natgillin/translations-raw huggingface dataset:
if the opinion recommends the variation to the terms of a Commission decision granting the marketing authorisation, the Commission shall, having regard to the final opinion and within the time limits foreseen in Article 23(1a), amend the decision(s) accordingly, provided that the revised versions of the documents referred to in Article 9(4) or Article 34(4) of Regulation (EC) No 726/2004 have been received.
če je v mnenju predlagana sprememba pogojev sklepa Komisije o izdaji dovoljenja za promet, Komisija ob upoštevanju končnega mnenja in v rokih iz člena 23(1a) sklepe ustrezno spremeni, če je prejela revidirane različice dokumentov iz člena 9(4) oz. člena 34(4) Uredbe (ES) št. 726/2004.
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;
the Member States concerned shall, within 60 days following receipt of the final opinion of the Agency, approve that final opinion, inform the Agency thereof and, where necessary, amend the marketing authorisations concerned accordingly, provided that the documents necessary for the amendment of the marketing authorisation have been transmitted to the Member States concerned.
zadevne države članice v 60 dneh po prejemu končnega mnenja Agencije odobrijo navedeno končno mnenje, o tem obvestijo Agencijo in po potrebi ustrezno spremenijo zadevna dovoljenja za promet, če je bila dokumentacija za spremembo dovoljenja za promet poslana zadevnim državam članicam.
Where the reference authority is the competent authority of a Member State:
Kadar je referenčni organ pristojni organ države članice:
it shall send its opinion to the holder and to all relevant authorities;
pošlje svoje mnenje 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 and inform the reference authority;
brez poseganja v člen 13 in v 30 dneh po prejemu končnega mnenja ustrezni organi odobrijo navedeno mnenje in obvestijo referenčni organ;
the concerned marketing authorisations shall be amended accordingly within 30 days following the approval of the opinion, provided that the documents necessary for the amendment of the marketing authorisation have been transmitted to the Member States concerned.’;
zadevna dovoljenja za promet se v 30 dneh po odobritvi mnenja ustrezno spremenijo, če je bila dokumentacija za spremembo dovoljenja za promet poslana zadevnim državam članicam.“;
the following paragraph 10 is inserted after paragraph 9:
za odstavkom 9 se doda odstavek 10:
Where harmonisation of a section of the summary of product characteristics of a purely national marketing authorisation has been achieved through a worksharing procedure, any subsequent variation submission affecting the harmonised section shall be transmitted simultaneously to all Member States concerned.’;
Kadar je bila uskladitev oddelka povzetka glavnih značilnosti zdravila izključno nacionalnega dovoljenja za promet dosežena s postopkom za delitev dela, se kakršna koli nadaljnja predložitev za spremembo, ki vpliva na usklajen oddelek, hkrati pošlje vsem zadevnim državam članicam.“
By way of derogation from Chapters I, II, IIa and III, where a pandemic situation with respect to human influenza is duly recognised by the World Health Organisation or by the Union in the framework of Decision 2119/98/EC of the European Parliament and of the Council, 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 poglavij I, II, IIa in III, kadar Svetovna zdravstvena organizacija ali Unija ustrezno prizna pandemične razmere glede človeške gripe v skladu z Odločbo št. 2119/98/ES Evropskega parlamenta in Sveta, lahko ustrezni organi ali Komisija v primeru centraliziranih dovoljenj za promet izjemoma in začasno sprejmejo spremembo pogojev dovoljenja za promet s cepivom proti človeški gripi, čeprav manjkajo nekateri neklinični ali klinični podatki.
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 Agency.
Kadar imetnik pri zdravilih za uporabo v humani medicini zaradi tveganja za javno zdravje ali pri zdravilih za uporabo v veterinarski medicini zaradi tveganja za zdravje ljudi ali živali ali za okolje na svojo pobudo sprejme nujne varnostne ukrepe, o tem takoj obvesti zadevne organe, pri centraliziranih dovoljenjih za promet pa Agencijo.
If the relevant authority or, in the case of a centralised marketing authorisation, the Agency has not raised objections within 24 hours following receipt of that information, the urgent safety restrictions shall be deemed accepted.’;
Če zadevni organ ali Agencija v primeru centraliziranih dovoljenj za promet ne vloži ugovora v 24 urah po prejemu navedenih informacij, se nujni varnostni ukrepi štejejo za sprejete.“
Amendments to the decision granting the marketing authorisation resulting from the procedures laid down in Chapters II and IIa shall be made:
Spremembe sklepa o izdaji dovoljenja za promet na podlagi postopkov iz poglavij II in IIa se opravijo:
in the case of major variations of type II, within two months following receipt of the information referred to in Article 11(1)(c) and Article 13e(a), provided that the documents necessary for the amendment of the marketing authorisation have been transmitted to the Member States concerned;
v primeru večjih sprememb tipa II v dveh mesecih po prejemu informacij iz člena 11(1)(c) in člena 13e(a), če je bila dokumentacija za spremembo dovoljenja za promet poslana zadevnim državam članicam;
in the other cases, within six months following receipt of the information referred to in Article 11(1)(c) and Article 13e(a), provided that the documents necessary for the amendment of the marketing authorisation have been transmitted to the Member States concerned.’;
v drugih primerih v šestih mesecih po prejemu informacij iz člena 11(1)(c) in člena 13e(a), če je bila dokumentacija za spremembo dovoljenja za promet poslana zadevnim državam članicam.“;
Amendments to the decision granting the marketing authorisation resulting from the procedures laid down in Chapter III shall be made:
Spremembe sklepa o izdaji dovoljenja za promet na podlagi postopkov iz poglavja III se opravijo:
within two months following receipt of the information referred to in Article 17(1)(c) for the following variations:
v dveh mesecih po prejemu informacij iz člena 17(1)(c) za naslednje spremembe:
variations related to the addition of a new contraindication;
spremembe, ki so povezane z dodatkom nove kontraindikacije;
variations related to a change in posology;
spremembe, ki so povezane s spremembo pri odmerjanju;
variations related to the addition of a non-food producing target species or the modification of an existing one for veterinary medicinal products;
spremembe, ki so povezane z dodatkom ciljnih vrst živali, ki niso namenjene prehrani ljudi, ali spremembo obstoječe vrste pri zdravilih za uporabo v veterinarski medicini;
variations concerning the replacement or addition of a serotype, strain, antigen or combination of serotypes, strains or antigens for a veterinary vaccine;
spremembe, ki so povezane z zamenjavo ali dodatkom serotipa, seva, antigena ali kombinacije serotipov, sevov ali antigenov pri veterinarskem cepivu;
variations related to changes to the withdrawal period for a veterinary medicinal product;
spremembe, ki so povezane s spremembami karence za zdravilo za uporabo v veterinarski medicini;
other type II variations that are intended to implement changes to the decision granting the marketing authorisation due to a significant public health concern or significant animal health or environmental concern in the case of veterinary medicinal products;
druge spremembe tipa II, s katerimi se uveljavijo spremembe sklepa o izdaji dovoljenja za promet zaradi hujše nevarnosti za javno zdravje ali hujše nevarnosti za zdravje živali ali nevarnost za okolje pri zdravilih za uporabo v veterinarski medicini;
within 12 months following receipt of the information referred to in Article 17(1)(c) in the other cases.
v dvanajstih mesecih po prejemu informacij iz člena 17(1)(c) v ostalih primerih.
The Agency shall determine the variations referred to in point (a)(viii) and provide reasons for such determination.’;
Agencija opredeli spremembe iz točke (a)(viii) in navede razloge za tako opredelitev.“;
Where the decision granting a marketing authorisation is amended as a result of one of the procedures laid down in Chapters II, IIa, III and IV, the relevant authority or, in the case of centralised marketing authorisations, the Commission shall notify the amended decision without delay to the holder.’;
Kadar se sklep o izdaji dovoljenja za promet spremeni zaradi enega od postopkov iz poglavij II, IIa, III in IV, zadevni organ ali Komisija v primeru centraliziranih dovoljenj za promet takoj obvesti imetnika o spremenjenem sklepu.“
the following Article 23a is inserted after Article 23:
Za členom 23 se vstavi naslednji člen 23a:
The statement indicating compliance with the agreed completed paediatric investigation plan provided for under Article 28(3) of Regulation (EC) No 1901/2006 shall be included within the technical dossier of the marketing authorisation.
Izjava o skladnosti z dogovorjenim in izvedenim načrtom pediatričnih raziskav iz člena 28(3) Uredbe (ES) št. 1901/2006 se vključi v tehnično dokumentacijo dovoljenja za promet.
The relevant authority shall provide the holder with a confirmation that the statement is included in the technical dossier within 30 days after the relevant assessment has been concluded.’;
Ustrezni organ v 30 dneh po zaključku zadevnega ocenjevanja imetniku predloži potrdilo, da je izjava vključena v tehnično dokumentacijo.“
Implementation of variations
Uveljavitev sprememb
Minor variations of type IA may be implemented any time before completion of the procedures laid down in Articles 8, 13a and 14.
Manjše spremembe tipa IA se lahko uveljavijo kadar koli pred zaključkom postopkov iz členov 8, 13a in 14.
Where a notification concerning one or several minor variations of type IA is rejected, the holder shall cease to apply the concerned variation(s) immediately after receipt of the information referred to in Articles 11(1)(a), 13e(a), and 17(1)(a).
Če se priglasitev ene ali več manjših sprememb tipa IA zavrne, imetnik preneha uporabljati zadevne spremembe takoj po prejemu informacij iz člena 11(1)(a), člena 13e(a) in člena 17(1)(a).
for variations submitted in accordance with the procedures laid down in Chapter II, after the competent authority of the reference Member State has informed the holder that it has accepted the notification pursuant to Article 9, or after the notification is deemed accepted pursuant to Article 9(2);
za spremembe, ki so bile predložene v skladu s postopki iz poglavja II, potem ko je pristojni organ referenčne države članice obvestil imetnika, da je sprejel priglasitev v skladu s členom 9, ali potem ko se priglasitev šteje za sprejeto v skladu s členom 9(2);
for variations submitted in accordance with the procedures laid down in Chapter IIa, after the relevant authority has informed the holder that it has accepted the notification pursuant to Article 13b, or after the notification is deemed accepted pursuant to Article 13b(2);
za spremembe, ki so bile predložene v skladu s postopki iz poglavja IIa, potem ko je pristojni organ obvestil imetnika, da je sprejel priglasitev v skladu s členom 13b, ali potem ko se priglasitev šteje za sprejeto v skladu s členom 13b(2);
for variations submitted in accordance with the procedures laid down in Chapter III, after the Agency has informed the holder that its opinion referred to in Article 15 is favourable, or after that opinion is deemed favourable pursuant to Article 15(2);
za spremembe, ki so bile predložene po postopkih iz poglavja III, potem ko je Agencija obvestila imetnika, da je njeno mnenje iz člena 15 pozitivno, ali potem ko se mnenje šteje za pozitivno v skladu s členom 15(2);
for variations submitted in accordance with the procedure laid down in Article 20, after the reference authority has informed the holder that its opinion is favourable.
za spremembe, ki so bile predložene po postopku iz člena 20, potem ko je ustrezni organ obvestil imetnika, da je njegovo mnenje pozitivno.
for variations submitted in accordance with the procedures laid down in Chapter II, 30 days after the competent authority of the reference Member State has informed the holder that it has accepted the variation pursuant to Article 10, under the condition that the documents necessary for the amendment to the marketing authorisation have been provided to the Member States concerned.
za spremembe, ki so bile predložene po postopkih iz poglavja II, 30 dni potem, ko je pristojni organ referenčne države članice obvestil imetnika, da je sprejel spremembo v skladu s členom 10, če so bili potrebni dokumenti za spremembo dovoljenja za promet predloženi zadevnim državam članicam.
Where an arbitration procedure has been initiated in accordance with Article 13, the holder shall not implement the variation until the arbitration procedure has concluded that the variation is accepted;
Kadar se je začel arbitražni postopek v skladu s členom 13, imetnik ne uveljavi spremembe, dokler iz arbitražnega postopka ne izhaja, da je sprememba sprejeta;
for variations submitted in accordance with the procedures laid down in Chapter IIa, after the competent authority has informed the holder that it has accepted the variation pursuant to Article 13c;
za spremembe, ki so bile predložene v skladu s postopki iz poglavja IIa, potem ko je pristojni organ imetnika obvestil, da je sprejel spremembo v skladu s členom 13c;
for variations submitted in accordance with the procedures laid down in Chapter III, after the Agency has informed the holder that its opinion referred to in Article 16 is favourable, unless the variation is one referred to in Article 23(1a)(a).
za spremembe, ki so bile predložene v skladu s postopki iz poglavja III, potem ko je Agencija imetnika obvestila, da je njeno mnenje iz člena 16 pozitivno, razen če gre za spremembo iz člena 23(1a)(a).
Variations referred to in Article 23(1a)(a) may only be implemented after the Commission has amended the decision granting the marketing authorisation and notified the holder thereof;
Spremembe iz člena 23(1a)(a) se lahko uveljavijo samo potem, ko Komisija spremeni sklep o izdaji dovoljenja za promet in o tem obvesti imetnika;
for variations submitted in accordance with the procedure laid down in Article 20, 30 days after the reference authority has informed the holder that its opinion is favourable, under the condition that the documents necessary for the amendment to the marketing authorisation have been provided to the Member States concerned; unless an arbitration procedure has been initiated in accordance with Article 13, or unless the procedure concerns a variation to a centralised marketing authorisation as referred to in Article 23(1a)(a).
za spremembe, ki so bile predložene po postopku iz člena 20, 30 dni potem, ko je referenčni organ obvestil imetnika, da je njegovo mnenje pozitivno, če so bili potrebni dokumenti za spremembo dovoljenja za promet predloženi zadevnim državam članicam; razen če se je začel arbitražni postopek v skladu s členom 13 ali razen če se postopek nanaša na spremembo centraliziranega dovoljenja za promet iz člena 23(1a)(a).
Where an arbitration procedure has been initiated in accordance with Article 13, or where the worksharing procedure concerns a variation to a centralised marketing authorisation as referred to in Article 23(1a)(a), the holder shall not implement the variation until the arbitration procedure has concluded that the variation is accepted, or until the Commission Decision amending the decision granting the marketing authorisation has been adopted.
Kadar se je začel arbitražni postopek v skladu s členom 13 ali kadar se postopek za delitev dela nanaša na spremembo centraliziranega dovoljenja za promet iz člena 23(1a)(a), imetnik ne uveljavi spremembe, dokler iz arbitražnega postopka ne izhaja, da je sprememba sprejeta, ali dokler ni sprejet sklep Komisije, ki spreminja sklep o izdaji dovoljenja za promet.
An extension may only be implemented after the relevant authority or, in the case of extensions to a centralised marketing authorisation, the Commission has amended the decision granting the marketing authorisation and notified the holder accordingly.
Razširitev se lahko začne izvajati, ko ustrezni organ, pri razširitvah centraliziranih dovoljenj za promet z zdravili pa Komisija, spremeni sklep o izdaji dovoljenja za promet z zdravilom in o tem obvesti imetnika.
Urgent safety restrictions and variations which are related to safety issues shall be implemented within a time frame agreed by the holder and the relevant authority and, in the case of a centralised marketing authorisation, the Agency.
Nujni varnostni ukrepi in spremembe, povezane z varnostnimi vprašanji, se uveljavijo v časovnem okviru, za katerega se dogovori imetnik z ustreznim organom, pri centraliziranih dovoljenjih za promet z zdravili pa z Agencijo.
By way of derogation from the first subparagraph, urgent safety restrictions and variations related to safety issues which concern marketing authorisations granted in accordance with Chapter 4 of Directive 2001/82/EC or Chapter 4 of Directive 2001/83/EC shall be implemented within a time frame agreed by the holder and the competent authority of the reference Member State, in consultation with the other relevant authorities.’;
Z odstopanjem od prvega pododstavka se nujni varnostni ukrepi in spremembe, povezane z varnostnimi vprašanji, ki se nanašajo na dovoljenja za promet z zdravili, izdana v skladu s poglavjem 4 Direktive 2001/82/ES ali poglavjem 4 Direktive 2001/83/ES, uveljavijo v časovnem okviru, za katerega se dogovorita imetnik in pristojni organ referenčne države članice po posvetovanju z drugimi ustreznimi organi.“
the title of Annex III is replaced by the following:
Naslov Priloge III se nadomesti z naslednjim besedilom:
‘Cases for grouping variations referred to in Article 7(2)(b) and Article 13d(2)(b)’;
„Primeri združevanja sprememb v skupine v skladu s členom 7(2)(b) in členom 13d(2)(b)“.
the following Article 24a is inserted after Article 24:
Za členom 24 se vstavi naslednji člen 24a:
Application of national provisions on variations to purely national marketing authorisations
Uporaba nacionalnih določb pri spremembah izključno nacionalnih dovoljenj za promet
Member States that, in accordance with Article 23b(4) of Directive 2001/83/EC, may continue to apply their national provisions on variations to certain purely national marketing authorisations are listed in Annex VI to this Regulation.’;
Države članice, ki v skladu s členom 23b(4) Direktive 2001/83 lahko nadaljujejo z uporabo nacionalnih določb pri spremembah izključno nacionalnih dovoljenj za promet, so navedene v Prilogi VI k tej uredbi.“
the Annex set out in the Annex to this Regulation is added.
Doda se Priloga, določena v Prilogi k tej uredbi.
From 2 November 2012, the following changes shall apply:
Od 2. novembra 2012 se začnejo uporabljati naslednje spremembe:
in Article 23(1) of Regulation (EC) No 1234/2008, the reference to ‘Chapters II and III’ is replaced by ‘Chapter II’;
v členu 23(1) Uredbe (ES) št. 1234/2008 se sklicevanje „iz poglavij II in III“ nadomesti z „iz poglavja II“;
in Article 23(1) of Regulation (EC) No 1234/2008, subparagraph (a) is deleted.
pododstavek (a) v členu 23(1) Uredbe (ES) št. 1234/2008 se črta.
It shall apply from 2 November 2012.
Uporabljati se začne 2. novembra 2012.
However, points (10), (15), (18)(a) and (c), (21), (22) and (23) of Article 1 shall apply from 4 August 2013.
Točke 10, 15, 18(a) in (c), 21, 22 in 23 člena 1 pa se začnejo uporabljati 4. avgusta 2013.
OJ L 15, 17.1.1987, p. 38.’;
UL L 15, 17.1.1987, str. 38.“;
OJ L 268, 3.10.1998, p. 1.’;
UL L 268, 3.10.1998, str. 1.“
List of Member States referred in Article 24a
Seznam držav članic iz člena 24a
the Republic of Bulgaria,
Republika Bolgarija,
the Federal Republic of Germany.’
Zvezna republika Nemčija.“
Commission Implementing Regulation (EU) No 713/2012
Izvedbena uredba Komisije (EU) št. 713/2012
Commission Implementing Regulation (EU) No 714/2012
Izvedbena uredba Komisije (EU) št. 714/2012
A product consisting of a flexible keypad membrane made of silicone with 19 incorporated keycaps and with dimensions of approximately 65 × 40 × 1 mm.
Izdelek je prožna membrana tipkovnice iz silikona z 19 vgrajenimi tipkami z merami približno 65 × 40 × 1 mm.
The product has printed keycaps representing an alpha/numeric keyboard, call buttons and other buttons typical of mobile phones.
Na tipkah ima natisnjene znake, ki predstavljajo alfa-numerično tipkovnico, klicne gumbe in druge gumbe, značilne za mobilne telefone.
Underneath each keycap there is an electrical contact element made of silicone impregnated with carbon.
Pod vsako tipko je element za električni stik iz silikona, impregniranega z ogljikom.
The product has a specific shape and design and is intended for incorporation in a particular model of a mobile phone.
Izdelek ima posebno obliko in zasnovo ter je namenjen vgradnji v mobilni telefon.
Classification is determined by General Rules 1 and 6 for the interpretation of the Combined Nomenclature, Note 2(b) to Section XVI and by the wording of CN codes 8517, 851770 and 85177090.
Uvrstitev opredeljujejo splošni pravili 1 in 6 za razlago kombinirane nomenklature, opomba 2(b) k oddelku XVI ter besedilo oznak KN 8517, 851770 in 85177090.
Classification under heading 8536 as a switch is excluded as the product comprises only a part (one side of the contact points) of a switching device (see also CN Explanatory Notes to heading 8536, point (8)).
Uvrstitev pod tarifno številko 8536 kot stikalo je izključena, saj izdelek vsebuje samo del (ena stran stičnih točk) stikalne naprave (glej tudi pojasnjevalne opombe KN k tarifni številki 8536, točka 8).
The product is an essential part for the operation of a mobile phone and cannot be used independently for other purposes.
Izdelek je nujni del za delovanje mobilnega telefona in se ne more uporabljati samostojno za druge namene.
Also, it is specially adapted for use in a particular model of a mobile phone.
Poleg tega je posebej prilagojen za uporabo v posebnem modelu mobilnega telefona.
In particular, its shape and method of operation preclude any other use (see also judgment of the Court of Justice of the European Union in Case C-183/06).
Zlasti njegova oblika in način delovanja izključujeta vsako drugo uporabo (glej tudi sodbo Sodišča Evropske unije v zadevi C-183/06).
Consequently, classification under heading 8538 as a part suitable for use solely or principally with a switching device is also excluded.
Uvrstitev pod tarifno številko 8538 kot naprava za vklapljanje in izklapljanje zato ne pride v poštev.
The product is therefore to be classified under CN code 85177090 as a part of a mobile phone.
Proizvod se zato uvrsti pod oznako KN 85177090 kot del mobilnega telefona.
A product (so-called ‘keyboard flex assembly’), the main body of which has dimensions of approximately 56 × 42 × 1 mm and which comprises two membranes constituting a switching device:
Izdelek (t. i. „prožni sestavni del tipkovnice“), katerega glavni element ima mere približno 56 × 42 × 1 mm in je sestavljen iz dveh membran, ki predstavljata stikalno napravo:
an upper membrane of polyimide containing 24 copper contact points on the bottom side,
zgornja membrana iz poliamida ima na spodnji strani 24 bakrenih stičnih točk,