natgillin/translations-raw huggingface dataset:
(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 člena 9(2) Direktive 2001/20/ES Evropskega parlamenta in Sveta 4 je razvidno, da morajo pred začetkom kakršnega koli kliničnega preskušanja naročniki zahtevati dovoljenje pri pristojnemu organu države članice, v kateri se bo izvajalo klinično preskušanje.
During the period in which the temporary derogation applies, the environmental risk assessment and consent under Articles 6 to 11 of Directive 2001/18/EC and Articles 6 to 13 of Directive 2009/41/EC should not be a prerequisite for the conduct of those clinical trials.
V obdobju uporabe začasnega odstopanja ocena tveganja za okolje in odobritev v skladu s členi 6 do 11 Direktive 2001/18/ES in členi 6 do 13 Direktive 2009/41/ES ne bi smeli biti nujno potrebni za izvedbo navedenih kliničnih preskušanj.
(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/ES se bo še naprej uporabljala in za klinična preskušanja zdravil v preskušanju za zdravljenje ali preprečevanje COVID-19, ki vsebujejo GSO ali so iz njih sestavljena, bo še naprej potrebno pisno dovoljenje pristojnega organa vsake države članice, v kateri se bo preskušanje izvajalo.
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.Za vse dejavnosti, povezane z izvajanjem kliničnih preskušanj, vključno s pakiranjem in označevanjem, shranjevanjem, prevozom, uničevanjem, odstranjevanjem, distribucijo, dobavo, dajanjem ali uporabo zdravil za uporabo v humani medicini v preskušanju za zdravljenje ali preprečevanje COVID-19, ki vsebujejo GSO ali so iz njih sestavljena, vendar z izjemo proizvodnje zdravila v preskušanju, se ne zahtevata predhodna ocena tveganja za okolje in/ali odobritev v skladu s členi 6 do 11 Direktive 2001/18/ES ali členi 6 do 13 Direktive 2009/41/ES, kadar so navedene dejavnosti povezane z izvajanjem kliničnega preskušanja, za katero je bilo izdano dovoljenje v skladu z Direktivo 2001/20/ES.
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.
Nekatere države članice so izrazile pomisleke glede uporabe določb Direktive 2001/18/ES in Direktive 2009/41/ES v primerih, obravnavanih v členu 5(1) in (2) Direktive 2001/83/ES ter členu 83 Uredbe (ES) št. 726/2004.
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 izvajanju kliničnih preskušanj zdravil za uporabo v humani medicini za zdravljenje ali preprečevanje koronavirusne bolezni, ki vsebujejo gensko spremenjene organizme ali so iz njih sestavljena, in njihovi dobavi
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.
Te določbe državam članicam omogočajo, da dovolijo dobavo in dajanje zdravil za uporabo v humani medicini (vključno z zdravili, ki vsebujejo GSO ali so iz njih sestavljena) brez dovoljenja za promet, kadar je nujno treba obravnavati posebne potrebe pacienta, za sočutno uporabo ali v odziv na domnevno ali potrjeno širjenje patogenih organizmov, toksinov, kemičnih snovi ali jedrskega sevanja, ki so lahko škodljivi.
In the unprecedented situation of public health emergency created by the COVID-19 pandemic, it is necessary that the protection of public health prevails.
V izrednih razmerah v javnem zdravju brez primere, ki jih je povzročila pandemija COVID-19, mora biti varovanje javnega zdravja na prvem mestu.
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.
V skladu s členom 5(2) Direktive 2001/83/ES lahko države članice začasno izdajo dovoljenje za distribucijo zdravila, za katero ni bilo izdano dovoljenje za promet, v odgovor na domnevno ali potrjeno širjenje povzročiteljev bolezni, toksinov, kemičnih snovi ali jedrskega sevanja, ki so lahko škodljivi.
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.
Vseeno pa Direktiva 2001/83/ES in Uredba (ES) št. 726/2004 določata izjeme od te zahteve, kadar je dajanje zdravila nujno potrebno, da se zadovoljijo posebne potrebe pacienta, za sočutno uporabo ali v odziv na domnevno ali potrjeno širjenje patogenih organizmov, toksinov, kemičnih snovi ali jedrskega sevanja, ki so lahko škodljivi.
(b)where such medicinal products have been authorised by a Member State pursuant to Article 5(2) of Directive 2001/83/EC ; or
(b)kadar država članica za taka zdravila izda dovoljenje v skladu s členom 5(2) Direktive 2001/83/ES ali
In the situation of public health emergency created by the COVID-19 pandemic, there is an overriding interest in protecting human health.
V izrednih razmerah v javnem zdravju, ki jih je povzročila pandemija COVID-19, je varovanje zdravja ljudi na prvem mestu.
In the current situation of public health emergency created by the COVID-19 pandemic, it is necessary to clarify the interpretation of Article 5(1) and (2) of Directive 2001/83/EC and Article 83(1) of Regulation (EC) No 726/2004 to avoid divergent interpretations and to ensure equal and as prompt as possible access to medicinal products for human use intended to treat or prevent COVID-19.
V trenutnih izrednih razmerah v javnem zdravju, ki jih je povzročila pandemija COVID-19, je treba pojasniti razlago člena 5(1) in (2) Direktive 2001/83/ES ter člena 83(1) Uredbe (ES) št. 726/2004, da bi se izognili različnim razlagam ter zagotovili enakopraven in čim hitrejši dostop do zdravil za uporabo v humani medicini, namenjenih za zdravljenje ali preprečevanje COVID-19.
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.
Z Direktivo 2001/83/ES in Uredbo (ES) št. 726/2004 je bil oblikovan usklajen okvir, predlagana pojasnila pa bodo prispevala k optimizaciji izvajanja člena 5(1) in (2) Direktive 2001/83/ES ter člena 83 Uredbe (ES) št. 726/2004 glede zdravil za uporabo v humani medicini za zdravljenje ali preprečevanje COVID-19, ki vsebujejo GSO ali so iz njih sestavljena.
(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)kadar država članica taka zdravila izvzame iz določb Direktive 2001/83/ES v skladu s členom 5(1) navedene direktive;
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.Klinična preskušanja, ki spadajo na področje uporabe člena 2 in za katera je bilo pred objavo obvestila iz odstavka 2 izdano dovoljenje na podlagi Direktive 2001/20/ES, se lahko veljavno nadaljujejo in uporabijo v podporo vlogi za pridobitev dovoljenja za promet brez ocene tveganja za okolje in/ali odobritve v skladu s členi 6 do 11 Direktive 2001/18/ES ali členi 6 do 13 Direktive 2009/41/ES.
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.Kadar je to izvedljivo, države članice izvedejo ustrezne ukrepe za zmanjšanje predvidljivih negativnih vplivov na okolje, ki so posledica namernega ali nenamernega sproščanja zdravila v preskušanju v okolje.
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.
Direktiva 2001/20/ES o kliničnem preskušanju ne posega v uporabo direktiv o GSO. Za ocenjevanje vidikov GSO pri kliničnih preskušanjih zdravil za uporabo v humani medicini v preskušanju ni skupnega pristopa EU, saj nekatere države članice uporabljajo direktivo o namernem sproščanju, nekatere uporabljajo direktivo o uporabi v zaprtih sistemih, nekatere pa uporabljajo obe ali se odločajo za vsak primer posebej.
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.
Cilj politike v tej predlagani uredbi je zagotoviti, da se lahko klinična preskušanja zdravil za uporabo v humani medicini za zdravljenje ali preprečevanje COVID-19, ki vsebujejo GSO ali so iz njih sestavljena, začnejo hitro in brez predhodne ocene tveganja za okolje in/ali odobritve na podlagi Direktive 2001/18/ES ali Direktive 2009/41/ES, če je Svetovna zdravstvena organizacija uradno razglasila pandemijo ali če so bile zaradi COVID-19 razglašene izredne razmere v skladu s Sklepom št. 1082/2013/EU, ki še vedno trajajo.
(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)Zato se za vloge za pridobitev dovoljenja za promet v skladu z Uredbo (ES) št. 726/2004 ali Direktivo 2001/83/ES za zdravila, namenjena za zdravljenje ali preprečevanje COVID-19, za klinična preskušanja katerih bi se uporabljalo odstopanje iz te uredbe, od predlagateljev ne bi smelo zahtevati, da vključijo pisno odobritev pristojnega organa glede namernega sproščanja GSO v okolje za namene raziskovanja in razvoja, kot je določeno v delu B Direktive 2001/18/ES.
(4)the definition of "genetically modified organism" (GMO) in point (2) of Article 2 of Directive 2001/18/EC.
(4)opredelitev „gensko spremenjenega organizma" (GSO) iz člena 2(2) Direktive 2001/18/ES.
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.
Namen predlagane uredbe je torej oblikovati skupni pristop za izvajanje kliničnih preskušanj zdravil za zdravljenje ali preprečevanje COVID-19, ki vsebujejo GSO ali so iz njih sestavljena, ter pojasniti, kako se za ta zdravila uporabljajo odločitve držav članic, sprejete v skladu s členom 5(1) in (2) Direktive 2001/83/ES in/ali členom 83 Uredbe (ES) št. 726/2004.
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.Naročniki izvedejo ustrezne ukrepe za zmanjšanje predvidljivih negativnih vplivov na okolje, ki so posledica namernega ali nenamernega sproščanja zdravila v preskušanju v okolje.
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.
Poleg tega bi bilo treba pojasniti, da se zdravila za uporabo v humani medicini za zdravljenje ali preprečevanje COVID-19, ki vsebujejo GSO ali so iz njih sestavljena, lahko hitro dajejo brez predhodne ocene tveganja za okolje in/ali odobritve na podlagi Direktive 2001/18/ES ali Direktive 2009/41/ES, in sicer v izjemnih razmerah, predvidenih v členu 5(1) in (2) Direktive 2001/83/ES ter členu 83 Uredbe (ES) št. 726/2004.
3.By way of derogation from Article 6(2)(a) of Regulation (EC) No 726/2004 and from the second indent of the fourth paragraph of point 1.6 of Part I of Annex I to Directive 2001/83/EC, in applications for marketing authorisations for medicinal products intended to treat or prevent COVID-19, the applicant shall not be required to include a copy of the written consent of the competent authority to the deliberate release into the environment of GMOs in accordance with Part B of Directive 2001/18/EC.
3.Z odstopanjem od člena 6(2)(a) Uredbe (ES) št. 726/2004 in druge alinee četrtega odstavka točke 1.6 dela I Priloge I k Direktivi 2001/83/ES se za vloge za pridobitev dovoljenja za promet za zdravila, namenjena za zdravljenje ali preprečevanje COVID-19, od predlagateljev ne zahteva, da vključijo kopijo pisne odobritve pristojnega organa glede namernega sproščanja GSO v okolje v skladu z delom B Direktive 2001/18/ES.
(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)Ker ciljev te uredbe, tj. zagotoviti začasno odstopanje od zakonodaje Unije o GSO, da se preprečijo zamude pri izvajanju kliničnih preskušanj zdravil v preskušanju za zdravljenje ali preprečevanje COVID-19, ki vsebujejo GSO ali so iz njih sestavljena, na ozemlju več držav članic, ter pojasniti uporabo člena 5(1) in (2) Direktive 2001/83/ES ter člena 83(1) Uredbe (ES) št. 726/2004 v zvezi z navedenimi zdravili, ni mogoče doseči na ravni posameznih držav članic, temveč se zaradi obsega in učinkov lažje dosežeta na ravni Unije, lahko Unija sprejme ukrepe v skladu z načelom subsidiarnosti iz člena 5 Pogodbe o Evropski uniji.
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.
Poleg tega bi bilo treba od naročnikov zahtevati, da izvedejo ustrezne ukrepe za zmanjšanje negativnih vplivov na okolje zaradi namernega ali nenamernega sproščanja zdravila v okolje, ki jih je na podlagi razpoložljivega znanja mogoče predvideti.
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.
Kot je določeno v četrtem pododstavku člena 6(3) Uredbe (ES) št. 726/2004, bo Evropska agencija za zdravila vzporedno z ocenjevanjem kakovosti, varnosti in učinkovitosti zdravil za zdravljenje ali preprečevanje COVID-19, ki vsebujejo GSO ali so iz njih sestavljena, še naprej izvajala tudi ocenjevanje njihovega vpliva na okolje, ob upoštevanju zahtev glede varovanja okolja iz Direktive 2001/18/ES.
(3)the definition of "medicinal product in point" 2 of Article 1 of Directive 2001/83/EC;
(3)opredelitev „zdravila" iz člena 1(2) Direktive 2001/83/ES;
(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)Glede na navedena cilja te uredbe, tj. preprečiti zamude pri začetku izvajanja kliničnih preskušanj zdravil za zdravljenje ali preprečevanje COVID-19 ter pojasniti uporabo člena 5(1) in (2) Direktive 2001/83/ES ter člena 83(1) Uredbe (ES) št. 726/2004 v zvezi z navedenimi zdravili, bi morala ta uredba začeti veljati čim prej -
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.
Zato pri sprejemanju odločitev držav članic v skladu s členom 5(1) in (2) Direktive 2001/83/ES ali členom 83(1) Uredbe (ES) št. 726/2004 glede zdravil, ki vsebujejo GSO ali so iz njih sestavljena, ocena tveganja za okolje in/ali odobritev v skladu z Direktivo 2001/18/ES ali Direktivo 2009/41/ES nista nujno potrebni.
(1)the definition of "clinical trial" in point (a) of Article 2 of Directive 2001/20/EC;
(1)opredelitev „kliničnega preskušanja" iz člena 2(a) Direktive 2001/20/ES;
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.
(23)Nekatere države članice so izrazile dvome glede razmerja med navedenimi določbami in zakonodajo o GSO. Glede na nujno potrebo, da se cepiva ali zdravila proti COVID-19 javnosti dajo na voljo takoj, ko bodo pripravljena za to, in da se preprečijo zamude ali negotovosti v zvezi s statusom navedenih proizvodov v nekaterih državah članicah, je primerno, da pri sprejemanju odločitev držav članic v skladu s členom 5(1) in (2) Direktive 2001/83/ES ali členom 83(1) Uredbe (ES) št. 726/2004 glede zdravil za zdravljenje ali preprečevanje COVID-19, ki vsebujejo GSO ali so iz njih sestavljena, ocena tveganja za okolje ali odobritev v skladu z Direktivo 2001/18/ES ali Direktivo 2009/41/ES ni nujno potrebna.
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.
Zato bi bilo treba pojasniti, da pri sprejemanju odločitev držav članic v skladu s členom 5(1) in (2) Direktive 2001/83/ES ali členom 83(1) Uredbe (ES) št. 726/2004 glede zdravil za zdravljenje ali preprečevanje COVID-19, ki vsebujejo GSO ali so iz njih sestavljena, ocena tveganja za okolje in/ali odobritev v skladu z Direktivo 2001/18/ES ali Direktivo 2009/41/ES nista nujno potrebni.
(2)the definition of "investigational medicinal product" in point (d) of Article 2 of Directive 2001/20/EC;
(2)opredelitev „zdravila v preskušanju" iz člena 2(d) Direktive 2001/20/ES;
The problems and the underlying causes are the same across all Member States.
Težave in temeljni vzroki so enaki v vseh državah članicah.
(4)Institutions will have a key role in contributing to the recovery.
(4)Institucije bodo imele ključno vlogo pri spodbujanju okrevanja.
Entry into force and application
Začetek veljavnosti in uporaba
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 je zavezana visokim standardom varstva temeljnih pravic in je podpisnica številnih konvencij o človekovih pravicah.
It is instrumental to ensuring the effectiveness of measures adopted by the Member States, the Commission and the European Central Bank.
Je bistvenega pomena za zagotovitev učinkovitosti ukrepov, ki jih sprejmejo države članice, Komisija in Evropska centralna banka.
The proposal introduces amendments to existing legislation.
Predlog uvaja spremembe obstoječe zakonodaje.
Nevertheless, uncertainty related to the pace of recovery of economic activity will inevitably have an impact on the banking sector.
Kljub temu bo negotovost, povezana s hitrostjo okrevanja gospodarske dejavnosti, neizogibno vplivala na bančni sektor.
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.
Zaradi reform, izvedenih po finančni krizi leta 2008, so kreditne institucije danes dobro kapitalizirane in precej bolj odporne, kot so bile leta 2008.