natgillin/translations-raw huggingface dataset:
Where the subjects are minors, specific consideration shall be given to the assessment of the application for authorisation of a clinical trial on the basis of paediatric expertise or after taking advice on clinical, ethical and psychosocial problems in the field of paediatrics.
V vseh vlogah za odobritev kliničnega preskušanja iz člena 35 se zlasti upoštevajo okoliščine izvajanja kliničnega preskušanja.
Where the subjects are incapacitated subjects, specific consideration shall be given to the assessment of the application for authorisation of a clinical trial on the basis of expertise in the relevant disease and the patient population concerned or after taking advice on clinical, ethical and psychosocial questions in the field of the relevant disease and the patient population concerned.
Člen 11
Where the subjects are pregnant or breastfeeding women, specific consideration shall be given to the assessment of the application for authorisation of a clinical trial on the basis of expertise in the relevant condition and the population represented by the subject concerned.
Predložitev in ocenjevanje vlog glede vidikov, zajetih v delu I ali delu II poročila o oceni
If according to the protocol a clinical trial provides for the participation of specific groups or subgroups of subjects, where appropriate, specific consideration shall be given to the assessment of the application for authorisation of that clinical trial on the basis of expertise in the population represented by the subjects concerned.
Kadar sponzor tako zahteva, se vlogo za odobritev kliničnega preskušanja, njeno oceno in ugotovitev o njej omeji na vidike, ki so zajeti v delu I poročila o oceni.
In any application for authorisation of a clinical trial referred to in Article 35, specific consideration shall be given to the circumstances of the conduct of the clinical trial.
Po obvestilu o ugotovitvi glede vidikov, zajetih v delu I poročila o oceni, lahko sponzor v dveh letih zaprosi za odobritev, ki je omejena na vidike, zajete v delu II poročila o oceni.
Article 11
Sponzor v tej vlogi izjavi, da ni seznanjen z nobenimi novimi bistvenimi znanstvenimi informacijami, ki bi spremenile veljavnost elementov, predloženih v vlogi o vidikih, zajetih v delu I poročila o oceni.
Submission and assessment of applications limited to aspects covered by Part I or Part II of the assessment report
V tem primeru se vloga oceni v skladu s členom 7, zadevna država članica pa svojo odločitev glede kliničnega preskušanja sporoči v skladu s členom 8.
Where the sponsor so requests, the application for authorisation of a clinical trial, its assessment and the conclusion shall be limited to the aspects covered by Part I of the assessment report.
V državah članicah, v katerih sponzor v dveh letih ne zaprosi za odobritev, ki je omejena na vidike, zajete v delu II poročila o oceni, se šteje, da je vloga o vidikih, zajetih v delu I poročila o oceni, zapadla.
After the notification of the conclusion on the aspects covered by Part I of the assessment report, the sponsor may within two years apply for an authorisation limited to aspects covered by Part II of the assessment report.
Člen 12
In that application the sponsor shall declare that he is not aware of any new substantial scientific information that would change the validity of any item submitted in the application on the aspects covered by Part I of the assessment report.
Umik
In this case, that application shall be assessed in accordance with Article 7 and the Member State concerned shall notify its decision on the clinical trial in accordance with Article 8.
Sponzor lahko kadar koli do datuma poročanja umakne vlogo.
In those Member States where the sponsor does not apply for an authorisation limited to aspects covered by Part II of the assessment report within two years, the application on the aspects covered by Part I of the assessment report shall be deemed to have lapsed.
V takem primeru se lahko vloga umakne le za vse zadevne države članice.
Article 12
Razlogi za umik se sporočijo prek portala EU.
Withdrawal
Člen 13
The sponsor may withdraw the application at any time until the reporting date.
Ponovna predložitev vloge
In such a case, the application may only be withdrawn with respect to all Member States concerned.
To poglavje ne posega v možnost sponzorja, da po zavrnitvi vloge za odobritev ali po umiku vloge ponovno predloži vlogo za odobritev v kateri koli zadevni ciljni državi članici.
The reasons for the withdrawal shall be communicated through the EU portal.
Ta vloga šteje za novo vlogo za odobritev drugega kliničnega preskušanja.
Resubmission
Naknadna vključitev zadevne države članice
This Chapter is without prejudice to the possibility for the sponsor to resubmit, following the refusal to grant an authorisation or the withdrawal of an application, an application for authorisation to any intended Member State concerned.
Kadar želi sponzor razširiti odobreno klinično preskušanje v drugo državo članico (v nadaljnjem besedilu: dodatna zadevna država članica), prek portala EU predloži dosje vloge tej državi članici.
That application shall be deemed to be a new application for authorisation of another clinical trial.
Dosje vloge se lahko predloži samo po datumu obvestila o odločitvi o prvotni odobritvi.
Article 14
Država članica poročevalka za dosje vloge iz odstavka 1 je država članica, ki je to nalogo opravljala tudi v postopku prvotne odobritve.
Subsequent addition of a Member State concerned
Dodatna zadevna država članica prek portala EU v 52 dneh od datuma predložitve dosjeja vloge iz odstavka 1 z eno enotno odločitvijo obvesti sponzorja o odobritvi kliničnega preskušanja, pogojni odobritvi kliničnega preskušanja ali zavrnitvi kliničnega preskušanja.
Where the sponsor wishes to extend an authorised clinical trial to another Member State (‘additional Member State concerned’), the sponsor shall submit an application dossier to that Member State through the EU portal.
Kadar država članica poročevalka ugotovi, da je izvedba kliničnega preskušanja glede dela I poročila o oceni sprejemljiva ali pogojno sprejemljiva, ta ugotovitev šteje kot ugotovitev dodatne zadevne države članice.
The application dossier may be submitted only after the notification date of the initial authorisation decision.
Ne glede na prvi pododstavek se lahko dodatna zadevna država članica ne strinja z ugotovitvami države članice poročevalke glede dela I poročila o oceni le na podlagi naslednjih razlogov:
The reporting Member State for the application dossier referred to in paragraph 1 shall be the reporting Member State for the initial authorisation procedure.
pomislekov zaradi varnosti udeleženca ter zanesljivosti in ponovljivosti podatkov, predloženih na podlagi odstavkov 5 ali 6.
The additional Member State concerned shall notify the sponsor through the EU portal, within 52 days from the date of submission of the application dossier referred to in paragraph 1, by way of one single decision as to whether the clinical trial is authorised, whether it is authorised subject to conditions, or whether the authorisation is refused.
Kadar se dodatna zadevna država članica ne strinja z ugotovitvijo na podlagi drugega pododstavka, o svojem nestrinjanju prek portala EU obvesti Komisijo, vse države članice in sponzorja ter priloži podrobno utemeljitev.
Where the conclusion of the reporting Member State as regards Part I of the assessment report is that the conduct of the clinical trial is acceptable or acceptable subject to compliance with specific conditions, that conclusion shall be deemed to be the conclusion of the additional Member State concerned.
V obdobju od datuma predložitve dosjeja vloge iz odstavka 1 in do pet dni pred iztekom roka iz odstavka 3 lahko dodatna zadevna država članica prek portala EU sporoči državi članici poročevalki in drugim zadevnim državam članicam vse pomisleke v zvezi z vlogo.
Notwithstanding the first subparagraph, an additional Member State concerned may disagree with the conclusion of the reporting Member State as regards Part I of the assessment report only on the following grounds:
V obdobju od datuma predložitve dosjeja vloge iz odstavka 1 in do izteka roka iz odstavka 3 lahko le država članica poročevalka od sponzorja zahteva dodatne informacije glede vidikov, zajetih v delu I poročila o oceni, pri čemer upošteva pomisleke iz odstavka 5.
considerations as regards subject safety and data reliability and robustness submitted under paragraph 5 or 6.
Za namene pridobitve in pregleda teh dodatnih informacij od sponzorja v skladu s tretjim in četrtim pododstavkom lahko država članica poročevalka rok iz prvega pododstavka odstavka 3 podaljša za največ 31 dni.
Where an additional Member State concerned disagrees with the conclusion on the basis of the second subparagraph, it shall communicate its disagreement, together with a detailed justification, through the EU portal, to the Commission, to all Member States, and to the sponsor.
Sponzor zahtevane dodatne informacije predloži v roku, ki ga določi država članica poročevalka in ni daljši od 12 dni od prejema zahteve.
Between the date of submission of the application dossier referred to in paragraph 1 and five days before the expiry of the period referred to in paragraph 3, the additional Member State concerned may communicate to the reporting Member State and the other Member States concerned any considerations relevant to the application through the EU portal.
Po prejemu dodatnih informacij dodatna zadevna država članica skupaj z vsemi drugimi zadevnimi državami članicami pregleda vse dodatne informacije, ki jih je zagotovil sponzor, vključno s prvotno vlogo, in z njimi izmenja vse pomisleke v zvezi z vlogo.
Between the date of submission of the application dossier referred to in paragraph 1 and the expiry of the period referred to in paragraph 3, only the reporting Member State may request additional information from the sponsor concerning the aspects addressed in Part I of the assessment report, taking into account the considerations referred to in paragraph 5.
Usklajeni pregled se izvede v največ 12 dneh po prejemu dodatnih informacij, nadaljnja konsolidacija pa v največ sedmih dneh po končani fazi usklajenega pregleda.
For the purpose of obtaining and reviewing this additional information from the sponsor in accordance with the third and fourth subparagraphs, the reporting Member State may extend the period referred to in the first subparagraph of paragraph 3 by a maximum of 31 days.
Država članica poročevalka ustrezno upošteva pomisleke zadevnih držav članic in zabeleži, kako so bili taki pomisleki obravnavani.
The sponsor shall submit the requested additional information within the period set by the reporting Member State which shall not exceed 12 days from receipt of the request.
Kadar sponzor v roku, ki ga določi država članica poročevalka v skladu s tretjim pododstavkom, ne predloži dodatnih informacij, se šteje, da je vloga v dodatni zadevni državi članici zapadla.
Upon receipt of the additional information, the additional Member State concerned together with all other Member States concerned shall jointly review any additional information provided by the sponsor together with the original application and shall share any considerations relevant to the application.
Dodatna zadevna država članica v roku iz odstavka 3 za svoje ozemlje oceni vidike, zajete v delu II poročila o oceni in prek portala EU predloži sponzorju del II poročila o oceni, vključno s svojo ugotovitvijo.
The coordinated review shall be performed within a maximum of 12 days from the receipt of the additional information and the further consolidation shall be performed within a maximum of seven days from the end of the coordinated review.
V tem roku lahko od sponzorja iz utemeljenih razlogov zahteva dodatne informacije glede vidikov, zajetih v delu II poročila o oceni, in sicer v zvezi s svojim ozemljem.
The reporting Member State shall take due account of the considerations of the Member States concerned and shall record how all such considerations have been dealt with.
Za namene pridobitve in pregleda dodatnih informacij iz odstavka 7 od sponzorja v skladu z drugim in tretjim pododstavkom lahko dodatna zadevna država članica rok iz odstavka 7 podaljša za največ 31 dni.
Where the sponsor does not provide additional information within the period set by the reporting Member State in accordance with the third subparagraph, the application shall be deemed to have lapsed in the additional Member State concerned.
Sponzor predloži zahtevane dodatne informacije v roku, ki ga določi dodatna zadevna država članica, ki ni daljši od 12 dni od prejema te zahteve.
The additional Member State concerned shall assess, for its territory, the aspects addressed in Part II of the assessment report within the period referred to in paragraph 3 and submit, through the EU portal, Part II of the assessment report, including its conclusion, to the sponsor.
Kadar sponzor v roku, ki ga določi dodatna zadevna država članica v skladu z drugim pododstavkom, ne predloži dodatnih informacij, se šteje, da je vloga v dodatni zadevni državi članici zapadla.
Within that period it may request, with justified reasons, additional information from the sponsor regarding aspects addressed in Part II of the assessment report as far as its territory is concerned.
Kadar je izvedba kliničnega preskušanja glede vidikov, zajetih v delu I poročila o oceni, sprejemljiva ali pogojno sprejemljiva, dodatna zadevna država članica vključi v svojo odločitev svoje ugotovitve glede dela II poročila o oceni.
For the purpose of obtaining and reviewing the additional information referred to in paragraph 7 from the sponsor in accordance with the second and third subparagraphs, the additional Member State concerned may extend the period referred to in paragraph 7 by a maximum of 31 days.
Kadar dodatna zadevna država članica sponzorja o svoji odločitvi ni obvestila v roku iz odstavka 3 ali če je bil ta rok v skladu z odstavkom 6 ali 8 podaljšan, kadar zadevna dodatna država članica sponzorja o svoji odločitvi ni obvestila v podaljšanem roku, ugotovitev o delu I poročila o oceni šteje za odločitev dodatne zadevne države članice o vlogi za odobritev kliničnega preskušanja.
The sponsor shall submit the requested additional information within the period set by the additional Member State concerned which shall not exceed 12 days from receipt of the request.
Kadar postopek iz poglavja III še ni končan, sponzor ne predloži dosjeja vloge v skladu s tem členom.
Where the sponsor does not provide additional information within the period set by the additional Member State concerned in accordance with the second subparagraph, the application shall be deemed to have lapsed in the additional Member State concerned.
POGLAVJE III
The additional Member State concerned shall refuse to authorise the clinical trial if it disagrees with the conclusion of the reporting Member State as regards Part I of the assessment report on any of the grounds referred to in second subparagraph of paragraph 4, or if it finds, on duly justified grounds, that the aspects addressed in Part II of the assessment report are not complied with, or where an ethics committee has issued a negative opinion which, in accordance with the law of the additional Member State concerned, is valid for that entire additional Member State.
Člen 15
That additional Member State concerned shall provide for an appeal procedure in respect of such refusal.
Splošna načela
Where the additional Member State concerned has not notified the sponsor of its decision within the period referred to in paragraph 3, or in case that period has been extended in accordance with paragraph 6 or 8 where that additional Member State concerned has not notified the sponsor of its decision within the extended period, the conclusion on Part I of the assessment report shall be deemed to be the decision of that additional Member State concerned on the application for authorisation of the clinical trial.
Bistvena sprememba, vključno z dodanim mestom kliničnega preskušanja ali zamenjavo glavnega raziskovalca na mestu kliničnega preskušanja, se lahko izvede samo, če je bila odobrena v skladu s postopkom iz tega poglavja.
A sponsor shall not submit an application dossier in accordance with this Article where a procedure set out in Chapter III is pending as regards that clinical trial.
Člen 16
CHAPTER III
Predložitev vloge
AUTHORISATION PROCEDURE FOR A SUBSTANTIAL MODIFICATION OF A CLINICAL TRIAL
Za odobritev vloge sponzor zadevnim državam članicam prek portala EU predloži dosje vloge.
Article 15
Člen 17
General principles
Potrditev vloge za odobritev bistvene spremembe vidika, zajetega v delu I poročila o oceni
A substantial modification, including the addition of a clinical trial site or the change of a principal investigator in the clinical trial site, may only be implemented if it has been approved in accordance with the procedure set out in this Chapter.
Država članica poročevalka za odobritev bistvene spremembe je država članica poročevalka iz postopka prvotne odobritve.
Article 16
Zadevne države članice lahko državi članici poročevalki sporočijo vse pomisleke v zvezi s potrditvijo vloge za bistveno spremembo v petih dneh po predložitvi dosjeja vloge.
Submission of application
V šestih dneh po predložitvi dosjeja vloge država članica poročevalka potrdi vlogo, pri čemer upošteva pomisleke druge zadevne države članice, ter prek portala EU obvesti ali:
In order to obtain an authorisation, the sponsor shall submit an application dossier to the Member States concerned through the EU portal.
se bistvena sprememba nanaša na vidik, zajet v delu I poročila o oceni, in
Article 17
je dosje vloge v skladu s Prilogo II popoln.
Validation of an application for the authorisation of a substantial modification of an aspect covered by Part I of the assessment report
Kadar država članica poročevalka sponzorja ni obvestila v roku iz odstavka 2, se šteje, da bistvena sprememba, za katero je bila vloga predložena, zadeva vidik, zajet v delu I poročila o oceni, in da je dosje vloge popoln.
The reporting Member State for the authorisation of a substantial modification shall be the reporting Member State for the initial authorisation procedure.
Kadar država članica poročevalka ob upoštevanju pomislekov druge zadevne države članice ugotovi, da se vloga ne nanaša na vidik, zajet v delu I poročila o oceni, ali da dosje vloge ni popoln, sponzorja o tem obvesti prek portala EU ter mu da na voljo največ deset dni za pripombe na vlogo ali dopolnitev dosjeja vloge prek portala EU.
Member States concerned may communicate to the reporting Member State any considerations relevant to the validation of the application of a substantial modification within five days from the submission of the application dossier.
Država članica poročevalka v petih dneh po prejetju pripomb ali dopolnjenega dosjeja vloge spisa sponzorja obvesti, ali vloga izpolnjuje zahteve iz točk (a) in (b) odstavka 2.
Within six days from the submission of the application dossier, the reporting Member State shall validate the application taking into account considerations expressed by the other Member States concerned and notify the sponsor through the EU portal as to whether:
Kadar država članica poročevalka sponzorja ni obvestila v roku iz drugega pododstavka, se šteje, da bistvena sprememba, za katero je bila vloga predložena, zadeva vidik, zajet v delu I poročila o oceni, in da je dosje vloge popoln.
the substantial modification concerns an aspect covered by Part I of the assessment report; and
Za namene členov 18, 19 in 22 se za datum potrditve vloge šteje dan, ko je sponzor obveščen v skladu z odstavkom 2 ali 4.
the application dossier is complete in accordance with Annex II.
Kadar sponzor ni obveščen, se za datum potrditve šteje zadnji dan ustreznih rokov iz odstavkov 2 in 4.
Where the reporting Member State has not notified the sponsor within the period referred to in paragraph 2, the substantial modification applied for shall be deemed to concern an aspect covered by Part I of the assessment report and the application dossier shall be deemed to be complete.
Člen 18
Where the reporting Member State, taking into account considerations expressed by the other Member States concerned, finds that the application does not concern an aspect covered by Part I of the assessment report or that the application dossier is not complete, it shall inform the sponsor thereof through the EU portal and shall set a maximum of 10 days for the sponsor to comment on the application or to complete the application dossier through the EU portal.
Ocena bistvene spremembe vidika, zajetega v delu I poročila o oceni
Within five days from receipt of the comments or the completed application dossier, the reporting Member State shall notify the sponsor as to whether or not the application complies with the requirements set out in points (a) and (b) of paragraph 2.
Država članica poročevalka oceni vlogo glede na vidik, zajet v delu I poročila o oceni, vključno s tem, ali bo klinično preskušanje po bistveni spremembi še naprej ostalo klinično preskušanje z minimalno intervencijo, in pripravi poročilo o oceni.
Where the reporting Member State has not notified the sponsor within the period referred to in the second subparagraph, the substantial modification applied for shall be deemed to concern an aspect covered by Part I of the assessment report and the application dossier shall be deemed to be complete.
bistvena sprememba je sprejemljiva glede na zahteve iz te uredbe;
For the purposes of Articles 18, 19 and 22, the date on which the sponsor is notified in accordance with paragraph 2 or 4 shall be the validation date of the application.
bistvena sprememba je sprejemljiva glede na zahteve iz te uredbe, vendar mora biti v skladu s posebnimi pogoji, ki so izrecno navedeni v navedeni ugotovitvi, ali
Where the sponsor is not notified, the validation date shall be the last day of the respective periods referred to in paragraphs 2 and 4.
bistvena sprememba ni sprejemljiva glede na zahteve iz te uredbe.
Article 18
Država članica poročevalka prek portala EU sponzorju in drugim zadevnim državam članicam predloži končno poročilo o oceni, vključno s svojo ugotovitvijo, v 38 dneh od datuma potrditve.
Assessment of a substantial modification of an aspect covered by Part I of the assessment report
Za namene tega člena ter členov 19 in 23 se za datum poročanja šteje datum predložitve končnega poročila o oceni sponzorju in drugim zadevnim državam članicam.
The reporting Member State shall assess the application with regard to an aspect covered by Part I of the assessment report, including whether the clinical trial will remain a low-intervention clinical trial after its substantial modification, and draw up an assessment report.
Za klinična preskušanja, pri katerih je udeležena več kot ena država članica, ocenjevalni postopek bistvene spremembe vključuje tri faze:
the substantial modification is acceptable in view of the requirements set out in this Regulation;
začetno ocenjevalno fazo, ki jo izvede država članica poročevalka v 19 dneh od datuma potrditve;
the substantial modification is acceptable in view of the requirements set out in this Regulation, but subject to compliance with specific conditions which shall be specifically listed in that conclusion; or
fazo usklajenega pregleda, ki se izvede v 12 dneh po končani začetni ocenjevalni fazi, v kateri so udeležene vse zadevne države članice, in
the substantial modification is not acceptable in view of the requirements set out in this Regulation.
V začetni ocenjevalni fazi država članica poročevalka pripravi osnutek poročila o oceni in ga posreduje vsem zadevnim državam članicam.
The reporting Member State shall submit, through the EU portal, the final assessment report including its conclusion, to the sponsor and to the other Member States concerned within 38 days from the validation date.
V fazi usklajenega pregleda vse zadevne države članice skupaj pregledajo vlogo na osnovi osnutka poročila o oceni in si izmenjajo vse pomisleke v zvezi z njo.