natgillin/translations-raw huggingface dataset:
The variations of all marketing authorisations granted in the EU in accordance with the acquis should be subject to the procedures laid down in Regulation (EC) No 1234/2008.
Za spremembe vseh dovoljenj za promet, izdanih v EU v skladu s pravnim redom EU, morajo veljati postopki iz Uredbe Komisije (ES) št. 1234/2008.
The definition of variation should be clarified and updated in particular to take into consideration the provisions of Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products [6], and the provisions of Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use [7].
Opredelitev spremembe je treba razjasniti in posodobiti, zlasti da se upoštevajo določbe Uredbe (EU) št. 1235/2010 Evropskega parlamenta in Sveta z dne 15. decembra 2010 o spremembah Uredbe (ES) št. 726/2004 o postopkih Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za humano in veterinarsko uporabo ter o ustanovitvi Evropske agencije za zdravila in Uredbe (ES) št. 1394/2007 o zdravilih za napredno zdravljenje [6], glede farmakovigilance zdravil za uporabo v humani medicini, ter določbe Direktive 2010/84/EU Evropskega parlamenta in Sveta z dne 15. decembra 2010 o spremembah Direktive 2001/83/ES o zakoniku Skupnosti o zdravilih za uporabo v humani medicini [7], glede farmakovigilance.
For reasons of consistency and with a view to reducing the administrative burden, variations to purely national marketing authorisations should be processed in accordance with the same principles that apply to variations of marketing authorisations granted under the mutual recognition procedure and the decentralised procedure.
Zaradi doslednosti in zmanjšanja upravnega bremena je treba spremembe izključno nacionalnih dovoljenj za promet obravnavati v skladu z istimi načeli, ki se uporabljajo za spremembe dovoljenj za promet, izdanih po postopku medsebojnega priznavanja in decentraliziranem postopku.
However, the possibilities for grouping variations should be adapted to the specific characteristics of purely national marketing authorisations.
Vendar je treba možnosti za združevanje sprememb prilagoditi specifičnim značilnostim izključno nacionalnih dovoljenj za promet.
It should be possible to process variations to purely national marketing authorisations in accordance with the worksharing procedure under certain conditions.
Pod nekaterimi pogoji je treba omogočiti obravnavo sprememb izključno nacionalnih dovoljenj za promet v skladu s postopkom za delitev dela.
Where the use of the worksharing procedure has lead to the harmonisation of a section of the summary of product characteristics, it should not be possible for the holder to later undermine the harmonisation achieved by submitting applications for variations to the section thus harmonised in some of the concerned Member States only.
Kadar postopek za delitev dela privede do uskladitve oddelka povzetka glavnih značilnosti zdravila, se imetniku ne sme omogočiti, da naknadno oslabi doseženo uskladitev s predložitvijo vlog za spremembe oddelka, ki je bil na tak način usklajen le v nekaterih zadevnih državah članicah.
Grouping of several variations in a single submission is possible in some cases.
V nekaterih primerih je možno združevanje več sprememb v eni vlogi.
It should be clarified that, where several variations are grouped, the procedure for the handling of the variations in the group and the rules for the implementation of those variations should be those of the variation of the highest grade.
Glede združitve več sprememb je treba pojasniti, da morajo postopek za obravnavo združenih sprememb in pravila za uveljavljanje navedenih sprememb ustrezati spremembi najvišje ravni.
In order to facilitate the acceptance of complex groupings by the relevant authorities, it should be possible to extend the assessment period.
Da bodo ustrezni organi lažje sprejemali zapletene združitve, je treba omogočiti podaljšanje obdobja ocenjevanja.
The worksharing procedure is intended to avoid duplication of work.
Namen postopka za delitev dela je preprečevanje podvajanja dela.
Accordingly, it should be possible for competent authorities to process under the same procedure variations to purely national marketing authorisations, variations to marketing authorisations granted under the mutual recognition or decentralised procedure, and variations to centralised marketing authorisations.
Zato je treba pristojnim organom omogočiti, da v istem postopku obravnavajo spremembe izključno nacionalnih dovoljenj za promet, spremembe dovoljenj za promet, izdanih po postopku medsebojnega priznavanja ali decentraliziranem postopku, in spremembe centraliziranih dovoljenj za promet.
The procedure for the variation of human influenza vaccines should be streamlined.
Izboljšati je treba postopek za spremembo cepiv proti človeški gripi.
Competent authorities should still be able to start the assessment in the absence of clinical and stability data and take a decision if no additional information is considered necessary.
Pristojni organi lahko še vedno začnejo ocenjevati brez kliničnih podatkov in podatkov o stabilnosti zdravila ter sprejmejo odločitev, če se dodatne informacije ne štejejo za potrebne.
However, if clinical and stability data is requested, the competent authorities should not be required to take a decision until the assessment thereof has been finalised.
Vendar če se zahtevajo klinični podatki in podatki o stabilnosti zdravila, se od pristojnih organov ne sme zahtevati, da sprejmejo odločitev pred končno oceno zdravila.
For medicinal products authorised under Regulation (EC) No 726/2004, the refusal of the European Medicines Agency to accept a variation should terminate the procedure.
Za zdravila, odobrena v skladu z Uredbo (ES) št. 726/2004, se postopek mora končati, kadar Evropska agencija za zdravila zavrne sprejetje spremembe.
Likewise, a Commission decision should not be required regarding variations that do not amend the terms of the decision granting the marketing authorisation.
Ravno tako se od Komisije ne sme zahtevati, da sprejme sklep glede sprememb, s katerimi se ne spreminjajo pogoji sklepa o izdaji dovoljenja za promet z zdravilom.
The European Medicines Agency has the expertise to assess the need for urgent safety restrictions regarding medicinal products authorised under the centralised procedure.
(9) Evropska agencija za zdravila lahko s strokovnim znanjem oceni potrebo po nujnih varnostnih ukrepih glede zdravil, odobrenih v skladu s centraliziranim postopkom.
Marketing authorisation holders of medicinal products authorised under Regulation (EC) No 726/2004 should therefore inform the Agency if they consider that urgent safety measures are necessary.
Zato morajo imetniki dovoljenj za promet z zdravilom, izdanih v skladu z Uredbo (ES) št. 726/2004, obvestiti Agencijo, če menijo, da so nujni varnostni ukrepi potrebni.
A proliferation of variation procedures leading to frequent changes in the terms of the decision granting the marketing authorisation for centralised marketing authorisations has been identified.
Ugotovljenih je bilo vedno več postopkov za spremembe, ki so privedli do spremenjenih pogojev glede odločitve o izdaji dovoljenja za promet za centralizirana dovoljenja za promet.
Changes that are critical for public health should be reflected in the decision granting the marketing authorisation promptly.
Spremembe, ki so nujne za javno zdravje, morajo biti nemudoma razvidne v odločitvi o izdaji dovoljenja za promet.
However, other changes should be reflected in the decision granting the marketing authorisation according to timelines that ensure reasonable periodic updates of the decision granting the marketing authorisations while facilitating the identification of variations with the greatest impact on public health.
Vendar morajo biti druge spremembe prav tako razvidne v odločitvi o izdaji dovoljenja za promet v skladu s časovnimi razporedi, ki zagotavljajo razumne redne posodobitve odločitev o izdaji dovoljenja za promet in hkrati omogočajo lažjo opredelitev sprememb, ki imajo največji vpliv na javno zdravje.
The principles governing the implementation of variations should be adjusted while keeping the principle that it should be possible for the marketing authorisation holder to implement certain variations prior to the relevant marketing authorisation being changed.
Treba je prilagoditi načela glede uveljavitve sprememb in hkrati ohraniti načelo, da lahko imetnik dovoljenja za promet uveljavlja nekatere spremembe pred spremembo ustreznega dovoljenja za promet.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Medicinal Products for Human Use and the Standing Committee on Veterinary Medicinal Products,
Ukrepi, predvideni s to uredbo, so v skladu z mnenjem Stalnega odbora za zdravila za ljudi in Stalnega odbora za zdravila za uporabo v veterinarski medicini –
Amendments to Regulation (EC) No 1234/2008
Spremembe Uredbe (ES) št. 1234/2008
Regulation (EC) No 1234/2008 is amended as follows:
Uredba (ES) št. 1234/2008 se spremeni:
This Regulation lays down provisions concerning the examination of variations to the terms of all marketing authorisations for medicinal products for human use and veterinary medicinal products granted in accordance with Regulation (EC) No 726/2004, Directive 2001/83/EC, Directive 2001/82/EC, and Council Directive 87/22/EEC.
Ta uredba vsebuje določbe o pregledu sprememb pogojev vseh dovoljenj za promet z zdravili za uporabo v humani medicini in zdravili za uporabo v veterinarski medicini, ki se izdajo v skladu z Uredbo (ES) št. 726/2004, Direktivo 2001/83/ES, Direktivo 2001/82/ES in Direktivo Sveta 87/22/EGS.
the following paragraph shall be inserted after paragraph (3):
za odstavkom 3 se vstavi naslednji odstavek:
Chapter IIa shall apply only to variations to the terms of purely national marketing authorisations.’;
Poglavje IIa se uporablja samo za spremembe pogojev izključno nacionalnih dovoljenj za promet.“
“Variation to the terms of a marketing authorisation” or “variation” means any amendment to:
‚Sprememba pogojev dovoljenja za promet z zdravilom‘ ali ‚sprememba‘ je kakršna koli sprememba:
the information referred to in Articles 12(3) to 14 of Directive 2001/82/EC and Annex I thereto, Articles 8(3) to 11 of Directive 2001/83/EC and Annex I thereto, Articles 6(2) and 31(2) of Regulation (EC) No 726/2004, or Article 7 of Regulation (EC) No 1394/2007;
informacij iz člena 12(3) do člena 14 Direktive št. 2001/82/ES in Priloge I k Direktivi, člena 8(3) do člena 11 Direktive št. 2001/83/ES in Priloge I k Direktivi, členov 6(2) in 31(2) Uredbe (ES) št. 726/2004 ali člena 7 Uredbe (ES) št. 1394/2007;
the terms of the decision granting the marketing authorisation for a medicinal product for human use, including the summary of the product characteristics and any conditions, obligations, or restrictions affecting the marketing authorisation, or changes to the labelling or the package leaflet connected with changes to the summary of the product characteristics;
pogojev sklepa o izdaji dovoljenja za promet z zdravilom za uporabo v humani medicini, vključno s povzetkom glavnih značilnosti zdravila, in katerih koli pogojev, obveznosti ali omejitev, ki vplivajo na dovoljenje za promet, ali sprememb označevanja ali navodil za uporabo, povezanih s spremembami povzetka glavnih značilnosti zdravila;
the terms of the decision granting the marketing authorisation for a veterinary medicinal product, including the summary of the product characteristics and any conditions, obligations, or restrictions affecting the marketing authorisation, or changes to the labelling or the package leaflet.’;
pogojev sklepa za izdajo dovoljenja za promet z zdravilom za uporabo v veterinarski medicini, vključno s povzetkom glavnih značilnosti zdravila, in katerih koli pogojev, obveznosti ali omejitev, ki vplivajo na dovoljenje za promet, ali sprememb označevanja ali navodil za uporabo.“;
“Urgent safety restriction” means an interim change in the terms of the marketing authorisation due to new information having a bearing on the safe use of the medicinal product.’;
‚Nujen varnostni ukrep‘ je začasna sprememba pogojev dovoljenja za promet zaradi novih informacij, ki vplivajo na varno uporabo zdravila.“;
the following paragraph 9 is added:
doda se odstavek 9:
“Purely national marketing authorisation” means any marketing authorisation granted by a Member State in accordance with the acquis outside the mutual recognition or decentralised procedure and that has not been subject to a complete harmonisation following a referral procedure.’;
„Izključno nacionalno dovoljenje za promet z zdravilom“ je kakršno koli dovoljenje za promet, ki ga izda država članica v skladu s pravnim redom, vendar ne v okviru postopka vzajemnega priznavanja ali decentraliziranega postopka, in za katerega po napotitvenem postopku ni bila opravljena popolna uskladitev.“
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 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 člena 4(1) in priporočil, danih v skladu s členom 5, se samodejno šteje za manjšo spremembo tipa IB.“
in paragraph 3, point (b) is replaced by the following:
točka (b) odstavka 3 se nadomesti z naslednjim:
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 the Agency in the case of a centralised marketing authorisation, or the competent authority in the case of a purely national marketing authorisation, concludes, following the assessment of validity of a notification in accordance with Article 9(1), Article 13b(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.’;
kadar pristojni organ referenčne države članice, kot je navedeno v členu 32 Direktive 2001/82/ES in členu 28 Direktive 2001/83/ES (v nadaljnjem besedilu: referenčna država članica), po posvetovanju z drugimi zadevnimi državami članicami, ali Agencija v primeru centraliziranih dovoljenj za promet ali pristojni organ v primeru izključno nacionalnega dovoljenja za promet po oceni formalne popolnosti priglasitve v skladu s členom 9(1), členom 13b(1) ali členom 15(1) in ob upoštevanju priporočil, danih v skladu s členom 5, ugotovi, da sprememba lahko bistveno vpliva na kakovost, varnost ali učinkovitost zadevnega zdravila.“
The Commission shall, after consulting the Member States and the Agency, draw up guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of this Regulation, and on the documentation to be submitted pursuant to those procedures.
Komisija po posvetovanju z državami članicami in Agencijo pripravi smernice o podrobnosti različnih skupin sprememb, uporabi postopkov iz poglavij II, IIa, III in IV te uredbe ter dokumentaciji, ki se predloži v skladu z navedenimi postopki.
The guidelines referred to in paragraph 1 shall be regularly updated.’;
Smernice iz odstavka 1 se redno posodabljajo.“
Prior to the submission of a variation whose classification is not provided for in this Regulation, a holder may request a recommendation on the classification of the variation as follows:
Pred predložitvijo spremembe, katere razvrstitev ni določena v tej uredbi, lahko imetnik glede razvrstitve spremembe zaprosi za priporočilo:
to the Agency, where the variation refers to a marketing authorisation granted under Regulation (EC) No 726/2004;
Agencijo, kadar gre za spremembo dovoljenja za promet, izdanega v skladu z Uredbo (ES) št. 726/2004;
to the competent authority of the Member State concerned, where the variation refers to a purely national marketing authorisation;
pristojni organ zadevne države članice, kadar gre za spremembo izključno nacionalnega dovoljenja za promet;
to the competent authority of the reference Member State, in the other cases.
pristojni organ referenčne države članice v vseh drugih primerih.
The recommendation referred to in the first subparagraph shall be consistent with the guidelines referred to in Article 4(1).
Priporočilo iz prvega pododstavka je skladno s smernicami iz člena 4(1).
It shall be delivered within 45 days following receipt of the request and sent to the holder, the Agency, and the coordination group referred to in Article 31 of Directive 2001/82/EC or in Article 27 of Directive 2001/83/EC.
Izda se v 45 dneh po prejemu zahtevka, pošlje pa se imetniku, Agenciji in koordinacijski skupini iz člena 31 Direktive 2001/82/ES ali člena 27 Direktive 2001/83/ES.
The 45-day period referred to in the second subparagraph may be extended by 25 days where the relevant authority deems it necessary to consult with the coordination group.’;
nevni rok iz drugega odstavka se lahko podaljša za 25 dni, kadar zadevni organ meni, da se je treba posvetovati s koordinacijsko skupino.“;
the following paragraph 1a is inserted after paragraph 1:
za odstavkom 1 se vstavi odstavek 1a:
Prior to the examination of a variation whose classification is not provided for in this Regulation, a competent authority of a Member State may request a recommendation on the classification of the variation to the coordination group.
Pred preučitvijo spremembe, katere razvrstitev ni določena v tej uredbi, lahko pristojni organ države članice zaprosi koordinacijsko skupino za priporočilo glede razvrstitve spremembe.
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.“
Where several variations are notified or applied for, a separate notification or application in accordance with Chapters II, III, or Article 19 as appropriate shall be submitted in respect of each variation sought.
Kadar 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 ali členom 19, kakor je primerno.
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 relevant authority, a single notification as referred to in Article 8 or 14 may cover all such variations;
kadar se istemu zadevnemu 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 8 ali 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;
kadar se hkrati predloži več sprememb pogojev istega dovoljenja za promet, lahko ena predložitev zajema vse take spremembe, če zadevne spremembe spadajo v enega od primerov iz Priloge III;
where several variations to the terms of the same marketing authorisation are submitted at the same time and the variations do not fall within one of the cases listed in Annex III, a single submission may cover all such variations provided that the competent authority of the reference Member State in consultation with the competent authorities of the Member States concerned or, in the case of a centralised marketing authorisation, the Agency agrees to such single submission.
kadar se hkrati predloži več sprememb pogojev istega dovoljenja za promet in spremembe ne spadajo v enega od primerov iz Priloge III, lahko ena predložitev zajema vse take spremembe, če pristojni organ referenčne države članice po posvetovanju s pristojnimi organi zadevnih držav članic ali z Agencijo v primeru centraliziranih dovoljenj za promet z zdravilom soglaša s tako predložitvijo.
The submission referred to in subparagraphs (b) and (c) shall be made simultaneously to all relevant authorities by means of the following:
Predložitev iz pododstavkov (b) in (c) se opravi sočasno pri vseh ustreznih organih na naslednji način:
a single notification in accordance with Article 9 or 15 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 9 ali 15, kadar je najmanj ena od sprememb manjša sprememba tipa IB in so ostale spremembe manjše spremembe;
a single application in accordance with Article 10 or 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 členom 10 ali 16, 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.“
in Article 9, the following paragraph 5 is added:
V členu 9 se doda odstavek 5:
This Article shall not apply where a type IB variation request is submitted in a grouping that includes a variation type II and does not contain an extension.
Ta člen se ne uporablja, kadar se zahtevek za spremembo tipa IB predloži v skupini, ki vključuje spremembo tipa II in ne vključuje razširitve.
In such case, the prior approval procedure in Article 10 shall apply.
V takem primeru se uporablja postopek predhodne odobritve iz člena 10.
This Article shall not apply where a type IB variation request is submitted in a grouping that includes an extension.
Ta člen se ne uporablja, kadar se zahtevek za spremembo tipa IB predloži v skupini, ki vključuje razširitev.
In such case, the procedure in Article 19 shall apply.’;
V takem primeru se uporablja postopek iz člena 19.“
‘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 or for grouping of variations in accordance with Article 7(2)(c).’;
„Pristojni organ referenčne države 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 7(2)(c).“;
This Article shall not apply where a type II variation request is submitted in a grouping that includes an extension.
Ta člen se ne uporablja, kadar se zahtevek za spremembo tipa II predloži v skupini, ki vključuje razširitev.
By way of derogation from Article 10, the procedure laid down in paragraphs 2 to 5 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 5 za pregled sprememb v zvezi s spremembami zdravilne učinkovine zaradi letne posodobitve cepiva proti človeški gripi.“;
paragraphs 3, 4 and 5 are replaced by the following:
odstavki 3, 4 in 5 se nadomestijo z naslednjim:
The competent authority of the reference Member State shall assess the application submitted.
Pristojni organ referenčne države članice oceni predloženo vlogo.