natgillin/translations-raw huggingface dataset:
For any newly recognised producer organisation, that support shall not exceed 12 % of the average annual value of the production placed on the market by the members of that organisation during the preceding three calendar years."
Za svaku novopriznatu organizaciju proizvođača ta potpora ne smije prijeći 12 % prosječne godišnje vrijednosti proizvodnje koju su članovi te organizacije stavili na tržište tijekom prethodne tri kalendarske godine."
(9)Given the suddenness and magnitude of the contraction of demand for fishery and aquaculture products resulting from the COVID-19 outbreak, it should be possible to increase the quantities eligible for storage aid to 25 % of the annual quantities of the products concerned put up for sale by the producer organisation concerned.
(9)S obzirom na naglost i razmjer smanjenja potražnje za proizvodima ribarstva i akvakulture uzrokovanog pandemijom bolesti COVID-19 trebalo bi biti moguće povećati količine prihvatljive za potporu za skladištenje na 25 % godišnje količine dotičnih proizvoda koju određena organizacija proizvođača stavi u prodaju.
(a) the following paragraph 4a is added:
(a) dodaje se sljedeći stavak 4.a:
-support to fishermen for the temporary cessation of fishing activities caused by the COVID-19 outbreak,
-potporu ribarima za privremeni prestanak ribolovnih aktivnosti prouzročen pandemijom bolesti COVID-19,
amending Regulation (EU) No 1379/2013 and Regulation (EU) No 508/2014 as regards specific measures to mitigate the impact of the COVID-19 outbreak in the fishery and aquaculture sector
o izmjeni Uredbe (EU) br. 1379/2013 i Uredbe (EU) br. 508/2014 u pogledu posebnih mjera za ublažavanje posljedica pandemije bolesti COVID-19 u sektoru ribarstva i akvakulture
The Commission is therefore adopting a legislative proposal to amend Regulation (EU) No 508/2014 (the EMFF Regulation), as well as Regulation (EU) No 1379/2013 (the CMO Regulation) to introduce specific measures in the EMFF to mitigate the impact of the COVID-19 outbreak in the fishery and aquaculture sector.
Komisija stoga donosi zakonodavni prijedlog o izmjeni Uredbe (EU) br. 508/2014 (Uredba o EFPR-u) i Uredbe (EU) br. 1379/2013 (Uredba o ZOT-u), radi uvođenja posebnih mjera u okviru EFPR-a za ublažavanje posljedica pandemije bolesti COVID-19 u sektoru ribarstva i akvakulture.
Fishery and aquaculture producer organisations may receive financial support for storage of products listed in Annex II or products of the CN code 0302 listed in Annex I, section (a) of Regulation (EU) No 1379/2013, provided that:
Organizacije proizvođača u sektoru ribarstva i akvakulture mogu primiti financijsku potporu za skladištenje proizvoda navedenih u Prilogu II. ili proizvoda razvrstanih u oznaku KN 0302 navedenih u Prilogu I. odjeljku (a) Uredbe (EU) br. 1379/2013 pod uvjetom da:
The stakeholders' assessment of the crisis situation and of how to fight its effects is almost entirely coherent and unanimous.
Dionici gotovo u potpunosti dosljedno i jednoglasno procjenjuju kriznu situaciju i načine ublažavanja njezinih posljedica.
Paragraph 2 shall not apply to the support referred to in Article 33(1)(a) to (c), Article 34 and Article 41(2).
„3. Stavak 2. ne primjenjuje se na potporu iz članka 33. stavka 1. točaka od (a) do (c), članka 34. te članka 41. stavka 2.";
4.EUR 192 500 000 of the budgetary resources referred to in paragraph 1 shall be allocated to the compensation of outermost regions under Chapter V of Title V. That compensation shall not exceed, per year:
4.Iznos od 192 500 000 EUR proračunskih sredstava iz stavka 1. dodjeljuje se kompenzacijama za najudaljenije regije iz glave V. poglavlja V.
(8) Article 55 is replaced by the following:
8. članak 55. zamjenjuje se sljedećim:
-support to aquaculture farmers for the temporary suspension or the reduction of production caused by the COVID-19 outbreak,
-potporu uzgajivačima u akvakulturi za privremenu suspenziju ili smanjenje proizvodnje uzrokovane pandemijom bolesti COVID-19,
Support granted per producer organisation per year under this Article shall not exceed 12 % of the average annual value of the production placed on the market by that producer organisation during the preceding three calendar years.
„3. Godišnja potpora po organizaciji proizvođača koja se dodjeljuje na temelju ovog članka ne smije prijeći 12 % prosječne godišnje vrijednosti proizvodnje koju je ta organizacija proizvođača stavila na tržište tijekom prethodne tri kalendarske godine.
(11) In Article 79, paragraph 2 is deleted;
11. u članku 79. stavak 2. briše se;
(1)Article 13 is replaced by the following:
1.članak 13. zamjenjuje se sljedećim:
3.CONTENT OF THE PROPOSAL
5.UTJECAJ NA PRORAČUN
(2) Article 30 is replaced by the following:
2. članak 30. zamjenjuje se sljedećim:
(12) Article 94(3)(c) is amended as follows:
12. članak 94. stavak 3. točka (c) mijenja se kako slijedi:
(7) Article 44 is amended as follows:
7. članak 44. mijenja se kako slijedi:
(10) Article 67(1) and (2) are amended as follows:
10. članak 67. stavci 1. i 2. mijenjaju se kako slijedi:
(b) the following paragraph 5 is added:
(b) dodaje se sljedeći stavak 5.:
These specific measures should also comprise support to producer organisations and associations of producer organisations for the storage of fishery and aquaculture products in accordance with Regulation (EU) No 1379/2013 3 .
Te bi posebne mjere trebale obuhvaćati i potporu organizacijama proizvođača i udruženjima organizacija proizvođača za skladištenje proizvoda ribarstva i akvakulture, u skladu s Uredbom (EU) br. 1379/2013 3 . Rashodi za aktivnosti koje primaju potporu u okviru tih mjera trebali bi biti prihvatljivi od 1. veljače 2020.
(6)Article 33(1) and (2) are amended as follows:
6.članak 33. stavci 1. i 2. mijenjaju se kako slijedi:
(b) paragraph 5 is amended as follows:
(b) stavak 5. mijenja se kako slijedi:
By way of derogation from the first subparagraph of Article 65(9) of Regulation (EU) No 1303/2013, expenditure for operations supported under point (d) shall be eligible as of 1 February 2020.
Odstupajući od članka 65. stavka 9. prvog podstavka Uredbe (EU) br. 1303/2013, rashodi za operacije koje primaju potporu na temelju točke (d) prihvatljivi su od 1. veljače 2020.
(9) Article 66(3) and (4) are amended as follows:
9. članak 66. stavci 3. i 4. mijenjaju se kako slijedi:
(c) where the temporary cessation is provided for in a management plan adopted in accordance with Council Regulation (EC) No 1967/2006 or in a multiannual plan adopted under Articles 9 and 10 of Regulation (EU) No 1380/2013, where, based on scientific advice, a reduction of fishing effort is needed in order to achieve the objectives referred to in Article 2(2) and point (a) of Article 2(5) of Regulation (EU) No 1380/2013;
Uredbe (EU) br. 1380/2013 ako je, na temelju znanstvenih savjeta, potrebno smanjiti ribolovni napor kako bi se postigli ciljevi iz članka 2. stavka 2. i članka 2. stavka 5. točke (a) Uredbe (EU) br. 1380/2013;
(3) Article 31 is amended as follows:
3. članak 31. mijenja se kako slijedi:
(a) paragraph 1 is amended as follows:
(a) stavak 1. mijenja se kako slijedi:
5.Member States shall have the possibility to use interchangeably the resources available under paragraphs 2 and 3.
5.Države članice mogu koristiti sredstva iz stavka 2. za mjere obuhvaćene stavkom 3. i obratno.";
The proposal does not have a budgetary impact for the EU institutions.
Prijedlog ne utječe na proračun institucija EU-a.
"(j)Article 59 shall apply from [insert date - date of entry into force of this Regulation]';
„(j)članak 59. primjenjuje se od [umetnuti datum - datum stupanja na snagu ove Uredbe]";
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.
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.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
Ti se provedbeni akti donose u skladu s postupkom ispitivanja iz članka 114. stavka 3.";
Those deferrals safeguard the presence of a functioning regulatory framework on medical devices from 26 May 2020.
Tim se odgodama postiže postojanje funkcionirajućeg regulatornog okvira za medicinske proizvode i nakon 26. svibnja 2020.
The proposal is based on Articles 114 and 168(4)(c) of the Treaty on the Functioning of the European Union (TFEU).
Prijedlog je utemeljen na članku 114. i članku 168. stavku 4. točki (c) Ugovora o funkcioniranju Europske unije (UFEU).
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 nacionalnih odstupanja proširi na područje Unije na ograničeni rok („odstupanje na razini Unije").
This proposal is not accompanied by a separate impact assessment, as an impact assessment for Regulation (EU) 2017/745 has already been undertaken.
Ovom prijedlogu nije priložena zasebna procjena učinka jer je ona već provedena za Uredbu (EU) 2017/745.
(12)The adoption of this Regulation takes place under exceptional circumstances arising from the COVID-19 outbreak and the associated public health crisis.
(12)Ova se Uredba donosi u iznimnim okolnostima koje su posljedica pandemije bolesti COVID-19 i povezane javnozdravstvene krize.
Regulation (EU) 2017/745 is amended as follows:
Uredba (EU) 2017/745 mijenja se kako slijedi:
(13)In light of the overriding need to immediately address the public health crisis associated with the COVID-19 outbreak, this Regulation should enter into force as a matter of urgency,
(13)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,
This proposal does not alter Regulation (EU) 2017/745 on substance and does not impose new obligations on the concerned parties.
Ovim se prijedlogom ne mijenja sadržaj Uredbe (EU) 2017/745 niti se njime uvode nove obveze predmetnih strana.
(6)The application should be deferred for provisions of Regulation (EU) 2017/745 that would otherwise start to apply from 26 May 2020.
(6)Primjenu bi trebalo odgoditi za odredbe Uredbe (EU) 2017/745 koje bi se inače počele primjenjivati od 26. svibnja 2020.
‘(g)with regard to reusable devices that are required to bear the UDI carrier on the device itself, Article 27(4) shall apply to:
„(g)u pogledu proizvoda za višekratnu uporabu koji sami nose oznaku nosača jedinstvene identifikacije proizvoda članak 27. stavak 4. primjenjuje se na sljedeće:
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.
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.
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.
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.
(10)Regulation (EU) 2017/745 should therefore be amended accordingly.
(10)Uredbu (EU) 2017/745 trebalo bi stoga na odgovarajući način izmijeniti.
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 datuma primjene određenih njezinih odredaba
(9)To ensure the continuous presence of a functioning and effective regulatory framework for medical devices it is necessary to also defer the application of the provision repealing Directives 90/385/EEC and 93/42/EEC.
(9)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.
‘4.Devices lawfully placed on the market pursuant to Directives 90/385/EEC and 93/42/EEC prior to 26 May 2021, and devices placed on the market from 26 May 2021 pursuant to paragraph 3 of this Article, may continue to be made available on the market or put into service until 26 May 2025.
„4.Proizvodi koji su zakonito stavljeni na tržište u skladu s direktivama 90/385/EEZ i 93/42/EEZ prije 26. svibnja 2021. te proizvodi stavljeni na tržište od 26. svibnja 2021. na temelju stavka 3. ovog članka mogu se i dalje stavljati na raspolaganje na tržištu ili u uporabu do 26. svibnja 2025.",
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.
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.
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 datuma primjene određenih odredaba, potrebno je da ova Uredba stupi na snagu prije 26. svibnja 2020.
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.
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.
At the same time, it is necessary to defer the date of repeal of Directives 90/385/EEC and 93/42/EEC.
Istodobno je potrebno odgoditi datum stavljanja izvan snage direktiva 90/385/EEZ i 93/42/EEZ.
Regulation (EU) 2017/745 significantly reinforces key elements of the existing regulatory approach in Council Directive 90/385/EEC 2 and Council Directive 93/42/EEC 3 , such as the supervision of notified bodies, conformity assessment procedures, clinical investigations and clinical evaluation, vigilance and market surveillance, whilst introducing provisions ensuring transparency and traceability regarding medical devices, to improve health and safety.
Uredbom (EU) 2017/745 znatno se poboljšavaju ključni elementi postojećeg regulatornog pristupa iz Direktive Vijeća 90/385/EEZ 2 i Direktive Vijeća 93/42/EEZ 3 , kao što su nadzor prijavljenih tijela, postupci ocjenjivanja sukladnosti, klinička ispitivanja i klinička procjena, vigilancija i nadzor tržišta, te se istodobno uvode odredbe za osiguravanje transparentnosti i sljedivosti u pogledu medicinskih proizvoda radi poboljšanja zdravlja i sigurnosti.
(3)Medical devices, such as medical gloves, surgical masks, equipment for intensive care and other medical equipment, play a crucial role in the context of the COVID-19 outbreak and the associated public health crisis to ensure the health and safety of Union citizens and to enable Member States to give patients urgently in need the necessary medical treatment.
(3)Medicinski 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.
(8)In order to cover any national derogations granted by the Member States in accordance with Directives 90/385/EEC or 93/42/EEC in the context of the COVID-19 outbreak before the entry into force of this Regulation, it is also necessary to provide for the possibility for the Member States to notify those national derogations and for the Commission to extend their validity to the territory of the Union.
(8)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.
Taking into account the COVID-19 outbreak and the associated public health crisis, the Commission should be able to adopt Union-wide derogations in response to national derogations in order to address potential shortages Union wide of vitally important medical devices in an effective manner.
Uzimajući u obzir pandemiju bolesti COVID-19 i povezanu javnozdravstvenu krizu, Komisija bi trebala moći 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.
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.
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.
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.
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.
"- 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]";
„- 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]";
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.
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.
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.
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.
(v)the following point (j) is added:
v.dodaje se sljedeća točka (j):
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.
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.
(11)Since the objectives of this Regulation, namely to defer the application of certain provisions of Regulation (EU) 2017/745 and to allow for the extension of the validity of national derogations, authorised under Directives 90/385/EEC or 93/42/EEC, to the territory of the Union, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union.
(11)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.
‘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].
„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].",
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.
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.
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.
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.