FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: For the control of the finished product, a batch of a finished product comprises all the units of a pharmaceutical form which are made from the same initial quantity of material and have undergone the same series of manufacturing and/or sterilization operations or, in the case of a continuous production process, all the units manufactured in a given period of time.
Slovenian: Za kontrolo končnega izdelka, serija končnega izdelka obsega vse enote farmacevtske oblike, ki so izdelane iz iste začetne količine snovi in ki je šla skozi iste vrste postopkov izdelave in/ali postopkov sterilizacije, ali, v primeru neprekinjenega postopka izdelave, vse enote, ki so bile izdelane v določenem časovnem obdobju.
English: The application for marketing authorization shall list those tests which are carried out routinely on each batch of finished product.
Slovenian: Vloga za pridobitev dovoljenja za promet z zdravilom mora vsebovati seznam preskusov, ki so opravljajo rutinsko pri vsaki seriji končnega izdelka.
English: The frequency of the tests which are not carried out routinely shall be stated.
Slovenian: Treba je navesti pogostost testov, ki se ne opravljajo rutinsko.
English: Release limits shall be indicated.
Slovenian: Treba je navesti meje za sproščanje serij.
English: The particulars and documents accompanying the application for marketing authorization pursuant to Article 12(3)(i) and (j) and also Article 13(1), shall include particulars relating to control tests on the finished product at release.
Slovenian: Podrobni podatki ter dokumentacija, ki spremlja vlogo za pridobitev dovoljenja za promet z zdravilom v skladu s členom 12(3)(i) ter (j) in tudi členom 13(1), morajo vsebovati podrobne podatke o kontrolnih testih končnega proizvoda ob sprostitvi.
English: They shall be submitted in accordance with the following requirements.
Slovenian: Te je treba predložiti v skladu z naslednjimi zahtevami.
English: The provisions of the general monographs of the European Pharmacopoeia, or failing that, of a Member State, shall be applicable to all products defined therein.
Slovenian: Določila splošnih monografij Evropske farmakopeje, ali v primeru odsotnosti le-te, držav članic, se morajo uporabiti za vse izdelke, ki so tam navedeni.
English: If test procedures and limits other than those mentioned in the general 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 postopki preskušanja ter mejne vrednosti, ki so različne od tistih, ki so navedeni v splošnih monografijah Evropske farmakopeje, ali v odsotnosti le-te, v nacionalni farmakopeji države članice, je treba predložiti dokaz, da končni izdelek, v primeru, da bo preskušan v skladu s temi monografijami, ustreza farmakopejskim zahtevam kakovosti za zadevno farmacevtsko obliko.
English: General characteristics of the finished product
Slovenian: Splošne lastnosti končnega izdelka
English: Certain tests of the general characteristics of a product shall always be included among the tests on the finished product.
Slovenian: Določene preskuse o splošnih lastnostih izdelka je treba vedno vključiti 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 morajo, kjer koli je to ustrezno, nanašati na preskus enakomernosti mase ter najvišja dovoljena odstopanja, na mehanske, fizikalne ali mikrobiološke preskuse, organoleptične lastnosti, fizikalne lastnosti kot so gostota, pH, lomni količnik, itd. Za vsako od teh lastnosti mora predlagatelj za vsak primer posebej specificirati 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 preskušanja, oprema/instrumenti kjer je to potrebno, ter standardi morajo biti podrobno opisani povsod, ko v Evropski farmakopeji ali v farmakopeji države članice takega opisa ni;
English: the same shall apply in cases where the methods prescribed by such pharmacopoeias are not applicable.
Slovenian: isto velja v primerih, kjer se ne uporabljajo predpisane metode iz teh 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 je treba pri trdnih farmacevtskih oblikah za peroralno uporabo izvede in vitro študije o sproščanju in hitrosti raztapljanja zdravilne(ih) učinkovin(e);
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 je prav tako treba opraviti v primeru, ko se daje zdravilo na kak drug način, 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) učinkovin(e)
English: Identification and assay of the active substance(s) shall be carried out either in a representative sample from the production batch or in a number of dosage-units analysed individually.
Slovenian: Identifikacija in določanje vsebnosti zdravilne(ih) učinkovine se mora opraviti bodisi na povprečnem reprezentativnem vzorcu proizvodne serije, ali pa na več odmernih enotah, ki se analizirajo posamično.
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 izdelave največja dopustna meja odstopanja vsebnosti zdravilne učinkovine v končnem izdelku ne sme presegati ± 5 %, razen če za to ni ustrezne obrazložitve.
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 mora izdelovalec predlagati ter upravičiti največje dopustne meje odstopanja vsebnosti zdravilne učinkovine v končnem izdelku do 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 nekaterih izjemnih primerih, posebno pri kompleksnih zmeseh, kjer bi bila zaradi vsebnosti številnih zdravilnih učinkovin ali pa zaradi nizkih vsebnosti potrebna zapletena raziskava, ki bi bila težko izvedljiva za vsako serijo posebej, se lahko opusti določanje vsebnosti ene ali več zdravilnih učinkovin v končnem izdelku, pod jasnim pogojem, da se taka določanja vsebnosti izvedejo v vmesnih fazah postopka izdelave.
English: This relaxation may not be extended to the characterization of the substances concerned.
Slovenian: Ta izjema pa se ne sme prenesti na opredelitev zadevnih učinkovin.
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 je treba dopolniti z metodo količinskega vrednotenja, kar bo omogočalo pristojnemu organu da bo preverjanje skladnosti zdravila s specifikacijo potem, ko je bilo zdravilo že dano v promet.
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: Biološko določanje vsebnosti in vivo ter in vitro je obvezno, kadar fizikalno-kemijske metode ne morejo dati ustreznih informacij o kakovosti zdravila.
English: Such an assay shall, whenever possible, include reference materials and statistical analysis allowing calculation of confidence limits.
Slovenian: Tako določanje vsebnosti mora, kadar koli je to možno, vključevati referenčne materiale ter statistične analize, ki omogočajo izračunavanje mej 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: V primeru, da takih preskusov ni moč izvesti na končnem izdelku, se lahko opravijo v vmesni fazi, čim pozneje v postopku izdelave.
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: Če podrobni podatki iz oddelka B kažejo, da je bil v izdelavi zdravila uporabljen znaten presežek zdravilne učinkovine, mora opis kontrolnih preskusov končnega izdelka vsebovati, kjer to ustreza, kemijsko in, po potrebi, toksikološko-farmakološke raziskave sprememb, do katerih je prišlo v tej snovi, in po možnosti še opis lastnosti in/ali določanje razpadnih produktov.
English: Identification and assay of excipient components
Slovenian: Identifikacija in določanje vsebnosti pomožnih snovi
English: In so far as is necessary, the excipient components shall be subject at least to identification tests.
Slovenian: Če je to potrebno, se morajo na pomožnih snovi opraviti 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 možnost preverjanja, da se take snovi uvrščena na seznamu, ki je 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 component liable to affect adversely physiological functions;
Slovenian: Preskus o zgornjih in spodnjih mejnih vrednostih je obvezen za konzervanse ter preskus o zgornjih mejnih vrednostih za vsako drugo pomožno snov, ki bi morda lahko imele neželen vpliv na fiziološke funkcije;
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 o zgornjih in spodnjih mejnih vrednostih je obvezen za pomožne snovi, če obstaja možnost, da bi te vplivale na biološko uporabnost zdravilne učinkovine, razen če se biološko uporabnost zagotavlja s kakšnimi drugimi ustreznimi preskusi.
English: Safety tests
Slovenian: Preskusi varnosti
English: Apart from the toxico-pharmacological 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 toksikološko-farmakoloških preskusov, ki spremljajo vlogo za pridobitev dovoljenja za promet z zdravilom, je treba povsod tam, kjer so taki preskusi potrebni kot rutinski, da bi se preverila kakovost proizvoda, v analizne podatke vključiti tudi podrobne podatke o preskusih varnosti, kot so preskusi sterilnosti, bakterijskih endotoksinov, pirogenosti ter lokalne tolerance pri živalih.
English: STABILITY TEST
Slovenian: TEST STABILNOSTI
English: The particulars and documents accompanying the application for marketing authorization pursuant to Article 12(3)(f) and (i) shall be submitted in accordance with the following requirements.
Slovenian: Podrobni podatki ter dokumentacija, ki spremlja vlogo za pridobitev dovoljenja za promet z zdravilom v skladu s členom 12(3)(f) in (i) mora biti vložena 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: Treba je dati opis raziskave, na podlagi katere je bil določen rok uporabnosti, priporočeni pogoji shranjevanja ter specifikacije po izteku roka uporabnosti, ki jih predlaga predlagatelj.
English: In the case of pre-mixes for medicated feedingstuffs, information shall also be given as necessary on the shelf life of the medicated feedingstuffs manufactured from these pre-mixes in accordance with the recommended instructions for use.
Slovenian: Za premikse za izdelavo medicinirane krme je treba obvezno podati informacijo o roku uporabnosti medicinirane krme, ki se izdelujejo iz teh premiksov v skladu s priporočenimi navodili za uporabo.
English: Where a finished product requires reconstitution prior to administration, details of the proposed shelf life for the reconstituted product are required, supported by relevant stability data.
Slovenian: Če končni izdelek zahteva rekonstitucijo pred dajanjem zdravila, se zahtevajo podatki o predlaganem roku uporabnosti za rekonstituirano zdravilo, kar je treba podpreti z ustreznimi podatki o stabilnosti.
English: In the case of multi-dose vials, stability data shall be presented to justify a shelf life for the vial after it has been punctured for the first time.
Slovenian: V primeru stekleničk z večkratnim odmerkom, je treba predložiti podatke o stabilnosti, ki bodo upravičile rok uporabnosti za stekleničko potem, ko je bil zamašek prvič predrt.
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: V primeru, da se v končnem izdelku hitro povečajo razpadni produkti, mora predlagatelj to prijaviti in navesti postopke karakterizacjie 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 of the finished product under these recommended storage conditions.
Slovenian: Zaključek mora vsebovati rezultate analiz, ki upravičujejo predlagani rok uporabnosti pod predlaganimi pogoji shranjevanja ter specifikacije končnega izdelka ob izteku roka uporabnosti končnega izdelka pod temi priporočenimi pogoji shranjevanja.
English: The maximum acceptable level of degradation products at the end of shelf life shall be indicated.
Slovenian: Treba je opredeliti najvišjo dopustno mejo razpadnih produktov ob izteku 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: Treba je predložiti študijo o medsebojnem delovanju med zdravilom in vsebnikom kadar koli obstaja možnost tveganja za tako medsebojno delovanje, posebno kjer gre za pripravke za injiciranje ali aerosole za notranjo uporabo.
English: PART 3
Slovenian: DEL 3
English: Safety and residues testing
Slovenian: Varnost in preskusi zaostankov
English: The particulars and documents which shall accompany the application for marketing authorization pursuant to Articles 12(3)(j) and 13(1) shall be submitted in accordance with the requirements below.
Slovenian: Podrobni podatki ter dokumentacija, ki mora spremljati vlogo za pridobitev dovoljenja za promet z zdravilom v skladu s členi 12(3)(j) in 13(l) mora biti vložena v skladu s spodaj naštetimi zahtevami.
English: Member States shall ensure that the tests are carried out in accordance with the provisions relating to good laboratory practice laid down by Council Directive 87/18/EEC of 18 December 1986 on the harmonization of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances(4) and Council Directive 88/320/EEC of 9 June 1988 on the inspection and verification of good laboratory practice (GLP)(5).
Slovenian: Države članice morajo zagotoviti, da bodo preskusi opravljeni v skladu z določili dobre laboratorijske prakse, ki jih določa Direktiva Sveta 87/18/EGS z dne 18. Decembra 1986 o prilagajanju zakonov in drugih predpisov v zvezi z uporabo načel dobre laboratorijske prakse ter verifikacijo uporabe preskusov o kemijskih snoveh [4] ter Direktivo Sveta 88/320/EGS z dne 9. junija 1988 o pregledu in verifikaciji dobre laboratorijske prakse (GLP) [5].
English: SAFETY TESTING
Slovenian: PRESKUSI VARNOSTI
English: Chapter I
Slovenian: Poglavje I
English: Performance of tests
Slovenian: Opravljanje testov
English: The safety documentation shall show:
Slovenian: Dokumentacija o varnosti mora izkazovati:
English: the potential toxicity of the medicinal product and any dangerous or undesirable effects which may occur under the proposed conditions of use in animals;
Slovenian: potencialno toksičnost zdravila ter vse nevarne in neželene učinke, do katerih lahko pride pod predlaganimi pogoji uporabe pri živalih;
English: these should be evaluated in relation to the severity of the pathological condition concerned;
Slovenian: te je treba oceniti glede na resnost zadevnega patološkega stanja;
English: the potential harmful effects to man of residues of the veterinary medicinal product or substance in foodstuffs obtained from treated animals and what difficulties these residues may create in the industrial processing of foodstuffs;
Slovenian: potencialne škodljive učinke zaostankov zdravila za uporabo v veterinarski medicini ali snovi na človeka iz živil, ki se pridobivajo iz zdravljenih živali ter težave, ki jih zaostanki povzročijo pri industrijski predelavi živil;
English: the potential risks which may result from the exposure of human beings to the medicinal product, for example during its administration to the animal;
Slovenian: potencialna tveganja, ki so lahko posledica izpostavljenosti človeka zdravilu, na primer med dajanjem zdravila živali;
English: the potential risks for the environment resulting from the use of the medicinal product.
Slovenian: potencialna tveganja za okolje, ki so posledica uporabe zdravila.
English: All results shall be reliable and valid generally.
Slovenian: Vsi rezultati morajo biti zanesljivi in splošno veljavni.
English: Whenever appropriate, mathematical and statistical procedures shall be used in designing the experimental methods and in evaluating the results.
Slovenian: Kadar to ustreza, je pri načrtovanju eksperimentalnih metod in pri vrednotenju rezultatov treba uporabiti matematične in statistične postopke.
English: Additionally, clinicians shall be given information about the therapeutic potential of the product and about the hazards connected with its use.
Slovenian: Poleg tega morajo klinični delavci razpolagati z informacijo o terapevtskem potencialu proizvoda ter o nevarnostih, povezanih z njegovo uporabo.
English: In some cases it may be necessary to test the metabolites of the parent compound where these represent the residues of concern.
Slovenian: V nekaterih primerih je potrebno preskušanje metabolitov matične spojine, če metaboliti predstavljajo zaostanke.
English: An excipient used in the pharmaceutical field for the first time shall be treated like an active substance.
Slovenian: Pomožno snov, ki se prvič uporablja na farmacevtskem področju je treba obravnavati kot zdravilno učinkovino.
English: Pharmacology
Slovenian: Farmakologija
English: Pharmacological studies are of fundamental importance in clarifying the mechanisms by which the medicinal product produces its therapeutic effects and therefore pharmacological studies conducted in experimental and target species of animal should be included in Part 4.
Slovenian: Farmakološke študije so ključnega pomena za razumevanje mehanizmov, iz katerih izhajajo terapevtski učinki zdravila, zato je treba farmakološke študije, ki so bile opravljene na poskusnih in ciljnih živalih vključiti v del 4.
English: However, pharmacological studies may also assist in the understanding of toxicological phenomena.
Slovenian: Vendar pa farmakološke študije lahko prav tako pomagajo pri razumevanju toksikoloških pojavov.
English: Moreover, where a medicinal product produces pharmacological effects in the absence of a toxic response, or at doses lower than those required to elicit toxicity, these pharmacological effects shall be taken into account during the evaluation of the safety of the medicinal product.
Slovenian: Razen tega, če ima zdravilo farmakološke učinke tudi v odsotnosti toksičnega odziva, ali v odmerkih, ki so nižji kot tisti, pri katerih se izzove toksičnost, je treba te farmakološke učinke upoštevati v oceni varnosti zdravila.
English: Therefore the safety documentation shall always be preceded by details of pharmacological investigations undertaken in laboratory animals and all relevant information observed during clinical studies in the target animal.
Slovenian: Zato je treba pred zbiranjem dokumentacije o varnosti pridobiti podatke o farmakoloških raziskavah na laboratorijskih živalih ter vse relevantne podatke, pridobljene med kliničnimi študijami na ciljni živali.
English: Single-dose toxicity
Slovenian: Toksičnost enkratnih odmerkov
English: Single-dose toxicity studies can be used to predict:
Slovenian: Študije toksičnosti enkratnih odmerkov lahko uporabimo za napoved:
English: the possible effects of acute overdosage in the target species,
Slovenian: možnih učinkov akutnega prevelikega odmerjanja na ciljnih živalih,
English: the possible effects of accidental administration to humans,
Slovenian: možnih učinkov po nenamernem zaužitju pri človeku,
English: the doses which may usefully be employed in the repeat dose studies.
Slovenian: odmerkov, ki bi jih bilo možno koristno uporabiti v študijah o ponovljenih odmerkih.
English: Single dose toxicity studies should reveal the acute toxic effects of the substance and the time course for their onset and remission.
Slovenian: Študije toksičnosti enkratnih odmerkov morajo pokazati akutne toksične učinke snovi, čas njihovega nastopa ter remisije.
English: These studies should normally be carried out in at least two mammalian species.
Slovenian: Te študije je treba izvesti najmanj na dveh živalskih vrstah sesalcev.
English: One mammalian species may be replaced, if appropriate, by an animal species for which the medicinal product is intended.
Slovenian: Eno vrsto sesalcev se lahko zamenja, če je to ustrezno, z živalsko vrsto, ki ji je zdravilo namenjeno.
English: At least two different routes of administration should normally be studied.
Slovenian: Normalno je treba preučiti najmanj dva različna načina dajanja zdravila.
English: One of these may be the same as, or similar to, that proposed for the target species.
Slovenian: Ena od teh je lahko enaka ali podobna tisti, ki je predlagana za ciljno živalsko vrsto.