natgillin/translations-raw huggingface dataset:
If the difference in structure between them is due to post-translational events (such as different glycosylation patterns) substances shall normally be considered similar.
če je razlika v strukturi med njimi nastala po translaciji (na primer različni vzorci glikozilacije), se običajno štejejo za podobne.
However, exceptionally some post-translational modifications may result in a non-similar substance, if there is significant effect on the functional characteristics of the substance.
Izjemoma pa je lahko rezultat nekaterih sprememb po translaciji nepodobna snov, če te znatno vplivajo na funkcionalne značilnosti snovi.
If the difference in the amino acid sequence is not major, substances shall normally be considered similar.
Če razlika v aminokislinskem zaporedju ni pomembna, se snovi običajno štejejo za podobne.
Therefore, two pharmacologically related protein substances of the same group (for example, having differences related to e.g. N-terminal methionine, naturally extracted versus rDNA-derived proteins or other minor variants) shall normally be considered similar.
Zato se dve farmakološko povezani proteinski snovi iste skupine (ki se na primer razlikujeta glede N-terminalnega metionina, naravno pridobljenih proteinov ali proteinov, pridobljenih iz rDNA, ali drugih manjših različic) običajno štejeta za podobni.
However, the addition of a structural element may result in substances being considered non-similar if this significantly affects the functional characteristics of the substance.
Vendar so rezultat dodajanja strukturnega elementa lahko snovi, ki se štejejo za nepodobne, če to znatno vpliva na funkcionalne značilnosti snovi.
Monoclonal antibodies binding to the same target epitope shall normally be considered similar.
Monoklonska protitelesa, ki se vežejo na isti ciljni epitop, se običajno štejejo za podobna.
However, two monoclonal antibody conjugates or fusion proteins could be determined to be non-similar if either the Complementary Determining Region sequences of the antibody or the additional structural element of the conjugated monoclonal antibody were different.
Vendar bi se konjugati dveh monoklonskih protiteles ali fuzijski proteini lahko šteli za nepodobne, če bi bila bodisi zaporedja določitvene regije za komplementarnost protitelesa bodisi dodatni strukturni element konjugiranega monoklonskega protitelesa različna.
Polysaccharide substances:
Za polisaharidne snovi velja naslednje:
If the substances have identical saccharide repeating units, even if the number of units varies, they shall normally be considered similar.
če imajo snovi enake ponavljajoče se sladkorne enote, čeprav število enot variira, se običajno štejejo za podobne.
A conjugated polysaccharide vaccine compared to a non-conjugated polysaccharide vaccine containing the same antigen is considered a non-similar substance.
Konjugirano polisaharidno cepivo se v primerjavi z nekonjugiranim polisaharidnim cepivom, ki vsebuje isti antigen, šteje za nepodobno snov.
Advanced Therapy Medicinal Products (ATMPs)
Zdravila za napredno zdravljenje
Cell-based ATMPs: Two related cell-based medicinal products are not similar if:
Zdravila za napredno zdravljenje na celični osnovi: dve povezani zdravili na celični osnovi nista podobni, če:
there are differences in starting materials or the final composition of the product which have significant impact on the biological characteristics and/or biological activity relevant for the intended therapeutic effect and/or safety attributes of the product.
obstajajo razlike v vhodnih snoveh ali končni sestavi izdelka, ki imajo pomemben vpliv na biološke značilnosti in/ali biološko aktivnost, pomembne za predvideni terapevtski učinek in/ali varnostne lastnosti izdelka.
The different source of the starting materials (e.g. as in the case of autologous ATMPs) is not sufficient to support a claim that two products are non-similar, or
Različen vir vhodnih snovi (npr. v primeru avtolognih zdravil za napredno zdravljenje) ne zadošča za potrditev trditve, da dva izdelka nista podobna, ali
there are differences in the manufacturing technology having a significant impact on the biological characteristics and/or biological activity relevant for the intended therapeutic effect and/or safety attributes of the product.
obstajajo razlike v proizvodni tehnologiji, ki imajo pomemben vpliv na biološke značilnosti in/ali biološko aktivnost, pomembne za predvideni terapevtski učinek in/ali varnostne lastnosti izdelka.
Gene therapy medicinal products: Two gene therapy medicinal products shall not be considered similar when there are differences in the therapeutic sequence, viral vector, transfer system, regulatory sequences or manufacturing technology that significantly affect the biological characteristics and/or biological activity relevant for the intended therapeutic effect and/or safety attributes of the product.
Zdravila za gensko zdravljenje: dve zdravili za gensko zdravljenje se ne štejeta za podobni, če obstajajo razlike v terapevtskem zaporedju, virusnem vektorju, prenosnem sistemu, regulatornih zaporedjih ali proizvodni tehnologiji, ki znatno vplivajo na biološke značilnosti in/ali biološko aktivnost, pomembne za predvideni terapevtski učinek in/ali varnostne lastnosti izdelka.
Differences in the therapeutic sequence without a significant impact on the intended therapeutic effect are not sufficient to support the claim that two gene therapy medicinal products are non-similar.
Razlike v terapevtskem zaporedju brez pomembnega vpliva na predvideni terapevtski učinek ne zadoščajo za potrditev trditve, da dve zdravili za gensko zdravljenje nista podobni.
Genetically modified cells.
Gensko spremenjene celice.
The considerations under (3.1) and (3.2) apply.
Uporabljajo se ugotovitve iz točk 3.1 in 3.2.
Radiopharmaceutical medicinal products
Radiofarmacevtska zdravila
The same radiopharmaceutical active substance, or one differing from the original in radionuclide, ligand, site of labelling or molecule-radionuclide coupling mechanism linking the molecule and radionuclide provided that it acts via the same mechanism shall be considered similar substances.’
Enaka radiofarmacevtska učinkovina ali radiofarmacevtska učinkovina, ki se od izvirne radiofarmacevtske učinkovine razlikuje v radionuklidu, ligandu, mestu označevanja ali mehanizmu spajanja molekule in radionuklida, če deluje po enakem mehanizmu, se šteje za podobno snov.“
Done at Brussels, 29 May 2018.
V Bruslju, 29. maja 2018
OJ L 18, 22.1.2000, p. 1.
UL L 18, 22.1.2000, str. 1.
Commission Regulation (EC) No 847/2000 of 27 April 2000 laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts ‘similar medicinal product’ and ‘clinical superiority’ ( OJ L 103, 28.4.2000, p. 5).
Uredba Komisije (ES) št. 847/2000 z dne 27. aprila 2000 o določbah za izvajanje meril za določitev zdravila kot zdravila sirote in opredelitvah za pojma „podobno zdravilo“ in „klinična superiornost“ ( UL L 103, 28.4.2000, str. 5).
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
Direktiva 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini (UL L 311, 28.11.2001, str. 67).
establishing the methodological principles for the risk assessment and risk management recommendations referred to in Regulation (EC) No 470/2009
o določitvi metodoloških načel ocene tveganja in priporočil za obvladovanje tveganja iz Uredbe (ES) št. 470/2009
Having regard to Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council, and in particular Article 13(2)(a) thereof,
ob upoštevanju Uredbe (ES) št. 470/2009 Evropskega parlamenta in Sveta z dne 6. maja 2009 o določitvi postopkov Skupnosti za določitev mejnih vrednosti ostankov farmakološko aktivnih snovi v živilih živalskega izvora in razveljavitvi Uredbe Sveta (EGS) št. 2377/90 in spremembi Direktive 2001/82/ES Evropskega parlamenta in Sveta ter Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta ter zlasti člena 13(2)(a) Uredbe,
Regulation (EC) No 470/2009 provides that, except in cases where the Codex Alimentarius procedure applies, any pharmacologically active substance intended for use in the Union in veterinary medicinal products which are to be administered to food-producing animals shall be subject to an opinion of the European Medicines Agency (‘Agency’) on the maximum residue limits (‘MRLs’) of pharmacologically active substances used or intended to be used in veterinary medicinal products.
Uredba (ES) št. 470/2009 določa, da mora Evropska agencija za zdravila (v nadaljnjem besedilu: agencija), razen v primerih, ko se uporablja postopek Codex Alimentarius, za vsako farmakološko aktivno snov, namenjeno uporabi v zdravilih za uporabo v veterinarski medicini v Uniji, ki se dajejo živalim, namenjenim za proizvodnjo hrane, podati mnenje glede najvišjih mejnih vrednosti ostankov farmakološko aktivnih snovi, ki se uporabljajo ali so namenjene za uporabo v zdravilih za uporabo v veterinarski medicini.
The Agency's opinion should consist of a scientific risk assessment and risk management recommendations.
Mnenje agencije vključuje znanstveno oceno tveganja in priporočila za obvladovanje tveganja.
Regulation (EC) No 470/2009 empowers the Commission to adopt measures establishing the methodological principles for the risk assessment and risk management recommendations regarding the establishment of the MRLs of pharmacologically active substances.
Z Uredbo (ES) št. 470/2009 so bila Komisiji podeljena pooblastila za sprejetje ukrepov, namenjenih določitvi metodoloških načel ocene tveganja in priporočil za obvladovanje tveganja v zvezi z določitvijo najvišjih mejnih vrednosti ostankov farmakološko aktivnih snovi.
In order to provide legal certainty, clarity and predictability with regard to the process of the establishment of MRLs, it is appropriate that the criteria against which the Agency appraise the applications are provided for in this Regulation.
Da se zagotovijo pravna varnost, jasnost in predvidljivost v zvezi s postopkom določitve najvišjih mejnih vrednosti ostankov, je primerno v tej uredbi določiti merila, na podlagi katerih agencija presoja vloge.
The methodological principles for the risk assessment and risk management recommendations should aim to ensure a high level of human health protection, whilst also ensuring that human health, animal health and animal welfare are not negatively affected by the lack of availability of appropriate veterinary medicinal products.
Namen metodoloških načel ocene tveganja in priporočil za obvladovanje tveganja bi moral biti zagotoviti visoko raven varovanja zdravja ljudi ter hkrati preprečiti, da bi premajhna razpoložljivost ustreznih zdravil za uporabo v veterinarski medicini negativno vplivala na zdravje ljudi in živali ter dobrobit živali.
Taking into account the requirements set out in Article 6 of Regulation (EC) No 470/2009, the detailed rules on the methodological principles for the scientific risk assessment part of the Agency's opinion should be laid down in this Regulation.
Ob upoštevanju zahtev iz člena 6 Uredbe (ES) št. 470/2009 bi bilo treba v tej uredbi določiti podrobna pravila o metodoloških načelih znanstvene ocene tveganja, ki je del mnenja agencije.
Taking into account the requirements set out in Article 7 of Regulation (EC) No 470/2009, the detailed rules on the methodological principles for the risk management recommendations part of Agency's opinion should be laid down in this Regulation.
Ob upoštevanju zahtev iz člena 7 Uredbe (ES) št. 470/2009 bi bilo treba v tej uredbi določiti podrobna pravila o metodoloških načelih priporočil za obvladovanje tveganja, ki so del mnenja agencije.
In the risk management recommendations, the Agency is also required to consider the availability of alternative substances and other legitimate factors, such as the technological aspects of food and feed production or the feasibility of controls.
Agencija mora v priporočilih za obvladovanje tveganja upoštevati tudi razpoložljivost alternativnih snovi in druge upravičene dejavnike, kot so tehnološki vidiki proizvodnje živil in krme ali izvedljivost nadzora.
Therefore it is appropriate to lay down rules on that requirement.
Zato je primerno določiti pravila v zvezi z navedeno zahtevo.
This Regulation sets out the methodological principles for the scientific risk assessment and risk management recommendations referred to in Articles 6 and 7 of Regulation (EC) No 470/2009 that shall be applied by the Agency when preparing opinions on the MRLs of pharmacologically active substances which may be permitted in food of animal origin under that Regulation.
Ta uredba določa metodološka načela znanstvene ocene tveganja in priporočil za obvladovanje tveganja iz členov 6 in 7 Uredbe (ES) št. 470/2009, ki jih agencija uporabi pri pripravi mnenj o najvišjih mejnih vrednostih ostankov farmakološko aktivnih snovi, ki so lahko v skladu z navedeno uredbo dovoljene v živilih živalskega izvora.
The methodological principles for the scientific risk assessment are set out in Annex I.
Metodološka načela znanstvene ocene tveganja so določena v Prilogi I.
The methodological principles for the risk management recommendations are set out in Annex II.
Metodološka načela priporočil za obvladovanje tveganja so določena v Prilogi II.
For the purposes of this Regulation, in addition to the definitions set out in Regulation (EC) No 470/2009, the following definitions shall apply:
V tej uredbi se poleg opredelitev pojmov iz Uredbe (ES) št. 470/2009 uporabljajo tudi naslednje opredelitve pojmov:
‘major metabolites’ means metabolites comprising ≥ 100 μg/kg or ≥ 10 % of the total residue in a sample collected from the target animal species in the metabolism study,
„glavni metaboliti“ pomenijo metabolite, ki vsebujejo ≥ 100 μg/kg ali ≥ 10 % skupnih ostankov v vzorcu, odvzetemu ciljni živalski vrsti v študiji o metabolizmu,
‘marker residue’ means a residue whose concentration is in a known relationship to the concentration of total residue in an edible tissue,
„ostanek označevalec“ pomeni ostanek, katerega koncentracija je v znanem razmerju s koncentracijo skupnih ostankov v užitnem tkivu,
‘dairy starter cultures’ means prepared cultures of microorganism employed in the manufacture of a variety of dairy products including butter, cheese, yoghurt and cultured milk.
„mlečne starterske kulture“ pomenijo pripravljene kulture mikroorganizma, ki se uporabljajo pri izdelavi različnih mlečnih izdelkov, vključno z maslom, sirom, jogurtom in fermentiranim mlekom.
Methodological principles for the scientific risk assessment referred to in Article 6 of Regulation (EC) No 470/2009
Metodološka načela znanstvene ocene tveganja iz člena 6 Uredbe (ES) št. 470/2009
Safety and residue tests for the establishment of maximum residue limits (‘MRLs’) shall be carried out in conformity with the provisions related to Good Laboratory Practice (‘GLP’) as laid down in Directive 2004/10/EC of the European Parliament and of the Council.
Preskusi varnosti in ostankov za določitev najvišjih mejnih vrednosti ostankov se izvedejo v skladu z določbami o dobri laboratorijski praksi iz Direktive 2004/10/ES Evropskega parlamenta in Sveta.
If data are available that have not been generated under GLP conditions, the potential impact of this shall be addressed.
Če so na voljo podatki, ki niso bili pridobljeni pod pogoji dobre laboratorijske prakse, se obravnava morebitni vpliv take pridobitve.
Use of experimental animals in safety and residue tests shall comply with Directive 2010/63/EU of the European Parliament and of the Council.
Uporaba poskusnih živali pri preskusih varnosti in ostankov je v skladu z Direktivo 2010/63/EU Evropskega parlamenta in Sveta.
Documentation presented in relation to safety and residue tests shall name the laboratory where the work was performed and shall be signed and dated.
V podpisani in datirani dokumentaciji, predloženi v zvezi s preskusi varnosti in ostankov, se navede ime laboratorija, v katerem je bilo delo opravljeno.
Summaries of any studies that are not accompanied by the raw data shall not be accepted as valid documentation.
Kot veljavna dokumentacija se ne sprejmejo povzetki študij, ki jim niso priloženi surovi podatki.
Design, methods and conduct of the studies, name and qualifications of investigator, place and period of time during which the study was undertaken shall be clear from the test reports.
Iz poročil o preskusih so jasno razvidni zasnova, metode in potek študij, ime in priimek ter kvalifikacije raziskovalca ter kraj in obdobje izvajanja študije.
The experimental techniques shall be described in such detail as to allow them to be reproduced, and the investigator shall establish their validity.
Eksperimentalne metode se opišejo dovolj podrobno, da jih je mogoče ponoviti, raziskovalec pa dokaže njihovo veljavnost.
All abbreviations and codes, irrespective of whether they are internationally accepted or not, shall be accompanied by a key.
Vsem okrajšavam in oznakam, ne glede na to, ali so mednarodno sprejete ali ne, se doda legenda.
Where applicable, all observed results from the studies submitted shall be evaluated by an appropriate statistical method and be discussed in conjunction with the other available studies.
Kjer je to ustrezno, se vsi ugotovljeni rezultati iz predloženih študij ovrednotijo z ustrezno statistično metodo in obravnavajo v povezavi z drugimi razpoložljivimi študijami.
The results of all studies shall be presented in a form that facilitates their review.
Rezultati vseh študij se predstavijo v taki obliki, da jih je mogoče zlahka pregledati.
Test reports shall include the following information (where applicable):
Poročila o preskusih vključujejo naslednje informacije (kjer je ustrezno):
chemical identification of the test pharmacologically active substance, including the isomer ratio and the enantiomers, if appropriate;
kemijske identifikacijske podatke testne farmakološko aktivne snovi, po potrebi vključno z razmerjem izomerov in enantiomeri;
purity of the test substance;
čistost testne snovi;
formulation of the administered drug and method of dose preparation;
formulacijo apliciranega zdravila in metodo priprave odmerka;
stability, including stability in vehicle and feed when so administered;
stabilnost, vključno s stabilnostjo v podlagi in krmi, kadar se daje v taki obliki;
mode of dose administration (dose (expressed in mg/kg body weight), frequency of dosing, and duration of treatment);
način dajanja odmerkov (odmerek [izražen v mg/kg telesne mase], pogostost odmerjanja in trajanje zdravljenja);
for administration of the test substance other than in the diet or drinking water: the characteristics of the vehicle, including toxicological characteristics;
za testno snov, ki se ne daje s hrano ali pitno vodo: značilnosti podlage, vključno s toksikološkimi značilnostmi;
species, strain and source of test animals used, use of specific pathogen free animals, sex of the dosed animals, age of the animals at the beginning of the dosing, number of dosed animals;
vrsto, sev in izvor uporabljenih poskusnih živali, uporabo živali brez specifičnih patogenov, spol živali, ki so prejemale odmerke, starost živali ob začetku odmerjanja, število živali, ki so prejemale odmerke;
dose levels and route and frequency of administration (with dosage in mg/kg bodyweight/day), test period, parameters followed, frequency of observation; conditions of animal husbandry including environmental conditions, water and food consumption (especially for drugs administered in drinking water and/or feed);
velikosti odmerkov ter način in pogostost dajanja (z odmerjanjem v mg/kg telesne mase/dan), preskusno obdobje, upoštevane parametre, pogostost opazovanj; pogoje živinoreje, vključno z okoljskimi razmerami ter porabo vode in hrane (zlasti za zdravila, ki se dajejo s pitno vodo in/ali krmo);
sampling time points;
časovne točke vzorčenja;
description of toxic signs with the inclusion of time of onset, degree and duration (for safety tests), where appropriate;
opis toksičnih znakov, vključno s časom nastanka, stopnjo in trajanjem (za preskuse varnosti), kadar je ustrezno;
results of the clinical observations, gross necropsy, histopathology and of all other parameters investigated (for safety tests), where appropriate;
rezultate kliničnih opazovanj, makroskopske nekropsije, histopatologije in vseh drugih raziskanih parametrov (za preskuse varnosti), kadar je ustrezno;
where appropriate, an estimate of a no observed (adverse) effect level (‘NO(A)EL’) or lowest observed (adverse) effect level (‘LO(A)EL’) or lower bound of the benchmark dose (‘BMDL’) (for safety tests);
kadar je ustrezno, oceno ravni brez opaženega (škodljivega) učinka ali najnižje ravni z opaženim (škodljivim) učinkom ali spodnje meje primerjalnega odmerka (za preskuse varnosti);
weight of dosed animals;
maso živali, ki so prejemale odmerke;
milk and egg production (if applicable);
proizvodnjo mleka in jajc (če je ustrezno);
specific activity and radio-purity of labelled substances (for residues tests);
specifično aktivnost ter radiokemijsko čistost označenih snovi (za preskuse ostankov);
sample collection, sample size, and sample storage;
odvzem vzorcev, velikost vzorca in hrambo vzorcev;
analytical methods: a complete description of the procedure, including preparation of analytical samples, instrumentation and data derived from standards, control tissues, fortified tissues and tissues with incurred residues; validation data for the analytical method shall be provided, including limit of detection, limit of quantification, linearity in and around the relevant range of concentrations, stability, accuracy, precision and susceptibility to interferences;
analizne metode: popoln opis postopka, vključno s pripravo analiznih vzorcev, instrumentov in podatkov, izpeljanih iz standardov, kontrolnimi tkivi, obogatenimi tkivi in tkivi z izpostavljenimi ostanki; zagotovijo se validacijski podatki za analizno metodo, vključno z mejo detekcije, mejo količinske določljivosti, linearnostjo v zadevnem območju koncentracije in okrog njega, stabilnostjo, natančnostjo, točnostjo in občutljivostjo za motnje;
raw data of all test results including those of the analytical method used to determine the residues in the edible tissues or products, methods of calculation.
surove podatke rezultatov vseh preskusov, vključno s tistimi iz analizne metode, uporabljene za določitev ostankov v užitnih tkivih ali izdelkih, metode za izračun.
Biological substances other than those identified in Article 1(2)(a) of Regulation (EC) No 470/2009 of the European Parliament and of the Council shall be:
Za biološke snovi razen tistih, ki so opredeljene v členu 1(2)(a) Uredbe (ES) št. 470/2009 Evropskega parlamenta in Sveta:
subject to a normal MRL where the biological substance is chemical-like insofar as it could be produced by chemical synthesis and so presents similar concerns to chemical substances and can be expected to leave residues in the same way as chemical substances (e.g. cytokines, hormones);
velja običajna najvišja mejna vrednost ostankov, kadar je biološka snov podobna kemijski, ker bi lahko nastala s kemično sintezo, tako da vzbuja podobne pomisleke kot kemijske snovi in bi lahko puščala ostanke enako kot kemijske snovi (npr. citokini, hormoni);