natgillin/translations-raw huggingface dataset:
Where requested by the competent authority of the reference Member State, the clinical data and data concerning the stability of the medicinal product shall be submitted by the holder to all relevant authorities within 12 days from the expiry of the period referred to in paragraph 5.
Če to zahteva pristojni organ referenčne države članice, imetnik predloži vsem ustreznim organom klinične podatke in podatke o stabilnosti zdravila v 12 dneh po izteku roka iz odstavka 5.
The competent authority of the reference Member State shall evaluate the data referred to in the first subparagraph and draft a final decision within seven days following receipt of the data.
Pristojni organ referenčne države članice oceni podatke iz prvega pododstavka in sestavi osnutek končne odločitve v sedmih dneh po prejemu podatkov.
The other relevant authorities shall, within seven days following its receipt, recognise that final decision and adopt a decision in accordance with the final decision.
Drugi ustrezni organi v sedmih dneh po prejemu končne odločitve le-to potrdijo in sprejmejo.
Coordination group and arbitration
Koordinacijska skupina in arbitraža
Where recognition of a decision in accordance with Article 10(4) or approval of an opinion in accordance with point (b) of Article 20(8) is not possible on grounds of a potential serious risk to public health in the case of medicinal products for human use or, in the case of veterinary medicinal products, on grounds of a potential serious risk to human or animal health or to the environment, a relevant authority shall request that the matter of disagreement be forthwith referred to the coordination group.
Če potrditev odločitve v skladu s členom 10(4) ali mnenja v skladu s točko (b) člena 20(8) ni mogoča zaradi morebitnega resnega tveganja za javno zdravje v primeru zdravil za uporabo v humani medicini ali, v primeru veterinarskih zdravil, zaradi morebitnega resnega tveganja za zdravje ljudi ali živali ali za okolje, ustrezni organ zahteva, naj se sporna zadeva takoj preda koordinacijski skupini.
The party in disagreement shall give a detailed statement of the reasons for its position to all Member States concerned and to the applicant.
Stranka, ki se ne strinja, podrobno obrazloži razloge za svoje stališče vsem vključenim državam članicam in predlagatelju.
Article 33(3), (4) and (5) of Directive 2001/82/EC or Article 29(3), (4) and (5) of Directive 2001/83/EC shall apply to the matter of disagreement referred to in paragraph 1.
Člen 33(3), (4) in (5) Direktive 2001/82/ES ali člen 29(3), (4) in (5) Direktive 2001/83/ES se uporabi za sporno zadevo iz odstavka 1.
VARIATIONS TO CENTRALISED MARKETING AUTHORISATIONS
SPREMEMBE CENTRALIZIRANIH DOVOLJENJ ZA PROMET Z ZDRAVILI
Where a minor variation of type IA is made, the holder shall submit to the Agency a notification containing the elements listed in Annex IV.
Pri manjši spremembi tipa IA imetnik predloži Agenciji priglasitev, ki vsebuje elemente iz Priloge IV.
This notification shall be submitted within 12 months following implementation of the variation.
Ta priglasitev se predloži v 12 mesecih po začetku uveljavitve spremembe.
Within 30 days following receipt of the notification, the measures provided for in Article 17 shall be taken.
V 30 dneh po prejemu priglasitve se uporabijo ukrepi iz člena 17.
The holder shall submit to the Agency a notification containing the elements listed in Annex IV.
Imetnik predloži Agenciji priglasitev, ki vsebuje elemente iz Priloge IV.
If the notification fulfils the requirement laid down in the first subparagraph, the Agency shall acknowledge receipt of a valid notification.
Če priglasitev izpolnjuje zahtevo iz prvega pododstavka, Agencija potrdi prejem formalno popolne priglasitve.
If within 30 days following the acknowledgement of receipt of a valid notification the Agency has not sent the holder an unfavourable opinion, its opinion shall be deemed favourable.
Če v 30 dneh po potrditvi prejema formalno popolne priglasitve Agencija imetniku ne pošlje negativnega mnenja, se šteje, da je njeno mnenje pozitivno.
Where the opinion of the Agency on the notification is favourable, the measures provided for in Article 17 shall be taken.
Če je mnenje Agencije o priglasitvi pozitivno, se uporabijo ukrepi iz člena 17.
Where the Agency 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.
Če Agencija meni, da priglasitve ni mogoče sprejeti, o tem obvesti imetnika in navede razloge, na katerih je utemeljila svoje negativno mnenje.
Within 30 days of receipt of the unfavourable opinion, the holder may submit to the Agency 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 Agenciji 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 and the measures provided for in Article 17 shall be taken.
Če imetnik priglasitve ne dopolni v skladu z drugim pododstavkom, se šteje, da je bila priglasitev zavrnjena, uporabijo pa se ukrepi iz člena 17.
Where an amended notification has been submitted, the Agency shall assess it within 30 days following its receipt and the measures provided for in Article 17 shall be taken.
Če se predloži dopolnjena priglasitev, jo Agencija oceni v 30 dneh po njenem prejemu, uporabijo pa se ukrepi iz člena 17.
The holder shall submit to the Agency an application containing the elements listed in Annex IV.
Imetnik predloži Agenciji vlogo, ki vsebuje elemente iz Priloge IV.
If the application fulfils the requirements laid down in the first subparagraph, the Agency shall acknowledge receipt of a valid application.
Če vloga izpolnjuje zahteve iz prvega pododstavka, Agencija potrdi prejem formalno popolne vloge.
The Agency shall issue an opinion on the valid application referred to in paragraph 1 within 60 days following its receipt.
Agencija izda mnenje o formalno popolni vlogi iz odstavka 1 v 60 dneh po njenem prejemu.
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.
Agencija lahko rok iz prvega pododstavka skrajša ob upoštevanju nujnosti zadeve ali podaljša na 90 dni za spremembe iz dela 1 Priloge V.
Within the period referred to in paragraph 2, the Agency may request the holder to provide supplementary information within a time limit set by the Agency.
V roku iz odstavka 2 lahko Agencija od imetnika zahteva, da zagotovi dodatne informacije v roku, ki ga določi Agencija.
The procedure shall be suspended until such time as the supplementary information has been provided.
Postopek se začasno ustavi, dokler se ne zagotovijo dodatne informacije.
In this case the Agency may extend the period referred to in paragraph 2.
V tem primeru lahko Agencija podaljša rok iz odstavka 2.
Article 9(1) and (2) and Article 34(1) and (2) of Regulation (EC) No 726/2004 shall apply to the opinion on the valid application.
Za mnenje o formalno popolni vlogi se uporabljata člen 9(1) in (2) ter člen 34(1) in (2) Uredbe (ES) št. 726/2004.
Within 15 days from the adoption of the final opinion on the valid application, the measures provided for in Article 17 shall be taken.
V 15 dneh po sprejetju končnega mnenja o formalno popolni vlogi se uporabijo ukrepi iz člena 17.
Measures to close the procedures of Articles 14 to 16
Ukrepi za zaključek postopkov iz členov 14 do 16
Where reference is made to this Article, the Agency shall take the following measures:
Pri sklicevanju na ta člen Agencija uporabi naslednje ukrepe:
it shall inform the holder and the Commission as to whether its opinion on the variation is favourable or unfavourable;
obvesti imetnika in Komisijo, ali je njeno mnenje o spremembi ali priglasitvi pozitivno ali negativno;
where its opinion on the variation is unfavourable, it shall inform the holder and the Commission of the grounds for that opinion;
kadar je njeno mnenje o spremembi ali priglasitvi negativno, obvesti imetnika in Komisijo o razlogih za tako mnenje;
it shall inform the holder and the Commission as to whether the variation requires any amendment to the decision granting the marketing authorisation.
obvesti imetnika in Komisijo, ali je treba zaradi spremembe spremeniti odločbo o izdaji dovoljenja za promet z zdravilom.
Where reference is made to this Article, the Commission shall, where necessary, based on a proposal from the Agency and within the time limit laid down in paragraph 1 of Article 23, amend the decision granting the marketing authorisation and update the Community Register of Medicinal Products provided for in Article 13(1) and Article 38(1) of Regulation (EC) No 726/2004 accordingly.
Pri sklicevanju na ta člen Komisija po potrebi na predlog Agencije in v skladu z rokom iz odstavka 1 člena 23 spremeni odločbo o izdaji dovoljenja za promet z zdravilom in skladno s tem posodobi Register zdravil Skupnosti iz člena 13(1) in člena 38(1) Uredbe (ES) št. 726/2004.
By way of derogation from Article 16, the procedure laid down in paragraphs 2 to 7 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 2 do 7 za pregled sprememb v zvezi s spremembami učinkovine zaradi letne posodobitve cepiva proti človeški gripi.
If the application fulfils the requirements laid down in the first subparagraph, the Agency shall acknowledge receipt of a valid application and inform the holder that the procedure starts from the date of such acknowledgement.
Če vloga izpolnjuje zahteve iz prvega pododstavka, Agencija potrdi prejem formalno popolne vloge in imetnika obvesti, da se postopek začne od datuma te potrditve.
Within 45 days following the acknowledgement of receipt of a valid application, the Agency shall give its opinion on the application.
V 45 dneh po potrditvi prejema formalno popolne vloge Agencija izda mnenje o vlogi.
Within the period referred to in paragraph 3, the Agency may request the holder to provide supplementary information.
V roku iz odstavka 3 lahko Agencija od imetnika zahteva, da zagotovi dodatne informacije.
The Agency shall submit forthwith its opinion to the Commission.
Agencija svoje mnenje takoj posreduje Komisiji.
The Commission shall, where necessary and on the basis of that opinion, adopt a decision on the variation to the terms of the marketing authorisation and inform the holder accordingly.
Komisija po potrebi in na podlagi tega mnenja sprejme odločitev o spremembi pogojev dovoljenja za promet z zdravilom in v skladu s tem obvesti imetnika.
Where requested, the holder shall submit the clinical data and the data concerning the stability of the medicinal product to the Agency within 12 days from the expiry of the period referred to in paragraph 3.
Če se to od imetnika zahteva, ta Agenciji predloži klinične podatke in podatke o stabilnosti zdravila v 12 dneh po izteku roka iz odstavka 3.
The Agency shall evaluate the data referred to in the first subparagraph and shall give its final opinion within 10 days following receipt of the data.
Agencija oceni podatke iz prvega pododstavka in v desetih dneh po njihovem prejemu izda končno mnenje.
The Agency shall communicate its final opinion to the Commission and to the holder within three days from the date of issue of its final opinion.
Agencija pošlje končno mnenje Komisiji in imetniku v treh dneh po datumu izdaje svojega končnega mnenja.
Where necessary and based on the final opinion of the Agency, the Commission shall amend the decision granting the marketing authorisation and update the Community Register of Medicinal Products provided for in Article 13(1) of Regulation (EC) No 726/2004 accordingly.
Komisija po potrebi in na podlagi končnega mnenja Agencije spremeni odločbo o izdaji dovoljenja za promet z zdravilom in skladno s tem posodobi Register zdravil Skupnosti iz člena 13(1) Uredbe (ES) št. 726/2004.
CHAPTER IV
POGLAVJE ÍV
Special procedures
Posebni postopki
Extensions of marketing authorisations
Razširitev dovoljenj za promet z zdravili
An application for an extension of a marketing authorisation shall be evaluated in accordance with the same procedure as for the initial marketing authorisation to which it relates.
Vloga za razširitev dovoljenja za promet z zdravilom se oceni po enakem postopku, kot velja za prvotno dovoljenje za promet z zdravilom, na katero se dovoljenje nanaša.
An extension shall either be granted a marketing authorisation in accordance with the same procedure as for the granting of the initial marketing authorisation to which it relates or be included in that marketing authorisation.
Za razširitev se izda dovoljenje za promet v skladu z enakim postopkom, kot velja za izdajo prvotnega dovoljenja za promet, na katero se dovoljenje nanaša, ali pa se razširitev vključi v navedeno dovoljenje za promet. V zadnjem primeru je ime zdravila za razširitev enako kot v veljavnem dovoljenju za promet z zdravilom.
Worksharing procedure
Postopek za delitev dela
By way of derogation from Article 7(1) and Articles 9, 10, 15 and 16, where a minor variation of type IB, a major variation of type II or a group of variations in the cases of point (b) of Article 7(2) which does not contain any extension relates to several marketing authorisations owned by the same holder, the holder of such authorisations may follow the procedure laid down in paragraphs 3 to 9 of this Article.
Z odstopanjem od člena 7(1) in členov 9, 10, 15 in 16 lahko imetnik takih dovoljenj, če se manjša sprememba tipa IB, večja sprememba tipa II ali skupina sprememb v primerih iz točke (b) člena 7(2), ki ne vsebujejo razširitve, nanaša na več dovoljenj za promet z zdravilom, ki jih ima isti imetnik, uporablja postopek iz odstavkov od 3 do 9 tega člena.
For the purposes of paragraphs 3 to 9, ‘reference authority’ shall mean one of the following:
Za namene odstavkov 3 do 9 je „referenčni organ“:
the Agency where at least one of the marketing authorisations referred to in paragraph 1 is a centralised marketing authorisation;
Agencija, če je najmanj eno od dovoljenj za promet z zdravilom iz odstavka 1 centralizirano dovoljenje za promet z zdravilom, ali
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 pristojni organ vključene države članice, ki ga izbere koordinacijska skupina ob upoštevanju priporočila imetnika.
The holder shall submit to all relevant authorities an application containing the elements listed in Annex IV, with an indication of the recommended reference authority.
Imetnik predloži vsem ustreznim organom vlogo, ki vsebuje elemente iz Priloge IV, in navede priporočeni referenčni organ.
If the application fulfils the requirements laid down in the first subparagraph, the coordination group shall chose a reference authority and that reference authority shall acknowledge receipt of a valid application.
Če vloga izpolnjuje zahteve iz prvega pododstavka, koordinacijska skupina izbere referenčni organ, ta referenčni organ pa potrdi prejem formalno popolne vloge.
Where the chosen reference authority is the competent authority of a Member State which has not granted a marketing authorisation for all the medicinal products affected by the application, the coordination group may request another relevant authority to assist the reference authority in the evaluation of that application.
Kadar je izbrani referenčni organ pristojni organ države članice, ki ni izdala dovoljenja za promet za vsa zdravila, ki jih zadeva vloga, lahko koordinacijska skupina zaprosi drug ustrezen organ za pomoč referenčnemu organu pri presoji navedene vloge.
The reference authority shall issue an opinion on the valid application 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 60 days following acknowledgement of receipt of a valid application in the case of minor variations of type IB or major variations of type II;
v 60 dneh po potrditvi prejema formalno popolne vloge pri manjših spremembah tipa IB ali večjih spremembah tipa II;
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, navedenih v delu 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.
Referenčni organ lahko rok iz točke (a) odstavka 4 ob upoštevanju nujnosti zadeve skrajša ali podaljša na 90 dni za spremembe iz dela 1 Priloge V.
Within the period referred to in paragraph 4, the reference authority may request the holder to provide supplementary information within a time limit set by the reference authority.
V roku iz odstavka 4 lahko referenčni organ od imetnika zahteva, da zagotovi dodatne informacije v roku, ki ga določi referenčni organ.
the reference authority shall inform the other relevant authorities of its request for supplementary information;
referenčni organ obvesti druge ustrezne organe o svoji zahtevi za dodatne informacije;
the reference authority may extend the period referred to in point (a) of paragraph 4.
lahko referenčni organ podaljša rok iz točke (a) odstavka 4.
Where the reference authority is the Agency, Article 9(1), (2) and (3) and Article 34(1), (2) and (3) of Regulation (EC) No 726/2004 shall apply to the opinion on a valid application referred to in paragraph 4.
Če je referenčni organ Agencija, se za mnenje o formalno popolni vlogi, navedeni v odstavku 4, uporabita člen 9(1), (2) in (3) ter člen 34(1), (2) in (3) Uredbe (ES) št. 726/2004.
Where the opinion on a valid application is favourable:
Če je mnenje o formalno popolni vlogi pozitivno:
the Commission shall, within 30 days following receipt of the final opinion and on the basis of a proposal from the Agency, amend where necessary the concerned centralised marketing authorisations and update the Community Register of Medicinal Products provided for in Article 13(1) and Article 38(1) of Regulation (EC) No 726/2004 accordingly;
Komisija v 30 dneh po prejemu končnega mnenja in na predlog Agencije po potrebi spremeni zadevna centralizirana dovoljenja za promet z zdravili in skladno s tem posodobi Register zdravil Skupnosti iz člena 13(1) in člena 38(1) Uredbe (ES) št. 726/2004;
the Member States concerned shall, within 30 days following receipt of the final opinion of the Agency, approve that final opinion, inform the Agency thereof and amend where necessary the concerned marketing authorisations accordingly, unless a referral procedure in accordance with Article 35 of Directive 2001/82/EC or Article 31 of Directive 2001/83/EC is initiated within 30 days following receipt of the final opinion.
zadevne države članice v 30 dneh po prejemu končnega mnenja Agencije potrdijo navedeno končno mnenje, o tem obvestijo Agencijo in v skladu s tem po potrebi spremenijo zadevna dovoljenja za promet z zdravili, razen če se v 30 dneh po prejemu končnega mnenja uvede postopek napotitve zadeve v skladu s členom 35 Direktive 2001/82/ES ali členom 31 Direktive 2001/83/ES.
Where the reference authority is the competent authority of a Member State:
Če je referenčni organ pristojni organ države članice:
it shall send its opinion on the valid application to the holder and to all relevant authorities;
pošlje svoje mnenje o formalno popolni vlogi imetniku in vsem ustreznim organom;
without prejudice to Article 13 and within 30 days following receipt of the opinion, the relevant authorities shall approve that opinion, inform the reference authority and amend the concerned marketing authorisations accordingly.
brez poseganja v člen 13 in v 30 dneh po prejemu končnega mnenja ustrezni organi odobrijo navedeno mnenje, obvestijo referenčni organ in skladno s tem spremenijo zadevna dovoljenja za promet z zdravili.
Upon request from the reference authority, the Member States concerned shall provide information related to the marketing authorisations affected by the variation for the purpose of verifying the validity of the application and of issuing the opinion on the valid application.
Zadevne države članice na zahtevo referenčnega organa zagotovijo informacije o dovoljenjih za promet z zdravili, na katera vpliva sprememba, zaradi preveritve formalne popolnosti vloge in izdaje mnenja o formalno popolni vlogi.
Pandemic situation with respect to human influenza
Pandemične razmere zaradi človeške gripe
By way of derogation from Articles 12, 18 and 19, where a pandemic situation with respect to human influenza is duly recognised by the World Health Organisation or by the Community in the framework of Decision 2119/98/EC of the European Parliament and of the Council [9], the relevant authorities or, in the case of centralised marketing authorisations, the Commission may exceptionally and temporarily accept a variation to the terms of a marketing authorisation for a human influenza vaccine, where certain non-clinical or clinical data are missing.
Z odstopanjem od členov 12, 18 in 19 lahko ustrezni organi ali pri centraliziranih dovoljenjih za promet z zdravili Komisija, če pandemične razmere zaradi človeške gripe, ki jih uradno prizna Svetovna zdravstvena organizacija ali Skupnost na podlagi Odločbe št. 2119/98/ES Evropskega parlamenta in Sveta [9], izjemoma in začasno sprejmejo spremembo pogojev dovoljenja za promet za cepivo proti človeški gripi, če manjkajo nekateri neklinični ali klinični podatki.
Where a variation is accepted pursuant to paragraph 1, the holder shall submit the missing non-clinical and clinical data within a time limit set by the relevant authority.
Če se sprememba sprejme v skladu z odstavkom 1, imetnik predloži manjkajoče neklinične in klinične podatke v roku, ki ga določi ustrezni organ.
Urgent safety restrictions
Nujni varnostni ukrepi
Where, in the event of a risk to public health in the case of medicinal products for human use or, in the case of veterinary medicinal products, in the event of a risk to human or animal health or to the environment, the holder takes urgent safety restrictions on its own initiative, it shall forthwith inform all relevant authorities and, in the case of a centralised marketing authorisation, the Commission.
Kadar imetnik zaradi nevarnosti za javno zdravje v primeru zdravil za humano uporabo ali, v primeru veterinarskih zdravil, zaradi nevarnosti za zdravje ljudi ali živali ali za okolje na svojo pobudo sprejme nujne varnostne ukrepe, o tem takoj obvesti ustrezne organe, pri centraliziranih dovoljenjih za promet z zdravili pa Komisijo.
If no relevant authority or, in the case of a centralised marketing authorisation, the Commission has raised objections within 24 hours following receipt of that information, the urgent safety restrictions shall be deemed accepted.
Če noben ustrezni organ ali pri centraliziranih dovoljenjih za promet Komisija ne vloži ugovora v 24 urah po prejemu teh informacij, se nujni varnostni ukrepi štejejo za sprejete.
In the event of a risk to public health in the case of medicinal products for human use or, in the case of veterinary medicinal products, in the event of a risk to human or animal health or to the environment, relevant authorities or, in the case of centralised marketing authorisations, the Commission may impose urgent safety restrictions on the holder.
Zaradi nevarnosti za javno zdravje v primeru zdravil za humano uporabo ali, v primeru veterinarskih zdravil, zaradi nevarnosti za zdravje ljudi ali živali ali za okolje lahko ustrezni organi ali pri centraliziranih dovoljenjih za promet Komisija uvedejo nujne varnostne ukrepe za imetnika.