims at providing, for exceptional reasons in the context of the current COVID-19 outbreak, a one-year deferral as regards the date of application of certain provisions of that Regulation.
Croatian: Prvenstveni je cilj ovog prijedloga jednogodišnja odgoda datuma primjene određenih odredaba te uredbe zbog iznimnih razloga u kontekstu aktualne pandemije bolesti COVID-19.
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.
Croatian: „1. Odstupajući od članka 52. ove Uredbe, ili za razdoblje od [umetnuti datum - datum stupanja na snagu ove Uredbe] do 25. svibnja 2021., odstupajući od članka 9. stavaka 1. i 2. Direktive 90/385/EEZ ili članka 11. stavaka od 1. do 6. Direktive 93/42/EEZ, svako nadležno tijelo može, na propisno utemeljen zahtjev, odobriti stavljanje na tržište ili u uporabu, na državnom području predmetne države članice, određenog proizvoda za koji nisu provedeni primjenjivi postupci iz tih članaka, ali čija je uporaba u interesu javnog zdravlja ili sigurnosti odnosno zdravlja pacijenata.",
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.
Croatian: Kako bi se osiguralo neometano funkcioniranje unutarnjeg tržišta i visoka razina zaštite javnog zdravlja i sigurnosti pacijenata te pružila pravna sigurnost i izbjegli mogući poremećaji na tržištu, nužno je odgoditi primjenu određenih odredaba Uredbe (EU) 2017/745 za jednu godinu.
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.
Croatian: (1) Uredbom (EU) 2017/745 Europskog parlamenta i Vijeća uspostavlja se novi regulatorni okvir za osiguravanje neometanog funkcioniranja unutarnjeg tržišta u pogledu medicinskih proizvoda obuhvaćenih tom uredbom, polazeći od visoke razine zaštite zdravlja pacijenata i korisnika te uzimajući u obzir mala i srednja poduzeća koja djeluju u tom sektoru.
English: (2) Article 17 is amended as follows:
Croatian: (2) članak 17. mijenja se kako slijedi:
English: (8) Article 123 is amended as follows:
Croatian: (8) članak 123. mijenja se kako slijedi:
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.
Croatian: Uredbom (EU) 2017/745 Europskog parlamenta i Vijeća donesenom 5. travnja 2017. uspostavlja se novi regulatorni okvir za osiguravanje neometanog funkcioniranja unutarnjeg tržišta u pogledu medicinskih proizvoda obuhvaćenih tom uredbom, polazeći od visoke razine zaštite zdravlja pacijenata i korisnika te uzimajući u obzir mala i srednja poduzeća koja djeluju u tom sektoru.
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;',
Croatian: „(f) Na proizvode II.a klase i II.b klase članak 27. stavak 4. primjenjuje se od 26. svibnja 2023., a na proizvode I. klase od 26. svibnja 2025.;",
English: (iii) class I devices from 26 May 2027;',
Croatian: iii. proizvodi I. klase: od 26. svibnja 2027.;",
English: (4) Article 59 is amended as follows:
Croatian: (4) članak 59. mijenja se kako slijedi:
English: (7) in Article 122, the first paragraph is amended as follows:
Croatian: (7) u članku 122. prvi stavak mijenja se kako slijedi:
English: (1) in Article 1(2), the second subparagraph is amended as follows:
Croatian: (1) u članku 1. stavku 2. drugi podstavak mijenja se kako slijedi:
English: (b) in paragraph 2, the following subparagraph is added:
Croatian: (b) u stavku 2. dodaje se sljedeći podstavak:
English: (iv) point (g) is replaced by the following:
Croatian: iv. točka (g) zamjenjuje se sljedećim:
English: (3) in Article 34(1), ‘25 March 2020' is replaced by '25 March 2021';
Croatian: (3) u članku 34. stavku 1. datum „25. ožujka 2020." zamjenjuje se datumom „25. ožujka 2021.";
English: (ii) class IIa and class IIb devices from 26 May 2025;
Croatian: ii. proizvodi II.a i II.b klase: od 26. svibnja 2025.;
English: (iii) point (f) is replaced by the following:
Croatian: iii. točka (f) zamjenjuje se sljedećim:
English: (6) Article 120 is amended as follows:
Croatian: (6) članak 120. mijenja se kako slijedi:
English: (9) in point (h) of point 5.1 of Annex IX,'26 May 2020' is replaced by '26 May 2021'.
Croatian: (9) u točki 5.1. podtočki (h) Priloga IX. datum „26. svibnja 2020." zamjenjuje se datumom „26. svibnja 2021.".
English: (c) in paragraph 3, the first subparagraph is replaced by the following:
Croatian: (c) u stavku 3. prvi podstavak zamjenjuje se sljedećim:
English: (f) paragraph 11 is amended as follows:
Croatian: (f) stavak 11. mijenja se kako slijedi:
English: (a) paragraph 1 is replaced by the following:
Croatian: (a) stavak 1. zamjenjuje se sljedećim:
English: Proposal for a
Croatian: Prijedlog
English: (i) implantable devices and class III devices from 26 May 2023;
Croatian: i. proizvodi za ugradnju i proizvodi III. klase: od 26. svibnja 2023.;
English: 13 Regional and Urban Policy
Croatian: 13 Regionalna i urbana politika
English: [XX.YY.YY.YY] NO NO NO NO
Croatian: [XX.YY.YY.YY] NE NE NE NE
English: framework Number 1b Smart and Inclusive Growth
Croatian: okvira Broj 1b Pametan i uključiv rast
English: Such eligible expenditure shall not exceed EUR 200 000.
Croatian: Takvi prihvatljivi izdaci ne smiju prelaziti 200 000 EUR.
English: In the meantime, the effects on our economies and societies become ever more serious.
Croatian: U međuvremenu posljedice za naša gospodarstva i društva postaju sve ozbiljnije.
English: There was no consultation of external stakeholders.
Croatian: Nije bilo savjetovanja s vanjskim dionicima.
English: These current limited and targeted changes do not require a separate impact assessment.
Croatian: Za te trenutačne ograničene i ciljane promjene nije potrebna zasebna procjena učinka.
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.
Croatian: U prvom paketu mjera koji je Komisija predložila 13. ožujka 2020. uveden je niz važnih promjena koje omogućuju djelotvorniji odgovor u trenutačnoj situaciji.
English: Furthermore, certain procedural requirements linked to audits and financial instruments will be simplified.
Croatian: Nadalje, pojednostavnit će se određeni postupovni zahtjevi povezani s revizijama i financijskim instrumentima.
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.
Croatian: U skladu s načelom proporcionalnosti utvrđenim u tom članku, ova Uredba ne prelazi ono što je potrebno za ostvarivanje tih ciljeva.
English: These measures are complementary and additional to the legislative modifications proposed on 13 March 2020.
Croatian: Te su dodatne mjere nadopuna zakonodavnim izmjenama predloženima 13. ožujka 2020.
English: Such operations may be selected even before the necessary programme amendment is approved by the Commission.
Croatian: Te se operacije mogu odabrati čak i prije nego što Komisija odobri potrebnu izmjenu programa.
English: Equally, the Commission will display the same flexibility in assessing the compliance of Member States with their obligations.
Croatian: Komisija će iskazati jednaku fleksibilnost kad bude procjenjivala jesu li države članice ispunile svoje obveze.
English: (3) However, the serious negative effects on EU economies and societies are becoming worse.
Croatian: (3) Međutim, pogoršavaju se ozbiljni negativni učinci na gospodarstva i društva EU-a.
English: framework 5 ‘Administrative expenditure'
Croatian: okvira 5 „Administrativni rashodi"
English: National authorities could also consider the possibility to select new operations or to launch new or additional calls for proposals if necessary.
Croatian: Nacionalna tijela mogu razmotriti i mogućnost odabira novih operacija ili pokretanja novih ili dodatnih poziva na podnošenje prijedloga ako je to potrebno.
English: Financial impact in 2020 - 2025
Croatian: financijski učinak od 2020. do 2025.
English: 4 Employment, Social affairs and Inclusion
Croatian: 4 Zapošljavanje, socijalna pitanja i uključivanje
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]
Croatian: [10: Informacije o načinima upravljanja i upućivanja na Financijsku uredbu dostupni su na internetskim stranicama BudgWeb: http://www.cc.cec/budg/man/budgmanag/budgmanag_en.html]
English: Payments =5+ 6
Croatian: Plaćanja =5+6
English: In order to contribute to an effective response to the current crisis, the scope of support from the ERDF was considerably expanded.
Croatian: Kako bi se pridonijelo djelotvornom odgovoru na trenutačnu krizu, opseg potpore iz EFRR-a znatno je proširen.
English: [8: ABM: activity-based management; ABB: activity-based budgeting.]
Croatian: [8: ABM: Activity-Based Management (upravljanje na temelju aktivnosti); ABB: Activity-Based Budgeting (priprema proračuna na temelju aktivnosti).]
English: "Article [25a]
Croatian: Članak [25.a]
English: [9: As referred to in Article 54(2)(a) or (b) of the Financial Regulation.]
Croatian: [9: Kako je navedeno u članku 54. stavku 2. točkama (a) ili (b) Financijske uredbe.]
English: SPECIFIC OBJECTIVE No 1…[17: As described in point 1.4.2.
Croatian: POSEBNI CILJ br. 1...[17: Na način opisan u odjeljku 1.4.2. „Posebni ciljevi…".
English: The direct and indirect effects of the COVID-19 outbreak continue to increase in all Member States.
Croatian: Izravni i neizravni učinci pandemije bolesti COVID-19 nastavljaju se povećavati u svim državama članicama.
English: DG: EMPL, REGIO 2020 2021 2022 2023 2024 2025 TOTAL
Croatian: GU: EMPL, REGIO 2020. 2021. 2022. 2023. 2024. 2025. UKUPNO
English: The total annual breakdown of commitment appropriations for the European Regional Development Fund, the European Social Fund and the Cohesion Fund remains unchanged.
Croatian: Ukupna godišnja raščlamba odobrenih sredstava za preuzimanje obveza za Europski fond za regionalni razvoj, Europski socijalni fond i Kohezijski fond ostaje nepromijenjena.
English: • Detailed explanation of the specific provisions of the proposal
Croatian: • Detaljno obrazloženje posebnih odredbi prijedloga
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.
Croatian: Komisija će pažljivo pratiti utjecaj predložene izmjene na odobrena sredstva za plaćanje u 2020. uzimajući u obzir i izvršenje proračuna i revidirane prognoze država članica.
English: SPECIFIC OBJECTIVE No 2 ...
Croatian: POSEBNI CILJ br. 2 ...
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)).
Croatian: Predlaže se i da se omogući dodatna fleksibilnost pri zaključivanju programa kako bi se osiguralo da se dostupna sredstva upotrebljavaju u najvećoj mjeri (članak 1. stavak 3.).
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.
Croatian: Rezultat su bliske suradnje s državama članicama putem radne skupine za CRII (Investicijska inicijativa kao odgovor na koronavirus), kojoj je već upućeno više od 200 pitanja.
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
Croatian: 1b Pametan i uključiv rast: Europski fond za regionalni razvoj, Europski socijalni fond, Kohezijski fond 4 Zapošljavanje, socijalna pitanja i uključivanje 13 Regionalna i urbana politika Dif.
English: (Reference amount) Commitments =4+ 6
Croatian: (referentni iznos) Obveze =4+6
English: The proposal is based on Articles 177, 178 and 322 of the Treaty on the Functioning of the European Union.
Croatian: Prijedlog se temelji na člancima 177., 178. i 322. Ugovora o funkcioniranju Europske unije.
English: It provides clarity on the eligibility of expenditure affected by the measures put in place as a response to the public health crisis.
Croatian: Osigurava se jasnoća u pogledu prihvatljivosti izdataka na koje utječu mjere uvedene kao odgovor na javnozdravstvenu krizu.
English: Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 177, 178 and 322(1)(a) thereof,
Croatian: uzimajući u obzir Ugovor o funkcioniranju Europske unije, a posebno njegov članak 177., članak 178. i članak 322. stavak 1. točku (a),
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.
Croatian: Sporazumi o partnerstvu ne bi se trebali mijenjati do kraja programskog razdoblja ni radi evidentiranja prethodnih izmjena operativnih programa ni radi uvođenja bilo kakvih drugih promjena.
English: Based on an assessment of the application of this exceptional co-financing rate, the Commission may propose an extension of this measure.
Croatian: Na temelju procjene primjene navedene iznimne stope sufinanciranja Komisija može predložiti produljenje te mjere.
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.
Croatian: Odstupajući od članka 125. stavka 3. točke (b), takve se operacije mogu odabrati za potporu iz EFRR-a ili ESF-a prije odobrenja izmijenjenog programa.
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.
Croatian: Usto, predlaže se da se države članice izuzmu od ispunjavanja zahtjeva u pogledu tematske koncentracije kako bi se omogućilo preusmjeravanje sredstava prema područjima koja su najpogođenija trenutačnom krizom.
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.
Croatian: "poduzetnike u teškoćama kako su definirani pravilima Unije o državnim potporama; poduzetnici koji primaju potporu u skladu s Privremenim okvirom za mjere državne potpore ili uredbama Komisije (EU) br. 1407/2013, (EU) br. 1408/2013 i (EU) br. 717/2014 ne smatraju se poduzetnicima u teškoćama za potrebe ove točke.".
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. ]
Croatian: Vanjsko osoblje (u ekvivalentu punog radnog vremena: EPRV)[20: UO = ugovorno osoblje; LO = lokalno osoblje; UNS = upućeni nacionalni stručnjaci; UsO = ustupljeno osoblje; MSD = mladi stručnjaci u delegacijama.
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.
Croatian: Kriza otežava rast u državama članicama, zbog čega je sve ozbiljniji manjak likvidnosti koji je posljedica iznenadnog i znatnog povećanja javnih ulaganja neophodnih za njihove sustave zdravstvene skrbi i druge gospodarske sektore.
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.
Croatian: Mogu postojati slučajevi u kojima se okolnosti koje proizlaze iz pandemije bolesti COVID-19 smatraju višom silom u skladu s nacionalnim pravom te stoga predstavljaju valjano opravdanje za nemogućnost ispunjenja obveze.
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.
Croatian: Države članice i regije moći će mobilizirati više resursa za veću primjenu i proširenje programa skraćenog radnog vremena, za potporu MSP-ovima u obliku radnog kapitala i za neposredne rashode u zdravstvenom sektoru.
English: These exceptional changes shall be without prejudice to the rules that should apply under regular circumstances.
Croatian: Tim izvanrednim promjenama ne dovode se u pitanje pravila koja bi se trebala primjenjivati u redovitim okolnostima.
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
Croatian: 1b: Gospodarska, socijalna i teritorijalna kohezija Europski fond za regionalni razvoj, Europski socijalni fond, Kohezijski fond Obveze (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.
Croatian: S obzirom na postojeća ograničenja za obavljanje potrebnih revizija, u slučaju EFRR-a, ESF-a, EFPR-a i Kohezijskog fonda trebalo bi izričito predvidjeti proširenje mogućnosti primjene nestatističke metode uzorkovanja.
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)).
Croatian: Kako bi se osiguralo da slabije razvijene regije ostanu u središtu pažnje, države članice trebale bi ispitati druge mogućnosti za prijenos sredstava prije nego što razmotre prijenos sredstava iz proračuna za slabije razvijene regije s obzirom na moguće negativne posljedice takvih prijenosa za ključna ulaganja u regiji podrijetla ili za završetak operacija odabranih prije zahtjeva za prijenos (članak 25.a stavci 3. i 4.).
English: Proposal/initiative in effect from 1/7/2020 to 30/6/2021
Croatian: prijedlog/inicijativa na snazi od 1.7.2020. do 30.6.2021.
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.
Croatian: Trebalo bi produljiti rok za podnošenje godišnjih izvješća o provedbi za 2019. te odgoditi slanje sažetog izvješća Komisije na temelju tih godišnjih izvješća o provedbi.
English: Furthermore, the possibilities for the support for working capital under the EAFRD should be extended (Article 25a(10) and (11)).
Croatian: Nadalje, trebalo bi proširiti mogućnosti potpore za radni kapital u okviru EPFRR-a (članak 25.a stavci 10. i 11.).
English: (1) the following new Chapter is added in Title II of Part Two:
Croatian: 1. u glavi II. dijela drugog dodaje se sljedeće novo poglavlje:
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.
Croatian: (15) S obzirom na hitnu situaciju uzrokovanu pandemijom bolesti COVID-19, primjereno je da ova Uredba stupi na snagu na dan objave u Službenom listu Europske Unije.
English: (10) In order to ensure that Member States can make full use of support from the Funds or the EMFF, additional flexibility should be provided for the calculation of the payment of the final balance at the end of the programming period.
Croatian: (10) Kako bi se osiguralo da države članice mogu u potpunosti iskoristiti potporu iz fondova ili EFPR-a, trebalo bi predvidjeti dodatnu fleksibilnost za izračun plaćanja konačne isplate na kraju programskog razdoblja.
English: The COVID-19 outbreak is also likely to have serious impacts on the implementation of ongoing operations.
Croatian: Pandemija bolesti COVID-19 vjerojatno će imati ozbiljne učinke na provedbu tekućih operacija.
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.
Croatian: Prijedlog je ograničena i ciljana promjena koja ne prelazi ono što je potrebno za ostvarivanje cilja osiguravanja dodatne fleksibilnosti i pravne sigurnosti za pokretanje ulaganja u odgovoru na sveobuhvatnu javnozdravstvenu krizu koja utječe na potencijal rasta regija i poduzeća te na dobrobit stanovništva.
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.]
Croatian: Proračunska linija prihoda: Odobrena sredstva dostupna za tekuću financijsku godinu Učinak prijedloga/inicijative[22: Kad je riječ o tradicionalnim vlastitim sredstvima (carine, pristojbe na šećer) navedeni iznosi moraju biti neto iznosi, to jest bruto iznosi umanjeni za 25 % na ime troškova naplate.]
English: The current situation is unprecedented and requires exceptional measures adapted to the situation to be applied in these circumstances.
Croatian: Trenutačna je situacija bez presedana i zahtijeva da se u tim okolnostima primijene izvanredne mjere prilagođene situaciji.
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,
Croatian: (16) Zbog pandemije bolesti COVID-19 i hitne potrebe za rješavanjem povezane javnozdravstvene krize, primjereno je predvidjeti iznimku od isteka osam tjedana iz članka 4. Protokola br. 1 o ulozi nacionalnih parlamenata u Europskoj uniji, priloženog Ugovoru o Europskoj uniji, Ugovoru o funkcioniranju Europske unije i Ugovoru o osnivanju Europske zajednice za atomsku energiju,
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.
Croatian: Provedba mjera pratit će se i o njoj će se izvješćivati u okviru općih mehanizama izvješćivanja utvrđenih u Uredbi (EU) br. 1303/2013.
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.
Croatian: Nadalje, kako bi se u trenutačnim okolnostima uklonilo administrativno opterećenje za nacionalne i europske javne uprave koje bi proizašlo iz izmjena programa, potrebno je suzdržati se od izmjene sporazuma o partnerstvu te odgoditi rok za podnošenje godišnjih izvješća o provedbi u 2020. kao i rok za podnošenje izvješća Komisije na temelju tih izvješća.
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.
Croatian: Za operacije kojima se jačaju kapaciteti za odgovor na krizu u kontekstu pandemije bolesti COVID-19, kako je navedeno u članku 65. stavku 10. drugom podstavku, ne primjenjuje se članak 65. stavak 6.
English: "CHAPTER V
Croatian: „POGLAVLJE V.
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.
Croatian: Nacionalna tijela stoga mogu razmotriti mogućnost prilagodbe operacija (npr. rezultata, roka izvršenja itd.) u skladu sa svojim nacionalnim pravilima gdje je to potrebno i opravdano, na način da se utjecaj pandemije bolesti COVID-19 na programe svede na najmanju moguću mjeru.
English: The 100% co-financing rate shall only apply if the corresponding programme amendment is approved by the Commission at the latest before the submission of the final application for an interim payment in accordance with Article 135(2) CPR.
Croatian: Stopa sufinanciranja od 100 % primjenjuje se samo ako je Komisija odobrila odgovarajuću izmjenu programa najkasnije prije predaje konačnog zahtjeva za međuplaćanje u skladu s člankom 135. stavkom 2. Uredbe o zajedničkim odredbama.
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.
Croatian: Kako bi se zadovoljile potrebe za rješavanjem trenutačnih specifičnih problema, države članice trebale bi moći zatražiti prijenos svojih dodijeljenih sredstava za 2020. iz jedne kategorije regija u drugu.
English: For the purpose of these transfers, the requirements laid down in Article 92(4) shall not apply.
Croatian: Za potrebe tih prijenosa ne primjenjuju se zahtjevi iz članka 92. stavka 4.
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.
Croatian: Konačno, prijedlogom se ublažavaju određeni zahtjevi za države članice ako stvaraju administrativno opterećenje koje bi moglo odgoditi provedbu mjera odgovora na pandemiju bolesti COVID-19.
English: (13) Since the objectives of this Regulation, namely to respond to the impact of the public health crisis by introducing flexibility measures in the field of providing support from the ESI Funds, cannot be sufficiently achieved by the Member States alone and can therefore, by reason of the scale and effects of the proposed action, 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.
Croatian: (13) Budući da ciljeve ove Uredbe, odnosno odgovor na posljedice javnozdravstvene krize uvođenjem mjera fleksibilnosti pri pružanju potpore iz ESI fondova, ne mogu dostatno ostvariti države članice, već se zbog opsega i učinaka predloženih mjera ti ciljevi mogu na bolji način ostvariti na razini Unije, Unija može donijeti mjere u skladu s načelom supsidijarnosti utvrđenim u članku 5. Ugovora o Europskoj uniji.
English: The proposal/initiative requires the use of existing operational appropriations (no changes):
Croatian: Za prijedlog/inicijativu potrebna su postojeća odobrena sredstva za poslovanje (bez izmjena):
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.
Croatian: Cilj je prijedloga omogućiti odstupanja od određenih ograničenja u skladu s trenutačno primjenjivim odredbama Unije kako bi se omogućila najveća moguća fleksibilnost za mobilizaciju postojećih sredstava za ulaganja radi rješavanja izravnih i neizravnih posljedica nezapamćene javnozdravstvene krize u kontekstu pandemije bolesti COVID-19.
English: For the purposes of Article 87(1)(b), where the COVID-19 outbreak is invoked as a reason of force majeure, information on the amounts for which it has not been possible to make a payment application shall be provided at an aggregate level by priority for operations of total eligible costs of less than EUR 1 000 000.
Croatian: Za potrebe članka 87. stavka 1. točke (b), ako se pandemija bolesti COVID-19 navodi kao razlog više sile, podaci o iznosima za koje nije bilo moguće podnijeti zahtjev za plaćanje pružaju se na ukupnoj razini po prioritetima za operacije za koje ukupni prihvatljivi troškovi iznose manje od 1 000 000 EUR.
English: [3: OJ C , , p.
Croatian: [3: SL C , , str.
English: By way of derogation from Article 16, as from [date of entry into force of this Regulation], Partnership Agreements shall not be amended and programme amendments shall not entail the amendment of Partnership Agreements.
Croatian: Odstupajući od članka 16., od [datuma stupanja na snagu ove Uredbe] sporazumi o partnerstvu ne mijenjaju se, a izmjene programa ne podrazumijevaju izmjenu sporazuma o partnerstvu.
English: XX 01 04 yy [21: Sub-ceiling for external staff covered by operational appropriations (former ‘BA' lines).]
Croatian: XX 01 04 yy [21: U okviru gornje granice za vanjsko osoblje iz odobrenih sredstava za poslovanje (prijašnje linije „BA").] - u sjedištima
English: [Heading………………………………………] Diff./Non-diff. from EFTA countries from candidate countries from third countries within the meaning of Article 21(2)(b) of the Financial Regulation
Croatian: [Naslov………………………………………] Dif./nedif. zemalja EFTA-e zemalja kandidatkinja trećih zemalja u smislu članka 21. stavka 2. točke (b) Financijske uredbe
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).
Croatian: Komisija smatra da treba primijeniti svu potrebnu fleksibilnost u slučajevima kada korisnici zbog razloga povezanih s pandemijom bolesti COVID-19 (npr. nedostupnost osoblja) ne mogu na vrijeme ispuniti svoje obveze.
English: The transmission of the summary report prepared by the Commission in 2020, in accordance with Article 53(1), may be postponed accordingly.
Croatian: Slanje sažetog izvješća, u skladu s člankom 53. stavkom 1., koje Komisija priprema 2020. može se u skladu s tim odgoditi.
English: By way of derogation from Regulation (EU) No 1305/2013, such support may also be provided by the EAFRD under measures referred to in Regulation (EU) No 1305/2013 and relevant to the implementation of financial instruments.
Croatian: Odstupajući od Uredbe (EU) br. 1305/2013, ta se potpora može pružiti i iz EPFRR-a u okviru mjera iz Uredbe (EU) br. 1305/2013, koje su relevantne za provedbu financijskih instrumenata.
English: In order to ensure that all support from the Funds can be mobilised to address the effects of the the COVID-19 outbreak on our economies and societies, as a temporary and exceptional measure, without prejudice to the rules that should apply under regular circumstances, it is necessary to allow for the temporary possibility of 100% co-financing from the EU budget for the implementation of cohesion policy programmes, as well as additional transfer possibilities between the European Regional Development Fund (ERDF), the European Social Fund (ESF), and the Cohesion Fund, and between categories of regions.
Croatian: Kako bi se omogućila mobilizacija sve potpore iz fondova radi svladavanja posljedica pandemije bolesti COVID-19 na naša gospodarstva i društva, potrebne su privremene i izvanredne mjere, ne dovodeći u pitanje pravila koja bi se trebala primjenjivati u redovitim okolnostima, što uključuje pružanje privremene mogućnosti 100 %-nog sufinanciranja iz proračuna EU-a za provedbu programa kohezijske politike, kao i dodatnih mogućnosti prijenosa između Europskog fonda za regionalni razvoj (EFRR), Europskog socijalnog fonda (ESF) i Kohezijskog fonda te prijenosa iz jedne kategorije regija u drugu.
English: In particular, Partnership Agreements should no longer be amended (Article 25a(6)), the deadline for the submission of the annual implementation report should be postponed (Article 25a(8)), and the extension of the possibility for the Funds and the EMFF to make use of a non-statistical sampling method should also be explicitly provided for (Article 25a(12)).
Croatian: Posebno, sporazume o partnerstvu više ne bi trebalo mijenjati (članak 25.a stavak 6.), rok za podnošenje godišnjeg izvješća o provedbi trebalo bi odgoditi (članak 25.a stavak 8.), a za fondove i EFPR trebalo bi izričito predvidjeti i proširenje mogućnosti primjene nestatističke metode uzorkovanja (članak 25.a stavak 12.).
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.
Croatian: Međutim, prijedlog se temelji na intenzivnom savjetovanju s državama članicama i Europskim parlamentom, a Komisija je uzela u obzir više od 200 pojašnjenja i savjeta koje su joj putem radne skupine za CRII (Investicijska inicijativa kao odgovor na koronavirus) uputila nacionalna tijela u vezi s mjerama koje su poduzela za svladavanje krize.
English: The total annual breakdown of commitment appropriations under Regulation (EU) No 1303/2013 remains unchanged.
Croatian: Ukupna godišnja raščlamba odobrenih sredstava za preuzimanje obveza u skladu s Uredbom (EU) br. 1303/2013 ostaje nepromijenjena.
English: from EFTA countries[12: EFTA: European Free Trade Association. ]
Croatian: = nediferencirana odobrena sredstva] zemalja EFTA-e[12: EFTA: Europsko udruženje slobodne trgovine.
English: (6) In order to enable Member States to quickly deploy available resources to respond to the COVID-19 outbreak and taking into account that, given the advanced stage of implementation of the 2014-2020 programming period, reallocation of resources may only concern resources available for programming for the year 2020, it is justified to exceptionally exempt Member States from the need to comply with thematic concentration requirements until the end of the programming period.
Croatian: (6) Kako bi se državama članicama omogućilo da brzo iskoriste raspoloživa sredstva kako bi odgovorile na pandemiju bolesti COVID-19 i s obzirom na to da je zbog uznapredovale faze provedbe programskog razdoblja 2014.-2020. preraspodjela sredstava moguća samo za sredstva raspoloživa u okviru programiranja za 2020., opravdano je iznimno izuzeti države članice od potrebe za ispunjavanjem zahtjeva za tematsku koncentraciju do kraja programskog razdoblja.