natgillin/translations-raw huggingface dataset:
For the purposes of this Article and Articles 19 and 23, the reporting date shall be the date on which the final assessment report is submitted to the sponsor and to the other Member States concerned.
V fazi konsolidacije država članica poročevalka pri dokončanju poročila o oceni ustrezno upošteva pomisleke zadevnih drugih držav članic in zabeleži, kako so bili vsi taki pomisleki obravnavani.
For clinical trials involving more than one Member State the assessment process of substantial modification shall include three phases:
Država članica poročevalka do datuma poročanja predloži končno poročilo o oceni sponzorju in vsem drugim zadevnim državam članicam.
an initial assessment phase performed by the reporting Member State within 19 days from the validation date;
Država članica poročevalka lahko za klinična preskušanja, ki vključujejo zdravilo za napredno zdravljenje ali zdravilo iz točke 1 Priloge k Uredbi (ES) št. 726/2004, tudi podaljša rok iz odstavka 3 za nadaljnjih 50 dni, da bi se posvetovala s strokovnjaki.
a coordinated review phase performed within 12 days from the end of the initial assessment phase involving all Member States concerned; and
V takem primeru se smiselno uporabljajo roki iz odstavkov 4 in 6 tega člena.
During the initial assessment phase, the reporting Member State shall develop a draft assessment report and circulate it to all Member States concerned.
V obdobju od datuma potrditve do datuma poročanja lahko samo država članica poročevalka od sponzorja zahteva dodatne informacije, pri čemer upošteva pomisleke iz odstavka 4.
During the coordinated review phase, all Member States concerned shall jointly review the application based on the draft assessment report and shall share any considerations relevant to the application.
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.
During the consolidation phase, the reporting Member State shall take due account of the considerations of the other Member States concerned when finalising the assessment report and shall record how all such considerations have been dealt with.
Usklajeni pregled se izvede v največ 12 dneh po prejemu dodatnih informacij, nadaljnja konsolidacija pa v največ sedmih dneh po končani fazi usklajenega pregleda.
The reporting Member State shall submit the final assessment report to the sponsor and all other Member States concerned by the reporting date.
Država članica poročevalka pri dokončanju poročila o oceni ustrezno upošteva pomisleke zadevnih drugih držav članic in zabeleži, kako so bili vsi taki pomisleki obravnavani.
The reporting Member State may extend the period referred to in paragraph 3 by a further 50 days for clinical trials involving an advanced therapy investigational medicinal product or a medicinal product as set out in point 1 of the Annex to Regulation (EC) No 726/2004, for the purpose of consulting with experts.
Kadar sponzor ne predloži dodatnih informacij v roku, ki ga določi država članica poročevalka v skladu s tretjim pododstavkom, se šteje, da je vloga v vseh zadevnih državah članicah zapadla.
In such case, the periods referred to in paragraphs 4 and 6 of this Article shall apply mutatis mutandis.
Člen 19
Between the validation date and the reporting date, only the reporting Member State may request additional information from the sponsor, taking into account the considerations referred to in paragraph 4.
Odločitev o bistveni spremembi vidika, zajetega v delu I poročila o oceni
For the purpose of obtaining and reviewing this additional information from the sponsor in accordance with the third and fourth subparagraph, the reporting Member State may extend the period referred to in the first subparagraph of paragraph 3 by a maximum of 31 days.
Vsaka zadevna država članica obvesti sponzorja prek portala EU o tem, ali je bistvena sprememba kliničnega preskušanja odobrena, pogojno odobrena ali je njena odobritev zavrnjena.
The coordinated review shall be performed within a maximum of 12 days from 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.
Obvesti se z eno enotno odločitvijo v petih dneh od datuma poročanja.
When finalising the assessment report, the reporting Member State shall take due account of the considerations of the other Member States concerned and shall record how all such considerations have been dealt with.
Pogojna odobritev kliničnega preskušanja je omejena na pogoje, ki zaradi svoje narave ne morejo biti izpolnjeni v času te odobritve.
Where the sponsor does not provide additional information within the period determined by the reporting Member State in accordance with the third subparagraph, the application shall be deemed to have lapsed in all Member States concerned.
Kadar država članica poročevalka ugotovi, da je bistvena sprememba sprejemljiva ali pogojno sprejemljiva, to šteje kot ugotovitev zadevne države članice.
Article 19
Ne glede na prvi pododstavek se lahko zadevna država članica s to ugotovitvijo države članice poročevalke ne strinja le na podlagi naslednjih razlogov:
Decision on the substantial modification of an aspect covered by Part I of the assessment report
pomislekov zaradi varnosti udeleženca ter zanesljivosti in ponovljivosti podatkov, predloženih v skladu z odstavkom 4 ali 6 člena 18.
Each Member State concerned shall notify the sponsor through the EU portal as to whether the substantial modification is authorised, whether it is authorised subject to conditions, or whether authorisation is refused.
Kadar se zadevna država članica ne strinja z ugotovitvijo na podlagi drugega pododstavka, o svojem nestrinjanju prek portala EU obvesti Komisijo, vse zadevne države članice in sponzorja ter priloži podrobno utemeljitev.
Notification shall be done by way of a single decision within five days from the reporting date.
Zadevna država članica zavrne odobritev bistvene spremembe, če se ne strinja z ugotovitvijo države članice poročevalke glede dela I poročila o oceni iz razlogov, navedenih v drugem pododstavku, ali kadar etični odbor izda negativno mnenje, ki v skladu s pravom zadevne države članice velja za to celotno državo članico.
An authorisation of a substantial modification subject to conditions is restricted to conditions which by their nature cannot be fulfilled at the time of that authorisation.
Kadar je ugotovitev države članice poročevalke, kar zadeva bistveno spremembo vidikov, zajetih v delu I poročila o oceni, da bistvena sprememba ni sprejemljiva, se ta ugotovitev šteje kot ugotovitev vseh zadevnih držav članic.
Where the conclusion of the reporting Member State is that the substantial modification is acceptable or acceptable subject to compliance with specific conditions, that conclusion shall be deemed to be the conclusion of the Member State concerned.
Kadar zadevna država članica sponzorja o svoji odločitvi ni obvestila v roku iz odstavka 1, ugotovitev iz poročila o oceni šteje za odločitev zadevne države članice o vlogi za odobritev bistvene spremembe.
Notwithstanding the first subparagraph, a Member State concerned may disagree with that conclusion of the reporting Member State only on the following grounds:
Člen 20
considerations as regards subject safety and data reliability and robustness submitted under paragraph 4 or 6 of Article 18.
Potrditev, ocena in odločitve o bistveni spremembi vidika, zajetega v delu II poročila o oceni
Where the 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.
Zadevna država članica v šestih dneh od predložitve dosjeja vloge sponzorja prek portala EU obvesti o naslednjem:
A Member State concerned shall refuse to authorise a substantial modification 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 the second subparagraph, or where an ethics committee has issued a negative opinion which, in accordance with the law of that Member State concerned, is valid for that entire Member State.
ali se bistvena sprememba nanaša na vidik, zajet v delu II poročila o oceni ter
Where the conclusion of the reporting Member State, as regards the substantial modification of aspects covered by Part I of the assessment report, is that the substantial modification is not acceptable, that conclusion shall be deemed to be the conclusion of all Member States concerned.
ali je dosje vloge v skladu s Prilogo II popoln.
Where the Member State concerned has not notified the sponsor of its decision within the period referred to in paragraph 1, the conclusion of the assessment report shall be deemed to be the decision of the Member State concerned on the application for authorisation of the substantial modification.
Kadar zadevna država članica sponzorja ni obvestila v roku iz odstavka 1, se šteje, da bistvena sprememba, za katero je bila vloga predložena, zadeva vidik, zajet v delu II poročila o oceni, in da je dosje vloge popoln.
Article 20
Kadar zadevna država članica ugotovi, da se bistvena sprememba ne nanaša na vidik, zajet v delu II poročila o oceni, ali da dosje vloge ni popoln, o tem prek portala EU obvesti sponzorja ter mu da na voljo največ deset dni, da prek portala EU predloži pripombe na vlogo ali dopolni dosje vloge.
Validation, assessment and decision regarding a substantial modification of an aspect covered by Part II of the assessment report
Država članica poročevalka v petih dneh po prejemu pripomb ali dopolnjenega dosjeja vloge obvesti sponzorja, ali vloga izpolnjuje zahteve iz točk (a) in (b) odstavka 1.
Within six days from the submission of the application dossier, the Member State concerned shall notify the sponsor through the EU portal of the following:
Kadar zadevna država članica sponzorja ni obvestila v roku iz drugega pododstavka, se šteje, da bistvena sprememba, za katero je bila vloga predložena, zadeva vidik, zajet v delu II poročila o oceni, in da je dosje vloge popoln.
whether the substantial modification concerns an aspect covered by Part II of the assessment report; and
Kadar sponzor ni predložil pripomb niti ni dopolnil dosjeja vloge v roku iz prvega pododstavka, se šteje, da je vloga v zadevni državi članici zapadla.
whether the application dossier is complete in accordance with Annex II.
Za namene tega člena se za datum potrditve vloge šteje dan, ko je sponzor obveščen v skladu z odstavkom 1 ali 3.
Where the Member State concerned has not notified the sponsor within the period referred to in paragraph 1, the substantial modification applied for shall be deemed to concern an aspect covered by Part II of the assessment report and the application dossier shall be deemed to be complete.
Kadar sponzor ni obveščen, se za datum potrditve šteje zadnji dan ustreznih rokov iz odstavkov 1 in 3.
Where the Member State concerned finds that the substantial modification does not concern an aspect covered by Part II 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.
Zadevna država članica oceni vlogo in sponzorju prek portala EU predloži del II poročila o oceni, skupaj z njeno ugotovitvijo ter odločitvijo, ali je bistvena sprememba odobrena, pogojno odobrena ali pa je njena odobritev zavrnjena.
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 1.
Obvesti se z eno enotno odločitvijo v 38 dneh od datuma potrditve.
Where the Member State concerned has not notified the sponsor within the period referred to in the second subparagraph, the substantial modification shall be deemed to concern an aspect covered by Part II of the assessment report and the application dossier shall be deemed to be complete.
Zadevna država članica lahko v roku iz drugega pododstavka odstavka 5 iz utemeljenih razlogov od sponzorja zahteva dodatne informacije glede bistvene spremembe v zvezi s svojim ozemljem.
Where the sponsor has not provided comments nor completed the application dossier within the period referred to in the first subparagraph, the application shall be deemed to have lapsed in the Member State concerned.
Za namene pridobitve in pregleda teh dodatnih informacij od sponzorja lahko zadevna država članica rok iz drugega pododstavka odstavka 5 podaljša za največ 31 dni.
For the purpose of this Article, the date on which the sponsor is notified in accordance with paragraph 1 or 3 shall be the validation date of the application.
Sponzor zahtevane dodatne informacije predloži v roku, ki ga določi zadevna država članica in ni daljši od 12 dni od prejema zahteve.
Where the sponsor is not notified, the validation date shall be the last day of the respective periods referred to in paragraphs 1 and 3.
Kadar sponzor ne predloži dodatnih informacij v roku, ki ga določi zadevna država članica v skladu s tretjim pododstavkom, se šteje, da je vloga v tej državi članici zapadla.
The Member State concerned shall assess the application and shall submit to the sponsor, through the EU portal, Part II of the assessment report, including its conclusion, and the decision as to whether the substantial modification is authorised, whether it is authorised subject to conditions, or whether authorisation is refused.
Zadevna država članica zavrne odobritev bistvene spremembe, če na podlagi ustrezno utemeljenih razlogov ugotovi, da niso upoštevani vidiki, zajeti v delu II poročila o oceni, ali če je etični odbor izdal negativno mnenje, ki v skladu s pravom te zadevne države članice velja za to celotno državo članico.
Notification shall be done by way of a single decision within 38 days from the validation date.
Kadar zadevna država članica sponzorja o svoji odločitvi ni obvestila v rokih iz odstavkov 5 in 6, se bistvena sprememba v tej državi članici šteje za odobreno.
During the period referred to in the second subparagraph of paragraph 5, the Member State concerned may request, with justified reasons, additional information from the sponsor regarding the substantial modification as far as its territory is concerned.
Člen 21
For the purpose of obtaining and reviewing this additional information from the sponsor, the Member State concerned may extend the period referred to in the second subparagraph of paragraph 5 by a maximum of 31 days.
Bistvena sprememba vidikov, zajetih v, delih I in II poročila o oceni
The sponsor shall submit the requested additional information within the period set by the Member State concerned which shall not exceed 12 days from receipt of the request.
Kadar se bistvena sprememba nanaša na vidike, zajete v delih I in II poročila o oceni, se vloga za odobritev te bistvene spremembe potrdi v skladu s členom 17.
Where the sponsor does not provide additional information within the period set by the Member State concerned in accordance with the third subparagraph, the application shall be deemed to have lapsed in that Member State.
Vidiki, zajeti v delu I poročila o oceni, se ocenijo v skladu s členom 18, vidiki, zajeti v delu II poročila o oceni, pa v skladu s členom 22.
A Member State concerned shall refuse to authorise a substantial modification if it finds, on duly justified grounds, that the aspects covered by 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 that Member State concerned, is valid for that entire Member State.
Člen 22
Where the Member State concerned has not notified the sponsor of its decision within the periods set out in paragraphs 5 and 6, the substantial modification shall be deemed to be authorised in that Member State.
Ocena bistvene spremembe vidikov, zajetih v delih I in II poročila o oceni – ocena vidikov, zajetih v delu II poročila o oceni
Article 21
Vsaka zadevna država članica za svoje ozemlje oceni vidike bistvene spremembe, ki so zajeti v delu II poročila o oceni, in sponzorju prek portala EU predloži to poročilo, skupaj s svojimi ugotovitvami, v 38 dneh od datuma potrditve.
Substantial modification of aspects covered by Parts I and II of the assessment report
Zadevna država članica lahko v roku iz odstavka 1 iz utemeljenih razlogov od sponzorja zahteva dodatne informacije glede te bistvene spremembe v zvezi s svojim ozemljem.
Where a substantial modification relates to aspects covered by Parts I and II of the assessment report, the application for authorisation of that substantial modification shall be validated in accordance with Article 17.
Za namen pridobitve in pregleda dodatnih informacij iz odstavka 2 od sponzorja v skladu s tretjim in četrtim pododstavkom lahko zadevna država članica rok iz odstavka 1 podaljša za največ 31 dni.
The aspects covered by Part I of the assessment report shall be assessed in accordance with Article 18 and the aspects covered by Part II of the assessment report shall be assessed in accordance with Article 22.
Kadar sponzor v roku, ki ga določi zadevna država članica v skladu z drugim pododstavkom, ne predloži dodatnih informacij, se šteje, da je vloga v tej državi članici zapadla.
Assessment of a substantial modification of aspects covered by Parts I and II of the assessment report — Assessment of the aspects covered by Part II of the assessment report
Odločitev o bistveni spremembi vidikov, zajetih v delih I in II poročila o oceni
Each Member State concerned shall assess, for its own territory, the aspects of the substantial modification which are covered by Part II of the assessment report and submit, through the EU portal, that report, including its conclusion, to the sponsor within 38 days from the validation date.
Obvesti se z eno enotno odločitvijo v petih dneh od datuma poročanja ali od zadnjega dneva roka za ocenjevanja iz člena 22, kar je pozneje.
During the period referred to in paragraph 1, the Member State concerned may request, with justified reasons, additional information from the sponsor regarding this substantial modification as far as its territory is concerned.
Kadar država članica poročevalka ugotovi, da je bistvena sprememba vidikov, zajetih v delu I, sprejemljiva ali pogojno sprejemljiva, to šteje kot ugotovitev zadevne države članice.
For the purpose of obtaining and reviewing the additional information referred to in paragraph 2 from the sponsor in accordance with the third and fourth subparagraph, the Member State concerned may extend the period referred to paragraph 1 by a maximum of 31 days.
Ne glede na prvi pododstavek se lahko zadevna država članica z ugotovitvijo države članice poročevalke ne strinja le na podlagi naslednjih razlogov:
Where the sponsor does not provide the requested additional information within the period set by the Member State concerned in accordance with the second subparagraph, the application shall be deemed to have lapsed in that Member State.
pomislekov zaradi varnosti udeleženca ter zanesljivosti in ponovljivosti podatkov, predloženih v skladu z odstavkom 4 ali 6 člena 18.
Article 23
Kadar se zadevna država članica ne strinja z ugotovitvijo glede bistvene spremembe vidikov, zajetih v delu I poročila o oceni na podlagi drugega pododstavka, o svojem nestrinjanju prek portala EU obvesti Komisijo, vse države članice in sponzorja ter priloži podrobno utemeljitev.
Decision on the substantial modification of aspects covered by Parts I and II of the assessment report
Kadar je bistvena sprememba vidikov, zajetih v delu I poročila o oceni, sprejemljiva ali pogojno sprejemljiva, zadevna država članica vključi v odločitev svojo ugotovitev glede bistvene spremembe vidikov, zajetih v delu II poročila o oceni.
Notification shall be done by way of a single decision within five days from the reporting date or from the last day of the assessment period referred to in Article 22, whichever is later.
Zadevna država članica zavrne odobritev bistvene spremembe, če se ne strinja z ugotovitvijo države članice poročevalke, kar zadeva bistveno spremembo vidikov, zajetih v delu I poročila o oceni, iz katerega koli od razlogov, navedenih v drugem pododstavku odstavka 2, ali če na podlagi ustrezno utemeljenih razlogov ugotovi, da niso upoštevani vidiki, zajeti v delu II poročila o oceni, ali če je etični odbor izdal negativno mnenje, ki v skladu s pravom zadevne države članice velja za to celotno državo članico.
Where the conclusion of the reporting Member State is that the substantial modification of aspects covered by Part I of the assessment report is acceptable or acceptable subject to compliance with specific conditions, that conclusion shall be deemed to be the conclusion of the Member State concerned.
Ta država članica na takšno zavrnitev omogoči postopek pritožbe.
Notwithstanding the first subparagraph, a Member State concerned may disagree with the conclusion of the reporting Member State only on the following grounds:
Kadar je ugotovitev države članice poročevalke, kar zadeva bistveno spremembo vidikov, zajetih v delu I poročila o oceni, da bistvena sprememba ni sprejemljiva, ta ugotovitev šteje kot ugotovitev zadevne države članice.
considerations as regards suject safety and data reliability and robustness submitted under paragraph 4 or 6 of Article 18.
Kadar zadevna država članica sponzorja o svoji odločitvi ni obvestila v rokih iz odstavka 1, ugotovitev glede bistvene spremembe vidikov, zajetih v delu I poročila o oceni, šteje za odločitev zadevne države članice o vlogi za odobritev bistvene spremembe.
Where the Member State concerned disagrees with the conclusion regarding the substantial modification of aspects covered by Part I of the assessment report 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.
Člen 24
Where, regarding the substantial modification of aspects covered by Part I of the assessment report, the substantial modification is acceptable or acceptable subject to compliance with specific conditions, the Member State concerned shall include in its decision its conclusion on the substantial modification of aspects covered by Part II of the assessment report.
Osebe, ki ocenjujejo vlogo za bistveno spremembo
A Member State concerned shall refuse to authorise a substantial modification if it disagrees with the conclusion of the reporting Member State as regards the substantial modification of aspects covered by Part I of the assessment report on any of the grounds referred to in second subparagraph of paragraph 2, or if it finds, on duly justified grounds, that the aspects covered by 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 Member State concerned, is valid for that entire Member State.
Za ocene iz tega poglavja se uporablja člen 9.
That Member State concerned shall provide for an appeal procedure in respect of such refusal.
POGLAVJE IV
Where the conclusion of the reporting Member State as regards the substantial modification of aspects covered by Part I of the assessment report is that the substantial modification is not acceptable, that conclusion shall be deemed to be the conclusion of the Member State concerned.
DOSJE VLOGE
Where the Member State concerned has not notified the sponsor of its decision within the periods referred to in paragraph 1, the conclusion on the substantial modification of aspects covered by Part I of the assessment report shall be deemed to be the decision of the Member State concerned on the application for authorisation of the substantial modification.
Člen 25
Article 24
Podatki v dosjeju vloge