natgillin/translations-raw huggingface dataset:
Applications based on Article 13 (generic veterinary medicinal products) shall contain the data referred to in Parts 1 and 2 of Title I of this Annex together with an environmental risk assessment and data demonstrating that the product has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product and data showing bio-equivalence with the reference medicinal product.
Vloge, predložene na podlagi člena 13 (generična zdravila za uporabo v veterinarski medicini), vsebujejo podatke iz delov 1 in 2 naslova I te priloge, oceno tveganja za okolje, podatke, ki dokazujejo, da ima zdravilo isto kakovostno in količinsko sestavo zdravilnih učinkovin in isto farmacevtsko obliko kot referenčno zdravilo, ter podatke, ki dokazujejo, da je zdravilo bioekvivalentno referenčnemu zdravilu.
If the reference veterinary medicinal product is a biological medicinal product, the documentation requirements in Section 2 for similar biological veterinary medicinal products shall be fulfilled.
Če je referenčno zdravilo za uporabo v veterinarski medicini biološko zdravilo, se upoštevajo zahteve iz oddelka 2 za podobna biološka zdravila za uporabo v veterinarski medicini.
For generic veterinary medicinal products the detailed and critical summaries on safety and efficacy shall particularly focus on the following elements:
Za generična zdravila za uporabo v veterinarski medicini se pri podrobnih in kritičnih povzetkih o varnosti in učinkovitosti opišejo zlasti naslednji elementi:
the grounds for claiming essential similarity,
razlogi za trditev o bistveni podobnosti,
a summary of impurities present in batches of the active substance(s) as well as those of the finished medicinal product (and where relevant decomposition products arising during storage) as proposed for use in the product to be marketed together with an evaluation of these impurities,
povzetek nečistoč, prisotnih v serijah zdravilnih učinkovin, in nečistoč v končnem zdravilu (ter, kadar je to ustrezno, razgradnih produktov, ki nastajajo med shranjevanjem), kakor se predlagajo za uporabo v zdravilu, ki bo dano na trg, skupaj z oceno teh nečistoč,
an evaluation of the bio-equivalence studies or a justification as to why studies were not performed with reference to established guidance,
ocena bioekvivalenčnih študij ali utemeljitev, zakaj niso bile opravljene študije ob upoštevanju uveljavljenih smernic,
if applicable, additional data in order to demonstrate the equivalence of safety and efficacy properties of different salts, esters or derivatives of an authorised active substance shall be provided by the applicant; those data shall include evidence that there is no change in the pharmacokinetic or pharmacodynamic properties of the therapeutic moiety and/or in toxicity, which could influence the safety/efficacy profile.
po potrebi predlagatelj predloži dodatne podatke za dokaz enakovrednosti lastnosti glede varnosti in učinkovitosti različnih soli, estrov ali derivatov odobrene zdravilne učinkovine; navedeni podatki vključujejo dokaz, da farmakokinetične ali farmakodinamične lastnosti in/ali toksičnost terapevtske molekule ni spremenjena, kar lahko vpliva na profil varnosti/učinkovitosti.
Every claim in the summary of product characteristics not known from or inferred from the properties of the medicinal product and/or its therapeutic group should be discussed in the non-clinical/clinical overviews/summaries and substantiated by published literature and/or additional studies.
Vsako trditev v povzetku glavnih značilnosti zdravila, ki ni znana ali povzeta iz lastnosti zdravila in/ali terapevtske skupine, je treba obravnavati v pregledih/povzetkih neklinične/klinične dokumentacije in utemeljiti z objavljeno literaturo in/ali dodatnimi študijami.
For generic veterinary medicinal products intended to be administered by intramuscular, subcutaneous or transdermal routes, the following additional data shall be provided:
Za generična zdravila za uporabo v veterinarski medicini, ki se bodo dajala intramuskularno, subkutano ali transdermalno, se predložijo naslednji dodatni podatki:
evidence to demonstrate equivalent or differing depletion of residues from the administration site, which may be substantiated by appropriate residue depletion studies,
dokaz enakega ali različnega izločanja ostankov z mesta dajanja, ki je lahko utemeljen z ustreznimi študijami izločanja ostankov,
evidence to demonstrate target animal tolerance at the administration site, which may be substantiated by appropriate target animal tolerance studies.
dokaz o toleranci pri ciljni živali na mestu dajanja, ki je lahko utemeljen z ustreznimi študijami izločanja ostankov.
In accordance with Article 13(4), where a biological veterinary medicinal product which is similar to a reference biological veterinary medicinal product does not meet the conditions in the definition of generic medicinal product, information to be supplied shall not be limited to Parts 1 and 2 (pharmaceutical, chemical and biological data), supplemented with bio-equivalence and bioavailability data.
Kadar biološko zdravilo za uporabo v veterinarski medicini, ki je podobno referenčnemu biološkemu zdravilu za uporabo v veterinarski medicini, v skladu s členom 13(4) ne izpolnjuje pogojev za opredelitev generičnega zdravila, se predložijo dodatne informacije poleg informacij iz delov 1 in 2 (farmacevtski, kemijski in biološki podatki) in podatki o bioekvivalenci in biološki uporabnosti.
In such cases, additional data shall be provided, in particular on the safety and efficacy of the product.
V teh primerih se posredujejo dodatni podatki zlasti glede varnosti in učinkovitosti zdravila.
The type and amount of additional data (i.e. toxicological and other safety studies and appropriate clinical studies) shall be determined on a case-by-case basis in accordance with relevant scientific guidelines.
Vrsta in količina dodatnih podatkov (tj. toksikoloških in drugih varnostnih študij in ustreznih kliničnih študij) se določi za vsak primer posebej v skladu z ustreznimi znanstvenimi smernicami.
Due to the diversity of biological veterinary medicinal products, the competent authority shall determine the necessary studies foreseen in Parts 3 and 4, taking into account the specific characteristic of each individual biological veterinary medicinal product.
Zaradi različnih bioloških zdravil za uporabo v veterinarski medicini pristojni organ ob upoštevanju posebnih lastnosti vsakega posameznega biološkega zdravila za uporabo v veterinarski medicini določi študije, ki so potrebne v skladu z deloma 3 in 4.
The general principles to be applied shall be addressed in guideline which shall be adopted by the Agency, taking into account the characteristics of the concerned biological veterinary medicinal product.
Splošna načela, ki se uporabljajo, se obravnavajo v smernici, ki jo ob upoštevanju lastnosti zadevnega biološkega zdravila za uporabo v veterinarski medicini objavi Agencija.
If the reference biological veterinary medicinal product has more than one indication, the efficacy and safety of the biological veterinary medicinal product claimed to be similar shall be justified or, if necessary, demonstrated separately for each of the claimed indications.
Če ima referenčno biološko zdravilo za uporabo v veterinarski medicini več kot eno indikacijo, se učinkovitost in varnost zdravila, za katera se trdi, da sta podobni, utemeljita ali, če je potrebno, dokažeta ločeno za vsako od navedenih indikacij.
For veterinary medicinal products the active substance(s) of which has/have been in “well-established veterinary use” as referred to in Article 13a, with recognised efficacy and an acceptable level of safety, the following specific rules shall apply.
Za zdravila za uporabo v veterinarski medicini, katerih uporaba zdravilnih učinkovin je dobro uveljavljena v veterinarski medicini v skladu s členom 13a in ki so priznano učinkovita in sprejemljivo varna, se uporabljajo naslednja posebna pravila.
The applicant shall submit Parts 1 and 2 as described in Title I of this Annex.
Predlagatelj predloži dela 1 in 2, kakor je opisano v naslovu I te priloge.
For Parts 3 and 4, a detailed scientific bibliography shall address all aspects of the safety and efficacy.
Pri delih 3 in 4 se v podrobni znanstveni bibliografiji navedejo vse raziskave, povezane z varnostjo in učinkovitostjo.
The following specific rules shall apply in order to demonstrate the well-established veterinary use:
Za dokazovanje dobro uveljavljene uporabe v veterinarski medicini se uporabljajo naslednja posebna pravila:
The following factors shall be taken into account in order to establish a well-established veterinary medicinal use of constituents of veterinary medicinal products:
dejavniki, ki se upoštevajo pri ugotavljanju dobro uveljavljene uporabe v veterinarski medicini sestavin zdravila za uporabo v veterinarski medicini, so naslednji:
the time over which an active substance has been used;
časovno obdobje, v katerem se učinkovina že uporablja,
quantitative aspects of the use of the active substance;
količine zdravilne učinkovine, ki se uporabljajo,
the degree of scientific interest in the use of the active substance (reflected in the published scientific literature);
stopnja znanstvenega zanimanja za uporabo zdravilne učinkovine (ki se odraža v objavljeni znanstveni literaturi),
the coherence of scientific assessments.
povezanost znanstvenih ocen.
Different periods of time may be necessary for establishing well-established use of different substances.
Za ugotavljanje dobro uveljavljene uporabe različnih snovi so morda potrebna različna časovna obdobja.
In any case, however, the period of time required for establishing a well-established veterinary use of a constituent of a medicinal product shall not be less than ten years from the first systematic and documented use of that substance as a veterinary medicinal product in the Community.
V vsakem primeru pa časovno obdobje, potrebno za ugotavljanje dobro uveljavljene uporabe sestavine zdravila v veterinarski medicini, ne sme biti krajše od desetih let od prve sistematične in dokumentirane uporabe navedene snovi kot zdravila za uporabo v veterinarski medicini v Skupnosti.
The documentation submitted by the applicant shall cover all aspects of the safety and/or efficacy assessment of the product for the proposed indication in the target species using the proposed route of administration and dosage regimen.
Dokumentacija, ki jo predloži predlagatelj, vključuje celotno oceno varnosti in učinkovitosti zdravila za predlagano indikacijo pri ciljni vrsti, pri čemer se nanaša na predlagani način dajanja in režim odmerjanja.
It must include or refer to a review of the relevant literature, taking into account pre- and post-marketing studies and published scientific literature concerning experience in the form of epidemiological studies and in particular of comparative epidemiological studies.
Mora vključevati ali se nanašati na pregled ustrezne literature, pri čemer se upoštevajo študije pred in po dajanju na trg ter objavljena znanstvena literatura glede epidemioloških študij in zlasti primerjalnih epidemioloških študij.
All documentation, both favourable and unfavourable, shall be communicated.
Predloži se ugodna in neugodna dokumentacija.
With respect to the provisions on well-established veterinary use, it is in particular necessary to clarify that bibliographic reference to other sources of evidence (post-marketing studies, epidemiological studies etc.) and not just data related to tests and trials may serve as a valid proof of safety and efficacy of a product if an application explains and justifies the use of these sources of information satisfactorily.
Glede na določbe o ‚dobro uveljavljeni uporabi v veterinarski medicini‘ je zlasti treba pojasniti, da se lahko poleg podatkov o preskusih in preskušanjih kot veljaven dokaz o varnosti in učinkovitosti zdravila uporabi sklic na bibliografije (študije po dajanju na trg, epidemiološke študije itd.), če je v vlogi zadovoljivo pojasnjena in utemeljena uporaba teh virov informacij.
Particular attention must be paid to any missing information and justification must be given as to why demonstration of an acceptable level of safety and/or efficacy can be supported although some studies are lacking.
Posebna pozornost je treba posvetiti kakršnim koli manjkajočim informacijam in predložiti je treba utemeljitev, zakaj prikaz sprejemljive stopnje varnosti in/ali učinkovitosti zadošča, čeprav nekatere študije manjkajo.
The detailed and critical summaries regarding safety and efficacy must explain the relevance of any data submitted which concern a product different from the product intended for marketing.
V podrobnih in kritičnih povzetkih o varnosti in učinkovitost je treba obrazložiti pomembnost vseh predloženih podatkov o zdravilu, ki se razlikuje od zdravila, namenjenega za dajanje na trg.
A judgement must be made whether or not the product studied can be considered as similar to the product, for which application for a marketing authorisation has been made in spite of the existing differences.
Presoditi je treba, ali se preiskovano zdravilo lahko šteje kot podobno zdravilu, za katerega je že bila predložena vloga za pridobitev dovoljenja za promet z zdravilom, kljub obstoječim razlikam.
Post-marketing experience with other products containing the same constituents is of particular importance and applicants shall put a special emphasis on this issue.
Izkušnje z drugimi zdravili po dajanju na trg, ki vsebujejo enake sestavine, so zlasti pomembne, zato vlagatelji to še posebej poudarijo.
For applications based on Article 13b, a dossier containing Parts 1, 2, 3 and 4 shall be provided for the combination veterinary medicinal product.
V vlogah za kombinacije zdravil za uporabo v veterinarski medicini, predloženih na podlagi člena 13b, se predloži dokumentacija z deli 1, 2, 3 in 4.
It shall not be necessary to provide studies on the safety and efficacy of each active substance.
Študije o varnosti in učinkovitosti vsake zdravilne učinkovine se ne predložijo.
It shall nevertheless be possible to include information on the individual substances in the application for a fixed combination.
Vendar je mogoče vključiti informacije o posameznih snoveh v vlogo za fiksno kombinacijo.
The submission of data on each individual active substance, in conjunction with the required user safety studies, residues depletion studies and clinical studies on the fixed combination product, may be considered a suitable justification for omitting data on the combination product, based on animal welfare grounds and unnecessary testing on animals, unless there is suspected interaction leading to added toxicity.
Predložitev podatkov o vsaki posamezni zdravilni učinkovini, skupaj z zahtevanimi študijami varnosti za uporabnike, študijami o izločanju ostankov in kliničnimi študijami o fiksni kombinaciji zdravila, se lahko obravnava kot ustrezna utemeljitev za manjkajoče podatke o kombinaciji zdravila, in sicer zaradi dobrega počutja živali in nepotrebnega preskušanja na živalih, razen če se zaradi domnevnega medsebojnega vpliva lahko poveča toksičnost.
Where applicable, information regarding the manufacturing sites and the safety evaluation of adventitious agents shall be provided.
Kadar je to primerno, se predložijo informacije o mestih izdelave in oceni varnosti naključnih snovi.
Applications based on Article 13c shall contain the data described in Part 1 of Title 1 of this Annex, provided that the marketing authorisation holder for the original veterinary medicinal product has given the applicant his consent to refer to the content of Parts 2, 3 and 4 of the dossier of that product.
Vloge, predložene na podlagi člena 13c, vključujejo podatke iz dela 1 naslova 1 te priloge, če je imetnik dovoljenja za promet z originalnim zdravilom za uporabo v veterinarski medicini dal predlagatelju soglasje, da se lahko sklicuje na vsebino delov 2, 3 in 4 dokumentacije navedenega zdravila.
In this case, there is no need to submit quality, safety and efficacy detailed and critical summaries.
V tem primeru ni treba predložiti podrobnih in kritičnih povzetkov kakovosti, varnosti in učinkovitosti.
A marketing authorisation may be granted subject to certain specific obligations requiring the applicant to introduce specific procedures, in particular concerning the safety and efficacy of the veterinary medicinal product, when, as provided for in Article 26(3) of this Directive, the applicant can show that he is unable to provide comprehensive data on the efficacy and safety under normal conditions of use.
Dovoljenje za promet z zdravilom se lahko izda, če predlagatelj izpolni nekatere posebne zahteve in uvede posebne postopke glede varnosti in učinkovitosti zdravila za uporabo v veterinarski medicini, kadar dokaže, da ne more predložiti izčrpnih podatkov o učinkovitosti in varnosti pri normalnih pogojih uporabe, kakor je določeno v členu 26(3) te direktive.
The identification of essential requirements for all applications mentioned in this section should be subject to guidelines which shall be adopted by the Agency.
Pri določitvi osnovnih zahtev za vse vloge, navedene v tem oddelku, je treba upoštevati smernice, ki jih sprejme Agencija.
Mixed marketing authorisation applications are applications where Part(s) 3 and/or 4 of the dossier consist of safety and efficacy studies carried out by the applicant as well as bibliographical references.
Mešane vloge za pridobitev dovoljenja za promet z zdravilom so vloge, v katerih so v delih 3 in/ali 4 dokumentacije navedene študije varnosti in učinkovitosti, ki jih je opravil predlagatelj, ter bibliografska sklicevanja.
All other part(s) are in accordance with the structure described in Part I of Title I of this Annex.
Vsi drugi deli so pripravljeni v skladu s strukturo, opisano v delu I naslova I te priloge.
The competent authority shall accept the proposed format presented by the applicant on a case-by-case basis.
Pristojni organ za vsak primer posebej sprejme predlagano strukturo, ki jo predloži predlagatelj.
This part lays down specific requirements for identified veterinary medicinal products related to the nature of the active substances contained therein.
V tem delu so določene posebne zahteve za zdravila za uporabo v veterinarski medicini glede na zdravilne učinkovine, ki jih vsebujejo.
VACCINE ANTIGEN MASTER FILE
GLAVNA DATOTEKA O ANTIGENU CEPIVA
For particular immunological veterinary medicinal products and by derogation from the provisions of Title II, Part 2 Section C on active substances, the concept of a Vaccine Antigen Master File is introduced.
Koncept glavne datoteke o antigenu cepiva se uvede za posebna imunološka zdravila za uporabo v veterinarski medicini in brez poseganja v določbe oddelka C dela 2 naslova II o zdravilnih učinkovinah.
For the purpose of this Annex, a Vaccine Antigen Master File means a stand-alone part of the marketing authorisation application dossier for a vaccine, which contains all relevant information on quality concerning each of the active substances, which are part of this veterinary medicinal product.
V tej prilogi pomeni glavna datoteka o antigenu cepiva samostojen del vloge za pridobitev dovoljenja za promet s cepivom, ki vsebuje vse pomembne podatke o kakovosti vsake posamezne zdravilne učinkovine, ki je del zdravila za uporabo v veterinarski medicini.
The stand-alone part may be common to one or more monovalent and/or combined vaccines presented by the same applicant or marketing authorisation holder.
Samostojni del je lahko skupen enemu ali več enovalentnim in/ali kombiniranim cepivom, ki ga predloži isti predlagatelj ali imetnik dovoljenja za promet z zdravilom.
Scientific guidelines for the submission and evaluation of a vaccine antigen master file shall be adopted by the Agency.
Agencija sprejme znanstvene smernice za predložitev in oceno glavne datoteke o antigenu cepiva.
The procedure for the submission and evaluation of a vaccine antigen master file shall follow the guidance published by the Commission in The rules governing medicinal products in the European Union, Volume 6B, Notice to Applicants.
Pri predložitvi in oceni glavne datoteke o antigenu cepiva se upošteva smernica, ki jo je Komisija objavila v Pravilih, ki urejajo zdravila v Evropski uniji, zvezek 6B, Obvestilo predlagateljem.
MULTI-STRAIN DOSSIER
DOKUMENTACIJA ZA VEČ SEVOV
For certain immunological veterinary medicinal products (foot-and-mouth disease, avian influenza and bluetongue) and by derogation from the provisions of Title II, Part 2 Section C on active substances the concept of the use of a multi-strain dossier is introduced.
Koncept dokumentacije za več sevov se uvede za nekatera imunološka zdravila za uporabo v veterinarski medicini (slinavka in parkljevka, aviarna influenca, bolezen modrikastega jezika) in brez poseganja v določbe oddelka C dela 2 naslova II o zdravilnih učinkovinah.
A multi-strain dossier means a single dossier containing the relevant data for a unique and thorough scientific assessment of the different options of strains/combinations of strains permitting the authorisation of vaccines against antigenically variable viruses.
Dokumentacija za več sevov je ena dokumentacija, ki vsebuje ustrezne podatke o posebni in natančni znanstveni oceni različnih vrst sevov/kombinacij sevov, na podlagi katere se lahko izda dovoljenje z promet s cepivi proti virusom z različnimi antigeni.
Scientific guidelines for the submission and evaluation of multi-strain dossiers shall be adopted by the Agency.
Agencija sprejme znanstvene smernice za predložitev in oceno dokumentacije za več sevov.
The procedure for the submission and evaluation of multi-strain dossiers shall follow the guidance published by the Commission in The rules governing medicinal products in the European Union, Volume 6B, Notice to Applicants.
Pri predložitvi in oceni dokumentacije za več sevov se upošteva smernica, ki jo je Komisija objavila v Pravilih, ki urejajo zdravila v Evropski uniji, zvezek 6B, Obvestilo predlagateljem.
This section sets out specific provisions on the application of Title I, Parts 2 and 3 to homeopathic veterinary medicinal products as defined in Article 1(8).
V tem oddelku so določene posebne zahteve o uporabi delov 2 in 3 naslova I za homeopatska zdravila za uporabo v veterinarski medicini, opredeljena v členu 1(8).
The provisions of Part 2 shall apply to the documents submitted in accordance with Article 18 in the simplified registration of homeopathic veterinary medicinal products referred to in Article 17(1) as well as to the documents for authorisation of other homeopathic veterinary medicinal products referred to in Article 19(1) with the following modifications.
Določbe iz dela 2 se uporabljajo za dokumente, predložene v skladu s členom 18 pri poenostavljeni registraciji homeopatskih zdravil za uporabo v veterinarski medicini iz člena 17(1), in za dokumente za pridobitev dovoljenja za druga homeopatska zdravila za uporabo v veterinarski medicini iz člena 19(1) z naslednjimi spremembami.
The Latin name of the homeopathic stock described in the marketing authorisation application dossier shall be in accordance with the Latin title of the European Pharmacopoeia or, in absence thereof, of an official pharmacopoeia of a Member State.
Latinsko ime homeopatske surovine, opisane v vlogi za pridobitev dovoljenja za promet z zdravilom, je v skladu z latinskim naslovom v Evropski farmakopeji ali, kadar ta ne obstaja, uradni farmakopeji države članice.
Where relevant the traditional name(s) used in each Member State shall be provided.
Kadar je primerno, se navedejo tradicionalna imena, ki se uporabljajo v posameznih državah članicah.
Control of starting materials
Kontrola vhodnih snovi