natgillin/translations-raw huggingface dataset:
Under agreement of the type-approval authority, if modelling is applied instead of the type 1 test-cycle, this value shall be the one provided by the modelling methodology.
Če se po dogovoru s homologacijskim organom namesto preskusnega cikla tipa 1 uporabi vzorčenje, se uporabi vrednost, pridobljena z metodologijo vzorčenja.
Sum of the emissions saving of each individual eco-innovation.
Splošna koda ekološke inovacije je sestavljena iz naslednjih elementov, ki so ločeni s presledkom:
If modelling is applied instead of the type 1 test-cycle, this value shall be the one provided by the modelling methodology.
Če se namesto preskusnega cikla tipa 1 uporabi vzorčenje, se uporabi vrednost, pridobljena z metodologijo vzorčenja.
The general code of the eco-innovation(s) shall consist of the following elements, each separated by a blank space:Code of the type-approval authority as set out in Annex VII to Directive 2007/46/EC;Individual code of each eco-innovation fitted in the vehicle, indicated in chronological order of the Commission approval decisions.(E.g. the general code of three eco-innovations approved chronologically as 10, 15 and 16 and fitted to a vehicle certified by the German type approval authority should be: “e1 10 15 16”) ’.
Številka sklepa Komisije o odobritvi ekološke inovacije.oznake homologacijskega organa iz Priloge VII k Direktivi 2007/46/ES,kod vseh ekoloških inovacij, vgrajenih v vozilo, ki se navedejo kronološko na podlagi sklepov Komisije o odobritvi.(Splošna koda treh ekoloških inovacij, ki so bile kronološko odobrene pod številkami 10, 15 in 16 ter so vgrajene v vozilo, ki ga je certificiral nemški homologacijski organ, bi na primer bila: ‚e1 10 15 16‘.) “
In the case of a vehicle type fitted with one or more eco-innovations, within the meaning of Article 12 of Regulation (EC) No 443/2009 of the European Parliament and of the Council and Commission Implementing Regulation (EU) No 725/2011, the conformity of production shall be demonstrated with respect to the eco-innovations by performing the tests provided for in the Commission Decision(s) approving the eco-innovation(s) in question.4.3.5.2. Points 4.3.1, 4.3.2 and 4.3.4 shall apply.
Pri tipih vozil z vgrajenimi ekološkimi inovacijami v smislu člena 12 Uredbe (ES) št. 443/2009 Evropskega parlamenta in Sveta in Izvedbene uredbe (EU) št. 725/2011 se skladnost proizvodnje glede ekoloških inovacij dokaže s preskusi iz sklepa Komisije o odobritvi zadevne ekološke inovacije.4.3.5.2 Uporabljajo se točke 4.3.1, 4.3.2 in 4.3.4.
In case the regulatory act has two or more implementation stages, indicate also the implementation stage: Fuel(s) … (diesel, petrol, LPG, NG, Bi-fuel: petrol/NG, LPG, Flex-fuel: petrol/ethanol, NG/H2NG…)
goriva … (dizelsko gorivo, bencin, utekočinjen naftni plin, zemeljski plin, dvojno gorivo: bencin/zemeljski plin, utekočinjen naftni plin, prilagodljiv tip goriva: bencin/etanol, zemeljski plin/mešanica vodika in zemeljskega plina …)
Commission Implementing Regulation (EU) No 196/2013
Izvedbena uredba Komisije (EU) št. 196/2013
amending Annex II to Regulation (EU) No 206/2010 as regards the new entry for Japan in the list of third countries or parts thereof from which imports into the European Union of certain fresh meat are authorised
o spremembi Priloge II k Uredbi (EU) št. 206/2010 glede novega vnosa za Japonsko na seznam tretjih držav ali njihovih delov, iz katerih se odobri uvoz nekaterega svežega mesa v Evropsko unijo
Having regard to Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption [1], and in particular the introductory phrase of Article 8, the first subparagraph of point (1) of Article 8 and point (4) of Article 8 thereof,
ob upoštevanju Direktive Sveta 2002/99/ES z dne 16. decembra 2002 o predpisih v zvezi z zdravstvenim varstvom živali, ki urejajo proizvodnjo, predelavo, distribucijo in uvoz proizvodov živalskega izvora, namenjenih prehrani ljudi [1], ter zlasti uvodnega stavka člena 8, prvega pododstavka točke 1 člena 8 in točke 4 člena 8 Direktive,
Commission Regulation (EU) No 206/2010 of 12 March 2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements [2] establishes sanitary conditions for the import of live animals and fresh meat thereof.
Uredba Komisije (EU) št. 206/2010 z dne 12. marca 2010 o seznamih tretjih držav, njihovih ozemelj ali delov, iz katerih se odobri vnos nekaterih živali in svežega mesa v Evropsko unijo, ter o zahtevah za izdajo veterinarskih spričeval [2] določa sanitarne pogoje za uvoz živih živali in njihovega svežega mesa.
According to Regulation (EU) No 206/2010 fresh meat intended for human consumption can only be imported if it comes from a territory of a third country or a part thereof listed in Part 1 of Annex II to that Regulation and meets the relevant requirements.
V skladu z Uredbo (EU) št. 206/2010 se lahko sveže meso, namenjeno za prehrano ljudi, lahko uvozi samo, če prihaja iz ozemlja tretje države ali njenega dela, navedenega v delu 1 Priloge II k navedeni uredbi, in izpolnjuje ustrezne zahteve.
Japan requested to be listed for the import of fresh bovine meat into the Union and the Commission audit on bovine meat in Japan in 2008 confirmed that the requirements were met.
Japonska je zaprosila, da se vključi na seznam za uvoz svežega govejega mesa v Unijo, in revizija govejega mesa na Japonskem, ki jo je izvedla Komisija leta 2008, je potrdila, da so zahteve izpolnjene.
The listing was, however, postponed when foot-and-mouth disease occurred in Japan in 2010.
Vendar je bila vključitev na seznam preložena zaradi pojava slinavke in parkljevke na Japonskem leta 2010.
Since then Japan eradicated the foot-and-mouth disease on its territory and was recognised as ‘free without vaccination’ for this disease by the World Organisation for Animal Health (OIE).
Japonska je od takrat na svojem ozemlju izkoreninila slinavko in parkljevko, Svetovna organizacija za zdravje živali (OIE) pa jo je priznala kot prosto teh bolezni brez cepljenja.
Japan thus provides sufficient animal health guarantees and has asked again to be included in the list of third countries authorised for the import of fresh bovine meat into the Union.
Japonska tako zagotavlja zadostna jamstva glede zdravstvenega varstva živali in je ponovno zaprosila za vključitev na seznam tretjih držav, iz katerih je odobren uvoz svežega govejega mesa v Unijo.
Japan should thus be allowed to import fresh bovine meat into the Union.
Japonski bi bilo treba dovoliti uvoz svežega govejega mesa v Unijo.
Part 1 of Annex II to Regulation (EU) No 206/2010 should therefore be amended accordingly.
Del 1 Priloge II k Uredbi (EU) št. 206/2010 bi zato bilo treba ustrezno spremeniti.
In Part 1 of Annex II to Regulation (EU) No 206/2010, the following entry for Japan is inserted after the entry for Iceland:
V delu 1 Priloge II k Uredbi (EU) št. 206/2010 se za vnosom za Islandijo vstavi naslednji vnos za Japonsko:
Closing date [3]
Končni datum [3]
Opening date [4]
Začetni datum [4]
‘JP — Japan
„JP - Japonska
Consignments carried on vessels on the high seas may be imported into the Union if certified before the date set out in column 7 for 40 days from that date.
Pošiljke na plovilih na odprtem morju, za katere je bilo spričevalo izdano pred datumom iz stolpca 7, se lahko uvozijo v Unijo do 40 dni po navedenem datumu.
: no date in column 7 means that there are no time restrictions).
(Opomba: če v stolpcu 7 ni datuma, pomeni, da ni časovne omejitve.)
Commission Implementing Regulation (EU) No 197/2013
Izvedbena uredba Komisije (EU) št. 197/2013
amending Implementing Regulation (EU) No 80/2012 establishing the list of biological or chemical substances provided for in Article 53(1)(b) of Council Regulation (EC) No 1186/2009 setting up a Community system of reliefs from custom duty
o spremembi Izvedbene uredbe (EU) št. 80/2012 o seznamu bioloških ali kemičnih snovi iz člena 53(1)(b) Uredbe Sveta (ES) št. 1186/2009 o sistemu oprostitev carin v Skupnosti
Having regard to Council Regulation (EC) No 1186/2009 of 16 November 2009 setting up a Community system of reliefs from customs duty [1], and in particular Article 53(1)(b) thereof,
ob upoštevanju Uredbe Sveta (ES) št. 1186/2009 z dne 16. novembra 2009 o sistemu oprostitev carin v Skupnosti [1] in zlasti člena 53(1)(b) Uredbe,
Commission Implementing Regulation (EU) No 80/2012 [2] sets out the list of biological or chemical substances provided for in Article 53(1)(b) of Regulation (EC) No 1186/2009.
Izvedbena uredba Komisije (EU) št. 80/2012 [2] določa seznam bioloških ali kemičnih snovi iz člena 53(1)(b) Uredbe (ES) št. 1186/2009.
Implementing Regulation (EU) No 80/2012 should be amended in order to include in the list two substances for which there is at present no equivalent production within the customs territory of the Union.
Izvedbeno uredbo (EU) št. 80/2012 bi bilo treba spremeniti, da se v seznam vključi dve snovi, za kateri na carinskem območju Unije trenutno ni enakovredne proizvodnje.
Moreover, it is no longer necessary to maintain in the list a substance which is currently listed in Annex 3 to Part Three of Annex I to Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff [3] concerning the pharmaceutical substances which are free of duty.
Poleg tega v seznamu ni več treba navajati snovi, ki je trenutno navedena v Prilogi 3 iz tretjega dela Priloge I k Uredbi Sveta (EGS) št. 2658/87 z dne 23. julija 1987 o tarifni in statistični nomenklaturi ter skupni carinski tarifi [3] glede farmacevtskih snovi, ki so proste dajatev.
Implementing Regulation (EU) No 80/2012 should therefore be amended accordingly.
Izvedbeno uredbo (EU) št. 80/2012 bi bilo zato treba ustrezno spremeniti.
Annex I to Implementing Regulation (EU) No 80/2012 is amended in accordance with the Annex to this Regulation.
Priloga I k Izvedbeni uredbi (EU) št. 80/2012 se spremeni v skladu s Prilogo k tej uredbi.
OJ L 29, 1.2.2012, p. 33.
UL L 29, 1.2.2012, str. 33.
Annex I to Implementing Regulation (EU) No 80/2012 is amended as follows:
Priloga I k Izvedbeni uredbi (EU) št. 80/2012 se spremeni:
the following row is inserted after the row containing the CN code ex28459090 for (Oxygen-18) Water:
Za vrstico z oznako KN ex28459090 (kisik-18) voda se vstavi naslednja vrstica:
Titanium silicon carbide powder of a purity by weight of 99 % or more’
Titanov silikonski karbid v prahu s čistočo 99 mas. % ali več“
the following row is inserted after the row containing the CN code ex29269095 for 2-Naphtonitrile:
Za vrstico z oznako KN ex29269095 za 2-naftonitril se vstavi naslednja vrstica:
Morpholino phosphorodiamidate oligomers (morpholino oligonucleotides)’
Morfolino fosforodiamidat oligomeri (morfolino oligonukleotidi)“
the following row is deleted:
Naslednja vrstica se črta:
Decamethonium bromide (INN)’
Dekametonbromid (INN)“
Commission Implementing Regulation (EU) No 198/2013
Izvedbena uredba Komisije (EU) št. 198/2013
on the selection of a symbol for the purpose of identifying medicinal products for human use that are subject to additional monitoring
o izbiri simbola za označevanje zdravil za uporabo v humani medicini, ki jih je treba dodatno spremljati
Having regard to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency [1], and in particular Article 23(4) thereof,
ob upoštevanju Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta z dne 31. marca 2004 o postopkih Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za humano in veterinarsko uporabo ter o ustanovitvi Evropske agencije za zdravila [1], zlasti člena 23(4) Uredbe,
Some medicinal products for human use are authorised subject to additional monitoring for reasons of their specific safety profile.
Nekatera zdravila za uporabo v humani medicini so odobrena, vendar jih je treba dodatno spremljati zaradi njihovih posebnih varnostnih lastnosti.
Pursuant to Article 23 of Regulation (EC) No 726/2004 this includes medicinal products with a new active substance, biological medicinal products and products for which post-authorisation data are required.
V skladu s členom 23 Uredbe (ES) št. 726/2004 so med temi zdravili tudi zdravila z novimi zdravilnimi učinkovinami, biološka zdravila in zdravila, pri katerih so potrebni podatki po izdaji dovoljenja za promet s tem zdravilom.
Patients and healthcare professionals should be able to easily identify medicinal products that are subject to additional monitoring in order to allow them to share with the competent authorities and the marketing authorisation holder any information they have from the use of the medicinal product and in particular to report suspected adverse reactions.
Pacienti in zdravstveni delavci bi morali zlahka prepoznati, katera zdravila je treba dodatno spremljati, s čimer bi jim omogočili, da pristojnim organom in imetniku dovoljenja za promet z zdravilom sporočijo vse izkušnje z uporabo zdravila ter zlasti da poročajo o vseh domnevnih neželenih učinkih.
To ensure transparency, all medicinal products that are subject to additional monitoring are included in a list that is set up and maintained by the European Medicines Agency in accordance with Article 23(1) of Regulation (EC) No 726/2004.
Za zagotovitev preglednosti so vsa zdravila, ki jih je treba dodatno spremljati, vključena na seznam, ki ga je sestavila in ga posodablja Evropska agencija za zdravila v skladu s členom 23(1) Uredbe (ES) št. 726/2004.
Additionally, they are labelled with a black symbol.
Poleg tega so zdravila označena s črnim simbolom.
On 3 October 2012 the Pharmacovigilance Risk Assessment Committee adopted a recommendation stating that the black symbol should be an inverted equilateral black triangle.
Odbor za ocenjevanje tveganja na področju farmakovigilance je 3. oktobra 2012 sprejel priporočilo, v katerem je navedeno, da je črn simbol navzdol obrnjen enakostranični črn trikotnik.
The recommendation took into account the views of patients and healthcare professionals as expressed by the Patients’ and Consumers’ Working Party and the Healthcare Professionals’ Working Group established by the European Medicines Agency.
Priporočilo upošteva stališča pacientov in zdravstvenih delavcev, kot jih je izrazila delovna skupina za sodelovanje s pacienti in potrošniki ter delovna skupina za sodelovanje z zdravstvenimi delavci, ki ju je ustanovila Evropska agencija za zdravila.
Holders of marketing authorisations that were granted before 1 September 2013 should be given sufficient time to adapt the product information of the products concerned.
Imetnikom dovoljenj za promet z zdravili, izdanih pred 1. septembrom 2013, bi bilo treba zagotoviti dovolj časa za prilagoditev informacij o zadevnih zdravilih.
In addition, competent authorities should be given the possibility to grant a longer period of time for that adaptation where exceptional circumstances so require.
Poleg tega bi morali imeti pristojni organi možnost zaradi izrednih okoliščin odobriti daljše obdobje za to prilagoditev.
The introduction of the black symbol should not cause difficulties on the market and in the supply chain.
Uvedba črnega simbola ne bi smela povzročiti težav na trgu in v dobavni verigi.
In order to avoid any disruptions, marketing authorisation holders should not be obliged to recall or repackage products which have been already placed on the market,
Da bi se izognili morebitnim oviram v trgovini, imetniki dovoljenj za promet z zdravili ne bi smeli biti obvezani preklicati ali prepakirati zdravil, ki so že na trgu –
The black symbol referred to in Article 23(4) of Regulation (EC) No 726/2004 shall be an inverted equilateral triangle.
Črn simbol iz člena 23(4) Uredbe (ES) št. 726/2004 je navzdol obrnjen enakostranični trikotnik.
It shall comply with the model and the dimensions set out in the Annex to this Regulation.
Je v skladu z vzorcem in dimenzijami iz Priloge k tej uredbi.
Holders of marketing authorisations granted before 1 September 2013 which concern medicinal products for human use that are subject to additional monitoring shall include the black symbol in the summary of product characteristics and the package leaflet relating to these medicinal products by 31 December 2013.
Imetniki dovoljenj, izdanih pred 1. septembrom 2013, za promet z zdravili za uporabo v humani medicini, ki jih je treba dodatno spremljati, do 31. decembra 2013 v povzetku glavnih značilnosti zdravila in v navodilih za uporabo navedejo črn simbol, ki označuje ta zdravila.
By derogation from paragraph 1, holders of marketing authorisations granted before 1 September 2013 which concern medicinal products for human use that are subject to additional monitoring may request a longer period of time to be granted by the competent authorities, where they can demonstrate that compliance with the date referred to in paragraph 1 may unduly affect the appropriate and continued supply of the medicinal product.
Z odstopanjem od odstavka 1 lahko imetniki dovoljenj, izdanih pred 1. septembrom 2013, za promet z zdravili za uporabo v humani medicini, ki jih je treba dodatno spremljati, zahtevajo daljše obdobje, ki ga odobrijo pristojni organi, če lahko dokažejo, da bi doseganje skladnosti v navedenem roku iz odstavka 1 lahko negativno vplivalo na ustrezno in neprekinjeno dobavo zdravila.
Stocks of human medicinal products produced, packaged and labelled before 1 January 2014, which do not include the black symbol in the package leaflet may continue to be placed on the market, distributed, dispensed, sold and used until stocks are exhausted.
Zaloge zdravil za uporabo v humani medicini, ki so bila proizvedena, pakirana in označena pred 1. januarjem 2014 in ne vključujejo črnega simbola v navodilih za uporabo, se lahko še naprej dajejo v promet, distribuirajo, izdajajo, prodajajo in uporabljajo do porabe zalog.
The black symbol referred to in Article 23(4) of Regulation (EC) No 726/2004 shall comply with the following model:
Črn simbol iz člena 23(4) Uredbe (ES) št. 726/2004 je v skladu z naslednjim vzorcem:
The black symbol shall be proportional to the font size of the subsequent standardised text and each side of the triangle shall have a minimum length of 5 mm.
Črn simbol je sorazmeren z velikostjo pisave nadaljnjega standardiziranega besedila, vsaka stranica trikotnika pa je dolga vsaj 5 mm.
Commission Implementing Regulation (EU) No 199/2013
Izvedbena uredba Komisije (EU) št. 199/2013
Commission Implementing Regulation (EU) No 200/2013
Izvedbena uredba Komisije (EU) št. 200/2013
of 8 March 2013
z dne 8. marca 2013
approving the active substance ametoctradin, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
o odobritvi aktivne snovi ametoktradin v skladu z Uredbo (ES) št. 1107/2009 Evropskega parlamenta in Sveta o dajanju fitofarmacevtskih sredstev v promet in spremembi Priloge k Izvedbeni uredbi Komisije (EU) št. 540/2011
In accordance with Article 6(2) of Directive 91/414/EEC the Netherlands received on 26 September 2008 an application from BASF SE for the inclusion of the active substance ametoctradin in Annex I to Directive 91/414/EEC.
V skladu s členom 6(2) Direktive 91/414/EGS je Nizozemska 26. septembra 2008 prejela zahtevek podjetja BASF SE za vključitev aktivne snovi ametoktradin v Prilogo I k Direktivi 91/414/EGS.
Decision 2009/535/EC confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.
Z Odločbo 2009/535/ES je bilo potrjeno, da je dokumentacija „popolna“ v smislu načelnega izpolnjevanja zahtev po podatkih in informacijah iz prilog II in III k Direktivi 91/414/EGS.
The designated rapporteur Member State submitted a draft assessment report on 15 September 2009.
Država članica, ki je bila določena kot poročevalka, je 15. septembra 2009 predložila osnutek poročila o oceni.
The Authority presented to the Commission its conclusion on the review of the pesticide risk assessment of the active substance ametoctradin [4] on 18 October 2012.
Agencija je 18. oktobra 2012 Komisiji predložila sklep o pregledu ocene tveganja za pesticide z aktivno snovjo ametoktradin [4].
The draft assessment report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and was finalised on 1 February 2013 in the format of the Commission review report for ametoctradin.
Osnutek poročila o oceni in sklep Agencije so države članice in Komisija pregledale v okviru Stalnega odbora za prehranjevalno verigo in zdravje živali ter končno različico pripravile 1. februarja 2013 v obliki poročila Komisije o pregledu ametoktradina.
It has appeared from the various examinations made that plant protection products containing ametoctradin may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report.
Različne preiskave so pokazale, da se za fitofarmacevtska sredstva, ki vsebujejo ametoktradin, lahko pričakuje, da na splošno izpolnjujejo zahteve iz člena 5(1)(a) in (b) ter člena 5(3) Direktive 91/414/EGS, zlasti v zvezi z uporabami, ki so bile proučene in podrobno navedene v poročilu Komisije o pregledu.
It is therefore appropriate to approve ametoctradin.
Zato je primerno, da se ametoktradin odobri.
Member States should be allowed a period of six months after approval to review authorisations of plant protection products containing ametoctradin.
Državam članicam bi bilo treba po odobritvi omogočiti šestmesečno obdobje, da pregledajo registracije fitofarmacevtskih sredstev, ki vsebujejo ametoktradin.
The experience gained from inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8 (2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market [5] has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data.
Izkušnje iz vključitev aktivnih snovi v Prilogo I k Direktivi 91/414/EGS, ocenjenih na podlagi Uredbe Komisije (EGS) št. 3600/92 z dne 11. decembra 1992 o podrobnih pravilih za izvajanje prve faze delovnega programa iz člena 8(2) Direktive Sveta 91/414/EGS o dajanju fitofarmacevtskih sredstev v promet [5], so pokazale, da se lahko pri razlagi dolžnosti imetnikov veljavnih registracij glede dostopa do podatkov pojavijo težave.
In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive.
Da bi se izognili nadaljnjim težavam, se zato zdi nujno razjasniti dolžnosti držav članic, zlasti dolžnost preveriti, ali ima imetnik registracije dostop do dokumentacije, ki izpolnjuje zahteve iz Priloge II k navedeni direktivi.
However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the Directives which have been adopted until now amending Annex I to that Directive or the Regulations approving active substances.
Vendar ta razjasnitev državam članicam ali imetnikom registracij ne nalaga novih dolžnosti v primerjavi z doslej sprejetimi direktivami o spremembah Priloge I k navedeni direktivi ali uredbami, s katerimi so bile odobrene aktivne snovi.