natgillin/translations-raw huggingface dataset:
Information from the sponsor at the end of a clinical investigation or in the event of a temporary halt or early termination
Postopek usklajenega ocenjevanja za klinične raziskave
If the sponsor has temporarily halted a clinical investigation or has terminated a clinical investigation early, it shall inform within 15 days the Member State in which that clinical investigation has been temporarily halted or terminated early, through the electronic system referred to in Article 73, of the temporary halt or early termination, providing a justification.
Sponzor klinične raziskave, ki se bo izvajala v več kot eni državi članici, lahko prek elektronskega sistema iz člena 73 za namene člena 70 predloži enotno vlogo, ki se ob prejemu elektronsko posreduje vsem državam članicam, v katerih bo ta raziskava potekala.
In the event that the sponsor has temporarily halted or terminated early the clinical investigation on safety grounds, it shall inform all Member States in which that clinical investigation is being conducted thereof within 24 hours.
Sponzor v enotni vlogi iz odstavka 1 predlaga, da ima ena od držav članic, v katerih bo potekala klinična raziskava, vlogo države članice koordinatorke.
The end of a clinical investigation shall be deemed to coincide with the last visit of the last subject unless another point in time for such end is set out in the clinical investigation plan.
Države članice, v katerih bo potekala klinična raziskava, se v šestih dneh po predložitvi vloge dogovorijo, katera od njih bo prevzela to vlogo.
The sponsor shall notify each Member State in which a clinical investigation was being conducted of the end of that clinical investigation in that Member State.
Če se ne morejo dogovoriti, vlogo prevzame država članica, ki jo predlaga sponzor.
That notification shall be made within 15 days of the end of the clinical investigation in relation to that Member State.
Zadevne države članice pod vodstvom države članice koordinatorke iz odstavka 2 usklajujejo svoje ocenjevanje vloge, zlasti dokumentacije iz poglavja II Priloge XV.
If an investigation is conducted in more than one Member State, the sponsor shall notify all Member States in which that clinical investigation was conducted of the end of the clinical investigation in all Member States.
Koliko je dokumentacija iz oddelkov 1.13, 3.1.3, 4.2, 4.3 in 4.4 poglavja II Priloge XV popolna, pa oceni vsaka zadevna država članica ločeno v skladu s členom 70(1) do (5).
That notification shall be made within 15 days of that end of the clinical investigation.
V zvezi z dokumentacijo, ki ni tista iz drugega pododstavka odstavka 3, država članica koordinatorka:
Irrespective of the outcome of the clinical investigation, within one year of the end of the clinical investigation or within three months of the early termination or temporary halt, the sponsor shall submit to the Member States in which a clinical investigation was conducted a clinical investigation report as referred to in Section 2.8 of Chapter I and Section 7 of Chapter III of Annex XV.
v šestih dneh od prejema enotne vloge sponzorja uradno obvesti, da je država članica koordinatorka ona (v nadaljnjem besedilu: datum uradnega obvestila);
The clinical investigation report shall be accompanied by a summary presented in terms that are easily understandable to the intended user.
za potrditev vloge upošteva vse pomisleke, ki jih katera koli zadevna država članica predloži v sedmih dneh od datuma uradnega obvestila;
Both the report and summary shall be submitted by the sponsor by means of the electronic system referred to in Article 73.
v desetih dneh od datuma uradnega obvestila oceni, ali klinična raziskava spada v področje uporabe te uredbe in ali je vloga popolna, ter o tem uradno obvesti sponzorja.
Where, for scientific reasons, it is not possible to submit the clinical investigation report within one year of the end of the investigation, it shall be submitted as soon as it is available.
Za državo članico koordinatorko se v zvezi s to oceno uporablja člen 70(1) in (3) do (5);
In such case, the clinical investigation plan referred to in Section 3 of Chapter II of Annex XV shall specify when the results of the clinical investigation are going to be available, together with a justification.
rezultate svoje ocene strne v osnutku ocenjevalnega poročila, ki se v 26 dneh po datumu potrditve pošlje zadevnim državam članicam.
The Commission shall issue guidelines regarding the content and structure of the summary of the clinical investigation report.
Druge zadevne države članice do 38. dne po datumu potrditve svoje pripombe in predloge glede osnutka ocenjevalnega poročila in osnovne vloge pošljejo državi članici koordinatorki, ki jih ustrezno upošteva pri dokončnem oblikovanju končnega ocenjevalnega poročila, ki mora biti v 45 dneh po datumu potrditve poslano sponzorju in drugim zadevnim državam članicam.
In addition, the Commission may issue guidelines for the formatting and sharing of raw data, for cases where the sponsor decides to share raw data on a voluntary basis.
Končno ocenjevalno poročilo upoštevajo vse zadevne države članice, ko odločajo o vlogi sponzorja v skladu s členom 70(7).
Those guidelines may take as a basis and adapt, where possible, existing guidelines for sharing of raw data in the field of clinical investigations.
Kar zadeva ocenjevanje dokumentacije iz drugega pododstavka odstavka 3, lahko vsaka zadevna država članica od sponzorja enkrat samkrat zahteva dodatne informacije.
The summary and the clinical investigation report referred to in paragraph 5 of this Article shall become publicly accessible through the electronic system referred to in Article 73, at the latest when the device is registered in accordance with Article 29 and before it is placed on the market.
Sponzor zahtevane dodatne informacije predloži v roku, ki ga določi zadevna država članica in ki ni daljši od 12 dni od prejema zahteve.
In cases of early termination or temporary halt, the summary and the report shall become publicly accessible immediately after submission.
Tek zadnjega roka iz točke (d) odstavka 4 se od datuma zahtevka do prejema dodatnih informacij prekine.
If the device is not registered in accordance with Article 29 within one year of the summary and the report having been entered into the electronic system pursuant to paragraph 5 of this Article, they shall become publicly accessible at that point in time.
Za pripomočke razredov IIb in III lahko država članica koordinatorka roke iz odstavka 4 podaljša za dodatnih 50 dni zaradi posvetovanja s strokovnjaki.
Article 78
Komisija lahko z izvedbenimi akti podrobneje določi postopke in časovne okvire za usklajena ocenjevanja, zadevne države članice pa te potem upoštevajo pri odločanju o vlogi sponzorja.
Coordinated assessment procedure for clinical investigations
V takšnih izvedbenih aktih so lahko določeni tudi postopki in časovni okviri za usklajeno ocenjevanje v primeru bistvenih sprememb na podlagi odstavka 12 tega člena, v primeru poročanja o neželenih dogodkih na podlagi člena 80(4) in v primeru kliničnih raziskav za izdelke, ki so kombinacija medicinskih pripomočkov in zdravil, če so slednja vključena v vzporedno usklajeno ocenjevanje kliničnega preskušanja na podlagi Uredbe (EU) št. 536/2014.
By means of the electronic system referred to in Article 73, the sponsor of a clinical investigation to be conducted in more than one Member State may submit, for the purpose of Article 70, a single application that, upon receipt, is transmitted electronically to all Member States in which the clinical investigation is to be conducted.
Kadar država članica koordinatorka v zvezi s področjem usklajenega ocenjevanja ugotovi, da je izvedba klinične raziskave sprejemljiva ali pogojno sprejemljiva, se ta ugotovitev šteje za ugotovitev vseh zadevnih držav članic.
The sponsor shall propose in the single application referred to in paragraph 1 that one of the Member States in which the clinical investigation is to be conducted acts as coordinating Member State.
Ne glede na prvi pododstavek lahko zadevna država članica nestrinjanje z ugotovitvijo države članice koordinatorke v zvezi s področjem usklajenega ocenjevanja izrazi le:
The Member States in which the clinical investigation is to be conducted shall, within six days of submission of the application, agree on one of them taking the role of the coordinating Member State.
kadar meni, da bi bilo zdravljenje udeleženca zaradi udeležbe v klinični raziskavi slabše kot pri običajni klinični praksi v tej zadeni državi članici;
If they do not agree on a coordinating Member State, the coordinating Member State proposed by the sponsor shall assume that role.
zaradi kršitev nacionalnega prava ali
Under the direction of the coordinating Member State referred to in paragraph 2, the Member States concerned shall coordinate their assessment of the application, in particular of the documentation referred to in Chapter II of Annex XV.
pomislekov glede varnosti udeleženca ter zanesljivosti in ponovljivosti podatkov, predloženih na podlagi točke (b) odstavka 4.
However, the completeness of the documentation referred to in Sections 1.13, 3.1.3, 4.2, 4.3 and 4.4 of Chapter II of Annex XV shall be assessed separately by each Member State concerned in accordance with Article 70(1) to (5).
Kadar se ena od zadevnih držav članic na podlagi drugega pododstavka tega odstavka z ugotovitvijo ne strinja, o tem prek elektronskega sistema iz člena 73 obvesti Komisijo, vse druge države članice in sponzorja ter priloži podrobno utemeljitev.
With regard to documentation other than that referred to in the second subparagraph of paragraph 3, the coordinating Member State shall:
Kadar država članica koordinatorka v zvezi s področjem usklajenega ocenjevanja ugotovi, da klinična raziskava ni sprejemljiva, se ta ugotovitev šteje za ugotovitev vseh zadevnih držav članic.
within six days of receipt of the single application, notify the sponsor that it is the coordinating Member State (‘notification date’);
Zadevna država članica odobritev klinične raziskave zavrne, če se ne strinja z ugotovitvami države članice koordinatorke glede katerega koli od razlogov, navedenih v drugem pododstavku odstavka 8, ali če na podlagi ustrezno utemeljenih razlogov meni, da niso upoštevani vidiki iz oddelkov 1.13., 3.1.3, 4.2, 4.3 in 4.4 poglavja II Priloge XV, ali če je odbor za etiko v zvezi z navedeno klinično raziskavo dal negativno mnenje, ki je veljavno za celotno zadevno državo članico v skladu z njenim nacionalnim pravom.
for the purpose of the validation of the application, take into account any considerations submitted within seven days of the notification date by any Member State concerned;
Ta država članica poskrbi, da je v zvezi s takšno zavrnitvijo omogočen postopek pritožbe.
within 10 days of the notification date, assess whether the clinical investigation falls within the scope of this Regulation and whether the application is complete, and shall notify the sponsor accordingly.
Vsaka zadevna država članica prek elektronskega sistema iz člena 73 sponzorja uradno obvesti o tem, ali je klinična raziskava odobrena, pogojno odobrena ali pa je njena odobritev zavrnjena.
Article 70(1) and (3) to (5) shall apply to the coordinating Member State in relation to that assessment;
To stori z eno samo odločitvijo v petih dneh po tem, ko država članica koordinatorka na podlagi točke (d) odstavka 4 pošlje končno ocenjevalno poročilo.
establish the results of its assessment in a draft assessment report to be transmitted within 26 days of the validation date to the Member States concerned.
Pri pogojni odobritvi klinične raziskave so pogoji lahko samo takšni, ki zaradi svoje narave ne morejo biti izpolnjeni ob odobritvi.
By day 38 after the validation date, the other Member States concerned shall transmit their comments and proposals on the draft assessment report and the underlying application to the coordinating Member State which shall take due account of those comments and proposals in its finalisation of the final assessment report, to be transmitted within 45 days of the validation date to the sponsor and the other Member States concerned.
Zadevne države članice so o vseh znatnih spremembah, navedenih v členu 75, uradno obveščene prek elektronskega sistema iz člena 73.
The final assessment report shall be taken into account by all Member States concerned when deciding on the sponsor's application in accordance with Article 70(7).
Vsakršno ocenjevanje o tem, ali obstajajo razlogi za nestrinjanje iz drugega pododstavka odstavka 8 tega člena, se izvede pod vodstvom države članice koordinatorke, razen če gre za bistvene spremembe v zvezi z oddelki 1.13, 3.1.3, 4.2, 4.3 in 4.4 poglavja II Priloge XV, ki jih vsaka zadevna država članica oceni sama.
As regards the assessment of the documentation referred to in the second subparagraph of paragraph 3, each Member State concerned may request, on a single occasion, additional information from the sponsor.
Komisija državi članici koordinatorki zagotovi administrativno podporo pri izvajanju njenih nalog v skladu s tem poglavjem.
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.
Postopek, določen v tem členu, se do 27. maja 2027 uporablja le za tiste zadevne države članice, v katerih se bo klinična raziskava izvajala in ki so se strinjale z njegovo uporabo.
The expiry of the last deadline pursuant to point (d) of paragraph 4 shall be suspended from the date of the request until such time as the additional information has been received.
Po 27. maju 2027 se uporaba tega postopka zahteva od vseh držav članic.
For class IIb and class III devices, the coordinating Member State may also extend the periods referred to in paragraph 4 by a further 50 days, for the purpose of consulting with experts.
Člen 79
The Commission may, by means of implementing acts, further specify the procedures and timescales for coordinated assessments to be taken into account by Member States concerned when deciding on the sponsor's application.
Pregled postopka usklajenega ocenjevanja
Such implementing acts may also set out the procedures and timescales for coordinated assessment in the case of substantial modifications pursuant to paragraph 12 of this Article, in the case of reporting of adverse events pursuant to Article 80(4) and in the case of clinical investigations of combination products between medical devices and medicinal products, where the latter are under a concurrent coordinated assessment of a clinical trial under Regulation (EU) No 536/2014.
Komisija do 27. maja 2026 Evropskemu parlamentu in Svetu predloži poročilo o izkušnjah, pridobljenih z uporabo člena 78, ter, če je potrebno, predlaga pregled člena 78(14) in točke (h) člena 123(3).
Where the conclusion of the coordinating Member State concerning the area of coordinated assessment is that the conduct of the clinical investigation is acceptable or acceptable subject to compliance with specific conditions, that conclusion shall be deemed to be the conclusion of all Member States concerned.
Člen 80
Notwithstanding the first subparagraph, a Member State concerned may only disagree with the conclusion of the coordinating Member State concerning the area of coordinated assessment on the following grounds:
Evidentiranje neželenih dogodkov, ki se zgodijo med izvajanjem kliničnih raziskav, in poročanje o njih
when it considers that participation in the clinical investigation would lead to a subject receiving treatment inferior to that received in normal clinical practice in that Member State concerned;
Sponzor v celoti evidentira:
infringement of national law; or
vse neželene dogodke, ki so v skladu z načrtom klinične raziskave opredeljeni kot ključni za oceno rezultatov te klinične raziskave;
considerations as regards subject safety and data reliability and robustness submitted under point (b) of paragraph 4.
vse resne neželene dogodke;
Where one of the Member States concerned disagrees with the conclusion on the basis of the second subparagraph of this paragraph, it shall communicate its disagreement, together with a detailed justification, through the electronic system referred to in Article 73, to the Commission, to all other Member States concerned and to the sponsor.
vseh pomanjkljivostih pripomočka, ki bi lahko povzročile resni neželeni dogodek v primeru, da ne bi bili sprejeti ustrezni ukrepi, ne bi prišlo do posredovanja ali bi bile okoliščine manj ugodne;
Where the conclusion of the coordinating Member State concerning the area of coordinated assessment is that the clinical investigation is not acceptable, that conclusion shall be deemed to be the conclusion of all Member States concerned.
vse nove ugotovitve v zvezi z vsakim dogodkom iz točk (a) do (c).
A Member State concerned shall refuse to authorise a clinical investigation if it disagrees with the conclusion of the coordinating Member State as regards any of the grounds referred to in the second subparagraph of paragraph 8, or if it finds, on duly justified grounds, that the aspects addressed in Sections 1.13, 3.1.3, 4.2, 4.3 and 4.4 of Chapter II of Annex XV are not complied with, or where an ethics committee has issued a negative opinion in relation to that clinical investigation, which is valid, in accordance with national law, for that entire Member State.
Sponzor vsem državam članicam, v katerih poteka klinična raziskava, prek elektronskega sistema iz člena 73 nemudoma poroča o vsem naslednjem:
That Member State shall provide for an appeal procedure in respect of such refusal.
vseh resnih neželenih dogodkih, ki so vzročno povezani s pripomočkom, ki je predmet raziskave, primerjalnim pripomočkom ali postopkom raziskave, ali kadar je taka vzročna povezava razumno mogoča;
Each Member State concerned shall notify the sponsor through the electronic system referred to in Article 73 as to whether the clinical investigation is authorised, whether it is authorised subject to conditions, or whether authorisation has been refused.
vseh novih ugotovitvah v zvezi z vsakršnimi dogodki iz točk (a) in (b).
Notification shall be done by way of one single decision within five days of the transmission, pursuant to point (d) of paragraph 4, by the coordinating Member State of the final assessment report.
Pri roku za poročanje se upošteva resnost dogodka.
Where an authorisation of a clinical investigation is subject to conditions, those conditions may only be such that, by their nature, they cannot be fulfilled at the time of that authorisation.
Po potrebi lahko sponzor zaradi zagotavljanja pravočasnega poročanja najprej predloži začetno poročilo, ki je nepopolno, pozneje pa še popolno poročilo.
Any substantial modifications as referred to in Article 75 shall be notified to the Member States concerned by means of the electronic system referred to in Article 73.
Sponzor na podlagi zahteve katere koli države članice, v kateri se izvaja klinična raziskava, zagotovi vse informacije iz odstavka 1.
Any assessment as to whether there are grounds for disagreement as referred to in the second subparagraph of paragraph 8 of this Article shall be carried out under the direction of the coordinating Member State, except for substantial modifications concerning Sections 1.13, 3.1.3, 4.2, 4.3 and 4.4 of Chapter II of Annex XV, which shall be assessed separately by each Member State concerned.
Sponzor državam članicam, v katerih se izvaja klinična raziskava, prek elektronskega sistema iz člena 73 poroča tudi o vseh dogodkih iz odstavka 2 tega člena, ki se zgodijo v tretjih državah, v katerih se klinična raziskava izvaja po enakem načrtu klinične raziskave, kot je tisti, ki se uporablja za klinično raziskavo, ki jo ureja ta uredba.
The Commission shall provide administrative support to the coordinating Member State in the accomplishment of its tasks under this Chapter.
Sponzor v primeru klinične raziskave, za katero je uporabil enotno vlogo iz člena 78, o vseh primerih iz odstavka 2 tega člena poroča prek elektronskega sistema iz člena 73.
The procedure set out in this Article shall, until 27 May 2027, be applied only by those of the Member States in which the clinical investigation is to be conducted which have agreed to apply it.
To poročilo se po prejemu v elektronski obliki pošlje vsem državam članicam, v katerih poteka klinična raziskava.
After 27 May 2027, all Member States shall be required to apply that procedure.
Države članice pod vodstvom države članice koordinatorke iz člena 78(2) uskladijo svoje ocenjevanje resnih neželenih dogodkov in pomanjkljivosti pripomočkov, da določijo, ali je treba klinično raziskavo spremeniti, prekiniti ali ustaviti, ali pa preklicati odobritev zanjo.
Article 79
Ta odstavek ne vpliva na pravice drugih držav članic, da izvajajo lastne ocene in sprejemajo ukrepe v skladu s to uredbo, da bi varovale javno zdravje in varnost pacientov.
Review of coordinated assessment procedure
Država članica koordinatorka in Komisija sta obveščeni o izidu vsake takšne ocene in sprejetju vseh takšnih ukrepov.
By 27 May 2026, the Commission shall submit to the European Parliament and to the Council a report on experience gained from the application of Article 78 and, if necessary, propose a review of Article 78(14) and point (h) of Article 123(3).
V primeru raziskav v sklopu kliničnega spremljanja po dajanju na trg iz člena 74(1) se namesto tega člena uporabljajo določbe o vigilanci iz členov 87 do 90 in iz aktov, sprejetih na podlagi člena 91.
Article 80
Brez poseganja v odstavek 5 se ta člen uporablja, če obstaja vzročna povezava med resnim neželenim dogodkom in prej izvedenim raziskovalnim postopkom.
Recording and reporting of adverse events that occur during clinical investigations
Člen 81
The sponsor shall fully record all of the following:
Izvedbeni akti
any adverse event of a type identified in the clinical investigation plan as being critical to the evaluation of the results of that clinical investigation;
Komisija lahko z izvedbenimi akti določi podrobne ureditve in postopkovne vidike, potrebne za izvajanje tega poglavja, v zvezi s:
any serious adverse event;
harmoniziranimi elektronskimi obrazci za vlogo za klinične raziskave in njihovo ocenjevanje iz členov 70 in 78, ob upoštevanju posebnih kategorij ali skupin pripomočkov;
any device deficiency that might have led to a serious adverse event if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate;
delovanjem elektronskega sistema iz člena 73;
any new findings in relation to any event referred to in points (a) to (c).
harmoniziranimi elektronskimi obrazci za priglasitev raziskave v sklopu kliničnega spremljanja po dajanju na trg iz člena 74(1) ter bistvenih sprememb iz člena 75;
The sponsor shall report, without delay to all Member States in which the clinical investigation is being conducted, all of the following by means of the electronic system referred to in Article 73:
izmenjavo informacij med državami članicami iz člena 76;
any serious adverse event that has a causal relationship with the investigational device, the comparator or the investigation procedure or where such causal relationship is reasonably possible;
harmoniziranimi elektronskimi obrazci za poročanje o resnih neželenih dogodkih in pomanjkljivostih pripomočkov iz člena 80;
any new findings in relation to any event referred to in points (a) and (b).
roki za poročanje o resnih neželenih dogodkih in pomanjkljivostih pripomočkov, ob upoštevanju resnosti dogodka, o katerem je treba poročati, kot je navedeno v členu 80;
The period for reporting shall take account of the severity of the event.
enotno uporabo zahtev, kar zadeva klinične dokaze ali podatke, ki so potrebni za dokazovanje skladnosti s splošnimi zahtevami glede varnosti in učinkovitosti iz Priloge I.
Where necessary to ensure timely reporting, the sponsor may submit an initial report that is incomplete followed up by a complete report.
Izvedbeni akti iz prvega odstavka se sprejmejo v skladu s postopkom pregleda iz člena 114(3).
Upon request by any Member State in which the clinical investigation is being conducted, the sponsor shall provide all information referred to in paragraph 1.
Člen 82