FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: Factors which have to be taken into account in order to establish a "well established medicinal use" of components of medicinal products are the time over which a substance has been used, quantitative aspects of the use of the substance, the degree of scientific interest in the use of the substance (reflected in the published scientific literature) and the coherence of scientific assessments.
Slovenian: Dejavniki, ki jih je treba upoštevati, da bi ugotovili "dobro uveljavljeno medicinsko uporabo" sestavin zdravil so čas uporabe snovi, količinski vidiki uporabe snovi, stopnja znanstvenega zanimanja za uporabo snovi (kar se odraža v objavljeni znanstveni literaturi) in skladnost znanstvenih ocen.
English: Therefore different periods of time may be necessary for establishing "well established use" of different substances.
Slovenian: Za različne snovi so zato potrebna različna časovna obdobja za ugotavljanje "dobro uveljavljene medicinske uporabe".
English: In any case, however, the period of time required for establishing a "well established medicinal use" of a component of a medicinal product must not be less than one decade from the first systematic and documented use of that substance as a medicinal product in the Community.
Slovenian: V vsakem primeru pa potrebno časovno obdobje za ugotavljanje "dobro uveljavljene medicinske uporabe" sestavine zdravila ne sme biti krajše od deset let od prve sistematične in dokumentirane uporabe snovi kot zdravila v Skupnosti.
English: The documentation submitted by the applicant should cover all aspects of the safety assessment and must include or refer to a review of the relevant literature, taking into account pre- and postmarketing studies and published scientific literature concerning experience in the form of epidemiological studies and in particular of comparative epidemiological studies.
Slovenian: Dokumentacija, ki jo vlagatelj predloži, mora zajemati vse vidike ocene varnosti in vključevati ali se sklicevati na pregled ustrezne literature, ob upoštevanju pre- in post-marketinških študij ter objavljene znanstvene literature o izkušnjah v obliki epidemioloških študij in zlasti primerjalnih epidemioloških študij.
English: All documentation, both favourable and unfavourable, should be communicated.
Slovenian: Predložiti je treba vso dokumentacijo, ugodno ali neugodno.
English: Particular attention must be paid to any missing information and justification must be given why demonstration of an acceptable level of safety can be supported although some studies are lacking.
Slovenian: Posebno pozornost je treba posvetiti manjkajočim informacijam in obvezno podati utemeljitev, zakaj prikaz sprejemljive stopnje varnosti zadostuje, čeprav nekatere študije manjkajo.
English: The Expert report must explain the relevance of any data submitted which concern a product different from the product intended for marketing.
Slovenian: V ekspertnem poročilu mora biti pojasnjena ustreznost vseh predloženih podatkov v zvezi z zdravilom, ki se razlikuje od zdravila, namenjenega za trženje.
English: A judgment must be made whether the product studied can be considered as similar to the product which will be granted a marketing authorisation in spite of the existing differences.
Slovenian: Presoditi je treba, ali se zdravilo, ki je predmet študije, lahko šteje kot podobno zdravilu, za katerega bo izdano dovoljenje za promet, kljub obstoječim razlikam.
English: Post-marketing experience with other products containing the same components is of particular importance and applicants should put a special emphasis on this issue.
Slovenian: Post-marketinške izkušnje z drugimi zdravili, ki vsebujejo enake sestavine so še posebej pomembne in vlagatelji morajo temu dati poseben poudarek.
English: CLINICAL DOCUMENTATION
Slovenian: KLINIČNA DOKUMENTACIJA
English: The particulars and documents accompanying applications for marketing authorizations pursuant to Articles 8(3)(i) and 10(1) of this Directive shall be submitted in accordance with the provisions below.
Slovenian: Podrobni podatki in dokumenti, ki spremljajo vloge za pridobitev dovoljenj za promet z zdravili na podlagi členov 8(3)(i) in 10(1) te direktive, se predložijo v skladu s spodaj navedenimi določbami.
English: A clinical trial is any systematic study of medicinal products in human subjects whether in patients or non-patient volunteers in order to discover or verify the effects of and/or identify any adverse reaction to investigational products, and/or study their absorption, distribution, metabolism and excretion in order to ascertain the efficacy and safety of the products.
Slovenian: Klinično preskušanje je vsaka sistematična študija zdravil na ljudeh, bolnikih ali zdravih prostovoljcih, ki ima namen odkriti ali potrditi učinke in/ali ugotoviti katere koli neželene učinke zdravil v preskušanju, in/ali raziskati absorpcijo, porazdelitev, presnovo in izločanje zdravila v preskušanju, da se preveri učinkovitost in varnost zdravil.
English: Evaluation of the application for marketing authorization shall be based on clinical trials including clinical pharmacological trials designed to determine the efficacy and safety of the product under normal conditions of use, having regard to the therapeutic indications for use in human beings.
Slovenian: Vrednotenje vloge za pridobitev dovoljenja za promet z zdravilom temelji na kliničnih preskušanjih, ki vključujejo klinična farmakološka preskušanja, namenjena ugotavljanju učinkovitosti in varnosti zdravila v predpisanih pogojih uporabe, ob upoštevanju terapevtskih indikacij za uporabo pri ljudeh.
English: Therapeutic advantages must outweigh potential risks.
Slovenian: Terapevtske koristi morajo prevladati nad možnimi tveganji.
English: General requirements
Slovenian: Splošne zahteve
English: The clinical particulars to be provided pursuant to Articles 8(3)(i) and 10(1) must enable a sufficiently well-founded and scientifically valid opinion to be formed as to whether the medicinal product satisfies the criteria governing the granting of a marketing authorization.
Slovenian: Podrobni klinični podatki, ki jih je treba predložiti na podlagi členov 8(3)(i) in 10(1), morajo omogočati oblikovanje dovolj trdnega in znanstveno tehtnega mnenja glede vprašanj, ali zdravilo izpolnjuje merila, ki vplivajo na odobritev dovoljenja za promet z zdravilom.
English: Consequently, an essential requirement is that the results of all clinical trials should be communicated, both favourable and unfavourable.
Slovenian: Zato je temeljna zahteva, da se predložijo rezultati vseh kliničnih preskušanj, ugodnih ali neugodnih.
English: Clinical trials must always be preceded by adequate pharmacological and toxicological tests, carried out on animals in accordance with the requirements of Part 3 of this Annex.
Slovenian: Pred kliničnimi preskušanji je vedno treba opraviti ustrezne farmakološke in toksikološke preskuse, ki se izvedejo na živalih v skladu z zahtevami dela 3 te Priloge.
English: The investigator must acquaint himself with the conclusions drawn from the pharmacological and toxicological studies and hence the applicant must provide him at least with the investigator's brochure, consisting of all the relevant information known prior to the onset of a clinical trial including chemical, pharmaceutical and biological data, toxicological, pharmacokinetic and pharmacodynamic data in animals and the results of earlier clinical trials, with adequate data to justify the nature, scale and duration of the proposed trial;
Slovenian: Raziskovalec se mora seznaniti z zaključki farmakoloških in toksikoloških raziskav in vlagatelj mu mora predložiti vsaj brošuro za raziskovalca, ki sestoji iz vseh pomembnih informacij, ki so bile poznane pred začetkom kliničnega preskušanja, vključno s kemijskimi, farmacevtskimi in biološkimi podatki, toksikološkimi, farmakokinetičnimi in farmakodinamičnimi podatki pri živalih ter rezultati prejšnjih kliničnih preskušanj, z ustreznimi podatki, ki utemeljujejo vrsto, obseg in trajanje predlaganega preskušanja;
English: the complete pharmacological and toxicological reports shall be provided on request.
Slovenian: na zahtevo se predložijo kompletna farmakološka in toksikološka poročila.
English: For materials of human or animal origin, all available means shall be employed to ensure safety from transmission of infectious agents prior to the commencement of the trial.
Slovenian: Za snovi človeškega ali živalskega izvora se uporabijo vsa razpoložljiva sredstva, da se pred začetkom preskušanja zagotovi varnost pred prenosom povzročiteljev infekcij.
English: Conduct of trials
Slovenian: Vodenje preskušanj
English: Good clinical practice
Slovenian: Dobra klinična praksa
English: All phases of clinical investigation, including bioavailability and bioequivalence studies, shall be designed, implemented and reported in accordance with good clinical practice.
Slovenian: Vse faze klinične raziskave, vključno s študijami biološke uporabnosti in študijami bioekvivalence, se načrtujejo, izvajajo ter se o njih poroča v skladu z načeli dobre klinične prakse.
English: All clinical trials shall be carried out in accordance with the ethical principles laid down in the current revision of the Declaration of Helsinki.
Slovenian: Vsa klinična preskušanja se izvajajo v skladu z etičnimi načeli, ki jih določa veljavna izdaja Helsinške deklaracije.
English: In principle, the freely given informed consent of each trial subject shall be obtained and documented.
Slovenian: Načeloma je treba od vsakega posameznega preizkušanca pridobiti in dokumentirati prostovoljno soglasje.
English: The trial protocol (including statistical design), the technical application and documentation shall be submitted by the sponsor and/or investigator for an opinion to the relevant ethics committee.
Slovenian: Naročnik preskušanja in/ali raziskovalec predložita protokol preskušanja (vključno s statističnim načrtom), tehnično vlogo in dokumentacijo ustrezni odboru za etiko, da poda svoje mnenje.
English: The trials shall not begin before the opinion of this committee has been received in writing.
Slovenian: Preskušanja se ne začnejo pred prejemom pisnega mnenja odbora za etiko.
English: Pre-established, systematic written procedures for the organization, conduct, data collection, documentation and verification of clinical trials shall be required.
Slovenian: Zahtevajo se naprej pripravljeni, sistematično napisani postopki za organizacijo, izvajanje, zbiranje podatkov, dokumentacijo ter preverjanje kliničnih preskušanj.
English: In the case of radiopharmaceuticals, clinical trials shall be carried out under the responsibility of a medical doctor authorized to use radionuclides for medical purposes.
Slovenian: Pri radiofarmacevtskih izdelkih je za izvajanje kliničnega preskušanja odgovoren zdravnik, ki je pooblaščen za uporabo readionuklidov za medicinske namene.
English: Archiving
Slovenian: Arhiviranje
English: The marketing authorization holder shall make arrangements for archiving of documentation.
Slovenian: Imetnik dovoljenja za promet z zdravilom poskrbi za arhiviranje dokumentacije.
English: The investigator shall arrange for the retention of the patient identification codes for at least 15 years after the completion or discontinuation of the trial.
Slovenian: Raziskovalec poskrbi za hrambo bolnikovih identifikacijskih oznak za obdobje najmanj 15 let po zaključku ali prekinitvi preskušanja.
English: Patient files and other source data shall be kept for the maximum period of time permitted by the hospital, institution or private practice.
Slovenian: Datoteke bolnikov ali drugi viri podatkov se hranijo najdaljše obdobje, ki ga bolnišnica, institucija ali privatna praksa dovoljujejo.
English: The sponsor or other owner of the data shall retain all other documentation pertaining to the trial as long as the product is authorized.
Slovenian: Naročnik preskušanja ali drug lastnik podatkov hrani vso ostalo dokumentacijo, ki se nanaša na preskušanje, vse dokler ima zdravilo dovoljenje za promet.
English: These procedures shall include:
Slovenian: Postopki vključujejo:
English: the protocol including the rationale, objectives and statistical design and methodology of the trial, with conditions under which it is performed and managed, and details of the investigational product, the reference medicinal product and/or the placebo used,
Slovenian: protokol, ki vključuje osnovo, cilje in statistični načrt ter metodologijo preskušanja, skupaj s pogoji izvedbe in vodenja, ter podrobnosti o zdravilu v preskušanju, referenčnim zdravilom in/ali uporabljenim placebom,
English: standard operating procedures,
Slovenian: standardne operativne postopke,
English: all written opinions on the protocol and procedures,
Slovenian: vsa pisna mnenja o protokolu in postopkih,
English: the investigator's brochure,
Slovenian: brošuro za raziskovalca,
English: case report forms on each trial subject,
Slovenian: obrazce za poročanje o primerih za vsakega preizkušanca,
English: final report,
Slovenian: zaključno poročilo,
English: audit certificate(s), if available.
Slovenian: potrdilo(a) o presoji(ah), če je(so) na voljo.
English: The final report shall be retained by the sponsor or subsequent owner, for five years after the medicinal product is no longer authorized.
Slovenian: Zaključno poročilo hrani naročnik preskušanja ali poznejši lastnik še pet let po izteku dovoljenja za promet z zdravilom.
English: Any change of ownership of the data shall be documented.
Slovenian: Vse spremembe lastništva podatkov se dokumentirajo.
English: All data and documents shall be made available if requested by relevant authorities.
Slovenian: Na zahtevo ustreznih organov morajo biti na voljo vsi podatki in dokumenti.
English: Presentation of results
Slovenian: Predstavitev rezultatov
English: The particulars of each clinical trial must contain sufficient detail to allow an objective judgement to be made:
Slovenian: Podrobni podatki vsakega kliničnega preskušanja morajo vsebovati dovolj podrobnosti, da se omogoči objektivna presoja:
English: the protocol, including the rationale, objectives and statistical design and methodology of the trial, with conditions under which it is performed and managed, and details of the investigational medicinal product used,
Slovenian: protokol, ki vključuje osnovo, cilje in statistični načrt ter metodologijo preskušanja, skupaj s pogoji izvedbe in vodenja, ter podrobnostmi o uporabljenem zdravilu v preskušanju,
English: audit certificate(s), if available,
Slovenian: potrdilo(a) o presoji(ah), če je(so) na voljo,
English: the list of investigator(s), and each investigator shall give his name, address, appointments, qualifications and clinical duties, state where the trial was carried out and assemble the information in respect of each patient individually, including case report forms on each trial subject,
Slovenian: seznam raziskovalca(ev); vsak posameznik navede svoje ime, naslov, dolžnosti, usposobljenost ter klinične dolžnosti, izjavo o kraju preskušanja ter zbere podatke o vsakem posameznem bolniku, vključno z obrazcem za poročilo o primeru za vsakega preizkušanca,
English: final report signed by the investigator and for multicentre trials, by all the investigators or the coordinating (principal) investigator.
Slovenian: zaključno poročilo, ki ga podpiše raziskovalec ter pri multicentričnih preskušanjih raziskovalci ali glavni raziskovalec koordinator.
English: The particulars of clinical trials referred to above shall be forwarded to the competent authorities.
Slovenian: Podrobne podatke zgoraj navedenih kliničnih preskušanj se pošlje pristojnim organom.
English: However, in agreement with the competent authorities, the applicant may omit part of this information.
Slovenian: Po dogovoru s pristojnimi organi vlagatelj lahko izpusti del teh podatkov.
English: Complete documentation shall be provided forthwith upon request.
Slovenian: Celotna dokumentacija se na zahtevo predloži takoj.
English: The clinical observations shall be summarized for each trial indicating:
Slovenian: Za posamezna preskušanja se povzamejo klinična opažanja, ki navajajo:
English: the number and sex of patients treated;
Slovenian: število in spol obravnavanih bolnikov;
English: the selection and age-distribution of the groups of patients being investigated and the comparative tests;
Slovenian: izbor in starostno porazdelitev skupin bolnikov, udeleženih v preskušanju, ter primerjalne preskuse;
English: the number of patients withdrawn prematurely from the trials and the reasons for such withdrawal;
Slovenian: število bolnikov, ki so bili predčasno umaknjeni iz preskušanj ter razloge za tak umik;
English: where controlled trials were carried out under the above conditions, whether the control group:
Slovenian: kadar so se izvajala kontrolna preskušanja pod zgoraj navedenimi pogoji, se navede, če kontrolna skupina:
English: received no treatment,
Slovenian: ni prejemala nobenega zdravljenja,
English: received a placebo,
Slovenian: je prejemala placebo,
English: received another medicinal product of known effect,
Slovenian: je prejemala drugo zdravilo z znanim učinkom,
English: received treatment other than therapy using medicinal products;
Slovenian: je prejemala zdravljenje, ki je bilo različno od zdravljenja z zdravili;
English: the frequency of observed adverse reactions;
Slovenian: pogostost opaženih neželenih učinkov;
English: details concerning patients who may be at increased risk, e.g. elderly people, children, women during pregnancy or menstruation, or whose physiological or pathological condition requires special consideration;
Slovenian: podrobnosti o bolnikih, pri katerih je tveganje lahko povečano, npr. starejši, otroci, ženske med nosečnostjo ali menstruacijo, ali katerih fiziološko ali patološko stanje zahteva posebno obravnavo;
English: parameters or evaluation criteria of efficacy and the results in terms of these parameters;
Slovenian: parametre ali merila vrednotenja učinkovitosti ter rezultate v smislu teh parametrov;
English: a statistical evaluation of the results when this is called for by the design of the trials and the variable factors involved.
Slovenian: statistično ovrednotenje rezultatov, če tako zahteva načrt preskušanj, ter vpletenih spremenljivih dejavnikov.
English: The investigator shall, in his conclusions on the experimental evidence, express an opinion on the safety of the product under normal conditions of use, its tolerance, its efficacy and any useful information relating to indications and contra-indications, dosage and average duration of treatment as well as any special precautions to be taken during treatment and the clinical symptoms of overdosage.
Slovenian: Raziskovalec v svojem zaključku o dokazih preskusa izrazi mnenje o varnosti zdravila v predpisanih pogojih uporabe, toleranco zdravila, učinkovitost zdravila ter druge koristne informacije glede indikacij ter kontraindikacij, odmerjanja in povprečnega trajanja zdravljenja, kot tudi vse posebne previdnostne ukrepe med zdravljenjem ter klinične simptome prevelikega odmerjanja.
English: In reporting the results of a multi-centre study, the principal investigator shall, in his conclusions, express an opinion on the safety and efficacy of the investigational medicinal product on behalf of all centres.
Slovenian: Pri poročanju o rezultatih multicentrične študije glavni raziskovalec v svojem zaključku v imenu vseh centrov poda mnenje o varnosti in učinkovitosti zdravila v preskušanju.
English: In addition, the investigator shall always indicate his observations on:
Slovenian: Poleg tega raziskovalec vedno navede svoja opažanja o:
English: any signs of habituation, addiction or difficulty in weaning patients from the medicinal product;
Slovenian: vseh morebitnih znakih navajanja na zdravilo, zasvojenosti z zdravilom ter težavami odvajanja bolnikov od zdravila;
English: any interactions that have been observed with other medicinal products administered concomitantly;
Slovenian: vseh morebitnih opaženih interakcijah z drugimi zdravili, ki jih je bolnik hkrati jemal;
English: the criteria determining exclusion of certain patients from the trials;
Slovenian: merilih, ki določajo izključitev nekaterih bolnikov iz preskušanj;
English: any deaths which occurred during the trial or within the follow-up period.
Slovenian: vseh morebitnih smrtnih primerih med preskušanjem ali med nadaljevalnim obdobjem.
English: Particulars concerning a new combination of medicinal substances must be identical to those required for new medicinal products and must substantiate the safety and efficacy of the combination.
Slovenian: Podrobni podatki o novih kombinacijah zdravilnih učinkovin morajo biti enaki tistim, ki se zahtevajo za nova zdravila in morajo dokazovati varnost in učinkovitost kombinacije.
English: Total or partial omission of data must be explained.
Slovenian: Popolno ali delno opustitev podatkov je treba obrazložiti.
English: Should unexpected results occur during the course of the trials, further preclinical toxicological and pharmacological tests must be undertaken and reviewed.
Slovenian: Če so rezultati, pridobljeni v času preskušanj, nepričakovani, je treba opraviti dodatne predklinične toksikološke in farmakološke preskuse ter jih ponovno preučiti.
English: If the medicinal product is intended for long-term administration, particulars shall be given of any modification of the pharmacological action following repeated administration, as well as the establishment of long-term dosage.
Slovenian: Če je zdravilo namenjeno za dolgotrajno dajanje, se podajo podrobni podatki za vsako spremembo farmakološkega delovanja pri večkratnem dajanju zdravila, ter določi dolgotrajno odmerjanje.
English: Clinical pharmacology
Slovenian: Klinična farmakologija
English: The pharmacodynamic action correlated to the efficacy shall be demonstrated including:
Slovenian: Dokaže se farmakodinamično delovanje v povezavi z učinkovitostjo, kar vključuje:
English: the dose-response relationship and its time course,
Slovenian: povezavo med odmerkom in njegovim učinkom ter časovni potek,
English: justification for the dosage and conditions of administration,
Slovenian: utemeljitev odmerjanja in pogojev dajanja zdravila,
English: the mode of action, if possible.
Slovenian: način delovanja, če je mogoče.
English: The pharmacodynamic action not related to efficacy shall be described.
Slovenian: Opiše se farmakodinamično delovanje, ki ni povezano z učinkovitostjo.
English: The demonstration of pharmacodynamic effects in human beings shall not in itself be sufficient to justify conclusions regarding any particular potential therapeutic effect.
Slovenian: Dokazovanje farmakodinamičnih učinkov pri ljudeh samo po sebi še ni dovolj za utemeljitev zaključkov glede kakršnega koli možnega posebnega terapevtskega učinka.
English: The following pharmacokinetic characteristics shall be described:
Slovenian: Opišejo se naslednje farmakokinetične lastnosti:
English: absorption (rate and extent),
Slovenian: absorpcija (stopnja in obseg),
English: distribution,
Slovenian: porazdelitev,
English: metabolism,
Slovenian: presnova,
English: excretion.
Slovenian: izločanje.
English: Clinically significant features including the implication of the kinetic data for the dosage regimen especially for patients at risk, and differences between man and animal species used in the preclinical studies, shall be described.
Slovenian: Opišejo se klinično pomembne značilnosti, ki vključujejo globlji pomen kinetičnih podatkov za predpisano odmerjanje, zlasti za bolnike s tveganjem, in razlike med človekom in živalskimi vrstami, uporabljenimi v predkliničnih raziskavah.
English: If the medicinal product is normally to be administered concomitantly with other medicinal products, particulars shall be given of joint administration tests performed to demonstrate possible modification of the pharmacological action.
Slovenian: Če se zdravilo običajno daje hkrati z drugimi zdravili, se podajo podrobni podatki o preskusih skupnega dajanja zdravil, da se dokaže možna sprememba farmakološkega delovanja.