natgillin/translations-raw huggingface dataset:
CHAPTER X
Informacije, ki morajo biti navedene na zunanji in stični ovojnini, zagotavljajo varnost udeležencev ter zanesljivost in ponovljivost podatkov iz kliničnega preskušanja, pri čemer se upošteva načrt kliničnega preskušanja in dejstvo, ali gre za zdravila v preskušanju ali pomožna zdravila ter ali gre za zdravila s posebnimi značilnostmi.
LABELLING
Informacije, ki morajo biti navedene na zunanji in stični ovojnini, so jasno čitljive.
Article 66
Seznam informacij, ki morajo biti navedene na zunanji in stični ovojnini, je naveden v Prilogi VI.
Unauthorised investigational and unauthorised auxiliary medicinal products
Člen 67
The following information shall appear on the outer packaging and on the immediate packaging of unauthorised investigational medicinal products and unauthorised auxiliary medicinal products:
Odobrena zdravila v preskušanju in odobrena pomožna zdravila
information to identify contact persons or persons involved in the clinical trial;
Odobrena zdravila v preskušanju in odobrena pomožna zdravila morajo biti označena
information to identify the clinical trial;
v skladu s členom 66(1) ali
information to identify the medicinal product;
v skladu z naslovom V Direktive 2001/83/ES.
information related to the use of the medicinal product.
Na zunanji in stični ovojnini odobrenih zdravil v preskušanju so ne glede na točko (b) odstavka 1 navedene tudi dodatne informacije o kliničnem preskušanju in kontaktni osebi, kadar je to potrebno zaradi posebnih okoliščin kliničnega preskušanja, navedenih v protokolu, da se zagotovijo varnost udeležencev ter zanesljivost in ponovljivost podatkov iz kliničnega preskušanja.
The information which is to appear on the outer packaging and immediate packaging shall ensure subject safety and reliability and robustness of the data generated in the clinical trial, while taking account of the design of the clinical trial, whether the products are investigational or auxiliary medicinal product, and whether they are products with particular characteristics.
Seznam teh dodatnih informacij, ki morajo biti navedene na zunanji in stični ovojnini, je naveden v oddelku C Priloge VI.
The information which is to appear on the outer packaging and immediate packaging shall be clearly legible.
Člen 68
A list of information which is to appear on the outer packaging and immediate packaging is set out in Annex VI.
Radiofarmaki, ki se uporabljajo kot zdravila v preskušanju ali kot pomožna zdravila za diagnosticiranje
Article 67
Člena 66 in 67 se ne uporabljata za radiofarmake, ki se uporabljajo kot diagnostična zdravila v preskušanju ali kot diagnostična pomožna zdravila.
Authorised investigational and authorised auxiliary medicinal products
Zdravila iz prvega odstavka so ustrezno označena, da se zagotovijo varnost udeleženca ter zanesljivost in ponovljivost podatkov iz kliničnega preskušanja.
Authorised investigational medicinal products and authorised auxiliary medicinal products shall be labelled:
Člen 69
in accordance with Article 66(1); or
Jezik
in accordance with Title V of Directive 2001/83/EC.
Jezik informacij na ovojninah določi zadevna država članica.
Notwithstanding point (b) of paragraph 1, where the specific circumstances, provided for in the protocol, of a clinical trial so require in order to ensure the safety of the subject or the reliability and robustness of data generated in a clinical trial, additional particulars relating to the identification of the clinical trial and of the contact person shall appear on the outer packaging and the immediate packaging of authorised investigational medicinal products.
Zdravilo je lahko označeno v več jezikih.
A list of these additional particulars appearing on the outer packaging and immediate packaging is set out in section C of Annex VI.
Člen 70
Article 68
Delegirani akt
Radiopharmaceuticals used as investigational medicinal products or as auxiliary medicinal products for a medical diagnosis
Na Komisijo se prenese pooblastilo za sprejetje delegiranih aktov v skladu s členom 89 v zvezi s spreminjanjem Priloge VI zaradi zagotavljanja varnosti udeleženca ter zanesljivosti in ponovljivosti podatkov iz kliničnega preskušanja ali zaradi upoštevanja tehničnega napredka.
Articles 66 and 67 shall not apply to radiopharmaceuticals used as diagnostic investigational medicinal products or as diagnostic auxiliary medicinal products.
POGLAVJE XI
The products referred to in the first paragraph shall be labelled appropriately in order to ensure the safety of the subject and the reliability and robustness of data generated in the clinical trial.
SPONZOR IN RAZISKOVALEC
Article 69
Člen 71
Language
Sponzor
The language of the information on the label shall be determined by the Member State concerned.
Klinično preskušanje ima lahko enega ali več sponzorjev.
The medicinal product may be labelled in several languages.
Vsak sponzor lahko s pisno pogodbo prenese katero od svojih nalog (ali vse) na posameznika, podjetje, ustanovo ali organizacijo.
Article 70
Prenesena pooblastila ne posegajo v odgovornost sponzorja, predvsem glede varnosti udeležencev ter zanesljivosti in ponovljivosti podatkov, pridobljenih v kliničnem preskušanju.
Delegated act
Raziskovalec in sponzor sta lahko ista oseba.
The Commission shall be empowered to adopt delegated acts in accordance with Article 89 in respect of amending Annex VI in order to ensure subject safety and the reliability and robustness of data generated in a clinical trial or to take account of technical progress.
Člen 72
CHAPTER XI
Sosponzorstvo
SPONSOR AND INVESTIGATOR
Brez poseganja v člen 74 velja, da kadar ima klinično preskušanje več sponzorjev, imajo vsi odgovornost sponzorja v skladu s to uredbo, razen če v pisni pogodbi, v kateri so določene njihove odgovornosti, ne določijo drugače.
Article 71
Kadar v pogodbi ni določeno, kateri sponzor je odgovoren za določeno vprašanje, so zanj odgovorni vsi sponzorji.
Sponsor
Z odstopanjem od odstavka 1 so sponzorji skupaj odgovorni za določitev:
A clinical trial may have one or several sponsors.
sponzorja, ki je odgovoren za skladnost z obveznostmi sponzorja v postopkih za odobritev iz poglavij II in III;
Any sponsor may delegate, in a written contract, any or all of its tasks to an individual, a company, an institution or an organisation.
sponzorja, ki je odgovoren, da je kontaktna točka za vsa vprašanja udeležencev, raziskovalcev ali katere koli zadevne države članice v zvezi s kliničnim preskušanjem in da jim zagotavlja odgovore;
Such delegation shall be without prejudice to the responsibility of the sponsor, in particular regarding the safety of subjects and the reliability and robustness of the data generated in the clinical trial.
sponzorja, ki je odgovoren za izvajanje ukrepov v skladu s členom 77.
The investigator and the sponsor may be the same person.
Člen 73
Article 72
Glavni raziskovalec
Co-sponsorship
Glavni raziskovalec zagotovi skladnost kliničnega preskušanja na kraju preskušanja z zahtevami te uredbe.
Without prejudice to Article 74, where a clinical trial has more than one sponsor, all sponsors shall have the responsibilities of a sponsor set out in this Regulation, unless the sponsors decide otherwise in a written contract setting out their respective responsibilities.
Članom skupine raziskovalcev dodeljuje naloge tako, da ne ogroža varnosti udeležencev ter zanesljivosti in ponovljivosti podatkov, pridobljenih v kliničnem preskušanju na kraju preskušanja.
Where the contract does not specify to which sponsor a given responsibility is attributed, that responsibility shall lie with all sponsors.
Člen 74
By way of derogation from paragraph 1, the sponsors shall be jointly responsible for establishing:
Zakoniti zastopnik sponzorja v Uniji
a sponsor responsible for compliance with the obligations of a sponsor in the authorisation procedures set out in Chapters II and III;
Kadar sponzor kliničnega preskušanja ni ustanovljen v Uniji, zagotovi, da ima v Uniji sedež fizična ali pravna oseba kot njegov zakoniti zastopnik.
a sponsor responsible for being a contact point for receiving all questions from subjects, investigators or any Member State concerned regarding the clinical trial and providing answers to them;
Tak zakonit zastopnik je odgovoren za zagotovitev, da sponzor izpolnjuje svoje obveznosti iz te uredbe in je kontaktna oseba za vso komunikacijo s sponzorjem, ki jo določa ta uredba.
a sponsor responsible for implementing the measures taken in accordance with Article 77.
Vsa komunikacija z zakonitim zastopnikom se šteje za komunikacijo s sponzorjem.
Article 73
Države članice lahko odločijo, da ne bodo uporabljale odstavka 1 pri kliničnih preskušanjih, ki se izvajajo samo na njihovem ozemlju ali na njihovem ozemlju in na ozemlju tretjih držav, pod pogojem, da zagotovijo, da sponzor na njihovem ozemlju določi vsaj kontaktno osebo za posamezno klinično preskušanje, ki bo naslovnik za vso komunikacijo s sponzorjem, predvideno v tej uredbi.
Principal investigator
Pri kliničnih preskušanjih, ki se izvajajo v več državah članicah, se lahko vse odločijo, da ne bodo uporabljale odstavka 1, pod pogojem, da zagotovijo, da sponzor v Uniji določi vsaj kontaktno osebo za posamezno klinično preskušanje, ki bo naslovnik za vso komunikacijo s sponzorjem, predvideno v tej uredbi.
A principal investigator shall ensure compliance of a clinical trial at a clinical trial site with the requirements of this Regulation.
Člen 75
The principal investigator shall assign tasks among the members of the team of investigators in a way which is not compromising the safety of subjects and the reliability and robustness of the data generated in the clinical trial at that clinical trial site.
Odškodninska odgovornost
Article 74
To poglavje ne vpliva na civilno in kazensko odgovornost sponzorja, raziskovalca ali oseb, na katere je sponzor prenesel naloge.
Legal representative of the sponsor in the Union
POGLAVJE XII
Where the sponsor of a clinical trial is not established in the Union, that sponsor shall ensure that a natural or legal person is established in the Union as its legal representative.
ODŠKODNINA
Such legal representative shall be responsible for ensuring compliance with the sponsor's obligations pursuant to this Regulation, and shall be the addressee for all communications with the sponsor provided for in this Regulation.
Člen 76
Any communication to that legal representative shall be deemed to be a communication to the sponsor.
Odškodnina
Member States may choose not to apply paragraph 1 as regards clinical trials to be conducted solely on their territory, or on their territory and the territory of a third country, provided that they ensure that the sponsor establishes at least a contact person on their territory in respect of that clinical trial who shall be the addressee for all communications with the sponsor provided for in this Regulation.
Države članice zagotovijo, da so na voljo odškodninski sistemi za morebitno škodo, ki jo utrpi udeleženec zaradi sodelovanja v kliničnem preskušanju, ki se izvaja na ozemlju teh držav, in sicer v obliki zavarovanja ali jamstva ali podobne ureditve, ki je enakovredna glede na namen ter ustreza naravi in obsegu tveganja.
As regards clinical trials to be conducted in more than one Member State, all those Member States may choose not to apply paragraph 1 provided that they ensure that the sponsor establishes at least a contact person in the Union in respect of that clinical trial who shall be the addressee for all communications with the sponsor provided for in this Regulation.
Sponzor in raziskovalec uporabljata sistem iz odstavka 1 v obliki, ki je primerna za zadevno državo članico, kjer se izvaja klinično preskušanje.
Article 75
Države članice od sponzorja ne zahtevajo dodatne uporabe sistema iz odstavka 1 za klinična preskušanja z minimalno intervencijo, če je morebitna škoda, ki bi jo mogel utrpeti udeleženec zaradi uporabe zdravila v preskušanju v skladu s protokolom tega posameznega kliničnega preskušanja, na ozemlju te države članice krita v že obstoječem odškodninskem sistemu.
Liability
POGLAVJE XIII
This Chapter shall not affect the civil and criminal liability of the sponsor, investigator, or persons to whom the sponsor has delegated tasks.
NADZOR S STRANI DRžAV ČLANIC TER PREGLEDI IN NADZOR S STRANI UNIJE
CHAPTER XII
Člen 77
DAMAGE COMPENSATION
Korektivni ukrepi, ki jih sprejmejo države članice
Article 76
Kadar zadevna država članica iz utemeljenih razlogov meni, da zahteve iz te uredbe niso več izpolnjene, lahko na svojem ozemlju sprejme naslednje ukrepe:
Damage compensation
prekliče odobritev kliničnega preskušanja;
Member States shall ensure that systems for compensation for any damage suffered by a subject resulting from participation in a clinical trial conducted on their territory are in place in the form of insurance, a guarantee, or a similar arrangement that is equivalent as regards its purpose and which is appropriate to the nature and the extent of the risk.
odloži klinično preskušanje;
The sponsor and the investigator shall make use of the system referred to in paragraph 1 in the form appropriate for the Member State concerned where the clinical trial is conducted.
od sponzorja zahteva, da spremeni katerega od vidikov kliničnega preskušanja.
Member States shall not require any additional use of the system referred to in paragraph 1 from the sponsor for low-intervention clinical trials, if any possible damage that could be suffered by a subject resulting from the use of the investigational medicinal product in accordance with the protocol of that specific clinical trial on the territory of that Member State is covered by the applicable compensation system already in place.
Država članica pred sprejetjem katerega koli ukrepa iz odstavka 1,– razen kadar je potrebno takojšnje ukrepanje,– prosi sponzorja in/ali raziskovalca za mnenje.
CHAPTER XIII
To mnenje se poda v sedmih dneh.
SUPERVISION BY MEMBER STATES, UNION INSPECTIONS AND CONTROLS
Zadevna država članica nemudoma po sprejetju ukrepa iz odstavka 1 to prek portala EU sporoči vsem zadevnim državam članicam.
Article 77
Vsaka zadevna država članica se lahko pred sprejetjem katerega koli od ukrepov iz odstavka 1 posvetuje z drugimi zadevnimi državami članicami.
Corrective measures to be taken by Member States
Člen 78
Where a Member State concerned has justified grounds for considering that the requirements set out in this Regulation are no longer met, it may take the following measures on its territory:
Pregledi s strani držav članic
revoke the authorisation of a clinical trial;
Države članice imenujejo inšpektorje, ki izvajajo preglede, s katerimi nadzirajo skladnost s to uredbo.
suspend a clinical trial;
Zagotovijo, da so ti inšpektorji ustrezno kvalificirani in usposobljeni.
require the sponsor to modify any aspect of the clinical trial.
Pregledi se izvajajo v pristojnosti države članice, v kateri poteka pregled.
Before the Member State concerned takes any of the measures referred to in paragraph 1 it shall, except where immediate action is required, ask the sponsor and/or the investigator for their opinion.
Kadar namerava zadevna država članica na svojem ozemlju ali v tretji državi izvesti pregled v zvezi z enim ali več kliničnimi preskušanji, ki se izvajajo v več zadevnih državah članicah, o tem prek portala EU obvesti druge zadevne države članice, Komisijo in Agencijo, po pregledu pa jih obvesti tudi o svojih ugotovitvah.
That opinion shall be delivered within seven days.
Nekomercialni sponzorji so oproščeni morebitnih inšpekcijskih taks.
The Member State concerned shall immediately after taking a measure referred to in paragraph 1 inform all Member States concerned through the EU portal.
Da bi se razpoložljivi viri uporabili čim gospodarneje in da se prepreči podvajanje, Agencija usklajuje sodelovanje med zadevnimi državami članicami pri pregledih, ki ga države članice izvajajo v tretjih državah, in pregledih, ki se izvaja v okviru vloge za pridobitev dovoljenja za promet z zdravilom v skladu z Uredbo (ES) št. 726/2004.
Each Member State concerned may consult the other Member States concerned before taking any of the measures referred to in paragraph 1.
Država članica, v pristojnosti katere je bil izveden pregled, po končanem pregledu pripravi poročilo o pregledu.
Article 78
Država članica poročilo o pregledu predloži subjektu, pri katerem se opravi pregled, in sponzorju kliničnega preskušanja in ga predloži prek portala EU.
Member State inspections
Komisija z izvedbenimi akti določi podrobno ureditev postopkov pregleda, vključno z zahtevami glede kvalifikacij in usposabljanja inšpektorjev.
Member States shall appoint inspectors to perform inspections in order to supervise compliance with this Regulation.
Člen 79
They shall ensure that those inspectors are adequately qualified and trained.
Preverjanje Unije
Inspections shall be conducted under the responsibility of the Member State where the inspection takes place.
Komisija lahko preverja:
Where a Member State concerned intends to carry out an inspection on its territory or in a third country with regard to one or several clinical trials which are conducted in more than one Member State concerned, it shall notify its intention to the other Member States concerned, the Commission and the Agency, through the EU portal, and shall inform them of its findings after the inspection.
ali države članice pravilno nadzirajo skladnosti s to uredbo;
Inspections fees, if any, may be waived for non-commercial sponsors.
ali regulatorni sistem, ki se uporablja za izvedbo kliničnih preskušanj zunaj Unije, zagotavlja skladnost s točko 8 Uvoda in splošnih navodil, vsebovanih v Prilogi I k Direktivi 2001/83/ES;
In order to efficiently use the resources available and to avoid duplications, the Agency shall coordinate the cooperation between Member States concerned on inspections conducted in Member States, in third countries, and inspections conducted in the framework of an application for a marketing authorisation under Regulation (EC) No 726/2004.
ali regulatorni sistem, ki se uporablja za izvedbo kliničnih preskušanj zunaj Unije, zagotavlja skladnost s členom 25(5) te uredbe.
Following an inspection, the Member State under whose responsibility the inspection has been conducted shall draw up an inspection report.
Preverjanje Unije iz točke (a) odstavka 1 se organizira v sodelovanju z zadevno državo članico.
That Member State shall make the inspection report available to the inspected entity and the sponsor of the relevant clinical trial and shall submit the inspection report through the EU portal.
Komisija v sodelovanju z državami članicami pripravi program za preverjanja iz točk (b) in (c) odstavka 1.
The Commission shall specify, by means of implementing acts, the detailed arrangements for the inspection procedures including the qualification and training requirements for inspectors.
Komisija poroča o ugotovitvah vsakega opravljenega preverjanja s strani Unije.
Article 79
Poročila po potrebi vsebujejo priporočila.
Union controls
Komisija ta poročila predloži prek portala EU.
The Commission may conduct controls in order to verify:
POGLAVJE XIV
whether Member States correctly supervise compliance with this Regulation;
INFRASTRUKTURA INFORMACIJSKE TEHNOLOGIJE
whether the regulatory system applicable to clinical trials conducted outside the Union ensures that point 8 of the Introduction and general principles contained in Annex I to Directive 2001/83/EC is complied with;
Člen 80
whether the regulatory system applicable to clinical trials conducted outside the Union ensures that Article 25(5) of this Regulation is complied with.
Portal EU
The Union controls referred to in point (a) of paragraph 1 shall be organised in cooperation with the Member States concerned.
Agencija v sodelovanju z državami članicami in Komisijo na ravni Unije vzpostavi in vzdržuje portal kot enotno vstopno točko za predložitev podatkov in informacij, ki se nanašajo na klinična preskušanja v skladu s to uredbo.
The Commission shall prepare in cooperation with the Member States a programme for the Union controls referred to in points (b) and (c) of paragraph 1.
Portal EU je tehnično napreden in uporabniku prijazen, da se prepreči nepotrebno delo.
The Commission shall report on the findings of each Union control carried out.
Podatki in informacije, predloženi prek portala EU, se hranijo v podatkovni zbirki EU.
Those reports shall, if appropriate, contain recommendations.
Člen 81
The Commission shall submit those reports through the EU portal.
Podatkovna zbirka EU
CHAPTER XIV
Agencija v sodelovanju z državami članicami in Komisijo vzpostavi in vzdržuje podatkovno zbirko EU na ravni Unije.
IT INFRASTRUCTURE
Šteje se, da je Agencija upravljavec podatkovne zbirke EU in je odgovorna za preprečevanje nepotrebnega podvajanja med to podatkovno zbirko EU in zbirkama EudraCT in EudraVigilance.
Article 80
Podatkovna zbirka EU vsebuje podatke in informacije, predložene v skladu s to uredbo.
EU portal
V podatkovni zbirki EU je vsako klinično preskušanje označeno z enotno številko EU preskušanja.
The Agency shall, in collaboration with the Member States and the Commission, set up and maintain a portal at Union level as a single entry point for the submission of data and information relating to clinical trials in accordance with this Regulation.
Sponzor se v naknadno predloženih vlogah, ki se nanašajo ali navezujejo na to klinično preskušanje, sklicuje na to številko EU preskušanja.
The EU portal shall be technically advanced and user-friendly so as to avoid unnecessary work.
Podatkovna zbirka EU se vzpostavi, da se omogoči sodelovanje pristojnih organov zadevnih držav članic, kolikor je to potrebno za uporabo te uredbe in iskanje določenih kliničnih preskušanj.
Data and information submitted through the EU portal shall be stored in the EU database.
Zbirka omogoča tudi lažjo komunikacijo med sponzorji in zadevnimi državami članicami, sponzorjem pa omogoča, da poiščejo predhodno predložene vloge za odobritev kliničnega preskušanja ali bistvene spremembe.
Article 81
Tudi državljanom Unije omogoča dostop do kliničnih informacij o zdravilih.
EU database
V ta namen so vsi podatki v podatkovni zbirki EU v obliki, ki omogoča enostavno iskanje, vsi sorodni podatki so medsebojno povezani s številko EU preskušanja, na voljo pa so tudi hiperpovezave, da se povežejo sorodni podatki in dokumenti v podatkovni zbirki EU in drugih podatkovnih zbirkah, ki jih upravlja Agencija.
The Agency shall, in collaboration with the Member States and the Commission, set up and maintain a EU database at Union level.
Podatkovna zbirka EU podpira evidentiranje in predložitev slovarja zdravil iz podatkovne zbirke EudraVigilance, vseh podatkov o zdravilih brez dovoljenja za promet v Uniji, in snoveh, ki niso dovoljene kot del zdravila v Uniji, ki so potrebne za vzdrževanje tega slovarja.
The Agency shall be considered to be the controller of the EU database and shall be responsible for avoiding unnecessary duplication between the EU database and the EudraCT and Eudravigilance databases.
V ta namen ter zato, da se bo sponzor lahko skliceval na prejšnje vloge, se za vsako zdravilo brez dovoljenja za promet izda EU številka zdravila, za vsako novo aktivno snov, ki še ni pridobila dovoljenja kot del zdravila v Uniji, pa se izda koda EU za aktivno snov.
The EU database shall contain the data and information submitted in accordance with this Regulation.
To se izvede pred ali med predložitvijo vloge za odobritev prvega kliničnega preskušanja z navedenim zdravilom ali aktivno snovjo, za katera je predložena vloga v skladu s to uredbo.
The EU database shall identify each clinical trial by a unique EU trial number.
Te številke se navedejo v vseh poznejših vlogah za klinično preskušanje in za bistvene spremembe.
The sponsor shall refer to this EU trial number in any subsequent submission relating or referring to that clinical trial.
Podatki, predloženi v skladu s prvim pododstavkom, ki opisujejo zdravila in snovi, so v skladu s standardi Unije in mednarodnimi standardi za identifikacijo zdravil in aktivnih snovi.