FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: In order to examine the application submitted in accordance with Articles 8 and 10(1), the competent authority of the Member State:
Slovenian: Za preučitev vloge, predložene v skladu s členi 8 in 10(1), pristojni organ države članice:
English: must verify whether the particulars submitted in support of the application comply with the said Articles 8 and 10(1) and examine whether the conditions for issuing an authorization to place medicinal products on the market (marketing authorization) are complied with.
Slovenian: mora preveriti, ali so podrobni podatki, predloženi v vlogi v skladu s členoma 8 in 10(1) in preučiti, če so izpolnjeni pogoji za izdajo dovoljenja za dajanje zdravila v promet (dovoljenje za promet z zdravilom).
English: may submit the medicinal product, its starting materials and, if need be, its intermediate products or other constituent materials, for testing by a State laboratory or by a laboratory designated for that purpose in order to ensure that the control methods employed by the manufacturer and described in the particulars accompanying the application in accordance with Article 8(3)(h) are satisfactory.
Slovenian: lahko zdravilo, njegove vhodne snovi, in če je potrebno, vmesne spojine ali druge sestavine predloži v preskušanje državnemu laboratoriju ali laboratoriju, pooblaščenemu za ta namen, da se zagotovi, da so kontrolne metode, ki jih je uporabil proizvajalec in so opisane v podrobnih podatkih vloge, zadovoljive in v skladu s členom 8(3)(h).
English: may, where appropriate, require the applicant to supplement the particulars accompanying the application in respect of the items listed in the Articles 8(3) and 10(1).
Slovenian: lahko zahteva od vlagatelja, kadar je to primerno, da dopolni podrobne podatke v vlogi glede postavk iz členov 8(3) in 10(1).
English: Where the competent authority avails itself of this option, the time limits laid down in Article 17 shall be suspended until such time as the supplementary information required has been provided.
Slovenian: Če pristojni organ izkoristi to možnost, časovni roki iz člena 17 začasno prenehajo teči do predložitve zahtevanih dodatnih informacij.
English: Likewise, these time limits shall be suspended for the time allowed the applicant, where appropriate, for giving oral or written explanation.
Slovenian: Prav tako časovni roki prenehajo teči za čas, ki ga vlagatelj potrebuje, kadar je to primerno, za ustno ali pisno obrazložitev.
English: Member States shall take all appropriate measures to ensure that:
Slovenian: Države članice sprejmejo vse potrebne ukrepe, da zagotovijo:
English: the competent authorities verify that manufacturers and importers of medicinal products coming from third countries are able to carry out manufacture in compliance with the particulars supplied pursuant to Article 8(3)(d), and/or to carry out controls according to the methods described in the particulars accompanying the application in accordance with Article 8(3)(h);
Slovenian: da pristojni organi preverijo, da so proizvajalci in uvozniki zdravil iz tretjih držav sposobni proizvajati zdravilo v skladu s podrobnimi podatki, predloženimi po členu 8(3)(d) in/ali izvajati kontrole po metodah, opisanih v podrobnih podatkih vloge, v skladu s členom 8(3)(h);
English: the competent authorities may allow manufacturers and importers of medicinal products coming from third countries, in exceptional and justifiable cases, to have certain stages of manufacture and/or certain of the controls referred to in (a) carried out by third parties;
Slovenian: da pristojni organi lahko dovolijo proizvajalcem in uvoznikom zdravil iz tretjih držav, v izjemnih in utemeljenih primerih, da določene faze proizvodnje in/ali določene kontrole iz točke (a) izvedejo tretje osebe;
English: in such cases, the verifications by the competent authorities shall also be made in the establishment designated.
Slovenian: v takih primerih se preverjanje s strani pristojnih organov opravi v pooblaščeni ustanovi.
English: When the marketing authorization is issued, the holder shall be informed, by the competent authorities of the Member State concerned, of the summary of the product characteristics as approved by it.
Slovenian: Ko pristojni organ zadevne države članice izda dovoljenje za promet z zdravilom, imetnika dovoljenja obvesti o povzetku glavnih značilnosti zdravila, kot ga je organ odobril.
English: The competent authorities shall take all necessary measures to ensure that the information given in the summary is in conformity with that accepted when the marketing authorization is issued or subsequently.
Slovenian: Pristojni organi sprejmejo vse potrebne ukrepe, da zagotovijo, da so podatki v povzetku skladni s sprejetimi ob izdaji dovoljenja za promet z zdravilom ali pozneje.
English: The competent authorities shall forward to the Agency a copy of the authorization together with the summary of the product characteristics.
Slovenian: Pristojni organi Agenciji pošljejo izvod dovoljenja za promet skupaj s povzetkom glavnih značilnosti zdravila.
English: The competent authorities shall draw up an assessment report and comments on the dossier as regards the results of the analytical and pharmacotoxicological tests and the clinical trials of the medicinal product concerned.
Slovenian: Pristojni organi izdelajo poročilo o oceni zdravila in pripombe na dosje v zvezi z rezultati analiznih in farmakološko-toksikoloških preskusov ter kliničnih preskušanj zadevnega zdravila.
English: The assessment report shall be updated whenever new information becomes available which is of importance for the evaluation of the quality, safety or efficacy of the medicinal product concerned.
Slovenian: Poročilo o oceni zdravila se dopolnjuje vedno, ko so na voljo novi podatki, ki so pomembni za vrednotenje kakovosti, varnosti ali učinkovitosti zadevnega zdravila.
English: In exceptional circumstances, and following consultation with the applicant, an authorization may be granted subject to certain specific obligations, including:
Slovenian: V izjemnih okoliščinah in po posvetu z vlagateljem se dovoljenje za promet lahko odobri ob upoštevanju nekaterih posebnih obveznosti, vključno z:
English: the carrying out of further studies following the granting of authorization,
Slovenian: izvajanjem nadaljnjih študij po izdaji dovoljenja za promet,
English: the notification of adverse reactions to the medicinal product.
Slovenian: obveščanjem o neželenih učinkih zdravila.
English: These exceptional decisions may be adopted only for objective and verifiable reasons and shall be based on one of the causes referred to in Part 4 (G) of Annex I.
Slovenian: Ti izjemni sklepi se lahko sprejmejo samo, če obstajajo objektivni in preverljivi razlogi, ki temeljijo na enem od razlogov iz dela 4(G) Priloge I.
English: After an authorization has been issued, the authorization holder must, in respect of the methods of manufacture and control provided for in Article 8(3)(d) and (h), take account of scientific and technical progress and introduce any changes that may be required to enable the medicinal product to be manufactured and checked by means of generally accepted scientific methods.
Slovenian: Po izdaji dovoljenja za promet mora imetnik dovoljenja, glede postopkov proizvodnje in nadzora, predpisanih v členu 8(3)(d) in (h) upoštevati znanstveni in tehnični napredek in uvajati vse zahtevane spremembe, da bi omogočil proizvodnjo in preverjanje zdravila po splošno sprejetih znanstvenih postopkih.
English: These changes shall be subject to the approval of the competent authority of the Member State concerned.
Slovenian: Tovrstne spremembe odobri pristojni organ zadevne države članice.
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 by the competent authority of a dossier containing in particular details of the data on pharmacovigilance and other information relevant to the monitoring of the medicinal product.
Slovenian: Dovoljenje za promet velja pet let in se podaljšuje za 5-letna obdobja, na predlog, ki ga imetnik predloži najmanj tri mesece pred datumom izteka in potem, ko pristojni organ preuči dosje, ki vsebuje zlasti podrobne podatke o farmakovigilanci ter druge podatke, pomembne za spremljanje zdravila.
English: Authorization shall not affect the civil and criminal liability of the manufacturer and, where applicable, of the marketing authorization holder.
Slovenian: Dovoljenje za promet ne vpliva na civilno in kazensko odgovornost proizvajalca, in kadar je to primerno, imetnika dovoljenja za promet z zdravilom.
English: The marketing authorisation shall be refused if, after verification of the particulars and documents listed in Articles 8 and 10(1), it proves that:
Slovenian: Dovoljenje za promet z zdravilom se zavrne, če se po preverjanju podrobnih podatkov in dokumentov, navedenih v seznamu iz členov 8 in 10(1) dokaže, da:
English: the medicinal product is harmful in the normal conditions of use, or
Slovenian: je zdravilo v predpisanih pogojih uporabe škodljivo; ali
English: that its therapeutic efficacy is lacking or is insufficiently substantiated by the applicant, or
Slovenian: da ni terapevtskega učinka, ali ga vlagatelj ni dovolj podkrepil z dokazi; ali
English: that its qualitative and quantitative composition is not as declared.
Slovenian: da kakovostna in količinska sestava zdravila ne ustreza deklarirani.
English: Authorisation shall likewise be refused if the particulars and documents submitted in support of the application do not comply with Articles 8 and 10(1).
Slovenian: Dovoljenje za promet se zavrne tudi, če predloženi podrobni podatki in dokumenti niso skladni s členoma 8 in 10(1).
English: In order to facilitate the adoption of common decisions by Member States on the authorization of medicinal products on the basis of the scientific criteria of quality, safety and efficacy, and to achieve thereby the free movement of medicinal products within the Community, a Committee for Proprietary Medicinal Products, hereinafter referred to as "the Committee", is hereby set up.
Slovenian: Za lažje sprejemanje skupnih odločitev držav članic glede pridobitve dovoljenj za promet z zdravili na podlagi znanstvenih meril kakovosti, varnosti in učinkovitosti, in za omogočanje prostega pretoka zdravil v Skupnosti se ustanovi Odbor za lastniška 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 this Directive.
Slovenian: Poleg drugih odgovornosti, poverjenih Odboru z zakonodajo Skupnosti, Odbor preučuje vsa vprašanja v zvezi z izdajo, spremembo, preklicem veljavnosti ali ukinitvijo dovoljenja za promet z zdravilom, predložena Odboru v skladu s to direktivo.
English: The Committee shall draw up its own Rules of Prodecure.
Slovenian: Odbor pripravi svoj poslovnik.
English: Before submitting the application for recognition of a marketing authorization, the holder of the authorization shall inform the Member State which granted the authorization on which the application is based (hereinafter "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: Pred predložitvijo vloge za priznavanje dovoljenja za promet z zdravilom, imetnik dovoljenja za promet obvesti državo članico, ki je izdala dovoljenje za promet, na katerem temelji vloga (v nadaljnjem besedilu "referenčna država članica"), da je vloga pripravljena v skladu s to direktivo in jo obvesti o vseh morebitnih dopolnitvah osnovnega dosjeja;
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: država članica od vlagatelja lahko zahteva, da predloži vse podrobne podatke in potrebne dokumente, ter državi tako omogoči, da preveri identičnost predloženih dosjejev.
English: In addition the holder of the authorization shall request the reference Member State to prepare an assessment report in respect of the medicinal product concerned, or, if necessary, to update any existing assessment report.
Slovenian: Imetnik dovoljenja za promet referenčno državo članico tudi zaprosi, da pripravi poročilo o oceni zdravila za zadevno zdravilo, ali, če je potrebno, da z zadnjimi podatki dopolni obstoječe poročilo o oceni zdravila.
English: That Member State shall prepare the assessment report, or update it, within 90 days of the receipt of the request.
Slovenian: Navedena država članica pripravi poročilo o oceni zdravila, ali ga dopolni v 90 dneh po prejemu zahteve.
English: At the same time as the application is submitted in accordance with paragraph 2, the reference Member State shall forward the assessment report to the Member State or Member States concerned by the application.
Slovenian: Hkrati s predložitvijo vloge v skladu z odstavkom 2, referenčna država članica pošlje poročilo o oceni zdravila državi članici ali državam članicam, ki jo/jih vloga zadeva.
English: In order to obtain the recognition according to the procedures 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 authorities of the Member State or Member States concerned, together with the information and particulars referred to in Articles 8, 10(1) and 11.
Slovenian: Za priznavanje dovoljenja za promet, ki ga je izdala ena država članica po postopkih iz tega poglavja, v eni ali več državah članicah, imetnik dovoljenja za promet predloži vlogo pristojnim organom zadevne države članice ali zadevnih držav članic, skupaj z informacijami in podrobnimi podatki iz členov 8, 10(1) in 11.
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 poda izjavo, da je dosje enak dosjeju, ki ga je prejela referenčna država članica ali pa opozori na vse dodatke ali spremembe, ki jih vsebuje.
English: In the latter case, he shall certify that the summary of the product characteristics proposed by him in accordance with Article 11 is identical to that accepted by the reference Member State in accordance with Article 21.
Slovenian: V primeru sprememb potrdi, da je povzetek glavnih značilnosti zdravila, ki ga vlagatelj predlaga v skladu s členom 11 enak povzetku, ki ga je potrdila referenčna država članica v skladu s členom 21.
English: Moreover, he shall certify that all the dossiers filed as part of the procedure are identical.
Slovenian: Potrdi tudi, da so vsi vloženi dosjeji v navedenem postopku enaki.
English: The holder of the marketing authorization shall communicate 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 pošlje vlogo Agenciji, jo obvesti o zadevnih državah članicah ter o datumih predložitve vloge, ter ji pošlje kopijo dovoljenja za promet, 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 medicinal product concerned, and shall indicate whether any application for authorization is currently under consideration in any Member State.
Slovenian: Agenciji pošlje tudi kopije vseh dovoljenj, ki so jih izdale druge države članice v zvezi z zadevnim zdravilom in navede, če je kakšna vloga za pridobitev dovoljenja za promet trenutno v obravnavi v katerikoli državi članici.
English: Save in the exceptional case provided for in Article 29(1), each Member State shall recognize 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, predpisanem v členu 29(1), vse države članice v 90 dneh po prejemu vloge in poročila o oceni zdravila priznajo dovoljenje za promet z zdravilom, ki ga je izdala referenčna država članica.
English: It shall inform the reference Member State which granted the initial authorization, the other Member States concerned by the application, the Agency, and the marketing authorization holder.
Slovenian: O tem obvestijo referenčno državo članico, ki je prva izdala dovoljenje za promet, ostale države članice, ki jih vloga zadeva, Agencijo ter imetnika dovoljenja za promet z zdravilom.
English: Where a Member State considers that there are grounds for supposing that the marketing authorization of the medicinal product concerned may present a risk to public health, it shall forthwith inform the applicant, the reference Member State which granted the initial authorization, any other Member States concerned by the application and the Agency.
Slovenian: Kadar država članica meni, da obstajajo razlogi za domnevo, da dovoljenje za promet z zadevnim zdravilom lahko predstavlja tveganje za javno zdravje, o tem takoj obvesti vlagatelja, referenčno državo članico, ki je prva izdala dovoljenje za promet, vse ostale države članice, ki jih vloga zadeva, ter Agencijo.
English: The Member State shall state its reasons in detail and shall indicate what action may be necessary to correct any defect in the application.
Slovenian: Država članica natančno navede razloge in tudi potrebne ukrepe za odpravo pomanjkljivosti 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 se kar najbolj potrudijo, da dosežejo dogovor o potrebnem ukrepanju glede vloge.
English: They shall provide the applicant with the opportunity to make his point of view known orally or in writing.
Slovenian: Vlagatelju dajo možnost, da izrazi svoje stališče ustno ali pisno.
English: However, if the Member States have not reached agreement within the time limit referred to in Article 28(4) they shall forthwith refer the matter to the Agency with regard to the Committee's reference for the application of the procedure laid down in Article 32.
Slovenian: Če države članice ne dosežejo dogovora v časovnem roku iz člena 28(4), zadevo nemudoma predajo Agenciji z napotitvijo Odboru za uporabo postopka iz člena 32.
English: Within the time limit referred to in Article 28(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: Zadevne države članice v časovnem roku iz člena 28(4) Odboru predložijo podrobno izjavo glede zadev, o katerih niso mogle doseči dogovora, ter razloge za njihovo nesoglasje.
English: The applicant shall be provided with a copy of this information.
Slovenian: Kopija te informacije se predloži tudi vlagatelju.
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 28(2).
Slovenian: Takoj, ko vlagatelj prejme obvestilo, da je bila zadeva predana Odboru, mu nemudoma pošlje kopijo informacij in podrobnih podatkov iz člena 28(2).
English: If several applications submitted in accordance with Articles 8, 10(1) and Article 11 have been made for marketing authorization for a particular medicinal product, and Member States have adopted divergent decisions concerning the authorization of the medicinal product or its suspension or withdrawal, 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 32.
Slovenian: Če je bilo v skladu s členi 8, 10(1) in 11 predloženih več vlog za pridobitev dovoljenja za promet z določenim zdravilom in so države članice sprejele različne odločitve v zvezi dovoljenjem za promet z določenim zdravilom, ali so ga začasno preklicale ali ukinile, lahko država članica, ali Komisija, ali pa imetnik dovoljenja za promet z zdravilom zadevo predloži Odboru za uporabo postopka iz člena 32.
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, where appropriate, shall inform the holder.
Slovenian: Zadevna država članica, imetnik dovoljenja za promet z zdravilom, ali Komisija jasno opredelijo vprašanje, predloženo Odboru v obravnavo, in kadar je to primerno, obvestijo imetnika.
English: The Member State and the marketing authorization holder shall forward to the Committee all available information relating to the matter in question.
Slovenian: Država članica in imetnik dovoljenja za promet z zdravilom Odboru pošljeta vse potrebne informacije v zvezi z omenjeno zadevo.
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 32 before reaching a decision on a request for a marketing authorization or on the suspension or withdrawal of an authorization, or on any other variation to the terms of a marketing authorization which appears necessary, in particular to take account of the information collected in accordance with Title IX.
Slovenian: Države članice, Komisija, vlagatelj ali imetnik dovoljenja za promet z zdravilom lahko v posebnih primerih, kadar so vpleteni interesi Skupnosti, zadevo predloži Odboru za uporabo postopka iz člena 32, pred sprejetjem odločitve glede prošnje za pridobitev dovoljenja za promet z zdravilom, glede začasnega preklica ali ukinitve dovoljenja za promet, ali kakršne koli spremembe pogojev izdaje dovoljenja za promet z zdravilom, ki je potrebna, zlasti ob upoštevanju informacij, zbranih v skladu z naslovom IX.
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: Zadevna država članica ali Komisija jasno opredeli vprašanje, predloženo Odboru v obravnavo, in obvesti imetnika dovoljenja za promet z zdravilom.
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 in imetnik dovoljenja za promet z zdravilom Odboru pošljeta vse razpoložljive informacije v zvezi z omenjeno 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: Pri napotitvah na postopek, opisan v tem členu, Odbor obravnava zadevo in izda mnenje z obrazložitvijo v 90 dneh od dneva predložitve zadeve.
English: However, in cases submitted to the Committee in accordance with Articles 30 and 31, this period may be extended by 90 days.
Slovenian: Pri zadevah, predloženih Odboru v skladu s členoma 30 in 31, se to obdobje lahko podaljša za 90 dni.
English: In case of urgency, on a proposal from its Chairman, the Committee may agree to a shorter deadline.
Slovenian: V nujnem primeru se Odbor na predlog svojega predsednika lahko odloči tudi 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 Odbor lahko enega svojih članov imenuje za poročevalca.
English: The Committee may also appoint individual experts to advise it on specific questions.
Slovenian: Odbor lahko tudi imenuje posamezne strokovnjake za svetovanje o posebnih vprašanjih.