FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: The marketing authorization may require the holder to indicate on the container and/or the outer wrapping and the package insert, where the latter is required, other particulars essential for safety or health protection, including any special precautions relating to use and any other warnings resulting from the clinical and pharmacological trials prescribed in Articles 12(3)(j) and 13(1) or from experience gained during the use of the veterinary medicinal product once it has been marketed.
Slovenian: Dovoljenje za promet z zdravilom lahko zahteva od imetnika, da na vsebniku in/ali zunanji ovojnini in na navodilu za uporabo, če je navodilo zahtevano, navede še druge podrobne podatke, potrebne za varnost ali varovanje zdravja, vključno z morebitnimi posebnimi previdnostnimi ukrepi glede uporabe ter druga opozorila, ki so rezultat kliničnih in farmakoloških preskusov, ki jih določata člena 12(3)(j) in 13(1), ali so rezultat izkušnje, pridobljene med uporabo zdravila za uporabo v veterinarski medicini, potem ko je že bilo v prometu.
English: The authorization may also require the inclusion of a tracer substance in the veterinary medicinal product.
Slovenian: Dovoljenje lahko zahteva tudi vključitev sledljive snovi v zdravilo za uporabo v veterinarski medicini.
English: In exceptional circumstances, and following consultation with the applicant, an authorization may be granted subject to certain specific obligations, and subject to annual review, including:
Slovenian: V izjemnih okoliščinah ter po posvetu s predlagateljem, se sme izdati dovoljenje pod določenimi posebnimi pogoji ter pod pogoji letnih ocen, kar vključuje:
English: the carrying out of further studies following the granting of authorization,
Slovenian: izvajanje nadaljnjih študij po tem, ko je bilo dovoljenje že izdano,
English: the notification of adverse reactions to the veterinary medicinal product.
Slovenian: obveščanje o škodljivih učinkih zdravila za uporabo v veterinarski medicini.
English: These exceptional decisions may only be adopted for objective and verifiable reasons.
Slovenian: Te izjemne odločitve je možno sprejeti le zaradi objektivnih in preverljivih razlogov.
English: Article 27
Slovenian: Člen 27
English: After a marketing authorization has been issued, the holder must, in respect of the manufacturing methods and control methods provided for in Article 12(3)(d) and (i), take account of scientific and technical progress and introduce any changes that may be required to enable that veterinary medicinal product to be manufactured and checked by means of generally accepted scientific methods.
Slovenian: Potem, ko je že bilo izdano dovoljenje za promet z zdravilom, mora imetnik, glede metod izdelave ter kontrolnih metod, ki jih določa člen 12(3)(d) ter (i), upoštevati dosežke na področju znanosti in tehnologije ter uvesti morebitne spremembe, ki so potrebne, da bi omogočile izdelavo in preverjanje zdravila s splošno veljavnimi znanstvenimi metodami.
English: These changes shall be subject to the approval of the competent authorities of the Member State concerned.
Slovenian: Te spremembe morajo odobriti pristojni organi zadevne države članice.
English: Upon request from the competent authorities, the marketing authorization holder shall also review the analytical detection methods provided for in Article 12(3)(h) and propose any changes which may be necessary to take account of scientific and technical progress.
Slovenian: Na zahtevo pristojnih organov mora imetnik dovoljenja za promet z zdravilom revidirati analitske metode določanja, ki jo določa člen 12(3)(h) ter predlagati morebitne spremembe, potrebne zaradi napredka znanosti in tehnologije.
English: The marketing authorization holder shall forthwith inform the competent authorities of any new information which might entail the amendment of the particulars and documents referred to in Articles 12 and 13(1) or of the approved summary of the product characteristics.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora nemudoma obvestiti pristojne organe o vsakršni novi informaciji, ki bi lahko zahtevala spremembo podrobnih podatkov ter dokumentov, določenih v členih 12 in 13(1), ali sprejetega povzetka glavnih značilnostih zdravila.
English: In particular, he shall forthwith inform the competent authorities of any prohibition or restriction imposed by the competent authorities of any country in which the veterinary medicinal product is marketed and of any serious unexpected adverse effect occurring in the animals concerned or human beings.
Slovenian: Še posebno mora imetnik nemudoma obvestiti pristojne organe o prepovedi ali omejitvi, ki jo lahko izreče pristojni organi katere koli države, v kateri so zdravila za uporabo v veterinarski medicini v prometu ter o resnih, nepričakovanih škodljivih učinkih, do katerih je prišlo pri zadevnih živalih ali pri ljudeh.
English: The marketing authorization holder shall be required to maintain records of all adverse reactions observed in animals or human beings.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zbirati podatke o vseh opaženih škodljivih učinkih pri živalih ali ljudeh.
English: The records so established shall be kept at least five years and shall be made available to the competent authorities upon request.
Slovenian: Tako zbrani podatki se morajo hraniti najmanj pet let in morajo biti dostopni pristojnim organom na njihovo zahtevo.
English: The marketing authorization holder shall immediately inform the competent authorities, with a view to authorization, of any alteration he proposes to make to the particulars and documents referred to in Articles 12 and 13(1).
Slovenian: Imetnik dovoljenja za promet z zdravilom mora takoj obvestiti pristojne organe o vseh morebitnih spremembah, ki jih namerava narediti, glede na dovoljenje, v ostalih podrobnih podatkih in dokumentaciji iz člena 12 in 13(1).
English: Article 28
Slovenian: Člen 28
English: Authorization shall be valid for five years and shall be renewable for five-year periods, on application by the holder at least three months before the expiry date and after consideration of a dossier updating the information previously submitted.
Slovenian: Dovoljenje velja pet let in ga je treba podaljšati vsakih pet let z vlogo, ki jo mora imetnik dovoljenja vložiti najmanj tri mesece pred datumom izteka in potem, ko se preveri dokumentacija, ki dopolnjuje predhodno predložene podatke.
English: The granting of authorization shall not diminish the general legal liability of the manufacturer and, where appropriate, of the authorization holder.
Slovenian: Izdaja dovoljenja ne sme zmanjšati splošne pravne odgovornosti izdelovalca in, kjer je to ustrezno, imetnika dovoljenja.
English: The marketing authorization shall be withheld if examination of the documents and particulars listed in Articles 12 and 13(1) establishes that:
Slovenian: Izdaja dovoljenja za promet z zdravilom se zavrne, če se s preverjanjem dokumentacije ter podrobnih podatkov, navedenih v členih 12 in 13(1) ugotovi, da:
English: the veterinary medical product is harmful under the conditions of use stated at the time of application for authorization;
Slovenian: je zdravilo za uporabo v veterinarski medicini škodljivo pod pogoji uporabe, ki so bili določeni v času vložitve vloge za pridobitev dovoljenja;
English: has no therapeutic effect or the applicant has not provided sufficient proof of such effect as regards the species of animal which is to be treated;
Slovenian: nima nobenega terapevtskega učinka ali pa predlagatelj ni predložil zadostnih dokazov za tak učinek za živalsko vrsto, ki bo zdravljena;
English: its qualitative or quantitative composition is not as stated;
Slovenian: kakovostna in količinska sestava ni enaka deklarirani;
English: the withdrawal period recommended by the applicant is not long enough to ensure that foodstuffs obtained from the treated animal do not contain residues which might constitute a health hazard to the consumer, or is insufficiently substantiated;
Slovenian: karenca, ki jo priporoča predlagatelj, ni dovolj dolga, da bi zagotovila, da živila, pridobljena iz zdravljenih živali ne bodo vsebovala zaostankov, ki bi lahko predstavljali tveganje za zdravje potrošnika, ali pa ni dovolj utemeljena;
English: the veterinary medicinal product is offered for sale for a use prohibited under other Community provisions.
Slovenian: se zdravilo za uporabo v veterinarski medicini daje v promet za uporabo, ki je prepovedana z 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 health, consumer or animal health.
Slovenian: Vendar pa, odvisno od pravil Skupnosti, lahko pristojni organi zavrnejo izdajo dovoljenja za promet z zdravilom za uporabo v veterinarski medicini, če je to potrebno za zavarovanje javnega zdravja, potrošnikov ali zdravje živali.
English: Authorization shall also be withheld if the application documents submitted to the competent authorities do not comply with Articles 12, 13(1) and 15.
Slovenian: Izdaja dovoljenja se prav tako lahko zavrne, če vložena dokumentacija, predložena pristojnim organom, ni v skladu z določili členov 12, 13(1) in 15.
English: CHAPTER 4
Slovenian: POGLAVJE 4
English: Mutual recognition of authorizations
Slovenian: Medsebojno priznavanje dovoljenj za promet z zdravili
English: In order to facilitate the adoption of common decisions by Member States on the authorization of veterinary medicinal products on the basis of the scientific criteria of quality, safety and efficacy, and to achieve thereby the free movement of veterinary medicinal products within the Community, a Committee for Veterinary Medicinal Products, hereinafter referred to as "the Committee", is hereby set up.
Slovenian: Da bi se omogočilo sprejemanje enotnih odločitev držav članic glede dovoljenja za promet z zdravili za uporabo v veterinarski medicini na podlagi znanstvenih meril o kakovosti, varnosti in učinkovitosti, in da bi s tem dosegli prost pretok zdravil za uporabo v veterinarski medicini znotraj skupnosti, se ustanovi Odbor za veterinarska zdravila, v nadaljnjem besedilu "odbor".
English: The Committee shall be part of the Agency.
Slovenian: Odbor je del agencije.
English: In addition to the other responsibilities conferred upon it by Community law, the Committee shall examine any question relating to the granting, variation, suspension or withdrawal of marketing authorization which is submitted to it in accordance with the provisions of this Directive.
Slovenian: Poleg ostalih odgovornosti, ki mu jih nalaga zakon Skupnosti, mora odbor preučiti vsa vprašanja z zvezi z izdajo, spremembo, preklicem veljavnosti ali ukinitvijo dovoljenja za promet z zdravilom, ki so odboru predložena v skladu z določili te direktive.
English: It shall also examine any question relating to tests of veterinary medicinal products.
Slovenian: Odbor mora prav tako preučiti vsa vprašanja, ki zadevajo preskušanje zdravil za uporabo v veterinarski medicini.
English: The Committee shall adopt its own rules of procedure.
Slovenian: Odbor sprejme svoj poslovnik.
English: Article 32
Slovenian: Člen 32
English: Before submitting an application for mutual recognition of marketing authorizations, the holder of the authorization shall inform the Member State which granted the authorization on which the application is based (hereinafter:
Slovenian: Pred vložitvijo vloge za medsebojno priznavanje dovoljenja za promet z zdravilom, mora imetnik dovoljenja obvestiti državo članico, ki mu je izdala dovoljenje, na katerem temelji vloga (v nadaljnjem besedilu:
English: the reference Member State) that an application is to be made in accordance with this Directive and shall notify it of any additions to the original dossier;
Slovenian: referenčna država članica), da namerava vložiti vlogo v skladu s to direktivo in jo mora obvestiti o morebitnih dodatkih k osnovni dokumentaciji;
English: that Member State may require the applicant to provide it with all the particulars and documents necessary to enable it to check that the dossiers filed are identical.
Slovenian: ta država članica lahko zahteva od predlagatelja, da ji predloži podrobne podatke ter potrebno dokumentacijo, s pomočjo katere je možno preveriti, da sta obe dokumentaciji identični.
English: In addition, the holder of the authorization shall request the reference Member State which granted the initial authorization to prepare an assessment report in respect of the veterinary medicinal product concerned, or, if necessary, to update it.
Slovenian: Poleg tega mora imetnik dovoljenja zaprositi referenčno državo članico, ki je izdala prvo dovoljenje, da pripravi poročilo o oceni zdravila za zadevno zdravilo za uporabo v veterinarski medicini, ali če je to potrebno, da ga dopolni.
English: That Member State shall prepare it within 90 days of receipt of the request.
Slovenian: Ta država članica ga mora pripraviti v roku 90 dni po prejemu zahtevka.
English: At the same time as the application is submitted in accordance with paragraph 2 the reference Member Sate which granted the initial authorization shall forward the assessment report to the Member State or Member States concerned by the application.
Slovenian: Istočasno, ko je vloga vložena v skladu z odstavkom 2, mora referenčna država članica, ki je izdala prvo dovoljenje, poslati poročilo o oceni zdravila zadevni državi članici ali državam članicam.
English: In order to obtain the recognition according to the procedure laid down in this Chapter in one or more of the Member States of a marketing authorization issued by a Member State, the holder of the authorization shall submit an application to the competent authority of the Member State or Member States concerned, together with the information and particulars referred to in Articles 12, 13(1), 14 and 25.
Slovenian: Da bi se priznalo dovoljenja za promet z zdravilom, ki ga je izdala država članica, v eni ali več državah članicah po postopku, ki ga določa to poglavje mora imetnik dovoljenja vložiti vlogo pri pristojnemu organu države članice ali zadevnih državah članicah skupaj z informacijami in podrobnimi podatki iz členov 12, 13(1), 14 in 25.
English: He shall testify that the dossier is identical to that accepted by the reference Member State, or shall identify any additions or amendments it may contain.
Slovenian: Imetnik mora izjaviti, da je dokumentacija identična tisti, ki jo je sprejela referenčna država članica, ali pa mora opisati vse dodatke ali spremembe, ki jih dokumentacija vsebuje.
English: In the latter case, he shall certify that the summary of the product characteristics proposed by him in accordance with Article 14 is identical to that accepted by the reference Member State in accordance with Article 25.
Slovenian: V slednjem primeru mora imetnik potrditi, da je v skladu s členom 14 predlagani povzetek glavnih značilnosti zdravila identičen tistemu, ki ga je sprejela referenčna država članica v skladu s členom 25.
English: Moreover, he shall certify that all the dossiers filed as part of this procedure are identical.
Slovenian: Poleg tega mora imetnik potrditi, da je dokumentacija, ki je bila vložena kot del postopka, identična.
English: The holder of the marketing authorization shall transmit the application to the Agency, inform it of the Member States concerned and of the dates of submission of the application and send it a copy of the authorization granted by the reference Member State.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora poslati vlogo agenciji, jo obvestiti o zadevnih državah članicah ter o datumih vloge za pridobitev dovoljenja ter ji poslati kopijo dovoljenja za promet z zdravilom, ki ga je izdala referenčna država članica.
English: He shall also send the Agency copies of any such authorization which may have been granted by the other Member States in respect of the veterinary medicinal product concerned, and shall indicate whether any application for authorization is currently under consideration in any Member State.
Slovenian: Prav tako mora imetnik poslati agenciji kopije dovoljenj, ki so jih za zadevno zdravilo za uporabo v veterinarski medicini izdale druge države članice ter navesti, ali je morebiti kaka vloga za pridobitev dovoljenja trenutno v postopku v kateri od držav članic.
English: Save in the exceptional case provided for in Article 33(1), each Member State shall recognise the marketing authorization granted by the reference Member State within 90 days of receipt of the application and the assessment report.
Slovenian: Razen v izjemnem primeru, predvidenem v členu 33(1), mora vsaka država članica priznati dovoljenje za promet z zdravilom, ki ga je izdala referenčna država članica v roku 90 dni od prejema vloge in poročila o oceni zdravila.
English: It shall inform the reference Member State, the other Member States concerned by the application, the Agency, and the holder of the authorization for placing the product on the market.
Slovenian: Obvestiti mora referenčno državo članico, ostale države članice, ki jih vloga zadeva, agencijo in imetnika o izdaji dovoljenja za promet z zdravilom.
English: Article 33
Slovenian: Člen 33
English: Where a Member State considers that there are grounds for supposing that the marketing authorization of the veterinary medicinal product concerned may present a risk to human or animal health or the environment, it shall forthwith inform the applicant, the reference Member State, any other Member States concerned by the application and the Agency.
Slovenian: Če država članica meni, da obstaja dvom, da bi lahko izdaja dovoljenja za promet z zdravilom za uporabo v veterinarski medicini predstavljala tveganje za zdravje človeka ali živali ali za okolje, mora nemudoma o tem obvestiti predlagatelja, referenčno državo članico, ostale države članice, ki jih taka vloga zadeva ter agencijo.
English: The Member State shall state its reason in detail and shall indicate what action may be necessary to correct any defect in the application.
Slovenian: Država članica mora navesti podrobne razloge ter nakazati ukrepe, ki bi bili potrebni za odpravo napake v vlogi.
English: All the Member States concerned shall use their best endeavours to reach agreement on the action to be taken in respect of the application.
Slovenian: Vse zadevne države članice morajo po svojih najboljših močeh doseči soglasje o potrebnih ukrepih v zvezi z vlogo.
English: They shall provide the applicant with the opportunity to make his point of view known orally or in writing.
Slovenian: Predlagatelju morajo omogočiti, da poda svoje mnenje ustno ali pisno.
English: However, if the Member States have not reached agreement within the time-limit referred to in Article 32(4) they shall forthwith refer the matter to the Agency, for referral to the Committee, for the application of the procedure laid down in Article 36.
Slovenian: Vendar pa, če države članice ne dosežejo soglasja v roku iz člena 32(4), morajo nemudoma odstopiti zadevo agenciji, da se vlogo preda odboru v postopek, določen v členu 36.
English: Within the time-limit referred to in Article 32(4), the Member States concerned shall provide the Committee with a detailed statement of the matters on which they have been unable to reach agreement and the reasons for their disagreement.
Slovenian: Znotraj roka iz člena 32(4), morajo zadevne države članice odboru podrobno navesti zadevo, glede katere niso mogle doseči soglasja ter razloge za to.
English: The applicant shall be provided with a copy of this information.
Slovenian: Predlagatelj mora prejeti kopijo teh podatkov.
English: As soon as he is informed that the matter has been referred to the Committee, the applicant shall forthwith forward to the Committee a copy of the information and particulars referred to in Article 32(2).
Slovenian: Takoj ko je predlagatelj obveščen, da je bila zadeva predana odboru, mora odboru nemudoma poslati kopijo podatkov ter ostale podrobne podatke iz člena 32(2).
English: If several applications submitted in accordance with Articles 12, 13(1) and 14 have been made for marketing authorization for a particular veterinary medicinal product and Member States have adopted divergent decisions concerning the authorization of that veterinary medicinal product, or suspension or withdrawal of that authorization, a Member State, or the Commission, or the marketing authorization holder may refer the matter to the Committee for application of the procedure laid down in Article 36.
Slovenian: V primeru, da je bilo vloženih več vlog za pridobitev dovoljenj za promet z določenim zdravilom za uporabo v veterinarski medicini v skladu s členom 12, 13(1) in 14 in če so države članice sprejele različne odločitve glede izdaje dovoljenja za promet z zdravilom za uporabo v veterinarski medicini, ali preklica dovoljenja ali ukinitve dovoljenja, lahko država članica, ali Komisija, ali imetnik dovoljenja za promet z zdravilom predloži zadevo odboru za obravnavo po postopku, določenem v členu 36.
English: The Member State concerned, the marketing authorization holder or the Commission shall clearly identify the question which is referred to the Committee for consideration and, if appropriate, shall inform the aforementioned holder thereof.
Slovenian: Zadevna država članica, imetnik dovoljenja, ali Komisija morajo jasno navesti vprašanje, ki ga naslavljajo odboru v obravnavo ter če je to ustrezno, obvestiti poprej imenovanega imetnika.
English: The Member States and the marketing authorization holder shall forward to the Committee all available information relating to the matter in question.
Slovenian: Države članice ter imetnik dovoljenja za promet z zdravilom morajo predložiti odboru vse podatke, ki jih imajo na voljo o zadevnem vprašanju.
English: The Member States or the Commission or the applicant or holder of the marketing authorization may, in specific cases where the interests of the Community are involved, refer the matter to the Committee for the application of the procedure laid down in Article 36 before reaching a decision on a request for a marketing authorization or on the suspension or withdrawal of an authorization, or on any other variations to the terms of a marketing authorization which appears necessary, in particular to take account of the information collected in accordance with Title VII.
Slovenian: Države članice ali odbor, ali predlagatelj ali pa imetnik dovoljenja za promet z zdravilom lahko v določenih primerih, kjer za to obstaja interes Skupnosti, predajo zadevo odboru za obravnavo po postopku, določenem v členu 36, preden je sprejeta odločitev o vlogi za pridobitev dovoljenja za promet z zdravilom, ali preklicu dovoljenja ali o ukinitvi dovoljenja, ali katera koli druga sprememba pogojev glede dovoljenja za promet z zdravilom, ki se izkaže kot nujna, še posebno ob upoštevanju podatkov, pridobljenih v skladu z naslovom VII.
English: The Member State concerned or the Commission shall clearly identify the question which is referred to the Committee for consideration and shall inform the marketing authorization holder.
Slovenian: Zadevne države članice ali Komisija morajo jasno opredeliti vprašanje, predano v obravnavo odboru in morajo o tem obvestiti imetnika dovoljenja za promet z zdravilom.
English: The Member States and the holder shall forward to the Committee all available information relating to the matter in question.
Slovenian: Države članice in imetnik dovoljenja morajo odboru predati vse razpoložljive podatke, ki se nanašajo na zadevo.
English: When reference is made to the procedure described in this Article, the Committee shall consider the matter concerned and issue a reasoned opinion within 90 days of the date on which the matter was referred to it.
Slovenian: Kadar se sklicuje na postopek, opisan v tem členu, mora odbor obravnavati zadevo ter izdati obrazloženo mnenje v roku 90 dni od datuma, ko mu je bila zadeva predana.
English: However, in cases submitted to the Committee in accordance with Articles 34 and 35, this period may be extended by 90 days.
Slovenian: Vendar pa se lahko v primerih, ko so bile zadeve odboru predane v skladu s členoma 34 in 35, ta doba podaljša za 90 dni.