natgillin/translations-raw huggingface dataset:
Those measures should also comprise the provision of working capital to aquaculture producers and processing enterprises and 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 of the European Parliament and of the Council (3) .
Te bi mjere trebale obuhvaćati i dodjelu radnog kapitala proizvođačima u sektoru akvakulture i poduzećima za preradu te potporu organizacijama proizvođača i udruženjima organizacija proizvođača za skladištenje proizvoda ribarstva i akvakulture, u skladu s Uredbom (EU) br. 1379/2013 Europskog parlamenta i Vijeća (3) . Rashodi za operacije koje primaju potporu na temelju tih mjera trebali bi biti prihvatljivi od 1. veljače 2020.
Those measures should comprise support for the temporary cessation of fishing activities, including for inland fishing and fishers on foot, and for certain economic losses for aquaculture producers and processing enterprises and in the outermost regions, provided that they are the consequence of the COVID‐19 outbreak.
Te bi mjere trebale obuhvaćati potporu za privremeni prestanak ribolovnih aktivnosti, uključujući ribolov u unutarnjim vodama i ribare bez plovila i za određene gospodarske gubitke za proizvođače u sektoru akvakulture, pod uvjetom da je do njih došlo uslijed izbijanja bolesti COVID-19.
REGULATION (EU) 2020/561 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
UREDBA (EU) 2020/561 EUROPSKOG PARLAMENTA
It was therefore considered to be 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 TEU, to the Treaty on the Functioning of the European Union and to the Treaty establishing the European Atomic Energy Community.
Stoga se smatralo primjerenim predvidjeti iznimku od roka od osam tjedana iz članka 4. Protokola br. 1 o ulozi nacionalnih parlamenata u Europskoj uniji, priloženog UEU-u, Ugovoru o funkcioniranju Europske unije i Ugovoru o osnivanju Europske zajednice za atomsku energiju.
The adoption of this Regulation takes place under exceptional circumstances arising from the COVID-19 outbreak and the associated public health crisis.
Ova se Uredba donosi u iznimnim okolnostima koje su posljedica izbijanja bolesti COVID-19 i s time povezane javnozdravstvene krize.
Regulation (EU) 2017/745 should therefore be amended accordingly,
Uredbu (EU) 2017/745 trebalo bi stoga na odgovarajući način izmijeniti,
The application should be deferred for provisions of Regulation (EU) 2017/745 that would otherwise start to apply from 26 May 2020.
Primjenu bi trebalo odgoditi za odredbe Uredbe (EU) 2017/745 koje bi se inače počele primjenjivati od 26. svibnja 2020.
Regulation (EU) 2017/745 also allows the Commission to extend, in exceptional cases, the validity of a national derogation for a limited period of time to the territory of the Union (‘Union-wide derogation').
Uredbom (EU) 2017/745 također se omogućuje Komisiji da, u iznimnim slučajevima, valjanost nacionalnog odstupanja proširi na područje Unije na ograničeni rok („odstupanje na razini Unije").
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.
Te izvanredne okolnosti imaju znatan utjecaj na različita područja obuhvaćena Uredbom (EU) 2017/745, kao što su imenovanje i rad prijavljenih tijela te stavljanje na tržište i stavljanje na raspolaganje na tržištu medicinskih proizvoda u Uniji.
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 necessary medical treatment to patients who are urgently in need of such treatment.
Medicinski proizvodi, kao što su medicinske rukavice, kirurške maske, oprema za intenzivnu njegu i ostala medicinska oprema, imaju ključnu ulogu u kontekstu izbijanja bolesti COVID-19 i s time povezane javnozdravstvene krize za osiguravanje zdravlja i sigurnosti građana Unije i omogućavanje državama članicama da pruže potrebno liječenje pacijentima kojima je ono hitno potrebno.
The COVID-19 outbreak and the associated public health crisis presents an unprecedented challenge to Member States and constitutes an immense burden for national authorities, health institutions, Union citizens, and economic operators.
Izbijanje bolesti COVID-19 i s time povezana javnozdravstvena kriza predstavljaju nezapamćen izazov za države članice i veliko opterećenje za nacionalna tijela, zdravstvene ustanove, građane Unije i gospodarske subjekte.
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.
Istodobno, Uredbom (EU) 2017/745 postavljaju se visoki standardi kvalitete i sigurnosti za medicinske proizvode kako bi se riješili zajednički sigurnosni problemi u vezi s tim proizvodima.
amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions
o izmjeni Uredbe (EU) 2017/745 o medicinskim proizvodima u pogledu datumâ primjene određenih njezinih odredaba
To ensure the continuous presence of a functioning and effective regulatory framework for medical devices, it is necessary to defer the application of the provision repealing Directives 90/385/EEC and 93/42/EEC.
Radi osiguravanja neprekidnog postojanja funkcionirajućeg i djelotvornog regulatornog okvira za medicinske proizvode, potrebno je odgoditi primjenu odredbe o stavljanju izvan snage direktiva 90/385/EEZ i 93/42/EEZ.
The public health 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.
Javnozdravstvena kriza dovela je do izvanrednih okolnosti koje zahtijevaju znatna dodatna sredstva i povećanu dostupnost životno važnih medicinskih proizvoda, a koje razumno nisu mogle biti predviđene u vrijeme donošenja Uredbe (EU) 2017/745.
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 laid down therein.
S obzirom na neviđene razmjere aktualnih izazova 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., kako je u njoj utvrđeno.
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 on the day of its publication in the Official Journal of the European Union.
S obzirom na to da je nužno odmah reagirati na javnozdravstvenu krizu povezanu s izbijanjem bolesti COVID-19, ova bi Uredba trebala hitno stupiti na snagu na dan objave u Službenom listu Europske unije.
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 Union-wide shortages of vitally important medical devices in an effective manner.
Uzimajući u obzir izbijanje bolesti COVID-19 i s time povezanu javnozdravstvenu krizu, Komisija bi trebala moći donijeti odstupanja na razini Unije kao odgovor na nacionalna odstupanja kako bi se djelotvorno reagiralo na potencijalne nestašice životno važnih medicinskih proizvoda na razini Unije.
Furthermore, Regulation (EU) 2017/745 significantly reinforces key elements of the existing regulatory approach in Council Directives 90/385/EEC (3) and 93/42/EEC (4) , 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.
Osim toga, Uredbom (EU) 2017/745 znatno se osnažuju ključni elementi postojećeg regulatornog pristupa iz direktiva Vijeća 90/385/EEZ (3) i 93/42/EEZ (4) , kao što su nadzor nad prijavljenim tijelima, postupci ocjenjivanja sukladnosti, klinička ispitivanja i kliničke procjene, vigilancija i nadzor tržišta, te se istodobno uvode odredbe za osiguravanje transparentnosti i sljedivosti u odnosu na medicinske proizvode, s ciljem poboljšanja zdravlja i sigurnosti.
It is for that 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 date.
Zbog tog razloga primjereno je da se dotična odredba Uredbe (EU) 2017/745 počne primjenjivati na najraniji mogući datum i da se odgovarajuće odredbe direktiva 90/385/EEZ i 93/42/EEZ stave izvan snage od tog datuma.
In order to cover any national derogations granted by Member States in accordance with Directive 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 necessary to provide for the possibility for Member States to notify those national derogations and for the Commission to extend their validity to the territory of the Union.
Kako bi se obuhvatila sva nacionalna odstupanja koja su države članice odobrile u skladu s Direktivom 90/385/EEZ ili Direktivom 93/42/EEZ u kontekstu izbijanja bolesti COVID-19 prije stupanja na snagu ove Uredbe, potrebno je predvidjeti mogućnost da države članice obavijeste Komisiju o tim nacionalnim odstupanjima i da Komisija proširi njihovu valjanost na područje Unije.
Regulation (EU) 2017/745 of the European Parliament and of the Council (2) 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.
Uredbom (EU) 2017/745 Europskog parlamenta i Vijeća (2) 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.
To attain the intended effect of amending Regulation (EU) 2017/745 as regards the dates of application of certain provisions, it is necessary for this Regulation to enter into force before 26 May 2020.
Kako bi se postigao predviđeni učinak izmjene Uredbe (EU) 2017/745 u pogledu datumâ primjene određenih odredaba, potrebno je da ova Uredba stupi na snagu prije 26. svibnja 2020.
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.
Kako bi se osigurala neprekidna dostupnost medicinskih proizvoda na tržištu Unije, uključujući medicinske proizvode koji su od životne važnosti u kontekstu izbijanja bolesti COVID-19 i s time povezane javnozdravstvene krize, potrebno je prilagoditi i određene prijelazne odredbe Uredbe (EU) 2017/745 koje se inače više ne bi primjenjivale.
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.
Kako bi se osiguralo neometano funkcioniranje unutarnjeg tržišta, visoka razina zaštite javnog zdravlja i sigurnosti pacijenata te pružila pravna sigurnost i izbjegli mogući poremećaji na tržištu, potrebno je odgoditi primjenu određenih odredaba Uredbe (EU) 2017/745.
Taking into account that the possibility to adopt Union-wide derogations, for a transitional period, is to 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.
Uzimajući u obzir da Komisiji tijekom prijelaznog razdoblja treba dati mogućnost donošenja odstupanjâ na razini Unije u vezi s nacionalnim odstupanjima od direktiva 90/385/EEZ i 93/42/EEZ, potrebne su određene izmjene dotičnih odredaba Uredbe (EU) 2017/745.
Taking into account the COVID-19 outbreak and the associated public health crisis, its epidemiological development, as well as the additional resources required by Member States, health institutions, economic operators and other relevant parties, it is appropriate to defer the application of those provisions of Regulation (EU) 2017/745 by one year.
Uzimajući u obzir izbijanje bolesti COVID-19 i s time povezanu javnozdravstvenu krizu, njezin epidemiološki razvoj te dodatna sredstva koja su potrebna državama članicama, zdravstvenim ustanovama, gospodarskim subjektima i drugim relevantnim stranama, primjereno je odgoditi primjenu tih odredaba Uredbe (EU) 2017/745 za godinu dana.
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').
I direktivama 90/385/EEZ i 93/42/EEZ i 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 od interesa za zaštitu zdravlja, od interesa za javno zdravlje odnosno sigurnost ili zdravlje pacijenata („nacionalno odstupanje").
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 Directive 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 their 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 (‘TEU').
S obzirom na to da ciljeve ove Uredbe, odnosno odgodu primjene određenih odredaba Uredbe (EU) 2017/745 i omogućivanje proširenja valjanosti nacionalnih odstupanja odobrenih u skladu s Direktivom 90/385/EEZ ili Direktivom 93/42/EEZ na područje Unije, ne mogu dostatno ostvariti države članice, nego se zbog njihovih 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 („UEU").
Regulation (EU) 2020/402, and its amendment, apply for a limited period of 6 weeks.
Uredba (EU) 2020/402 i njezina izmjena primjenjuju se na ograničeno razdoblje od šest tjedana.
The main objective of such system would be to protect public health within the Union.
Glavni cilj takvog sustava bio bi zaštita javnog zdravlja u Uniji.
These initiatives are proving successful, and equipment is planned to be made available 2 weeks after the Member States sign the contracts with the bidders.
Te su se inicijative pokazale uspješnima, a planirano je da se oprema stavi na raspolaganje dva tjedna nakon što države članice potpišu ugovore s ponuditeljima.
This concerns the territories of Büsingen, Heligoland, Livigno, Ceuta and Melilla.
To se odnosi na područja Büsingena, Helgolanda, Livigna, Ceute i Melille.
Pursuant to Article 127(3) of the Withdrawal Agreement, during the transition period, the United Kingdom of Great Britain and Northern Ireland is to be considered as a Member State, and not as a third country.
U skladu s člankom 127. stavkom 3. Sporazuma o povlačenju, tijekom prijelaznog razdoblja Ujedinjena Kraljevina Velike Britanije i Sjeverne Irske smatra se državom članicom, a ne trećom zemljom.
This is particularly the case of the member States of the European Free Trade Association, and the Western Balkans which are engaged in a process of deep integration with the Union.
To se osobito odnosi na države članice Europskog udruženja za slobodnu trgovinu i na zapadni Balkan, koji su uključeni u proces snažne integracije s Unijom.
These measures, aimed at protecting health and impacting on trade, should be targeted, proportionate, transparent and temporary.
Te mjere, usmjerene na zaštitu zdravlja i s posljedicama za trgovinu, trebaju biti ciljane, razmjerne, transparentne i privremene.
The production capacities of personal protective equipment have been ramped-up.
Proizvodni kapaciteti za osobnu zaštitnu opremu povećani su.
The Commission finalised a joint procurement for personal protective equipment, in which 25 Member States took part.
Komisija je dovršila postupak zajedničke javne nabave za osobnu zaštitnu opremu, u kojem je sudjelovalo 25 država članica.
Continuous efforts are being made to help ensuring urgent and adequate provision of protective equipment throughout the EU.
Kontinuirano se ulažu napori kako bi se osigurala hitna i dostatna opskrba zaštitnom opremom u cijelom EU-u.
It is not the intention of the Union to restrict exports any more than absolutely necessary, and the Union also wishes to uphold the principle of international solidarity in this situation of a global pandemic.
Unija izvoz ne želi ograničiti više nego što je apsolutno nužno i svakako želi podržati načelo međunarodne solidarnosti tijekom ove globalne pandemije.
On that basis, a need may arise to review the scope of Annex I and products covered by this Regulation.
S obzirom na to može se pojaviti potreba za preispitivanjem područja primjene Priloga I. i proizvoda obuhvaćenih ovom Uredbom.
In a Joint Statement of 26 March the members of the European Council underlined that the adoption of the decision on the authorisation for export of PPE should lead to the full and effective lifting of all forms of internal bans or restrictions.
U zajedničkoj izjavi od 26. ožujka članovi i članice Europskog vijeća istaknuli su da bi donošenje odluke o odobrenju za izvoz osobne zaštitne opreme trebalo dovesti do potpunog i djelotvornog ukidanja svih oblika unutarnjih zabrana ili ograničenja.
It is therefore appropriate to exclude such countries from the scope of application of this Regulation.
Stoga je primjereno isključiti te zemlje iz područja primjene ove Uredbe.
The CN codes should be given for information only.
Oznake KN trebale bi biti navedene samo u informativne svrhe.
An export authorisation system should remedy or prevent a situation of a shortage of essential products within the borders of the Union.
Sustav odobrenja za izvoz trebao bi riješiti ili spriječiti nestašicu osnovnih proizvoda unutar granica Unije.
The single market for medical and personal protective equipment is closely integrated beyond the boundaries of the Union, and so are its production value chains and distribution networks.
Jedinstveno tržište za medicinsku i osobnu zaštitnu opremu usko je integrirano izvan granica Unije, kao i njegovi proizvodni vrijednosni lanci i distribucijske mreže.
The measures provided for in this Regulation should not apply to trade between the EU Member States.
Mjere predviđene ovom Uredbom ne bi se trebale primjenjivati na trgovinu među državama članicama EU-a.
This Regulation should apply to exports of Union goods from the customs territory of the Union.
Ova bi se Uredba trebala primjenjivati na izvoz robe Unije iz carinskog područja Unije.
Union measures should therefore be proportionate and ensure that exports remain possible, subject to a prior authorisation.
Stoga bi Unijine mjere trebale biti razmjerne i osigurati da izvoz i dalje bude moguć, uz prethodno odobrenje.
As the epidemiological crisis caused by the COVID-19 disease continues, the demand within the Union for personal protective equipment (‘PPE'), which consists of protective masks (and surgical masks), gloves, goggles, face-shields, and overalls, remains very high and is even continuously increasing.
Budući da se epidemiološka kriza uzrokovana bolešću COVID-19 nastavlja, potražnja u Uniji za osobnom zaštitnom opremom, koja se sastoji od zaštitnih maski (i kirurških maski), rukavica, zaštitnih naočala, štitnika za lice i zaštitnih odijela, i dalje je iznimno velika te se čak i stalno povećava.
Likewise, it would be counterproductive to disrupt closely integrated value chains and distribution networks established on the basis of those arrangements or otherwise, in particular in the case of neighbouring countries and economies.
Isto tako, bilo bi kontraproduktivno narušiti izrazito integrirane vrijednosne lance i distribucijske mreže uspostavljene na temelju tih aranžmana ili na drugi način, posebice u slučaju susjednih zemalja i gospodarstava.
A review of the scope should be based on a continuous assessment of needs of critical equipment related to the fight against COVID-19 and their potential shortages.
Preispitivanje područja primjene trebalo bi se temeljiti na kontinuiranom ocjenjivanju potreba za osnovnom opremom za borbu protiv bolesti COVID-19 i mogućoj nestašici te opreme.
Based on the principle of international solidarity, Member States should authorise exports to enable the provisions of emergency supplies in the context of humanitarian aid.
Na temelju načela međunarodne solidarnosti države članice trebale bi odobriti izvoz kojim bi se omogućile hitne isporuke u kontekstu humanitarne pomoći.
Member States do however not have to contact the Clearing House in the case of authorisations for emergency supplies in the context of humanitarian aid.
Međutim, države članice ne moraju stupiti u kontakt s mehanizmom za razmjenu u slučaju odobrenja za hitnu opskrbu u kontekstu humanitarne pomoći.
In contrast, Member States should not authorise exports that would create speculative distortion and serve stockpiling and hoarding of essential equipment by those with little or no objective need.
S druge strane, države članice ne bi trebale odobriti izvoz koji bi uzrokovao spekulativne poremećaje i služio stvaranju zaliha i gomilanju osnovne opreme od strane onih kojima je potrebno malo opreme ili im uopće nije potrebna.
Likewise, exports to the continental shelf of a Member State or the exclusive economic zone declared by a Member State pursuant to UNCLOS should be exempted from the application of this regulation.
Isto tako, izvoz u epikontinentalni pojas države članice ili isključivi gospodarski pojas koji je država članica prijavila u skladu s UNCLOS-om trebao bi biti izuzet od primjene ove Uredbe.
Under the Union Civil Protection Mechanism (UCPM), the European Commission has decided to create a strategic rescEU stockpile of medical equipment such as ventilators and protective masks to help EU countries in the context of the COVID-19 pandemic.
Europska komisija je u okviru Mehanizma Unije za civilnu zaštitu odlučila u sustavu rescEU stvoriti strateške zalihe medicinske opreme, kao što su respiratori i zaštitne maske, kako bi pomogla zemljama EU-a u borbi protiv pandemije bolesti COVID-19.