natgillin/translations-raw huggingface dataset:
In the light of the importance of ensuring a high level of protection of the environment in all policies and in accordance with the proportionality principle, this Regulation should be limited to the present situation of emergency which involves an urgent threat to human health where it is not possible to attain otherwise the objective to protect human health and does not go beyond what is necessary in order to achieve that objective.
S obzirom na važnost visoke razine zaštite okoliša u svim politikama i u skladu s načelom proporcionalnosti, ova bi Uredba trebala biti ograničena na trenutačno izvanredno stanje u kojem postoji velika prijetnja zdravlju ljudi, a nije moguće na drugi način ostvariti cilj zaštite zdravlja ljudi i ne bi trebala prelaziti ono što je potrebno za ostvarivanje tog cilja.
The proposal builds on the experience gained with the existing regulatory framework for medicines as well as the experience in the application of the legislation on GMOs to medicinal products for human use.
Prijedlog se temelji na iskustvu stečenom s postojećim regulatornim okvirom za lijekove, kao i na iskustvu u primjeni propisa o GMO-u na lijekove za humanu uporabu.
(18)With a view to ensure a high level of protection to the environment, sites where the genetic modification of wild-type viruses takes place and related activities, should continue to be subject to compliance with the Directive 2009/41/EC.
(18)Da bi se osigurala visoka razina zaštite okoliša, lokacije na kojima se odvija genetska modifikacija divljih virusa i povezane aktivnosti i dalje bi trebale biti u skladu s Direktivom 2009/41/EZ.
Moreover, the intrinsic characteristics of the conduct of clinical trials (i.e. limited number of patients, limited volumes of medicinal products involved and administration in a highly controlled environment), substantially limit any potential environmental exposure.
Osim toga, upravo inherentna svojstva provedbe kliničkih ispitivanja (ograničen broj pacijenata, ograničene količine lijekova i strogo kontrolirana primjena) znatno ograničavaju svaku potencijalnu izloženost okoliša.
(17)The main objective of the Union legislation on medicinal products is to safeguard public health.
(17)Glavni je cilj Unijinih propisa o lijekovima zaštita javnog zdravlja.
That legislative framework is supplemented by the rules in Directive 2001/20/EC laying down specific standards for the protection of clinical trial subjects.
Taj je zakonodavni okvir dopunjen pravilima iz Direktive 2001/20/EZ o utvrđivanju posebnih standarda za zaštitu ispitanika u kliničkim ispitivanjima.
(11)The COVID-19 pandemic has created an unprecedented public health emergency that has claimed the life of thousands of people, affecting in particular the elderly and those with pre-existing health conditions.
(11)Pandemija bolesti COVID-19 izazvala je dosad nezabilježenu izvanrednu javnozdravstvenu situaciju u kojoj su život izgubile tisuće ljudi, posebno starije osobe i osobe s postojećim zdravstvenim poteškoćama.
Hospitals routinely deal with hazardous biological substances and protocols exist to ensure safe handling of biological waste in a hospital setting.
U bolnicama se rutinski radi s opasnim biološkim tvarima i postoje protokoli za sigurno rukovanje biološkim otpadom u bolnicama.
There is not a common approach for assessment of GMO aspects of clinical trials with investigational medicinal products for human use in the EU as some Member States apply the deliberate release Directive, other Member States apply the contained use Directive and others decide on a case-by-case basis or apply both.
EU nema jedinstven pristup procjeni aspekata GMO-a u kliničkim ispitivanjima ispitivanih lijekova za humanu uporabu jer neke države članice primjenjuju Direktivu o namjernom uvođenju, druge države članice primjenjuju Direktivu o ograničenoj uporabi, a ostale odlučuju na pojedinačnoj osnovi ili primjenjuju obje.
The Coronavirus outbreak has created an unprecedented public health emergency.
Pojava koronavirusa dovela je do dosad nezabilježene izvanredne javnozdravstvene situacije.
The development of vaccines and therapies against the virus is of major public interest and we are collectively called to make safe and efficacious medicinal products available to our citizens as soon as possible.
Razvoj cjepiva i terapija protiv virusa od velikog je javnog interesa i od svih nas očekuje se da našim građanima što prije stavimo na raspolaganje sigurne i učinkovite lijekove.
Moreover, the proposal is limited in scope so as to avoid going beyond what is necessary to achieve the objectives pursued in the exceptional circumstances created by the COVID-19 pandemic.
Nadalje, ograničava se područje primjene Prijedloga kako bi se izbjeglo prekoračenje onoga što je nužno za ostvarenje ciljeva u iznimnim okolnostima izazvanima pandemijom bolesti COVID-19.
In this context, the Commission has also adopted guidelines on waste management in the COVID-19 crisis 1 .
Zato je Komisija donijela i smjernice o gospodarenju otpadom u krizi uzrokovanoj bolešću COVID-19 1 .
Potential treatments and vaccines are in development.
U razvoju su mogući lijekovi i cjepiva.
The purpose of the Union legislation on GMOs is to protect both human health and the environment.
Svrha je propisa EU-a o GMO-u zaštititi zdravlje ljudi i okoliš.
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and 168(4)(c),
uzimajući u obzir Ugovor o funkcioniranju Europske unije, a posebno članak 114. i članak 168. stavak 4. točku (c),
There are also variations between national requirements as to the contents of the technical dossier.
Nacionalni zahtjevi o sadržaju tehničke dokumentacije također se razlikuju.
This proposal is based on Articles 114 and 168(4)(c) of the Treaty on the Functioning of the European Union (TFEU).
Ovaj se Prijedlog temelji na članku 114. i članku 168. stavku 4. točki (c) Ugovora o funkcioniranju Europske unije (UFEU).
To that end, Article 4(2) of that Directive provides that the user is to assess the risks that the specific type of contained use may pose, using as a minimum the elements of assessment and the procedure set out in Sections A and B of Annex III to that Directive.
Zato je člankom 4. stavkom 2. te direktive propisano da je rizik od određene vrste ograničene uporabe dužan procijeniti korisnik primjenjujući barem elemente procjene i postupak iz odjeljaka A i B Priloga III. toj direktivi.
A common approach for all the Union Member States is deemed necessary as threats to health arising from the COVID-19 pandemic have, by their nature, transnational implications.
Zajednički pristup svih država članica Unije smatra se nužnim jer su i prijetnje zdravlju proizašle iz pandemije COVID-19 po svojoj prirodi transnacionalne.
2.The Commission shall, when the conditions for the cessation of application referred to in paragraph (1) are fulfilled, publish a notice in the Official Journal of the European Union to that effect.
2.Kada se ispune uvjeti za prestanak primjene iz stavka 1., Komisija je dužna o tome objaviti obavijest u Službenom listu Europske unije.
Compliance with ethical requirements and good clinical practice in the conduct of clinical trials will continue to be mandatory as well as compliance with good manufacturing practice in the manufacture or importation of investigational medicinal products containing or consisting of GMOs.
Usklađenost s etičkim zahtjevima i dobra klinička praksa u provedbi kliničkih ispitivanja i dalje će biti obvezni, kao i usklađenost s dobrom proizvođačkom praksom u proizvodnji ili uvozu ispitivanih lijekova koji sadržavaju GMO ili se od njega sastoje.
(7)Clinical trials necessitate the performance of multiple operations, including, for example, the manufacture, transport and storage of the investigational medicinal products, packaging and labelling, the administration thereof to trial subjects and subsequent monitoring of the subjects and the disposal of waste and unused investigational medicinal products.
(7)Klinička ispitivanja zahtijevaju provedbu brojnih postupaka, npr. proizvodnju, prijevoz i skladištenje ispitivanih lijekova, pakiranje i označivanje, njihovu primjenu na ispitanicima i praćenje tih ispitanika te odlaganje otpada i neiskorištenih ispitivanih lijekova.
(25)In view of that urgency, it is considered to be appropriate to use the exception from 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.
(25)S obzirom na hitnost, smatra se 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.
The Union legislation on GMOs encompasses Directive 2009/41/EC on the contained use of genetically modified microorganisms (the "contained use Directive") and Directive 2001/18/EC on the deliberate release into the environment of GMOs (the "deliberate release Directive").
Propisi EU-a o GMO-u obuhvaćaju Direktivu 2009/41/EZ o ograničenoj uporabi genetski modificiranih mikroorganizama („Direktiva o ograničenoj uporabi") i Direktivu 2001/18/EZ o namjernom uvođenju GMO-a u okoliš („Direktiva o namjernom uvođenju").
The purpose of the authorisation is to protect the rights, safety and well-being of persons taking part in clinical trials, and to ensure the reliability and robustness of the data generated by the clinical trial.
Svrha je tog odobrenja zaštititi prava, sigurnost i dobrobit osoba koje sudjeluju u kliničkim ispitivanjima te zajamčiti pouzdanost i kvalitetu podataka dobivenih kliničkim ispitivanjem.
(c)where such medicinal products are made available by a Member State pursuant to Article 83(1) of Regulation (EC) No 726/2004.
(c)ako je država članica takve lijekove stavila na raspolaganje u skladu s člankom 83. stavkom 1. Uredbe (EZ) br. 726/2004.
Some of the vaccines under development are based on genetically modified viruses and may fall within the definition of GMO.
Neka cjepiva koja su u razvoju temelje se na genetski modificiranim virusima i mogu biti obuhvaćena definicijom GMO-a.
1.This Regulation applies as long as COVID-19 is regarded as a pandemic by the World Health Organisation or as long as a Commission decision recognising a situation of public health emergency due to COVID-19 in accordance with Article 12 of Decision No 1082/2013/EU of the European Parliament and of the Council 7 applies.
1.Ova se Uredba primjenjuje sve dok Svjetska zdravstvena organizacija bolest COVID-19 smatra pandemijom ili dok se primjenjuje odluka Komisije o izvanrednoj javnozdravstvenoj situaciji nastaloj zbog pandemije bolesti COVID-19 u skladu s člankom 12. Odluke br. 1082/2013/EU Europskog parlamenta i Vijeća 7 .
(14)To achieve the objective of making available safe and efficacious medicinal products to treat or prevent COVID-19, a range of measures have been taken at Union level by the European Medicines Agency (EMA) and by the network of national competent authorities to facilitate, support and speed up the development and marketing authorisation of treatments and vaccines.
(14)Kako bi se postigao cilj stavljanja na raspolaganje sigurnih i učinkovitih lijekova za liječenje ili sprečavanje bolesti COVID-19, Europska agencija za lijekove (EMA) i Europska mreža nadležnih tijela poduzele su na razini Unije niz mjera za olakšavanje, potporu i ubrzanje razvoja i odobravanje stavljanja u promet lijekova i cjepiva.
(22)As a general rule, no medicinal product may be placed on the market in the Union or in a Member State unless a marketing authorisation has been granted by the competent authorities under Regulation (EC) No 726/2004 or Directive 2001/83/EC.
(22)U pravilu se nijedan lijek ne smije staviti u promet u Uniji ili u državi članici ako nadležna tijela nisu izdala odobrenje za stavljanje u promet u skladu s Uredbom (EZ) br. 726/2004 ili Direktivom 2001/83/EZ.
In so far as the proposed Regulation will allow Member States to facilitate the development and/or availability of high quality and safe medicinal products for human use in response to the situation of public health emergency created by the COVID-19 pandemic, the adoption thereof should be based on Article 168(4)(c) TFEU.
Budući da će se predloženom uredbom omogućiti državama članicama da olakšaju razvoj i/ili dostupnost visokokvalitetnih i sigurnih lijekova za humanu uporabu kao odgovor na izvanrednu javnozdravstvenu situaciju nastalu zbog pandemije bolesti COVID-19, njezino donošenje trebalo bi se temeljiti na članku 168. stavku 4. točki (c) UFEU-a.
Directive 2001/20/EC on clinical trials is without prejudice to the application of the GMO Directives.
Direktivom 2001/20/EZ o kliničkim ispitivanjima ne dovodi se u pitanje primjena direktiva o GMO-u.
Under Article 83(1) of Regulation (EC) No 726/2004, Member States may make a medicinal product for human use available for compassionate reasons to a group of patients with a chronically or seriously debilitating disease or whose disease is considered to be life-threatening, and who cannot be treated satisfactorily by an authorised medicinal product.
U skladu s člankom 83. stavkom 1. Uredbe (EZ) br. 726/2004 države članice mogu iz milosrdnih razloga lijek za humanu uporabu staviti na raspolaganje skupini bolesnika s kroničnom ili ozbiljnom iscrpljujućom bolešću ili s bolešću koja se smatra opasnom po život, a koji se ne mogu na zadovoljavajući način liječiti odobrenim lijekom.
(9)The complexity of that procedure increases greatly in the case of multi-centre clinical trials conducted in several Member States, as sponsors of clinical trials need to submit multiple requests for authorisation to multiple competent authorities in different Member States in parallel.
(9)Složenost tog postupka znatno se povećava u slučaju multicentričnih kliničkih ispitivanja koja se provode u više država članica jer naručitelji kliničkih ispitivanja moraju istodobno podnijeti nekoliko zahtjeva za odobrenje većem broju tijela u različitim državama članicama.
It is necessary to adapt the regulatory framework on GMOs so that the conduct of clinical trials with these vaccines can start within the shortest possible timelines while ensuring the rights, safety, dignity and well-being of those individuals that take part in a clinical trial, as well as the reliability and robustness of the data generated and adequate protection of the environment and of human health via the environment.
Regulatorni okvir o GMO-u treba prilagoditi da bi klinička ispitivanja tih cjepiva počela što prije, uz zaštitu prava, sigurnosti, dostojanstva i dobrobiti osoba koji sudjeluju u kliničkom ispitivanju, kao i pouzdanosti i kvalitete dobivenih podataka te uz odgovarajuću zaštitu okoliša i ljudskog zdravlja putem okoliša.
(10)This makes it particularly difficult to perform multi-centre clinical trials with investigational medicinal products that contain or consist of GMOs in several Member States.
(10)Zbog toga je posebno teško multicentrična klinička ispitivanja na ispitivanim lijekovima koji sadržavaju GMO ili se od njega sastoje provoditi u više država članica.
Furthermore, some Member States apply Directive 2001/18/EC, others apply Directive 2009/41/EC and there are Member States that apply either Directive 2009/41/EC or Directive 2001/18/EC depending on the specific circumstances of a clinical trial, so it is not possible to determine a priori the national procedure that is to be followed.
Nadalje, neke države članice primjenjuju Direktivu 2001/18/EZ, druge primjenjuju Direktivu 2009/41/EZ, a neke države članice primjenjuju ili Direktivu 2009/41/EZ ili Direktivu 2001/18/EZ, ovisno o okolnostima određenog kliničkog ispitivanja, tako da nije moguće a priori odrediti nacionalni postupak kojega se treba držati.
(6)Directive 2009/41/EC ensures that the risks to human health and the environment associated with the contained use of genetically modified micro-organisms is assessed on a case-by-case basis.
(6)Direktivom 2009/41/EZ propisano je da se rizici za zdravlje ljudi i za okoliš povezani s ograničenom uporabom genetski modificiranih mikroorganizama procjenjuju od slučaja do slučaja.
On 30 January 2020, the World Health Organization (WHO) declared the outbreak a public health emergency of international concern.
Svjetska zdravstvena organizacija proglasila je 30. siječnja 2020. izvanrednu javnozdravstvenu situaciju.
(2)Directive 2001/83/EC of the European Parliament and of the Council 2 and Regulation (EC) No 726/2004 of the European Parliament and of the Council 3 require that applications for authorisation to place a medicinal product on the market, in a Member State or in the Union, be accompanied by a dossier containing the results of clinical trials carried out on the product.
(2)Direktivom br. 2001/83/EZ Europskog parlamenta i Vijeća 2 i Uredbom (EZ) br. 726/2004 Europskog parlamenta i Vijeća 3 propisuje se da se uz zahtjeve za izdavanje odobrenja za stavljanje lijeka u promet u državi članici ili u Uniji prilaže dokumentacija s rezultatima kliničkih ispitivanja provedenih na proizvodu.
For this purpose, it is necessary to grant a temporary derogation, for the duration of the COVID-19 pandemic, limited to clinical trials with investigational medicinal products to treat or prevent COVID-19.
Zato je potrebno odobriti privremeno odstupanje, dok traje pandemija bolesti COVID-19, ograničeno na klinička ispitivanja koja se provode na ispitivanim lijekovima za liječenje ili sprečavanje bolesti COVID-19.
However, the specific characteristics of the setting of clinical trials in a situation of a public health emergency such as the one created by the COVID-19 pandemic are not foreseen in Directive 2001/18/EC or Directive 2009/41/EC.
Međutim, izuzetni uvjeti u kojima se odvijaju klinička ispitivanja u izvanrednoj javnozdravstvenoj situaciji nastaloj zbog pandemije bolesti COVID-19, nisu predviđeni ni Direktivom 2001/18/EZ ni Direktivom 2009/41/EZ.
Some of the vaccines in development contain attenuated viruses or live vectors, which may fall within the definition of GMO.
Neka cjepiva u razvoju sadržavaju atenuirane viruse ili žive vektore koji mogu biti obuhvaćeni definicijom GMO-a.
In addition, the proposal also aims at clarifying certain aspects of the application of provisions of the pharmaceutical acquis that allow the national competent authorities to authorise the supply and administration of medicinal products that do not have a marketing authorisation to situations of urgency and/or emergency, such as the COVID-19 pandemic.
Osim toga, Prijedlogom se žele razjasniti određeni aspekti primjene odredaba pravne stečevine u području farmaceutskih proizvoda koje nacionalnim tijelima dopuštaju da odobre nabavu i primjenu lijekova bez odobrenja za stavljanje u promet u hitnim i/ili izvanrednim situacijama kao što je pandemija bolesti COVID-19.
(16)It is of paramount importance that clinical trials with investigational medicinal products against COVID-19 containing or consisting of GMOs can be conducted within the Union, that they can begin as soon as possible, and that they are not delayed due to the complexity of differing national procedures put in place by Member States in implementation of Directives 2001/18/EC and 2009/41/EC.
(16)Iznimno je važno da se klinička ispitivanja ispitivanih lijekova protiv bolesti COVID-19 koji sadržavaju GMO ili se od njega sastoje mogu provoditi unutar Unije, da mogu brzo početi te da ne kasne zbog složenosti različitih nacionalnih postupaka koje su države članice uspostavile u provedbi direktiva 2001/18/EZ i 2009/41/EZ.
In those exceptional and urgent situations, where there is a lack of a suitable approved medicinal product, the Union legislator has made a choice that the need to protect public health or the health of individual patients and the benefits of the medicinal product must prevail over other considerations, in particular the need to obtain a marketing authorization and consequently, to have available complete information about the risks posed by the medicinal product, therefore including any risks to the environment from medicinal products containing or consisting of GMOs.
Unije odlučio je da u tim iznimnim i hitnim situacijama u kojima nije dostupan odgovarajući odobreni lijek potreba za zaštitom javnog zdravlja ili zdravlja pojedinačnih pacijenata i korist od lijeka moraju prevladati nad drugim argumentima, posebno nad potrebom pribavljanja odobrenja za stavljanje u promet i raspolaganja potpunim informacijama o rizicima koje taj lijek nosi, što onda uključuje i mogući rizik za okoliš koji proizlazi iz lijeka koji sadržava GMO ili se od njega sastoji.
In the unprecedented situation of public health emergency created by the COVID-19 pandemic, it is necessary that the protection of public health prevails.
U dosad nezabilježenoj izvanrednoj javnozdravstvenoj situaciji nastaloj zbog pandemije bolesti COVID-19 nužno je da prevlada zaštita javnog zdravlja.
Directives 2001/18/EC and 2009/41/EC have the objective of ensuring a high level of protection of human health and the environment, through the assessment of the risks from the deliberate release or the contained used of GMOs.
Direktivama 2001/18/EZ i 2009/41/EZ nastoji se postići visoka razina zaštite zdravlja ljudi i okoliša procjenom rizika od namjernog uvođenja ili ograničene uporabe GMO-a.
(4)In accordance with Article 9(7) of Directive 2001/20/EC, the authorisation for clinical trials is without prejudice to the application of Directives 2001/18/EC 5 and 2009/41/EC 6 of the European Parliament and of the Council.
(4)U skladu s člankom 9. stavkom 7. Direktive 2001/20/EZ, odobrenjem kliničkih ispitivanja ne dovodi se u pitanje primjena direktiva 2001/18/EZ 5 i 2009/41/EZ 6 Europskog parlamenta i Vijeća.
Those operations may fall within the scope of Directive 2001/18/EC or Directive 2009/41/EC in cases where the investigational medicinal product contains or consists of GMOs.
Te operacije mogu biti obuhvaćene područjem primjene Direktive 2001/18/EZ ili Direktive 2009/41/EZ ako ispitivani lijek sadržava GMO ili se od njega sastoji.
It would be incoherent and contrary to the very purpose and "effet utile" of those exemptions, and with the objective of protecting human health in Directive 2001/18/EC, Directive 2009/41/EC and in Union legislation on medicinal products, to consider that it was the legislator's intention to still require an authorization under Directive 2001/18/EC or Directive 2009/41/EC when the legislator, taking into account the objective of protecting human health and the environment has made a choice that in those exceptional and urgent situations the protection of public health or the health of individual patients must prevail and has provided an exemption from the authorization procedure in the Union legislation on medicinal products.
Bilo bi u suprotnosti sa svrhom i korisnim učinkom („effet utile") tih izuzeća te s ciljem zaštite zdravlja ljudi iz Direktive 2001/18/EZ, Direktive 2009/41/EZ i zakonodavstva Unije o lijekovima smatrati da je namjera zakonodavca inzistirati na odobrenju u skladu s Direktivom 2001/18/EZ ili Direktivom 2009/41/EZ ako je zakonodavac uzeo u obzir cilj zaštite zdravlja ljudi i okoliša, odlučio da u tim iznimnim i hitnim situacijama zaštita javnog zdravlja ili zdravlja pojedinačnih pacijenata mora prevladati i u zakonodavstvu Unije o lijekovima predvidio izuzeće od postupka odobravanja.
(21)Directive 2001/20/EC will continue to apply and clinical trials with investigational medicinal products containing or consisting of GMOs intended to treat or prevent COVID-19 will continue to require written authorisation granted by the competent authority in each Member State in which the trial will be conducted.
(21)Direktiva 2001/20/EZ i dalje će se primjenjivati, a za klinička ispitivanja ispitivanih lijekova koji sadržavaju GMO ili se od njega sastoje, a namijenjeni su liječenju ili sprečavanju bolesti COVID-19 i dalje će se zahtijevati pisano odobrenje nadležnog tijela u svakoj državi članici u kojoj će se ispitivanje provoditi.