natgillin/translations-raw huggingface dataset:
Articles 12(3), 13, 13a, 13b, 13c, 13d and 14 of Directive 2001/82/EC and Annex I thereto, and Article 31(2) of Regulation (EC) No 726/2004 in the case of veterinary medicinal products;
člena 12(3), členov 13, 13a, 13b, 13c, 13d in 14 Direktive 2001/82/ES in Priloge I k Uredbi ter člena 31(2) Uredbe (ES) št. 726/2004 pri zdravilih za uporabo v veterinarski medicini;
Articles 8(3), 9, 10, 10a, 10b, 10c and 11 of Directive 2001/83/EC and Annex I thereto, Article 6(2) of Regulation (EC) No 726/2004, point (a) of Article 7(1) and Article 34(1) of Regulation (EC) No 1901/2006 of the European Parliament and of the Council [7] and Articles 7 and 14(1) of Regulation (EC) No 1394/2007 of the European Parliament and of the Council [8] in the case of medicinal products for human use;
člena 8(3), členov 9, 10, 10a, 10b, 10c in 11 Direktive 2001/83/ES in Priloge I k Direktivi, člena 6(2) Uredbe (ES) št. 726/2004, točke (a) člena 7(1) in člena 34(1) Uredbe (ES) št. 1901/2006 Evropskega parlamenta in Sveta [7] ter člena 7 in člena 14(1) Uredbe (ES) št. 1394/2007 Evropskega parlamenta in Sveta [8] pri zdravilih za uporabo v humani medicini.
‘Minor variation of type IA’ means a variation which has only a minimal impact, or no impact at all, on the quality, safety or efficacy of the medicinal product concerned;
„Manjša sprememba tipa IA“ je sprememba, ki ima samo majhen vpliv na kakovost, varnost ali učinkovitost nekega zdravila ali pa vpliva sploh nima.
‘Major variation of type II’ means a variation which is not an extension and which may have a significant impact on the quality, safety or efficacy of the medicinal product concerned;
„Večja sprememba tipa II“ je sprememba, ki ni razširitev in lahko pomembno vpliva na kakovost, varnost ali učinkovitost nekega zdravila.
‘Extension of a marketing authorisation’ or ‘extension’ means a variation which is listed in Annex I and fulfils the conditions laid down therein;
„Razširitev dovoljenja za promet z zdravilom“ ali „razširitev“ je sprememba, ki je navedena v Prilogi I in izpolnjuje v njej določene pogoje.
‘Minor variation of type IB’ means a variation which is neither a minor variation of type IA nor a major variation of type II nor an extension;
„Manjša sprememba tipa IB“ je sprememba, ki ni niti manjša sprememba tipa IA, niti večja sprememba tipa II niti razširitev.
‘Member State concerned’ means a Member State whose competent authority has granted a marketing authorisation for the medicinal product in question;
„Vključena država članica“ je država članica, katere pristojni organ je izdal dovoljenje za promet z zadevnim zdravilom.
‘Relevant authority’ means:
„Ustrezni organ“ je:
the competent authority of each Member State concerned;
pristojni organ posameznih zadevnih držav članic;
in the case of centralised marketing authorisations, the Agency;
pri centraliziranih dovoljenjih za promet z zdravili pa Agencija.
‘Urgent safety restriction’ means an interim change to the product information due to new information having a bearing on the safe use of the medicinal product, concerning in particular one or more of the following items in the summary of product characteristics: therapeutic indications, posology, contra-indications, warnings, target species and withdrawal periods.
„Nujen varnostni ukrep“ je začasna sprememba podatkov o zdravilu zaradi novih podatkov, ki vplivajo na varno uporabo zdravila, zlasti glede ene ali več naslednjih postavk iz povzetka glavnih značilnosti zdravila: terapevtskih indikacij, odmerjanja, kontraindikacij, opozoril, ciljnih vrst in karence.
Classification of variations
Razvrstitev sprememb
In relation to any variation which is not an extension the classification laid down in Annex II shall apply.
Za vse spremembe, ki niso razširitev, se uporablja razvrstitev iz Priloge II.
A variation which is not an extension and whose classification is undetermined after application of the rules provided for in this Regulation, taking into account the guidelines referred to in point (a) of Article 4(1) and, where relevant, any recommendations delivered pursuant to Article 5, shall by default be considered a minor variation of type IB.
Sprememba, ki ni razširitev in katere razvrstitev po uporabi pravil iz te uredbe ni določena, ob upoštevanju smernic iz točke (a) člena 4(1) in priporočil, pripravljenih na podlagi člena 5, se samodejno šteje za manjšo spremembo tipa IB.
By way of derogation from paragraph 2, a variation which is not an extension and whose classification is undetermined after application of the rules provided for in this Regulation shall be considered a major variation of type II in the following cases:
Z odstopanjem od odstavka 2 se sprememba, ki ni razširitev in katere razvrstitev po uporabi pravil iz te uredbe ni določena, šteje za večjo spremembo tipa II v naslednjih primerih:
upon request from the holder when submitting the variation;
na zahtevo imetnika, ko vloži spremembo;
where the competent authority of the reference Member State as referred to in Article 32 of Directive 2001/82/EC and Article 28 of Directive 2001/83/EC (hereinafter the reference Member State), in consultation with the other Member States concerned or, in the case of a centralised marketing authorisation, the Agency concludes, following the assessment of validity of a notification in accordance with Article 9(1) or Article 15(1) and taking into account the recommendations delivered pursuant to Article 5, that the variation may have a significant impact on the quality, safety or efficacy of the medicinal product concerned.
če pristojni organ referenčne države članice, kot je navedeno v členu 32 Direktive 2001/82/ES in členu 28 Direktive 2001/83/ES (v nadaljevanju „referenčna država članica“) ali v primeru centraliziranih dovoljenj za promet, Agencija po presoji formalne popolnosti priglasitve v skladu s členom 9(1) ali členom 15(1) in ob upoštevanju priporočil, danih v skladu s členom 5, ugotovi, da sprememba lahko pomembno vpliva na kakovost, varnost in učinkovitost zadevnega zdravila.
The Commission shall, after consulting the Member States, the Agency and interested parties, draw up:
Komisija po posvetovanju z državami članicami, Agencijo in zainteresiranimi stranmi pripravi:
guidelines on the details of the various categories of variations;
smernice glede podrobnosti o različnih skupinah sprememb;
guidelines on the operation of the procedures laid down in Chapters II, III and IV of this Regulation as well as on the documentation to be submitted pursuant to these procedures.
smernice glede uporabe postopkov iz poglavij II, III in IV te uredbe ter glede dokumentacije, ki se predloži v skladu s temi postopki.
Guidelines referred to in point (a) of paragraph 1 shall be drawn up by the date referred to in the second subparagraph of Article 28 and shall be regularly updated, taking into account the recommendations delivered in accordance with Article 5 as well as scientific and technical progress.
Smernice iz točke (a) odstavka 1 se pripravijo do datuma iz drugega pododstavka člena 28 in se redno posodabljajo ob upoštevanju priporočil, danih v skladu s členom 5, ter znanstvenega in tehničnega napredka.
Recommendation on unforeseen variations
Priporočilo glede nepredvidenih sprememb
Prior to submission or examination of a variation whose classification is not provided for in this Regulation, a holder or a competent authority of a Member State may request the coordination group referred to in Article 31 of Directive 2001/82/EC or in Article 27 of Directive 2001/83/EC (hereinafter the coordination group) or, in the case of a variation to the terms of a centralised marketing authorisation, the Agency to provide a recommendation on the classification of the variation.
Pred predložitvijo ali preučitvijo spremembe, katere razvrstitev ni predvidena v tej uredbi, lahko imetnik ali pristojni organ države članice zaprosi koordinacijsko skupino iz člena 31 Direktive 2001/82/ES ali člena 27 Direktive 2001/83/ES (v nadaljnjem besedilu „koordinacijska skupina“) ali pri spremembi pogojev centraliziranih dovoljenj za promet Agencijo, da mu izda priporočilo glede razvrstitve spremembe.
The recommendation referred to in the first subparagraph shall be consistent with the guidelines referred to in point (a) of Article 4(1).
Priporočilo iz prvega pododstavka je skladno s smernicami iz točke (a) člena 4(1).
It shall be delivered within 45 days following receipt of the request and sent to the holder, the Agency and the competent authorities of all Member States.
Izda se v 45 dneh po prejemu zahtevka, pošlje pa se imetniku, Agenciji in pristojnim organom vseh držav članic.
The Agency and the two coordination groups referred to in paragraph 1 shall cooperate to ensure the coherence of the recommendations delivered in accordance with that paragraph and publish those recommendations after deletion of all information of commercial confidential nature.
Agencija in koordinacijski skupini iz odstavka 1 sodelujejo pri zagotavljanju usklajenosti priporočil, danih v skladu z navedenim odstavkom, ki jih objavijo, potem ko izbrišejo vse informacije z značajem poslovne tajnosti.
Variations leading to the revision of product information
Spremembe, ki imajo za posledico revizijo podatkov o zdravilu
Where a variation leads to the revision of the summary of product characteristics, labelling or package leaflet, this revision shall be considered as part of that variation.
Če ima sprememba za posledico revizijo povzetka glavnih značilnosti zdravila, označevanja ali navodil za uporabo, se ta revizija šteje kot sestavni del navedene spremembe.
Grouping of variations
Združevanje sprememb v skupine
Where several variations are notified or applied for, a separate notification or application as laid down in Chapters II, III and IV shall be submitted in respect of each variation sought.
Če se priglasi več sprememb ali se odda vloga za več sprememb, se za vsako zahtevano spremembo predloži ločena priglasitev ali vloga v skladu s poglavji II, III in IV.
By way of derogation from paragraph 1, the following shall apply:
Z odstopanjem od odstavka 1 se uporablja naslednje:
where the same minor variations of type IA to the terms of one or several marketing authorisations owned by the same holder are notified at the same time to the same relevant authority, a single notification as referred to in Articles 8 and 14 may cover all such variations;
če se istemu ustreznemu organu hkrati priglasijo enake manjše spremembe tipa IA pogojev enega ali več dovoljenj za promet istega imetnika, se lahko vse take spremembe zajamejo v eno priglasitev v skladu s členoma 8 in 14;
where several variations to the terms of the same marketing authorisation are submitted at the same time, a single submission may cover all such variations provided that the variations concerned fall within one of the cases listed in Annex III or, if they do not fall within one of those cases, provided that the competent authority of the reference Member State in consultation with the other Member States concerned or, in the case of a centralised marketing authorisation, the Agency agrees to subject those variations to the same procedure.
če se hkrati predloži več sprememb pogojev istega dovoljenja za promet, lahko ena predložitev vključuje vse takšne spremembe, če zadevne spremembe spadajo v enega od primerov iz Priloge III ali če ne spadajo v enega od teh primerov, če pristojni organ referenčne države članice ali pri centraliziranih dovoljenjih za promet Agencija soglaša, da za te spremembe uporabi isti postopek.
The submission referred to in point (b) of the first subparagraph shall be made by means of the following:
Predložitev iz točke (b) prvega pododstavka se opravi na naslednji način:
a single notification as referred to in Articles 9 and 15 where at least one of the variations is a minor variation of type IB and all variations are minor variations;
z eno priglasitvijo v skladu s členoma 9 in 15, če je najmanj ena od sprememb manjša sprememba tipa IB in če so vse spremembe manjše spremembe,
a single application as referred to in Articles 10 and 16 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 členoma 10 in 16, če je najmanj ena od sprememb večja sprememba tipa II in nobena od sprememb ni razširitev,
a single application as referred to in Article 19 where at least one of the variations is an extension.
z eno vlogo v skladu s členom 19, če je najmanj ena od sprememb razširitev.
VARIATIONS TO MARKETING AUTHORISATIONS GRANTED IN ACCORDANCE WITH DIRECTIVE 87/22/EEC, CHAPTER 4 OF DIRECTIVE 2001/82/EC OR CHAPTER 4 OF DIRECTIVE 2001/83/EC
SPREMEMBE DOVOLJENJ ZA PROMET Z ZDRAVILI, KI SE IZDAJO V SKLADU Z DIREKTIVO 87/22/EGS, POGLAVJEM 4 DIREKTIVE 2001/82/ES ALI POGLAVJEM 4 DIREKTIVE 2001/83/ES
Notification procedure for minor variations of type IA
Postopek priglasitve manjših sprememb tipa IA
Where a minor variation of type IA is made, the holder shall submit simultaneously to all relevant authorities a notification containing the elements listed in Annex IV.
Pri manjši spremembi tipa IA imetnik hkrati predloži vsem ustreznim organom 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 uveljavitve spremembe.
However, the notification shall be submitted immediately after the implementation of the variation in the case of minor variations requiring immediate notification for the continuous supervision of the medicinal product concerned.
Priglasitev pa se predloži takoj po začetku uveljavitve spremembe pri manjših spremembah, ki zahtevajo takojšnjo priglasitev zaradi stalnega nadzora zadevnega zdravila.
Within 30 days following receipt of the notification, the measures provided for in Article 11 shall be taken.
V 30 dneh po prejemu priglasitve se uporabijo ukrepi iz člena 11.
Notification procedure for minor variations of type IB
Postopek priglasitve manjših sprememb tipa IB
The holder shall submit simultaneously to all relevant authorities a notification containing the elements listed in Annex IV.
Imetnik vsem ustreznim organom hkrati predloži priglasitev, ki vsebuje elemente iz Priloge IV.
If the notification fulfils the requirement laid down in the first subparagraph, the competent authority of the reference Member State shall, after consulting the other Member States concerned, acknowledge receipt of a valid notification.
Če priglasitev izpolnjuje zahtevo iz prvega pododstavka, pristojni organ referenčne države članice potrdi prejem formalno popolne priglasitve.
If within 30 days following the acknowledgement of receipt of a valid notification, the competent authority of the reference Member State has not sent the holder an unfavourable opinion, the notification shall be deemed accepted by all relevant authorities.
Če v 30 dneh po potrditvi prejema formalno popolne priglasitve pristojni organ referenčne države članice imetniku ne pošlje negativnega mnenja, se šteje, da so priglasitev sprejeli vsi ustrezni organi.
Where the notification is accepted by the competent authority of the reference Member State, the measures provided for in Article 11 shall be taken.
Če pristojni organ referenčne države članice sprejme priglasitev, se uporabijo ukrepi iz člena 11.
Where the competent authority of the reference Member State is of the opinion that the notification cannot be accepted, it shall inform the holder and the other relevant authorities, stating the grounds on which its unfavourable opinion is based.
Če pristojni organ referenčne države članice meni, da priglasitve ni mogoče sprejeti, o tem obvesti imetnika in druge ustrezne organe ter navede razloge, na katerih je utemeljil svoje negativno mnenje.
Within 30 days following the receipt of the unfavourable opinion, the holder may submit to all relevant authorities 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 predloži vsem ustreznim organom 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 by all relevant authorities and the measures provided for in Article 11 shall be taken.
Če imetnik priglasitve ne dopolni v skladu z drugim pododstavkom, se šteje, da so priglasitev zavrnili vsi ustrezni organi, uporabijo pa se ukrepi iz člena 11.
Where an amended notification has been submitted, the competent authority of the reference Member State shall assess it within 30 days following its receipt and the measures provided for in Article 11 shall be taken.
Če se predloži dopolnjena priglasitev, jo pristojni organ referenčne države članice oceni v 30 dneh po njenem prejemu, uporabijo pa se ukrepi iz člena 11.
‘Prior Approval’ procedure for major variations of type II
Postopek „predhodne odobritve“ za večje spremembe tipa II
The holder shall submit simultaneously to all relevant authorities an application containing the elements listed in Annex IV.
Imetnik vsem ustreznim organom hkrati predloži vlogo, ki vsebuje elemente iz Priloge IV.
If the application fulfils the requirements laid down in the first subparagraph, the competent authority of the reference Member State shall acknowledge receipt of a valid application and inform the holder and the other relevant authorities that the procedure starts from the date of such acknowledgement.
Če vloga izpolnjuje zahteve iz prvega pododstavka, pristojni organ referenčne države članice potrdi prejem formalno popolne vloge ter obvesti imetnika in druge ustrezne organe, da se postopek začne po datumu te potrditve.
Within 60 days following the acknowledgement of receipt of a valid application, the competent authority of the reference Member State shall prepare an assessment report and a decision on the application, which shall be communicated to the other relevant authorities.
V 60 dneh po potrditvi prejema formalno popolne vloge pristojni organ referenčne države članice pripravi poročilo o oceni in sprejme odločitev o vlogi, kar sporoči drugim ustreznim organom.
The competent authority of the reference Member State 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.
Pristojni organ referenčne države članice lahko rok iz prvega pododstavka skrajša ob upoštevanju nujnosti zadeve ali ga podaljša na 90 dni za spremembe iz dela 1 Priloge V.
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 znaša 90 dni za spremembe iz dela 2 Priloge V.
Within the period referred to in paragraph 2, the competent authority of the reference Member State may request the holder to provide supplementary information within a time limit set by that competent authority.
V roku iz odstavka 2 lahko pristojni organ referenčne države članice od imetnika zahteva, da zagotovi dodatne informacije v roku, ki ga določi navedeni pristojni organ.
the competent authority of the reference Member State shall inform the other competent authorities concerned of its request for supplementary information;
pristojni organ referenčne države članice obvesti druge zadevne pristojne organe o svoji zahtevi za dodatne informacije;
the procedure shall be suspended until such supplementary information has been provided;
se postopek začasno ustavi do zagotovitve takih dodatnih informacij;
the competent authority of the reference Member State may extend the period referred to in paragraph 2.
pristojni organ referenčne države članice lahko podaljša rok iz odstavka 2.
Without prejudice to Article 13 and within 30 days following receipt of the decision and of the assessment report referred to in paragraph 2, the relevant authorities shall recognise the decision and inform the competent authority of the reference Member State accordingly.
Brez poseganja v člen 13 in v 30 dneh po prejemu odločbe in poročila o oceni iz odstavka 2 ustrezni organi potrdijo odločitev ter o tem obvestijo pristojni organ referenčne države članice.
If, within the period referred to in the first subparagraph, a relevant authority has not expressed its disagreement in accordance with Article 13, the decision shall be deemed recognised by that relevant authority.
Če v roku iz prvega pododstavka ustrezni organ ne izrazi nestrinjanja v skladu s členom 13, se šteje, da je ustrezni organ odločitev potrdil.
Where the decision referred to in paragraph 2 has been recognised by all relevant authorities in accordance with paragraph 4, the measures provided for in Article 11 shall be taken.
Če so odločitev iz odstavka 2 potrdili vsi ustrezni organi v skladu z odstavkom 4, se uporabijo ukrepi iz člena 11.
Measures to close the procedures of Articles 8 to 10
Ukrepi za zaključek postopkov iz členov 8 do 10
Where reference is made to this Article, the competent authority of the reference Member State shall take the following measures:
Pri sklicevanju na ta člen pristojni organ referenčne države članice uporabi naslednje ukrepe:
it shall inform the holder and the other relevant authorities as to whether the variation is accepted or rejected;
obvesti imetnika in druge ustrezne organe, ali je bila sprememba ali priglasitev sprejeta ali zavrnjena;
where the variation is rejected, it shall inform the holder and the other relevant authorities of the grounds for the rejection;
kadar se sprememba ali priglasitev zavrne, pristojni organ referenčne države članice obvesti imetnika in druge ustrezne organe o razlogih za zavrnitev;
it shall inform the holder and the other relevant authorities as to whether the variation requires any amendment to the decision granting the marketing authorisation.
obvesti imetnika in druge ustrezne organe, ali je treba zaradi spremembe ali priglasitve spremeniti odločbo o izdaji dovoljenja za promet z zdravilom.
Where reference is made to this Article, each relevant authority shall, where necessary and within the time limit laid down in paragraph 1 of Article 23, amend the decision granting the marketing authorisation in accordance with the accepted variation.
Pri sklicevanju na ta člen vsak ustrezen organ po potrebi in v skladu z rokom iz odstavka 1 člena 23 spremeni odločbo o izdaji dovoljenja za promet z zdravilom v skladu s sprejeto spremembo.
Human influenza vaccines
Cepiva proti človeški gripi
By way of derogation from Article 10, 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 10 se uporablja postopek iz odstavkov od 2 do 6 za pregled sprememb v zvezi s spremembami učinkovine zaradi letne posodobitve cepiva proti človeški gripi.
Within 30 days following the acknowledgement of receipt of a valid application, the competent authority of the reference Member State shall prepare an assessment report and a decision on the application, which shall be communicated to the other relevant authorities.
V 30 dneh po potrditvi prejema formalno popolne vloge pristojni organ referenčne države članice pripravi poročilo o oceni in sprejme odločitev o vlogi, ki jo sporoči drugim ustreznim organom.
Within the period referred to in paragraph 3, the competent authority of the reference Member State may request the holder to provide supplementary information.
V roku iz odstavka 3 lahko pristojni organ referenčne države članice od imetnika zahteva, naj zagotovi dodatne informacije.
It shall inform the other relevant authorities accordingly.
O tem obvesti druge ustrezne organe.
Within 12 days from the date of receipt of the decision and of the assessment report referred to in paragraph 3, the relevant authorities shall recognise the decision and inform the competent authority of the reference Member State accordingly.
V 12 dneh po datumu prejema odločitve in poročila o oceni iz odstavka 3 ustrezni organi potrdijo odločitev in o tem obvestijo pristojni organ referenčne države članice.