natgillin/translations-raw huggingface dataset:
on the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease 
o provedbi kliničkih ispitivanja i nabavi lijekova za humanu uporabu namijenjenih liječenju ili sprečavanju koronavirusne bolesti koji sadržavaju genetski modificirane organizme ili se od njih sastoje
(5)Article 6 of Directive 2001/18/EC provides that a release into the environment of Genetically Modified Organisms (GMOs) for any other purpose than for placing on the market is subject to a notification and to written consent by the competent authority of the Member State within whose territory the release is to take place. 
(5)Člankom 6. Direktive 2001/18/EZ propisano je da je za uvođenje u okoliš genetski modificiranih organizama (GMO) u bilo koju drugu svrhu osim za stavljanje na tržište potrebna prijava i pisana suglasnost nadležnog tijela države članice na čijem se državnom području to uvođenje provodi.
Doubts have been raised by some Member States regarding the application of the provisions of Directive 2001/18/EC and Directive 2009/41/EC in the situations contemplated in Article 5(1) and (2) of Directive 2001/83/EC and Article 83 of Regulation (EC) No 726/2004. 
Neke su države članice izrazile sumnju prema primjeni odredaba Direktive 2001/18/EZ i Direktive 2009/41/EZ u situacijama iz članka 5. stavaka 1. i 2. Direktive 2001/83/EZ i članka 83. Uredbe (EZ) br. 726/2004.
These provisions allow Member States to authorise the supply and administration of medicinal products for human use (including medicinal products that contain or consist of GMOs) in the absence of a marketing authorisation where there is an urgent need to address the specific needs of a patient, for compassionate use, or in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation that could cause harm. 
Tim se odredbama dopušta državama članicama da odobre nabavu i upotrebu lijekova za humanu uporabu (među kojima su i lijekovi koji sadržavaju GMO ili se od njega sastoje) i bez odobrenja za stavljanje u promet u slučajevima hitne potrebe za odgovorom na posebne potrebe pacijenta, milosrdne uporabe ili reakcije na sumnju ili na potvrđeno širenje štetnih patogenih agensa, toksina, kemijskih agensa ili nuklearnog zračenja.
(3)It follows from Article 9(2) of Directive 2001/20/EC of the European Parliament and of the Council 4 that, before commencing any clinical trial, sponsors are required to request authorisation from the competent authority of the Member State in which the clinical trial is to be conducted. 
(3)Iz članka 9. stavka 2. Direktive br. 2001/20/EZ Europskog parlamenta i Vijeća 4 proizlazi da je naručitelj ispitivanja prije početka kliničkog ispitivanja dužan zatražiti odobrenje nadležnog tijela države članice u kojoj će se provesti to kliničko ispitivanje.
3.Clinical trials within the scope of Article 2 that have been authorised under Directive 2001/20/EC prior to the publication of the notice referred in paragraph (2) may validly continue and be used in support of a marketing authorisation application in the absence of an environmental risk assessment and/or consent in accordance with Articles 6 to 11 of Directive 2001/18/EC or Articles 6 to 13 of Directive 2009/41/EC. 
3.Klinička ispitivanja u području primjene članka 2. odobrena u skladu s Direktivom 2001/20/EZ prije objave obavijesti iz stavka 2. mogu se valjano nastaviti i upotrijebiti kao potpora zahtjevu za odobrenje za stavljanje u promet bez procjene rizika za okoliš i/ili odobrenja u skladu s člancima od 6. do 11. Direktive 2001/18/EZ ili člancima od 6. do 13. Direktive 2009/41/EZ.
Whereas in some Member States a single request for authorisation concerning the conduct of the clinical trial and the GMO aspects can be submitted to a single competent authority, in other Member States parallel requests need to be submitted to different competent authorities. 
U nekim državama članicama jednom se nadležnom tijelu može podnijeti jedinstveni zahtjev za odobrenje provedbe kliničkog ispitivanja i aspekata GMO-a, a u drugima se zahtjevi usporedno podnose različitim nadležnim tijelima.
The environmental risks of all medicinal products are assessed as part of the marketing authorisation procedures, including for medicinal products that contain or consist of genetically modified organisms ("GMOs"). 
U okviru postupaka izdavanja odobrenja za stavljanje u promet svih lijekova procjenjuju se rizici koje oni nose za okoliš, a to vrijedi i za lijekove koji sadržavaju genetski modificirane organizme („GMO") ili se od njih sastoje,
In addition, sponsors should be required to implement appropriate measures to minimize negative environmental impacts that, on the basis of the available knowledge, may be expected as a result from the intended or unintended release of the medicinal product into the environment. 
Osim toga, od naručitelja bi trebalo zahtijevati da provedu odgovarajuće mjere da smanje negativan utjecaj na okoliš koji se na temelju dostupnih spoznaja može očekivati kao rezultat namjernog ili nenamjernog uvođenja lijeka u okoliš.
On the basis of the available evidence, it is concluded that it is unlikely that the concerns arising from the lack of tools in the Union legislation to address the specific characteristics of clinical trials with investigational medicinal products for human use that contain or consist of GMOs in the current situation of public health emergency created by COVID-19 will be resolved unless this situation is addressed at Union level. 
Na temelju dostupnih dokaza zaključeno je da se bez djelovanja na razini Unije vjerojatno neće riješiti problemi koji proizlaze iz nepostojanja Unijinih propisa s posebnim karakteristikama kliničkih ispitivanja koja se u ovoj izvanrednoj javnozdravstvenoj situaciji nastaloj zbog pandemije bolesti COVID-19 provode na ispitivanim lijekovima za humanu uporabu koji sadržavaju GMO ili se od njega sastoje.
As provided in the fourth subparagraph of Article 6(3) of Regulation (EC) No 726/2004, the environmental impact of medicinal products containing or consisting of GMOs intended to treat or prevent COVID-19 will continue to be assessed by the European Medicines Agency in parallel with the evaluation of the quality, safety and efficacy of the medicinal product concerned, respecting the environmental safety requirements set out in Directive 2001/18/EC. 
Kako je propisano u članku 6. stavku 3. četvrtom podstavku Uredbe (EZ) br. 726/2004, utjecaj na okoliš lijekova koji sadržavaju GMO ili se od njega sastoje, a namijenjeni su liječenju ili sprečavanju bolesti COVID-19, i dalje će ocjenjivati Europska agencija za lijekove usporedno s ocjenom kakvoće, neškodljivosti i djelotvornosti tih lijekova, poštujući zahtjeve sigurnosti za okoliš utvrđene u Direktivi 2001/18/EZ.
(4)the definition of "genetically modified organism" (GMO) in point (2) of Article 2 of Directive 2001/18/EC. 
4.definicija „genetski modificiranog organizma" (GMO) iz članka 2. točke (2) Direktive 2001/18/EZ.
(19)Consequently, for applications for marketing authorisation under Regulation (EC) No 726/2004 or Directive 2001/83/EC for medicinal products intended to treat or prevent COVID-19 for which the clinical trials would be covered by the derogation provided for in this Regulation, the applicant should not be required to include the written consent of the competent authority for the deliberate release into the environment of GMOs for research and development purposes as set out in Part B of Directive 2001/18/EC. 
(19)Stoga, za zahtjeve za odobrenje za stavljanje u promet na temelju Uredbe (EZ) br. 726/2004 ili Direktive 2001/83/EZ za lijekove namijenjene liječenju ili sprečavanju bolesti COVID-19 za koje bi klinička ispitivanja bila obuhvaćena odstupanjem predviđenim ovom Uredbom, ne bi trebalo zahtijevati da podnositelj zahtjeva priloži pisanu suglasnost nadležnog tijela za namjerno uvođenje GMO-a u okoliš radi istraživanja i razvoja, kako je utvrđeno u dijelu B Direktive 2001/18/EZ.
1.All operations related to the conduct of clinical trials, including packaging and labelling, storage, transport, destruction, disposal, distribution, supply, administration or use of investigational medicinal products for human use containing or consisting of GMOs intended to treat or prevent COVID-19, with the exception of the manufacturing of the investigational medicinal product, shall not require a prior environmental risk assessment and/or consent in accordance with Articles 6 to 11 of Directive 2001/18/EC or Articles 6 to 13 of Directive 2009/41/EC when these activities relate to the conduct of a clinical trial authorised in accordance with Directive 2001/20/EC. 
1.S iznimkom proizvodnje ispitivanog lijeka, nijedan postupak povezan s provedbom kliničkih ispitivanja, a riječ je o pakiranju i označivanju, skladištenju, prijevozu, uništavanju, odlaganju, distribuciji, isporuci, primjeni ili uporabi ispitivanih lijekova za humanu uporabu koji sadržavaju GMO ili se od njega sastoje, a namijenjeni su liječenju ili sprečavanju bolesti COVID-19, ne zahtijeva prethodnu procjenu rizika za okoliš i/ili suglasnost u skladu s člancima od 6. do 11. Direktive 2001/18/EZ ili člancima od 6. do 13. Direktive 2009/41/EZ ako je kliničko ispitivanje odobreno u skladu s Direktivom 2001/20/EZ.
On 11 March 2020, WHO characterised COVID-19 as a pandemic. 
Pandemiju bolesti COVID-19 Svjetska zdravstvena organizacija proglasila je 11. ožujka 2020.
Directive 2001/83/EC and Regulation (EC) No 726/2004 have created a harmonised framework and the clarifications proposed will contribute to optimise the implementation of Articles 5(1) and 5(2) of Directive 2001/83/EC and Article 83 of Regulation (EC) No 726/2004 for medicinal products for human use containing or consisting of GMOs intended to treat or prevent COVID-19. 
Direktivom 2001/83/EZ i Uredbom (EZ) br. 726/2004 uspostavljen je usklađeni okvir, a predloženim tumačenjima unaprijedit će se primjena članka 5. stavaka 1. i 2. Direktive 2001/83/EZ i članka 83. Uredbe (EZ) br. 726/2004 na lijekove za humanu uporabu koji sadržavaju GMO ili se od njega sastoje, a namijenjeni su liječenju i/ili sprečavanju bolesti COVID-19.
2.Where feasible, Member States shall implement appropriate measures to minimize foreseeable negative environmental impacts resulting from the intended or unintended release of the investigational medicinal product into the environment. 
2.Ako je to moguće, države članice dužne su provesti odgovarajuće mjere kako bi se na najmanju moguću mjeru sveo predvidivi negativni utjecaj na okoliš koji je posljedica namjernog ili nenamjernog uvođenja ispitivanog lijeka u okoliš.
In addition, national requirements and procedures for the environmental risk assessment and consent by competent authorities for the release of GMOs under Directive 2001/18/EC vary greatly from one Member State to another. 
Osim toga, među državama članicama znatno se razlikuju zahtjevi i postupci za procjenu rizika za okoliš i odobrenje nadležnih tijela za uvođenje GMO-a u skladu s Direktivom 2001/18/EZ.
Thus, the proposed Regulation aims to create a common approach for the conduct of clinical trials with medicinal products that contain or consist of GMOs intended to treat or prevent COVID-19 and to clarify aspects of the application of decisions by Member States taken in accordance with Article 5(1) and (2) of Directive 2001/83/EC and/or Article 83 of Regulation (EC) No 726/2004 to these products. 
Stoga se predloženom uredbom želi uspostaviti zajednički pristup provedbi kliničkih ispitivanja lijekova koji sadržavaju GMO ili se od njega sastoje, a namijenjeni su liječenju i/ili sprečavanju bolesti COVID-19 i jasno navesti kako se na te lijekove primjenjuju odluke koje države članice donesu u skladu s člankom 5. stavcima 1. i 2. Direktive 2001/83/EZ i/ili člankom 83. Uredbe (EZ) br. 726/2004.
(13)In this situation of public health emergency, it is of major interest for the Union that safe and efficacious medicinal products to treat or prevent COVID-19 can be developed and be made available within the Union as soon as possible. 
Uniji je stalo da se sigurni i učinkoviti lijekovi za liječenje ili sprečavanje bolesti COVID-19 što prije razviju i stave na raspolaganje u Uniji.
The policy objective of this proposed Regulation is to ensure that clinical trials with medicinal products for human use that contain or consist of GMOs and are intended to treat or prevent COVID-19 can start swiftly and without a prior environmental risk assessment and/or consent under Directive 2001/18/EC or Directive 2009/41/EC in so far as there is a valid declaration of pandemic by the World Health Organisation, or if COVID-19 is declared an emergency situation in accordance with Decision No 1082/2013/EU and remains so. 
Predloženoj je uredbi cilj brz početak kliničkih ispitivanja lijekova za humanu primjenu koji sadržavaju GMO ili se sastoje od GMO-a, a namijenjeni su liječenju ili sprečavanju bolesti COVID-19, bez prethodne procjene utjecaja na okoliš i/ili odobrenja u skladu s Direktivom 2001/18/EZ ili Direktivom 2009/41/EZ ako još traje pandemija koju je Svjetska zdravstvena organizacija valjano proglasila ili ako se situacija nastala zbog bolesti COVID-19 i dalje smatra izvanrednom u skladu s Odlukom 1082/2013/EU.
(24)Since the objective of this Regulation, namely to provide a temporary derogation from the Union legislation on GMOs to ensure that the conduct of clinical trials in the territory of several Member States with investigational medicinal products containing or consisting of GMOs intended to treat or prevent COVID-19 is not delayed and to clarify the application of Article 5(1) and (2) of Directive 2001/83/EC and Article 83(1) of Regulation (EC) No 726/2004 as regards those products, cannot be achieved by the Member States but can, 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. 
(24)Budući da države članice ne mogu ostvariti cilj ove Uredbe, a to su privremeno odstupanje od Unijinih propisa o GMO-u kako se na državnom području nekoliko država članica ne bi odgodila provedba kliničkih ispitivanja ispitivanih lijekova koji sadržavaju GMO ili se od njega sastoje, a namijenjeni su liječenju ili sprečavanju bolesti COVID-19, te tumačenje primjene članka 5. stavaka 1. i 2. Direktive 2001/83/EZ i članka 83. stavka 1. Uredbe (EZ) br. 726/2004 u pogledu tih lijekova, nego se on zbog svojeg opsega i učinaka bolje može ostvariti na razini Unije, Unija može donijeti mjere u skladu s načelom supsidijarnosti iz članka 5. Ugovora o Europskoj uniji.
(8)Experience shows that, in clinical trials with investigational medicinal products containing or consisting of GMOs, the procedure to achieve compliance with the requirements of Directives 2001/18/EC and 2009/41/EC as regards the environmental impact assessment and authorization by the competent authority of a Member State is complex and may take a significant amount of time. 
(8)Dosadašnja klinička ispitivanja provedena na ispitivanim lijekovima koji sadržavaju GMO ili se od njega sastoje pokazala su složenost i moguću dugotrajnost postupka za postizanje usklađenosti sa zahtjevima direktiva 2001/18/EZ i 2009/41/EZ u procjeni utjecaja na okoliš i izdavanju odobrenja nadležnog tijela države članice.
(3)the definition of "medicinal product in point" 2 of Article 1 of Directive 2001/83/EC; 
3.definicija „lijeka" iz članka 1. točke 2. Direktive 2001/83/EZ;
(26)Given the aforementioned objectives of this Regulation, to ensure that clinical trials with medicinal products to treat or prevent COVID-19 can start without delay and to clarify the application of Article 5(1) and (2) of Directive 2001/83/EC and Article 83(1) of Regulation (EC) No 726/2004 as regards those products, this Regulation should enter into force as a matter of urgency. 
(26)S obzirom na prethodno navedene ciljeve ove Uredbe, da bi klinička ispitivanja lijekova za liječenje ili sprečavanje bolesti COVID-19 mogla početi bez odgode te radi tumačenja primjene članka 5. stavaka 1. i 2. Direktive 2001/83/EZ i članka 83. stavka 1. Uredbe (EZ) br. 726/2004 u pogledu tih lijekova, ova bi Uredba trebala hitno stupiti na snagu.
The notification is to include an environmental risk assessment performed in accordance with Annex II to Directive 2001/18/EC and a technical dossier supplying the information specified in Annex III to that Directive. 
Direktivi 2001/18/EZ i tehničku dokumentaciju s informacijama navedenima u Prilogu III. toj Direktivi.
In the light of the urgent need to make available vaccines or treatments for COVID-19 available to the public as soon as they are ready for this purpose, and to avoid delays or uncertainties as regards the status of these products in certain Member States, it is appropriate that, where Member States adopt decisions pursuant to Article 5(1) and (2) of Directive 2001/83/EC or Article 83(1) of Regulation (EC) No 726/2004 concerning medicinal products containing or consisting of GMOs intended to treat or prevent COVID-19, an environmental risk assessment or consent in accordance with Directive 2001/18/EC or Directive 2009/41/EC are not a prerequisite. 
S obzirom na hitnu potrebu da se cjepiva ili lijekovi za bolest COVID-19 stave na raspolaganje javnosti čim budu spremni za tu svrhu te da se izbjegne kašnjenje ili nesigurnost u vezi sa statusom tih proizvoda u određenim državama članicama, prikladno je da procjena rizika za okoliš ili odobrenje u skladu s Direktivom 2001/18/EZ ili Direktivom 2009/41/EZ ne budu preduvjet kada države članice donose odluke u skladu s člankom 5. stavcima 1. i 2. Direktive 2001/83/EZ ili člankom 83. stavkom 1. Uredbe (EZ) br. 726/2004 o lijekovima koji sadržavaju GMO ili se od njega sastoje, a namijenjeni su liječenju ili sprečavanju bolesti COVID-19.
2.Sponsors shall implement appropriate measures to minimize foreseeable negative environmental impacts resulting from the intended or unintended release of the investigational medicinal product into the environment. 
2.Naručitelj je dužan provesti odgovarajuće mjere kako bi se na najmanju moguću mjeru sveo predvidivi negativni utjecaj na okoliš koji je posljedica namjernog ili nenamjernog uvođenja ispitivanog lijeka u okoliš.
(1)the definition of "clinical trial" in point (a) of Article 2 of Directive 2001/20/EC; 
1.definicija „kliničkog ispitivanja" iz članka 2. točke (a) Direktive 2001/20/EZ;
Therefore, where Member States adopt decisions pursuant to Article 5(1) and (2) of Directive 2001/83/EC or Article 83(1) of Regulation (EC) No 726/2004 concerning medicinal products containing or consisting of GMOs, an environmental risk assessment and/or consent in accordance with Directive 2001/18/EC or Directive 2009/41/EC are not a prerequisite. 
Stoga, kada države članice donose odluke u skladu s člankom 5. stavcima 1. i 2. Direktive 2001/83/EZ ili člankom 83. stavkom 1. Uredbe (EZ) br. 726/2004 o lijekovima koji sadržavaju GMO ili se od njega sastoje, procjena rizika za okoliš i/ili odobrenje u skladu s Direktivom 2001/18/EZ ili Direktivom 2009/41/EZ nisu preduvjet.
In addition, it should be clarified that medicinal products for human use containing or consisting of GMOs intended to treat or prevent COVID-19 can be administered swiftly in the absence of a prior environmental risk assessment and/or consent under Directive 2001/18/EC or Directive 2009/41/EC in the exceptional situations foreseen in Article 5(1) and (2) of Directive 2001/83/EC, and Article 83 of Regulation (EC) No 726/2004. 
Osim toga, trebalo bi jasno navesti da se lijekovi za humanu uporabu koji sadržavaju GMO ili se od njega sastoje, a namijenjeni su liječenju ili sprečavanju bolesti COVID-19, u iznimnim situacijama predviđenima člankom 5. stavcima 1. i 2. Direktive 2001/83/EZ i člankom 83. Uredbe (EZ) br. 726/2004 mogu brzo primijeniti i bez prethodne procjene rizika za okoliš i/ili odobrenja u skladu s Direktivom 2001/18/EZ ili Direktivom 2009/41/EZ.
Therefore, it should be clarified that, where Member States adopt decisions pursuant to Article 5(1) and (2) of Directive 2001/83/EC or Article 83(1) of Regulation (EC) No 726/2004 concerning medicinal products containing or consisting of GMOs intended to treat or prevent COVID-19, an environmental risk assessment and/or consent in accordance with Directive 2001/18/EC or Directive 2009/41/EC are not a prerequisite. 
Stoga bi trebalo jasno navesti da kada države članice donose odluke u skladu s člankom 5. stavcima 1. i 2. Direktive 2001/83/EZ ili člankom 83. stavkom 1. Uredbe (EZ) br. 726/2004 o lijekovima za humanu uporabu namijenjenima liječenju ili sprečavanju bolesti COVID-19 koji sadržavaju GMO ili se od njega sastoje, procjena rizika za okoliš i/ili odobrenje u skladu s Direktivom 2001/18/EZ ili Direktivom 2009/41/EZ nisu preduvjet.
(4)Institutions will have a key role in contributing to the recovery. 
(4)Institucije će imati ključnu ulogu u doprinosu oporavku.
The proposal does not have a budgetary impact for the Union institutions. 
Prijedlog ne utječe na proračun institucija Unije.
The problems and the underlying causes are the same across all Member States. 
Problemi i uzroci tih problema isti su u svim državama članicama.
At the same time they are likely to be impacted by the deteriorating economic situation. 
Istovremeno će vjerojatno osjećati posljedice pogoršanja gospodarske situacije.
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. 
U skladu s načelom proporcionalnosti iz tog članka, ova Uredba ne prelazi ono što je potrebno za ostvarivanje tih ciljeva.
The Union is committed to high standards of protection of fundamental rights and is signatory to a broad set of conventions on human rights. 
Unija se zalaže za visoke standarde zaštite temeljnih prava i potpisnik je brojnih konvencija o ljudskim pravima.
This will enhance the flexibility to act appropriately and purposefully during possible future shocks and crises and enhance the effectiveness of the measure. 
Time bi se povećala fleksibilnost za odgovarajuće i svrhovito djelovanje za vrijeme mogućih budućih šokova i kriza i poboljšala učinkovitost mjere.
It is instrumental to ensuring the effectiveness of measures adopted by the Member States, the Commission and the European Central Bank. 
Njime se osigurava djelotvornost mjera koje su donijele države članice, Komisija i Europska središnja banka.
Due to the reforms undertaken in the aftermath of the 2008 financial crisis, credit institutions are today well capitalised and much more resilient than they were in 2008. 
Zahvaljujući reformama poduzetima nakon financijske krize 2008. godine, kreditne su institucije danas dobro kapitalizirane i znatno otpornije nego što su bile 2008.
The amount that could be added back from 2022 to 2024 would decrease in a linear manner. 
Iznos koji bi se mogao uključiti od 2022. do 2024. linearno bi se smanjivao.
Nevertheless, uncertainty related to the pace of recovery of economic activity will inevitably have an impact on the banking sector. 
Unatoč tome, neizvjesna dinamika oporavka gospodarske aktivnosti neizbježno će utjecati na bankarski sektor.
Therefore, these amendments would allow resetting the 5-year transition period which started in 2018. 
Stoga bi se tim izmjenama omogućilo ponovno određivanje petogodišnjeg prijelaznog razdoblja koje je započelo 2018.
In this context, the proposal is not likely to have a direct impact on these rights, as listed in the main UN conventions on human rights, the Charter of Fundamental Rights of the European Union, which is an integral part of the EU Treaties and the European Convention on Human Rights (ECHR). 
U tom kontekstu prijedlog vjerojatno neće izravno utjecati na ta prava, kako su navedena u glavnim konvencijama UN-a o ljudskim pravima, Povelji Europske unije o temeljnim pravima, koja je sastavni dio Ugovorâ EU-a, te Europskoj konvenciji o ljudskim pravima.