FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: In case of urgency, the Member State concerned may suspend the marketing authorization of a veterinary medicinal product, provided the Agency, the Commission and the other Member States are informed at the latest on the following working day.
Slovenian: V nujnih primerih, lahko zadevna država članica prekliče dovoljenje za promet z zdravilom za uporabo v veterinarski medicini pod pogojem, da o tem obvesti agencijo, Komisijo ter druge države članice najpozneje naslednji delovni dan.
English: Article 79
Slovenian: Člen 79
English: Any amendments which may be necessary to update the provisions of Articles 72 to 78 to take account of scientific and technical progress shall be adopted in accordance with the procedure referred to in Article 89(2).
Slovenian: Kakršne koli spremembe, potrebne za dopolnitev določil iz členov 72 do 78 glede na znanstveni in tehnični napredek, se morajo sprejeti v skladu s postopkom iz člena 89(2).
English: TITLE VIII
Slovenian: NASLOV VIII
English: SUPERVISION AND SANCTIONS
Slovenian: NADZOR IN SANKCIJE
English: Article 80
Slovenian: Člen 80
English: The competent authority of the Member State concerned shall ensure by means of repeated inspection that the legal requirements relating to veterinary medicinal products are complied with.
Slovenian: Pristojni organ zadevne države članice mora s ponavljanjem pregledov zagotoviti, da so izpolnjene pravne zahteve glede zdravil za uporabo v veterinarski medicini.
English: Such inspections shall be carried out by authorized representatives of the competent authority who shall be empowered to:
Slovenian: Preglede morajo opraviti pooblaščeni predstavniki pristojnega organa, ki morajo imeti pooblastila za:
English: inspect manufacturing or trading establishments and any laboratories entrusted by the holder of the manufacturing authorization, with the task of carrying out control tests pursuant to Article 24;
Slovenian: pregled obratov za izdelavo ali trgovino ter laboratorijev, ki jih je za opravljanje kontrolnih testov iz člena 24 pooblastil imetnik dovoljenja za izdelavo;
English: take samples;
Slovenian: jemanje vzorcev;
English: examine any documents relating to the object of the inspection, subject to current provisions in the Member States from 9 October 1981 which place restrictions on these powers with regard to the description of the manufacturing method.
Slovenian: pregled vseh dokumentov, ki se nanašajo na predmet pregleda, ki je v skladu s trenutnimi določili držav članic z dne 9. oktobra 1981, omejen na opis metode izdelave.
English: Member States shall take all appropriate measures to ensure that the manufacturing processess used in the manufacture of immunological veterinary medicinal products are completely validated and batch-to-batch consistency is ensured.
Slovenian: Države članice uvedejo ustrezne ukrepe, da bodo postopki izdelave, ki se uporabljajo v izdelavi imunoloških zdravil za uporabo v veterinarski medicini, popolnoma validirani ter da bo zagotovljena konsistenca med serijami.
English: The officials representing the competent authority shall report after each of the inspections mentioned in the first paragraph on whether the manufacturer complies with the principles and guidelines of good manufacturing practice referred to in Article 51.
Slovenian: Uradniki, ki predstavljajo pristojni organ, morajo po vsakem pregledu, opredeljenem v prvem odstavku poročati, ali izdelovalec upošteva načela in smernice dobre proizvodne prakse iz člena 51.
English: The inspected manufacturer shall be informed of the content of such reports.
Slovenian: Izdelovalec, pri katerem je bil opravljen pregled, mora biti seznanjen z vsebino poročila.
English: Article 81
Slovenian: Člen 81
English: Member States shall take all appropriate measures to ensure that the marketing authorization holder and, where appropriate, the holder of the manufacturing authorization furnish proof of the control tests carried out on the veterinary medical product and/or on the constituents and intermediate products of the manufacturing process, in accordance with the methods laid down for the purposes of marketing authorization.
Slovenian: Države članice sprejmejo ukrepe, da imetnik dovoljenja za promet z zdravilom in, kjer je to ustrezno, imetnik dovoljenja za izdelavo, predloži dokazila o opravljenih kontrolnih preskusih zdravila za uporabo v veterinarski medicini in/ali sestavin in vmesnih proizvodov v procesu izdelave, v skladu z metodami, določenimi za namen dovoljenja za promet z zdravilom.
English: For the purposes of implementing paragraph 1, Member States may require the marketing authorization holder for immunological veterinary medicinal products to submit to the competent authorities copies of all the control reports signed by the qualified person in accordance with Article 55.
Slovenian: Za izvajanje odstavka 1 lahko države članice zahtevajo, da imetnik dovoljenja za promet z imunološkimi zdravili za uporabo v veterinarski medicini predloži pristojnim organom kopije vseh poročil o kontroli, ki jih je podpisala usposobljena oseba v skladu s členom 55.
English: The marketing authorization holder for immunological veterinary medicinal products shall ensure that an adequate number of representative samples of each batch of veterinary medical products is held in stock at least up to the expiry date, and provide samples promptly to the competent authorities on request.
Slovenian: Imetnik dovoljenja za promet z imunološkimi zdravili za uporabo v veterinarski medicini mora zagotoviti, da bo ustrezno število reprezentativnih vzorcev vsake serije zdravila za uporabo v veterinarski medicini hranjeno na zalogi najmanj do izteka roka uporabnosti ter da bo vzorce na zahtevo lahko nemudoma predložil pristojnim organom.
English: Article 82
Slovenian: Člen 82
English: Where it considers it necessary, a Member State may require the marketing authorization holder for immunological products to submit samples from the batches of the bulk and/or medical product for examination by a State laboratory or an approved laboratory before entry into circulation.
Slovenian: Država članica lahko zahteva, če meni, da je potrebno, da imetnik dovoljenja za promet z imunološkim zdravilom predloži vzorce vsake serije, iz zbirnega vsebnika in/ali zdravila v preskušanje državnemu laboratoriju, ali pooblaščenemu laboratoriju, preden se zdravilo sprosti v promet.
English: In the case of a batch manufactured in another Member State, examined by the competent authority of another Member State and declared to be in conformity with national specifications, such a control may be carried out only after the control reports of the batch in question have been examined, after the Commission has been informed, and where the difference in veterinary conditions between the two Member States concerned justifies it.
Slovenian: V primeru, da je serija izdelana v drugi državi članici, in da pristojni organ v drugi državi članici po pregledu izda potrdilo, da je serija v skladu z nacionalnimi specifikacijami, se lahko taka kontrola opravi šele po pregledu poročila o kontroli zadevne serije, potem, ko je o tem obveščena Komisija, in če razlike v veterinarskih pogojih med obema zadevnima državama članicama to upravičujejo.
English: Except where the Commission has been informed that a longer period is necessary to complete the analyses, Member States shall ensure that any such examination is completed within 60 days of receipt of the samples.
Slovenian: Razen v primeru, ko je bila Komisija obveščena, da je za dokončanje analiz potrebno daljše obdobje, morajo države članice zagotoviti, da se preskušanje zaključi v roku 60 dni od prejema vzorca.
English: The marketing authorization holder shall be notified of the results of the examination within the same time-limit.
Slovenian: Imetnika dovoljena za promet z zdravilom je potrebno obvestiti o rezultatih preskušanja v istem časovnem roku.
English: Before 1 January 1992, the Member States shall notify the Commission of the immunological veterinary medicinal products subject to compulsory official control before being placed on the market.
Slovenian: Države članice pred 1. januarjem 1992 obvestijo Komisijo o imunoloških zdravilih za uporabo v veterinarski medicini, za katera je obvezna uradna kontrola pred sproščanjem v promet.
English: Article 83
Slovenian: Člen 83
English: The competent authorities of the Member States shall suspend or withdraw marketing authorization when it is clear that:
Slovenian: Pristojni organi držav članic morajo preklicati ali ukiniti dovoljenje za promet, kadar je jasno, da:
English: the veterinary medicinal product proves to be harmful under the conditions of use stated at the time of application for authorization or subsequently;
Slovenian: je dokazano, da je zdravilo za uporabo v veterinarski medicini škodljivo pod pogoji uporabe, navedenimi ob času vloge za izdajo dovoljenja za promet, ali pozneje;
English: the veterinary medicinal product does not have any therapeutic effect on the species of animal for which the treatment is intended;
Slovenian: zdravilo za uporabo v veterinarski medicini nima terapevtskega učinka na živalsko vrsto, ki ji je zdravljenje namenjeno;
English: its qualitative and quantitative composition is not as stated;
Slovenian: kakovostna in količinska sestava zdravila ni enaka navedeni;
English: the recommended withdrawal period is inadequate to ensure that foodstuffs obtained from the treated animal do not contain residues which might constitute a health hazard to the consumer;
Slovenian: je priporočena karenca neustrezna in ne zagotavlja, da živila, pridobljena iz zdravljene živali, ne bodo vsebovala zaostankov, ki bi lahko predstavljali tveganje za zdravje potrošnika;
English: the veterinary medicinal product is offered for sale for a use which is prohibited by other community provisions.
Slovenian: se zdravilo za uporabo v veterinarski medicini v prometu ponuja za uporabo, ki je prepovedana z drugimi določili skupnosti.
English: However, pending Community rules, the competent authorities may refuse to grant authorization for a veterinary medicinal product where such action is necessary for the protection of public, consumer or animal health;
Slovenian: Vendar pa, odvisno od predpisov Skupnosti, lahko pristojni organi zavrnejo izdajo dovoljenja za promet z zdravilom za uporabo v veterinarski medicini, kjer je to potrebno za zavarovanje javnega zdravja, zdravja potrošnika ali živali;
English: the information given in the application documents pursuant to Article 12, 13(1) and 27 is incorrect;
Slovenian: so podatki, podani v dokumentaciji, skladni s členom 12, 13(1) ter 27, nepravilni;
English: the control tests referred to in Article 81(1) have not been carried out;
Slovenian: kontrolni preskusi iz člena 81(1), niso bili opravljeni;
English: the obligation referred to in Article 26(2) has not been fulfilled.
Slovenian: obveznost iz člena 26(2) ni bila izpolnjena.
English: Authorization may be suspended, or withdrawn where it is established that:
Slovenian: Dovoljenje se lahko prekliče, ali ukine, če se ugotovi da:
English: the particulars supporting the application, as provided for in Articles 12 and 13(1), have not been amended in accordance with Article 27(1) and (5);
Slovenian: podrobni podatki, ki spremljajo vlogo, kakor je predvideno v členih 12 in 13(1), niso bili spremenjeni v skladu s členom 27(1) in (5);
English: any new information as referred to in Article 27(3) has not been communicated to the competent authorities.
Slovenian: pristojnim organom niso bile posredovane nove informacije v skladu s členom 27(3).
English: Article 84
Slovenian: Člen 84
English: Without prejudice to Article 83, Member States shall take all necessary measures to ensure that supply of a veterinary medicinal product is prohibited and that the medicinal product concerned is withdrawn form the market where:
Slovenian: Brez poseganja v člen 83, morajo države članice izvesti potrebne ukrepe da bi zagotovile, da se prepove dobavo zdravil za uporabo v veterinarski medicini in da se zadevno zdravilo umakne iz prometa, če:
English: it is clear that the veterinary medicinal product is harmful under the conditions of use stated at the time of the application for authorization or subsequently, pursuant to Article 27(5);
Slovenian: je jasno, da je zdravilo za uporabo v veterinarski medicini škodljivo pod pogoji uporabe, ki so bili navedeni v vlogi za pridobitev dovoljenja za promet ali pozneje, v skladu z določili člena 27(5);
English: the veterinary medicinal product has no therapeutic effect on the species of animal for which the treatment was intended;
Slovenian: zdravilo za uporabo v veterinarski medicini nima terapevtskega učinka na živalsko vrsto, ki ji je bilo zdravljenje namenjeno;
English: the qualitative and quantitative composition of the veterinary medicinal product is not as stated;
Slovenian: kakovostna in količinska sestava zdravila za uporabo v veterinarski medicini ni enaka navedeni;
English: the recommended withdrawal period is inadequate to ensure that foodstuffs obtained from the treated animal do not contain residues which might constitute a health hazard to the consumer;
Slovenian: je priporočena karenca neustrezna, in ne zagotavlja, da živila, pridobljena iz zdravljene živali, ne bodo vsebovala zaostankov, ki bi lahko predstavljali tveganje za zdravje potrošnika;
English: the control tests referred to in Article 81(1) have not been carried out, or any other requirement or obligation relating to the grant of the manufacturing authorization referred to in Article 44(1) has not been complied with.
Slovenian: kontrolni preskusi iz člena 81(1) niso bili opravljeni, ali ni bila izpolnjena kaka druga zahteva ali obveznost iz člena 44(1), ki se nanaša na izdajo dovoljenja za izdelavo.
English: The competent authority may confine the prohibition on supply and withdrawal from the market solely to the contested production batches.
Slovenian: Pristojni organ si lahko pridrži pravico da prepove dobavo in zahteva umik iz prometa samo za oporečne proizvodne serije.
English: Article 85
Slovenian: Člen 85
English: The competent authority of a Member State shall suspend or withdraw the manufacturing authorization for a category of preparations or for all preparations if any of the requirements laid down in Article 45 are no longer met.
Slovenian: Pristojni organ države članice mora preklicati ali ukiniti dovoljenje za izdelavo za kategorijo pripravkov ali za vse pripravke, če katera koli od zahtev, ki jih določa člen 45 ni izpolnjena.
English: The competent authority of a Member State may, in addition to the measures provided for in Article 84, either suspend manufacture or imports of veterinary medicinal products from third countries or suspend or withdraw the manufacturing authorization for a category of preparations or for all preparations in the event of non-compliance with the provisions regarding manufacture or imports from third countries.
Slovenian: Poleg ukrepov, predvidenih v členu 84, lahko pristojni organ države članice, bodisi začasno ustavi izdelavo ali uvoz zdravil za uporabo v veterinarski medicini iz tretjih držav, ali prekliče ali ukine dovoljenje za izdelavo za tisto kategorijo pripravkov, ali za vse pripravke v primeru, če niso bila upoštevana določila, ki zadevajo izdelavo ali uvoz iz tretjih držav.
English: Article 86
Slovenian: Člen 86
English: The provisions of this Title shall apply to homeopathic veterinary medicinal products.
Slovenian: Določila tega naslova se morajo nanašati na homeopatska zdravila za uporabo v veterinarski medicini.
English: Article 87
Slovenian: Člen 87
English: Member States shall take appropriate measures to encourage veterinarians and other professionals concerned to report to the competent authorities any adverse reaction of veterinary medicinal products.
Slovenian: Države članice uvedejo ustrezne ukrepe, da bi spodbudile veterinarje in druge zadevne strokovnjake, da poročajo pristojnim organom o neželenih škodljivih učinkih zdravil za uporabo v veterinarski medicini.
English: TITLE IX
Slovenian: NASLOV IX
English: STANDING COMMITTEE
Slovenian: STALNI ODBOR
English: Article 88
Slovenian: Člen 88
English: Any changes which are necessary in order to adapt Annex I to take account of technical progress shall be adopted in accordance with the procedure referred to in Article 89(2).
Slovenian: Vse spremembe, potrebne za spremembo Priloge I zaradi tehničnega napredka, se morajo sprejeti v skladu s postopkom iz člena 89(2).
English: Article 89
Slovenian: Člen 89
English: The Commission shall be assisted by a Standing Committee on Veterinary Medicinal Products for the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Veterinary Medicinal Products Sector, (hereinafter referred to as the "Standing Committee".
Slovenian: Komisiji pomaga Stalni odbor za zdravila za uporabo v veterinarski medicini za prilagajanja direktiv tehničnemu napredku o odstranitvi tehničnih ovir za trgovino z zdravili za uporabo v veterinarski medicini v Sektorju zdravil za uporabo v veterinarski medicini (v nadaljnjem besedilu: "stalni odbor").
English: Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
Slovenian: Pri sklicevanju na ta odstavek, se uporabljata člena 5 in 7 Sklepa 1999/468/ES, ob upoštevanju določitev člena 8 Sklepa.
English: The period provided for in Article 5(6) of Decision 1999/468/EC shall be set at three months.
Slovenian: Doba, predvidena v členu 6(6) Odločbe 1999/468/ES je tri mesece.
English: The Standing Committee shall adopt its rules of procedure.
Slovenian: Stalni odbor sprejme svoj poslovnik.
English: TITLE X
Slovenian: NASLOV X
English: Article 90
Slovenian: Člen 90
English: Member States shall take all measures necessary to ensure that the competent authorities concerned communicate the appropriate information to each other, in particular regarding compliance with the requirements adopted for manufacturing authorization, or for authorization to place products on the market.
Slovenian: Države članice sprejmejo vse potrebne ukrepe, da bi si zadevni pristojni organi lahko medsebojno izmenjevali ustrezne informacije, še posebno glede skladnosti z zahtevami, sprejetimi za dovoljenje za izdelavo, ali za dovoljenje za promet z zdravili.
English: Upon reasoned request, Member States shall forthwith communicate the reports referred to in Article 80(3) to the competent authorities of another Member State.
Slovenian: Na utemeljeno zahtevo morajo države članice nemudoma poslati poročila iz člena 80(3) pristojnim organom druge države članice.
English: If, after considering the reports, the Member State receiving the reports considers that it cannot accept the conclusions reached by the competent authority of the Member State in which the report was established, it shall inform the competent authorities concerned of its reasons and may request further information.
Slovenian: V primeru, da po pregledu poročila država članica, ki je prejela poročila meni, da ne more sprejeti sklepov, ki jih je sprejel pristojni organ države članice, v kateri je bilo poročilo izdelano, mora o tem obvestiti zadevne pristojne organe o razlogih ter lahko zahteva dodatne informacije.
English: The Member States concerned shall attempt to reach agreement.
Slovenian: Zadevne države članice si morajo prizadevati doseči soglasje.
English: If necessary, in the event of serious differences of opinion, one of the Member States concerned shall inform the Commission.
Slovenian: Po potrebi in v primeru resnih razhajanj mnenj, morajo zadevne države članice o tem obvestiti Komisijo.
English: Article 91
Slovenian: Člen 91
English: Each Member State shall take all appropriate measures to ensure that the Agency is informed immediately of decisions granting marketing authorization and of all decisions refusing or withdrawing marketing authorization, cancelling a decision refusing or withdrawing marketing authorization, prohibiting supply or withdrawing a product from the market, together with the reasons on which such decisions are based.
Slovenian: Vsaka država članica mora sprejeti ustrezne ukrepe, da bi bila agencija takoj obveščena o odločitvah o dovoljenjih za promet ter o vseh odločitvah, ki se nanašajo na zavrnitev ali umik dovoljenja za promet z zdravilom, razveljavitvi odločitve, zavrnitvi ali ukinitvi dovoljenja za promet z zdravilom, prepovedi dobave ali umiku zdravila iz prometa, skupaj z razlogi, na katerih take odločitve temeljijo.
English: The marketing authorization holder shall be obliged to notify the Member States forthwith of any action taken by him to suspend the marketing of a veterinary medicinal product or to withdraw a product from the market, together with the reasons for such action if it concerns the effectiveness of the veterinary medicinal product or the protection of public health.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora nemudoma obvestiti države članice o vseh svojih ukrepih za začasno prekinitev prometa z zdravilom za uporabo v veterinarski medicini ali za umik zdravila iz prometa, skupaj z razlogi za tak ukrep, če to zadeva učinkovitost zdravila za uporabo v veterinarski medicini ali varovanje javnega zdravja.
English: Member States shall ensure that this information is brought to the attention of the Agency.
Slovenian: Države članice morajo zagotoviti da bo ta informacija posredovana agenciji.
English: Member States shall ensure that appropriate information about actions taken pursuant to paragraphs 1 and 2 which may affect the protection of health in third countries is forthwith brought to the attention of the relevant international organizations, with a copy to the Agency.
Slovenian: Države članice zagotovijo, da bodo ustrezne mednarodne organizacije nemudoma obveščene o ustreznih informacijah o ukrepih, izvedenih v skladu z odstavkoma 1 in 2, ki lahko vplivajo na varovanje zdravja v tretjih državah, kopijo le-te pa mora prejeti agencija.
English: Article 92
Slovenian: Člen 92
English: Member States shall communicate to each other all the information necessary to guarantee the quality and safety of homeopathic veterinary medicinal products manufactured and marketed within the Community, and in particular the information referred to in Articles 90 and 91.
Slovenian: Države članice se medsebojno obveščajo o vseh potrebnih informacijah za zagotavljanje kakovosti in varnosti homeopatskih zdravil za uporabo v veterinarski medicini, ki se izdelujejo in so v prometu znotraj Skupnosti in še posebno o informacijah iz členov 90 in 91.
English: Article 93
Slovenian: Člen 93
English: At the request of the manufacturer or exporter of veterinary medicinal products, or the authorities of an importing third country, Member States shall certify that such manufacturer is in possession of the manufacturing authorization.
Slovenian: Na zahtevo izdelovalca ali izvoznika zdravil za uporabo v veterinarski medicini, ali organov tretje države uvoznice, morajo države članice izdati potrdilo, da ima tak izdelovalec dovoljenje za izdelavo.
English: When issuing such certificates, Member States shall comply with the following conditions:
Slovenian: Pri izdaji tovrstnih potrdil se morajo države članice držati naslednjih pogojev:
English: they shall have regard to the prevailing administrative arrangements of the World Health Organization;
Slovenian: morajo se upoštevati prevladujoči upravni predpisi Svetovne zdravstvene organizacije;
English: for veterinary medicinal products intended for export which are already authorized in their territory, they shall supply the summary of the product characteristics as approved in accordance with Article 25 or, in the absence thereof, an equivalent document.
Slovenian: za zdravila za uporabo v veterinarski medicini namenjene izvozu, ki že imajo dovoljenje na svojem ozemlju, morajo dostaviti povzetek glavnih značilnosti zdravila odobrenega v skladu s členom 25, ali v odsotnosti le-tega, enakovreden dokument.