natgillin/translations-raw huggingface dataset:
In order to verify that the rights, safety and well-being of subjects are protected, that the reported data are reliable and robust, and that the conduct of the clinical trial is in compliance with the requirements of this Regulation, the sponsor shall adequately monitor the conduct of a clinical trial.
Člen 50
The extent and nature of the monitoring shall be determined by the sponsor on the basis of an assessment that takes into consideration all characteristics of the clinical trial, including the following characteristics:
Primernost mest kliničnega preskušanja
whether the clinical trial is a low-intervention clinical trial;
Prostori, v katerih se izvaja preskušanje, morajo biti primerni za izvajanje kliničnega preskušanja v skladu z zahtevami te uredbe.
the objective and methodology of the clinical trial; and
Člen 51
the degree of deviation of the intervention from normal clinical practice.
Sledljivost, hramba, vračanje in uničevanje zdravil v preskušanju
Article 49
Za zdravila v preskušanju se zagotovi sledljivost.
Suitability of individuals involved in conducting the clinical trial
Hranijo, vrnejo in/ali uničijo se, ko je ustrezno in sorazmerno, da se zagotovijo varnost udeležencev ter zanesljivost in ponovljivost podatkov iz kliničnega preskušanja, pri čemer se upošteva, ali je zdravilo v preskušanju odobreno in ali gre za klinično preskušanje z minimalno intervencijo.
The investigator shall be a medical doctor as defined in national law, or a person following a profession which is recognised in the Member State concerned as qualifying for an investigator because of the necessary scientific knowledge and experience in patient care.
Prvi pododstavek se uporablja tudi za neodobrena pomožna zdravila.
Other individuals involved in conducting a clinical trial shall be suitably qualified by education, training and experience to perform their tasks.
Informacije o sledljivosti, hrambi, vračanju in uničenju zdravil iz odstavka 1 se vključijo v dosje vloge.
Article 50
Člen 52
Suitability of clinical trial sites
Poročanje o hudih kršitvah
The facilities where the clinical trial is to be conducted shall be suitable for the conduct of the clinical trial in compliance with the requirements of this Regulation.
Sponzor obvesti zadevne države članice o hudi kršitvi te uredbe ali takrat veljavne različice protokola prek portala EU brez odlašanja, a najpozneje v sedmih dneh, ko je izvedel za kršitev.
Article 51
Za namene tega člena za „hudo kršitev“ šteje kršitev, ki lahko znatno vpliva na varnost in pravice udeleženca ali zanesljivost in ponovljivost podatkov iz kliničnega preskušanja.
Traceability, storage, return and destruction of investigational medicinal products
Člen 53
Investigational medicinal products shall be traceable.
Druge obveznosti poročanja, pomembne za varnost udeležencev
They shall be stored, returned and/or destroyed as appropriate and proportionate to ensure the safety of the subject and the reliability and robustness of the data generated in the clinical trial, in particular, taking into account whether the investigational medicinal product is an authorised investigational medicinal product, and whether the clinical trial is a low-intervention clinical trial.
Sponzor prek portala EU obvesti zadevne države članice o vseh nepričakovanih dogodkih, ki vplivajo na spremembo razmerja med koristmi in tveganji pri kliničnem preskušanju, vendar pri njih ne gre za sum na nepričakovane resne neželene učinke iz člena 42.
The first subparagraph shall also apply to unauthorised auxiliary medicinal products.
Obvestilo se pošlje brez odlašanja, vendar najpozneje v 15 dneh od dneva, ko sponzor izve za dogodek.
The relevant information regarding the traceability, storage, return and destruction of medicinal products referred to in paragraph 1 shall be contained in the application dossier.
Sponzor prek portala EU predloži zadevnim državam članicam vsa poročila o nadzoru s strani organov tretjih držav v zvezi s kliničnim preskušanjem.
Article 52
Kadar zadevna država članica to zahteva, sponzor predloži prevod poročila ali njegov povzetek v katerem od uradnih jezikov Unije, navedenih v zahtevku.
Reporting of serious breaches
Člen 54
The sponsor shall notify the Member States concerned about a serious breach of this Regulation or of the version of the protocol applicable at the time of the breach through the EU portal without undue delay but not later than seven days of becoming aware of that breach.
Nujni varnostni ukrepi
For the purposes of this Article, a ‘serious breach’ means a breach likely to affect to a significant degree the safety and rights of a subject or the reliability and robustness of the data generated in the clinical trial.
Kadar je verjetno, da bo nepričakovan dogodek pomembno vplival na razmerje med koristmi in tveganji, sponzor in raziskovalec sprejmeta ustrezne nujne varnostne ukrepe za zaščito udeležencev.
Article 53
Sponzor prek portala EU obvesti zadevne države članice o dogodku in sprejetih ukrepih.
Other reporting obligations relevant for subject safety
Obvestilo se pošlje brez odlašanja, vendar najpozneje v sedmih dneh od dneva, ko se sprejmejo ukrepi.
The sponsor shall notify the Member States concerned through the EU portal of all unexpected events which affect the benefit-risk balance of the clinical trial, but are not suspected unexpected serious adverse reactions as referred to in Article 42.
Ta člen ne posega v poglavji III in VII.
That notification shall be made without undue delay but no later than 15 days from the date the sponsor became aware of this event.
Člen 55
The sponsor shall submit to the Member States concerned, through the EU portal, all inspection reports of third country authorities concerning the clinical trial.
Brošura za raziskovalca
When requested by a Member State concerned, the sponsor shall submit a translation of the report or of its summary in an official language of the Union indicated in the request.
Sponzor raziskovalcu predloži brošuro za raziskovalca.
Article 54
Brošura za raziskovalca se dopolni, če so na voljo nove in relevantne informacije o varnosti in jo sponzor vsaj enkrat letno pregleda.
Urgent safety measures
Člen 56
Where an unexpected event is likely to seriously affect the benefit-risk balance, the sponsor and the investigator shall take appropriate urgent safety measures to protect the subjects.
Evidentiranje, obdelava, obravnava in shranjevanje informacij
The sponsor shall notify the Member States concerned, through the EU portal, of the event and the measures taken.
Sponzor ali raziskovalec, kar je ustrezno, evidentira, obdeluje, obravnava in shranjuje vse informacije o kliničnem preskušanju tako, da je omogočeno natančno poročanje, razlaga in preverjanje informacij, zaupnost evidenc in osebnih podatkov udeležencev pa je še vedno zagotovljena v skladu z veljavnim pravom o varstvu osebnih podatkov.
That notification shall be made without undue delay but no later than seven days from the date the measures have been taken.
Izvedejo se ustrezni tehnični in organizacijski ukrepi za zaščito obdelanih informacij in osebnih podatkov pred nepooblaščenim ali nezakonitim dostopanjem, razkritjem, razširjanjem, spreminjanjem, uničenjem ali nenamerno izgubo, zlasti kadar obdelava zajema prenos prek omrežja.
This Article is without prejudice to Chapters III and VII.
Člen 57
Article 55
Glavna dokumentacija kliničnega preskušanja
Investigator's brochure
Sponzor in raziskovalec pripravljata glavno dokumentacijo kliničnega preskušanja.
The sponsor shall provide the investigator with the investigator's brochure.
Glavna dokumentacija v vsakem trenutku vsebuje najpomembnejše dokumente kliničnega preskušanja, tako da je mogoče preveriti izvajanje kliničnega preskušanja in kakovost pridobljenih podatkov ob upoštevanju vseh značilnosti kliničnega preskušanja, vključno s tem, ali gre za klinično preskušanje z minimalno intervencijo.
The investigator's brochure shall be updated where new and relevant safety information becomes available, and shall be reviewed by the sponsor at least once per year.
Državam članicam je na zahtevo takoj na voljo in neposredno dostopna.
Article 56
Vsebina glavne dokumentacije kliničnega preskušanja, ki jo pripravi raziskovalec, in tiste, ki jo pripravi sponzor, se lahko razlikujeta, če je to upravičeno zaradi različne narave odgovornosti raziskovalca in sponzorja.
Recording, processing, handling and storage of information
Člen 58
All clinical trial information shall be recorded, processed, handled, and stored by the sponsor or investigator, as applicable, in such a way that it can be accurately reported, interpreted and verified while the confidentiality of records and the personal data of the subjects remain protected in accordance with the applicable law on personal data protection.
Arhiviranje glavne dokumentacije kliničnega preskušanja
Appropriate technical and organisational measures shall be implemented to protect information and personal data processed against unauthorised or unlawful access, disclosure, dissemination, alteration, or destruction or accidental loss, in particular where the processing involves the transmission over a network.
Sponzor in raziskovalec arhivirata vsebino glavne dokumentacije kliničnega preskušanja vsaj 25 let po koncu kliničnega preskušanja, razen če drugo pravo Unije določa daljše arhiviranje.
Article 57
Vendar pa se zdravstvene kartoteke udeležencev arhivirajo v skladu z nacionalnim pravom.
Clinical trial master file
Vsebina glavne dokumentacije kliničnega preskušanja se arhivira tako, da je na zahtevo takoj na voljo in dostopna pristojnim organom.
The sponsor and the investigator shall keep a clinical trial master file.
Vsak prenos lastništva vsebine glavne dokumentacije kliničnega preskušanja se zabeleži.
The clinical trial master file shall at all times contain the essential documents relating to that clinical trial which allow verification of the conduct of a clinical trial and the quality of the data generated, taking into account all characteristics of the clinical trial, including in particular whether the clinical trial is a low-intervention clinical trial.
Novi lastnik prevzame odgovornosti iz tega člena.
It shall be readily available, and directly accessible upon request, to the Member States.
Sponzor v svoji organizaciji imenuje posameznike, odgovorne za arhive.
The clinical trial master file kept by the investigator and that kept by the sponsor may have a different content if this is justified by the different nature of the responsibilities of the investigator and the sponsor.
Dostop do arhivov je omejen na te posameznike.
Article 58
Nosilci podatkov, ki se uporabljajo za arhiviranje vsebine glavne dokumentacije kliničnega preskušanja, so taki, da zagotavljajo celovitost in berljivost vsebine v celotnem obdobju iz prvega odstavka.
Archiving of the clinical trial master file
Vsaka sprememba vsebine glavne dokumentacije o kliničnem preskušanju mora biti sledljiva.
Unless other Union law requires archiving for a longer period, the sponsor and the investigator shall archive the content of the clinical trial master file for at least 25 years after the end of the clinical trial.
Člen 59
However, the medical files of subjects shall be archived in accordance with national law.
Pomožna zdravila
The content of the clinical trial master file shall be archived in a way that ensures that it is readily available and accessible, upon request, to the competent authorities.
V kliničnem preskušanju se lahko uporabljajo samo odobrena pomožna zdravila.
Any transfer of ownership of the content of the clinical trial master file shall be documented.
Odstavek 1 se ne uporablja, kadar v Uniji ni na voljo odobrenega pomožnega zdravila ali kadar od sponzorja ni mogoče upravičeno pričakovati, da bo uporabil odobreno pomožno zdravilo.
The new owner shall assume the responsibilities set out in this Article.
Utemeljitev v zvezi s tem se vključi v protokol.
The sponsor shall appoint individuals within its organisation to be responsible for archives.
Države članice zagotovijo, da lahko neodobrena pomožna zdravila prihajajo na njihovo ozemlje za njihovo uporabo v kliničnem preskušanju v skladu z odstavkom 2.
Access to archives shall be restricted to those individuals.
POGLAVJE IX
The media used to archive the content of the clinical trial master file shall be such that the content remains complete and legible throughout the period referred to in the first paragraph.
PROIZVODNJA IN UVOZ ZDRAVIL V PRESKUŠANJU IN POMOžNIH ZDRAVIL
Any alteration to the content of the clinical trial master file shall be traceable.
Člen 60
Article 59
Področje uporabe tega poglavja
Auxiliary medicinal products
To poglavje se uporablja za proizvodnjo in uvoz zdravil v preskušanju in pomožnih zdravil.
Only authorised auxiliary medicinal products may be used in a clinical trial.
Člen 61
Paragraph 1 shall not apply where no authorised auxiliary medicinal product is available in the Union or where the sponsor cannot reasonably be expected to use an authorised auxiliary medicinal product.
Dovoljenje za proizvodnjo in uvoz
A justification to this effect shall be included in the protocol.
Za proizvodnjo zdravil v preskušanju in njihov uvoz v Unijo je potrebno dovoljenje.
Member States shall ensure that unauthorised auxiliary medicinal products may enter their territories for the purpose of their use in a clinical trial in accordance with paragraph 2.
Za pridobitev dovoljenja iz odstavka 1 mora vlagatelj izpolnjevati naslednje zahteve:
CHAPTER IX
za proizvodnjo ali uvoz mora imeti na voljo primerne in dovolj velike prostore, tehnično opremo ter objekte in naprave za nadzor, ki so v skladu z zahtevami iz te uredbe;
MANUFACTURING AND IMPORT OF INVESTIGATIONAL MEDICINAL PRODUCTS AND AUXILIARY MEDICINAL PRODUCTS
stalno in nepretrgoma mora imeti na voljo storitve vsaj ene usposobljene osebe, ki izpolnjuje pogoje o usposobljenosti iz člena 49(2) in (3) Direktive 2001/83/ES (v nadaljnjem besedilu: usposobljena oseba).
Article 60
Vlagatelj v vlogi za dovoljenje navede vrste in farmacevtske oblike zdravil v preskušanju, ki se proizvajajo ali uvažajo, proizvodno ali uvozno dejavnost, postopek proizvodnje, kadar je ustrezno, kraj proizvodnje zdravil v preskušanju ali kraj v Uniji, kamor se bodo uvažala, ter podrobne informacije o usposobljeni osebi.
Scope of this Chapter
Za dovoljenje iz odstavka 1 se smiselno uporabljajo členi 42 do 45 in točka (e) člena 46 Direktive 2001/83/ES.
This Chapter shall apply to the manufacture and import of investigational medicinal products and auxiliary medicinal products.
Odstavek 1 se ne uporablja za naslednje postopke:
Article 61
ponovno označevanje ali ponovno pakiranje, kadar ta postopka v bolnišnicah, zdravstvenih domovih ali klinikah izvajajo farmacevti ali druge osebe, ki so v zadevni državi članici zakonito pooblaščene za izvajanje takih postopkov, in če so zdravila v preskušanju namenjena izključno za uporabo v bolnišnicah, zdravstvenih domovih ali klinikah, ki sodelujejo v istem kliničnem preskušanju v isti državi članici;
Authorisation of manufacturing and import
pripravo radiofarmakov, ki se uporabljajo kot zdravila v preskušanju za diagnosticiranje, kadar ta postopek v bolnišnicah, zdravstvenih domovih ali klinikah izvajajo farmacevti ali druge osebe, ki so v zadevni državi članici zakonito pooblaščene za izvajanje takega postopka, in če so zdravila v preskušanju namenjena izključno za uporabo v bolnišnicah, zdravstvenih domovih ali klinikah, ki sodelujejo v istem kliničnem preskušanju v isti državi članici;
The manufacturing and import of investigational medicinal products in the Union shall be subject to the holding of an authorisation.
pripravo zdravil iz točk (1) in (2) člena 3 Direktive 2001/83/ES, ki se uporabljajo kot zdravila v preskušanju, kadar se ta postopek izvaja v bolnišnicah, zdravstvenih domovih ali klinikah, ki so v zadevni državi članici zakonito pooblaščene za izvajanje takega postopka, in če so zdravila v preskušanju namenjena izključno za uporabo v bolnišnicah, zdravstvenih domovih ali klinikah, ki sodelujejo v istem kliničnem preskušanju v isti državi članici.
In order to obtain the authorisation referred to in paragraph 1, the applicant shall meet the following requirements:
Države članice za postopke iz odstavka 5 določijo ustrezne in sorazmerne zahteve, da zagotovijo varnost udeležencev ter zanesljivost in ponovljivost podatkov iz kliničnega preskušanja.
it shall have at its disposal, for manufacture or import, suitable and sufficient premises, technical equipment and control facilities complying with the requirements set out in this Regulation;
Za postopke določijo redne preglede.
it shall have permanently and continuously at its disposal the services of at least one qualified person who fulfils the conditions of qualification set out in Article 49(2) and (3) of Directive 2001/83/EC (‘qualified person’).
Člen 62
The applicant shall specify, in the application for authorisation, the types and pharmaceutical forms of the investigational medicinal product manufactured or imported, the manufacturing or import operations, the manufacturing process where relevant, the site where the investigational medicinal products are to be manufactured or the site in the Union to which they are to be imported, and detailed information concerning the qualified person.
Odgovornosti usposobljene osebe
Articles 42 to 45, and point (e) of Article 46 of Directive 2001/83/EC shall apply mutatis mutandis to the authorisation referred to in paragraph 1.
Usposobljena oseba zagotovi, da je vsaka serija zdravil v preskušanju, proizvedena v Uniji ali uvožena v Unijo, skladna z zahtevami iz člena 63, in potrdi, da so te zahteve izpolnjene.
Paragraph 1 shall not apply to any of the following processes:
Sponzor na zahtevo zadevne države članice zagotovi potrdilo iz odstavka 1.
re-labelling or re-packaging, where those processes are carried out in hospitals, health centres or clinics, by pharmacists or other persons legally authorised in the Member State concerned to carry out such processes, and if the investigational medicinal products are intended to be used exclusively in hospitals, health centres or clinics taking part in the same clinical trial in the same Member State;
Člen 63
preparation of radiopharmaceuticals used as diagnostic investigational medicinal products where this process is carried out in hospitals, health centres or clinics, by pharmacists or other persons legally authorised in the Member State concerned to carry out such process, and if the investigational medicinal products are intended to be used exclusively in hospitals, health centres or clinics taking part in the same clinical trial in the same Member State;
Proizvodnja in uvoz
the preparation of medicinal products referred to in points (1) and (2) of Article 3 of Directive 2001/83/EC for use as investigational medicinal products, where this process is carried out in hospitals, health centres or clinics legally authorised in the Member State concerned to carry out such process and if the investigational medicinal products are intended to be used exclusively in hospitals, health centres or clinics taking part in the same clinical trial in the same Member State.
Pri proizvodnji zdravil v preskušanju se uporablja proizvodna praksa, ki zagotavlja kakovost takih zdravil zaradi zagotavljanja varnosti udeležencev ter zanesljivosti in ponovljivosti kliničnih podatkov iz kliničnega preskušanja (v nadaljnjem besedilu: dobra proizvodna praksa).
Member States shall make the processes set out in paragraph 5 subject to appropriate and proportionate requirements to ensure subject safety and reliability and robustness of the data generated in the clinical trial.
Na Komisijo se prenese pooblastilo za sprejetje delegiranih aktov v skladu s členom 89, da se ob upoštevanju varnosti udeležencev ali zanesljivosti in ponovljivosti podatkov, tehničnega napredka ter sprememb v mednarodnem ureditvenem okviru, v katerem sodelujejo Unija ali države članice, določijo načela in smernice za dobro proizvodno prakso in podrobno ureditev postopkov nadzora zaradi zagotavljanja kakovosti zdravil v preskušanju.
They shall subject the processes to regular inspections.
Poleg tega Komisija sprejme in objavi podrobne smernice v skladu s temi načeli dobre proizvodne prakse in jih po potrebi pregleda, da se upošteva tehnični in znanstveni napredek.
Article 62
Odstavek 1 se ne uporablja za postopke iz člena 61(5).
Responsibilities of the qualified person
Pri proizvodnji zdravil v preskušanju, ki se uvažajo v Unijo, morajo biti upoštevani standardi kakovosti, ki so vsaj enakovredni standardom, določenim na podlagi odstavka 1.
The qualified person shall ensure that each batch of investigational medicinal products manufactured in or imported into the Union complies with the requirements set out in Article 63 and shall certify that those requirements are fulfilled.
Države članice zagotovijo izpolnjevanje zahtev iz tega člena z izvajanjem pregledov.
The certification referred to in paragraph 1 shall be made available by the sponsor at the request of the Member State concerned.
Člen 64
Article 63
Sprememba odobrenih zdravil v preskušanju
Manufacturing and import
Členi 61, 62 in 63 se za odobrena zdravila v preskušanju uporabljajo samo, kadar katera sprememba teh zdravil ni zajeta v dovoljenju za promet.
Investigational medicinal products shall be manufactured by applying manufacturing practice which ensures the quality of such medicinal products in order to safeguard the safety of the subject and the reliability and robustness of clinical data generated in the clinical trial (‘good manufacturing practice’).
Člen 65
The Commission shall be empowered to adopt delegated acts in accordance with Article 89 in order to specify the principles and guidelines of good manufacturing practice and the detailed arrangements for inspection for ensuring the quality of investigational medicinal products, taking account of subject safety or data reliability and robustness, technical progress and global regulatory developments in which the Union or the Member States are involved.
Proizvodnja pomožnih zdravil
In addition, the Commission shall also adopt and publish detailed guidelines in line with those principles of good manufacturing practice and revise them when necessary in order to take account of technical and scientific progress.
Kadar pomožno zdravilo ni odobreno ali kadar je odobreno pomožno zdravilo spremenjeno, taka sprememba pa ni zajeta v dovoljenju za promet z zdravilom, se pri proizvodnji upošteva dobra proizvodna praksa iz člena 63(1) ali vsaj enakovreden standard za zagotovitev ustrezne kakovosti.
Paragraph 1 shall not apply to the processes referred to in Article 61(5).
POGLAVJE X
Investigational medicinal products imported into the Union shall be manufactured by applying quality standards at least equivalent to those laid down pursuant to paragraph 1.
OZNAČEVANJE
The Member States shall ensure compliance with the requirements of this Article by means of inspections.
Člen 66
Article 64
Neodobrena zdravila v preskušanju in neodobrena pomožna zdravila
Modification of authorised investigational medicinal products
Na zunanji in stični ovojnini neodobrenih zdravil v preskušanju ter neodobrenih pomožnih zdravil je navedeno naslednje:
Articles 61, 62 and 63 shall apply to authorised investigational medicinal products only as regards any modification of such products not covered by a marketing authorisation.
informacije o kontaktnih osebah ali osebah, ki sodelujejo pri kliničnem preskušanju;
Article 65
informacije o kliničnem preskušanju;
Manufacturing of auxiliary medicinal products
informacije o zdravilu;
Where the auxiliary medicinal product is not authorised, or where an authorised auxiliary medicinal product is modified while such modification is not covered by a marketing authorisation, it shall be manufactured according to the good manufacturing practice referred to in Article 63(1) orto at least an equivalent standard, in order to ensure appropriate quality.
informacije o uporabi zdravila.