natgillin/translations-raw huggingface dataset:
The Kingdom of Denmark and the Federal Republic of Germany provided the following information: (1) the annual probability of the significant wave height's exceeding two metres is less than 10 % on the identified routes; (2) the ships to which the derogation would apply are engaged in regular services; (3) the voyages do not exceed thirty miles from the point of departure; (4) the sea area where the passenger ships are sailing is provided with shore-based navigational guidance and reliable weather forecast services as well as adequate and sufficient search and rescue facilities; (5) the profile of the journey and the schedule of the voyages are not compatible with registering passenger details in a synchronised way with land transport; and (6) the derogation request would not have any adverse effect on competition.
Direktive 98/41/EZ u vezi s osobama na svim putničkim brodovima koji plove na liniji Rostock – Gedser u oba pravca.
The final outcome of the assessment demonstrates that all the conditions for the approving the derogation are fulfilled.
Kako bi mogla ocijeniti zahtjev, Komisija je 5. studenoga 2015. zatražila dodatne informacije od Kraljevine Danske i Savezne Republike Njemačke.
The measures provided for in this Decision are in accordance with the opinion of the Committee on Safe Seas and the Prevention of Pollution from Ships,
Kraljevina Danska i Savezna Republika Njemačka odgovorile su 25. svibnja 2016.
HAS ADOPTED THIS DECISION:
Na temelju informacija kojima raspolaže, Komisija je uz pomoć EMSA-e ocijenila zahtjev za odstupanje.
Article 1
Kraljevina Danska i Savezna Republika Njemačka obavijestile su o sljedećem: 1. godišnja vjerojatnost značajne visine vala, veće od dva metra, manja je od 10 % na utvrđenim plovidbenim linijama; 2. brodovi na koje bi se primjenjivalo odstupanje plove na redovnim linijama; 3. plovidbe nisu dulje od trideset milja od točke isplovljavanja; 4. na području mora kojim plove putnički brodovi moguće je navigacijsko vođenje s kopna, dostupna je pouzdana vremenska prognoza te postoje odgovarajuća i dovoljna sredstva traganja i spašavanja; 5. profil i red plovidbe ne omogućuju upisivanje detalja o putnicima uz zadržavanje usklađenosti s kopnenim prometom; 6. zahtjev za odstupanje ne bi naštetio tržišnom natjecanju.
The derogation request of the Kingdom of Denmark and the Federal Republic of Germany pursuant to Article 9(4) of Directive 98/41/EC regarding recording information specified in Article 5(1) of this Directive for persons on board all passenger ships in regular service sailing on the route Rostock-Gedser and vice versa, is hereby approved.
Konačni rezultati procjene pokazuju da su ispunjeni svi uvjeti za odobrenje odstupanja.
Article 2
Mjere predviđene ovom Odlukom u skladu su s mišljenjem Odbora za sigurnost na moru i sprečavanje onečišćenja s brodova,
This Decision is addressed to the Kingdom of Denmark and the Federal Republic of Germany.
DONIJELA JE OVU ODLUKU:
Done at Brussels, 18 April 2017.
Članak 1.
For the Commission
Odobrava se zahtjev za odstupanje Kraljevine Danske i Savezne Republike Njemačke u skladu s člankom 9. stavkom 4.
Member of the Commission
Direktive 98/41/EZ u vezi s bilježenjem informacija navedenih u članku 5. stavku 1. navedene Direktive o osobama na svim putničkim brodovima koji plove na liniji Rostock – Gedser u oba pravca.
OJ L 188, 2.7.1998, p.
Članak 2.
Council Decision (EU) 2017/715
Odluka Vijeća (EU) 2017/715
on the position to be adopted, on behalf of the European Union, within the EEA Joint Committee concerning an amendment to Annex II (Technical Regulations, Standards, Testing and Certification) and Annex XVII (Intellectual Property) to the EEA Agreement (Paediatric Regulation)
o stajalištu koje treba zauzeti, u ime Europske unije, u okviru Zajedničkog odbora EGP-a u vezi s izmjenom Priloga II.
THE COUNCIL OF THE EUROPEAN UNION,
(Tehnički propisi, norme, ispitivanje i potvrđivanje) i Priloga XVII.
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 in conjunction with Article 218(9) thereof,
(Intelektualno vlasništvo) Sporazumu o EGP-u (Uredba o lijekovima za pedijatrijsku upotrebu) VIJEĆE EUROPSKE UNIJE,
Having regard to Council Regulation (EC) No 2894/94 of 28 November 1994 concerning arrangements for implementing the Agreement on the European Economic Area [1], and in particular Article 1(3) thereof,
uzimajući u obzir Ugovor o funkcioniranju Europske unije, a posebno njegov članak 114. u vezi s člankom 218. stavkom 9.,
Pursuant to Article 98 of the EEA Agreement, the EEA Joint Committee may decide to amend, inter alia, Annex II (Technical Regulations, Standards, Testing and Certification) and Annex XVII (Intellectual Property) to the EEA Agreement.
Sporazum o Europskom gospodarskom prostoru [2] („Sporazum o EGP-u”) stupio je na snagu 1. siječnja 1994.
Regulation (EC) No 1901/2006 of the European Parliament and of the Council [3] is to be incorporated into the EEA Agreement.
Na temelju članka 98.
Regulation (EC) No 1902/2006 of the European Parliament and of the Council [4] is to be incorporated into the EEA Agreement.
Sporazuma o EGP-u Zajednički odbor EGP-a može odlučiti izmijeniti, među ostalim, Prilog II.
Regulation (EC) No 469/2009 of the European Parliament and of the Council [5] is to be incorporated into the EEA Agreement.
(Tehnički propisi, norme, ispitivanje i potvrđivanje) i Prilog XVII.
Commission Regulation (EU) No 488/2012 [6] is to be incorporated into the EEA Agreement.
(Intelektualno vlasništvo) Sporazumu o EGP-u.
Regulation (EC) No 469/2009 repeals Council Regulation (EEC) No 1768/92 [7], which has been incorporated into the EEA Agreement and which is therefore to be repealed under the EEA Agreement.
Uredbu (EZ) br. 1901/2006 Europskog parlamenta i Vijeća [3] treba uključiti u Sporazum o EGP-u.
Commission Regulation (EC) No 658/2007 [8] lays down rules concerning the application of financial penalties to the holders of marketing authorisations granted under Regulation (EC) No 726/2004.
Uredbu (EZ) br. 1902/2006 Europskog parlamenta i Vijeća [4] treba uključiti u Sporazum o EGP-u.
Once the Commission has granted a marketing authorisation, the EFTA States should simultaneously take corresponding decisions within 30 days from the grant.
Uredbu (EZ) br. 469/2009 Europskog parlamenta i Vijeća [5] treba uključiti u Sporazum o EGP-u.
Due to the special circumstances, namely, 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 the application of financial penalties to the holders of marketing authorisations established in an EFTA State.
Uredbu Komisije (EU) br. 488/2012 [6] treba uključiti u Sporazum o EGP-u.
Annex II (Technical Regulations, Standards, Testing and Certification) and Annex XVII (Intellectual Property) to the EEA Agreement should therefore be amended accordingly.
Uredbom (EZ) br. 469/2009 stavlja se izvan snage Uredba Vijeća (EEZ) br. 1768/92 [7], koja je uključena u Sporazum o EGP-u i koju stoga treba isključiti iz njega.
The position of the Union within the EEA Joint Committee should therefore be based on the attached draft decision,
Uredbom Komisije (EZ) br. 658/2007 [8] utvrđuju se pravila o primjeni novčanih kazni na nositelje odobrenja za stavljanje u promet dodijeljenih u skladu s Uredbom (EZ) br. 726/2004.
HAS ADOPTED THIS DECISION:
Nakon što Komisija dodijeli odobrenje za stavljanje u promet, države EFTA-e trebale bi istodobno i u roku od 30 dana od dodjele donijeti odgovarajuće odluke.
Article 1
Zbog posebnih okolnosti, posebice toga da Komisija dodjeljuje odobrenja za stavljanje u promet, toga da kršenja utječu na Uniju i njezine interese, te zbog složene i tehničke prirode postupaka utvrđivanja kršenja obveza, Nadzorno tijelo EFTA-e trebalo bi blisko surađivati s Komisijom i pričekati njezinu ocjenu i prijedlog djelovanja prije donošenja odluke o primjeni novčanih kazni na nositelje odobrenjâ za stavljanje u promet koji imaju poslovni nastan u državi EFTA-e.
The position to be adopted, on behalf of the Union within the EEA Joint Committee, on the proposed amendment to Annex II (Technical Regulations, Standards, Testing and Certification) and Annex XVII (Intellectual Property) to the EEA Agreement, shall be based on the draft decision of the EEA Joint Committee attached to this Decision.
Prilog II.
Article 2
(Tehnički propisi, norme, ispitivanje i potvrđivanje) i Prilog XVII.
This Decision shall enter into force on the date of its adoption.
(Intelektualno vlasništvo) Sporazumu o EGP-u trebalo bi stoga na odgovarajući način izmijeniti.
Done at Brussels, 27 March 2017.
Stajalište Unije u okviru Zajedničkog odbora EGP-a trebalo bi se stoga temeljiti na priloženom nacrtu odluke,
For the Council
DONIO JE OVU ODLUKU:
The President
Članak 1.
OJ L 305, 30.11.1994, p. 6.
Stajalište koje treba zauzeti u ime Unije u okviru Zajedničkog odbora EGP-a o predloženoj izmjeni Priloga II.
OJ L 1, 3.1.1994, p. 3.
(Tehnički propisi, norme, ispitivanje i potvrđivanje) i Priloga XVII.
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 (OJ L 378, 27.12.2006, p. 1).
(Intelektualno vlasništvo) Sporazumu o EGP-u temelji se na nacrtu Odluke Zajedničkog odbora EGP-a priloženom ovoj Odluci.
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 (OJ L 378, 27.12.2006, p. 20).
Članak 2.
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 (OJ L 152, 16.6.2009, p. 1).
Ova Odluka stupa na snagu na dan donošenja.
Commission Regulation (EU) No 488/2012 of 8 June 2012 amending Commission 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 (OJ L 150, 9.6.2012, p. 68).
Sastavljeno u Bruxellesu 27. ožujka 2017.
OJ L 182, 2.7.1992, p. 1.
Za Vijeće
Commission Regulation (EC) No 658/2007 of 14 June 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 (OJ L 155, 15.6.2007, p. 10).
Predsjednik
DRAFT
SL L 305, 30.11.1994., str. 6.
DECISION OF THE EEA JOINT COMMITTEE No …/2017
SL L 1, 3.1.1994., str. 3.
amending Annex II (Technical Regulations, Standards, Testing and Certification) and Annex XVII (Intellectual Property) to the EEA Agreement
Uredba (EZ) br. 1901/2006 Europskog parlamenta i Vijeća od 12. prosinca 2006. o lijekovima za pedijatrijsku upotrebu i izmjeni Uredbe (EEZ) br. 1768/92, Direktive 2001/20/EZ, Direktive 2001/83/EZ i Uredbe (EZ) br. 726/2004 (SL L 378, 27.12.2006., str. 1.).
THE EEA JOINT COMMITTEE,
Uredba (EZ) br. 1902/2006 Europskog parlamenta i Vijeća od 20. prosinca 2006. o izmjeni Uredbe 1901/2006 o lijekovima za pedijatrijsku upotrebu (SL L 378, 27.12.2006., str. 20.).
Having regard to the Agreement on the European Economic Area (‘the EEA Agreement’), and in particular Article 98 thereof,
Uredba (EZ) br. 469/2009 Europskog parlamenta i Vijeća od 6. svibnja 2009. o svjedodžbi o dodatnoj zaštiti za lijekove (SL L 152, 16.6.2009., str. 1.).
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 [1] is to be incorporated into the EEA Agreement.
Uredba Komisije (EU) br. 488/2012 od 8. lipnja 2012. o izmjeni Uredbe (EZ) br. 658/2007 o novčanim sankcijama za kršenja određenih obveza u vezi s odobrenjima za stavljanje u promet koja su dodijeljena na temelju Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća (SL L 150, 9.6.2012., str. 68.).
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 [2] is to be incorporated into the EEA Agreement.
SL L 182, 2.7.1992., str. 1.
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) [3] is to be incorporated into the EEA Agreement.
Uredba Komisije (EZ) br. 658/2007 od 14. lipnja 2007. o novčanim kaznama u slučaju kršenja određenih obveza vezanih uz odobrenja za stavljanje u promet dana u skladu s Uredbom (EZ) br. 726/2004 Europskog parlamenta i Vijeća (SL L 155, 15.6.2007., str. 10.).
Commission Regulation (EU) No 488/2012 of 8 June 2012 amending Commission 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 [4], as corrected by OJ L 338, 12.12.2012, p. 44, is to be incorporated into the EEA Agreement.
NACRT
Regulation (EC) No 469/2009 repeals Council Regulation (EEC) No 1768/92 [5], which has been incorporated into the EEA Agreement and which is therefore to be repealed under the EEA Agreement.
ODLUKA ZAJEDNIČKOG ODBORA EGP-a br. …/2017
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.
o izmjeni Priloga II.
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.
(Tehnički propisi, norme, ispitivanje i potvrđivanje) i Priloga XVII.
Annexes II and XVII to the EEA Agreement should therefore be amended accordingly,
(Intelektualno vlasništvo) Sporazumu o EGP-u ZAJEDNIČKI ODBOR EGP-a,
Chapter XIII of Annex II to the EEA Agreement shall be amended as follows:
uzimajući u obzir Sporazum o Europskom gospodarskom prostoru („Sporazum o EGP-u”), a posebno njegov članak 98.,
The following text is inserted after the words ‘Committee on Orphan Medicinal Products (COMP)’ in the 13th paragraph of the introductory text:
Uredbu (EZ) br. 1901/2006 Europskog parlamenta i Vijeća od 12. prosinca 2006. o lijekovima za pedijatrijsku upotrebu i izmjeni Uredbe (EEZ) br. 1768/92, Direktive 2001/20/EZ, Direktive 2001/83/EZ i Uredbe (EZ) br. 726/2004 [1] treba uključiti u Sporazum o EGP-u.
‘, the Paediatric Committee’
Uredbu (EZ) br. 1902/2006 Europskog parlamenta i Vijeća od 20. prosinca 2006. o izmjeni Uredbe 1901/2006 o lijekovima za pedijatrijsku upotrebu [2] treba uključiti u Sporazum o EGP-u.
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):
Uredbu (EZ) br. 469/2009 Europskog parlamenta i Vijeća od 6. svibnja 2009. o svjedodžbi o dodatnoj zaštiti za lijekove [3] treba uključiti u Sporazum o EGP-u.
32006 R 1901: Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 (OJ L 378, 27.12.2006, p. 1).’
Uredbu Komisije (EU) br. 488/2012 od 8. lipnja 2012. o izmjeni Uredbe (EZ) br. 658/2007 o novčanim sankcijama za kršenja određenih obveza u vezi s odobrenjima za stavljanje u promet koja su dodijeljena na temelju Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća [4], kako je ispravljena u SL L 338, 12.12.2012., str. 44., treba uključiti u Sporazum o EGP-u.
The adaptation text of point 15zb (Regulation (EC) No 726/2004 of the European Parliament and of the Council) is replaced by the following:
Uredbom (EZ) br. 469/2009 stavlja se izvan snage Uredba Vijeća (EEZ) br. 1768/92 [5], koja je uključena u Sporazum o EGP-u i koju stoga treba isključiti iz njega.
‘The powers vested in the European Commission in relation to the infringement procedure foreseen in Article 84(3), including the power to impose financial penalties on the holders of marketing authorisations, shall, in the cases where the marketing authorisation holder is established in an EFTA State, be carried out by the EFTA Surveillance Authority in close cooperation with the Commission.
Uredbom Komisije (EZ) br. 658/2007 utvrđuju se pravila o primjeni novčanih kazni na nositelje odobrenja za stavljanje u promet dodijeljenih u skladu s Uredbom (EZ) br. 726/2004.
Before the EFTA Surveillance Authority takes a decision regarding financial penalties, the Commission shall provide it with its assessment and a proposal on how to act.’
Zbog posebnih okolnosti, posebice toga da Komisija dodjeljuje odobrenja za stavljanje u promet, toga da kršenja utječu na Uniju i njezine interese, te zbog složene i tehničke prirode postupaka utvrđivanja kršenja obveza, Nadzorno tijelo EFTA-e trebalo bi blisko surađivati s Komisijom i pričekati njezinu ocjenu i prijedlog djelovanja prije donošenja odluke o novčanim kaznama protiv nositelja odobrenjâ za stavljanje u promet koji imaju poslovni nastan u državi EFTA-e.
The text of point 15zj (Commission Regulation (EC) No 658/2007) is replaced by the following:
Priloge II. i XVII.
‘32007 R 0658: Commission Regulation (EC) No 658/2007 of 14 June 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 (OJ L 155, 15.6.2007, p. 10), as amended by:
Sporazumu o EGP-u trebalo bi stoga na odgovarajući način izmijeniti,
32012 R 0488: Commission Regulation (EU) No 488/2012 of 8 June 2012 (OJ L 150, 9.6.2012, p. 68), as corrected by OJ L 338, 12.12.2012, p. 44.
Poglavlje XIII.
The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following adaptation:
Priloga II.
The powers vested in the European Commission in relation to the infringement procedure, including the power to impose financial penalties on the holders of marketing authorisations, shall, in the cases where the marketing authorisation holder is established in an EFTA State, be carried out by the EFTA Surveillance Authority in close cooperation with the Commission.
Sporazumu o EGP-u mijenja se kako slijedi:
Before the EFTA Surveillance Authority takes a decision regarding financial penalties, the Commission shall provide it with its assessment and a proposal on how to act.’
U trinaestom stavku uvodnog teksta iza riječi „Odbora za lijekove za rijetke bolesti” umeće se sljedeći tekst:
The following point is inserted after point 15zo (Commission Implementing Regulation (EU) No 198/2013):
„Odbora za pedijatrijske lijekove”.
32006 R 1901: 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 (OJ L 378, 27.12.2006, p. 1), as amended by:
U točkama 15.q (Direktiva 2001/83/EZ Europskog parlamenta i Vijeća) i 15.zb (Uredba (EZ) br. 726/2004 Europskog parlamenta i Vijeća) dodaje se sljedeća alineja:
32006 R 1902: Regulation (EC) No 1902/2006 of the European Parliament and of the Council of 20 December 2006 (OJ L 378, 27.12.2006, p. 20).
32006 R 1901: Uredbom (EZ) br. 1901/2006 Europskog parlamenta i Vijeća od 12. prosinca 2006.
The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following adaptations:
(SL L 378, 27.12.2006., str. 1.).”.
The application of Article 36(3) shall not be made dependent on an authorisation of the medicinal product in Liechtenstein.
Tekst prilagodbe točke 15.zb (Uredba (EZ) br. 726/2004 Europskog parlamenta i Vijeća) zamjenjuje se sljedećim:
The powers vested in the European Commission in relation to the infringement procedure foreseen in Article 49(3), including the power to impose financial penalties on the holders of marketing authorisations, shall, in the cases where the marketing authorisation holder is established in an EFTA State, be carried out by the EFTA Surveillance Authority in close cooperation with the Commission.
„Ovlasti dodijeljene Europskoj komisiji u vezi s postupkom zbog povrede propisa predviđenim u članku 84. stavku 3., uključujući ovlast za određivanje novčanih kazni nositeljima odobrenjâ za stavljanje u promet, u slučajevima kada nositelj odobrenja za stavljanje u promet ima poslovni nastan u državi EFTA-e, provodi Nadzorno tijelo EFTA-e u bliskoj suradnji s Komisijom.
Before the EFTA Surveillance Authority takes a decision regarding financial penalties, the Commission shall provide it with its assessment and a proposal on how to act.’.
Prije nego što Nadzorno tijelo EFTA-e donese odluku o novčanim kaznama Komisija mu dostavlja svoju ocjenu i prijedlog o tome kako postupiti.”.
The text of point 6 (Council Regulation (EEC) No 1768/92) of Annex XVII to the EEA Agreement is replaced by the following:
Tekst točke 15.zj (Uredba Komisije (EZ) br. 658/2007) zamjenjuje se sljedećim:
‘32009 R 0469: 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) (OJ L 152, 16.6.2009, p. 1).
„32007 R 0658: Uredba Komisije (EZ) br. 658/2007 od 14. lipnja 2007. o novčanim kaznama u slučaju kršenja određenih obveza vezanih uz odobrenja za stavljanje u promet dana u skladu s Uredbom (EZ) br. 726/2004 Europskog parlamenta i Vijeća (SL L 155, 15.6.2007., str. 10.), kako je izmijenjena:
The following paragraphs shall be added to Article 7:
32012 R 0488: Uredbom Komisije (EU) br. 488/2012 od 8. lipnja 2012.
Paragraph 5 shall not apply to the EFTA States.
(SL L 150, 9.6.2012., str. 68.), kako je ispravljena u SL L 338, 12.12.2012., str. 44.
Notwithstanding paragraph 4, for five years following the entry into force of Regulation (EC) No 1901/2006 in the EFTA State concerned, the application for an extension of the duration of a certificate already granted shall be lodged not later than six months before the expiry of the certificate.’;
Za potrebe ovog Sporazuma odredbe Uredbe sadržavaju sljedeću prilagodbu:
The following paragraphs shall be added to Article 21:
Ovlasti dodijeljene Europskoj komisiji u vezi s postupkom utvrđivanja kršenja obveza, uključujući ovlast za određivanje novčanih kazni nositeljima odobrenjâ za stavljanje u promet, u slučajevima kada nositelj odobrenja za stavljanje u promet ima poslovni nastan u državi EFTA-e, provodi Nadzorno tijelo EFTA-e u bliskoj suradnji s Komisijom.
An application for an extension of the duration of a certificate can only be granted in an EFTA State where the certificate expires less than 6 months prior to the entry into force of Regulation (EC) No 1901/2006 in the EFTA state concerned.
Prije nego što Nadzorno tijelo EFTA-e donese odluku o novčanim kaznama Komisija mu dostavlja ocjenu i prijedlog o tome kako postupiti.”.
In cases where the certificate expires prior to the entry into force of Regulation (EC) No 1901/2006 in the EFTA state concerned, the extension shall take effect only with respect to the time following after both such entry into force in the EFTA state concerned and the date of the publication of the application for the extension.
Iza točke 15.zo (Provedbena uredba Komisije (EU) br. 198/2013) umeće se sljedeća točka: