natgillin/translations-raw huggingface dataset:
GODKENDELSESPROCEDURE FOR ET KLINISK FORSØG
Article 3
Artikel 4
General principle
Forhåndsgodkendelse
A clinical trial may be conducted only if:
Et klinisk forsøg skal underkastes en videnskabelig og etisk vurdering og godkendes i overensstemmelse med denne forordning.
the rights, safety, dignity and well-being of subjects are protected and prevail over all other interests; and
Den etiske vurdering foretages af en etisk komité i overensstemmelse med lovgivningen i den berørte medlemsstat.
it is designed to generate reliable and robust data.
Den etiske komités vurdering kan omfatte aspekter omhandlet i del I i vurderingsrapporten vedrørende godkendelsen af et klinisk forsøg, jf. artikel 6, og i del II af denne vurderingsrapport, jf. artikel 7, som det passer sig for den berørte medlemsstat.
CHAPTER II
Medlemsstaten sikrer, at fristerne og procedurerne for den etiske komités vurdering er forenelige med de frister og procedurer, der er fastsat i denne forordning for vurdering af ansøgningen om godkendelse af et klinisk forsøg.
AUTHORISATION PROCEDURE FOR A CLINICAL TRIAL
Indgivelse af en ansøgning
Prior authorisation
For at opnå en godkendelse indgiver sponsor et ansøgningsdossier til den berørte medlemsstat via den i artikel 80 omhandlede portal (»EU- portalen«).
A clinical trial shall be subject to scientific and ethical review and shall be authorised in accordance with this Regulation.
Sponsor foreslår en af de berørte medlemsstater som rapporterende medlemsstat.
The ethical review shall be performed by an ethics committee in accordance with the law of the Member State concerned.
Er en anden berørt medlemsstat end den foreslåede rapporterende medlemsstat villig til at være rapporterende medlemsstat, eller ønsker den foreslåede rapporterende medlemsstat ikke at være rapporterende medlemsstat, skal dette meddeles via EU-portalen til alle berørte medlemsstater senest tre dage efter, at ansøgningsdossieret er indgivet.
The review by the ethics committee may encompass aspects addressed in Part I of the assessment report for the authorisation of a clinical trial as referred to in Article 6 and in Part II of that assessment report as referred to in Article 7 as appropriate for each Member State concerned.
Er kun én berørt medlemsstat villig til at være rapporterende medlemsstat, eller involverer det kliniske forsøg kun én medlemsstat, er denne medlemsstat den rapporterende medlemsstat.
Member States shall ensure that the timelines and procedures for the review by the ethics committees are compatible with the timelines and procedures set out in this Regulation for the assessment of the application for authorisation of a clinical trial.
Er ingen berørt medlemsstat villig til at være rapporterende medlemsstat, eller er mere end én berørt medlemsstat villig til at være rapporterende medlemsstat, udvælges den rapporterende medlemsstat ved aftale mellem de berørte medlemsstater under hensyntagen til anbefalingerne i artikel 85, stk. 2, litra c).
Article 5
Er der ingen aftale mellem de berørte medlemsstater, er den foreslåede rapporterende medlemsstat den rapporterende medlemsstat.
Submission of an application
Den rapporterende medlemsstat meddeler sponsor og de øvrige berørte medlemsstater, at den er rapporterende medlemsstat, via EU-portalen senest seks dage efter indgivelse af ansøgningsdossieret.
In order to obtain an authorisation, the sponsor shall submit an application dossier to the intended Member States concerned through the portal referred to in Article 80 (the ‘EU portal’).
Sponsor skal, når der ansøges om et klinisk lav-interventionsforsøg, hvor forsøgslægemidlet ikke anvendes i overensstemmelse med vilkårene i markedsføringstilladelsen, men hvor anvendelsen af forsøgslægemidlet er evidensbaseret og understøttet af offentliggjort videnskabelig evidens for sikkerhed og effekt af forsøgslægemidlet, foreslå en af de berørte medlemsstater, i hvilken anvendelsen er evidensbaseret, som rapporterende medlemsstat.
The sponsor shall propose one of the Member States concerned as reporting Member State.
Senest ti 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 via EU-portalen sponsor:
If a Member State concerned other than the proposed reporting Member State is willing to be the reporting Member State or where the proposed reporting Member State does not wish to be the reporting Member State, this shall be notified through the EU portal to all Member States concerned not later than three days after the application dossier is submitted.
om det kliniske forsøg, der er ansøgt om, er omfattet af denne forordning
If only one Member State concerned is willing to be the reporting Member State or if the clinical trial involves only one Member State, that Member State shall be the reporting Member State.
om ansøgningsdossieret er fuldstændigt i overensstemmelse med bilag I.
If there is no Member State concerned willing to be the reporting Member State or if there is more than one Member State concerned willing to be the reporting Member State, the reporting Member State shall be selected by agreement among the Member States concerned taking into account the recommendations referred to in point (c) of Article 85(2).
Berørte medlemsstater kan meddele den rapporterende medlemsstat eventuelle overvejelser, som er relevante for valideringen af ansøgningen, senest syv dage efter indgivelsen af ansøgningsdossieret.
If there is no agreement among the Member States concerned, the proposed reporting Member State shall be the reporting Member State.
Har den rapporterende medlemsstat ikke underrettet sponsor inden for den frist, der er nævnt i stk. 3, første afsnit, anses det kliniske forsøg, der er ansøgt om, for at falde ind under denne forordnings anvendelsesområde, og ansøgningsdossieret anses for at være fuldstændigt.
The reporting Member State shall notify the sponsor and the other Member States concerned that it is the reporting Member State, through the EU portal, within six days from the submission of the application dossier.
Finder den rapporterende medlemsstat under hensyntagen til de overvejelser, som de øvrige berørte medlemsstater har givet udtryk for, at ansøgningsdossieret ikke er fuldstændig, eller at det kliniske forsøg, der er ansøgt om, ikke falder ind under denne forordnings anvendelsesområde, 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.
The sponsor shall, when applying for a low-intervention clinical trial, where the investigational medicinal product is not used in accordance with the terms of the marketing authorisation but the use of that product is evidence-based and supported by published scientific evidence on the safety and efficacy of that product, propose one of the Member States concerned where the use is evidence-based, as reporting Member State.
Den rapporterende medlemsstat underretter sponsor senest fem dage efter modtagelsen af de fremsatte bemærkninger eller det fuldstændiggjorte ansøgningsdossier om hvorvidt ansøgningen opfylder kravene i stk. 3, første afsnit, litra a) og b).
Within 10 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, of the following:
Har den rapporterende medlemsstat ikke underrettet sponsor inden for den frist, der er nævnt i andet afsnit, anses det kliniske forsøg for at falde ind under denne forordnings anvendelsesområde, og ansøgningsdossieret anses for at være fuldstændigt.
whether the clinical trial applied for falls within the scope of this Regulation;
Har sponsor ikke fremsat bemærkninger eller fuldstændiggjort ansøgningsdossieret inden for den frist, der er nævnt i første afsnit, anses ansøgningen for at være bortfaldet i alle berørte medlemsstater.
whether the application dossier is complete in accordance with Annex I;
Ved anvendelsen af dette kapitel er ansøgningens valideringsdato den dato, hvor sponsor underrettes i overensstemmelse med stk. 3 eller 5.
Member States concerned may communicate to the reporting Member State any considerations relevant to the validation of the application within seven 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. 3 og 5.
Where the reporting Member State has not notified the sponsor within the period referred to in the first subparagraph of paragraph 3, the clinical trial applied for shall be deemed to fall within the scope of this Regulation and the application dossier shall be considered complete.
Artikel 6
Where the reporting Member State, taking into account considerations expressed by the other Member States concerned, finds that the application dossier is not complete, or that the clinical trial applied for does not fall within the scope of this Regulation, 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.
Vurderingsrapport — aspekter omfattet af del I
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 the first subparagraph of paragraph 3.
Den rapporterende medlemsstat vurderer ansøgningen med hensyn til følgende aspekter:
Where the reporting Member State has not notified the sponsor within the period referred to in the second subparagraph, the clinical trial applied for shall be deemed to fall within the scope of this Regulation and the application dossier shall be considered complete.
hvorvidt det kliniske forsøg er et klinisk lav-interventionsforsøg, såfremt dette hævdes af sponsor
Where the sponsor has not provided comments or completed the application dossier within the period referred to in the first subparagraph, the application shall be deemed to have lapsed in all Member States concerned.
overensstemmelse med kapitel V med hensyn til følgende:
For the purposes of this Chapter, the date on which the sponsor is notified in accordance with paragraph 3 or 5 shall be the validation date of the application.
den forventede gevinst i terapeutisk henseende og for folkesundheden under hensyntagen til følgende:
Where the sponsor is not notified, the validation date shall be the last day of the respective periods referred to in paragraphs 3 and 5.
forsøgslægemidlernes egenskaber og viden om forsøgslægemidlerne
Article 6
det kliniske forsøgs relevans, herunder om grupperne af forsøgspersoner, der deltager i det kliniske forsøg, er repræsentative for den befolkningsgruppe, der skal behandles, eller hvis ikke, den forklaring og den begrundelse, der er givet i overensstemmelse med denne forordnings bilag I, punkt 17, litra y); den aktuelle videnskabelige viden; om det kliniske forsøg er blevet anbefalet eller pålagt af de kontrolmyndigheder, der er ansvarlige for at vurdere og godkende markedsføringen af lægemidler, samt, hvor det er relevant, en udtalelse udarbejdet af Det Pædiatriske Udvalg om en pædiatrisk godkendelsesplan i overensstemmelse med Europa-Parlamentets og Rådets forordning (EF) nr. 1901/2006 [12]pålideligheden og robustheden af de data, der genereres i det kliniske forsøg, under hensyntagen til statistiske metoder, det kliniske forsøges design og metodologi (herunder stikprøvestørrelse og randomisering, komparator og endepunkter).
Assessment report — Aspects covered by Part I
risici og ulemper for forsøgspersonen under hensyntagen til følgende:
The reporting Member State shall assess the application with regard to the following aspects:
forsøgslægemidlernes og hjælpelægemidlernes egenskaber og viden om forsøgslægemidlerne og hjælpelægemidlerne
Whether the clinical trial is a low-intervention clinical trial, where claimed by the sponsor;
karakteristika ved interventionen sammenlignet med normal klinisk praksis
Compliance with Chapter V with respect to the following:
sikkerhedsforanstaltningerne, herunder bestemmelser om risikominimeringsforanstaltninger, monitorering, sikkerhedsindberetning og sikkerhedsplanen
The anticipated therapeutic and public health benefits taking account of all of the following:
den risiko, som sygdomstilstanden, mod hvilken forsøgslægemidlet afprøves, medfører for forsøgspersonens sundhed
the characteristics of and knowledge about the investigational medicinal products;
overholdelse af kravene vedrørende fremstilling og import af forsøgslægemidler og hjælpelægemidler, jf. kapitel IX
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;
overholdelse af mærkningskravene, jf. kapitel X
The risks and inconveniences for the subject, taking account of all of the following:
investigatorbrochurens fuldstændighed og hensigtsmæssighed.
the characteristics of and knowledge about the investigational medicinal products and the auxiliary medicinal products;
Den rapporterende medlemsstat udarbejder en vurderingsrapport.
the characteristics of the intervention compared to normal clinical practice;
Vurderingen af de aspekter, der er nævnt i stk. 1, udgør del I af vurderingsrapporten.
the safety measures, including provisions for risk minimisation measures, monitoring, safety reporting, and the safety plan;
Vurderingsrapporten skal indeholde en af følgende konklusioner vedrørende de aspekter, der er omhandlet i del I i vurderingsrapporten:
the risk to subject health posed by the medical condition for which the investigational medicinal product is being investigated;
gennemførelsen af det kliniske forsøg kan accepteres på baggrund af de krav, der er fastsat i denne forordning
Compliance with the requirements concerning the manufacturing and import of investigational medicinal products and auxiliary medicinal products set out in Chapter IX;
gennemførelsen af det kliniske forsøg 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
Compliance with the labelling requirements set out in Chapter X;
gennemførelsen af det kliniske forsøg kan ikke accepteres på baggrund af de krav, der er fastsat i denne forordning.
The completeness and adequateness of the investigator's brochure.
Den rapporterende medlemsstat forelægger via EU-portalen den endelige del I af vurderingsrapporten, herunder konklusionen, for sponsor og de øvrige berørte medlemsstater senest 45 dage efter valideringsdatoen.
The reporting Member State shall draw up an assessment report.
Vurderingsprocessen for kliniske forsøg, som involverer mere end én medlemsstat, skal omfatte tre faser:
The assessment of the aspects referred to in paragraph 1 shall constitute Part I of the assessment report.
en indledende vurderingsfase gennemført af den rapporterende medlemsstat senest 26 dage efter valideringsdatoen
The assessment report shall contain one of the following conclusions concerning the aspects addressed in Part I of the assessment report:
en koordineret revisionsfase gennemført senest 12 dage efter den indledende vurderingsfases afslutning under inddragelse af alle berørte medlemsstater
the conduct of the clinical trial is acceptable in view of the requirements set out in this Regulation;
en konsolideringsfase gennemført af den rapporterende medlemsstat senest syv dage efter den koordinerede revisionsfases afslutning.
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
Den rapporterende medlemsstat udarbejder under den indledende vurderingsfase et udkast til del I af vurderingsrapporten og rundsender det til alle øvrige berørte medlemsstater.
the conduct of the clinical trial is not 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 del I af vurderingsrapporten og deler alle overvejelser, der er relevante for ansøgningen.
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.
Under konsolideringsfasen tager den rapporterende medlemsstat i forbindelse med færdiggørelsen af vurderingsrapportens del I behørigt hensyn til de øvrige berørte medlemsstaters overvejelser og registrerer, hvorledes alle sådanne overvejelser er blevet behandlet.
For clinical trials involving more than one Member State, the assessment process shall include three phases:
Den rapporterende medlemsstat forelægger den endelige del I af vurderingsrapporten for sponsor og alle øvrige berørte medlemsstater inden for den frist, der er nævnt i stk. 4.
an initial assessment phase performed by the reporting Member State within 26 days from the validation date;
Ved anvendelsen af dette kapitel er den dato, på hvilken den endelige del I af vurderingsrapporten forelægges af den rapporterende medlemsstat for sponsor og de øvrige berørte medlemsstater, rapporteringsdatoen.
a coordinated review phase performed within 12 days from the end of the initial assessment phase involving all Member States concerned;
Den rapporterende medlemsstat kan ligeledes forlænge den i stk. 4 nævnte frist med yderligere 50 dage for så vidt angår kliniske forsøg, der involverer et lægemiddel til avanceret terapi eller lægemidler, som defineret i nr. 1 i bilaget til forordning (EF) nr. 726/2004, med henblik på at konsultere eksperter.
a consolidation phase performed by the reporting Member State within seven days from the end of coordinated review phase.
I sådanne tilfælde finder fristerne i denne artikels stk. 5 og 6 tilsvarende anvendelse.
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.
Mellem valideringsdatoen og rapporteringsdatoen kan alene den rapporterende medlemsstat anmode sponsor om supplerende oplysninger under hensyntagen til de overvejelser, der er nævnt i stk. 5.
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.
Med henblik på indhentning og revision af disse supplerende oplysninger fra sponsor, jf. tredje og fjerde afsnit, kan den rapporterende medlemsstat forlænge den i stk. 4 omhandlede frist med højst 31 dage.
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.
Sponsor forelægger de supplerende oplysninger, der anmodes om, inden for den frist den rapporterende medlemsstat har fastsat, som ikke må overstige 12 dage fra modtagelsen af anmodningen.
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.
Efter modtagelsen af de supplerende oplysninger gennemgår de berørte medlemsstater i fællesskab de supplerende oplysninger, som sponsor har fremlagt, sammen med den oprindelige ansøgning og deler alle overvejelser, som er relevante for ansøgningen.
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.
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.
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.
Den rapporterende medlemsstat tager i forbindelse med færdiggørelsen af vurderingsrapportens del I behørigt hensyn til de berørte medlemsstaters overvejelser og registrerer, hvorledes alle sådanne overvejelser er blevet behandlet.
In such case, the periods referred to in paragraphs 5 and 8 of this Article shall apply mutatis mutandis.
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.
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.
Anmodningen om supplerende oplysninger og de supplerende oplysninger forelægges via EU-portalen.
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.
Artikel 7
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.
Vurderingsrapport — aspekter omfattet af del II
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.
Hver berørt medlemsstat vurderer, for så vidt angår dens område, ansøgningen med hensyn til følgende aspekter:
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.
opfyldelse af kravene til informeret samtykke, jf. kapitel V
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.
reglerne for udbetaling af honorar eller kompensation til forsøgspersoner opfylder kravene i kapitel V og investigatorer
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.
reglerne for rekruttering af forsøgspersoner opfylder kravene i kapitel V
The request for additional information and the additional information shall be submitted through the EU portal.
overensstemmelse med direktiv 95/46/EF
Article 7