natgillin/translations-raw huggingface dataset:
In the case of fixed installed medical devices, that information shall also be provided on the device itself.
V primeru pritrjenih nameščenih medicinskih pripomočkov se navedene informacije zagotovijo tudi na samem pripomočku.
Manufacturers shall provide information on how to access the instructions for use in electronic form.
Proizvajalci zagotovijo informacije, kako dostopati do navodil za uporabo v elektronski obliki.
That information shall be provided as set out in the second subparagraph of paragraph 1 or, if not practicable, in a paper document supplied with each device.
Navedene informacije se zagotovijo v skladu z drugim pododstavkom odstavka 1 ali, v primeru, da to ni izvedljivo, na papirnatem dokumentu, ki je priložen vsakemu pripomočku.
The information on how to access the instructions for use in electronic form shall contain the following:
Informacije, kako dostopati do navodil za uporabo v elektronski obliki, vsebujejo naslednje:
any information needed to view the instructions for use;
vse informacije, potrebne za ogled navodil za uporabo;
a unique reference, giving direct access, and any other information needed by the user to identify and access the appropriate instructions for use;
posebni sklic za neposreden dostop in vse ostale informacije, ki jih uporabnik potrebuje za prepoznavanje ustreznih navodil za uporabo in dostopanje do njih;
relevant manufacturer contact details;
bistvene kontaktne podatke proizvajalca;
where, how and within which time instructions for use in paper form can be requested and shall be obtained at no additional cost in conformity with Article 5.
kje, kako in v katerem časovnem obdobju je mogoče zahtevati in brez dodatnih stroškov prejeti navodila za uporabo na papirju v skladu s členom 5.
Where a part of the instructions for use is intended to be provided to the patient, that part shall not be provided in electronic form.
Kadar je predvideno, da se del navodil za uporabo zagotovi pacientu, se ta del ne zagotovi v elektronski obliki.
The instructions for use in electronic form shall be available entirely as text which may contain symbols and graphics with at least the same information as the instructions for use in paper form.
Navodila za uporabo v elektronski obliki so na voljo v celoti kot besedilo, ki lahko vsebuje simbole in slike ter najmanj enako količino informacij kot navodila za uporabo na papirju.
Video or audio files may be offered in addition to the text.
Video ali avdio datoteke so lahko na voljo poleg besedila.
Where manufacturers provide the instructions for use in electronic form on an electronic storage medium together with the device or where the device itself is fitted with a built-in system visually displaying the instructions for use, the instructions for use in electronic form shall also be made accessible to the users through a website.
Kadar proizvajalci zagotovijo navodila za uporabo v elektronski obliki na elektronskem nosilcu podatkov skupaj s pripomočkom ali kadar ima sam pripomoček vgrajen sistem za vizualni prikaz navodil za uporabo, so navodila za uporabo v elektronski obliki uporabnikom na voljo tudi prek spletne strani.
Any website containing instructions for use of a device which are provided in electronic form instead of in paper form shall comply with the following requirements:
Vsaka spletna stran, ki vsebuje navodila za uporabo pripomočka, ki so zagotovljena v elektronski obliki namesto na papirju, ustreza naslednjim zahtevam:
the instructions for use shall be provided in a commonly used format that can be read with freely available software;
navodila za uporabo so zagotovljena v splošno uporabljenem formatu, ki je berljiv s prosto dostopno programsko opremo;
it shall be protected against hardware and software intrusion;
zaščitena je pred vdorom v programsko in strojno opremo;
it shall be provided in such a way that the server downtime and display errors are reduced as far as possible;
zagotovljena je na tak način, da so izpadi strežnika in motnje v prikazu minimalni;
it shall mention in which Union languages the manufacturer provides the instructions for use in electronic form;
na njej je navedeno, v katerih jezikih Unije proizvajalec zagotavlja navodila za uporabo v elektronski obliki;
it shall fulfil the requirements of Directive 95/46/EC;
izpolnjuje zahteve Direktive 95/46/ES;
the Internet address as displayed in accordance with Article 6(2) shall be stable and directly accessible during the periods set out in points (9) and (10) of Article 5;
internetni naslov, ki je prikazan v skladu s členom 6(2), je stalen in neposredno dostopen v časovnih obdobjih, določenih v točkah 9 in 10 člena 5;
all previous versions of the instructions for use issued in electronic form and their date of publication shall be available on the website.
vse prejšnje različice navodil za uporabo, ki so bila izdane v elektronski obliki, so na voljo na spletni strani skupaj z datumom objave.
Except for medical devices of Class I, as defined in Annex IX to Directive 93/42/EEC, the fulfilment of the obligations laid down in Articles 4 to 7 of this Regulation shall be reviewed by a notified body during the procedure applicable for conformity assessment as referred to in Article 9 of Directive 90/385/EEC or Article 11 of Directive 93/42/EEC.
Razen za medicinske pripomočke iz razreda I, kakor so opredeljeni v Prilogi IX k Direktivi 93/42/EGS, priglašeni organ pregleda izpolnjevanje obveznosti iz členov 4 in 7 te uredbe med postopkom, ki se uporablja za ocenjevanje skladnosti, kot je to opredeljeno v členu 9 Direktive 90/385/EGS ali členu 11 Direktive 93/42/EGS.
The review shall be based on a specific sampling method adapted to the class and the complexity of the product.
Pregled temelji na posebni metodi vzorčenja, prilagojeni razredu in kompleksnosti proizvoda.
Instructions for use in electronic form which are provided in addition to complete instructions for use in paper form shall be consistent with the content of the instructions for use in paper form.
Navodila za uporabo v elektronski obliki, ki so zagotovljena poleg popolnih navodil za uporabo na papirju, so skladna z vsebino navodil za uporabo na papirju.
Where such instructions for use are provided through a website, this website shall fulfil the requirements set out in points (b), (e) and (g) of paragraph 2 of Article 7.
Kadar so taka navodila za uporabo zagotovljena prek spletne strani, spletna stran izpolnjuje zahteve iz točk (b), (e) in (g) odstavka 2 člena 7.
Commission Implementing Regulation (EU) No 208/2012
Izvedbena uredba Komisije (EU) št. 208/2012
amending Implementing Regulation (EU) No 562/2011 adopting the plan allocating to the Member States resources to be charged to the 2012 budget year for the supply of food from intervention stocks for the benefit of the most deprived persons in the European Union and derogating from certain provisions of Regulation (EU) No 807/2010
o spremembi Izvedbene uredbe (EU) št. 562/2011 o sprejetju načrta za dodeljevanje sredstev državam članicam za dobavo hrane iz intervencijskih zalog v korist najbolj ogroženih oseb v Evropski uniji za proračunsko leto 2012 in odstopanju od nekaterih določb Uredbe (EU) št. 807/2010
Article 27 of Regulation (EC) No 1234/2007 as amended by Regulation (EU) No 121/2012 of the European Parliament and of the Council [3] has established a scheme whereby food products may be distributed to the most deprived persons in the Union.
S členom 27 Uredbe (ES) št. 1234/2007, kot je bila spremenjena z Uredbo (EU) št. 121/2012 Evropskega parlamenta in Sveta [3], je bil vzpostavljen program, na podlagi katerega se prehrambni proizvodi lahko razdelijo najbolj ogroženim osebam v Uniji.
For that purpose, products in intervention stocks may be made available or, where intervention stocks suitable for the food distribution scheme are not available, food products may be purchased on the market.
Proizvodi za ta namen se lahko zagotovijo iz intervencijskih zalog oziroma, če intervencijske zaloge, primerne za program za razdeljevanje hrane, ne zadostujejo, se lahko prehrambni proizvodi kupijo na trgu.
For 2012 and 2013, that scheme is included in the list of measures eligible for financing by the European Agricultural Guarantee Fund (EAGF) set out in Council Regulation (EC) No 1290/2005 of 21 June 2005 on the financing of the common agricultural policy [4], within an annual ceiling of EUR 500 million.
Za leti 2012 in 2013 je zadevni program vključen na seznam ukrepov iz Uredbe Sveta (ES) št. 1290/2005 z dne 21. junija 2005 o financiranju skupne kmetijske politike [4], na katerem so navedeni ukrepi, ki so upravičeni do financiranja iz Evropskega kmetijskega jamstvenega sklada (EKJS), pri čemer letni prag znaša 500 milijonov EUR.
In accordance with Article 27(3) of Regulation (EC) No 1234/2007 the Commission has to adopt annual plans.
V skladu s členom 27(3) Uredbe (ES) št. 1234/2007 mora Komisija sprejeti letne načrte.
The annual distribution plan for 2012 was adopted on 10 June 2011 by Commission Implementing Regulation (EU) No 562/2011 [5] solely on the basis of products available in intervention stocks.
Letni načrt razdeljevanja za leto 2012 je bil sprejet 10. junija 2011 z Izvedbeno uredbo Komisije (EU) št. 562/2011 [5] zgolj na podlagi proizvodov, ki so na voljo v intervencijskih zalogah.
The additional resources made available on the 2012 budget year for the distribution of food products to the most deprived persons in the Union, as a result of the amendment of Article 27 of Regulation (EC) No 1234/2007 by Regulation (EU) No 121/2012, should be allocated to the Member States.
Dodatna sredstva, ki so na voljo v proračunskem letu 2012 za razdeljevanje prehrambnih izdelkov najbolj ogroženim osebam v Uniji zaradi spremembe člena 27 Uredbe (ES) št. 1234/2007 z Uredbo (EU) št. 121/2012, je treba dodeliti državam članicam.
Taking into account the shortened time-frame left to the Member States for the implementation of the 2012 distribution plan as a consequence of the date of entry into force of Regulation (EU) No 121/2012, it is appropriate to grant an extension of the deadlines provided for in Article 3(1) and (3) of Regulation (EU) No 807/2010 as regards the implementation period of the annual plan and the completion of the payment operations for products mobilised on the market.
Ob upoštevanju skrajšanega časovnega okvira, ki ga imajo države članice za izvedbo načrta razdeljevanja za leto 2012 zaradi datuma začetka veljavnosti Uredbe (EU) št. 121/2012, je primerno odobriti podaljšanje rokov iz člena 3(1) in (3) Uredbe (EU) št. 807/2010 glede obdobja izvajanja letnega načrta in zaključitve plačilnih postopkov za proizvode, sproščene na trgu.
That revision of the distribution plan for 2012 being made at a time when national administrative arrangements for the implementation of the plan should be approaching completion, the quantities of products available in intervention stocks which are reallocated following the decision of Finland to renounce to a part of its allocation of skimmed milk powder or to reassessment of the exact quantities in intervention storage should not be taken into account for calculating whether Member States have respected the obligation laid down in the second and third subparagraphs of Article 3(2) of Regulation (EU) No 807/2010 to have withdrawn 70 % of cereals and skimmed milk powder by the deadlines fixed in that Article.
Ker revizija načrta razdeljevanja za leto 2012 poteka v času, ko bi morale biti nacionalne upravne ureditve za izvedbo načrta že skoraj zaključene, se količin proizvodov, ki so na voljo v intervencijskih zalogah, ki se prerazporedijo zaradi odločitve Finske, da se odpove delu svojega dodeljenega posnetega mleka v prahu oziroma da ponovno oceni dejanske količine v intervencijskem skladišču, ne sme upoštevati pri izračunu, ali so države članice upoštevale obveznost iz drugega in tretjega pododstavka člena 3(2) Uredbe (EU) št. 807/2010, da do rokov, določenih v navedenem členu, umaknejo 70 % žit in posnetega mleka v prahu.
In view of the fact that the implementation period of the 2012 distribution plan is already advanced and to allow Member States as much time as possible to proceed to the actions needed for the implementation of the amended plan, this Regulation should enter into force on the day of its publication.
Zaradi dejstva, da obdobje izvajanja načrta razdeljevanja za leto 2012 že poteka, in da bi državam članicam omogočili čim več časa za izvedbo ukrepov, ki so potrebni za izvajanje spremenjenega načrta, mora ta uredba začeti veljati na dan njene objave.
Implementing Regulation (EU) No 562/2011 should therefore be amended accordingly.
Izvedbeno uredbo (EU) št. 562/2011 je zato treba ustrezno spremeniti.
Implementing Regulation (EU) No 562/2011 is amended as follows:
Izvedbena uredba Sveta (EU) št. 562/2011 se spremeni:
In 2012, the distribution of food to the most deprived persons in the Union under Article 27 of Regulation (EC) No 1234/2007 shall be implemented in accordance with the annual distribution plan set out in Annex I to this Regulation.
Za proračunsko leto 2012 se živila najbolj ogroženim osebam v Uniji na podlagi člena 27 Uredbe (ES) št. 1234/2007 razdelijo v skladu z letnim načrtom razdeljevanja iz Priloge I k tej uredbi.
Financial resources available to implement the 2012 plan can be used by Member States within the limits set out in point (a) of Annex I.
Države članice lahko finančna sredstva, ki so na voljo za izvajanje načrta za leto 2012, uporabijo v okviru omejitev iz točke (a) Priloge I.
The quantities of each type of product to be withdrawn from intervention stocks are set out in point (b) of that Annex.
Količine za posamezne vrste proizvodov, ki se umaknejo iz intervencijskih zalog, so določene v točki (b) navedene priloge.
Indicative allocations to Member States for the purchase of food products on the Union market are set out in point (c) of that Annex.
Okvirne dodelitve državam članicam za nakup prehrambnih proizvodov na trgu Unije, so določene v točki (c) navedene priloge.
The use of cereals as payment for mobilising rice products on the market is authorised, as referred to in Article 4(2) of Regulation (EU) No 807/2010.
Uporaba žit kot plačila za sprostitev proizvodov iz riža na trg je dovoljena v skladu s členom 4(2) Uredbe (EU) št. 807/2010.
Indicative allocations to Member States for the reimbursement of the cost of intra-Union transfers, as required under the annual distribution plan referred to in Article 1, are set out in point (d) of Annex I.’;
Okvirne dodelitve državam članicam za povračilo stroškov premestitev znotraj Unije, kot se zahtevajo na podlagi letnega načrta razdeljevanja iz člena 1, so določene v točki (d) Priloge I.“;
the following Articles 2a to 2d are inserted:
vstavijo se členi 2a do 2d:
By way of derogation from Article 3(1) of Regulation (EU) No 807/2010, the implementation period of the 2012 distribution plan shall end on 28 February 2013.
Ne glede na člen 3(1) Uredbe (EU) št. 807/2010 se obdobje izvajanja načrta razdeljevanja za leto 2012 zaključi 28. februarja 2013.
By way of derogation from Article 3(3) of Regulation (EU) No 807/2010, for the 2012 distribution plan, payment operations for products to be supplied by the operator shall, in case of products to be mobilised on the market under Article 2(3)(a)(iii) and (iv) of Regulation (EU) No 807/2010, be effected before 15 October 2012.
Ne glede na člen 3(3) Uredbe (EU) št. 807/2010 se za načrt razdeljevanja za leto 2012 postopki plačila za proizvode, ki jih dobavi izvajalec, za proizvode, ki jih je treba zbrati na trgu ob uporabi člena 2(3)(a)(iii) in (iv) Uredbe (EU) št. 807/2010, izvršijo pred 15. oktobrom 2012.
For the 2012 distribution plan, the first sentence of the second subparagraph and the third subparagraph of Article 3(2) of Regulation (EU) No 807/2010, where relevant, shall not apply to the following quantities of intervention stocks:
Za načrt razdeljevanja za leto 2012 se prvi stavek drugega pododstavka in tretji pododstavek člena 3(2) Uredbe (EU) št. 807/2010, kadar je potrebno, ne uporabljata za naslednje količine intervencijskih zalog:
5,46 tonnes of cereals stored in the United Kingdom and allocated to Bulgaria;
5,46 ton žit, skladiščenih v Združenem kraljestvu in dodeljenih Bolgariji;
0,651 tonne of cereals stored in Finland and allocated to Bulgaria;
0,651 ton žit, skladiščenih na Finskem in dodeljenih Bolgariji;
249,04 tonnes of cereals stored in France and allocated to France;
249,04 ton žit, skladiščenih v Franciji in dodeljenih Franciji;
635,325 tonnes of skimmed milk powder stored in Estonia and allocated to Estonia.
635,325 ton posnetega mleka v prahu, skladiščenega v Estoniji in dodeljenega Estoniji.
Expenditure, within the limits set out in point (a) of Annex I, shall only be eligible for Union financing if it has been paid by the Member State to the beneficiary by 15 October 2012 at the latest.’;
Izdatki v okviru omejitev iz točke (a) Priloge I so do financiranja Unije upravičeni samo, če jih je država članica upravičencu plačala najkasneje do 15. oktobra 2012.“;
OJ L 44, 16.2.2012, p. 1.
UL L 44, 16.2.2012, str. 1.
Total amounts of financial resources broken down per Member State:
Skupni zneski finančnih sredstev za posamezno državo članico:
Quantity of each type of product to be withdrawn from Union intervention stocks for distribution per Member State within the limits set out in point (a) of this Annex:
Količina posamezne vrste proizvoda, ki se vzame iz intervencijskih zalog Unije za razdeljevanje v posamezni državi članici v okviru omejitev iz točke (a) te priloge:
Indicative allocations to Member States for the purchase of food products on the Union market within the limits set out in point (a) of this Annex:
Okvirne dodelitve državam članicam za nakup prehrambnih proizvodov na trgu Unije v okviru omejitev iz točke (a) te priloge:
Indicative allocations to Member States for the reimbursement of intra-Union transfer costs within the limits set out in point (a) of this Annex:
Okvirne dodelitve državam članicam za povrnitev stroškov premestitev znotraj Unije v okviru omejitev iz točke (a) te priloge:
Intra-Union transfers of cereals authorised under the distribution plan for the 2012 budget year:
Premestitve žit znotraj Unije, odobrene v skladu z načrtom razdeljevanja za proračunsko leto 2012:
Agency for Rural Affairs, Finland
Agency for Rural Affairs, Finska
Държавен фонд "Земеделие" — Разплащателна агенция, Bulgaria
Държавен фонд „Земеделие“ — Разплащателна агенция, Bolgarija
RPA, United Kingdom
RPA, Združeno kraljestvo
SZIF, Czech Republic
SZIF, Češka
Agenția de Plăți și Intervenție pentru Agricultură, Romania
Agenția de Plăți și Intervenție pentru Agricultură, Romunija
FranceAgriMer, France
FranceAgriMer, Francija
Pôdohospodárska platobná agentúra, Slovakia
Pôdohospodárska platobná agentúra, Slovaška
Intra-Union transfers of skimmed milk powder authorised under the distribution plan for the 2012 budget year:
Premestitve posnetega mleka v prahu znotraj Unije, odobrene v skladu z načrtom razdeljevanja za proračunsko leto 2012:
OPEKEPE, Greece
OPEKEPE, Grčija
OFI, Ireland
OFI, Irska
Dienst Regelingen Roermond, Netherlands
Dienst Regelingen Roermond, Nizozemska
Rural Support Service, Latvia
Rural Support Service, Latvija
Mezőgazdasági és Vidékfejlesztési Hivatal, Hungary
Mezőgazdasági és Vidékfejlesztési Hivatal, Madžarska
IFAP I.P. Portugal
IFAP I.P., Portugalska
Agencija Republike Slovenije za kmetijske trge in razvoj podeželja, Slovenia
Agencija Republike Slovenije za kmetijske trge in razvoj podeželja, Slovenija
In order to enforce the annual budgetary ceiling, the intra-Union transfer costs, where relevant, should be included into the total financial allocation made available for each Member State to implement the 2012 distribution plan.
Da bi uveljavili letni proračunski prag, je po potrebi treba stroške premestitve znotraj Unije vključiti v celotno finančno dodelitev, ki je na voljo vsaki državi članici za izvajanje načrta razdeljevanja 2012.
Moreover, the deadlines fixed by Article 9 of Commission Regulation (EU) No 807/2010 of 14 September 2010 laying down detailed rules for the supply of food from intervention stocks for the benefit of the most deprived persons in the Union [6] for the requests for payment and the execution of payments by the competent authorities should be adjusted, in order to ensure that the resources allocated within the 2012 distribution plan are only eligible for Union support if those payments are made in the 2012 budget year.
Poleg tega je treba prilagoditi roke, določene v členu 9 Uredbe Komisije (EU) št. 807/2010 z dne 14. septembra 2010 o podrobnih pravilih za dobavo hrane iz intervencijskih zalog v korist najbolj ogroženih oseb v Uniji [6] za zahtevke za plačila in izvršitev plačil s strani pristojnih organov, da se zagotovi, da so sredstva, ki so bila dodeljena v okviru načrta razdeljevanja za leto 2012, do podpore Unije upravičena samo, če se navedena plačila opravijo v proračunskem letu 2012.
By way of derogation from Article 9 of Regulation (EU) No 807/2010, for the 2012 distribution plan, requests for payment shall be submitted to the competent authorities of each Member State by 30 September 2012.
Z odstopanjem od člena 9 Uredbe (EU) št. 807/2010 se za načrt razdeljevanja za leto 2012 zahtevki za plačila do 30. septembra 2012 pošljejo pristojnim organom posameznih držav članic.
Except in cases of force majeure, requests submitted after that date shall not be accepted.
Razen v primerih višje sile se zahtevki, poslani po navedenem datumu, ne sprejmejo.
Commission Implementing Regulation (EU) No 209/2012
Izvedbena uredba Komisije (EU) št. 209/2012
Commission Implementing Regulation (EU) No 210/2012
Izvedbena uredba Komisije (EU) št. 210/2012
fixing the allocation coefficient to be applied to applications for import licences for olive oil lodged from 5 to 6 March 2012 under the Tunisian tariff quota and suspending the issue of import licences for the month of March 2012
o določitvi koeficienta dodelitve, ki se bo uporabil za zahtevke za izdajo uvoznih dovoljenj za oljčno olje, vložene od 5. in 6. marca 2012 v okviru tunizijske tarifne kvote, in o začasni ukinitvi izdaje uvoznih dovoljenj za mesec marec 2012
Import licence applications have been submitted to the competent authorities under Article 3(1) of Regulation (EC) No 1918/2006 in respect of a total quantity exceeding the limit laid down for the month of March in Article 2(2) of that Regulation.
V skladu s členom 3(1) Uredbe (ES) št. 1918/2006 so bili pri pristojnih organih vloženi zahtevki za izdajo uvoznih dovoljenj za skupno količino, ki presega mesečno vrednost, ki je v členu 2(2) navedene uredbe določena za mesec marec.
Since the limit for the month of March has been reached, no more import licences can be issued for that month,
Ker je vrednost za mesec marec dosežena, se za zadevni mesec uvozna dovoljenja ne morejo več izdati –
The quantities for which import licence applications were lodged for 5 and 6 March 2012 under Article 3(1) of Regulation (EC) No 1918/2006 shall be multiplied by an allocation coefficient of 57,099350 %.
Za zahtevke za izdajo uvoznih dovoljenj, vložene od 5. in 6. marca 2012 v skladu s členom 3(1) Uredbe (ES) št. 1918/2006, se določi koeficient dodelitve 57,099350 %.
The issue of import licences in respect of amounts applied for as from 12 March 2012 shall be suspended for March 2012.
Izdaja uvoznih dovoljenj za količine, zahtevane od 12. marca 2012, se za marec 2012 začasno ukine.
This Regulation shall enter into force on 10 March 2012.
Ta uredba začne veljati 10. marca 2012.
Commission Implementing Regulation (EU) No 211/2012
Izvedbena uredba Komisije (EU) št. 211/2012
of 12 March 2012
z dne 12. marca 2012
Done at Brussels, 12 March 2012.
V Bruslju, 12. marca 2012
The product has the following composition (% by weight):
Proizvod z naslednjo sestavo (mas. %):
gasoline 30
bencin 30
The product is transported in bulk.
Proizvod se prevaža v razsutem stanju.
Classification is determined by the General Rules 1, 3(a) and 6 for the interpretation of the Combined Nomenclature and by the wording of CN codes 2207 and 22072000.
Uvrstitev je določena s splošnimi pravili 1, 3(a) in 6 za razlago kombinirane nomenklature ter z besedilom oznak KN 2207 in 22072000.