natgillin/translations-raw huggingface dataset:
Legislation regarding foodstuffs shall not apply to Liechtenstein as long as the application of the Agreement between the European Community and the Swiss Confederation on trade in agricultural products is extended to Liechtenstein, as specified in the introduction to Chapter XII of Annex II to the EEA Agreement.
Zakonodaja v zvezi z živili se ne uporablja za Lihtenštajn, dokler se Sporazum med Evropsko skupnostjo in Švicarsko konfederacijo o trgovini s kmetijskimi proizvodi uporablja tudi za Lihtenštajn, kakor je določeno v uvodu k poglavju XII Priloge II k Sporazumu EGP.
The following point is inserted after point 86 (Regulation (EU) No 1169/2011 of the European Parliament and of the Council):
za točko 86 (Uredba (EU) št. 1169/2011 Evropskega parlamenta in Sveta) se vstavi naslednje:
32013 R 1337: Commission Implementing Regulation (EU) No 1337/2013 of 13 December 2013 laying down rules for the application of Regulation (EU) No 1169/2011 of the European Parliament and of the Council as regards the indication of the country of origin or place of provenance for fresh, chilled and frozen meat of swine, sheep, goats and poultry (OJ L 335, 14.12.2013, p. 19).’
32013 R 1337: Izvedbena uredba Komisije (EU) št. 1337/2013 z dne 13. decembra 2013 o določitvi pravil za uporabo Uredbe (EU) št. 1169/2011 Evropskega parlamenta in Sveta v zvezi z navedbo države izvora ali kraja porekla za sveže, ohlajeno in zamrznjeno prašičje, ovčje, kozje in perutninsko meso (UL L 335, 14.12.2013, str. 19).“;
The following is added in point 54zo (Council Directive 2001/110/EC):
v točki 54zo se doda naslednje (Direktiva Sveta 2001/110/ES):
32014 L 0063: Directive 2014/63/EU of the European Parliament and of the Council of 15 May 2014 (OJ L 164, 3.6.2014, p. 1).’
32014 L 0063: Direktiva 2014/63/EU Evropskega parlamenta in Sveta z dne 15. maja 2014 (UL L 164, 3.6.2014, str. 1).“
The texts of Implementing Regulation (EU) No 1337/2013 and Directive 2014/63/EU in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.
Besedili Izvedbene uredbe (EU) št. 1337/2013 in Direktive 2014/63/EU v islandskem in norveškem jeziku, ki se objavita v Dopolnilu EGP k Uradnemu listu Evropske unije, sta verodostojni.
OJ L 335, 14.12.2013, p. 19.
UL L 335, 14.12.2013, str. 19.
OJ L 164, 3.6.2014, p. 1.
UL L 164, 3.6.2014, str. 1.
amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2019/196]
o spremembi Priloge II (Tehnični predpisi, standardi, preskušanje in certificiranje) k Sporazumu EGP [2019/196]
Commission Implementing Regulation (EU) 2016/662 of 1 April 2016 concerning a coordinated multiannual control programme of the Union for 2017, 2018 and 2019 to ensure compliance with maximum residue levels of pesticides and to assess the consumer exposure to pesticide residues in and on food of plant and animal origin is to be incorporated into the EEA Agreement.
Izvedbeno uredbo Komisije (EU) 2016/662 z dne 1. aprila 2016 o usklajenem večletnem programu nadzora Unije za leta 2017, 2018 in 2019 za zagotavljanje skladnosti z mejnimi vrednostmi ostankov pesticidov v ali na živilih rastlinskega in živalskega izvora ter oceno izpostavljenosti potrošnikov ostankom teh pesticidov je treba vključiti v Sporazum EGP.
Implementing Regulation (EU) 2016/662 repeals Commission Implementing Regulation (EU) 2015/595, which is incorporated into the EEA Agreement and which is consequently to be repealed under the EEA Agreement
Izvedbena uredba (EU) 2016/662 razveljavlja Izvedbeno uredbo Komisije (EU) 2015/595, ki je vključena v Sporazum EGP in jo je zato treba v okviru Sporazuma EGP razveljaviti.
The following is inserted after point 120 (Commission Regulation (EU) 2016/1412) of Chapter XII of Annex II to the EEA Agreement:
za točko 120 (Uredba Komisije (EU) 2016/1412) poglavja XII Priloge II k Sporazumu EGP se vstavi naslednja točka:
32016 R 0662: Commission Implementing Regulation (EU) 2016/662 of 1 April 2016 concerning a coordinated multiannual control programme of the Union for 2017, 2018 and 2019 to ensure compliance with maximum residue levels of pesticides and to assess the consumer exposure to pesticide residues in and on food of plant and animal origin (OJ L 115, 29.4.2016, p. 2).
32016 R 0662: Izvedbena uredba Komisije (EU) 2016/662 z dne 1. aprila 2016 o usklajenem večletnem programu nadzora Unije za leta 2017, 2018 in 2019 za zagotavljanje skladnosti z mejnimi vrednostmi ostankov pesticidov v ali na živilih rastlinskega in živalskega izvora ter oceno izpostavljenosti potrošnikov ostankom teh pesticidov (UL L 115, 29.4.2016, str. 2).
In the table in point (5) in annex II, the following shall be added:
v tabeli v točki 5 Priloge II se doda naslednje:
The text of point 102 (Commission Implementing Regulation (EU) 2015/595) is deleted.
besedilo točke 102 (Izvedbena uredba Komisije (EU) 2015/595) se črta.
The text of Implementing Regulation (EU) 2016/662 in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.
Besedilo Izvedbene uredbe (EU) 2016/662 v islandskem in norveškem jeziku, ki se objavi v Dopolnilu EGP k Uradnemu listu Evropske unije, je verodostojno.
OJ L 115, 29.4.2016, p. 2.
UL L 115, 29.4.2016, str. 2.
OJ L 99, 16.4.2015, p. 7.
UL L 99, 16.4.2015, str. 7.
amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2019/197]
o spremembi Priloge II (Tehnični predpisi, standardi, preskušanje in certificiranje) k Sporazumu EGP [2019/197]
Directive (EU) 2015/2203 of the European Parliament and of the Council of 25 November 2015 on the approximation of the laws of the Member States relating to caseins and caseinates intended for human consumption and repealing Council Directive 83/417/EEC is to be incorporated into the EEA Agreement.
Direktivo (EU) 2015/2203 Evropskega parlamenta in Sveta z dne 25. novembra 2015 o približevanju zakonov držav članic v zvezi s kazeini in kazeinati, namenjenimi prehrani ljudi, ter razveljavitvi Direktive Sveta 83/417/EGS je treba vključiti v Sporazum EGP.
Directive (EU) 2015/2203 repeals Council Directive 83/417/EEC which is incorporated into the EEA Agreement and which is consequently to be repealed under the EEA Agreement.
Direktiva (EU) 2015/2203 razveljavlja Direktivo Sveta 83/417/EGS, ki je vključena v Sporazum EGP, in jo je zato treba v okviru Sporazuma EGP razveljaviti.
The following point is inserted after point 121 (Commission Implementing Regulation (EU) 2016/662):
za točko 121 (Izvedbena uredba Komisije (EU) 2016/662) se vstavi naslednja točka:
32015 L 2203: Directive (EU) 2015/2203 of the European Parliament and of the Council of 25 November 2015 on the approximation of the laws of the Member States relating to caseins and caseinates intended for human consumption and repealing Council Directive 83/417/EEC (OJ L 314, 1.12.2015, p. 1).’
32015 L 2203: Direktiva (EU) 2015/2203 Evropskega parlamenta in Sveta z dne 25. novembra 2015 o približevanju zakonov držav članic v zvezi s kazeini in kazeinati, namenjenimi prehrani ljudi, ter razveljavitvi Direktive Sveta 83/417/EGS (UL L 314, 1.12.2015, str. 1).“;
The text of point 32 (Council Directive 83/417/EEC) is deleted.
besedilo točke 32 (Direktiva Sveta 83/417/EGS) se črta.
The text of Directive (EU) 2015/2203 in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.
Besedilo Direktive (EU) 2015/2203 v islandskem in norveškem jeziku, ki se objavi v Dopolnilu EGP k Uradnemu listu Evropske unije, je verodostojno.
OJ L 314, 1.12.2015, p. 1.
UL L 314, 1.12.2015, str. 1.
OJ L 237, 26.8.1983, p. 25.
UL L 237, 26.8.1983, str. 25.
amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2019/198]
o spremembi Priloge II (Tehnični predpisi, standardi, preskušanje in certificiranje) k Sporazumu EGP [2019/198]
Commission Regulation (EU) 2017/236 of 10 February 2017 refusing to authorise a health claim made on foods and referring to the reduction of disease risk is to be incorporated into the EEA Agreement.
Uredbo Komisije (EU) 2017/236 z dne 10. februarja 2017 o zavrnitvi odobritve zdravstvene trditve na živilih, ki se nanaša na zmanjšanje tveganja za nastanek bolezni, je treba vključiti v Sporazum EGP.
The following point is inserted after point 122 (Directive (EU) 2015/2203 of the European Parliament and of the Council) of Chapter XII of Annex II to the EEA Agreement:
Za točko 122 (Direktiva (EU) 2015/2203 Evropskega parlamenta in Sveta) poglavja XII Priloge II k Sporazumu EGP se vstavi naslednja točka:
32017 R 0236: Commission Regulation (EU) 2017/236 of 10 February 2017 refusing to authorise a health claim made on foods and referring to the reduction of disease risk (OJ L 36, 11.2.2017, p. 9).’
32017 R 0236: Uredba Komisije (EU) 2017/236 z dne 10. februarja 2017 o zavrnitvi odobritve zdravstvene trditve na živilih, ki se nanaša na zmanjšanje tveganja za nastanek bolezni (UL L 36, 11.2.2017, str. 9).“
The text of Regulation (EU) 2017/236 in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.
Besedilo Uredbe (EU) 2017/236 v islandskem in norveškem jeziku, ki se objavi v Dopolnilu EGP k Uradnemu listu Evropske unije, je verodostojno.
This Decision shall enter into force on 6 May 2017, provided that all the notifications under Article 103(1) of the EEA Agreement have been made.
Ta sklep začne veljati 6. maja 2017 pod pogojem, da so bila predložena vsa uradna obvestila v skladu s členom 103(1) Sporazuma EGP.
OJ L 36, 11.2.2017, p. 9.
UL L 36, 11.2.2017, str. 9.
amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2019/199]
o spremembi Priloge II (Tehnični predpisi, standardi, preskušanje in certificiranje) k Sporazumu EGP [2019/199]
Commission Implementing Regulation (EU) 2016/2045 of 23 November 2016 amending Regulation (EU) No 37/2010 as regards the substance gamithromycin is to be incorporated into the EEA Agreement.
Izvedbeno uredbo Komisije (EU) 2016/2045 z dne 23. novembra 2016 o spremembi Uredbe (EU) št. 37/2010 glede snovi gamitromicin je treba vključiti v Sporazum EGP.
Commission Implementing Regulation (EU) 2016/2074 of 25 November 2016 amending Regulation (EU) No 37/2010 as regards the substance aluminium salicylate, basic is to be incorporated into the EEA Agreement.
Izvedbeno uredbo Komisije (EU) 2016/2074 z dne 25. novembra 2016 o spremembi Uredbe (EU) št. 37/2010 glede snovi aluminijev salicilat, bazičen, je treba vključiti v Sporazum EGP.
32016 R 2045: Commission Implementing Regulation (EU) 2016/2045 of 23 November 2016 (OJ L 318, 24.11.2016, p. 3),
32016 R 2045: Izvedbena Uredba Komisije (EU) 2016/2045 z dne 23. novembra 2016 (UL L 318, 24.11.2016, str. 3),
32016 R 2074: Commission Implementing Regulation (EU) 2016/2074 of 25 November 2016 (OJ L 320, 26.11.2016, p. 29).’
32016 R 2074: Izvedbena Uredba Komisije (EU) 2016/2074 z dne 25. novembra 2016 (UL L 320, 26.11.2016, str. 29).“
The texts of Implementing Regulations (EU) 2016/2045 and (EU) 2016/2074 in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.
Besedili izvedbenih uredb (EU) 2016/2045 in (EU) 2016/2074 v islandskem in norveškem jeziku, ki se objavita v Dopolnilu EGP k Uradnemu listu Evropske unije, sta verodostojni.
OJ L 318, 24.11.2016, p. 3.
UL L 318, 24.11.2016, str. 3.
OJ L 320, 26.11.2016, p. 29.
UL L 320, 26.11.2016, str. 29.
amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2019/200]
o spremembi Priloge II (Tehnični predpisi, standardi, preskušanje in certificiranje) k Sporazumu EGP [2019/200]
Commission Implementing Decision (EU) 2016/1658 of 13 September 2016 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products is to be incorporated into the EEA Agreement.
Izvedbeni sklep Komisije (EU) 2016/1658 z dne 13. septembra 2016 o spremembi Odločbe 2008/911/ES o vzpostavitvi seznama rastlinskih snovi, pripravkov in kombinacij iz njih za uporabo v tradicionalnih zdravilih rastlinskega izvora je treba vključiti v Sporazum EGP.
Commission Implementing Decision (EU) 2016/1659 of 13 September 2016 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products is to be incorporated into the EEA Agreement.
Izvedbeni sklep Komisije (EU) 2016/1659 z dne 13. septembra 2016 o spremembi Odločbe 2008/911/ES o vzpostavitvi seznama rastlinskih snovi, pripravkov in kombinacij iz njih za uporabo v tradicionalnih zdravilih rastlinskega izvora je treba vključiti v Sporazum EGP.
The following indents are added in point 15zl (Commission Decision 2008/911/EC) of Chapter XIII of Annex II to the EEA Agreement:
V točki 15zl (Odločba Komisije 2008/911/ES) poglavja XIII Priloge II k Sporazumu EGP se dodata naslednji alinei:
32016 D 1658: Commission Implementing Decision (EU) 2016/1658 of 13 September 2016 (OJ L 247, 15.9.2016, p. 19),
32016 D 1658: Izvedbeni sklep Komisije (EU) 2016/1658 z dne 13. septembra 2016 (UL L 247, 15.9.2016, str. 19),
32016 D 1659: Commission Implementing Decision (EU) 2016/1659 of 13 September 2016 (OJ L 247, 15.9.2016, p. 22).’
32016 D 1659: Izvedbeni sklep Komisije (EU) 2016/1659 z dne 13. septembra 2016 (UL L 247, 15.9.2016, str. 22).“
The texts of Implementing Decisions (EU) 2016/1658 and (EU) 2016/1659 in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.
Besedili izvedbenih sklepov (EU) 2016/1658 in (EU) 2016/1659 v islandskem in norveškem jeziku, ki se objavita v Dopolnilu EGP k Uradnemu listu Evropske unije, sta verodostojni.
OJ L 247, 15.9.2016, p. 19.
UL L 247, 15.9.2016, str. 19.
OJ L 247, 15.9.2016, p. 22.
UL L 247, 15.9.2016, str. 22.
amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2019/201]
o spremembi Priloge II (Tehnični predpisi, standardi, preskušanje in certificiranje) k Sporazumu EGP [2019/201]
Commission Regulation (EU) 2017/227 of 9 February 2017 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards bis(pentabromophenyl)ether is to be incorporated into the EEA Agreement.
Uredbo Komisije (EU) 2017/227 z dne 9. februarja 2017 o spremembi Priloge XVII k Uredbi (ES) št. 1907/2006 Evropskega parlamenta in Sveta o registraciji, evalvaciji, avtorizaciji in omejevanju kemikalij (REACH) glede bis(pentabromofenil)etra je treba vključiti v Sporazum.
32017 R 0227: Commission Regulation (EU) 2017/227 of 9 February 2017 (OJ L 35, 10.2.2017, p. 6).’
32017 R 0227: Uredba Komisije (EU) 2017/227 z dne 9. februarja 2017 (UL L 35, 10.2.2017, str. 6).“
The text of Regulation (EU) 2017/227 in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.
Besedilo Uredbe (EU) 2017/227 v islandskem in norveškem jeziku, ki se objavi v Dopolnilu EGP k Uradnemu listu Evropske unije, je verodostojno.
OJ L 35, 10.2.2017, p. 6.
UL L 35, 10.2.2017, str. 6.
amending Annex I (Veterinary and phytosanitary matters) and Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2019/202]
o spremembi Priloge I (Veterinarske in fitosanitarne zadeve) in Priloge II (Tehnični predpisi, standardi, preskušanje in certificiranje) k Sporazumu EGP [2019/202]
Commission Regulation (EU) 2016/1726 of 27 September 2016 amending Annex IV to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards carvone, diammonium phosphate, Saccharomyces cerevisiae strain LAS02 and whey is to be incorporated into the EEA Agreement.
Uredbo Komisije (EU) 2016/1726 z dne 27. septembra 2016 o spremembi Priloge IV k Uredbi Evropskega parlamenta in Sveta (ES) št. 396/2005 glede karvona, diamonijevega fosfata, Saccharomyces cerevisiae, sev LAS02, in sirotke je treba vključiti v Sporazum EGP.
32016 R 1726: Commission Regulation (EU) 2016/1726 of 27 September 2016 (OJ L 261, 28.9.2016, p. 3).’
32016 R 1726: Uredba Komisije (EU) 2016/1726 z dne 27. septembra 2016 (UL L 261, 28.9.2016, str. 3).“
The text of Regulation (EU) 2016/1726 in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.
Besedilo Uredbe (EU) 2016/1726 v islandskem in norveškem jeziku, ki se objavi v Dopolnilu EGP k Uradnemu listu Evropske unije, je verodostojno.
OJ L 261, 28.9.2016, p. 3.
UL L 261, 28.9.2016, str. 3.
amending Annex I (Veterinary and phytosanitary matters) and Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2019/203]
o spremembi Priloge I (Veterinarske in fitosanitarne zadeve) in Priloge II (Tehnični predpisi, standardi, preskušanje in certificiranje) k Sporazumu EGP [2019/203]
Commission Regulation (EU) 2016/1902 of 27 October 2016 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for acetamiprid, ametoctradin, azoxystrobin, cyfluthrin, difluoroacetic acid, dimethomorph, fenpyrazamine, flonicamid, fluazinam, fludioxonil, flupyradifurone, flutriafol, fluxapyroxad, metconazole, proquinazid, prothioconazole, pyriproxyfen, spirodiclofen and trifloxystrobin in or on certain products is to be incorporated into the EEA Agreement.
Uredbo Komisije (EU) 2016/1902 z dne 27. oktobra 2016 o spremembi prilog II in III k Uredbi Evropskega parlamenta in Sveta (ES) št. 396/2005 glede mejnih vrednosti ostankov za acetamiprid, ametoktradin, azoksistrobin, ciflutrin, difluorocetno kislino, dimetomorf, fenpirazamin, flonikamid, fluazinam, fludioksonil, flupiradifuron, flutriafol, fluksapiroksad, metkonazol, prokvinazid, protiokonazol, piriproksifen, spirodiklofen in trifloksistrobin v ali na nekaterih proizvodih je treba vključiti v Sporazum EGP.
32016 R 1902: Commission Regulation (EU) 2016/1902 of 27 October 2016 (OJ L 298, 4.11.2016, p. 1).’
32016 R 1902: Uredba Komisije (EU) 2016/1902 z dne 27. oktobra 2016 (UL L 298, 4.11.2016, str. 1).“
The text of Regulation (EU) 2016/1902 in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.
Besedilo Uredbe (EU) 2016/1902 v islandskem in norveškem jeziku, ki se objavi v Dopolnilu EGP k Uradnemu listu Evropske unije, je verodostojno.
OJ L 298, 4.11.2016, p. 1.
UL L 298, 4.11.2016, str. 1.
amending Annex II (Technical regulations, standards, testing and certification) and Annex XVII (Intellectual Property) to the EEA Agreement [2019/204]
o spremembi Priloge II (Tehnični predpisi, standardi, preskušanje in certificiranje) in Priloge XVII (Intelektualna lastnina) k Sporazumu EGP [2019/204]
Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 is to be incorporated into the EEA Agreement.
Uredbo (ES) št. 1901/2006 Evropskega parlamenta in Sveta z dne 12. decembra 2006 o zdravilih za pediatrično uporabo in spremembah Uredbe (EGS) št. 1768/92, Direktive 2001/20/ES, Direktive 2001/83/ES in Uredbe (ES) št. 726/2004 je treba vključiti v Sporazum EGP.
Regulation (EC) No 1902/2006 of the European Parliament and of the Council of 20 December 2006 amending Regulation (EC) No 1901/2006 on medicinal products for paediatric use is to be incorporated into the EEA Agreement.
Uredbo (ES) št. 1902/2006 Evropskega parlamenta in Sveta z dne 20. decembra 2006 o spremembah Uredbe 1901/2006 o zdravilih za pediatrično uporabo je treba vključiti v Sporazum EGP.
Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (Codified version) is to be incorporated into the EEA Agreement.
Uredbo (ES) št. 469/2009 Evropskega parlamenta in Sveta z dne 6. maja 2009 o dodatnem varstvenem certifikatu za zdravila (Kodificirana različica) je treba vključiti v Sporazum EGP.
Commission Regulation (EU) No 488/2012 of 8 June 2012 amending Regulation (EC) No 658/2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council, as corrected by OJ L 338, 12.12.2012, p. 44, is to be incorporated into the EEA Agreement.
Uredbo Komisije (EU) št. 488/2012 z dne 8. junija 2012 o spremembi Uredbe Komisije (ES) št. 658/2007 o denarnih kaznih za kršitev nekaterih obveznosti v zvezi z dovoljenji za promet, izdanimi v skladu z Uredbo (ES) št. 726/2004 Evropskega parlamenta in Sveta, kakor je bila popravljena z UL L 338, 12.12.2012, str. 44, je treba vključiti v Sporazum EGP.
Regulation (EC) No 469/2009 repeals Council Regulation (EEC) No 1768/92 which has been incorporated into the EEA Agreement and which is therefore to be repealed under the EEA Agreement.
Uredba (ES) št. 469/2009 razveljavlja Uredbo Sveta (EGS) št. 1768/92, ki je vključena v Sporazum EGP in jo je zato treba v okviru Sporazuma EGP razveljaviti.
Commission Regulation (EC) No 658/2007 lays down rules concerning the application of financial penalties to the holders of marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council.
Uredba Komisije (ES) št. 658/2007 določa pravila o uporabi denarnih kazni za imetnike dovoljenj za promet, izdanih v skladu z Uredbo (ES) št. 726/2004 Evropskega parlamenta in Sveta.
Once the Commission has granted a marketing authorisation, the EFTA States should simultaneously take corresponding decisions within 30 days from the grant.
Potem ko Komisija izda dovoljenje za promet, bi morale države Efte hkrati ter v 30 dneh od izdaje dovoljenja sprejeti ustrezne odločitve.
Due to the special circumstances, notably that the Commission grants marketing authorisations, that the infringements affect the Union and its interests and the complex and technical nature of the infringement procedures, the EFTA Surveillance Authority should cooperate closely with the Commission and await the Commission's assessment and proposal for action before taking a decision regarding financial penalties to the holders of marketing authorisations established in an EFTA State.
Zaradi posebnih okoliščin, zlasti da Komisija izdaja dovoljenja za promet, da kršitve vplivajo na Unijo in njene interese ter zaradi zapletene in tehnične lastnosti postopkov za ugotavljanje kršitev, bi moral Nadzorni organ Efte tesno sodelovati s Komisijo ter počakati na oceno Komisije in predloge za ukrepanje, preden sprejme odločitev glede denarnih kazni za imetnike dovoljenj za promet s sedežem v državi Efte.
Annexes II and XVII to the EEA Agreement should therefore be amended accordingly,
Prilogi II in XVII k Sporazumu EGP bi bilo zato treba ustrezno spremeniti –
The following text is inserted after the words ‘Committee on Orphan Medicinal Products (COMP)’ in the 13th paragraph of the introductory text:
za besede „Odbora za zdravila sirote (COMP)“ v 13. odstavku uvodnega besedila se vstavi naslednje besedilo:
‘, the Paediatric Committee’.
„Odbora za pediatrijo“;
The following indent is added in points 15q (Directive 2001/83/EC of the European Parliament and of the Council) and 15zb (Regulation (EC) No 726/2004 of the European Parliament and of the Council):
v točkah 15q (Direktiva 2001/83/ES Evropskega parlamenta in Sveta) in 15zb (Uredba (ES) št. 726/2004 Evropskega parlamenta in Sveta) se doda naslednja alinea: