natgillin/translations-raw huggingface dataset:
(a)where such medicinal products have been excluded from the provisions of Directive 2001/83/EC by a Member State pursuant to its Article 5(1);
(a)ako je država članica takve lijekove isključila iz odredaba Direktive 2001/83/EZ u skladu s njezinim člankom 5. stavkom 1.;
The proposed Regulation aims to expedite the conduct of clinical trials with medicinal products that contain or consist of GMOs in the current scenario of public health emergency created by the COVID-19 pandemic so as to facilitate the availability of high quality, safe and efficacious medicinal products to treat or prevent COVID-19.
Cilj je predložene uredbe ubrzati provedbu kliničkih ispitivanja lijekova koji sadržavaju GMO ili se sastoje od GMO-a u aktualnoj izvanrednoj javnozdravstvenoj situaciji nastaloj zbog pandemije bolesti COVID-19 kako bi bili dostupniji visokokvalitetni, sigurni i učinkoviti lijekovi za liječenje ili sprečavanje bolesti COVID-19.
Under Article 5(2) of Directive 2001/83/EC, Member States may temporarily authorise the distribution of an unauthorised medicinal product in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation any of which could cause harm.
U skladu s člankom 5. stavkom 2. Direktive 2001/83/EZ države članice mogu privremeno odobriti distribuciju neodobrenog lijeka kao odgovor na moguće ili potvrđeno širenja patogenih uzročnika bolesti, toksina, kemijskih sredstava ili nuklearnog zračenja, koji mogu uzrokovati štetu.
In particular, Article 5(1) of Directive 2001/83/EC allows Member States to fulfil special needs, to exclude from the provisions of that Directive medicinal products supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of an authorised health-care professional and for use by an individual patient under his or her direct personal responsibility.
Konkretno, člankom 5. stavkom 1. Direktive 2001/83/EZ državama članicama dopušta se da iz primjene odredbe te direktive isključi lijekove nabavljene kao odgovor na nepoticanu narudžbu izdanu u dobroj vjeri, prema specificiranim podacima ovlaštenog zdravstvenog radnika, na njegovu odgovornost, a za primjenu na konkretnom pacijentu.
(15)To generate the robust clinical evidence necessary to support applications for marketing authorisation of medicinal products to treat or prevent COVID-19 multi-centre clinical trials involving several Member States will need to be conducted.
(15)Za izvođenje kvalitetnih kliničkih dokaza nužnih da potkrijepe zahtjev za izdavanje odobrenja za stavljanje u promet lijekova za liječenje ili sprečavanje bolesti COVID-19 morat će se provesti multicentrična klinička ispitivanja u više država članica.
1.Articles 6 to 11 and 13 to 24 of Directive 2001/18/EC and Articles 6 to 13 of Directive 2009/41/EC shall not apply to operations related to the use of medicinal products containing or consisting of GMOs that are intended to treat or prevent COVID-19, including packaging and labelling, storage, transport, destruction, disposal, distribution, supply, administration but excluding the manufacturing of the medicinal product, in any of the following cases:
1.S iznimkom proizvodnje lijeka, članci od 6. do 11. i od 13. do 24. Direktive 2001/18/EZ i članci od 6. do 13. Direktive 2009/41/EZ ne primjenjuju se na postupke koji se tiču uporabe lijekova koji sadržavaju GMO ili se od njega sastoje, a namijenjeni su liječenju ili sprečavanju bolesti COVID-19, među ostalima na pakiranje i označivanje, skladištenje, prijevoz, uništavanje, odlaganje, distribuciju, isporuku i primjenu, u sljedećim slučajevima:
(b)where such medicinal products have been authorised by a Member State pursuant to Article 5(2) of Directive 2001/83/EC ; or
(b)ako je država članica takve lijekove odobrila u skladu s člankom 5. stavkom 2. Direktive 2001/83/EZ; ili
Nonetheless, Directive 2001/83/EC and Regulation (EC) No 726/2004 provide for exceptions from this requirement in situations characterised by the urgent need to administer a medicinal product 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.
Međutim, Direktivom 2001/83/EZ i Uredbom (EZ) br. 726/2004 predviđene su iznimke od tog zahtjeva u situacijama u kojima postoji potreba za primjenom lijeka zbog posebnih potreba pacijenta, milosrdne uporabe ili reakcije na sumnju ili na potvrđeno širenje patogenih agensa, toksina, kemijskih agensa ili štetnog nuklearnog zračenja.
In the situation of public health emergency created by the COVID-19 pandemic, there is an overriding interest in protecting human health.
U izvanrednoj javnozdravstvenoj situaciji nastaloj zbog pandemije bolesti COVID-19 glavni je interes zaštita ljudi.
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.