FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: the frequency of observed adverse reactions;
Slovenian: pogostost opaženih škodljivih učinkov;
English: observations as to the effect on performance (e.g. egg-laying, milk production, reproductive function and food quality);
Slovenian: opažanja v zvezi s proizvodnostjo (npr. valjenje jajc, proizvodnja mleka, reproduktivne funkcije ter kakovost živil);
English: details concerning test animals which may be at increased risk owing to their age, their mode of rearing or feeding, or the purpose for which they are intended, or animals the physiological or pathological condition of which requires special consideration;
Slovenian: podrobnosti pri poskusnih živalih, pri katerih je tveganje povečano glede na njihovo starost, glede na način gojenja ali hranjenja ali na namen njihove uporabe, ali živali, katerih fiziološko ali patološko stanje zahteva posebno obravnavo;
English: a statistical evaluation of the results, when this is called for by the test programme.
Slovenian: statistično ovrednotenje rezultatov, če tako zahteva program preskušanja.
English: Finally, the investigator shall draw general conclusions from the experimental evidence, expressing his opinion on the harmlessness of the medicinal product under the proposed conditions of use, its therapeutic effect and any useful information relating to indications and contra-indications, dosage and average duration of treatment and where appropriate, any interactions observed with other medicinal products or feed additives as well as any special precautions to be taken during treatment and the clinical symptoms of overdosage.
Slovenian: Na koncu mora preiskovalec narediti splošne zaključke iz eksperimentalnih podatkov in podati svoje mnenje o neškodljivosti zdravila pod predlaganimi pogoji uporabe, o terapevtskih učinkih ter o vseh koristnih informacijah glede indikacij in kontraindikacij, odmerkov ter povprečnega trajanje zdravljenja in kjer je to ustrezno, o opažanjih glede medsebojnega delovanja z ostalimi zdravili ali krmnimi dodatki, ali pa glede posebnih previdnostnih ukrepov, ki jih je treba upoštevati med zdravljenjem ter pri kliničnih znakih prevelikega odmerjanja.
English: In the case of fixed combination products, the investigator shall also draw conclusions concerning the safety and the efficacy of the product when compared with the separate administration of the active substances involved.
Slovenian: Če gre za zdravila s fiksno kombinacijo, mora preiskovalec podati tudi sklepe o varnosti ter učinkovitosti zdravila v primerjavi z ločenim dajanjem zdravilnih učinkovin, ki so vključene v zdravilo.
English: Concluding expert report
Slovenian: Sklepno izvedensko poročilo
English: The concluding expert report shall provide a detailed critical analysis of all the pre-clinical and clinical documentation in the light of the state of scientific knowledge at the time the application is submitted together with a detailed summary of the results of the tests and trials submitted and precise bibliographic references.
Slovenian: Sklepno izvedensko poročilo mora vsebovati podrobno kritično analizo celotne predklinične in klinične dokumentacije glede na stopnjo razvoja znanosti v času, ko je bila vloga vložena, skupaj s podrobnim povzetkom rezultatov preskusov in preskušanj ter točnimi bibliografskimi referencami.
English: Requirements for immunological veterinary medicinal products
Slovenian: Zahteve pri imunološka zdravila za uporabo v veterinarski medicini
English: Without prejudice to the specific requirements laid down by Community legislation for the control and eradication of animal desease, the following requirements shall apply to immunological veterinary medicinal products.
Slovenian: Brez poseganja v specifične zahteve, ki jih določa zakonodaja Skupnosti za kontrolo ter izkoreninjanje bolezni živali, se morajo na imunološka zdravila za uporabo v veterinarski medicini nanašajo naslednje zahteve.
English: PART 5
Slovenian: DEL 5
English: The immunological veterinary medicinal product which is the subject of the application shall be identified by name and by name of the active substances, together with the strength and pharmaceutical form, the method and route of administration, and a description of the final sales presentation of the product.
Slovenian: Imunološko zdravilo za uporabo v veterinarski medicini, ki je predmet vloge, je treba identificirati z imenom ter z imeni zdravilnih učinkovin, skupaj z jakostjo ter farmacevtsko obliko, metodo in načinom dajanja zdravila ter opisom končnega pakiranja in ovojnine zdravila.
English: The name and address of the applicant shall be given, together with the name and address of the manufacturer and the sites involved in the different stages of manufacture (including the manufacturer of the finished product and the manufacturer(s) of the active substance(s)) and where relevant the name and address of the importer.
Slovenian: Treba je podati ime in naslov predlagatelja, ime in naslov izdelovalcev in mest v različnih fazah izdelave (vključno izdelovalca končnega zdravila ter izdelovalca(e) zdravilne(ih) učinkovin(e)), in kjer je to potrebno, ime in naslov uvoznika.
English: Annexed to the administrative data shall be copies of a document showing that the manufacturer is authorized to produce immunological veterinary medicinal products, as defined in Article 44 (with a brief description of the production site).
Slovenian: Priloga k administrativnim podatkom so kopije dokumentov, ki dokazujejo, da ima izdelovalec dovoljenje za izdelavo imunoloških zdravil za uporabo v veterinarski medicini, kot to določa člen 44 (skupaj s kratkim opisom mestom izdelave).
English: Moreover, the list of organisms handled at the production site shall be given.
Slovenian: Poleg tega je treba podati seznam organizmov, ki so bili uporabljeni na mestu izdelave.
English: The applicant shall submit a list of countries in which authorization has been granted, copies of all the summaries of product characteristics in accordance with Article 14 as approved by Member States and a list of countries in which an application has been submitted.
Slovenian: Predlagatelj mora predložiti seznam držav, v katerih je bilo izdano dovoljenje za promet, kopije vseh povzetkov glavnih značilnosti zdravila v skladu s členom 14, kakor so jih odobrile države članice ter seznam držav, v katerih je bila vloga vložena.
English: The applicant shall propose a summary of the product characteristics, in accordance with Article 14.
Slovenian: Predlagatelj mora predlagati povzetek glavnih značilnosti zdravila v skladu s členom 14.
English: In addition the applicant shall provide one or more specimens or mock-ups of the sales presentation of the immunological veterinary medicinal product, together with a package insert, where one is required.
Slovenian: Poleg tega mora predlagatelj predložiti enega ali več vzorcev ali predlogov stične in zunanje ovojnine imunološkega zdravila za uporabo v veterinarski medicini, skupaj z navodilom za uporabo, če se le-ta zahteva.
English: In accordance with Article 15(2) and (3) expert reports must be provided on all aspects of the documentation.
Slovenian: V skladu s členom 15(2) in (3) morajo biti izvedenska poročila predložena glede vseh vidikov dokumentacije.
English: Each expert report shall consist of a critical evaluation of the various tests and/or trials, which have been carried out in accordance with this Directive, and bring out all the data relevant for evaluation.
Slovenian: Vsako izvedensko poročilo mora vsebovati kritično oceno različnih preskusov in/ali preskušanj, ki so bili izvedeni v skladu s to direktivo, kjer bodo izpostavljeni vsi podatki, potrebni za oceno.
English: The expert shall give his opinion as to whether sufficient guarantees have been provided as to the quality, safety and efficacy of the product concerned.
Slovenian: Izvedenec mora podati svoje mnenje o tem, ali so podana zadostna zagotovila glede kakovosti, varnosti in učinkovitosti zadevnega zdravila.
English: A factual summary is not sufficient.
Slovenian: Faktografski povzetek ne zadostuje.
English: All important data shall be summarized in an appendix to the expert report, whenever possible in tabular or graphic form.
Slovenian: Vse pomembne podatke je treba povzeti v prilogi k izvedenskemu poročilu, če je to le mogoče v obliki tabel ali grafov.
English: The expert report and the summaries shall contain precise cross references to the information contained in the main documentation.
Slovenian: Izvedensko poročilo ter povzetki morajo vsebovati točno sklicevanje na informacije, ki jih vsebuje glavna dokumentacija.
English: It shall be signed and dated by the expert, and attached to the report shall be brief information about the educational background, training and occupational experience of the expert.
Slovenian: Poročilo mora izvedenec podpisati in datirati, k poročilu pa mora biti priložena kratka informacija o izobrazbi, usposabljanju ter delovnih izkušnjah izvedenca.
English: PART 6
Slovenian: DEL 6
English: Analytical (physico-chemical, biological or microbiological) tests of immunological veterinary medicinal products
Slovenian: Analitski (fizikalno-kemijski, biološki ali mikrobiološki) preskusi imunoloških zdravil za uporabo v veterinarski medicini
English: All test procedures used shall correspond to the state of scientific progress at the time and shall be validated procedures;
Slovenian: Vsi postopki preskušanja morajo ustrezati stopnji znanstvenega napredka v času izvajanja preskusov, postopki pa morajo biti validirani;
English: results of the validation studies shall be provided.
Slovenian: treba je predložiti rezultate študij validacije.
English: All the test procedure(s) shall be described in sufficiently precise detail so as to be reproducible in control tests, carried out at the request of the competent authority;
Slovenian: Vse postopke preskušanja je treba opisati dovolj natančno, da bi se jih lahko ponovilo v kontrolnih preskusih, ki jih lahko zahteva pristojni organ;
English: any special apparatus and equipment which may be used shall be described in adequate detail, possibly accompanied by a diagram.
Slovenian: ustrezno podrobno je treba opisati vse možne posebne naprave in opremo, po možnosti s shemo.
English: The formulae of the laboratory reagents shall be supplemented, if necessary, by the manufacturing method.
Slovenian: Treba je dodati formule laboratorijskih reagentov in če je potrebno, postopke priprave.
English: In the case of test procedures included in the European Pharmacopoeia or the pharmacopoeia of a Member State, this description may be replaced by a detailed reference to the pharmacopoeia in question.
Slovenian: V primeru postopkov preskušanja, ki jih vključuje Evropska farmakopeja ali farmakopeja države članice, se lahko ta opis nadomesti s podrobnim sklicem na zadevno farmakopejo.
English: The particulars and documents which must accompany applications for marketing authorization, pursuant to Article 12(3)(c), shall be submitted in accordance with the following requirements.
Slovenian: Podrobni podatki in dokumentacija, ki mora spremljati vlogo za pridobitev dovoljenja za promet z zdravilom v skladu s členom 12(3) (c),se morajo predložiti v skladu z naslednjimi zahtevami.
English: Qualitative particulars
Slovenian: Podrobni podatki o kakovostni sestavi
English: "Qualitative particulars" of all the constituents of the immunological veterinary medicinal product shall mean the designation or description of:
Slovenian: "Podrobni podatki o kakovostni sestavi" vseh sestavin imunološkega zdravila za uporabo v veterinarski medicini pomenijo oznako ali opis:
English: the constituents of the adjuvants,
Slovenian: sestavin dodatkov,
English: the constituent(s) of the excipients, whatever their nature or the quantity used, including preservatives, stabilisers, emulsifiers, colouring matter, flavouring, aromatic substances, markers, etc.,
Slovenian: sestavin pomožnih snovi, ne glede na njihovo vrsto ali uporabljeno količino, vključno s konzervansi, stabilizatorji, emulgatorji, barvili, snovmi za izboljšanje okusa in aromami, označevalci, itd.
English: the constituents of the pharmaceutical form administered to animals.
Slovenian: sestavin farmacevtskih oblik, ki se dajejo živalim.
English: These particulars shall be supplemented by any relevant data concerning the container and, where appropriate, its manner of closure, together with details of devices with which the immunological veterinary medicinal product will be used or administered and which will be delivered with the medicinal product.
Slovenian: Podrobne podatke je treba dopolniti z ustreznimi podatki o vsebniku, in kjer je to ustrezno, o načinu zapiranja vsebnika, skupaj s podatki o pripomočkih, s katerimi se bo zdravilo za uporabo v veterinarski medicini uporabljalo ali dajalo in ki se bo izdajalo skupaj z zdravilom.
English: The "usual terminology", to be used in describing the constituents of immunological veterinary medicinal products, shall mean, notwithstanding the application of the other provisions of Article 12(3)(c):
Slovenian: Izraz "običajna terminologija", ki se uporablja za opis sestavin imunoloških zdravil za uporabo v veterinarski medicini ne glede na uporabo ostalih določil člena 12(3)(c), pomeni:
English: in respect of substances which appear in the European Pharmacopoeia or, failing this, in the national pharmacopoeia of one of the Member States, the main title of the monograph in question, which will be obligatory for all such substances, with reference to the pharmacopoeia concerned,
Slovenian: pri snoveh, ki so navedene v Evropski farmakopeji, ali v odsotnosti le-te, v nacionalni farmakopeji ene od držav članic, glavni naslov zadevne monografije, ki je obvezna za vse take snovi, s sklicem na zadevno farmakopejo,
English: in respect of other substances, the international non-proprietary name recommended by the World Health Organization, which may be accompanied by another non-proprietary name or, failing these, the exact scientific designation;
Slovenian: pri drugih snoveh mednarodno nelastniško ime, ki ga priporoča Svetovna zdravstvena organizacija, ki ga lahko spremlja neko drugo nelastniško ime, ali v odsotnosti le-tega natančna znanstvena oznaka;
English: substances not having an international non-proprietary name or an exact scientific designation shall be described by a statement of how and from what they were prepared, supplemented, where appropriate, by any other relevant details,
Slovenian: snovi, ki nimajo mednarodnega nelastniškega imena ali natančne znanstvene oznake, je treba opisati z navedbo o tem, kako in iz česa so pripravljene, in če to ustreza, je treba dodati še druge ustrezne podatke;
English: in respect of colouring matter, designation by the "E" code assigned to them in Directive 78/25/EEC.
Slovenian: barvila je treba označiti s številko "E" kode iz Direktive 78/25/EGS.
English: In order to give the "quantitative particulars" of the active substances of an immunological veterinary medicinal product, it is necessary to specify whenever possible the number of organisms, the specific protein content, the mass, the number of International Units (IU) or units of biological activity, either per dosage-unit or volume, and with regard to the adjuvant and to the constituents of the excipients, the mass or the volume of each of them, with due allowance for the details provided in section B.
Slovenian: Za "podrobne podatke o količinski sestavi" zdravilnih učinkovin imunoloških zdravilih za uporabo v veterinarski medicini je potrebno, če je to le mogoče, opredeliti število organizmov, vsebnost specifičnih beljakovin, maso, število mednarodnih enot (IE) ali enot biološke aktivnosti, bodisi na enoto odmerka ali volumna, in pri dodatkih ter pomožnih snoveh, maso in volumen za vsakega posebej, ob upoštevanju podatkov, predvidenih v oddelku B.
English: Where an International Unit of biological activity has been defined, this shall be used.
Slovenian: Tam, kjer je določena mednarodna enota biološke aktivnosti, jo je treba uporabiti.
English: The units of biological activity for which no published data exist shall be expressed in such a way as to provide unambiguous information on the activity of the ingredients, e.g. by stating the immunological effect on which the method of determining the dose is based.
Slovenian: Enote biološke aktivnosti, za katere ne obstajajo objavljeni podatki, se morajo izraziti na tak način, da omogočajo nedvoumno informacijo o aktivnosti sestavin, npr. navedbo imunološkega učinka, na podlagi katerega se določa odmerek.
English: An explanation shall be provided with regard to the composition, components and containers, supported by scientific data on development pharmaceutics.
Slovenian: Podati je treba obrazložitev glede izbire sestave, sestavin in vsebnika in to podpreti z znanstvenimi podatki o farmacevtskem razvoju.
English: The overage, with justification thereof, shall be stated.
Slovenian: Treba je navesti in obrazložiti presežek.
English: The efficacy of any preservative system shall be demonstrated.
Slovenian: Dokazati je treba učinkovitost sistema konzerviranja.
English: DESCRIPTION OF MANUFACTURING METHOD OF THE FINISHED PRODUCT
Slovenian: OPIS POSTOPKA IZDELAVE KONČNEGA IZDELKA
English: The description of the manufacturing method accompanying the application for marketing authorization pursuant to Article 12(3)(d), shall be drafted in such a way as to give an adequate description of the nature of the operations employed.
Slovenian: Opis postopka izdelave, ki spremlja vlogo za pridobitev dovoljenja za promet z zdravilom v skladu s členom 12(3)(d) je treba izdelati tako, da bo podan ustrezen opis narave uporabljenih postopkov.
English: For this purpose the description shall include at least:
Slovenian: V ta namen je treba, da opis vsebuje najmanj:
English: the various stages of manufacture (including purification procedures) so that an assessment can be made of the reproducibility of the manufacturing procedure and of the risks of adverse effects on the finished products, such as microbiological contamination,
Slovenian: različne faze izdelave (vključno s postopki čiščenja), tako da je možno opraviti oceno ponovljivosti postopka izdelave ter oceno tveganj škodljivih učinkov na končne izdelke, kot je na primer mikrobiološka kontaminacija,
English: in the case of continuous manufacture, full details concerning precautions taken to ensure the homogeneity and consistency of each batch of the finished product,
Slovenian: v primeru neprekinjene izdelave, popolne podatke o previdnostnih ukrepih za zagotavljanje homogenosti in konsistentnosti med serijami končnega izdelka,
English: mention of substances which cannot be recovered in the course of manufacture,
Slovenian: navedbo snovi, ki jih med izdelavo ni možno reciklirati,
English: the details of the blending, with the quantitative particulars of all the substances used,
Slovenian: podatke o mešanju, skupaj z podrobnimi podatki o količini vseh uporabljenih snovi,
English: a statement of the stage of manufacture at which sampling is carried out for in-process control tests.
Slovenian: navedbo o fazi izdelave v kateri se opravi vzorčenje za kontrolne preskuse med izdelavo.
English: PRODUCTION AND CONTROL OF STARTING MATERIALS
Slovenian: IZDELAVA IN KONTROLA VHODNIH SNOVI
English: For the purposes of this paragraph "starting materials" means all components used in the production of the immunological veterinary medicinal product.
Slovenian: Za potrebe tega odstavka so "vhodne snovi" vse sestavine, ki so bile uporabljene v izdelavi imunološkega zdravila za uporabo v veterinarski medicini.
English: Culture media used for the production of the active substance are considered as one single starting material.
Slovenian: Gojišče za celične kulture, ki se uporablja v izdelavi zdravilne učinkovine se šteje kot ena vhodna snov.
English: an active substance not described in the European Pharmacopoeia or in the pharmacopoeia of a Member State,
Slovenian: da zdravilna učinkovina ni opisana v Evropski farmakopeji ali farmakopeji države članice,
English: an active substance described in the European Pharmacopoeia or in the pharmacopoeia of a Member State when prepared by a method liable to leave impurities not mentioned in the pharmacopoeial monograph and for which the monograph is inappropriate to adequately control its quality,
Slovenian: če je bila zdravilna učinkovina, ki je opisana v Evropski farmakopeji, ali v farmakopeji države članice, pripravljena po postopku, za katerega je verjetno, da lahko pušča nečistote, ki jih farmakopeja ne navaja in je za katere je monografija farmakopeje neprimerna za ustrezno kontrolo kakovosti zdravilne učinkovine,
English: The manufacturer shall confirm in writing to the applicant that he shall ensure batch-to-batch consistency and not modify the manufacturing process or specifications without informing the applicant.
Slovenian: Izdelovalec mora predlagatelju pisno potrditi, da zagotavlja konsistentnost med serijami ter da ne bo spreminjal procesa izdelave ali specifikacij brez obveščanja predlagatelja.
English: The particulars and documents accompanying the application for marketing authorization pursuant to Article 12(3)(i) and (j) and Article 13(1) shall include the results of the tests relating to quality control of all the components used and shall be submitted in accordance with the following provisions.
Slovenian: Podrobni podatki ter dokumentacija, ki spremlja vlogo za pridobitev dovoljenja za promet z zdravilom v skladu s členom 12(3)(i) in (j) ter členom 13(1), morajo vsebovati rezultate kontrole kakovosti vseh uporabljenih sestavin ter biti dostavljeni v skladu z naslednjimi pogoji.
English: Starting materials listed in pharmacopoeias
Slovenian: Vhodne snovi, ki jih naštevajo farmakopeje
English: The monographs of the European Pharmacopoeia shall be applicable to all substances appearing in it.
Slovenian: Monografije Evropske farmakopeje se uporabljajo za vse snovi, ki so v njej objavljene.
English: In respect of other substances, each Member State may require observance of its own national pharmacopoeia with regard to products manufactured in its territory.
Slovenian: Za ostale snovi lahko vsaka država članica zahteva, da se upošteva njena nacionalna farmakopeja kadar gre za izdelke, ki se izdelujejo na njenem ozemlju.
English: Components fulfilling the requirements of the European Pharmacopoeia or the pharmacopoeia of one of the Member States shall be deemed to comply sufficiently with Article 12(3)(i).
Slovenian: Za sestavine, ki izpolnjujejo zahteve Evropske farmakopeje ali farmakopeje ene od držav članic se šteje, da v zadostni meri izpolnjujejo pogoje iz člena 12(3)(i).
English: Reference to pharmacopoeias of third countries may be permitted in cases where the substance is described neither in the European Pharmacopoeia nor in the national pharmacopoeia concerned;
Slovenian: Sklic na farmakopeje tretjih držav se lahko dovoli v primerih, kjer snov ni opisana niti v Evropski farmakopeji niti v nacionalni farmakopeji;
English: in that case the monograph shall be submitted, accompanied where necessary by a translation for which the applicant will be responsible.
Slovenian: v tem primeru je treba predložiti farmakopejo in po potrebi priložiti prevode, za kar je odgovoren predlagatelj.
English: The routine tests carried out on each batch of starting materials must be as stated in the application for marketing authorization.
Slovenian: Rutinski testi, ki se izvajajo na vsaki seriji vhodne snovi, morajo biti taki, kot so navedeni v vlogi za pridobitev dovoljenja za promet z zdravilom.
English: If tests other than those mentioned in the pharmacopoeia are used, proof must be supplied that the starting materials meet the quality requirements of that pharmacopoeia.
Slovenian: Če se uporabljajo še drugi preskusi, ki so navedeni v farmakopeji, je treba predložiti dokaze, da vhodna snov ustreza zahtevam glede kakovosti iz zadevne farmakopeje.