natgillin/translations-raw huggingface dataset:
the relevance of the clinical trial, including whether the groups of subjects participating in the clinical trial represent the population to be treated, or if not, the explanation and justification provided in accordance with point (y) of paragraph 17 of Annex I to this Regulation; the current state of scientific knowledge; whether the clinical trial has been recommended or imposed by regulatory authorities in charge of the assessment and authorisation of the placing on the market of medicinal products; and, where applicable, any opinion formulated by the Paediatric Committee on a paediatric investigation plan in accordance with Regulation (EC) No 1901/2006 of the European Parliament and of the Council [12];the reliability and robustness of the data generated in the clinical trial, taking account of statistical approaches, design of the clinical trial and methodology, including sample size and randomisation, comparator and endpoints;
varnostni ukrepi, vključno z ukrepi za zmanjšanje tveganja, spremljanje, varnostna poročila in varnostni načrt,
The risks and inconveniences for the subject, taking account of all of the following:
tveganje za zdravje udeleženca, ki je posledica zdravstvenega stanja, za zdravljenje katerega se zdravilo v preskušanju raziskuje,
the characteristics of and knowledge about the investigational medicinal products and the auxiliary medicinal products;
skladnost z zahtevami glede proizvodnje in uvoza zdravil v preskušanju ter pomožnih zdravil iz poglavja IX;
the characteristics of the intervention compared to normal clinical practice;
skladnost z zahtevami glede označevanja iz poglavja X;
the safety measures, including provisions for risk minimisation measures, monitoring, safety reporting, and the safety plan;
popolnost in primernost brošure za raziskovalca.
the risk to subject health posed by the medical condition for which the investigational medicinal product is being investigated;
Država članica poročevalka pripravi poročilo o oceni.
Compliance with the requirements concerning the manufacturing and import of investigational medicinal products and auxiliary medicinal products set out in Chapter IX;
Ocena vidikov iz odstavka 1 je zajeta v delu I poročila o oceni.
Compliance with the labelling requirements set out in Chapter X;
Poročilo o oceni vključuje eno od naslednjih ugotovitev v zvezi z vidiki, zajetimi v delu I poročila o oceni:
The completeness and adequateness of the investigator's brochure.
izvajanje kliničnega preskušanja je sprejemljivo glede na zahteve iz te uredbe;
The reporting Member State shall draw up an assessment report.
izvajanje kliničnega preskušanja je sprejemljivo glede na zahteve iz te uredbe, vendar mora biti v skladu s posebnimi pogoji, ki so izrecno našteti v navedeni ugotovitvi, ali
The assessment of the aspects referred to in paragraph 1 shall constitute Part I of the assessment report.
izvajanje kliničnega preskušanja ni sprejemljivo glede na zahteve iz te uredbe.
The assessment report shall contain one of the following conclusions concerning the aspects addressed in Part I of the assessment report:
Država članica poročevalka prek portala EU predloži sponzorju in drugim zadevnim državam članicam končni del I poročila o oceni, vključno s svojo ugotovitvijo, v 45 dneh od datuma potrditve.
the conduct of the clinical trial is acceptable in view of the requirements set out in this Regulation;
Za klinična preskušanja, pri katerih je udeležena več kot ena država članica, ocenjevalni postopek vključuje tri faze:
the conduct of the clinical trial 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
začetno ocenjevalno fazo, ki jo izvede država članica poročevalka v 26 dneh od datuma potrditve;
the conduct of the clinical trial is not acceptable in view of the requirements set out in this Regulation.
fazo usklajenega pregleda, ki se izvede v 12 dneh po končani začetni ocenjevalni fazi, v kateri so udeležene vse zadevne države članice;
The reporting Member State shall submit, through the EU portal, the final Part I of the assessment report, including its conclusion, to the sponsor and to the other Member States concerned within 45 days from the validation date.
fazo konsolidacije, ki jo država članica poročevalka izvede v sedmih dneh po končani fazi usklajenega pregleda.
For clinical trials involving more than one Member State, the assessment process shall include three phases:
V začetni ocenjevalni fazi država članica poročevalka pripravi osnutek dela I poročila o oceni in ga posreduje vsem drugim zadevnim državam članicam.
an initial assessment phase performed by the reporting Member State within 26 days from the validation date;
V fazi usklajenega pregleda vse zadevne države članice skupaj pregledajo vlogo na osnovi osnutka dela I poročila o oceni in si izmenjajo vse pomisleke v zvezi z njo.
a coordinated review phase performed within 12 days from the end of the initial assessment phase involving all Member States concerned;
V fazi konsolidacije država članica poročevalka pri dokončanju dela I poročila o oceni ustrezno upošteva pomisleke zadevnih drugih držav članic in zabeleži, da so bili taki pomisleki obravnavani.
a consolidation phase performed by the reporting Member State within seven days from the end of coordinated review phase.
Država članica poročevalka predloži končni del I poročila o oceni sponzorju in vsem drugim zadevnim državam članicam v roku iz odstavka 4.
During the initial assessment phase, the reporting Member State shall develop a draft Part I of the assessment report and circulate it to all other Member States concerned.
Za namene tega poglavja se za datum, ko država članica poročevalka sponzorju in drugim zadevnim državam članicam predloži končni del I poročila o oceni, šteje datum poročanja.
During the coordinated review phase, all Member States concerned shall jointly review the application based on the draft Part I of the assessment report and shall share any considerations relevant to the application.
Država članica poročevalka lahko za preskušanje, ki vključuje zdravilo za napredno zdravljenje v preskušanju ali zdravilo iz točke 1 Priloge k Uredbi (ES) št. 726/2004, tudi podaljša rok iz odstavka 4 za dodatnih 50 dni, da bi se posvetovala s strokovnjaki.
During the consolidation phase, the reporting Member State shall take due account of the considerations of the other Member States concerned when finalising Part I of the assessment report and shall record how all such considerations have been dealt with.
V takem primeru se smiselno uporabljajo roki iz odstavkov 5 in 8 tega člena.
The reporting Member State shall submit the final Part I of the assessment report to the sponsor and all other Member States concerned within the period referred to in paragraph 4.
V obdobju od datuma potrditve do datuma poročanja lahko samo država članica poročevalka od sponzorja zahteva dodatne informacije, pri čemer upošteva pomisleke iz odstavka 5.
For the purposes of this Chapter, the date on which the final Part I of the assessment report is submitted by the reporting Member State to the sponsor and to the other Member States concerned shall be the reporting date.
Zaradi pridobitve in pregleda teh dodatnih informacij od sponzorja v skladu s tretjim in četrtim pododstavkom lahko država članica poročevalka podaljša rok iz odstavka 4 za največ 31 dni.
The reporting Member State may also extend the period referred to in paragraph 4 by a further 50 days for clinical trials involving an advanced therapy investigational medicinal products or a medicinal product as defined in point 1 of the Annex to Regulation (EC) No 726/2004, for the purpose of consulting with experts.
Sponzor predloži zahtevane dodatne informacije v roku, ki ga določi država članica poročevalka, ki pa ne presega 12 dni od prejema te zahteve.
In such case, the periods referred to in paragraphs 5 and 8 of this Article shall apply mutatis mutandis.
Po prejemu dodatnih informacij zadevne države članice skupaj pregledajo vse dodatne informacije, ki jih je zagotovil sponzor, skupaj s prvotno vlogo, in si izmenjajo vse pomisleke v zvezi vlogo.
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 5.
Usklajeni pregled se izvede v največ 12 dneh po prejemu dodatnih informacij, nadaljnja konsolidacija pa v 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 subparagraph, the reporting Member State may extend the period referred to in paragraph 4 by a maximum of 31 days.
Država članica poročevalka pri dokončanju dela I poročila o oceni ustrezno upošteva pomisleke zadevnih držav članic in zabeleži, na kakšen način so bili takšni 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 the receipt of the request.
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.
Upon receipt of the additional information, the 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.
Zahteva za dodatne informacije in same dodatne informacije se predložijo prek portala EU.
The coordinated review shall be performed within a maximum of 12 days of the receipt of the additional information and the further consolidation shall be performed within a maximum of seven days of the end of coordinated review.
Člen 7
When finalising Part I of the assessment report, 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.
Poročilo o oceni – vidiki, zajeti v delu II
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 all Member States concerned.
Vsaka zadevna država članica za svoje ozemlje oceni vlogo glede na naslednje vidike:
The request for additional information and the additional information shall be submitted through the EU portal.
skladnost z zahtevami za prostovoljno privolitev po poučitvi iz poglavja V;
Article 7
skladnost ureditve izplačila plačil ali nadomestil za udeležence z zahtevami iz poglavja V in za raziskovalce;
Assessment report — Aspects covered by Part II
skladnost ureditve glede pridobivanja udeležencev z zahtevami iz poglavja V;
Each Member State concerned shall assess, for its own territory, the application with respect to the following aspects:
skladnost z Direktivo 95/46/ES;
compliance with the requirements for informed consent as set out in Chapter V;
skladnost s členom 49;
compliance of the arrangements for rewarding or compensating subjects with the requirements set out in Chapter V and investigators;
skladnost s členom 50;
compliance of the arrangements for recruitment of subjects with the requirements set out in Chapter V;
skladnost s členom 76;
compliance with Directive 95/46/EC;
skladnost z veljavnimi pravili za zbiranje, shranjevanje in prihodnjo uporabo bioloških vzorcev udeležencev.
compliance with Article 49;
Ocena vidikov iz prvega pododstavka sestavlja del II poročila o oceni.
compliance with Article 50;
Vsaka zadevna država članica mora oceno končati v 45 dneh od datuma potrditve in prek EU portala predložiti sponzorju del II poročila o oceni, vključno z njeno ugotovitvijo.
compliance with Article 76;
Vsaka zadevna država članica lahko iz utemeljenih razlogov samo v roku iz prvega pododstavka od sponzorja zahteva dodatne informacije glede vidikov iz odstavka 1.
compliance with the applicable rules for the collection, storage and future use of biological samples of the subject.
Zaradi pridobitve in pregleda dodatnih informacij iz drugega pododstavka odstavka 2 od sponzorja v skladu z drugim in tretjim pododstavkom lahko zadevna država članica podaljša rok iz prvega pododstavka odstavka 2 za največ 31 dni.
The assessment of the aspects referred to in the first subparagraph shall constitute Part II of the assessment report.
Sponzor zahtevane dodatne informacije predloži v roku, ki ga določi zadevna država članica in ki ni daljši od 12 dni od prejema zahteve.
Each Member State concerned shall complete its assessment within 45 days from the validation date and submit, through the EU portal, Part II of the assessment report, including its conclusion, to the sponsor.
Zadevna država članica po prejemu dodatnih informacij dopolni svojo oceno v največ 19 dneh.
Each Member State concerned may request, with justified reasons, additional information from the sponsor regarding the aspects referred to in paragraph 1 only within the period referred to in the first subparagraph.
Kadar sponzor ne predloži dodatnih informacij v roku, ki ga določi zadevna država članica v skladu z drugim pododstavkom, se v tej zadevni državi članici šteje vloga za zapadlo.
For the purpose of obtaining and reviewing the additional information referred to in the second subparagraph of paragraph 2 from the sponsor in accordance with the second and third subparagraph, the Member State concerned may extend the period referred to in the first subparagraph of paragraph 2 by a maximum of 31 days.
Člen 8
The sponsor shall submit the requested additional information within the period set by the Member State concerned which shall not exceed 12 days from the receipt of the request.
Odločitev o kliničnem preskušanju
Upon receipt of the additional information, the Member State concerned shall complete its assessment within a maximum of 19 days.
Vsaka zadevna država članica obvesti sponzorja prek portala EU o tem, ali je klinično preskušanje odobreno, pogojno odobreno ali zavrnjeno.
Where the sponsor does not provide 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 concerned.
Sponzorja obvesti z eno samo odločitvijo v petih dneh od datuma poročanja ali zadnjega dneva ocenjevanja iz člena 7, kar je pozneje.
Article 8
Pogojna odobritev kliničnega preskušanja je omejena na pogoje, ki zaradi svoje narave ne morejo biti izpolnjeni v času odobritve.
Decision on the clinical trial
Kadar država članica poročevalka ugotovi, da je izvedba kliničnega preskušanja glede dela I poročila o oceni sprejemljiva ali pogojno sprejemljiva, se ta ugotovitev šteje za ugotovitev zadevne države članice.
Each Member State concerned shall notify the sponsor through the EU portal as to whether the clinical trial is authorised, whether it is authorised subject to conditions, or whether authorisation is refused.
Ne glede na prvi pododstavek pa se lahko zadevna država članica ne strinja z ugotovitvijo države članice poročevalke glede dela I poročila o oceni le na podlagi naslednjih razlogov:
Notification shall be done by way of one single decision within five days from the reporting date or from the last day of the assessment referred to in Article 7, whichever is later.
kadar meni, da bi zaradi udeležbe v kliničnem preskušanju prišlo do slabšega zdravljenja udeleženca kot pri običajni klinični praksi v zadevni državi članici;
An authorisation of a clinical trial subject to conditions is restricted to conditions which by their nature cannot be fulfilled at the time of that authorisation.
kršitve nacionalnega prava iz člena 90;
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 Member State concerned.
pomislekov glede varnosti udeleženca ter zanesljivosti in ponovljivosti podatkov, predloženih po odstavku 5 ali 8 člena 6.
Notwithstanding the first subparagraph, a 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:
Kadar se 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.
when it considers that participation in the clinical trial would lead to a subject receiving an inferior treatment than in normal clinical practice in the Member State concerned;
Kadar je klinično preskušanje glede vidikov, zajetih v delu I poročila o oceni, sprejemljivo ali pogojno sprejemljivo, zadevna država članica vključi v odločitev svoje ugotovitve glede dela II poročila o oceni.
infringement of its national law as referred to in Article 90;
Zadevna država članica zavrne odobritev kliničnega preskušanja, če se ne strinja z zaključkom države članice poročevalke glede dela I poročila o oceni iz razlogov, navedenih v drugem pododstavku odstavka 2 ali če na podlagi ustrezno utemeljenih razlogov meni, da niso upoštevani vidiki iz dela II poročila o oceni, ali kadar etični odbor izda negativno mnenje, ki v skladu s pravom zadevne države članice velja za to celotno državo članico.
considerations as regards subject safety and data reliability and robustness submitted under paragraph 5 or 8 of Article 6.
Ta država članica na takšno zavrnitev omogoči postopek pritožbe.
Where a 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.
Kadar je ugotovitev države članice poročevalke glede dela I poročila o oceni, da klinično preskušanje ni sprejemljivo, se ta ugotovitev šteje kot ugotovitev vseh zadevnih držav članic.
Where, regarding the aspects covered by Part I of the assessment report, the clinical trial is acceptable or acceptable subject to compliance with specific conditions, the Member State concerned shall include in its decision its conclusion on Part II of the assessment report.
Kadar zadevna država članica sponzorja o svoji odločitvi ni obvestila v ustreznih rokih iz odstavka 1, se ugotovitev glede dela I poročila o oceni šteje za odločitev zadevne države članice o vlogi za odobritev kliničnega preskušanja.
A Member State concerned shall refuse to authorise a 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 the second subparagraph of paragraph 2, 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 Member State concerned is valid for that entire Member State.
Zadevne države članice po datumu poročanja od sponzorja ne zahtevajo dodatnih informacij v zvezi z vidiki, zajetimi v delu I poročila o oceni.
That Member State shall provide for an appeal procedure in respect of such refusal.
V tem poglavju se za datum obvestila šteje datum, ko je sponzor obveščen o odločitvi iz odstavka 1.
Where the conclusion of the reporting Member State as regards Part I of the assessment report is that the clinical trial is not acceptable, that conclusion shall be deemed to be the conclusion of all Member States concerned.
Kadar sponzor ni bil obveščen v skladu z odstavkom 1, se za datum obvestila šteje zadnji dan roka iz odstavka 1.
Where the Member State concerned has not notified the sponsor of its decision within the relevant periods referred to in paragraph 1, the conclusion on 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 clinical trial.
Če v dveh letih od datuma odobritve ni bil v zadevni državi članici vključen noben udeleženec v klinično preskušanje, odobritev v tej zadevni državi članici preneha veljati, razen če je bilo na zahtevo sponzorja odobreno podaljšanje v skladu s postopkom iz Poglavja III.
The Member States concerned shall not request additional information regarding the aspects addressed in Part I of the assessment report from the sponsor after the reporting date.
Člen 9
For the purposes of this Chapter, the notification date shall be the date on which the decision referred to in paragraph 1 is notified to the sponsor.
Osebe, ki ocenjujejo vlogo
Where the sponsor has not been notified in accordance with paragraph 1, the notification date shall be deemed to be the last day of the period provided for in paragraph 1.
Države članice zagotovijo, da osebe, ki preverjajo in ocenjujejo vlogo, nimajo nasprotnih interesov, so neodvisne od sponzorja, mesta kliničnega preskušanja in raziskovalcev, ki sodelujejo pri preskušanju, ter oseb, ki klinično preskušanje financirajo, ter so tudi sicer nepristranske.
If no subject has been included in the clinical trial in a Member State concerned within two years from the notification date of the authorisation, the authorisation shall expire in that Member State concerned unless an extension, on request of the sponsor, has been approved following the procedure set out in Chapter III.
Da bi zagotovile neodvisnost in preglednost, države članice zagotovijo, da osebe, ki sprejmejo in ocenjujejo vlogo glede vidikov, zajetih v delih I in II poročila o oceni, nimajo finančnih ali osebnih interesov, ki bi lahko vplivali na njihovo nepristranskost.
Article 9
Te osebe pripravijo letno izjavo o svojih finančnih interesih.
Persons assessing the application
Države članice zagotovijo, da pri oceni sodeluje ustrezno število oseb, ki imajo skupaj potrebne kvalifikacije in izkušnje.
Member States shall ensure that the persons validating and assessing the application do not have conflicts of interest, are independent of the sponsor, of the clinical trial site and the investigators involved and of persons financing the clinical trial, as well as free of any other undue influence.
Pri oceni sodeluje vsaj en nestrokovnjak.
In order to guarantee independence and transparency, the Member States shall ensure that persons admitting and assessing the application as regards the aspects addressed in Parts I and II of the assessment report have no financial or personal interests which could affect their impartiality.
Člen 10
These persons shall make an annual declaration of their financial interests.
Posebna obravnava občutljivejših skupin prebivalstva
Member States shall ensure that the assessment is done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience.
Kadar so udeleženci mladoletne osebe, se pri ocenjevanju vloge za odobritev kliničnega preskušanja zlasti upošteva strokovno znanje s področja pediatrije ali se vključi posvetovanje o kliničnih, etičnih in psihosocioloških težavah na področju pediatrije.
At least one layperson shall participate in the assessment.
Kadar so udeleženci nezmožne osebe, se pri ocenjevanju vloge za odobritev kliničnega preskušanja zlasti upošteva strokovno znanje o ustrezni bolezni in zadevni populaciji pacientov ali se vključi posvetovanje o kliničnih, etičnih in psihosocioloških vprašanjih v zvezi z ustrezno boleznijo in zadevno populacijo pacientov.
Article 10
Kadar so udeleženke nosečnice ali doječe matere, se poseben poudarek nameni oceni vloge za odobritev kliničnega preskušanja na podlagi izvedenskega mnenja o ustreznem stanju in populaciji, ki jo predstavlja zadevna udeleženka.
Specific considerations for vulnerable populations
Če klinično preskušanje v skladu s protokolom predvideva sodelovanje posebnih skupin ali podskupin udeležencev, se po potrebi nameni posebna pozornost oceni vloge za odobritev kliničnega preskušanja na podlagi izvedenskega mnenja o populaciji, ki jo predstavljajo zadevni udeleženci.