natgillin/translations-raw huggingface dataset:
Efter modtagelsen af de supplerende oplysninger reviderer den yderligere berørte medlemsstat sammen med alle øvrige berørte medlemsstater de supplerende oplysninger, som sponsor har fremlagt, sammen med den oprindelige ansøgning og deler alle de overvejelser, som er relevante for ansøgningen.
considerations as regards subject safety and data reliability and robustness submitted under paragraph 5 or 6.
Den koordinerede revision foretages inden for højst 12 dage efter modtagelsen af de supplerende oplysninger og den yderligere konsolidering foretages inden for højst syv dage efter afslutningen af den koordinerede revision.
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.
Den rapporterende medlemsstat tager behørigt hensyn til de berørte medlemsstaters overvejelser og registrerer, hvorledes alle sådanne overvejelser er blevet behandlet.
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.
Fremlægger sponsor ikke de supplerende oplysninger inden for den frist, der er fastsat af den rapporterende medlemsstat i overensstemmelse med tredje afsnit, anses ansøgningen for at være bortfaldet i den yderligere berørte medlemsstat.
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.
Den yderligere berørte medlemsstat vurderer, for så vidt angår dens område, de aspekter, der er omfattet af del II af vurderingsrapporten inden for den i stk. 3 nævnte frist og via EU-portalen forelægge sponsor del II af vurderingsrapporten, herunder dens konklusioner.
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.
Inden for denne frist kan den af begrundede årsager anmode sponsor om supplerende oplysninger vedrørende aspekter omfattet af del II af vurderingsrapporten, for så vidt angår dens område.
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.
Med henblik på indhentning og revision af supplerende oplysninger som omhandlet i stk. 7 fra sponsor i overensstemmelse med andet og tredje afsnit kan den yderligere berørte medlemsstat forlænge den i stk. 7 nævnte frist med højst 31 dage.
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.
Sponsor forelægger de supplerende oplysninger inden for den frist der er fastsat af den yderligere medlemsstat, som ikke må overstige 12 dage fra modtagelsen af anmodningen.
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.
Fremlægger sponsor ikke de supplerende oplysninger inden for den frist, der er fastsat af den yderligere medlemsstat i overensstemmelse med andet afsnit, anses ansøgningen for at være bortfaldet i den yderligere berørte medlemsstat.
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.
Såfremt det kliniske forsøg for så vidt angår de aspekter, der er omfattet af del I af vurderingsrapporten, kan accepteres eller kan accepteres under overholdelse af særlige betingelser, skal den yderligere berørte medlemsstats afgørelse indeholde dens konklusion vedrørende del II af vurderingsrapporten.
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.
Har den yderligere berørte medlemsstat ikke meddelt sponsor sin afgørelse inden for den frist, der er nævnt i stk. 3, eller i tilfælde af, at denne frist er blevet forlænget i overensstemmelse med stk. 6 eller 8, hvis den yderligere berørte medlemsstat ikke har meddelt sponsoren sin afgørelse inden for den forlængede frist, anses konklusionen vedrørende del I af vurderingsrapporten for at være denne yderligere berørte medlemsstats afgørelse om ansøgningen om godkendelse af det kliniske forsøg.
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.
En sponsor må ikke indgive et ansøgningsdossier i henhold til denne artikel, hvis en procedure som fastsat i kapitel III vedrørende det kliniske forsøg endnu ikke er afsluttet.
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.
KAPITEL III
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.
GODKENDELSESPROCEDURE FOR EN VÆSENTLIG ÆNDRING AF ET KLINISK FORSØG
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.
Artikel 15
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.
En væsentlig ændring, herunder tilføjelse af et klinisk forsøgssted eller udskiftning af en hovedinvestigator på det kliniske forsøgssted, må kun gennemføres, hvis den er godkendt efter den procedure, der er fastsat i dette kapitel.
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.
Artikel 16
That additional Member State concerned shall provide for an appeal procedure in respect of such refusal.
Indgivelse af ansøgning
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.
For at opnå en godkendelse indgiver sponsor et ansøgningsdossier til de berørte medlemsstater gennem EU-portalen.
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.
Artikel 17
CHAPTER III
Validering af en ansøgning om godkendelse af en væsentlig ændring af et aspekt, der er omfattet af del I af vurderingsrapporten
AUTHORISATION PROCEDURE FOR A SUBSTANTIAL MODIFICATION OF A CLINICAL TRIAL
Den rapporterende medlemsstat for godkendelsen af en væsentlig ændring er den rapporterende medlemsstat for den oprindelige godkendelsesprocedure.
Article 15
Berørte medlemsstater kan meddele den rapporterende medlemsstat de overvejelser, som er relevante for valideringen af ansøgningen om en væsentlig ændring, senest fem dage efter indgivelsen af ansøgningsdossieret.
General principles
Senest seks dage efter indgivelse af ansøgningsdossieret validerer den rapporterende medlemsstat ansøgningen under hensyntagen til de overvejelser, som de øvrige berørte medlemsstater har givet udtryk for, og underretter sponsor via EU-portalen, om:
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.
den væsentlige ændring vedrører et aspekt, der er omfattet af del I af vurderingsrapporten, og
Article 16
ansøgningsdossieret i overensstemmelse med bilag II er fuldstændigt.
Submission of application
Har den rapporterende medlemsstat ikke underrettet sponsor inden for den frist, der er nævnt i stk. 2, anses den væsentlige ændring, der er ansøgt om, for at vedrøre et aspekt, der er omfattet af del I af vurderingsrapporten og ansøgningsdossieret anses for at være fuldstændigt.
In order to obtain an authorisation, the sponsor shall submit an application dossier to the Member States concerned through the EU portal.
Finder den rapporterende medlemsstat under hensyntagen til overvejelserne fra de øvrige berørte medlemsstater, at ansøgningen ikke vedrører et aspekt, der er omfattet af del I af vurderingsrapporten, eller at ansøgningsdossieret ikke er fuldstændigt, underretter den sponsor herom via EU-portalen og fastsætter en frist på højst ti dage for sponsor til at fremsætte bemærkninger til ansøgningen eller til at fuldstændiggøre ansøgningsdossieret via EU-portalen.
Article 17
Den rapporterende medlemsstat underretter senest fem dage efter modtagelse af bemærkningerne eller det fuldstændiggjorte ansøgningsdossier sponsor om, hvorvidt ansøgningen opfylder kravene i stk. 2, litra a) og b).
Validation of an application for the authorisation of a substantial modification of an aspect covered by Part I of the assessment report
Har den rapporterende medlemsstat ikke underrettet sponsor inden for den frist, der er nævnt i andet afsnit, anses den væsentlige ændring, der er ansøgt om, for at vedrøre et aspekt, der er omfattet af del I af vurderingsrapporten og ansøgningsdossieret anses for at være fuldstændigt.
The reporting Member State for the authorisation of a substantial modification shall be the reporting Member State for the initial authorisation procedure.
Med henblik på artikel 18, 19 og 22 er ansøgningens valideringsdato den dato, hvor sponsor underrettes i overensstemmelse med stk. 2 eller 4.
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.
Hvis sponsor ikke underrettes, er valideringsdatoen den sidste dag i de respektive frister, der er nævnt i stk. 2 og 4.
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:
Artikel 18
the substantial modification concerns an aspect covered by Part I of the assessment report; and
Vurdering af en væsentlig ændring af et aspekt, der er omfattet af del I af vurderingsrapporten
the application dossier is complete in accordance with Annex II.
Den rapporterende medlemsstat vurderer ansøgningen for så vidt angår et aspekt, der er omfattet af del I af vurderingsrapporten, herunder om det kliniske forsøg fortsat vil være et klinisk lav-interventionsforsøg efter den væsentlige ændring, og udarbejder en vurderingsrapport.
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.
den væsentlige ændring kan accepteres på baggrund af de krav, der er fastsat i denne forordning
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.
den væsentlige ændring kan accepteres på baggrund af de krav, der er fastsat i denne forordning, dog kun på særlige betingelser, der specifikt er anført i konklusionen, eller
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.
den væsentlige ændring kan ikke accepteres på baggrund af de krav, der er fastsat i denne forordning.
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.
Den rapporterende medlemsstat forelægger via EU-portalen den endelige vurderingsrapport, herunder konklusionen, for sponsor og de øvrige berørte medlemsstater senest 38 dage efter valideringsdatoen.
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.
Ved anvendelsen af denne artikel samt artikel 19 og 23 er rapporteringsdatoen den dato, hvor den endelige vurderingsrapport forelægges for sponsor og de øvrige berørte medlemsstater.
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.
Processen for vurdering af væsentlige ændringer i forbindelse med kliniske forsøg, som involverer mere end én medlemsstat, skal omfatte tre faser:
Article 18
en indledende vurderingsfase gennemført af den rapporterende medlemsstat senest 19 dage efter valideringsdatoen
Assessment of a substantial modification of an aspect covered by Part I of the assessment report
en koordineret revisionsfase gennemført senest 12 dage efter den indledende vurderingsfases afslutning under inddragelse af alle berørte medlemsstater, og
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.
Den rapporterende medlemsstat udarbejder under den indledende vurderingsfase et udkast til en vurderingsrapport og rundsender dette udkast til alle berørte medlemsstater.
the substantial modification is acceptable in view of the requirements set out in this Regulation;
Under den koordinerede revisionsfase vurderer alle berørte medlemsstater i fællesskab ansøgningen på grundlag af udkastet til vurderingsrapporten og deler alle overvejelser, der er relevante for ansøgningen.
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
Under konsolideringsfasen tager den rapporterende medlemsstat i forbindelse med færdiggørelsen af vurderingsrapporten behørigt hensyn til de øvrige berørte medlemsstaters overvejelser og registrerer, hvorledes sådanne overvejelser er blevet behandlet.
the substantial modification is not acceptable in view of the requirements set out in this Regulation.
Den rapporterende medlemsstat forelægger sponsor og alle øvrige medlemsstater den endelige vurderingsrapport senest på rapporteringsdatoen.
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.
Den rapporterende medlemsstat kan ligeledes forlænge den i stk. 3 nævnte frist med yderligere 50 dage for så vidt angår kliniske forsøg, der involverer et forsøgslægemiddel til avanceret terapi eller et lægemiddel som omhandlet i nr. 1 i bilaget til forordning (EF) nr. 726/2004, med henblik på at konsultere eksperter.
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.
I sådanne tilfælde finder fristerne i denne artikels stk. 4 og 6 tilsvarende anvendelse.
For clinical trials involving more than one Member State the assessment process of substantial modification shall include three phases:
Mellem valideringsdatoen og rapporteringsdatoen kan alene den rapporterende medlemsstat anmode sponsor om supplerende oplysninger under hensyntagen til de overvejelser, der er nævnt i stk. 4.
an initial assessment phase performed by the reporting Member State within 19 days from the validation date;
Med henblik på indhentning og revision af disse supplerende oplysninger fra sponsor i overensstemmelse med tredje og fjerde afsnit kan den rapporterende medlemsstat forlænge den i stk. 3, første afsnit, nævnte frist med højst 31 dage.
a coordinated review phase performed within 12 days from the end of the initial assessment phase involving all Member States concerned; and
Den koordinerede revision foretages inden for højst 12 dage efter modtagelse af de supplerende oplysninger og den yderligere konsolidering foretages inden for højst syv dage efter den koordinerede revision er tilendebragt.
During the initial assessment phase, the reporting Member State shall develop a draft assessment report and circulate it to all Member States concerned.
Den rapporterende medlemsstat tager i forbindelse med færdiggørelsen af vurderingsrapporten behørigt hensyn til de øvrige berørte medlemsstaters overvejelser og registrerer hvorledes, sådanne overvejelser er blevet behandlet.
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.
Fremlægger sponsor ikke de supplerende oplysninger inden for den frist, der er fastsat af den rapporterende medlemsstat i overensstemmelse med tredje afsnit, anses ansøgningen for at være bortfaldet i alle berørte medlemsstater.
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.
Artikel 19
The reporting Member State shall submit the final assessment report to the sponsor and all other Member States concerned by the reporting date.
Afgørelse om den væsentlige ændring af et aspekt, der er omfattet af del I af vurderingsrapporten
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.
Hver berørt medlemsstat meddeler via EU-portalen sponsor, om den væsentlige ændring godkendes, om den godkendes på visse betingelser, eller om der gives afslag på godkendelse.
In such case, the periods referred to in paragraphs 4 and 6 of this Article shall apply mutatis mutandis.
Meddelelsen sker ved hjælp af en enkelt afgørelse senest fem dage efter rapporteringsdatoen.
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.
En godkendelse af en væsentlig ændring på visse betingelser er begrænset til betingelser, som ifølge deres natur ikke kan opfyldes på tidspunktet for denne godkendelse.
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.
Er den rapporterende medlemsstats konklusion, at den væsentlige ændring kan accepteres eller kan accepteres under overholdelse af særlige betingelser, anses den pågældende konklusion for at være den berørte medlemsstats konklusion.
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.
Uanset første afsnit må en berørt medlemsstat kun erklære sig uenig i den rapporterende medlemsstats konklusion af følgende grunde:
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.
overvejelser vedrørende forsøgspersoners sikkerhed eller dataenes pålidelighed og robusthed, som er fremført i henhold til artikel 18, stk. 4 eller 6.
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.
Er den berørte medlemsstat ikke enig i konklusionen på grundlag af andet afsnit, underretter den via EU-portalen Kommissionen, alle medlemsstater og sponsor herom og giver en detaljeret begrundelse.
Article 19
En berørt medlemsstat afviser at godkende en væsentlig ændring, hvis den af de i andet afsnit anførte grunde ikke er enig i den rapporterende medlemsstats konklusioner for så vidt angår del I af vurderingsrapporten, eller hvis en etisk komité har afgivet en negativ udtalelse, som i overensstemmelse med lovgivningen i denne berørte medlemsstat, er gældende for hele denne medlemsstat.
Decision on the substantial modification of an aspect covered by Part I of the assessment report
Er den rapporterende medlemsstats konklusion for så vidt angår den væsentlige ændring af aspekter, der er omfattet af del I af vurderingsrapporten, at den væsentlige ændring ikke kan accepteres, anses den pågældende konklusion for at være alle berørte medlemsstaters konklusion.
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.
Har den berørte medlemsstat ikke meddelt sponsor sin afgørelse inden for den i stk. 1 nævnte frist, anses konklusionen i vurderingsrapporten for at være den berørte medlemsstats afgørelse om ansøgningen om godkendelse af den væsentlige ændring.
Notification shall be done by way of a single decision within five days from the reporting date.