natgillin/translations-raw huggingface dataset:
the detailed guidelines, provided for in Article 15(5) of Directive 2001/20/EC, on the documentation relating to clinical trials, archiving, qualifications of inspectors and inspection procedures.
podrobne smernice, določene v členu 15(5) Direktive 2001/20/ES, o dokumentaciji v zvezi s kliničnimi preskušanji, arhiviranjem, kvalifikacijami inšpektorjev in inšpekcijskim nadzorom.
When applying the principles, detailed guidelines and requirements referred to in paragraph 1, Member States shall take into account the technical implementing modalities provided for in the detailed guidance published by the Commission in The Rules governing medicinal products in the European Union.
Pri uporabi načel, podrobnih smernic in zahtev iz odstavka 1, države članice upoštevajo tehnične pogoje in načine za izvajanje, določene v podrobnih navodilih, ki jih je objavila Komisija v Pravilih, ki urejajo zdravila v Evropski skupnosti.
When applying the principles, detailed guidelines and requirements referred to in paragraph 1 to non-commercial clinical trials conducted by researchers without the participation of the pharmaceutical industry, Member States may introduce specific modalities in order to take into account the specificity of these trials as far as Chapters 3 and 4 are concerned.
Pri uporabi načel, podrobnih smernic in zahtev iz odstavka 1 za nekomercialna klinična preskušanja, ki jih izvajajo raziskovalci brez sodelovanja farmacevtske industrije, lahko države članice uvedejo posebne pogoje in načine, da bi upoštevale posebno naravo teh preskušanj glede Poglavja 3 in 4.
Member States may take into account the special position of trials whose planning does not require particular manufacturing or packaging processes, carried out with medicinal products with marketing authorisations within the meaning of Directive 2001/83/EC, manufactured or imported in accordance with the same Directive and conducted on patients with the same characteristics as those covered by the indication specified in the marketing authorisation.
Države članice upoštevajo tudi poseben položaj preskušanj, katerih načrtovanje ne zahteva posebnih proizvodnih postopkov ali postopkov za pakiranje, in se izvajajo z zdravili, ki imajo dovoljenje za promet v smislu Direktive 2001/83/ES, proizvedenimi in uvoženimi v skladu z isto direktivo, in izvedenimi na bolnikih z enakimi značilnostmi, kot so tisti, na katere se nanašajo indikacije, določene v dovoljenju za promet.
Labelling of investigational medicinal products intended for trials of that nature may be subject to simplified provisions laid down in the good manufacturing practice guidelines on investigational medicinal products.
Za označevanje zdravil v preskušanju, ki so namenjena za preskušanja take narave, lahko veljajo poenostavljene določbe, določene v smernice o dobri proizvodni praksi za zdravila v preskušanju.
Member States shall inform the Commission as well as the other Member States of any specific modalities implemented in accordance with this paragraph.
Države članice obvestijo Komisijo in druge države članice o kakršnih koli posebnih pogojih in načinih, ki se izvajajo v skladu s tem odstavkom.
These modalities will be published by the Commission.
Te pogoje in načine Komisija objavi.
GOOD CLINICAL PRACTICE FOR THE DESIGN, CONDUCT, RECORDING AND REPORTING OF CLINICAL TRIALS
DOBRA KLINIČNA PRAKSA ZA OBLIKOVANJE, IZVAJANJE, EVIDENTIRANJE IN POROČANJE O KLINIČNIH PRESKUŠANJIH
GOOD CLINICAL PRACTICE
DOBRA KLINIČNA PRAKSA
The rights, safety and well being of the trial subjects shall prevail over the interests of science and society.
Pravice, varnost in dobro počutje preizkušancev imajo prednost pred interesi znanosti in družbe.
Each individual involved in conducting a trial shall be qualified by education, training, and experience to perform his tasks.
Vsak posameznik, ki je vključen v izvajanje preskušanja, je za opravljanje svojih nalog kvalificiran po izobrazbi, usposabljanju in izkušnjah.
Clinical trials shall be scientifically sound and guided by ethical principles in all their aspects.
Klinična preskušanja so znanstveno utemeljena in v vseh pogledih vodena z etičnimi načeli.
The necessary procedures to secure the quality of every aspect of the trials shall be complied with.
Upoštevajo se vsi potrebni postopki za zagotovitev kakovosti vseh vidikov preskušanj.
The available non-clinical and clinical information on an investigational medicinal product shall be adequate to support the proposed clinical trial.
Razpoložljive neklinične in klinične informacije o zdravilu v preskušanju, se zagotovijo v podporo predlaganemu kliničnemu preskušanju.
Clinical trials shall be conducted in accordance with the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects, adopted by the General Assembly of the World Medical Association (1996).
Klinična preskušanja se izvajajo v skladu s Helsinško deklaracijo o etičnih načelih za zdravstvene raziskave, ki vključujejo ljudi, ki jo je sprejela Generalna skupščina Svetovnega zdravniškega združenja (1996).
The protocol referred to in point (h) of Article 2 of Directive 2001/20/EC shall provide for the definition of inclusion and exclusion of subjects participating in a clinical trial, monitoring and publication policy.
Protokol iz točke (h) člena 2 Direktive 2001/20/ES zagotavlja opredelitev vključitve ali izključitve posameznikov iz kliničnega preskušanja, spremljanja in iz odločitev v zvezi z objavljanjem.
The investigator and sponsor shall consider all relevant guidance with respect to commencing and conducting a clinical trial.
Raziskovalec in naročnik preučita vsa ustrezna navodila glede začetka in izvajanja kliničnega preskušanja.
All clinical trial information shall be recorded, handled, and stored in such a way that it can be accurately reported, interpreted and verified, while the confidentiality of records of the trial subjects remains protected.
Vse informacije o kliničnih preskušanjih se evidentirajo, obdelujejo in shranjujejo tako, da to omogoča točno poročanje, razlago in preverjanje informacij, pri čemer ostane zagotovljena zaupnost evidenc preizkušancev.
THE ETHICS COMMITTEE
ODBOR ZA ETIKO
Each Ethics Committee established under Article 6(1) of Directive 2001/20/EC shall adopt the relevant rules of procedure necessary to implement the requirements set out in that Directive and, in particular, in Articles 6 and 7 thereof.
Vsak Odbor za etiko, ustanovljen s členom 6(1) Direktive 2001/20/ES, sprejme svoj poslovnik, potreben za izvajanje zahtev iz navedene direktive in zlasti členov 6 in 7 Direktive.
The Ethics Committees shall, in every case, retain the essential documents relating to a clinical trial, as referred to in Article 15(5) of Directive 2001/20/EC, for at least three years after completion of that trial.
Odbori za etiko v vsakem primeru shranjujejo bistvene dokumente v zvezi s kliničnim preskušanjem, navedene v členu 15(5) Direktive 2001/20/ES, še vsaj 3 leta po zaključku preskušanja.
They shall retain the documents for a longer period, where so required under other applicable requirements.
Dokumente shranjujejo daljše obdobje, če to zahtevajo druge veljavne zahteve.
Communication of information between the Ethics Committees and the competent authorities of the Member States shall be ensured through appropriate and efficient systems.
Posredovanje informacij med Odbori za etiko in pristojnimi organi držav članic je zagotovljeno z ustreznimi in učinkovitimi sistemi.
THE SPONSORS
NAROČNIKI
A sponsor may delegate any or all of his trial-related functions to an individual, a company, an institution or an organisation.
Naročnik lahko katero koli od svojih funkcij, povezanih s preskušanjem, ali vse navedene funkcije, prenese na posameznika, podjetje, ustanovo ali organizacijo.
However, in such cases, the sponsor shall remain responsible for ensuring that the conduct of the trials and the final data generated by those trials comply with Directive 2001/20/EC as well as this Directive.
Vendar ostane v teh primerih naročnik še naprej odgovoren za zagotavljanje, da so izvajanje preskušanj in končni podatki, ki nastanejo pri teh preskušanjih, v skladu z Direktivo 2001/20/ES kot tudi s to direktivo.
The investigator and the sponsor may be the same person.
Raziskovalec in naročnik sta lahko ista oseba.
INVESTIGATOR’S BROCHURE
BROŠURA ZA RAZISKOVALCA
The information in the investigator’s brochure, referred to in Article 2(g) of Directive 2001/20/EC, shall be presented in a concise, simple, objective, balanced and non-promotional form that enables a clinician or potential investigator to understand it and make an unbiased risk-benefit assessment of the appropriateness of the proposed clinical trial.
Informacije v brošuri za raziskovalca iz člena 2(g) Direktive 2001/20/ES so predstavljene v jasni, preprosti, objektivni, uravnoteženi in nepromocijski obliki, ki omogoča, da jih klinični zdravnik ali morebitni raziskovalec razume in da lahko nepristransko oceni koristi in tveganja primernosti predlaganega kliničnega preskušanja.
The first subparagraph shall apply also to any update of the investigator’s brochure.
Prvi pododstavek se uporablja tudi pri kakršnih koli posodobitvah brošure za raziskovalca.
If the investigational medicinal product has a marketing authorisation, the Summary of Product Characteristics may be used instead of the investigator’s brochure.
Če ima zdravilo v preskušanju dovoljenje za promet, se lahko namesto brošure za raziskovalca uporabi Povzetek značilnosti izdelka.
The investigator’s brochure shall be validated and updated by the sponsor at least once a year.
Brošuro za raziskovalca naročnik vsaj enkrat letno potrdi in posodobi.
MANUFACTURING OR IMPORT AUTHORISATION
DOVOLJENJE ZA PROIZVODNJO ALI UVOZ
Authorisation, as provided for in Article 13(1) of Directive 2001/20/EC, shall be required for both total and partial manufacture of investigational medicinal products, and for the various processes of dividing up, packaging or presentation.
Dovoljenje, določeno v členu 13(1) Direktive 2001/20/ES, se zahteva za celotno kot tudi za delno proizvodnjo zdravil v preskušanju in za razne postopke delitve, pakiranja ali predstavitve.
Such authorisation shall be required even if the products manufactured are intended for export.
Takšno dovoljenje se zahteva tudi če so proizvedena zdravila namenjena za izvoz.
Authorisation shall also be required for imports from third countries into a Member State.
Dovoljenje se zahteva tudi za uvoz iz tretjih držav v državo članico.
Authorisation, as provided for in Article 13(1) of Directive 2001/20/EC, shall not be required for reconstitution prior to use or packaging, where those processes are carried out in hospitals, health centres or clinics, by pharmacists or other persons legally authorised in the Member States to carry out such processes and if the investigational medicinal products are intended to be used exclusively in those institutions.
Dovoljenje iz člena 13(1) Direktive 2001/20/ES se ne zahteva za rekonstitucijo pred uporabo ali pakiranjem, kjer navedene postopke v bolnicah, zdravstvenih domovih ali klinikah izvajajo farmacevti ali druge osebe, ki so v državah članicah zakonsko pooblaščene za opravljanje takšnih postopkov, in če so zdravila v preskušanju namenjena izključno za uporabo v teh ustanovah.
In order to obtain the authorisation the applicant must meet at least the following requirements:
Za pridobitev dovoljenja mora prosilec izpolnjevati vsaj naslednje zahteve:
specify in his application the types of medicinal products and pharmaceutical forms to be manufactured or imported;
v svoji vlogi natančno opredeliti tipe zdravil in farmacevtske oblike, ki naj bi se proizvajale ali uvažale;
specify in his application the relevant manufacture or import operations;
v svoji vlogi natančno opredeliti ustrezne proizvodne in uvozne postopke;
specify in his application, where relevant as in the case of viral or non-conventional agents’ inactivation, the manufacturing process;
v svoji vlogi natančno opredeliti postopek proizvodnje, kjer je to ustrezno, kot na primer pri inaktivaciji virusnih in nekonvencionalnih agensov.
specify in his application the place where the products are to be manufactured or have at his disposal, for their manufacture or importation, suitable and sufficient premises, technical equipment and control facilities complying with the requirements of Directive 2003/94/EC as regards the manufacture, control and storage of the products;
v svoji vlogi natančno opredeliti kraj, na katerem naj bi potekala proizvodnja zdravil, ali razpolagati za njihovo proizvodnjo ali uvoz s primernimi in zadostnimi prostori, tehnično opremo ter objekte in naprave za nadzor, ki so v skladu z zahtevami Direktive 2003/94/ES v zvezi s proizvodnjo, nadzorom in skladiščenjem zdravil;
have permanently and continuously at his disposal the services of at least one qualified person as referred to in Article 13(2) of Directive 2001/20/EC.
imeti stalno in nenehno na razpolago storitve vsaj ene kvalificirane osebe iz člena 13(2) Direktive 2001/20/ES.
For the purposes of point (a) of the first subparagraph, ‘types of medicinal products’ include blood products, immunological products, cell therapy products, gene therapy products, biotechnology products, human or animal extracted products, herbal products, homeopathic products, radiopharmaceutical products and products containing chemical active ingredients.
Za namen točke (a) prvega pododstavka »tipi zdravil« vključuje krvne proizvode, imunološke proizvode za celično zdravljenje, proizvode za gensko zdravljenje, biotehnološke proizvode, proizvode iz človeških ali živalskih izvlečkov, zeliščne proizvode, homeopatske proizvode, radiofarmacevtske proizvode in proizvode, ki vsebujejo kemijske aktivne sestavine.
The applicant shall provide with his application documentary evidence that he complies with paragraph 1.
Prosilec v podporo svoji vlogi zagotovi dokumentarna dokazila, da upošteva odstavek 1.
The competent authority shall issue the authorisation only after verifying the accuracy of the particulars provided by the applicant pursuant to Article 10 by the means of an inquiry carried out by its agents.
Pristojni organ izda dovoljenje šele potem, ko s poizvedbo, ki jo opravijo njegovi zastopniki, preveri točnost podatkov, ki jih je predložil prosilec na podlagi člena 10.
Member States shall take all appropriate measures to ensure that the procedure for granting an authorisation is completed within 90 days of the day on which the competent authority receives a valid application.
Države članice sprejmejo vse ustrezne ukrepe za zagotovitev, da se postopek za izdajo dovoljenja zaključi v 90 dneh od dneva, ko je pristojni organ prejel veljavno vlogo.
The competent authority of the Member State may require from the applicant further information concerning the particulars supplied pursuant to Article 10(1), including in particular information concerning the qualified person at the disposal of the applicant in accordance with point (e) of Article 10(1).
Pristojni organ države članice lahko od prosilca zahteva dodatne informacije v zvezi s podatki, predloženimi na podlagi člena 10(1), vključno z informacijami o kvalificirani osebi, ki je prosilcu na razpolago v skladu s točko (e) člena 10(1).
Where the competent authority concerned exercises that right, the application of the time-limits laid down in paragraph 2 shall be suspended until the additional data required have been supplied.
Kadar zadevni pristojni organ uveljavlja navedeno pravico, se začasno opusti uporaba roka iz člena 2, dokler prosilec ne predloži zahtevanih dodatnih podatkov.
In order to ensure that the requirements laid down in Article 10 are complied with, authorisation may be made conditional on the carrying out of certain obligations imposed either when authorisation is granted or at a later date.
Da bi zagotovili upoštevanje zahtev, določenih v členu 10, je pridobitev dovoljenja lahko pogojena z izpolnitvijo določenih obveznosti, ki se določijo ob izdaji dovoljenja ali pozneje.
An authorisation shall apply only to the premises specified in the application and to the types of medicinal products and pharmaceutical forms specified in that application pursuant to point (a) of Article 10(1).
Dovoljenje velja samo za prostore, opredeljene v vlogi, ter za tipe zdravil in farmacevtske oblike, opredeljene v navedeni vlogi na podlagi točke (a) člena 10(1).
The holder of the authorisation shall at least comply with the following requirements:
Imetnik dovoljenja mora izpolnjevati vsaj naslednje zahteve:
to have at his disposal the services of staff that comply with the legal requirements existing in the Member State concerned both as regards manufacture and controls;
imeti na razpolago storitve osebja, ki izpolnjuje zakonske zahteve, ki veljajo v zadevni državi članici tako glede proizvodnje in nadzora;
to dispose of the investigational/authorised medicinal products only in accordance with the legislation of the Member State concerned;
razpolagati z zdravili v preskušanju/odobrenimi zdravili samo v skladu z zakonodajo zadevne države članice;
to give prior notice to the competent authority of any changes he may wish to make to any of the particulars supplied pursuant Article 10(1) and, in particular, to inform the competent authority immediately if the qualified person referred to in Article 13(2) of Directive 2001/20/EC is replaced unexpectedly;
predhodno obvestiti pristojni organ o kakršnih koli spremembah, ki jih želi narediti na podatkih, predloženih na podlagi člena 10(1) in zlasti nemudoma obvestiti pristojni organ o nepričakovani zamenjavi kvalificirane osebe iz člena 13(2) Direktive 2001/20/ES;
to allow agents of the competent authority of the Member State concerned access to his premises at any time;
ob vsakem času omogočiti zastopnikom pristojnega organa zadevne države članice dostop do njegovih prostorov;
to enable the qualified person referred to in Article 13(2) of Directive 2001/20/EC to carry out his duties, for example by placing at his disposal all the necessary facilities;
omogočiti kvalificirani osebi iz člena 13(2) Direktive 2001/20/ES, da opravi svoje dolžnosti, na primer tako, da ji da na razpolago vse potrebne objekte in naprave;
to comply with the principles and guidelines for good manufacturing practice for medicinal products as laid down by Community law.
upoštevati načela in smernice o dobri proizvodni praksi za zdravila, kot so določene z zakonodajo Skupnosti.
Detailed guidelines in line with the principles referred to in point (f) of the first paragraph will be published by the Commission and revised where necessary to take account of technical and scientific progress.
Podrobne smernice v skladu z načeli iz točke (f) prvega odstavka bo objavila in, da bi se upošteval tehnični in znanstveni napredek, po potrebi ponovno preučila Komisija.
If the holder of the authorisation requests a change in any of the particulars referred to in points (a) to (e) of Article 10(1), the time taken for the procedure relating to the request shall not exceed 30 days.
Če imetnik dovoljenja zaprosi za spremembo podatkov iz točk (a) do (e) člena 10(1), je obdobje za postopek v zvezi s takšno zahtevo največ 30 dni.
In exceptional cases, this period of time may be extended to 90 days.
V izjemnih primerih se lahko ta rok podaljša na 90 dni.
The competent authority shall suspend or revoke the authorisation, as a whole or in part, if the holder of the authorisation fails at any time to comply with the relevant requirements.
Pristojni organ v celoti ali delno začasno odvzame ali prekliče dovoljenje, če imetnik dovoljenja kadar koli ne izpolnjuje ustreznih zahtev.
THE TRIAL MASTER FILE AND ARCHIVING
GLAVNA DATOTEKA O PRESKUŠANJU IN ARHIVIRANJE
The documentation referred to Article 15(5) of Directive 2001/20/EC as the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.
Dokumentacija, ki je v členu 15(5) Direktive 2001/20/ES opredeljena kot glavna datoteka o preskušanju, je sestavljena iz bistvenih dokumentov, ki omogočajo tako izvajanje kliničnega preskušanja kot tudi oceno kvalitete pridobljenih podatkov.
Those documents shall show whether the investigator and the sponsor have complied with the principles and guidelines of good clinical practice and with the applicable requirements and, in particular, with Annex I to Directive 2001/83/EC.
Iz navedenih dokumentov je razvidno, ali sta raziskovalec in naročnik upoštevala načela in smernice dobre klinične prakse, veljavne zahteve, ter zlasti Prilogo I k Direktivi 2001/83/ES.
The trial master file shall provide the basis for the audit by the sponsor’s independent auditor and for the inspection by the competent authority.
Glavna datoteka o preskušanju predstavlja osnovo za presojo neodvisnega revizorja naročnika in za inšpekcijski pregled pristojnega organa.
The content of the essential documents shall be in accordance with the specificities of each phase of the clinical trial.
Vsebina zgoraj bistvenih dokumentov je v skladu s posebnostmi vsake faze kliničnega preskušanja.
The Commission shall publish additional guidance in order to specify the content of these documents.
Komisija objavi dodatna navodila, da natančno določi vsebino teh dokumentov.
The sponsor and the investigator shall retain the essential documents relating to a clinical trial for at least five years after its completion.
Naročnik in raziskovalec shranjujeta bistvene dokumente o kliničnem preskušanju vsaj 5 let po njegovem zaključku.
They shall retain the documents for a longer period, where so required by other applicable requirements or by an agreement between the sponsor and the investigator.
Dokumente shranjujeta daljše obdobje, če tako določajo druge veljavne zahteve, ali dogovor med naročnikom in raziskovalcem.
Essential documents shall be archived in a way that ensures that they are readily available, upon request, to the competent authorities.
Bistveni dokumenti se arhivirajo tako, da so na zahtevo pristojnim organom nemudoma na voljo.
The medical files of trial subjects shall be retained in accordance with national legislation and in accordance with the maximum period of time permitted by the hospital, institution or private practice.
Zdravniške kartone preizkušancev se shranjuje v skladu z nacionalno zakonodajo in v skladu z najdaljšim časovnim obdobjem, ki ga dovoljuje bolnišnica, ustanova ali zasebni zdravnik.
Any transfer of ownership of the data or of documents shall be documented.
Kakršen koli prenos lastništva podatkov ali dokumentov se evidentira.
The new owner shall assume responsibility for data retention and archiving in accordance with Article 17.
Novi lastnik prevzame obveznost za shranjevanje podatkov in arhiviranje v skladu s členom 17.
The sponsor shall appoint individuals within its organisation who are responsible for archives.
Naročnik imenuje posameznike v svoji organizaciji, ki so odgovorni za arhive.
Access to archives shall be restricted to the named individuals responsible for the archives.
Dostop do arhivov je omejen na imenovane posameznike, ki so odgovorni za arhive.
The media used to store essential documents shall be such that those documents remain complete and legible throughout the required period of retention and can be made available to the competent authorities upon request.
Mediji, ki se uporabljajo za shranjevanje bistvenih dokumentov, so takšni, da omenjeni dokumenti ostanejo celostni in berljivi v celotnem obdobju shranjevanja, in se na zahtevo lahko dajo na razpolago pristojnim organom.
Any alteration to records shall be traceable.
Vsem spremembam evidenc je mogoče slediti.
INSPECTORS
INŠPEKTORJI