natgillin/translations-raw huggingface dataset:
For veterinary medicinal products other than immunological veterinary medicinal products, with respect to the quality (pharmaceutical) part (physico-chemical, biological and microbiological tests) of the dossier, all relevant monographs including general monographs and the general chapters of the European Pharmacopoeia are applicable.
Za zdravila za uporabo v veterinarski medicini, razen imunoloških zdravil za uporabo v veterinarski medicini, se v zvezi s (farmacevtskim) delom vloge o kakovosti (fizikalno-kemijski, biološki in mikrobiološki preskusi) uporabljajo vse ustrezne monografije, vključno s splošnimi monografijami in splošnimi poglavji Evropske farmakopeje.
For immunological veterinary medicinal products, with respect to the quality, safety and efficacy parts of the dossier, all relevant monographs including general monographs and the general chapters of the European Pharmacopoeia are applicable.
Za imunološka zdravila za uporabo v veterinarski medicini se za del vloge o kakovosti, varnosti in učinkovitosti uporabljajo vse monografije, vključno s splošnimi monografijami in splošnimi poglavji Evropske farmakopeje.
The manufacturing process shall comply with the requirements of Commission Directive 91/412/EEC [1] laying down the principles and guidelines for veterinary medicinal products and with the principles and guidelines on Good Manufacturing Practice (GMP), published by the Commission in The rules governing medicinal products in the European Union, Volume 4.
Postopek izdelave izpolnjuje zahteve iz Direktive Komisije 91/412/EGS [1] o določitvi načel in smernic dobre proizvodne prakse za zdravila za uporabo v veterinarski medicini ter je v skladu z načeli in smernicami dobre proizvodne prakse, ki jih je Komisija objavila v zvezku 4 Pravil, ki urejajo zdravila v Evropski uniji.
All information which is relevant to the evaluation of the veterinary medicinal product concerned shall be included in the application, whether favourable or unfavourable to the product.
V vlogo se vključijo vse ugodne in neugodne informacije, ki so pomembne za oceno zadevnega zdravila za uporabo v veterinarski medicini.
In particular, all relevant details shall be given of any incomplete or abandoned test or trial relating to the veterinary medicinal product.
Še zlasti se predložijo vsi pomembni podatki za vsak nedokončan ali opuščen preskus ali preskušanje v zvezi z zdravilom za uporabo v veterinarski medicini.
In such cases, relevant scientific guidelines and/or scientific advice should be taken into account.
V teh primerih je treba upoštevati ustrezne znanstvene smernice in/ali znanstvene predloge.
This Annex is divided in four titles:
Ta priloga je razdeljena na štiri dele:
Title I describes the standardised requirements for applications for veterinary medicinal products other than immunological veterinary medicinal products.
v naslovu I so opisane standardne zahteve za vloge za pridobitev dovoljenj za promet z zdravili za uporabo v veterinarski medicini, razen imunoloških zdravil za uporabo v veterinarski medicini.
Title II describes the standardised requirements for applications for immunological veterinary medicinal products.
V naslovu II so opisane standardne zahteve za vloge za pridobitev dovoljenja za promet z imunološkimi zdravili za uporabo v veterinarski medicini.
Title III describes specific types of marketing authorisation dossiers and requirements.
V naslovu III so opisane posebne vloge za pridobitev dovoljenja za promet z zdravilom in posebne zahteve.
Title IV describes the dossier requirements for particular types of veterinary medicinal products.
V naslovu IV so opisane zahteve za vloge za pridobitev dovoljenja za promet s posebnimi vrstami zdravil za uporabo v veterinarski medicini.
The following requirements shall apply to veterinary medicinal products other than immunological veterinary medicinal products, except where otherwise set out in Title III.
Naslednje zahteve se uporabljajo za zdravila za uporabo v veterinarski medicini, razen za imunološka zdravila za uporabo v veterinarski medicini, razen kadar je drugače določeno v naslovu III.
The veterinary medicinal product, which is the subject of the application, shall be identified by its name and by the name of the active substance(s), together with the strength, the pharmaceutical form, the route and method of administration (see Article 12(3)(f) of Directive) and a description of the final presentation of the product, including packaging, labelling and package leaflet (see Article 12(3)(l) of Directive).
Zdravilo za uporabo v veterinarski medicini, na katerega se nanaša vloga, se identificira s svojim imenom, imeni zdravilnih učinkovin, jakostjo, farmacevtsko obliko, načinom in metodo dajanja (glej člen 12(3)(f) Direktive) ter opisom končnega pakiranja zdravila, vključno z ovojnino, oznakami in navodilom za uporabo (glej člen 12(3)(l) Direktive).
The name and address of the applicant shall be given, together with the name and address of the manufacturers and the sites involved in the different stages of the manufacture, testing and release (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.
Predložijo se ime in naslov predlagatelja, ime in naslov izdelovalcev in obratov, vključenih v različne stopnje izdelave, preskušanja in sproščanja (vključno z izdelovalcem končnega zdravila ter izdelovalci zdravilnih učinkovin), ter, kadar je potrebno, ime in naslov uvoznika.
The applicant shall identify the number and titles of volumes of documentation submitted in support of the application and indicate what samples, if any, are also provided.
Predlagatelj navede število in naslove zvezkov dokumentacije, ki je priložena vlogi, ter kateri vzorci, če ti obstajajo, so priloženi.
Annexed to the administrative information shall be a document showing that the manufacturer is authorised to produce the veterinary medicinal products concerned, as defined in Article 44, together with a list of countries in which authorisation 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 or refused.
K upravnim informacijam se priloži dokument, ki dokazuje, da izdelovalec ima dovoljenje za izdelavo zadevnih zdravil za uporabo v veterinarski medicini, opredeljenih v členu 44, seznam držav, v katerih je bilo dovoljenje izdano, kopije vseh povzetkov glavnih značilnosti zdravila v skladu s členom 14, kot so ga odobrile države članice, ter seznam držav, v katerih je bila vloga vložena ali zavrnjena.
The applicant shall propose a summary of the product characteristics, in accordance with Article 14 of this Directive.
Predlagatelj predlaga povzetek glavnih značilnosti zdravila v skladu s členom 14 te direktive.
A proposed labelling text for the immediate and outer packaging shall be provided in accordance with Title V of this Directive, together with a package leaflet where one is required pursuant to Article 61.
Predlagano besedilo oznake na stični in zunanji ovojnini ter navodilo za uporabo, kadar je zahtevano v skladu s členom 61, se pripravita v skladu z naslovom V te direktive.
In addition the applicant shall provide one or more specimens or mock-ups of the final presentation(s) of the veterinary medicinal product in at least one of the official languages of the European Union; the mock-up may be provided in black and white and electronically where prior agreement from the competent authority has been obtained.
Poleg tega predlagatelj predloži enega ali več vzorcev ali osnutkov končnih pakiranj zdravila za uporabo v veterinarski medicini v vsaj enem uradnem jeziku Evropske unije; osnutek je lahko črno-bel in v elektronski obliki, kadar je bilo pridobljeno soglasje pristojnega organa.
In accordance with Article 12(3), detailed and critical summaries shall be provided on the results of pharmaceutical (physico-chemical, biological or microbiological) tests, of the safety tests and residue tests, of the pre-clinical and clinical trials and of the tests assessing the potential risks posed by the veterinary medicinal product for the environment.
V skladu s členom 12(3) se predložijo podrobni in kritični povzetki rezultatov farmacevtskih (fizikalno-kemijskih, bioloških ali mikrobioloških) preskusov, preskusov varnosti in ostankov, predkliničnih in kliničnih preskušanj ter preskusov, ki ocenjujejo mogoča tveganja zdravila za uporabo v veterinarski medicini za okolje.
Each detailed and critical summary shall be prepared in the light of the state of scientific knowledge at the time of submission of the application.
Vsak podroben in kritičen povzetek se pripravi ob upoštevanju trenutnih znanstvenih spoznanj ob predložitvi vloge.
It shall contain an evaluation of the various tests and trials, which constitute the marketing authorisation dossier, and shall address all points relevant to the assessment of the quality, safety and efficacy of the veterinary medicinal product.
Povzetek vsebuje oceno raznih preskusov in preskušanj iz vloge za pridobitev dovoljenja za promet z zdravilom ter obravnava vse točke v zvezi z oceno kakovosti, varnosti in učinkovitosti zdravila za uporabo v veterinarski medicini.
It shall give detailed results of the tests and trials submitted and precise bibliographic references.
V njem se navedejo podrobni rezultati predloženih preskusov in preskušanj ter natančna bibliografska sklicevanja.
All important data shall be summarised in an appendix, whenever possible in tabular or graphic form.
Vsi pomembni podatki se povzamejo v dodatku, če je le mogoče v obliki tabel ali grafov.
The detailed and critical summaries and the appendices shall contain precise cross references to the information contained in the main documentation.
Podrobni in kritični povzetki ter dodatki vsebujejo natančna sklicevanja na informacije, ki jih vsebuje glavna dokumentacija.
The detailed and critical summaries shall be signed and dated, and information about the author's educational background, training and occupational experience shall be attached.
Podrobni in kritični povzetki se podpišejo in datirajo ter se priložijo informacije o izobrazbi, usposabljanju ter poklicnih izkušnjah izvedenca.
The professional relationship of the author with the applicant shall be declared.
Z izjavo se opredeli tudi poslovna povezava med izvedencem in predlagateljem.
Where the active substance has been included in a medicinal product for human use authorised in accordance with the requirements of Annex I to Directive 2001/83/EC of the European Parliament and of the Council [9] the overall quality summary provided for in Module 2, section 2.3 of that Annex may replace the summary regarding the documentation related to the active substance or the product, as appropriate.Where the competent authority has publicly announced that the chemical, pharmaceutical and biological/microbiological information for the finished product may be included in the dossier in the Common Technical Document (CTD) format only, the detailed and critical summary on the results of pharmaceutical tests may be presented in the quality overall summary format.
Kadar je zdravilna učinkovina vključena v zdravilo za uporabo v humani medicini, odobreno v skladu z zahtevami iz Priloge I k Direktivi 2001/83/ES Evropskega parlamenta in Sveta [9], se lahko celoten povzetek o kakovosti zdravila iz modula 2 oddelka 2.3 navedene priloge nadomesti s povzetkom dokumentacije o zdravilni učinkovini ali zdravilu, kakor je primerno.Kadar je pristojni organ javno objavil, da se lahko kemijske, farmacevtske in biološke/mikrobiološke informacije končnega zdravila vključijo v vlogo v obliki skupnega tehničnega dokumenta (STD), se lahko podroben in kritičen povzetek rezultatov farmacevtskih preskusov predloži v obliki celotnega povzetka o kakovosti zdravila.
In the case of application for an animal species or for indications representing smaller market sectors, the quality overall summary format may be used without prior agreement of the competent authorities.
Pri vlogi za zdravilo, ki je namenjeno živalskim vrstam ali indikacijam, ki predstavljajo manjše tržne sektorje, se lahko celoten povzetek o kakovosti zdravila uporabi brez predhodnega dovoljenja pristojnega organa.
The particulars and documents which shall accompany the application for marketing authorisation pursuant to the first indent of Article 12(3)(j) shall be submitted in accordance with the requirements below.
Podrobni podatki in dokumenti, ki se priložijo vlogi za pridobitev dovoljenja za promet z zdravilom v skladu s prvo alineo člena 12(3)(j), se predložijo v skladu s spodaj navedenimi zahtevami.
The pharmaceutical (physico-chemical, biological or microbiological) data shall include for the active substance(s) and for the finished veterinary medicinal product information on the manufacturing process, the characterisation and properties, the quality control procedures and requirements, the stability as well as a description of the composition, the development and presentation of the veterinary medicinal product.
Za zdravilne učinkovine in končna zdravila za uporabo v veterinarski medicini se poleg farmacevtskih (fizikalno-kemijskih, bioloških ali mikrobioloških) podatkov navedejo informacije o postopku izdelave, lastnostih in značilnostih, postopkih in zahtevah za nadzor kakovosti, stabilnosti ter opis sestave, razvoja in pakiranja zdravila za uporabo v veterinarski medicini.
All monographs, including general monographs and general chapters of the European Pharmacopoeia, or failing that, of a Member State are applicable.
Uporabljajo se vse monografije, vključno s splošnimi monografijami in splošnimi poglavji iz Evropske farmakopeje ali, kadar ta ne obstaja, farmakopeje države članice.
All test procedures shall fulfil the criteria for analysis and control of the quality of the starting materials and the finished product and should take account of established guidance and requirements.
Vsi postopki preskušanja izpolnjujejo merila za analizo in nadzor kakovosti vhodnih snovi in končnih zdravil ter upoštevajo uveljavljene smernice in zahteve.
The results of the validation studies shall be provided.
Predložijo se rezultati potrditvenih študij.
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; any special apparatus and equipment, which may be used shall be described in adequate detail, possibly accompanied by a diagram.
Vsi postopki preskušanja se opišejo natančno, da se lahko ponovijo v kontrolnih preskusih, ki jih lahko zahteva pristojni organ; ustrezno podrobno se opišejo kakršne koli posebne naprave in oprema, po možnosti s shemo.
The formulae of the laboratory reagents shall be supplemented, if necessary, by the method of preparation.
Dodajo se formule laboratorijskih reagentov in po potrebi metoda priprave.
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.
Pri postopkih preskušanja, vključenih v Evropsko farmakopejo ali farmakopejo države članice, se lahko ta opis nadomesti s podrobnim sklicem na zadevno farmakopejo.
Where relevant, chemical and biological reference material of the European Pharmacopoeia shall be used.
Kadar je ustrezno, se uporablja kemijska in biološka referenčna snov iz Evropske farmakopeje.
If other reference preparations and standards are used, they shall be identified and described in detail.
Kadar se uporabijo drugi referenčni pripravki in standardi, se opredelijo in podrobno opišejo.
In cases where the active substance has been included in a medicinal product for human use authorised in accordance with the requirements of Annex I to Directive 2001/83/EC the chemical, pharmaceutical and biological/microbiological information provided for in Module 3 of that Directive may replace the documentation related to the active substance or the finished product, as appropriate.
Kadar je zdravilna učinkovina vključena v zdravilo za uporabo v humani medicini, odobreno v skladu z zahtevami iz Priloge I k Direktivi 2001/83/ES, lahko kemijske, farmacevtske in biološke/mikrobiološke informacije iz modula 3 navedene direktive nadomestijo dokumentacijo o zdravilni učinkovini ali končnem zdravilu, kakor je primerno.
The chemical, pharmaceutical and biological/microbiological information for the active substance or the finished product may be included in the dossier in CTD format only where the competent authority has publicly announced this possibility.
Kemijske, farmacevtske in biološke/mikrobiološke informacije o zdravilni učinkovini ali končnem zdravilu se lahko vključijo v dokumentacijo v obliki skupnega tehničnega dokumenta le, kadar je pristojni organ javno objavil to možnost.
In the case of any application for an animal species or for indications representing smaller market sectors the CTD format may be followed without prior agreement of the competent authorities.
Pri vlogi za zdravilo, ki je namenjeno živalskim vrstam ali indikacijam, ki predstavljajo manjše tržne sektorje, se lahko oblika skupnega tehničnega dokumenta uporabi brez predhodnega dovoljenja pristojnega organa.
“Qualitative particulars” of all the constituents of the medicinal product shall mean the designation or description of:
‚Podrobni podatki o kakovostni sestavi‘ vseh sestavin zdravila pomenijo navedbo ali opis:
the active substance(s),
zdravilnih učinkovin,
the constituents of the excipients, whatever their nature or the quantity used, including colouring matter, preservatives, adjuvants, stabilisers, thickeners, emulsifiers, flavouring and aromatic substances,
sestavin pomožnih snovi, ne glede na lastnosti ali uporabljeno količino, vključno z barvili, konzervansi, dodatki, stabilizatorji, zgoščevalci, emulgatorji, snovmi za izboljšanje okusa in aromami,
the constituents, intended to be ingested or otherwise administered to animals, of the outer covering of the veterinary medicinal products, such as capsules, gelatine capsules.
sestavin, ki jih žival zaužije ali se kako drugače dajejo živalim, ki jih vsebuje zunanji del zdravil za uporabo v veterinarski medicini – kapsul, želatinskih kapsul.
These particulars shall be supplemented by any relevant data concerning the immediate packaging and if relevant the secondary packaging and, where appropriate, its manner of closure, together with details of devices with which the medicinal product will be used or administered and which will be supplied with the medicinal product.
Ti podrobni podatki se dopolnijo z vsemi ustreznimi podatki o zunanji ovojnini in po potrebi sekundarni ovojnini in, kadar je to primerno, načinu zapiranja ovojnine, ter podatki o pripomočkih, s katerimi se zdravilo uporablja ali daje in bodo priloženi zdravilu.
The usual terminology to be used in describing the constituents of veterinary medicinal products means, notwithstanding the application of the other provisions of Article 12(3)(c):
‚Običajna terminologija‘, ki se uporablja pri opisovanju sestavin zdravil za uporabo v veterinarski medicini, pomeni ne glede na uporabo drugih določb člena 12(3)(c):
in respect of constituents which appear in the European Pharmacopoeia or, failing this, in the national pharmacopoeia of one of the Member States, the main title at the head of the monograph in question, with reference to the pharmacopoeia concerned,
pri sestavinah, ki so navedene v Evropski farmakopeji ali, kadar ta ne obstaja, farmakopeji ene od držav članic, glavni naslov v zadevni monografiji s sklicem na zadevno farmakopejo,
in respect of other constituents, the international non-proprietary name (INN) recommended by the World Health Organisation (WHO), which may be accompanied by another non-proprietary name, or, failing these, the exact scientific designation; constituents 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,
pri drugih sestavinah mednarodno nelastniško ime (INN), ki ga priporoča Svetovna zdravstvena organizacija, ki ga lahko spremlja drugo nelastniško ime, ali če tega ni, natančna znanstvena oznaka, pri sestavinah, ki nimajo mednarodnega nelastniškega imena ali natančne znanstvene oznake, se opiše način priprave in navedejo sestavine, iz katerih so bile pripravljene in dopolnjene, ter, kadar je to potrebno, drugi ustrezni podatki,
in respect of colouring matter, designation by the “E” code assigned to them by Council Directive 78/25/EEC [10].3.
barvila s kodami iz Direktive Sveta 78/25/EGS [10] se označijo s kodo ‚E‘.
In order to give “quantitative particulars” of all the active substances of the veterinary medicinal products, it is necessary, depending on the pharmaceutical form concerned, to specify the mass, or the number of units of biological activity, either per dosage-unit or per unit of mass or volume, of each active substance.
Za ‚podrobne podatke o količinski sestavi‘ vseh zdravilnih učinkovin v zdravilu za uporabo v veterinarski medicini je treba glede na zadevno farmacevtsko obliko za vsako zdravilno učinkovino navesti maso ali število enot biološke aktivnosti na enoto odmerka ali enoto mase ali volumna.
Units of biological activity shall be used for substances, which cannot be defined chemically.
Enote biološke aktivnosti se uporabljajo za snovi, ki jih ni mogoče kemijsko opredeliti.
Where an International Unit of biological activity has been defined by the World Health Organisation, this shall be used.
Kadar je Svetovna zdravstvena organizacija opredelila mednarodno enoto biološke aktivnosti, se ta uporablja.
Where no International Unit has been defined, the units of biological activity shall be expressed in such a way as to provide unambiguous information on the activity of the substances by using where applicable the European Pharmacopoeia Units.
Kadar mednarodna enota ni opredeljena, se enote biološke aktivnosti izrazijo tako, da nedvoumno izražajo aktivnost učinkovin s pomočjo enot Evropske farmakopeje, kadar je to primerno.
Whenever possible, biological activity per units of mass or volume shall be indicated.
Kadar koli je mogoče, se označi biološka aktivnost na enoto mase ali volumna.
This information shall be supplemented:
Ti podatki se dopolnijo:
in respect of single-dose preparations, by the mass or units of biological activity of each active substance in the unit container, taking into account the usable volume of the product, after reconstitution, where appropriate,
pri pripravkih z enkratnim odmerkom z maso ali z enotami biološke aktivnosti za vsako zdravilno učinkovino v enem vsebniku, ob upoštevanju uporabnega volumna zdravila po rekonstituciji, kadar je primerno,
in respect of veterinary medicinal products to be administered by drops, by the mass or units of biological activity of each active substance contained per drop or contained in the number of drops corresponding to 1 ml or 1 g of the preparation,
pri zdravilih za uporabo v veterinarski medicini, ki se dajejo po kapljicah, z maso ali enotami biološke aktivnosti za vsako zdravilno učinkovino, ki jo vsebuje kapljica ali tako število kapljic, ki ustreza 1 ml ali 1 g pripravka,
in respect of syrups, emulsions, granular preparations and other pharmaceutical forms to be administered in measured quantities, by the mass or units of biological activity of each active substance per measured quantity.
pri sirupih, emulzijah, granulatih ter drugih farmacevtskih oblikah, ki se dajejo v odmerjenih količinah, z maso ali enotami biološke aktivnosti za vsako zdravilno učinkovino na odmerjeno količino.
Active substances present in the form of compounds or derivatives shall be described quantitatively by their total mass, and if necessary or relevant, by the mass of the active entity or entities of the molecule.
Za zdravilne učinkovine, ki so prisotne v obliki spojin ali derivatov, se količina izrazi s celotno maso, in če je potrebno ali ustrezno, z maso aktivnega dela ali delov molekule.