natgillin/translations-raw huggingface dataset:
Import licence applications lodged from 20 November to 30 November 2008 for certain tariff quotas referred to in Annex I to Commission Regulation (EC) No 2535/2001 of 14 December 2001 laying down detailed rules for applying Council Regulation No 1255/1999 as regards the import arrangements for milk and milk products and opening tariff quotas [3] relate to quantities greater than those available.
Količine v zahtevkih za uvozna dovoljenja, predloženih od 20. do 30. novembra 2008, za nekatere tarifne kvote iz Priloge I k Uredbi Komisije (ES) št. 2535/2001 z dne 14. decembra 2001 o podrobnih pravilih za uporabo Uredbe Sveta (ES) št. 1255/1999 glede uvoznega režima za mleko in mlečne proizvode ter o odprtju tarifnih kvot [3], presegajo razpoložljive količine.
The extent to which licences may be issued should therefore be determined by establishing the allocation coefficient to be applied to the quantities requested,HAS ADOPTED THIS REGULATION:
Zato je treba z določitvijo koeficientov dodeljevanja, ki se bodo uporabili za zahtevane količine, določiti, v kakšnem obsegu se izdajo uvozna dovoljenja –SPREJELA NASLEDNJO UREDBO:
For import licence applications lodged from 20 November to 30 November 2008 for the tariff quotas referred to in parts I.A, I.D, I.F, I.H, I.I, and I.J of Annex I to Regulation (EC) No 2535/2001, licences shall be issued for the quantities requested, multiplied by the allocation coefficient(s) set out in the Annex to this Regulation.
Na podlagi zahtevkov za uvozna dovoljenja za proizvode v okviru tarifnih kvot iz delov I.A, I.D, I.F, I.H, I.I in I.J Priloge I k Uredbi (ES) št. 2535/2001, predloženih v obdobju od 20. do 30. novembra 2008, se izdajo uvozna dovoljenja za zahtevane količine, za katere se uporabijo koeficienti dodeljevanja iz Priloge k tej uredbi.
Tariff quota number
Številka tarifne kvote
Products originating in Switzerland
Proizvodi s poreklom iz Švice
Products originating in Iceland
Izdelki s poreklom iz Islandije
Products originating in the Republic of Moldova
Proizvodi s poreklom iz Republike Moldavije
Commission Regulation (EC) No 1225/2008
Uredba Komisije (ES) št. 1225/2008
It shall apply from 10 December 2008.
Uporablja se od 10. decembra 2008.
Import duties on the products referred to in Article 136(1) of Regulation (EC) No 1234/2007 applicable from 10 December 2008
Uvozne dajatve za proizvode iz člena 136(1) Uredbe (ES) št. 1234/2007, ki se uporabljajo od 10. decembra 2008
Commission Regulation (EC) No 1226/2008
Uredba Komisije (ES) št. 1226/2008
Having regard to Council Regulation (EC) No 314/2004 of 19 February 2004 concerning certain restrictive measures in respect of Zimbabwe [1], and in particular Article 11(b) thereof,
ob upoštevanju Uredbe Sveta (ES) št. 314/2004 z dne 19. februarja 2004 o nekaterih omejevalnih ukrepih v zvezi z Zimbabvejem [1] in zlasti člena 11(b) Uredbe,
Council Decision 2008/922/CFSP [2] amends the Annex to Common Position 2004/161/CFSP [3] by adding 11 individuals and removing one individual.
Sklep Sveta 2008/922/SZVP [2] spreminja Prilogo k Skupnemu stališču 2004/161/SZVP [3] tako, da se doda 11 imen in izbriše eno ime.
The following natural persons are added after number 168 of the list:
Na seznamu se za številko 168 dodajo naslednje fizične osebe:
FUNCTION / REASONS FOR LISTING
POLOŽAJ / RAZLOGI ZA UVRSTITEV NA SEZNAM
Member of Parliament for Mudzi North, directly involved in the campaign of terror waged before and after the elections
poslanec za okrožje Mudzi North, neposredno vpleten v kampanjo groze pred volitvami in po njih
Zimbabwe National Army (ZNA), directly involved in the campaign of terror waged before and after the elections
vojska Zimbabveja (ZNA), neposredno vpleten v kampanjo groze pred volitvami in po njih
Promoted on 12 August 2008 to the rank of Major General (retired); former Acting Permanent Under Secretary (PUS) for Ministry of Defence, directly involved in the campaign of terror waged before and after the elections
avgusta 2008 povišan v čin generalmajorja (v pokoju); nekdanji vršilec dolžnosti stalnega podsekretarja na ministrstvu za obrambo, neposredno vpleten v kampanjo groze pred volitvami in po njih
Directly involved in the campaign of terror waged before and after the elections
neposredno vpleten v kampanjo groze pred volitvami in po njih
Assistant Inspector Zimbabwe Republic Police (ZRP), directly involved in the campaign of terror waged before and after the elections
pomočnik inšpektorja policije Zimbabveja (Zimbabwe Republic Police – ZRP), neposredno vpleten v kampanjo groze pred volitvami in po njih
Superintendent, directly involved in the campaign of terror waged before and after the elections
nadzornik, neposredno vpleten v kampanjo groze pred volitvami in po njih
Assistant Commissioner, directly involved in the campaign of terror waged before and after the elections
pomočnik komisarja, neposredno vpleten v kampanjo groze pred volitvami in po njih
Sergeant (SGT), directly involved in the campaign of terror waged before and after the elections
višji vodnik, neposredno vpleten v kampanjo groze pred volitvami in po njih
Provincial Governor for Mashonaland Central
guverner province Mashonaland Central
Provincial Governor for Mashonaland West’
guverner province Mashonaland West“
The following natural person is deleted from the list:
Naslednja fizična oseba se izbriše s seznama:
ZANU (PF) Politburo Deputy Secretary General for Economic Affairs (former Minister of Finance), born 22.3.1950; member of the Politburo and as such with strong ties to the Government and its policy.’
namestnik generalnega sekretarja za gospodarske zadeve v politbiroju ZANU (PF) (nekdanji minister za finance), rojen 22.3.1950; kot član politbiroja je tesno povezan z vlado in njeno politiko“
Brigadier General Sibusio Bussie Moyo
Brigadni general Sibusio Bussie Moyo
Brigadier General Richard Ruwodo
Brigadni general Richard Ruwodo
Commission Regulation (EC) No 1227/2008
Uredba Komisije (ES) št. 1227/2008
prohibiting fishing for black scabbardfish in Community waters and waters not under the sovereignty or jurisdiction of third countries of V, VI, VII and XII by vessels flying the flag of Spain
o prepovedi ribolova na črnega morskega biča v vodah Skupnosti in vodah, ki niso pod suverenostjo ali jurisdikcijo tretjih držav, v območjih V, VI, VII in XII s plovili, ki plujejo pod zastavo Španije
Community waters and waters not under the sovereignty or jurisdiction of third countries of V, VI, VII and XII
vode Skupnosti in vode, ki niso pod suverenostjo ali jurisdikcijo tretjih držav, v območjih V, VI, VII in XII
Commission Regulation (EC) No 1228/2008
Uredba Komisije (ES) št. 1228/2008
This Regulation shall enter into force on 11 December 2008.
Ta uredba začne veljati 11. decembra 2008.
Commission Regulation (EC) No 1229/2008
Uredba Komisije (ES) št. 1229/2008
entering certain names in the Register of protected designations of origin and protected geographical indications (San Simón da Costa (PDO), Ail blanc de Lomagne (PGI), Steirischer Kren (PGI))
o vpisu nekaterih imen v register zaščitenih označb porekla in zaščitenih geografskih označb (San Simón da Costa (ZOP), Ail blanc de Lomagne (ZGO), Steirischer Kren (ZGO))
Pursuant to the first subparagraph of Article 6(2) of Regulation (EC) No 510/2006 and in accordance with Article 17(2) thereof, Spain’s application to register the name ‘San Simón da Costa’, France’s application to register the name ‘Ail blanc de Lomagne’ and Austria’s application to register the name ‘Steirischer Kren’ were published in the Official Journal of the European Union [2].
V skladu s prvim pododstavkom člena 6(2) in členom 17(2) Uredbe (ES) št. 510/2006 so bile vloga za registracijo imena „San Simón da Costa“, ki jo je vložila Španija, vloga za registracijo imena „Ail blanc de Lomagne“, ki jo je vložila Francija, in vloga za registracijo imena „Steirischer Kren“, ki jo je vložila Avstrija, objavljene v Uradnem listu Evropske unije [2].
OJ C 85, 4.4.2008, p. 13 (San Simón da Costa), OJ C 87, 8.4.2008, p. 8 (Ail blanc de Lomagne), OJ C 91, 12.4.2008, p. 26 (Steirischer Kren).
UL C 85, 4.4.2008, str. 13 (San Simón da Costa), UL C 87, 8.4.2008, str. 8 (Ail blanc de Lomagne), UL C 91, 12.4.2008, str. 26 (Steirischer Kren).
San Simón da Costa (AOP)
San Simón da Costa (ZOP)
Ail blanc de Lomagne (IGP)
Ail blanc de Lomagne (ZGO)
Steirischer Kren (IGP)
Steirischer Kren (ZGO)
Commission Regulation (EC) No 1230/2008
Uredba Komisije (ES) št. 1230/2008
This Regulation shall enter into force on 12 December 2008.
Ta uredba začne veljati 12. decembra 2008.
Done at Brussels, 11 December 2008.
V Bruslju, 11. decembra 2008
Commission Regulation (EC) No 1231/2008
Uredba Komisije (ES) št. 1231/2008
to the Commission Regulation of 11 December 2008 fixing representative prices in the poultrymeat and egg sectors and for egg albumin, and amending Regulation (EC) No 1484/95
k Uredbi Komisije z dne 11. decembra 2008 o določitvi reprezentativnih cen v sektorjih perutninskega mesa in jajc ter za jajčni albumin in o spremembi Uredbe (ES) št. 1484/95
Commission Regulation (EC) No 1232/2008
Uredba Komisije (ES) št. 1232/2008
Pursuant to Article 6 of Commission Regulation (EC) No 1454/2007 of 10 December 2007 laying down common rules for establishing a tender procedure for fixing export refunds for certain agricultural products [3] and following an examination of the tenders submitted in response to the invitation to tender, it is appropriate not to grant any refund for the tendering period ending on 9 December 2008.
V skladu s členom 6 Uredbe Komisije (ES) št. 1454/2007 z dne 10. decembra 2007 o določitvi skupnih pravil za uvedbo razpisnega postopka za določitev izvoznih nadomestil za nekatere kmetijske proizvode [3] in po pregledu predloženih ponudb je primerno, da se za razpisno obdobje, ki se zaključi 9. decembra 2008, ne dodeli nobeno nadomestilo.
For the standing invitation to tender opened by Regulation (EC) No 619/2008, for the tendering period ending on 9 December 2008, no export refund shall be granted for the products and destinations referred to in points (a) and (b) of Article 1 and in Article 2 of that Regulation.
V okviru stalnega razpisa, odprtega z Uredbo (ES) št. 619/2008 za razpisno obdobje, ki se zaključi 9. decembra 2008, se ne dodeli nobeno izvozno nadomestilo za proizvode in namembne kraje iz člena 1(a) in (b) ter člena 2 navedene uredbe.
Commission Regulation (EC) No 1233/2008
Uredba Komisije (ES) št. 1233/2008
For the standing invitation to tender opened by Regulation (EC) No 619/2008, for the tendering period ending on 9 December 2008, no export refund shall be granted for the product and destinations referred to in point (c) of Article 1 and in Article 2 respectively of that Regulation.
V okviru stalnega razpisa, odprtega z Uredbo (ES) št. 619/2008 za razpisno obdobje, ki se zaključi 9. decembra 2008, se za proizvod iz člena 1(c) in namembne kraje iz člena 2 navedene uredbe ne dodeli nobeno nadomestilo.
Commission Regulation (EC) No 1234/2008
Uredba Komisije (ES) št. 1234/2008
concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products
o pregledu sprememb pogojev dovoljenj za promet z zdravili za uporabo v humani medicini in zdravili za uporabo v veterinarski medicini
Having regard to Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products [1], and in particular Article 39(1) thereof,
ob upoštevanju Direktive 2001/82/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v veterinarski medicini [1] in zlasti člena 39(1) Direktive,
Having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use [2], and in particular Article 35(1) thereof,
ob upoštevanju Direktive 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini [2] in zlasti člena 35(1) Direktive,
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 [3], and in particular of Article 16(4) and Article 41(6) 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 [3] in zlasti člena 16(4) in člena 41(6) Uredbe,
The Community legal framework regarding variations to the terms of marketing authorisations is laid down in Commission Regulation (EC) No 1084/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a competent authority of a Member State [4] and Commission Regulation (EC) No 1085/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products falling within the scope of Council Regulation (EEC) No 2309/93 [5].
Pravni okvir Skupnosti za spremembe pogojev dovoljenj za promet z zdravili je določen z Uredbo Komisije (ES) št. 1084/2003 z dne 3. junija 2003 o pregledu sprememb pogojev dovoljenja za promet z zdravili za uporabo v humani medicini in zdravili za uporabo v veterinarski medicini, ki ga je izdal pristojni organ države članice [4], in z Uredbo Komisije (ES) št. 1085/2003 z dne 3. junija 2003 o pregledu sprememb pogojev dovoljenja za promet z zdravili za uporabo v humani medicini in zdravili za uporabo v veterinarski medicini, ki spadajo na področje uporabe Uredbe Sveta (EGS) št. 2309/93 [5].
In the light of practical experience in the application of those two Regulations, it is appropriate to proceed to their review in order to establish a simpler, clearer and more flexible legal framework, while guaranteeing the same level of public and animal health protection.
Ob upoštevanju praktičnih izkušenj pri uporabi navedenih dveh uredb je ustrezno, da se ponovno preučita, da se vzpostavi preprostejši, jasnejši in prožnejši pravni okvir ob zagotavljanju enake ravni zdravstvenega varstva ljudi in živali.
The procedures laid down in Regulations (EC) No 1084/2003 and (EC) No 1085/2003 should therefore be adjusted, without departing from the general principles on which those procedures are based.
Postopke iz uredb (ES) št. 1084/2003 in (ES) št. 1085/2003 bi bilo zato treba prilagoditi brez odstopanja od splošnih načel, na katerih ti postopki temeljijo.
For reasons of proportionality, homeopathic and traditional herbal medicinal products which have not been granted a marketing authorisation but are subject to a simplified registration procedure should remain excluded from the scope of the Regulation.
Zaradi sorazmernosti bi morala ostati homeopatska zdravila in tradicionalna zdravila rastlinskega izvora, za katera ni bilo izdano dovoljenje za promet, vendar se zanje uporablja poenostavljeni postopek registracije, še naprej izključena s področja uporabe Uredbe.
Variations to medicinal products can be classified in different categories, depending on the level of risk to public or animal health and the impact on the quality, safety and efficacy of the medicinal product concerned.
Spremembe zdravil se lahko razvrstijo v različne skupine, odvisno od ravni tveganja za zdravje ljudi ali živali ter vpliva na kakovost, varnost in učinkovitost zadevnega zdravila.
Definitions for each of those categories should therefore be laid down.
Zato bi bilo treba opredeliti vsako od teh skupin.
In order to bring further predictability, guidelines on the details of the various categories of variations should be established and regularly updated in the light of scientific and technical progress, taking in particular account of developments regarding international harmonisation.
Da se zagotovi večja predvidljivost, bi bilo treba določiti smernice o podrobnostih različnih skupin sprememb in jih redno posodabljati ob upoštevanju znanstvenega in tehničnega napredka, zlasti razvoja dogodkov pri mednarodnem usklajevanju.
The European Medicines Agency (hereinafter the Agency) and the Member States should also be empowered to give recommendations on the classification of unforeseen variations.
Evropsko agencijo za zdravila (v nadaljnjem besedilu „Agencija“) in države članice bi bilo treba pooblastiti za dajanje priporočil za razvrstitev nepredvidenih sprememb.
It should be clarified that certain changes which have the highest potential impact on the quality, safety or efficacy of medicinal products require a complete scientific assessment, in the same way as for the evaluation of new marketing authorisation applications.
Treba bi bilo pojasniti, da nekatere spremembe, ki imajo največji možen vpliv na kakovost, varnost ali učinkovitost zdravil, zahtevajo popolno znanstveno presojo, ki se opravi enako kot presoja vlog za pridobitev novega dovoljenja za promet z zdravilom.
In order to further reduce the overall number of variations procedures and to enable competent authorities to focus on those variations that have a genuine impact on quality, safety or efficacy, an annual reporting system should be introduced for certain minor variations.
Da bi se še naprej zmanjševalo skupno število postopkov za spremembe in da se pristojnim organom omogoči, da se osredotočijo se na tiste spremembe, ki dejansko vplivajo na kakovost, varnost ali učinkovitost, bi bilo treba uvesti sistem letnega poročanja za določene manjše spremembe.
Such variations should not require any prior approval and should be notified within 12 months following implementation.
Takšnih sprememb ne bi bilo treba predhodno odobriti in bi jih bilo treba priglasiti v 12 mesecih po začetku uveljavitve.
However, other types of minor variations whose immediate reporting is necessary for the continuous supervision of the medicinal product concerned should not be subject to the annual reporting system.
Druge vrste manjših sprememb, ki jih je treba zaradi stalnega nadzora zadevnega zdravila sporočiti takoj, pa ni treba vključiti v sistem letnega poročanja.
Each variation should require a separate submission.
Vsako spremembo je treba predložiti posebej.
Grouping of variations should nevertheless be allowed in certain cases, in order to facilitate the review of the variations and reduce the administrative burden.
Vendar je treba v nekaterih primerih dovoljeno združevanje sprememb v skupine, da se olajša pregled sprememb in zmanjša administrativna obremenitev.
Grouping of variations to the terms of several marketing authorisations from the same marketing authorisation holder should be allowed only insofar as all concerned marketing authorisations are affected by the exact same group of variations.
Združevanje sprememb pogojev več dovoljenj za promet istega imetnika dovoljenja za promet v skupine bi se dovolilo samo, če natančno ista skupina sprememb vpliva na vsa zadevna dovoljenja za promet z zdravili.
In order to avoid duplication of work in the evaluation of variations to the terms of several marketing authorisations, a worksharing procedure should be established under which one authority, chosen amongst the competent authorities of the Member States and the Agency, should examine the variation on behalf of the other concerned authorities.
Da se prepreči podvajanje dela pri presoji sprememb pogojev več dovoljenj za promet z zdravili, je treba vzpostaviti postopek za delitev dela, po katerem bi en organ, izbran izmed pristojnih organov držav članic in Agencije, presodil spremembo v imenu drugih zadevnih organov.
Provisions should be established reflecting those laid down in Directive 2001/82/EC and Directive 2001/83/EC as regards the role of the coordination groups established under Article 31 of Directive 2001/82/EC and Article 27 of Directive 2001/83/EC, to increase cooperation between Member States and allow for the settlement of disagreements in the evaluation of certain variations.
Treba je predvideti določbe, v katerih bi se izražale določbe iz direktiv 2001/82/ES in 2001/83/ES o vlogi koordinacijskih skupin, ustanovljenih na podlagi člena 31 Direktive 2001/82/ES in člena 27 Direktive 2001/83/ES, da se okrepi sodelovanje med državami članicami in omogoči reševanje nesoglasij pri presoji nekaterih sprememb.
This Regulation should clarify when the holder of a marketing authorisation is allowed to implement a given variation as such clarification is essential for economic operators.
Ta uredba mora pojasnjevati, kdaj lahko imetnik dovoljenja za promet z zdravilom začne izvajati neko spremembo, ker je takšno pojasnilo za gospodarske subjekte bistveno.
A transitional period should be established in order to give all interested parties, in particular Member States authorities and the industry, time to adapt to the new legal framework.
Treba bi bilo določiti prehodno obdobje, da se vsem zainteresiranim stranem, zlasti organom držav članic in industriji zagotovi čas za prilagoditev novemu pravnemu okviru.
The measures provided for in this Regulation are in accordance with the opinions of the Standing Committee on Medicinal Products for Human Use and the Standing Committee on Veterinary Medicinal Products,
Ukrepi, predvideni s to uredbo, so v skladu z mnenjem Stalnega odbora za zdravila za uporabo v humani medicini in Stalnega odbora za zdravila za uporabo v veterinarski medicini –
This Regulation lays down provisions concerning the examination of variations to the terms of the following marketing authorisations for medicinal products for human use and veterinary medicinal products:
S to uredbo so predpisane določbe o pregledu sprememb pogojev naslednjih dovoljenj za promet z zdravili za uporabo v humani medicini in zdravili za uporabo v veterinarski medicini:
authorisations granted in accordance with Council Directive 87/22/EEC [6], Articles 32 and 33 of Directive 2001/82/EC, Articles 28 and 29 of Directive 2001/83/EC and Regulation (EC) No 726/2004;
dovoljenj, ki se izdajo v skladu z Direktivo Sveta 87/22/EGS [6], členoma 32 in 33 Direktive 2001/82/ES, členoma 28 in 29 Direktive 2001/83/ES in Uredbo (ES) št. 726/2004;
authorisations granted following a referral, as provided for in Articles 36, 37 and 38 of Directive 2001/82/EC or Articles 32, 33 and 34 of Directive 2001/83/EC, which has led to complete harmonisation.
dovoljenj, ki se izdajo po napotitvi zadeve v skladu s členi 36, 37 in 38 Direktive 2001/82/ES ali členi 32, 33 in 34 Direktive 2001/83/ES, s katero je bila zagotovljena popolna uskladitev.
This Regulation shall not apply to transfers of a marketing authorisation from one marketing authorisation holder (hereinafter holder) to another.
Ta uredba se ne uporablja za prenose dovoljenja za promet z zdravilom z enega imetnika dovoljenja za promet z zdravilom (v nadaljnjem besedilu „imetnik“) na drugega.
Chapter II shall apply only to variations to the terms of marketing authorisations granted in accordance with Directive 87/22/EEC, Chapter 4 of Directive 2001/82/EC or Chapter 4 of Directive 2001/83/EC.
Poglavje II se uporablja samo za spremembe pogojev dovoljenj za promet z zdravili, ki se izdajo v skladu z Direktivo 87/22/EGS, poglavjem 4 Direktive 2001/82/ES ali poglavjem 4 Direktive 2001/83/ES.
Chapter III shall apply only to variations to the terms of marketing authorisations granted in accordance with Regulation (EC) No 726/2004 (hereinafter centralised marketing authorisations).
Poglavje III se uporablja samo za spremembe pogojev dovoljenj za promet z zdravili, ki se izdajo v skladu z Uredbo (ES) št. 726/2004 (v nadaljnjem besedilu „centralizirana dovoljenja za promet z zdravili“).
‘Variation to the terms of a marketing authorisation’ or ‘variation’ means an amendment to the contents of the particulars and documents referred to in:
„Sprememba pogojev dovoljenja za promet z zdravilom“ ali „sprememba“ je sprememba vsebine podatkov in dokumentov iz: