FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: In case of urgency, on a proposal from its Chairman, the Committee may agree to a shorter deadline.
Slovenian: V nujnih primerih, če tako predlaga predsednik, se lahko odbor odloči za krajši rok.
English: In order to consider the matter, the Committee may appoint one of its members to act as rapporteur.
Slovenian: Za obravnavo zadeve lahko odbor imenuje enega svojih članov, da prevzame vlogo poročevalca.
English: The Committee may also appoint individual experts to advise it on specific questions.
Slovenian: Prav tako lahko odbor imenuje posamezne strokovnjake za svetovanje glede specifičnih vprašanj.
English: When appointing experts, the Committee shall define their tasks and specify the time-limit for the completion of these tasks.
Slovenian: Pri imenovanju izvedencev mora odbor opredeliti njihove naloge ter določiti časovni okvir za izvedbo nalog.
English: In the cases referred to in Articles 33 and 34, before issuing its opinion, the Committee shall provide the marketing authorization holder with an opportunity to present written or oral explanations.
Slovenian: V zadevah iz členov 33 in 34, mora odbor pred izdajo mnenja imetniku dovoljenja za promet z zdravilom omogočiti, da poda ustno ali pisno izjavo.
English: In the case referred to in Article 35, the marketing authorization holder may be asked to explain himself orally or in writing.
Slovenian: V primeru iz člena 35, se lahko od imetnika dovoljenja za promet z zdravilom zahteva, da poda svoje mnenje ustno ali v pisni obliki.
English: If it considers it appropriate, the Committee may invite any other person to provide information relating to the matter before it.
Slovenian: Če se odboru zdi potrebno, lahko povabi katero koli drugo osebo, da pred odborom poda podatke za razjasnitev zadeve.
English: The Committee may suspend the time-limit referred to in paragraph 1 in order to allow the marketing authorization holder to prepare explanations.
Slovenian: Odbor lahko odloži rok iz prvega odstavka zato, da bi imetnik dovoljenja za promet z zdravilom lahko pripravil obrazložitve.
English: The Agency shall forthwith inform the marketing authorization holder where the opinion of the Committee is that:
Slovenian: Agencija mora nemudoma obvestiti imetnika dovoljenja za promet z zdravilom v primeru, če je mnenje odbora da:
English: the application does not satisfy the criteria for authorization, or
Slovenian: vloga ne ustreza merilom za pridobitev dovoljenja, ali
English: the summary of the product characteristics proposed by the applicant in accordance with Article 14 should be amended, or
Slovenian: je treba povzetek glavnih značilnosti zdravila, ki ga v skladu s členom 14 predlaga predlagatelj dopolniti, ali
English: the authorization should be granted subject to conditions, with regard to conditions considered essential for the safe and effective use of the veterinary medicinal product including pharmacovigilance, or
Slovenian: je treba izdati dovoljenje ob upoštevanju pogojev, ki se zdijo bistveni za varno in učinkovito uporabo zdravila za uporabo v veterinarski medicini, vključno s farmakovigilanco, ali
English: a marketing authorization should be suspended, varied or withdrawn.
Slovenian: je treba dovoljenju za promet z zdravilom preklicati veljavnost, ga spremeniti ali ukiniti.
English: Within 15 days of the receipt of the opinion, the holder may notify the Agency in writing of his intention to appeal.
Slovenian: V roku 15 dni od prejema mnenja lahko imetnik v pisni obliki obvesti agencijo, da namerava vložiti pritožbo.
English: In that case, he shall forward the detailed grounds for appeal to the Agency within 60 days of receipt of the opinion.
Slovenian: V tem primeru mora 60 dni od prejema mnenja sporočiti agenciji podrobne razloge za pritožbo.
English: Within 60 days of receipt of the grounds for appeal, the Committee shall consider whether its opinion should be revised, and the conclusions reached on the appeal shall be annexed to the assessment report referred to in paragraph 5.
Slovenian: Odbor mora v roku 60 dni po prejemu razlogov za pritožbo ugotoviti, ali je treba mnenje revidirati in mora sklepe, sprejete na pritožbo, priložiti k poročilu o oceni zdravila iz odstavka 5.
English: Within 30 days of its adoption, the Agency shall forward the final opinion of the Committee to the Member States, the Commission and the marketing authorization holder together with a report describing the assessment of the veterinary medicinal product and the reasons for its conclusions.
Slovenian: V roku 30 dni od sprejema mnenja, mora agencija poslati končno mnenje odbora državam članicam, Komisiji ter imetniku dovoljenja za promet z zdravilom, skupaj s poročilom, ki vsebuje opis ocene zdravila za uporabo v veterinarski medicini ter z obrazložitvijo svojih sklepov.
English: In the event of an opinion in favour of granting or maintaining an authorization to place the veterinary medicinal product concerned on the market, the following documents shall be annexed to the opinion:
Slovenian: V primeru, da je bilo mnenje v prid izdaji ali vzdrževanju dovoljenja za promet zdravila za uporabo v veterinarski medicini, morajo biti k mnenju priloženi naslednji dokumenti:
English: a draft summary of the product characteristics, as referred to in Article 14;
Slovenian: osnutek povzetka glavnih značilnosti zdravila, kakor je opredeljeno v členu 14;
English: where necessary this will reflect differences in the veterinary conditions pertaining in the Member States;
Slovenian: po potrebi bo ta odražal razlike v veterinarskih pogojih, ki veljajo v državah članicah;
English: any conditions affecting the authorization within the meaning of paragraph 4.
Slovenian: katere koli pogoje, ki bi lahko imeli vpliv na dovoljenje v smislu odstavka 4.
English: Article 37
Slovenian: Člen 37
English: Within 30 days of receipt of the opinion, the Commission shall prepare a draft of the decision to be taken in respect of the application, taking into account Community law.
Slovenian: V roku 30 dni od prejema mnenja, mora Komisija pripraviti osnutek odločbe v zvezi z vlogo, upoštevajoč zakonodajo Skupnosti.
English: In the event of a draft decision which envisages the granting of marketing authorization, the documents referred to in Article 36(5)(2), (a) and (b) shall be annexed.
Slovenian: Če osnutek odločbe predvideva izdajo dovoljenja za promet z zdravilom, je treba priložiti dokumente iz člena 36(5)(2), (a) in (b).
English: Where, exceptionally, the draft decision is not in accordance with the opinion of the Agency, the Commission shall also annex a detailed explanation of the reasons for the differences.
Slovenian: V izjemnem primeru, da osnutek odločbe ni v skladu z mnenjem agencije, mora Komisija priložiti podrobno obrazložitev za razlike.
English: The draft decision shall be forwarded to the Member States and the applicant.
Slovenian: Osnutek odločbe je treba poslati državam članicam ter predlagatelju.
English: Article 38
Slovenian: Člen 38
English: A final decision on the application shall be adopted in accordance with the procedure referred to in Article 89(2).
Slovenian: Končna odločba o vlogi mora biti sprejeta v skladu s postopkom iz člena 89(2).
English: The rules of procedure of the Standing Committee set up by Article 89(1) shall be adjusted to take account of the tasks incumbent upon it in accordance with this Chapter.
Slovenian: Poslovnik Stalnega odbora, ustanovljenega s členom 89(1), mora biti prilagojen nalogam, ki so mu naložene v skladu s tem poglavjem.
English: These adjustments shall involve the following:
Slovenian: Te prilagoditve morajo vključevati naslednje:
English: except in cases referred to in the third paragraph of Article 37, the opinion of the Standing Committee shall be obtained in writing,
Slovenian: z izjemo primerov iz tretjega odstavka člena 37, mora biti mnenje Stalnega odbora v pisni obliki,
English: each Member State is allowed at least 28 days to forward written observations on the draft decision of the Commission,
Slovenian: vsaka država članica ima na voljo najmanj 28 dni, da v pisni obliki pošlje odboru svoje pripombe na osnutek odločbe Komisije,
English: each Member State is able to require in writing that the draft decision be discussed by the Standing Committee, giving its reasons in detail.
Slovenian: vsaka država članica lahko v pisni obliki, s podrobno obrazložitvijo razlogov, predloži zahtevo, da osnutek odločbe obravnava Stalni odbor.
English: Where, in the opinion of the Commission, the written observations of a Member State raise important new questions of a scientific or technical nature which have not been addressed in the opinion of the Agency, the Chairman shall suspend the procedure and refer the application back to the Agency for further consideration.
Slovenian: V primeru, če po mnenju Komisije zapisana opažanja države članice zastavijo nova pomembna vprašanja znanstvene ali tehnične narave, ki niso bila obravnavana v mnenju agencije, mora predsednik začasno prekiniti postopek ter vlogo vrniti agenciji v nadaljnjo obravnavo.
English: The provisions necessary for the implementation of this paragraph shall be adopted by the Commission in accordance with the procedure referred to in Article 89(2).
Slovenian: Zahteve, potrebne za izvajanje tega odstavka, mora Komisija sprejeti v skladu s postopkom iz člena 89(2).
English: A decision as referred to in paragraph 1 shall be addressed to the Member States concerned by the matter and communicated to the marketing authorization holder.
Slovenian: Odločba, kakor je opredeljena v odstavku 1, mora biti naslovljena na države članice, ki jih ta problem zadeva ter posredovan imetniku dovoljenja za promet z zdravilom.
English: The Member States shall either grant or withdraw marketing authorization, or vary the terms of a marketing authorization as necessary to comply with the decision within 30 days of its notification.
Slovenian: Države članice morajo zaradi uskladitve z odločbo v roku 30 dni po uradnem obvestilu ali izdati dovoljenje ali ga ukiniti, ali po potrebi spremeniti določbe dovoljenja za promet z zdravilom.
English: They shall inform the Commission and the Agency thereof.
Slovenian: O tem morajo obvestiti Komisijo in agencijo.
English: Article 39
Slovenian: Člen 39
English: Any application by the marketing authorization holder to vary a marketing authorization which has been granted in accordance with the provisions of this Chapter shall be submitted to all the Member States which have previously authorized the veterinary medicinal product concerned.
Slovenian: Vsaka vloga imetnika dovoljenja za promet z zdravilom za spremembo dovoljenja, ki je bilo izdano v skladu z določili tega poglavja, mora biti posredovana vsem državam članicam, ki so predhodno izdale dovoljenje za zadevno zdravilo za uporabo v veterinarski medicini.
English: The Commission shall, in consultation with the Agency, adopt appropriate arrangements for the examination of variations to the terms of a marketing authorization.
Slovenian: Po posvetu z agencijo mora Komisija sprejeti ustrezne dogovore za preučitev sprememb pogojev dovoljenja za promet z zdravilom.
English: These arrangements shall include a notification system or administration procedures concerning minor variations and define precisely the concept of "a minor variation".
Slovenian: Dogovori morajo vsebovati sistem notifikacije ali upravne postopke, ki se nanašajo na manjše spremembe ter natančno opredelitev pojma "manjša sprememba".
English: These arrangements shall be adopted by the Commission in the form of an implementing regulation in accordance with the procedure referred to in Article 89(2).
Slovenian: Dogovore mora sprejeti Komisija v obliki izvedbenega predpisa v skladu s postopkom iz člena 89(2).
English: In case of arbitration submitted to the Commission, the procedure laid down in Articles 36, 37 and 38 shall apply by analogy to variations made to marketing authorizations.
Slovenian: V primeru arbitraže, ki je bila naslovljena na Komisijo, se mora za spremembe dovoljenja za promet z zdravilom analogno uporabiti postopek, določen v členih 36, 37 in 38.
English: Article 40
Slovenian: Člen 40
English: Where a Member State considers that the variation of the terms of a marketing authorization which has been granted in accordance with the provisions of this Chapter or its suspension or withdrawal is necessary for the protection of human or animal health or the environment, the Member State concerned shall forthwith refer the matter to the Agency for the application of the procedures laid down in Articles 36, 37 and 38.
Slovenian: Če država članica meni, da je treba spremeniti pogoje dovoljenja za promet z zdravilom, izdanega v skladu z določili tega poglavja, ali pa da sta potrebna preklic ali ukinitev dovoljena zaradi zavarovanja zdravja človeka ali živali ali okolja, mora zadevna država članica zadevo nemudoma predati agenciji v obravnavo po postopku, določenem v členih 36, 37 ter 38.
English: Without prejudice to the provisions of Article 35, in exceptional cases, where urgent action is essential to protect human or animal health or the environment, until a definitive decision is adopted, a Member State may suspend the marketing and the use of the veterinary medicinal product concerned on its territory.
Slovenian: Brez poseganja v določila člena 35, lahko v izjemnih primerih, kjer so potrebni nujna ukrepi za zavarovanje zdravja človeka ali živali ali okolja, in dokler ni sprejeta dokončna odločitev, država članica na svojem območju začasno ustavi promet in uporabo zadevnih zdravil za uporabo v veterinarski medicini.
English: It shall inform the Commission and the other Member States no later than the following working day of the reasons for its action.
Slovenian: O razlogih za te ukrepe mora obvestiti Komisijo ter ostale države članice najpozneje naslednji delovni dan.
English: Article 41
Slovenian: Člen 41
English: Articles 39 and 40 shall apply by analogy to veterinary medicinal products authorized by Member States following an opinion of the Committee given in accordance with Article 4 of Directive 87/22/EEC before 1 January 1995.
Slovenian: Člena 39 in 40 se smiselno uporabljata za zdravila za uporabo v veterinarski medicini, za katera so države članice izdale dovoljenje na podlagi mnenja odbora podanega pred 1. januarjem 1995 v skladu s členom 4 direktive 87/22/EGS.
English: Article 42
Slovenian: Člen 42
English: The Agency shall publish an annual report on the operation of the procedures laid down in this Chapter and shall forward it to the European Parliament and the Council for information.
Slovenian: Agencija mora izdati letno poročilo o izvajanju postopkov, določeno v tem poglavju, in ga posredovati v vednost Evropskemu parlamentu ter Svetu.
English: By 1 January 2001, the Commission shall publish a detailed review of the operation of the procedures laid down in this Chapter and shall propose any amendments which may be necessary to improve these procedures.
Slovenian: Do 1. januarja 2001 mora Komisija objaviti podrobno oceno o izvajanju postopkov, določenih v tem poglavju, in predlagati spremembe, potrebne za izboljšanje postopkov.
English: The Council shall decide, under the conditions provided for in the Treaty, on the Commission proposal within one year of its submission.
Slovenian: Svet mora pod pogoji, predvidenimi v Pogodbi, o predlogu Komisije odločiti v enem letu po predložitvi predloga.
English: Article 43
Slovenian: Člen 43
English: The provisions of Articles 31 to 38 shall not apply to homeopathic veterinary medicinal products referred to in Article 19(2).
Slovenian: Določila členov 31 do 38 se ne uporabljajo za homeopatska zdravila za uporabo v veterinarski medicini iz člena 19(2).
English: TITLE IV
Slovenian: NASLOV IV
English: MANUFACTURE AND IMPORTS
Slovenian: IZDELAVA IN UVOZ
English: Article 44
Slovenian: Člen 44
English: Member States shall take all appropriate measures to ensure that the manufacture of veterinary medicinal products in their territory is subject to the holding of an authorization.
Slovenian: Države članice morajo sprejeti vse ustrezne ukrepe da bi zagotovile, da se zdravila za uporabo v veterinarski medicini na njihovem ozemlju izdelujejo le na podlagi dovoljenja.
English: This manufacturing authorization shall likewise be required for veterinary medicinal products intended for export.
Slovenian: Podobno, se dovoljenje za izdelavo zahteva tudi za zdravila za uporabo v veterinarski medicini, namenjena za izvoz.
English: The authorization referred to in paragraph 1 shall be required both for total and partial manufacture and for the various processes of dividing up, packaging or presentation.
Slovenian: Dovoljenje iz odstavka 1, se zahteva za celoten in del postopka izdelave ter za različne postopke delitve zdravila na manjše enote, pakiranja ali opremljanja zdravila.
English: However, such authorization shall not be required for preparation, dividing up, changes in packaging or presentation where these processes are carried out solely for retail supply by pharmacists in dispensing pharmacies or by persons legally authorized in the Member States to carry out such processes.
Slovenian: Vendar pa tako dovoljenje ni potrebno za pripravo, delitev zdravila na manjše enote, spremembe v pakiranju ali opremljanju zdravil v primeru, ko se te postopke izključno za promet na drobno izvajajo farmacevti v lekarnah ali osebe, ki so v državah članicah pooblaščene za izvajanje takih postopkov.
English: The authorization referred to in paragraph 1 shall also be required for imports from third countries into a Member State;
Slovenian: Dovoljenje iz odstavka 1 se prav tako zahteva za uvoz iz tretjih držav v državo članico;
English: this Title and Article 83 shall apply to such imports in the same way as to manufacture.
Slovenian: pri takem uvozu je treba uporabiti ta naslov ter člen 83 na isti način kot pri izdelavi.
English: Member States shall take all appropriate measures to ensure that veterinary medicinal products brought into their territory from a third country and destined for another Member State are accompanied by a copy of the authorization referred to in paragraph 1.
Slovenian: Države članice morajo sprejeti ustrezne ukrepe, da zagotovijo, da bo zdravila za uporabo v veterinarski medicini, ki so vnesena na njihovo ozemlje iz tretje države in ki so namenjena drugi državi članici, spremljala kopija dovoljenja iz prvega odstavka.
English: Article 45
Slovenian: Člen 45
English: In order to obtain the manufacturing authorization, the applicant shall meet at least the following requirements:
Slovenian: Za pridobitev dovoljenja za izdelavo mora predlagatelj zadostiti najmanj naslednjim zahtevam:
English: he shall specify the veterinary medicinal products and pharmaceutical forms which are to be manufactured or imported and also the place where they are to be manufactured and/or controlled;
Slovenian: specificirati mora zdravila za uporabo v veterinarski medicini ter farmacevtske oblike, ki se bodo izdelovale ali uvažale ter tudi mesto, kjer naj bi se izdelovale in/ali kontrolirale;
English: he shall have at his disposal, for the manufacture or import of the above, suitable and sufficient premises, technical equipment and control facilities complying with the legal requirements which the Member State concerned lays down as regards both manufacture and control and the storage of products, in accordance with Article 24;
Slovenian: za izdelavo ali uvoz zgoraj navedenega morajo imeti na razpolago primerne in zadostne prostore, tehnično opremo ter kontrolne zmogljivosti, ki so v skladu s pravnimi zahtevami, ki jih je zadevna država članica predpisala za izdelavo in nadzor ter za shranjevanje zdravil v skladu s členom 24;
English: he shall have at his disposal the services of at least one qualified person within the meaning of Article 52.
Slovenian: na voljo mora imeti z najmanj eno, v smislu člena 52 usposobljeno osebo.
English: The applicant shall provide particulars in his application to establish his compliance with the above requirements.
Slovenian: Predlagatelj mora v vlogi podati podrobne podatke, s katerimi dokaže, da ustreza zgoraj navedenim zahtevam.
English: Article 46
Slovenian: Člen 46
English: The competent authority of the Member State shall not issue the manufacturing authorization until it has established the accuracy of the particulars supplied pursuant to Article 45 by means of an inquiry carried out by its representatives.
Slovenian: Pristojni organ države članice ne sme izdati dovoljenja za izdelavo vse dokler predstavniki pristojnega organa ne opravijo pregleda, s katerim se ugotavlja točnost podrobnih posredovanih podatkov iz člena 45.
English: In order to ensure that the requirements referred to in Article 45 are complied with, authorization may be made conditional on the fulfilment of certain obligations imposed either when authorization is granted or at a later date.
Slovenian: Da bi zagotovili, da so zahteve iz člena 45 izpolnjene, se lahko izda dovoljenje pod pogojem, da so izpolnjene določene naložene obveznosti, bodisi ob izdaji dovoljenja ali pa pozneje.
English: The authorization shall apply only to the premises specified in the application and to the veterinary medicinal products and pharmaceutical forms specified in that application.
Slovenian: Dovoljenje se sme nanašati samo na poslovne prostore, ki so specificirani v vlogi ter na zdravila za uporabo v veterinarski medicini ter farmacevtske oblike, ki so opredeljena v vlogi.
English: Article 47
Slovenian: Člen 47
English: The Member States shall take all appropriate measures to ensure that the time taken for the procedure for granting the manufacturing authorization does not exceed 90 days from the day on which the competent authority receives the application.
Slovenian: Države članice morajo sprejeti ustrezne ukrepe, da bi zagotovile, da čas, potreben za postopek za izdajo dovoljenja ne preseže 90 dni od dneva, ko je pristojni organ prejel vlogo.
English: Article 48
Slovenian: Člen 48
English: If the holder of the manufacturing authorization requests a change in any of the particulars referred to in Article 45, first paragraph, (a) and (b), the time taken for the procedure relating to this request shall not exceed 30 days.
Slovenian: Če imetnik dovoljena za izdelavo zahteva spremembo katere koli podrobnosti iz (a) in (b) prvega odstavka člena 45 čas za postopek, ki se nanaša na to vlogo, ne sme biti daljši od 30 dni.
English: In exceptional cases, this period of time may be extended to 90 days.
Slovenian: V izjemnih primerih se lahko ta doba podaljša na 90 dni.
English: Article 49
Slovenian: Člen 49
English: The competent authority of the Member States may require from the applicant further information concerning both the particulars supplied pursuant to Article 45 and the qualified person referred to in Article 52;
Slovenian: Pristojni organ države članice lahko zahteva od predlagatelja nadaljnje podatke, tako glede podrobnih podatkov v skladu s členom 45, kakor glede usposobljene osebe iz člena 52;
English: where the competent authority concerned exercises this right, application of the time-limits referred to in Articles 47 and 48 shall be suspended until the additional data required have been supplied.
Slovenian: v primeru, da zadevni pristojni organ uveljavi to pravico, se lahko roki iz členov 47 in 48 začasno prekinejo, dokler se ne pridobijo zahtevani dodatni podatki.
English: Article 50
Slovenian: Člen 50
English: The holder of a manufacturing authorization shall at least be obliged to:
Slovenian: Imetnik dovoljenja za izdelavo mora izpolnjevati najmanj:
English: have at his disposal the services of staff complying with the legal requirements existing in the Member State concerned as regards both manufacture and controls;
Slovenian: da ima na voljo storitve osebja v skladu s pravnimi zahtevami v zadevni državi članici za izdelavo in kontrolo;
English: dispose of the authorized veterinary medicinal products only in accordance with the legislation of the Member States concerned;
Slovenian: da razpolaga z zdravili za uporabo v veterinarski medicini z dovoljenjem za promet samo v skladu z zakonodajo zadevne države članice;