natgillin/translations-raw huggingface dataset:
Article 49
Vloga za decentralizirano dovoljenje za promet se predloži pristojnemu organu v državi članici, ki ga predlagatelj izbere za pripravo poročila o oceni in ki ravna v skladu s tem oddelkom (v nadaljnjem besedilu: referenčna država članica), in pristojnim organom v drugih zadevnih državah članicah.
Procedure for decentralised marketing authorisation
Zadevne države članice se navedejo v vlogi.
An application for a decentralised marketing authorisation shall be submitted to the competent authority in the Member State chosen by the applicant to prepare an assessment report and to act in accordance with this Section (‘reference Member State’) and to the competent authorities in the other Member States concerned.
Če predlagatelj navede, da ena ali več zadevnih držav članic ne šteje več za zadevno, pristojni organi v teh državah članicah zagotovijo pristojnim organom v referenčni državi članici in drugih zadevnih državah članicah vse informacije, za katere presodijo, da so pomembne za umik vloge.
The application shall list the Member States concerned.
Pristojni organ v referenčni državi članici v 120 dneh od prejema veljavne vloge pripravi poročilo o oceni, ki vsebuje informacije iz člena 33, in ga pošlje pristojnim organom v drugih zadevnih državah članicah in predlagatelju.
If the applicant indicates that one or more of the Member States concerned shall no longer be considered as such, the competent authorities in those Member States shall provide to the competent authority in the reference Member State and to the competent authorities in the other Member States concerned any information they consider relevant with respect to the withdrawal of the application.
Pristojni organi v zadevnih državah članicah poročilo o oceni iz odstavka 4 pregledajo v 90 dneh po prejemu ter obvestijo pristojni organ v referenčni državi članici, ali imajo k poročilu pripombe, ker bi zdravilo za uporabo v veterinarski medicini utegnilo povzročiti potencialno resno tveganje za zdravje ljudi ali živali ali za okolje.
Within 120 days of receipt of a valid application, the competent authority in the reference Member State shall prepare an assessment report containing the information referred to in Article 33 and shall forward it to the competent authorities in the Member States concerned and to the applicant.
Pristojni organ v referenčni državi članici poročilo o oceni, ki nastane pri tem pregledu, pošlje pristojnim organom v zadevnih državah in predlagatelju.
Within 90 days of receipt of the assessment report referred to in paragraph 4, the competent authorities in the Member States concerned shall examine the report and inform the competent authority in the reference Member State whether they have any objections to it on the ground that the veterinary medicinal product would pose a potential serious risk to human or animal health or to the environment.
Na zahtevo pristojnega organa v referenčni državi članici ali v pristojnega organa v kateri od zadevnih držav članic se skliče usklajevalna skupina, ki v roku iz odstavka 5 pregleda poročilo o oceni.
The competent authority in the reference Member State shall forward the assessment report resulting from that examination to the competent authorities in the Member States concerned and to the applicant.
Kadar je poročilo o oceni ugodno in kadar noben pristojni organ ne obvesti pristojnega organa v referenčni državi članici o pripombah, kakor je določeno v odstavku 5, pristojni organ v referenčni državi članici zabeleži, da je dosežen dogovor, zaključi postopek in o tem brez nepotrebnega odlašanja obvesti predlagatelja in pristojne organe v vseh državah članicah.
On the request of the competent authority in the reference Member State or the competent authority in any of the Member States concerned, the coordination group shall be convened to examine the assessment report within the period referred to in paragraph 5.
Pristojni organi v zadevnih državah članicah izdajo dovoljenje za promet z zdravilom v skladu s poročilom o oceni v roku 30 dni po tem, ko od pristojnega organa v referenčni državi članici prejmejo informacijo o doseženem dogovoru ter od predlagatelja popolne prevode povzetka glavnih značilnosti zdravila, označevanja in navodil za uporabo.
Where the assessment report is favourable and where no competent authority has informed the competent authority in the reference Member State of an objection thereto, as referred to in paragraph 5, the competent authority in the reference Member State shall record that there is an agreement, close the procedure and, without undue delay, inform the applicant and the competent authorities in all Member States accordingly.
Kadar poročilo o oceni ni ugodno in noben pristojni organ v zadevni državi članici ne obvesti pristojnega organa v referenčni državi članici o pripombah, kakor je določeno v odstavku 5, pristojni organ v referenčni državi članici zabeleži, da se dovoljenje za promet z zdravilom zavrne, zaključi postopek in o tem brez nepotrebnega odlašanja obvesti predlagatelja in pristojne organe v vseh državah članicah.
The competent authorities in the Member States concerned shall grant a marketing authorisation in conformity with the assessment report within 30 days of receipt of both the information on the agreement from the competent authority in the reference Member State and the complete translations of the summary of product characteristics, labelling and package leaflet from the applicant.
Kadar pristojni organ v zadevni državi članici v skladu z odstavkom 5 tega člena obvesti pristojni organ v referenčni državi članici o pripombi k poročilu o oceni, se uporabi postopek iz člena 54.
Where the assessment report is unfavourable and where none of the competent authorities in the Member States concerned has informed the competent authority in the reference Member State of an objection thereto, as set out in paragraph 5, the competent authority in the reference Member State shall record that there is a refusal to grant the marketing authorisation, close the procedure and, without undue delay, inform the applicant and the competent authorities in all Member States accordingly.
Če se pristojni organ v zadevni državi članici v kateri koli fazi postopka za pridobitev decentraliziranega dovoljenja za promet sklicuje na razloge iz člena 110(1) za prepoved zdravila za uporabo v veterinarski medicini, ta država članica ne šteje več za zadevno državo članico.
Where a competent authority in a Member State concerned informs the competent authority in the reference Member State of an objection to the assessment report in accordance with paragraph 5 of this Article, the procedure referred to in Article 54 shall apply.
Pristojni organ v referenčni državi članici poročilo o oceni po izbrisu vseh poslovno zaupnih informacij objavi.
If at any stage of the procedure for a decentralised marketing authorisation the competent authority in a Member State concerned invokes the reasons referred to in Article 110(1) for prohibiting the veterinary medicinal product, that Member State shall no longer be considered as a Member State concerned.
Člen 50
The competent authority in the reference Member State shall make the assessment report publicly available, after deleting any commercially confidential information.
Zahteva predlagatelja za ponovni pregled poročila o oceni
Article 50
Predlagatelj lahko v 15 dneh po prejemu poročila o oceni iz člena 49(5) pristojnemu organu v referenčni državi članici predloži pisno obvestilo z zahtevo po ponovnem pregledu poročila o oceni.
Request by the applicant for re-examination of the assessment report
V tem primeru predlagatelj v 60 dneh po prejemu poročila o oceni pošlje pristojnemu organu v referenčni državi članici podrobne razloge za to zahtevo.
Within 15 days of receipt of the assessment report referred to in Article 49(5), the applicant may provide written notice to the competent authority in the reference Member State requesting a re-examination of the assessment report.
Pristojni organ v referenčni državi članici zahtevo in podrobne razloge zanjo brez odlašanja pošlje usklajevalni skupini.
In that case, the applicant shall forward to the competent authority in the reference Member State detailed grounds for such a request within 60 days of receipt of that assessment report.
Usklajevalna skupina ponovno pregleda poročilo o oceni v 60 dneh od prejema podrobnih razlogov za to zahtevo.
The competent authority in the reference Member State shall without delay forward that request and the detailed grounds to the coordination group.
Poročilu o oceni se priložijo sklepne ugotovitve usklajevalne skupine in razlogi zanje, oboje pa je sestavni del poročila.
Within 60 days of receipt of the detailed grounds for the request for re-examination of the assessment report, the coordination group shall re-examine the assessment report.
Pristojni organ v referenčni državi članici v 15 dneh od ponovnega pregleda pošlje poročilo o oceni predlagatelju.
The conclusions reached by the coordination group and the reasons for those conclusions shall be annexed to the assessment report and shall form an integral part thereof.
Po izvedenem postopku iz odstavka 3 tega člena se uporablja člen 49(7), (8), (10) in (11).
Within 15 days of the re-examination of the assessment report, the competent authority in the reference Member State shall forward the assessment report to the applicant.
Vzajemno priznavanje nacionalnih dovoljenj za promet
Subsequent to the procedure set out in paragraph 3 of this Article, Article 49(7), (8), (10) and (11) shall apply.
Člen 51
Mutual recognition of national marketing authorisations
Področje uporabe vzajemno priznanih nacionalnih dovoljenj za promet
Article 51
Nacionalna dovoljenja za promet z zdravilom za uporabo v veterinarski medicini, izdana v skladu s členom 47, se v drugih državah članicah priznajo v skladu s postopkom iz člena 52.
Scope of mutual recognition of national marketing authorisations
Člen 52
A national marketing authorisation for a veterinary medicinal product, granted in accordance with Article 47, shall be recognised in other Member States in accordance with the procedure laid down in Article 52.
Postopek za vzajemno priznanje nacionalnih dovoljenj za promet
Article 52
Vloga za vzajemno priznanje nacionalnega dovoljenja za promet se predloži pristojnemu organu v državi članici, ki je v skladu s členom 47 izdal prvo nacionalno dovoljenje za promet (v nadaljnjem besedilu: referenčna država članica), in pristojnim organom v državah članicah, v katerih želi predlagatelj pridobiti dovoljenje za promet (v nadaljnjem besedilu: zadevne države članice).
Procedure for mutual recognition of national marketing authorisations
Zadevne države članice se navedejo v vlogi za vzajemno priznanje.
An application for mutual recognition of a national marketing authorisation shall be submitted to the competent authority in the Member State that granted the national marketing authorisation in accordance with Article 47 (‘reference Member State’) and to the competent authorities in the Member States where the applicant seeks to obtain a marketing authorisation (‘Member States concerned’).
Med sklepom o izdaji nacionalnega dovoljenja za promet in predložitvijo vloge za njegovo vzajemno priznanje preteče najmanj šest mesecev.
The application for mutual recognition shall list the Member States concerned.
Pristojni organ v referenčni državi članici v 90 dneh od prejema veljavne vloge za vzajemno priznanje za zdravilo za uporabo v veterinarski medicini pripravi posodobljeno poročilo o oceni, ki vsebuje informacije iz člena 33, ter ga pošlje pristojnim organom v zadevnih državah članicah in predlagatelju.
A minimum of six months shall elapse between the decision granting the national marketing authorisation and the submission of the application for mutual recognition of that national marketing authorisation.
Pristojni organi v zadevnih državah članicah posodobljeno poročilo o oceni iz odstavka 5 v 90 dneh po prejemu pregledajo ter obvestijo pristojni organ v referenčni državi članici, ali imajo k poročilu pripombe, ker bi zdravilo za uporabo v veterinarski medicini utegnilo povzročiti potencialno resno tveganja za zdravje ljudi ali živali ali za okolje.
Within 90 days of receipt of a valid application for mutual recognition, the competent authority in the reference Member State shall prepare an updated assessment report containing the information referred to in Article 33 for the veterinary medicinal product and shall forward it to the competent authorities in the Member States concerned and to the applicant.
Na zahtevo pristojnega organa v referenčni državi članici ali pristojnega organa v kateri koli zadevni državi članici se skliče usklajevalna skupina, ki v roku iz odstavka 6 pregleda posodobljeno poročilo o oceni.
Within 90 days of receipt of the updated assessment report referred to in paragraph 5, the competent authorities in the Member States concerned shall examine it and inform the competent authority in the reference Member State of whether they have any objections to it on the ground that the veterinary medicinal product would pose a potential serious risk to human or animal health or to the environment.
Kadar noben pristojni organ v zadevni državi članici ne obvesti pristojnega organa v referenčni državi članici o pripombah k posodobljenemu poročilu o oceni, kakor je določeno v odstavku 6, pristojni organ v referenčni državi članici zabeleži, da je dosežen dogovor, in postopek zaključi ter o tem brez nepotrebnega odlašanja obvesti predlagatelja in pristojne organe v vseh državah članicah.
On the request of the competent authority in the reference Member State or the competent authority in any of the Member States concerned, the coordination group shall be convened to examine the updated assessment report within the period referred to in paragraph 6.
Pristojni organi v zadevnih državah članicah izdajo dovoljenje za promet z zdravilom v skladu s posodobljenim poročilom o oceni v 30 dneh po tem, ko od pristojnega organa v referenčni državi članici prejmejo informacijo o doseženem dogovoru, od predlagatelja pa popolne prevode povzetka glavnih značilnosti zdravila, označevanja in navodil za uporabo.
Where no competent authority of any Member State concerned has informed the competent authority in the reference Member State of an objection to the updated assessment report, as referred to in paragraph 6, the competent authority in the reference Member State shall record that there is an agreement, close the procedure and, without undue delay, inform the applicant and the competent authorities in all Member States accordingly.
Kadar pristojni organ v zadevni državi članici v skladu z odstavkom 6 tega člena obvesti pristojni organ v referenčni državi članici o pripombi k posodobljenemu poročilu o oceni, se uporabi postopek iz člena 54.
The competent authorities in the Member States concerned shall grant a marketing authorisation in conformity with the updated assessment report within 30 days of receipt of both the information on the agreement from the competent authority in the reference Member State and the complete translations of the summary of product characteristics, labelling and package leaflet from the applicant.
Če se pristojni organ v zadevni državi članici v kateri koli fazi postopka za vzajemno priznanje sklicuje na razloge iz člena 110(1) za prepoved zdravila za uporabo v veterinarski medicini, ta država članica ne šteje več za zadevno državo članico.
Where a competent authority in a Member State concerned informs the competent authority in the reference Member State of an objection to the updated assessment report in accordance with paragraph 6 of this Article, the procedure referred to in Article 54 shall apply.
Naknadno priznanje pri postopku vzajemnega priznavanja in postopku za pridobitev centraliziranega dovoljenja za promet
If at any stage of the procedure for mutual recognition the competent authority in a Member State concerned invokes the reasons referred to in Article 110(1) for prohibiting the veterinary medicinal product, that Member State shall no longer be considered as a Member State concerned.
Člen 53
Subsequent recognition in the mutual recognition and decentralised marketing authorisation procedures
Naknadno priznanje dovoljenj za promet v dodatnih zadevnih državah članicah
Article 53
Ko se opravi decentralizirani postopek iz člena 49 ali postopek vzajemnega priznavanja iz člena 52 in se izda dovoljenje za promet z zdravilom, lahko imetnik dovoljenja v skladu s postopkom iz tega člena predloži vlogo za dovoljenje za promet pri pristojnih organih v dodatnih zadevnih državah članicah in pri pristojnem organu v referenčni državi članici iz člena 49 ali 52, kakor je ustrezno.
Subsequent recognition of marketing authorisations by additional Member States concerned
Poleg podatkov iz člena 8 vloga vsebuje tudi:
After completion of a decentralised procedure laid down in Article 49 or a mutual recognition procedure laid down in Article 52 granting a marketing authorisation, the marketing authorisation holder may submit an application for a marketing authorisation for the veterinary medicinal product to the competent authorities in additional Member States concerned and to the competent authority in the reference Member State referred to in Article 49 or 52, as applicable, in accordance with the procedure laid down in this Article.
seznam vseh sklepov o izdaji, začasnem odvzemu ali odvzemu dovoljenj za promet, ki zadevajo zdravilo za uporabo v veterinarski medicini;
In addition to the data referred to in Article 8, the application shall include the following:
informacije o spremembah, ki so bile uvedene od izdaje dovoljenja za promet po decentraliziranem postopku iz člena 49(7) ali po postopku medsebojnega priznavanja iz člena 52(8);
a list of all decisions granting, suspending or revoking marketing authorisations which concern the veterinary medicinal product;
zbirno poročilo o podatkih o farmakovigilanci.
information on the variations introduced since the grant of the marketing authorisation by decentralised procedure laid down in Article 49(7) or by mutual recognition procedure laid down in Article 52(8);
Pristojni organ v referenčni državi članici iz člena 49 ali 52, kakor je ustrezno, v 60 dneh pošlje pristojnim organom v dodatnih zadevnih državah članicah sklep o izdaji dovoljenja za promet z zdravilom in vse njegove spremembe ter v tem času pripravi in posreduje posodobljeno poročilo o oceni tega dovoljenja za promet in njegovih sprememb, kakor je ustrezno, ter o tem obvesti predlagatelja.
a summary report on pharmacovigilance data.
Pristojni organ v vsaki dodatni zadevni državi članici izda dovoljenje za promet z zdravilom v skladu s posodobljenim poročilom o oceni iz odstavka 2 v 60 dneh po tem, ko prejme tako podatke kot informacije iz odstavka 1 ter popolne prevode povzetka glavnih značilnosti zdravila, označevanja in navodil za uporabo.
The competent authority in the reference Member State referred to in Article 49 or 52, as applicable, shall forward within 60 days to the competent authorities in the additional Member States concerned the decision to grant the marketing authorisation and any variations thereto and shall, within that period, prepare and forward an updated assessment report concerning that marketing authorisation and those variations, as applicable, and inform the applicant accordingly.
Z odstopanjem od odstavka 3 tega člena, če pristojni organ v dodatni zadevni državi članici meni, da obstajajo razlogi za zavrnitev dovoljenja za promet, ker bi zdravilo za uporabo v veterinarski medicini utegnilo povzročiti potencialno resno tveganje za zdravje ljudi ali živali ali za okolje, te svoje pripombe sporoči najpozneje v 60 dneh od prejetja tako podatkov kot informacij iz odstavka 1 in posodobljenega poročila o oceni iz odstavka 2 tega člena ter navede razloge za to v podrobni izjavi, ki jo pošlje pristojnemu organu v referenčni državi članici iz člena 49 ali 52, kakor je ustrezno, in pristojnim organom v zadevnih državah članicah iz navedenih členov ter predlagatelju.
The competent authority in each additional Member State concerned shall grant a marketing authorisation in conformity with the updated assessment report referred to in paragraph 2 within 60 days of receipt of both the data and information referred to in paragraph 1 and the complete translations of the summary of product characteristics, labelling and package leaflet.
Če pristojni organ v dodatni zadevni državi članici v skladu z odstavkom 4 sporoči svoje pripombe, pristojni organ v referenčni državi članici sprejme ustrezne korake za dosego dogovora glede sporočenih pripomb.
By derogation from paragraph 3 of this Article, if the competent authority in an additional Member State concerned has reasons for refusing the marketing authorisation on the ground that the veterinary medicinal product would pose a potential serious risk to human or animal health or to the environment, it shall, at the latest within a period of 60 days of receipt of both the data and information referred to in paragraph 1 and updated assessment report referred to in paragraph 2 of this Article raise its objections and provide a detailed statement of the reasons to the competent authority in the reference Member State referred to in Article 49 or 52, as applicable, and to the competent authorities in the Member States concerned, referred to in those Articles, and to the applicant.
Pristojni organi v referenčni državi članici in v dodatni zadevni državi članici si po najboljših močeh prizadevajo doseči dogovor o potrebnih ukrepih.
In the case of objections raised by the competent authority in an additional Member State concerned in accordance with paragraph 4, the competent authority in the reference Member State shall take any appropriate steps in order to seek an agreement as regards the objections made.
Pristojni organ v referenčni državi članici da predlagatelju možnost, da ustno ali pisno predstavi stališče predlagatelja kar zadeva sporočene pripombe s strani pristojnega organa v dodatni zadevni državi članici.
The competent authorities in the reference Member State and in the additional Member State concerned shall make their best efforts to reach an agreement on the action to be taken.
Kadar je po sprejetih korakih pristojnega organa v referenčni državi članici dosežen dogovor med pristojnimi organi v referenčni državi članici in v državah članicah, kjer je že izdano dovoljenje za promet, ter pristojnimi organi v dodatnih zadevnih državah članicah, pristojni organi v dodatnih zadevnih državah članicah izdajo dovoljenje za promet z zdravilom v skladu z odstavkom 3.
The competent authority in the reference Member State shall provide the applicant with the opportunity to provide, orally or in writing, the applicant’s point of view as regards the objections raised by the competent authority in an additional Member State concerned.
Če pristojni organ v referenčni državi članici najpozneje v 60 dneh od sporočenih pripomb iz odstavka 4 tega člena ne more doseči dogovora s pristojnimi organi v zadevnih državah članicah in dodatnih zadevnih državah članicah, vlogo skupaj s posodobljenim poročilom o oceni iz odstavka 2 tega člena in pripombami pristojnih organov v dodatnih zadevnih državah članicah v skladu s postopkom preučitve iz člena 54 pošlje usklajevalni skupini.
Where, following the steps taken by the competent authority in the reference Member State, an agreement is reached by the competent authorities in the reference Member State and in the Member States which have already granted a marketing authorisation and the competent authorities in the additional Member States concerned, the competent authorities in the additional Member States concerned shall grant a marketing authorisation in accordance with paragraph 3.
Postopek preučitve