FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: The provisions of the monographs for pharmaceutical forms, immunosera, vaccines and radiopharmaceutical preparations of the European Pharmacopoeia or failing that, of a Member State, shall be applicable to all products defined therein.
Slovenian: Za vse izdelke se uporabljajo določbe monografij za farmacevtske oblike, imunske serume, cepiva in radiofarmacevtske izdelke iz Evropske farmakopeje ali, če jih ta ne vsebuje, iz farmakopeje države članice.
English: For all controls of biological medicinal products such as immunological medicinal products and medicinal products derived from human blood or plasma which are not specified in the European Pharmacopoeia or failing this, in the pharmacopoeia of a Member State, the procedures and the criteria of acceptability published as recommendations in the WHO (Requirements for Biological Substances) shall serve as guidelines.
Slovenian: Za vse kontrole bioloških zdravil, kot so imunološka zdravila in zdravila, pridobljena iz človeške krvi ali plazme, ki niso navedena v Evropski farmakopeji ali, če jih ta ne vsebuje, v farmakopeji države članice, se kot smernice uporabljajo postopki in merila sprejemljivosti, objavljeni kot priporočila WHO (Zahteve za biološke snovi).
English: If test procedures and limits other than those mentioned in the monographs of the European Pharmacopoeia, or failing this, in the national pharmacopoeia of a Member State, are used, proof shall be supplied that the finished product would, if tested in accordance with those monographs, meet the quality requirements of that pharmacopoeia for the pharmaceutical form concerned.
Slovenian: Če se uporabljajo drugi postopki preskušanja in mejne vrednosti, ki niso navedeni v monografijah Evropske farmakopeje ali, če jih ta ne vsebuje, v farmakopeji države članice, se predloži dokaz, da bi končni izdelek, če bi se preskus izvajal v skladu z monografijami, ustrezal farmakopejskim zahtevam kakovosti za zadevno farmacevtsko obliko.
English: Certain tests of the general characteristics of a product shall always be included among the tests on the finished product.
Slovenian: Določeni preskusi splošnih lastnosti izdelka so vedno vključeni med preskuse končnega izdelka.
English: These tests shall, wherever applicable, relate to the control of average masses and maximum deviations, to mechanical, physical or microbiological tests, organoleptic characteristics, physical characteristics such as density, pH, refractive index, etc. For each of these characteristics, standards and tolerance limits shall be specified by the applicant in each particular case.
Slovenian: Ti preskusi se, kadarkoli je to ustrezno, nanašajo na preskus enakomernosti mase in najvišja dovoljena odstopanja, mehanske, fizikalne ali mikrobiološke preskuse, organoleptične lastnosti, fizikalne lastnosti, kot so gostota, pH, lomni količnik, itd. Za vsako od teh lastnosti vlagatelj za vsak posamezen primer navede standarde in dopustne meje odstopanja.
English: The conditions of the tests, where appropriate, the equipment/apparatus employed and the standards shall be described in precise details whenever they are not given in the European Pharmacopoeia or the pharmacopoeia of the Member States;
Slovenian: Pogoji preskusov, kadar je to primerno, uporabljena oprema in standardi se podrobno opišejo vedno, kadar niso opisani v Evropski farmakopeji ali v farmakopeji države članice;
English: the same shall apply in cases where the methods prescribed by such pharmacopoeias are not applicable.
Slovenian: enako velja tudi, kadar se ne uporabljajo predpisani postopki iz farmakopej.
English: Furthermore, solid pharmaceutical forms having to be administered orally shall be subjected to in vitro studies on the liberation and dissolution rate of the active substance or substances;
Slovenian: Poleg tega se za trdne farmacevtske oblike za peroralno uporabo izvedejo in vitro študije o sproščanju in hitrosti raztapljanja zdravilne(ih) učinkovin;
English: these studies shall also be carried out where administration is by another means if the competent authorities of the Member State concerned consider this necessary.
Slovenian: te študije se opravijo tudi, kadar se zdravilo daje na druge načine, če pristojni organi zadevne države članice menijo, da je to potrebno.
English: Identification and assay of active substance(s)
Slovenian: Identifikacija in določanje vsebnosti zdravilne(ih) učinkovine
English: Identification and assay of the active substance(s) shall be carried out either in an average representative sample from the production batch or in a number of dosage-units analysed individually.
Slovenian: Identifikacija in določanje vsebnosti zdravilne(ih) učinkovine se izvede na povprečnem reprezentativnem vzorcu proizvodne serije, ali pa na več odmernih enotah, ki se analizirajo posamezno.
English: Unless there is appropriate justification, the maximum acceptable deviation in the active substance content of the finished product shall not exceed ± 5 % at the time of manufacture.
Slovenian: V času proizvodnje največja dopustna meja odstopanja vsebnosti zdravilne učinkovine v končnem izdelku ne presega ± 5 %, razen če za to ni ustrezne utemeljitve.
English: On the basis of the stability tests, the manufacturer must propose and justify maximum acceptable tolerance limits in the active substance content of the finished product up to the end of the proposed shelf-life.
Slovenian: Na osnovi testov stabilnosti, proizvajalec predlaga ter utemelji največje dopustne meje odstopanja vsebnosti zdravilne učinkovine v končnem izdelku do konca izteka predlaganega roka uporabnosti.
English: In certain exceptional cases of particularly complex mixtures, where assay of active substances which are very numerous or present in very low amounts would necessitate an intricate investigation difficult to carry out in respect of each production batch, the assay of one or more active substances in the finished product may be omitted, on the express condition that such assays are made at intermediate stages in the production process.
Slovenian: V določenih izjemnih primerih posebej kompleksnih zmesi, kadar bi bile zaradi vsebnosti številnih zdravilnih učinkovin ali pa zaradi zelo nizkih vsebnosti potrebna zapletena raziskava, težko izvedljiva v vsaki proizvodni seriji, se določanje vsebnosti ene ali več zdravilnih učinkovin v končnem izdelku lahko opusti, pod izrecnim pogojem, da se določanja vsebnosti izvedejo v vmesnih fazah postopka proizvodnje.
English: This simplified technique shall be supplemented by a method of quantitative evaluation, enabling the competent authority to have the conformity of the medicinal product with its specification verified after it has been placed on the market.
Slovenian: Ta poenostavljen način izvajanja se dopolni z metodo količinskega vrednotenja, kar pristojnemu organu omogoča preverjanje skladnosti zdravila s specifikacijo potem, ko je zdravilo že v prometu.
English: An in vivo or in vitro biological assay shall be obligatory when physico-chemical methods cannot provide adequate information on the quality of the product.
Slovenian: In vivo ali in vitro biološko določanje vsebnosti je obvezno, kadar s fizikalno-kemijskimi postopki ni mogoče dobiti ustreznih podatkov o kakovosti zdravila.
English: Such an assay shall, whenever possible, include reference materials and statistical analysis allowing calculation of confidence limits.
Slovenian: Določanje vsebnosti vključuje, kadarkoli je to mogoče, referenčne materiale in statistične analize, ki omogočajo izračun meja zaupanja.
English: Where these tests cannot be carried out on the finished product, they may be performed at an intermediate stage, as late as possible in the manufacturing process.
Slovenian: Kadar teh preskusov ni mogoče izvesti na končnem izdelku, se lahko opravijo v vmesni fazi, čim kasneje v postopku proizvodnje.
English: Where the particulars given in section B show that a significant overage of an active substance is employed in the manufacture of the medicinal product, the description of the control tests on the finished product shall include, where appropriate, the chemical and, if necessary, the toxico-pharmacological investigation of the changes that this substance has undergone, and possibly the characterization and/or assay of the degradation products.
Slovenian: Kadar podatki v oddelku B kažejo, da se je pri proizvodnji zdravila uporabil znaten presežek zdravilne učinkovine, mora opis kontrolnih preskusov končnega izdelka vključevati, kadar je to primerno, kemijske in, po potrebi, toksikološko-farmakološke raziskave sprememb, do katerih je prišlo v snovi, ter po možnosti še opis lastnosti in/ali določanje vsebnosti razpadnih produktov.
English: Identification and assay of excipient constituents
Slovenian: Identifikacija in določanje vsebnosti pomožnih snovi
English: In so far as is necessary, the excipient(s) shall be subject at least to identification tests.
Slovenian: Če je potrebno, se na pomožni snovi (pomožnih snoveh) izvedejo vsaj identifikacijski preskusi.
English: The test procedure proposed for identifying colouring matters must enable a verification to be made that such matters appear in the list annexed to Directive 78/25/EEC.
Slovenian: Predlagani postopek za identifikacijo barvil mora omogočati preverjanje, da so barvila uvrščena na seznam, priložen k Direktivi 78/25/EGS.
English: An upper and lower limit test shall be obligatory in respect of preserving agents and an upper limit test for any other excipient constituent liable to affect adversely organic functions;
Slovenian: Obvezen je preskus zgornje in spodnje mejne vrednosti za konzervanse ter preskus zgornjih mejnih vrednostih za vse druge pomožne snovi, ki bi lahko imele neželen vpliv na funkcije organov;
English: an upper and lower limit test shall be obligatory in respect of the excipient if it is liable to affect the bio-availability of an active substance, unless bio-availability is guaranteed by other appropriate tests.
Slovenian: preskus zgornje in spodnje mejne vrednosti je obvezen za pomožno snov, če obstaja možnost, da bi vplival na biološko uporabnost zdravilne učinkovine, razen če je ta zagotovljena z drugimi ustreznimi preskusi.
English: Apart from the pharmacotoxicological tests submitted with the application for marketing authorization, particulars of safety tests, such as sterility, bacterial endotoxin, pyrogenicity and local tolerance in animals shall be included in the analytical particulars wherever such tests must be undertaken as a matter of routine in order to verify the quality of the product.
Slovenian: Poleg farmakološko-toksikoloških preskusov, predloženih z vlogo za pridobitev dovoljenja za promet z zdravilom, se vključijo tudi podrobni podatki preskusov varnosti, kot so preskusi sterilnosti, bakterijskih endotoksinov, pirogenosti ter lokalne tolerance pri živalih, kadarkoli so taki preskusi potrebni kot redni preskusi preverjanje kakovosti zdravila.
English: For all controls of biological medicinal products, such as immunological medicinal products and medicinal products derived from human blood or plasma, which are not specified in the European Pharmacopoeia, or failing this, in the national pharmacopoeia of a Member State, the procedures and the criteria of acceptability published as recommendations in the World Health Organization (Requirements for Biological Substances) shall serve as guidelines.
Slovenian: Pri vseh kontrolah bioloških zdravil, kot so imunološka zdravila ter zdravila, pridobljena iz človeške krvi ali plazme, ki niso navedene v Evropski farmakopeji ali v nacionalni farmakopeji države članice, se kot smernice uporabljajo postopki in merila sprejemljivosti, objavljeni kot priporočila WHO (Zahteve za biološke snovi).
English: For radiopharmaceuticals, radionuclidic purity, radiochemical purity and specific activity shall be described.
Slovenian: Pri radiofarmacevtskih izdelkih se opišejo radionuklidna čistota, radiokemična čistota ter specifična aktivnost.
English: For content of radioactivity, the deviation from that stated on the label should not exceed ± 10 %.
Slovenian: Radioaktivnost ne sme odstopati od vrednosti, navedene na nalepki, za več kot ± 10 %.
English: For generators, details on the testing for mother and daughter radionuclides are required.
Slovenian: Pri generatorjih se zahtevajo podrobnosti o preskušanju starševskih in hčerinskih radionuklidov.
English: For generator-eluates, tests for mother radionuclides and for other components of the generator system shall be provided.
Slovenian: Pri eluatih generatorjev se predložijo preskusi starševskih radionuklidov in ostalih sestavin generatorskega sistema.
English: For kits, the specifications of the finished product shall include tests on performance of products after radiolabelling.
Slovenian: Pri kompletih specifikacije končnega izdelka vključujejo preskuse delovanja izdelkov po radioaktivnem označevanju.
English: Appropriate controls on radiochemical and radionuclidic purity of the radiolabelled compound shall be included.
Slovenian: Vključijo se ustrezne kontrole radiokemične in radionuklidne čistote radioaktivno označene spojine.
English: Any material essential for radiolabelling shall be identified and assayed.
Slovenian: Vsaka snov, ki je bistvena za radioaktivno označevanje, se identificira in se ji določi vsebnost.
English: Stability tests
Slovenian: Testi stabilnosti
English: The particulars and documents accompanying the application for marketing authorization pursuant to Article 8(3)(g) and (h) shall be submitted in accordance with the following requirements.
Slovenian: Podrobni podatki in dokumenti, ki spremljajo vlogo za pridobitev dovoljenja za promet z zdravilom na podlagi člena 8(3)(g) in (h), se predložijo v skladu z naslednjimi zahtevami.
English: A description shall be given of the investigations by which the shelf life, the recommended storage conditions and the specifications at the end of the shelf-life proposed by the applicant have been determined.
Slovenian: Predložijo se opisi raziskav, na podlagi katerih je določen rok uporabnosti, priporočeni pogoji shranjevanja ter specifikacije do konca izteka roka uporabnosti, ki jih predlaga vlagatelj.
English: Where a finished product is liable to give rise to degradation products, the applicant must declare these and indicate characterization methods and test procedures.
Slovenian: Kadar je končni izdelek podvržen nastanku razpadnih produktov, mora vlagatelj to navesti in opredeliti metode karakterizacije ter postopke preskušanja.
English: The conclusions shall contain the results of analyses, justifying the proposed shelf life under the recommended storage conditions and the specifications of the finished product at the end of the shelf-life under these recommended storage conditions.
Slovenian: Zaključki vsebujejo rezultate analiz, ki utemeljujejo predlagani rok uporabnosti v priporočenih pogojih shranjevanja ter specifikacije končnega izdelka do konca izteka roka uporabnosti v priporočenih pogojih shranjevanja.
English: The maximum acceptable level of degradation products at the end of shelf-life shall be indicated.
Slovenian: Navede se največja dopustna raven razpadnih produktov do konca izteka roka uporabnosti.
English: A study of the interaction between product and container shall be submitted wherever the risk of such interaction is regarded as possible, especially where injectable preparations or aerosols for internal use are concerned.
Slovenian: Vedno kadar se ocenjuje, da obstaja tveganje za medsebojno delovanje med zdravilom in vsebnikom, se predloži študija medsebojnega delovanja, zlasti kadar gre za pripravke za injiciranje ali aerosole za notranjo uporabo.
English: Where for biological medicinal products, such as immunological medicinal products and medicinal products derived from human blood or plasma, stability tests cannot be carried out on the finished products, it is acceptable to carry out stability indicating tests at an intermediate stage of production as late as possible in the manufacturing process.
Slovenian: Kadar pri bioloških zdravilih, kot so imunološka zdravila ter zdravila, pridobljena iz človeške krvi ali plazme, testov stabilnosti ni mogoče izvajati na končnem izdelku, je sprejemljiva izvedba testov, ki pokažejo stabilnost v vmesni fazi postopka proizvodnje, čim kasneje v postopku proizvodnje.
English: In addition, there should be an evaluation of the stability of the finished product using other secondary tests.
Slovenian: Poleg tega je stabilnost končnega izdelka treba ovrednotiti z uporabo drugih sekundarnih testov.
English: For radiopharmaceuticals, information on stability shall be given for radionuclide generators, radionuclide kits and radiolabelled products.
Slovenian: Pri radiofarmacevtskih izdelkih se predloži informacija o stabilnosti za radionuklidne generatorje, radionuklidno komplete in radioaktivno označene izdelke.
English: The stability during use of radiopharmaceuticals in multi-dose vials shall be documented.
Slovenian: Dokumentira se stabilnost med uporabo radiofarmacevtskih izdelkov v večodmernih vialah.
English: TOXICOLOGICAL AND PHARMACOLOGICAL TESTS
Slovenian: TOKSIKOLOŠKI IN FARMAKOLOŠKI PRESKUSI
English: The particulars and documents accompanying the application for marketing authorization pursuant to Articles 8(3)(i) and 10(1) shall be given in accordance with the requirements below.
Slovenian: Podrobni podatki in dokumenti, priloženi vlogi za pridobitev dovoljenja za promet z zdravilom na podlagi členov 8(3)(i) in 10(1), se predložijo v skladu z naslednjimi zahtevami.
English: Member States shall ensure that the safety tests are carried out in conformity with the provisions relating to good laboratory practice laid down by Council Directives 87/18/EEC(4) and 88/320/EEC(5).
Slovenian: Države članice zagotovijo, da se preskusi varnosti opravljajo skladno z načeli dobre laboratorijske prakse, predpisanimi z direktivama Sveta 87/18/EGS [4] in 88/320/EGS [5].
English: The toxicological and pharmacological tests must show:
Slovenian: Toksikološki in farmakološki preskusi morajo pokazati:
English: the potential toxicity of the product and any dangerous or undesirable toxic effects that may occur under the proposed conditions of use in human beings;
Slovenian: morebitno toksičnost zdravila in vse nevarne ali neželene toksične učinke, ki lahko nastopijo v predlaganih pogojih uporabe pri ljudeh;
English: these should be evaluated in relation to the pathological condition concerned;
Slovenian: te je treba ovrednotiti v zvezi z zadevnimi patološkimi stanji;
English: the pharmacological properties of the product, in both qualitative and quantitative relationship to the proposed use in human beings.
Slovenian: farmakološke lastnosti zdravila v kakovostnem in količinskem odnosu na predlagano uporabo pri ljudeh.
English: All results must be reliable and of general applicability.
Slovenian: Vsi rezultati morajo biti zanesljivi ter splošno uporabni.
English: Whenever appropriate, mathematical and statistical procedures shall be used in designing the experimental methods and in evaluating the results.
Slovenian: Kadarkoli je primerno, se uporabijo matematični in statistični postopki pri načrtovanju poskusnih metod ter pri ovrednotenju rezultatov.
English: Additionally, it is necessary for clinicians to be given information about the therapeutic potential of the product.
Slovenian: Pomembno je tudi, da so klinični zdravniki obveščeni o terapevtskem potencialu zdravila.
English: Where a medicinal product is intended for topical use, systemic absorption must be investigated, due account also being taken of the possible use of the product on broken skin and absorption through other relevant surfaces.
Slovenian: Kadar je zdravilo namenjeno za topikalno uporabo, je treba raziskati sistemsko absorpcijo, ob upoštevanju možne uporabe zdravila na razpokani koži ter absorpcijo prek drugih ustreznih površin.
English: Only if it is proved that systemic absorption under these conditions is negligible may repeated dose systemic toxicity tests, foetal toxicity tests and studies of reproductive function be omitted.
Slovenian: Samo v primeru, če se dokaže, da je sistemska absorpcija v teh pogojih zanemarljiva, se lahko opustijo preskusi sistemske toksičnosti pri večkratnih odmerkih, preskusi toksičnosti za zarodek ter študije vpliva na sposobnost razmnoževanja.
English: If, however, systemic absorption is demonstrated during therapeutic experimentation, toxicity tests shall be carried out on animals, including where necessary, foetal toxicity tests.
Slovenian: Če se med terapevtskimi poskusi pokaže sistemska absorpcija, se preskusi toksičnosti izvedejo na živalih, vključno, kadar je to potrebno, s preskusi toksičnosti za zarodek.
English: In all cases, tests of local tolerance after repeated application shall be carried out with particular care and include histological examinations;
Slovenian: V vseh primerih se posebej skrbno izvedejo preskusi lokalne tolerance pri večkratni uporabi; vključijo se tudi histološke preiskave;
English: the possibility of sensitization shall be investigated and any carcinogenic potential investigated in the cases referred to in Section II E of this Part.
Slovenian: razišče se možnost za pojav preobčutljivosti in katerikoli rakotvorni potencial v primerih, navedenih v oddelku II E tega dela.
English: For biological medicinal products such as immunological medicinal products and medicinal products derived from human blood or plasma, the requirements of this Part may have to be adapted for individual products;
Slovenian: Pri bioloških zdravilih, kot so imunološka zdravila ter zdravilih, pridobljenih iz človeške krvi ali plazme, bo morda treba prilagoditi zahteve tega dela posameznim zdravilom;
English: therefore the testing programme carried out shall be justified by the applicant.
Slovenian: zato vlagatelj utemelji izveden program preskušanja.
English: In establishing the testing programme, the following shall be taken into consideration:
Slovenian: Pri vzpostavljanju programa preskušanja se upošteva naslednje:
English: all tests requiring repeated administration of the product shall be designed to take account of the possible induction of, and interference by, antibodies;
Slovenian: vsi preskusi, ki zahtevajo večkratno dajanje zdravila, so načrtovani tako, da upoštevajo možno indukcijo in interferenco s protitelesi;
English: examination of reproductive function, of embryo/foetal and perinatal toxicity, of mutagenic potential and of carcinogenic potential shall be considered.
Slovenian: upoštevajo se raziskave vplivov na sposobnost razmnoževanja, toksičnosti za zarodek/plod in obporodne toksičnosti, mutagenega potenciala in rakotvornega potenciala.
English: Where components other than the active substance(s) are incriminated, validation of their removal may replace the study.
Slovenian: Kadar se potencial pripisuje sestavinam, ki niso zdravilne učinkovine, se študije lahko nadomestijo z validacijo njihove odstranitve.
English: For radiopharmaceuticals, it is appreciated that toxicity may be associated with a radiation dose.
Slovenian: Pri radiofarmacevtskih izdelkih se ocenjuje, da je toksičnost morda povezana z odmerkom sevanja.
English: In diagnosis, this is a consequence of the use of radiopharmaceuticals;
Slovenian: Pri diagnostiki je to posledica uporabe radiofarmacevtskih izdelkov;
English: in therapy, it is the wanted property.
Slovenian: pri terapiji je to želena lastnost.
English: The evaluation of safety and efficacy of radiopharmaceuticals shall, therefore, address requirements for medicinal products and radiation dosimetry aspects.
Slovenian: Vrednotenje varnosti in učinkovitosti radiofarmacevtskih izdelkov obravnava zahteve za zdravila in vidike merjenja odmerkov sevanja.
English: Organ/tissue exposure to radiation shall be documented.
Slovenian: Dokumentira se izpostavljenost organa/tkiva sevanju.
English: Absorbed radiation dose estimates shall be calculated according to a specified, internationally recognized system by a particular route of administration.
Slovenian: Izračunajo se ocene absorbiranega odmerka sevanja po določenem, mednarodno priznanem sistemu s posebno potjo uporabe.