natgillin/translations-raw huggingface dataset:
Where deemed necessary, the competent authority of the reference Member State may request additional data to the holder in order to complete its assessment.
Pristojni organ referenčne države članice lahko po potrebi od imetnika zahteva dodatne podatke, da dopolni svojo oceno.
The competent authority shall prepare a decision and an assessment report within 45 days from the receipt of a valid application.
Pristojni organ pripravi odločitev in poročilo o oceni v 45 dneh od prejema veljavne vloge.
The 45-day period referred to in the first subparagraph shall be suspended from the moment when the additional data referred to in paragraph 3 is requested until the data is submitted.
nevni rok iz prvega pododstavka se začasno ustavi od trenutka, ko se zahtevajo dodatni podatki iz člena 3, do trenutka njihove predložitve.
Within 12 days from the receipt of the decision and the assessment report of the competent authority of the reference Member State, the relevant authorities shall adopt a decision accordingly and inform the competent authority of the reference Member State and the holder thereof.’;
Zadevni organi v 12 dneh po prejemu odločitve in poročila o oceni pristojnega organa referenčne države članice sprejmejo ustrezno odločitev ter o njej obvestijo pristojni organ referenčne države članice in imetnika.“;
the following Chapter IIa is inserted after Article 13:
Za členom 13 se vstavi naslednje poglavje IIa:
VARIATIONS TO PURELY NATIONAL MARKETING AUTHORISATIONS
SPREMEMBE IZKLJUČNO NACIONALNIH DOVOLJENJ ZA PROMET
Where a minor variation of type IA is made, the holder shall submit to the competent authority a notification containing the elements listed in Annex IV.
Pri manjši spremembi tipa IA imetnik pristojnemu organu predloži priglasitev, ki vsebuje elemente iz Priloge IV.
This notification shall be submitted within 12 months following the implementation of the variation.
Ta priglasitev se predloži v 12 mesecih po začetku uveljavljanja spremembe.
Within 30 days following receipt of the notification, the measures provided for in Article 13e shall be taken.
V 30 dneh po prejemu priglasitve se uporabijo ukrepi iz člena 13e.
The holder shall submit to the competent authority a notification containing the elements listed in Annex IV.
Imetnik pristojnemu organu predloži priglasitev, ki vsebuje elemente iz Priloge IV.
If the notification fulfils the requirement laid down in the first subparagraph, the competent authority shall acknowledge receipt of a valid notification.
Če priglasitev izpolnjuje zahtevo iz prvega pododstavka, pristojni organ potrdi prejem formalno popolne priglasitve.
If within 30 days following the acknowledgement of receipt of a valid notification, the competent authority has not sent the holder an unfavourable opinion, the notification shall be deemed accepted by the competent authority.
Če v 30 dneh po potrditvi prejema formalno popolne priglasitve pristojni organ imetniku ne pošlje negativnega mnenja, se šteje, da je pristojni organ priglasitev sprejel.
Where the notification is accepted by the competent authority, the measures provided for in Article 13e shall be taken.
Kadar pristojni organ sprejme priglasitev, se uporabijo ukrepi iz člena 13e.
Where the competent authority is of the opinion that the notification cannot be accepted, it shall inform the holder, stating the grounds on which its unfavourable opinion is based.
Kadar pristojni organ meni, da priglasitve ni mogoče sprejeti, o tem obvesti imetnika in navede razloge, na katerih je utemeljil svoje negativno mnenje.
Within 30 days following the receipt of the unfavourable opinion, the holder may submit to the competent authority an amended notification in order to take due account of the grounds laid down in that opinion.
V 30 dneh po prejemu negativnega mnenja lahko imetnik pristojnemu organu predloži dopolnjeno priglasitev, v kateri ustrezno upošteva razloge iz navedenega mnenja.
If the holder does not amend the notification in accordance with the second subparagraph, the notification shall be deemed rejected.
Če imetnik ne dopolni priglasitve v skladu z drugim pododstavkom, se priglasitev šteje za zavrnjeno.
Where an amended notification has been submitted, the competent authority shall assess it within 30 days following its receipt and the measures provided for in Article 13e shall be taken.
Kadar se predloži dopolnjena priglasitev, jo pristojni organ oceni v 30 dneh po prejemu, uporabijo pa se ukrepi iz člena 13e.
In such case, the prior approval procedure in Article 13c shall apply.
V takem primeru se uporablja postopek predhodne odobritve iz člena 13c.
In such case, the procedure in Article 19 shall apply.
V takem primeru se uporablja postopek iz člena 19.
“Prior Approval” procedure for major variations of type II
Postopek „predhodne odobritve“ za večje spremembe tipa II
The holder shall submit to the competent authority an application containing the elements listed in Annex IV.
Imetnik pristojnemu organu predloži vlogo, ki vsebuje elemente iz Priloge IV.
If the application fulfils the requirements laid down in the first subparagraph, the competent authority shall acknowledge receipt of a valid application.
Če vloga izpolnjuje zahteve iz prvega pododstavka, pristojni organ potrdi prejem formalno popolne vloge.
Within 60 days following the acknowledgement of receipt of a valid application, the competent authority shall conclude the assessment.
V 60 dneh po potrditvi prejema formalno popolne vloge pristojni organ zaključi oceno.
The competent authority may reduce the period referred to in the first subparagraph, having regard to the urgency of the matter, or extend it to 90 days for variations listed in Part 1 of Annex V or for grouping of variations in accordance with Article 13d(2)(c).
Pristojni organ članice lahko ob upoštevanju nujnosti zadeve rok iz prvega pododstavka skrajša ali podaljša na 90 dni za spremembe iz dela 1 Priloge V ali za združevanje sprememb v skladu s členom 13d(2)(c).
The period referred to in the first subparagraph shall be 90 days for variations listed in Part 2 of Annex V.
Rok iz prvega pododstavka je 90 dni za spremembe iz dela 2 Priloge V.
Within the periods referred to in paragraph 2, the competent authority may request the holder to provide supplementary information within a time limit set by the competent authority.
V rokih iz odstavka 2 lahko pristojni organ od imetnika zahteva, da zagotovi dodatne informacije v roku, ki ga določi pristojni organ.
In this case the procedure shall be suspended until such supplementary information has been provided and the competent authority may extend the period referred to in paragraph 2.
V tem primeru se postopek začasno ustavi do zagotovitve takih dodatnih informacij, pristojni organ pa lahko podaljša rok iz odstavka 2.
Within 30 days after the conclusion of the assessment, the measures provided for in Article 13e shall be taken.
V 30 dneh po končani oceni se uporabijo ukrepi iz člena 13e.
Article 13d
Člen 13d
Grouping of variations to purely national marketing authorisations
Združevanje sprememb v skupine izključno nacionalnih dovoljenj za promet
Where several variations are notified or applied for, a separate notification or application in accordance with Articles 13a, 13b, 13c, or 19 as appropriate shall be submitted to the competent authority in respect of each variation sought.
Kadar se priglasi več sprememb ali se odda vloga za več sprememb, se za vsako zahtevano spremembo pristojnemu organu predloži ločena priglasitev ali vloga v skladu s členi 13a, 13b, 13c ali 19, kakor je primerno.
By way of derogation from paragraph 1 the following shall apply:
Z odstopanjem od odstavka 1 se uporablja naslednje:
where the same minor variation(s) of type IA to the terms of one or more marketing authorisations owned by the same holder are notified at the same time to the same competent authority, a single notification as referred to in Article 13a may cover all such variations;
kadar se istemu pristojnemu organu hkrati priglasijo enake manjše spremembe tipa IA pogojev enega ali več dovoljenj za promet istega imetnika, lahko ena priglasitev zajema vse take spremembe v skladu s členom 13a;
where several variations to the terms of the same marketing authorisation are submitted at the same time to the same competent authority, a single submission may cover all such variations provided that the variations concerned fall within one of the cases listed in Annex III;
kadar se istemu pristojnemu organu hkrati predloži več sprememb pogojev istega dovoljenja za promet, lahko ena priglasitev zajema vse take spremembe, če zadevne spremembe spadajo v enega od primerov iz Priloge III;
where the same variation(s) to the terms of one or more marketing authorisations owned by the same holder are submitted at the same time to the same competent authority and they are not covered under subparagraph (a) or (b), a single submission may cover all such variations provided that the competent authority agrees to such single submission.
kadar se istemu pristojnemu organu hkrati predložijo iste spremembe pogojev enega ali več dovoljenj za promet istega imetnika in niso zajete v pododstavku (a) ali (b), lahko ena priglasitev zajema vse take spremembe, če pristojni organ soglaša s tako predložitvijo.
The submission referred to in points (b) and (c) shall be made by means of the following:
Predložitev iz točk (b) in (c) se opravi na naslednji način:
a single notification in accordance with Article 13b where at least one of the variations is a minor variation of type IB and the remaining variations are minor variations;
z eno priglasitvijo v skladu s členom 13b, kadar je najmanj ena od sprememb manjša sprememba tipa IB in so ostale spremembe manjše spremembe;
a single application in accordance with Article 13c where at least one of the variations is a major variation of type II and none of the variations is an extension;
z eno vlogo v skladu s členom 13c, kadar je najmanj ena od sprememb večja sprememba tipa II in nobena od sprememb ni razširitev;
a single application in accordance with Article 19 where at least one of the variations is an extension.
z eno vlogo v skladu s členom 19, kadar je najmanj ena od sprememb razširitev.
Article 13e
Člen 13e
Measures to close the procedures of Articles 13a to 13c
Ukrepi za zaključek postopkov iz členov 13a do 13c
Where reference is made to this Article, the competent authority shall take the following measures:
Pri sklicevanju na ta člen pristojni organ sprejme naslednje ukrepe:
it shall inform the holder as to whether the variation is accepted or rejected;
obvesti imetnika, ali je bila sprememba sprejeta ali zavrnjena;
where the variation is rejected, it shall inform the holder of the grounds for the rejection;
obvesti imetnika o razlogih za zavrnitev, kadar se sprememba zavrne;
where necessary, it shall amend the decision granting the marketing authorisation in accordance with the accepted variation within the time limit laid down in paragraph 1 of Article 23.
po potrebi dopolni odločitev o izdaji dovoljenja za promet v skladu s sprejeto spremembo v roku iz odstavka 1 člena 23.
Article 13f
Člen 13f
By way of derogation from Article 13c, the procedure laid down in paragraphs 2 to 4 shall apply to the examination of variations concerning changes to the active substance for the purposes of the annual update of a human influenza vaccine.
Z odstopanjem od člena 13c se uporablja postopek iz odstavkov od 2 do 4 za pregled sprememb v zvezi s spremembami zdravilne učinkovine zaradi letne posodobitve cepiva proti človeški gripi.
The competent authority shall assess the application submitted.
Pristojni organ oceni predloženo vlogo.
Where deemed necessary, the competent authority may request additional data to the holder in order to complete its assessment.
Po potrebi lahko pristojni organ od imetnika zahteva dodatne podatke, da dopolni svojo oceno.
The competent authority shall adopt a decision within 45 days from the receipt of a valid application and shall take the measures provided for in Article 13e.
Pristojni organ sprejme odločitev v 45 dneh od prejema formalno popolne vloge in uporabi ukrepe iz člena 13e.
The 45-day period referred to in the first subparagraph shall be suspended from the moment when the additional data referred to in paragraph 3 is requested until the data is submitted.’;
nevni rok iz prvega pododstavka se začasno ustavi od trenutka, ko se zahtevajo dodatni podatki iz člena 3, do trenutka njihove predložitve.“
in paragraph 3, the third subparagraph is replaced by the following:
v odstavku 3 se tretji pododstavek nadomesti z naslednjim:
‘If the holder does not amend the notification in accordance with the second subparagraph, the notification shall be deemed rejected.’;
„Če imetnik ne dopolni priglasitve v skladu z drugim pododstavkom, se priglasitev šteje za zavrnjeno.“;
In such case, the prior approval procedure in Article 16 shall apply.
V takem primeru se uporablja postopek predhodne odobritve iz člena 16.
‘The Agency may reduce the period referred to in the first subparagraph, having regard to the urgency of the matter, or extend it to 90 days for variations listed in Part 1 of Annex V or for grouping of variations in accordance with Article 7(2)(c).’;
„Agencija lahko ob upoštevanju nujnosti zadeve rok iz prvega pododstavka skrajša ali podaljša na 90 dni za spremembe iz dela 1 Priloge V ali za združevanje sprememb v skladu s členom 7(2)(c).“;
Where reference is made to this Article, the Agency shall take the following measures:
Agencija pri sklicevanju na ta člen uporabi naslednje ukrepe:
it shall inform the holder of the outcome of the assessment;
obvesti imetnika o rezultatu ocene;
where the outcome of the assessment is favourable and the variation affects the terms of the Commission decision granting the marketing authorisation, the Agency shall transmit to the Commission its opinion and the grounds for its opinion as well as the revised versions of the documents referred to in Article 9(4) or Article 34(4) of Regulation (EC) No 726/2004 as appropriate.
kadar je rezultat ocene pozitiven in sprememba vpliva na pogoje sklepa Komisije o izdaji dovoljenja za promet, lahko Agencija Komisiji pošlje svoje mnenje in razloge zanj ter revidirane različice dokumentov iz člena 9(4) oz. člena 34(4) Uredbe (ES) št. 726/2004, kakor je ustrezno.
In the cases identified under paragraph 1(c), the Commission, having regard to the opinion from the Agency and within the time limit foreseen in Article 23(1a), shall amend where necessary the decision granting the marketing authorisation.
Komisija v primerih iz odstavka 1(c) ob upoštevanju mnenja Agencije in v roku iz člena 23(1a) po potrebi spremeni sklep o izdaji dovoljenja za promet.
The Community Register of Medicinal Products provided for in Article 13(1) and Article 38(1) of Regulation (EC) No 726/2004 shall be updated accordingly.’;
Register zdravil Skupnosti iz členov 13(1) in 38(1) Uredbe (ES) št. 726/2004 se ustrezno posodobi.“
By way of derogation from Article 16, the procedure laid down in paragraphs 2 to 6 shall apply to the examination of variations concerning changes to the active substance for the purposes of the annual update of a human influenza vaccine.’;
Z odstopanjem od člena 16 se uporablja postopek iz odstavkov od 2 do 6 za pregled sprememb v zvezi s spremembami zdravilne učinkovine zaradi letne posodobitve cepiva proti človeški gripi.“;
paragraphs 3, 4, 5 and 6 are replaced by the following:
odstavki 3, 4, 5 in 6 se nadomestijo z naslednjim:
The Agency shall assess the application submitted.
Agencija oceni predloženo vlogo.
Where deemed necessary, the Agency may request additional data to complete its assessment.
Po potrebi lahko Agencija zahteva dodatne podatke za dopolnitev svoje ocene.
Within 55 days from the receipt of a valid application, the Agency shall adopt an opinion.
Agencija v 55 dneh od prejema formalno popolne vloge sprejme mnenje.
The Agency’s opinion on the application shall be transmitted to the applicant.
Mnenje Agencije o vlogi se pošlje predlagatelju.
Where the Agency’s opinion is favourable, the Agency shall also transmit to the Commission its opinion and the grounds for its opinion as well as the revised versions of the documents referred in Article 9(4) of Regulation (EC) No 726/2004.
Kadar je mnenje Agencije pozitivno, lahko Agencija Komisiji pošlje tudi svoje mnenje in razloge zanj ter revidirane različice dokumentov iz člena 9(4) Uredbe (ES) št. 726/2004.
The 55-day period referred to in paragraph 4 shall be suspended from the moment when the additional data referred to in paragraph 3 is requested until the data is submitted.
nevni rok iz odstavka 4 se začasno ustavi od trenutka, ko se zahtevajo dodatni podatki iz odstavka 3, do trenutka njihove predložitve.
Having regard to the favourable opinion of the Agency, the Commission shall amend where necessary the decision granting the marketing authorisation.
Komisija ob upoštevanju pozitivnega mnenja Agencije po potrebi spremeni sklep o izdaji dovoljenja za promet.
The Community Register of Medicinal Products provided for in Article 13(1) of Regulation (EC) No 726/2004 shall be updated accordingly.’;
Register zdravil Skupnosti iz člena 13(1) Uredbe (ES) št. 726/2004 se ustrezno posodobi.“;
paragraph 7 is deleted;
odstavek 7 se črta.
By way of derogation from Articles 7(1), 9, 10, 13b, 13c, 13d, 15 and 16 the holder of a marketing authorisation may choose to follow the worksharing procedure laid down in paragraphs 3 to 9 in the following cases:
Z odstopanjem od člena 7(1) ter členov 9, 10, 13b, 13c, 13d, 15 in 16 lahko imetnik dovoljenja za promet izbere postopek za delitev dela iz odstavkov od 3 do 9 v naslednjih primerih:
for marketing authorisations referred to in Chapters II and III, where a minor variation of type IB, a major variation of type II, or a group of variations as provided for in Article 7(2)(b) or (c) that does not contain any extension relates to several marketing authorisations owned by the same holder;
za dovoljenja za promet iz poglavij I in II, kadar se manjša sprememba tipa IB, večja sprememba tipa II ali skupina sprememb iz člena 7(2) (b) ali (c), ki ne vsebuje nobene razširitve, nanaša na več dovoljenj za promet istega imetnika;
for purely national marketing authorisations referred to in Chapter IIa, where a minor variation of type IB, a major variation of type II, or a group of variations as provided for in Article 13d(2)(b) or (c) that does not contain any extension relates to several marketing authorisations owned by the same holder;
za izključno nacionalna dovoljenja za promet iz poglavja IIa, kadar se manjša sprememba tipa IB, večja sprememba tipa II ali skupina sprememb iz člena 13d(2)(b) ali (c), ki ne vsebuje nobene razširitve, nanaša na več dovoljenj za promet istega imetnika;
for purely national marketing authorisations referred to in Chapter IIa, where a minor variation of type IB, a major variation of type II, or a group of variations as provided for in Article 13d(2)(b) or (c) that does not contain any extension relates to one marketing authorisation that is owned by the same holder in more than one Member State.
za izključno nacionalna dovoljenja za promet iz poglavja IIa, kadar se manjša sprememba tipa IB, večja sprememba tipa II ali skupina sprememb iz člena 13d(2)(b) ali (c), ki ne vsebuje nobene razširitve, nanaša na eno dovoljenje za promet istega imetnika v več kot eni državi članici.
Variations covered under (a), (b) or (c) may be subject to the same worksharing procedure.
Za spremembe iz (a), (b) ali (c) lahko velja enak postopek delitve dela.
The reference authority or, in the case of purely national marketing authorisations, the competent authority may refuse to process a submission under the worksharing procedure where the same change(s) to different marketing authorisations require the submission of individual supportive data for each medicinal product concerned or a separate product-specific assessment.’;
Referenčni organ ali pristojni organ v primeru izključno nacionalnega dovoljenja za promet lahko zavrne obravnavo predložitve po postopku za delitev dela, kadar se za iste spremembe različnih dovoljenj za promet zahteva predložitev ločenih podpornih podatkov za vsako zadevno zdravilo ali ločeno oceno, specifično za zdravilo.“;
For the purposes of this Article, “reference authority” shall mean one of the following:
V tem členu je „referenčni organ“:
the Agency where at least one of the marketing authorisations referred to paragraph 1 is a centralised marketing authorisation;
Agencija, kadar je najmanj eno od dovoljenj za promet z zdravili iz odstavka 1 centralizirano dovoljenje za promet z zdravilom;
the competent authority of a Member State concerned chosen by the coordination group, taking into account a recommendation of the holder, in the other cases.’;
v drugih primerih pa pristojni organ zadevne države članice, ki ga izbere koordinacijska skupina ob upoštevanju priporočila imetnika.“;
in paragraph 3, the first and second subparagraphs are replaced by the following:
v odstavku 3 se prvi in drugi pododstavek nadomestita z naslednjim:
The holder shall submit to all relevant authorities an application containing the elements listed in Annex IV, with an indication of the preferred reference authority.
Imetnik vsem ustreznim organom predloži vlogo, ki vsebuje elemente iz Priloge IV, in navede referenčni organ, ki mu daje prednost.
The coordination group shall choose a reference authority.
Koordinacijska skupina izbere referenčni organ.
If the application fulfils the requirements laid down in the first subparagraph, that reference authority shall acknowledge receipt of a valid application.’;
Če vloga izpolnjuje zahteve iz prvega pododstavka, navedeni referenčni organ potrdi prejem formalno popolne vloge.“;
The reference authority shall issue an opinion on a valid application as referred to in paragraph 3 within one of the following periods:
Referenčni organ izda mnenje o formalno popolni vlogi iz odstavka 3 v enem od naslednjih rokov:
a period of 90 days following acknowledgement of receipt of a valid application in the case of variations listed in Part 2 of Annex V.
v 90 dneh po potrditvi prejema formalno popolne vloge v primeru sprememb iz dela 2 Priloge V.
The reference authority may reduce the period referred to in point (a) of paragraph 4, having regard to the urgency of the matter, or extend it to 90 days for variations listed in Part 1 of Annex V or for grouping of variations in accordance with Article 7(2)(c) or Article 13d(2)(c).’;
Referenčni organ lahko ob upoštevanju nujnosti zadeve rok iz točke (a) odstavka 4 skrajša ali podaljša na 90 dni za spremembe iz dela 1 Priloge V ali za združevanje sprememb v skladu s členom 7(2)(c) ali členom 13d(2)(c).“;
Where the reference authority is the Agency, Article 9(1) and (2) and Article 34(1) and (2) of Regulation (EC) No 726/2004 shall apply to the opinion referred to in paragraph 4.
Kadar je referenčni organ Agencija, se za mnenje iz odstavka 4 uporabita člen 9(1) in (2) ter člen 34(1) in (2) Uredbe (ES) št. 726/2004.
The Agency’s opinion on the application shall be transmitted to the applicant and the Member States, together with the assessment report.
Mnenje Agencije o vlogi se skupaj s poročilom o oceni pošlje vložniku in državam članicam.
Where the outcome of the assessment is favourable and the variation affects the terms of the Commission decision granting the marketing authorisation, the Agency shall also transmit to the Commission its opinion and the grounds for its opinion as well as the revised versions of the documents referred in Article 9(4) of Regulation (EC) No 726/2004.
Kadar je rezultat ocene pozitiven in sprememba vpliva na pogoje sklepa Komisije o izdaji dovoljenja za promet, lahko Agencija Komisiji pošlje tudi svoje mnenje in razloge zanj ter revidirane različice dokumentov iz člena 9(4) Uredbe (ES) št. 726/2004.
Where the Agency issues a favourable opinion, the following shall apply:
Kadar Agencija izda pozitivno mnenje, se uporabi naslednje: