qanastek/ELRC-Medical-V2 huggingface dataset:
English: The consequent serious impact on air carriers has set in as early as January 2020 in respect of the People's Republic of China and Hong Kong Special Administrative Region of the People's Republic of China, has been pervasive since 1 March 2020, and is likely to affect at least two scheduling periods, those of winter 2019/2020 and summer 2020.
Translation (en-hr): Ozbiljne posljedice za zračne prijevoznike počele su se osjećati već u siječnju 2020. u Narodnoj Republici Kini i Posebnom Upravnom Području Narodne Republike Kine Hong Kongu, a sveopće posljedice osjećaju se od 1. ožujka 2020. te će vjerojatno utjecati na najmanje dva razdoblja reda letenja, odnosno zimsko razdoblje reda letenja 2019./2020. i ljetno razdoblje reda letenja 2020.
English: It is therefore necessary to define the conditions under which non-operated slots should be considered as operated slots for those purposes, in respect of the corresponding following season.
Translation (en-hr): Stoga je nužno definirati uvjete pod kojima bi se za tu svrhu u odgovarajućoj sezoni koja slijedi neiskorišteni slotovi trebali smatrati iskorištenima.
English: Regulation (EEC) No 95/93 sets the rules on the allocation of slots at EU airports.
Translation (en-hr): Uredbom Vijeća (EEZ) br. 95/93 utvrđuju se pravila za dodjelu slotova u zračnim lukama EU-a.
English: The negative year-on-year trend extends into the summer season, for which, according to IATA, air carriers are experiencing a 40-60% year-on-year drop in forward bookings for the period March-June 2020 for non-Italian routes with a somewhat larger impact on short-haul than long-haul routes.
Translation (en-hr): Taj pad u odnosu na prošlu godinu produljuje se i na ljetnu sezonu, za koju je, prema podacima IATA-e, pad u broju rezervacija zračnih prijevoznika u usporedbi s prošlom godinom iznosio 40-60 % za razdoblje od ožujka do lipnja 2020. za linije izvan Italije, a taj je pad bio izraženiji na kraćim nego na duljim letovima.
English: However, given the decline in passenger demand, air carriers have already started and continue to cancel flights which, for the winter 2019-2020 and summer 2020 scheduling periods, will result in slot usage below the 80% threshold imposed by the Regulation.
Translation (en-hr): Međutim, s obzirom na pad potražnje za prijevozom putnika, zračni prijevoznici već su počeli otkazivati letove te ih i dalje otkazuju, zbog čega će iskorištenost slotova tijekom zimskog razdoblja reda letenja 2019.-2020. i ljetnog razdoblja reda letenja 2020. pasti ispod praga od 80 % koji je utvrđen Uredbom.
English: Article 10a is replaced with a new article to oblige the coordinators to consider that for the purposes of assessing accrual of grandfathering rights, slots allocated for the period from 1 March 2020 until 30 June 2020 have been operated by the air carrier to which they had initially been allocated.
Translation (en-hr): Članak 10.a zamjenjuje se novim člankom kako bi se koordinatori, u svrhu procjene stjecanja stečenih prava, obvezali smatrati da je zračni prijevoznik kojem su slotovi prvotno dodijeljeni za razdoblje od 1. ožujka 2020. do 30. lipnja 2020. iskoristio te slotove.
English: ‘Article 12a
Translation (en-hr): „Članak 12.a
English: Regulation (EEC) No 95/93 does not allow Member States, for reasons such as those in question here, to oblige coordinators to consider unused slots as operated.
Translation (en-hr): Države članice ne mogu ostvariti ciljeve prijedloga u dovoljnoj mjeri iz sljedećih razloga: Uredbom (EEZ) br. 95/93 ne dopušta se državama članicama da obvežu koordinatore da nekorištene slotove smatraju iskorištenima zbog razloga poput onih koji se ovdje navode.
English: (5) Article 10(4) of Regulation (EEC) No 95/93 allows slot coordinators to disregard, for the purpose of calculating historic precedence, the non-operation of airport slots for periods during which the air carrier is unable to operate the planned air services due to, for example, airport closures.
Translation (en-hr): (5) Prema članku 10. stavku 4. Uredbe (EEZ) br. 95/93 koordinatori slotova, u svrhu izračuna prije stečene prednosti, smiju zanemariti nekorištenje slotova u zračnim lukama tijekom razdoblja kad zračni prijevoznik ne može obavljati letove zbog, primjerice, zatvaranja zračne luke.
English: Air carriers are reporting large falls in forward bookings and are implementing significant cancellations of flights into the winter 2019-2020 and summer 2020 scheduling periods as a result of the outbreak.
Translation (en-hr): Zračni prijevoznici javljaju velik pad rezervacija i otkazuju znatan broj letova u zimskom razdoblju reda letenja 2019.-2020. i ljetnom razdoblju reda letenja 2020. zbog pojave virusa.
English: EXPLANATORY MEMORANDUM
Translation (en-hr): OBRAZLOŽENJE
English: (8) The further development of SARS-CoV-2 and its further impact on air carriers are difficult to predict.
Translation (en-hr): (8) Teško je predvidjeti kako će se dalje razvijati širenje virusa SARS-CoV-2 i kakve će posljedice imati za zračne prijevoznike.
English: Under Regulation (EEC) No 95/93, the slot coordinator is the sole person responsible for the allocation of slots and is obliged to act in accordance with the Regulation [Article 4(5) thereof].
Translation (en-hr): Prema Uredbi (EEZ) br. 95/93 koordinator slotova jedina je osoba odgovorna za dodjelu slotova i obvezan je djelovati u skladu s Uredbom [njezinim člankom 4. stavkom 5.]. Koordinatori u obavljanju svoje zadaće dodjele slotova djeluju samostalno i bez uputa drugih osoba.
English: Prolonging the proposed measure for the entire summer 2020 season (which ends on 24 October 2020) could be disproportionate to the clearly-defined objective should the situation indeed to return to normal in the intervening period.
Translation (en-hr): Ako se situacija u međuvremenu zaista vrati u normalno stanje, produljenje predložene mjere na cijelu ljetnu sezonu 2020. (koja završava 24. listopada 2020.) moglo bi biti nerazmjerno jasno definiranom cilju.
English: This measure is similar in scope and effect to previous amendments of Regulation (EEC) 95/93 triggered by other emergencies.
Translation (en-hr): Opseg i učinak ove mjere slični su prethodnim izmjenama Uredbe (EEZ) br. 95/93 potaknutima drugim hitnim situacijama.
English: (9) In order to extend, if necessary and justified, the measures set out in this Regulation, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend this Regulation to prolong the period during which the measures envisaged by this Regulation apply.
Translation (en-hr): (9) Radi produljenja mjera navedenih u ovoj Uredbi, ako je to potrebno i opravdano, Komisiji bi trebalo delegirati ovlast za donošenje akata u skladu s člankom 290.
English: Returned slots which are subsequently reallocated to other air carriers would not be eligible for grandfathering for the air carrier operating them.
Translation (en-hr): Za vraćene slotove koji se naknadno preraspodjeljuju drugim zračnim prijevoznicima zračni prijevoznik koji ih koristi neće moći dobiti stečena prava.
English: Based on the information available to it, it shall present a summary report on this matter by 15 April 2020.
Translation (en-hr): Komisija neprekidno prati situaciju s obzirom na kriterije iz članka 4. Na temelju podataka koji su joj dostupni, Komisija do 15. travnja 2020. predstavlja sažeto izvješće.
English: (4) Under Article 8(2) read in conjunction with Article 10(2) of Council Regulation (EEC) No 95/93, the failure by an air carrier to operate 80% of a series of slots which it has been allocated at a coordinated airport threatens the historic precedence for these slots.
Translation (en-hr): (4) Prema članku 8. stavku 2. u vezi s člankom 10. stavkom 2. Uredbe Vijeća (EEZ) br. 95/93 ako zračni prijevoznik ne koristi seriju slotova najmanje 80 % vremena koje mu je dodijeljeno u koordiniranoj zračnoj luci, riskira gubitak prije stečene prednosti u pogledu tih slotova.
English: However, this measure is similar in scope and effect to previous amendments of Regulation (EEC) No 95/93 triggered by other emergencies.
Translation (en-hr): Međutim, opseg i učinak ove mjere slični su prethodnim izmjenama Uredbe (EEZ) br. 95/93 potaknutima drugim hitnim situacijama.
English: OTHER ELEMENTS
Translation (en-hr): 5. DRUGI ELEMENTI
English: The amendment of the slot Regulation to address the major current concern of air carriers is therefore of utmost importance.
Translation (en-hr): Stoga je iznimno važno izmijeniti Uredbu o dodjeli slotova kako bi se riješio taj problem zračnih prijevoznika.
English: An additional, earlier period is included in respect of slots used for flights between the EU and People's Republic of China or between the EU and Hong Kong Special Administrative Region of the People's Republic of China (from 23 January 2020).
Translation (en-hr): U pogledu slotova za letove između EU-a i Narodne Republike Kine ili između EU-a i Posebnog Upravnog Područja Narodne Republike Kine Hong Konga predviđeno je dodatno, ranije razdoblje (od 23. siječnja 2020.).
English: The delegation of power referred to in Article 10a may be revoked at any time by the European Parliament or by the Council.
Translation (en-hr): Europski parlament ili Vijeće u svakom trenutku mogu opozvati delegiranje ovlasti iz članka 10.a.
English: However, under the slots regulation, in order to guarantee allocation of the same slots in respect of the same season the following year, air carriers are obliged to use slots at least 80% of the time over the scheduling period for which they have been allocated.
Translation (en-hr): Međutim, prema Uredbi o dodjeli slotova, zračni prijevoznici obvezni su koristiti slotove najmanje 80 % vremena tijekom razdoblja reda letenja za koje su im dodijeljeni kako bi se zajamčila dodjela istih slotova u toj sezoni sljedeće godine.
English: The measure also serves an important sustainability objective as it removes the incentive for air carriers to operate flights with low load factors merely to protect their slots.
Translation (en-hr): Ta mjera služi i za ispunjavanje važnog cilja održivosti jer zračni prijevoznici više neće imati razlog da obavljaju letove unatoč niskoj popunjenosti samo da ne bi izgubili svoje slotove.
English: The proposal does not go beyond what is necessary to achieve the objective of alleviating the impact of the current SARS-CoV-2 outbreak for the purposes of the operation of Regulation (EEC) No 95/93.
Translation (en-hr): Ovaj prijedlog ne prelazi ono što je potrebno za ostvarivanje cilja ublažavanja posljedica pojave virusa SARS-CoV-2 u svrhu funkcioniranja Uredbe (EEZ) br. 95/93. Predložena mjera stoga je proporcionalna, među ostalim i zbog pravovremene provedbe za različite vrste odredišta.
English: Regulation (EEC) No 95/93 does not address the problems that air carriers are facing due to the outbreak of SARS-CoV-2 in relation to their possibilities to maintain their slots for following scheduling periods.
Translation (en-hr): Uredba (EEZ) br. 95/93 ne odnosi se na probleme povezane s mogućnošću zadržavanja slotova u sljedećim razdobljima reda letenja s kojima se suočavaju zračni prijevoznici zbog pojave virusa SARS-CoV-2.
English: Delegated acts adopted under this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2.
Translation (en-hr): Delegirani akti doneseni na temelju ovog članka stupaju na snagu bez odgode i primjenjuju se sve dok nije podnesen nikakav prigovor u skladu sa stavkom 2. Prilikom priopćenja delegiranog akta Europskom parlamentu i Vijeću navode se razlozi za primjenu hitnog postupka.
English: EN 8 EN
Translation (en-hr): HR 8 HR
English: EN EN
Translation (en-hr): I VIJEĆA
English: For the purposes of Articles 8(2) and 10(2), coordinators shall consider slots allocated for the period from 1 March 2020 until 30 June 2020 as having been operated by the air carrier to which they had initially been allocated.
Translation (en-hr): Za potrebe članka 8. stavka 2. i članka 10. stavka 2. koordinatori smatraju da je zračni prijevoznik kojem su slotovi prvotno dodijeljeni za razdoblje od 1. ožujka 2020. do 30. lipnja 2020. iskoristio te slotove.
English: • Choice of the instrument
Translation (en-hr): • Odabir instrumenta
English: Reasons for and objectives of the proposal
Translation (en-hr): Razlozi i ciljevi prijedloga
English: In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.
Translation (en-hr): U skladu s načelom proporcionalnosti utvrđenim u tom članku, ova Uredba ne prelazi ono što je potrebno za ostvarivanje tih ciljeva.
English: The proposal does not have a budgetary impact for the EU institutions.
Translation (en-hr): Prijedlog ne utječe na proračun institucija EU-a.
English: Proportionality
Translation (en-hr): Proporcionalnost
English: According to the principle of subsidiarity, Union action may only be taken if the envisaged aims cannot be achieved by Member States alone.
Translation (en-hr): U skladu s načelom supsidijarnosti djelovanje na razini Unije može se poduzeti samo ako države članice predviđene ciljeve ne mogu ostvariti same.
English: Legal basis
Translation (en-hr): Pravna osnova
English: "(j) Article 59 shall apply from [insert date - date of entry into force of this Regulation]';
Translation (en-hr): „(j) članak 59. primjenjuje se od [umetnuti datum - datum stupanja na snagu ove Uredbe]";
English: In this regard, the legislation, that is being amended, is adopted in full compliance with the principle of subsidiarity and any amendment thereto must be made through a Commission proposal.
Translation (en-hr): U tom pogledu, zakonodavstvo koje se izmjenjuje donosi se u potpunosti u skladu s načelom supsidijarnosti i svaka njegova izmjena mora se provesti na temelju Komisijina prijedloga.
English: After consulting the European Economic and Social Committee,
Translation (en-hr): nakon savjetovanja s Europskim gospodarskim i socijalnim odborom,
English: Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
Translation (en-hr): Ti se provedbeni akti donose u skladu s postupkom ispitivanja iz članka 114. stavka 3.";
English: Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and Article 168(4)(c) thereof,
Translation (en-hr): uzimajući u obzir Ugovor o funkcioniranju Europske unije, a posebno njegov članak 114. i članak 168. stavak 4. točku (c),
English: Those deferrals safeguard the presence of a functioning regulatory framework on medical devices from 26 May 2020.
Translation (en-hr): Tim se odgodama postiže postojanje funkcionirajućeg regulatornog okvira za medicinske proizvode i nakon 26. svibnja 2020.
English: 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 Treaty on European Union, to the Treaty on the Functioning of the European Union and to the Treaty establishing the European Atomic Energy Community.
Translation (en-hr): Stoga se smatra primjerenim predvidjeti iznimku od osmotjednog roka 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 proposal is based on Articles 114 and 168(4)(c) of the Treaty on the Functioning of the European Union (TFEU).
Translation (en-hr): Prijedlog je utemeljen na članku 114. i članku 168. stavku 4. točki (c) Ugovora o funkcioniranju Europske unije (UFEU).
English: This proposal is not accompanied by a separate impact assessment, as an impact assessment for Regulation (EU) 2017/745 has already been undertaken.
Translation (en-hr): Ovom prijedlogu nije priložena zasebna procjena učinka jer je ona već provedena za Uredbu (EU) 2017/745.
English: (12) The adoption of this Regulation takes place under exceptional circumstances arising from the COVID-19 outbreak and the associated public health crisis.
Translation (en-hr): (12) Ova se Uredba donosi u iznimnim okolnostima koje su posljedica pandemije bolesti COVID-19 i povezane javnozdravstvene krize.
English: 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').
Translation (en-hr): Uredbom (EU) 2017/745 također se omogućuje Komisiji da, u iznimnim slučajevima, valjanost nacionalnih odstupanja proširi na područje Unije na ograničeni rok („odstupanje na razini Unije").
English: Regulation (EU) 2017/745 is amended as follows:
Translation (en-hr): Uredba (EU) 2017/745 mijenja se kako slijedi:
English: (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,
Translation (en-hr): (13) S obzirom na to da je potrebno odmah reagirati na javnozdravstvenu krizu povezanu s pandemijom bolesti COVID-19, ova bi Uredba trebala hitno stupiti na snagu,
English: This proposal does not alter Regulation (EU) 2017/745 on substance and does not impose new obligations on the concerned parties.
Translation (en-hr): Ovim se prijedlogom ne mijenja sadržaj Uredbe (EU) 2017/745 niti se njime uvode nove obveze predmetnih strana.
English: (6) The application should be deferred for provisions of Regulation (EU) 2017/745 that would otherwise start to apply from 26 May 2020.
Translation (en-hr): (6) Primjenu bi trebalo odgoditi za odredbe Uredbe (EU) 2017/745 koje bi se inače počele primjenjivati od 26. svibnja 2020.
English: ‘(g) with regard to reusable devices that are required to bear the UDI carrier on the device itself, Article 27(4) shall apply to:
Translation (en-hr): „(g) u pogledu proizvoda za višekratnu uporabu koji sami nose oznaku nosača jedinstvene identifikacije proizvoda članak 27. stavak 4. primjenjuje se na sljedeće:
English: After consulting the Committee of the Regions,
Translation (en-hr): nakon savjetovanja s Odborom regija,
English: This Union action is necessary to achieve the objective of the proper implementation and application of Regulation (EU) 2017/745 by all involved parties, taking into account the magnitude of the current COVID-19 outbreak and the associated public health crisis.
Translation (en-hr): To djelovanje Unije nužno je za postizanje cilja pravilne provedbe i primjene Uredbe (EU) 2017/745 od strane svih uključenih strana, uzimajući u obzir razmjere aktualne pandemije bolesti COVID-19 i s njom povezane javnozdravstvene krize.
English: In addition, the proposed amendment seeks to ensure that the Commission is able to adopt, in exceptional cases, Union-wide derogations in response to national derogations at the earliest date possible in order to address potential shortages Union wide of vitally important medical devices in an effective manner.
Translation (en-hr): Osim toga, predloženom izmjenom nastoji se osigurati da Komisija u iznimnim slučajevima može u najkraćem mogućem roku donijeti odstupanja na razini Unije kao odgovor na nacionalna odstupanja kako bi se učinkovito reagiralo na problem potencijalne nestašice životno važnih medicinskih proizvoda u Uniji.
English: (10) Regulation (EU) 2017/745 should therefore be amended accordingly.
Translation (en-hr): (10) Uredbu (EU) 2017/745 trebalo bi stoga na odgovarajući način izmijeniti.
English: amending Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions
Translation (en-hr): o izmjeni Uredbe (EU) 2017/745 o medicinskim proizvodima u pogledu datuma primjene određenih njezinih odredaba
English: Those extraordinary circumstances have a significant impact on various areas covered by Regulation (EU) 2017/745, such as the designation and work of notified bodies and the placing on the market and making available on the market of medical devices in the Union.
Translation (en-hr): 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.
English: (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.
Translation (en-hr): (9) Kako bi se osiguralo neprekinuto važenje funkcionirajućeg i djelotvornog regulatornog okvira za medicinske proizvode, potrebno je odgoditi i primjenu odredbe o stavljanju izvan snage direktiva 90/385/EEZ i 93/42/EEZ.
English: Union intervention is required to ensure a high level of protection of health for patients and users, the smooth functioning of the internal market and avoid potential market disruption.
Translation (en-hr): Djelovanje Unije potrebno je kako bi se osigurala visoka razina zaštite zdravlja pacijenata i korisnika i neometano funkcioniranje unutarnjeg tržišta te izbjegli mogući poremećaji na tržištu.
English: 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.
Translation (en-hr): Kako bi se postigao predviđeni učinak izmjene Uredbe (EU) 2017/745 u pogledu datuma primjene određenih odredaba, potrebno je da ova Uredba stupi na snagu prije 26. svibnja 2020.
English: It is for this reason appropriate that the relevant provision of Regulation (EU) 2017/745 applies at the earliest date possible and that the corresponding provisions of Directives 90/385/EEC and 93/42/EEC are repealed from that same date.
Translation (en-hr): Iz tog je razloga primjereno da se relevantna 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 istog tog datuma.
English: At the same time, it is necessary to defer the date of repeal of Directives 90/385/EEC and 93/42/EEC.
Translation (en-hr): Istodobno je potrebno odgoditi datum stavljanja izvan snage direktiva 90/385/EEZ i 93/42/EEZ.
English: (8) In order to cover any national derogations granted by the Member States in accordance with Directives 90/385/EEC or 93/42/EEC in the context of the COVID-19 outbreak before the entry into force of this Regulation, it is also necessary to provide for the possibility for the Member States to notify those national derogations and for the Commission to extend their validity to the territory of the Union.
Translation (en-hr): (8) 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 pandemije bolesti COVID-19 prije stupanja na snagu ove Uredbe, također je potrebno predvidjeti mogućnost da države članice obavijeste Komisiju o tim nacionalnim odstupanjima i da Komisija proširi njihovu valjanost na područje Unije.
English: (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.
Translation (en-hr): (3) Medicinski proizvodi kao npr. medicinske rukavice, kirurške maske, oprema za intenzivnu njegu i ostala medicinska oprema imaju ključnu ulogu u osiguravanju zdravlja i sigurnosti građana Unije i omogućavanju liječenja najhitnijih pacijenata u državama članicama u kontekstu pandemije bolesti COVID-19 i s njom povezane javnozdravstvene krize.