natgillin/translations-raw huggingface dataset:
This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union.
32016 R 2074: Provedbenom uredbom Komisije (EU) 2016/2074 od 25. studenoga 2016.
Done at Brussels, 5 May 2017.
(SL L 320, 26.11.2016., str. 29.),”.
The President
Vjerodostojni su tekstovi provedbenih uredbi (EU) 2016/2045 i (EU) 2016/2074 na islandskom i norveškom jeziku koji se objavljuju u Dodatku o EGP-u Službenom listu Europske unije.
OJ L 318, 24.11.2016, p. 3.
Članak 3.
OJ L 320, 26.11.2016, p. 29.
Ova Odluka stupa na snagu 6. svibnja 2017. pod uvjetom da su podnesene sve obavijesti iz članka 103. stavka 1.
amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2019/200]
o izmjeni Priloga II.
THE EEA JOINT COMMITTEE,
(Tehnički propisi, norme, ispitivanje i potvrđivanje) Sporazumu o EGP-u [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.
budući da:
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.
Provedbena odluka Komisije (EU) 2016/1658 оd 13. rujna 2016. o izmjeni Odluke 2008/911/EZ o izradi Popisa biljnih tvari, pripravaka i njihovih kombinacija za uporabu u tradicionalnim biljnim lijekovima treba se uključiti u Sporazum o EGP-u.
Annex II to the EEA Agreement should therefore be amended accordingly,
Provedbena odluka Komisije (EU) 2016/1659 оd 13. rujna 2016. o izmjeni Odluke 2008/911/EZ o izradi Popisa biljnih tvari, pripravaka i njihovih kombinacija za uporabu u tradicionalnim biljnim lijekovima treba se uključiti u Sporazum o EGP-u.
The following indents are added in point 15zl (Commission Decision 2008/911/EC) of Chapter XIII of Annex II to the EEA Agreement:
DONIO JE OVU ODLUKU:
32016 D 1658: Commission Implementing Decision (EU) 2016/1658 of 13 September 2016 (OJ L 247, 15.9.2016, p. 19),
Članak 1.
32016 D 1659: Commission Implementing Decision (EU) 2016/1659 of 13 September 2016 (OJ L 247, 15.9.2016, p. 22).’
U točki 15.zl (Odluka Komisije 2008/911/EZ) u poglavlju XIII.
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.
Sporazumu o EGP-u dodaju se sljedeće alineje:
Article 3
32016 D 1658: Provedbenom odlukom Komisije (EU) 2016/1658 od 13. rujna 2016.
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.
(SL L 247, 15.9.2016., str. 19.),
Article 4
32016 D 1659: Provedbenom odlukom Komisije (EU) 2016/1659 od 13. rujna 2016.
This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union.
(SL L 247, 15.9.2016., str. 22.).”
For the EEA Joint Committee
Vjerodostojni su tekstovi provedbenih odluka (EU) 2016/1658 i (EU) 2016/1659 na islandskom i norveškom jeziku koji se objavljuju u Dodatku o EGP-u Službenom listu Europske unije.
OJ L 247, 15.9.2016, p. 19.
Ova Odluka stupa na snagu 6. svibnja 2017. pod uvjetom da su podnesene sve obavijesti iz članka 103. stavka 1.
OJ L 247, 15.9.2016, p. 22.
Sporazuma o EGP-u.
amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2019/201]
o izmjeni Priloga II.
THE EEA JOINT COMMITTEE,
(Tehnički propisi, norme, ispitivanje i potvrđivanje) Sporazumu o EGP-u [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.
budući da:
Annex II to the EEA Agreement should therefore be amended accordingly,
Uredba Komisije (EU) 2017/227 оd 9. veljače 2017. o izmjeni Priloga XVII.
HAS ADOPTED THIS DECISION:
Uredbi (EZ) br. 1907/2006 Europskog parlamenta i Vijeća o registraciji, evaluaciji, autorizaciji i ograničavanju kemikalija (REACH) u pogledu bis(pentabromofenil)etera treba se uključiti u Sporazum o EGP-u.
32017 R 0227: Commission Regulation (EU) 2017/227 of 9 February 2017 (OJ L 35, 10.2.2017, p. 6).’
DONIO JE OVU ODLUKU:
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.
U točki 12.zc (Uredba (EZ) br. 1907/2006 Europskog parlamenta i Vijeća) u poglavlju XV.
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.
Sporazumu o EGP-u dodaje se sljedeća alineja:
Article 4
32017 R 0227: Uredbom Komisije (EU) 2017/227 od 9. veljače 2017.
This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union.
(SL L 35, 10.2.2017., str. 6.),”.
For the EEA Joint Committee
Vjerodostojni su tekstovi Uredbe (EU) 2017/227 na islandskom i norveškom jeziku koji se objavljuju u Dodatku o EGP-u Službenom listu Europske unije.
OJ L 35, 10.2.2017, p. 6.
Ova Odluka stupa na snagu 6. svibnja 2017. pod uvjetom da su podnesene sve obavijesti iz članka 103. stavka 1.
amending Annex I (Veterinary and phytosanitary matters) and Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2019/202]
o izmjeni Priloga I.
Having regard to the Agreement on the European Economic Area (‘the EEA Agreement’), and in particular Article 98 thereof,
(Tehnički propisi, norme, ispitivanje i potvrđivanje) Sporazumu o EGP-u [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.
uzimajući u obzir Sporazum o Europskom gospodarskom prostoru (Sporazum o EGP-u), a posebno njegov članak 98.,
Legislation regarding feedingstuffs and 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 sectoral adaptations to Annex I and the introduction to Chapter XII of Annex II to the EEA Agreement.
Uredba Komisije (EU) 2016/1726 оd 27. rujna 2016. o izmjeni Priloga IV.
This Decision is therefore not to apply to Liechtenstein.
Uredbi (EZ) br. 396/2005 Europskog parlamenta i Vijeća u pogledu karvona, diamonijeva fosfata, Saccharomycesa cerevisiae soj LAS02 i sirutke treba se uključiti u Sporazum o EGP-u.
32016 R 1726: Commission Regulation (EU) 2016/1726 of 27 September 2016 (OJ L 261, 28.9.2016, p. 3).’
Ova se Odluka stoga ne primjenjuje na Lihtenštajn.
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.
Članak 1.
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.
(Uredba (EZ) br. 396/2005 Europskog parlamenta i Vijeća) u poglavlju II.
This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union.
32016 R 1726: Uredbom Komisije (EU) 2016/1726 od 27. rujna 2016.
Done at Brussels, 5 May 2017.
(SL L 261, 28.9.2016., str. 3.),”.
OJ L 261, 28.9.2016, p. 3.
Priloga II.
amending Annex I (Veterinary and phytosanitary matters) and Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2019/203]
o izmjeni Priloga I.
Having regard to the Agreement on the European Economic Area (‘the EEA Agreement’), and in particular Article 98 thereof,
(Tehnički propisi, norme, ispitivanje i potvrđivanje) Sporazumu o EGP-u [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.
uzimajući u obzir Sporazum o Europskom gospodarskom prostoru (Sporazum o EGP-u), a posebno njegov članak 98.,
Legislation regarding feedingstuffs and 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 sectoral adaptations to Annex I and the introduction to Chapter XII of Annex II to the EEA Agreement.
Uredba Komisije (EU) 2016/1902 оd 27. listopada 2016. o izmjeni priloga II. i III.
This Decision is therefore not to apply to Liechtenstein.
Uredbi (EZ) br. 396/2005 Europskog parlamenta i Vijeća u pogledu maksimalnih razina ostataka za acetamiprid, ametoktradin, azoksistrobin, ciflutrin, difluorooctenu kiselinu, dimetomorf, fenpirazamin, flonikamid, fluazinam, fludioksonil, flupiradifuron, flutriafol, fluksapiroksad, metkonazol, prokinazid, protiokonazol, piriproksifen, spirodiklofen i trifloksistrobin u ili na određenim proizvodima treba se uključiti u Sporazum o EGP-u.
32016 R 1902: Commission Regulation (EU) 2016/1902 of 27 October 2016 (OJ L 298, 4.11.2016, p. 1).’
Ova se Odluka stoga ne primjenjuje na Lihtenštajn.
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.
Članak 1.
This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union.
32016 R 1902: Uredbom Komisije (EU) 2016/1902 od 27. listopada 2016.
Done at Brussels, 5 May 2017.
(SL L 298, 4.11.2016., str. 1.),”.
OJ L 298, 4.11.2016, p. 1.
Priloga II.
amending Annex II (Technical regulations, standards, testing and certification) and Annex XVII (Intellectual Property) to the EEA Agreement [2019/204]
o izmjeni Priloga II.
THE EEA JOINT COMMITTEE,
(Tehnički propisi, norme, ispitivanje i potvrđivanje) i Priloga XVII.
Having regard to the Agreement on the European Economic Area (‘the EEA Agreement’), and in particular Article 98 thereof,
(Intelektualno vlasništvo) Sporazumu o EGP-u [2019/204] ZAJEDNIČKI ODBOR EGP-a,
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.
budući da:
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.
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 treba se uključiti u Sporazum o EGP-u.
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.
Uredba (EZ) br. 1902/2006 Europskog parlamenta i Vijeća od 20. prosinca 2006. o izmjeni Uredbe 1901/2006 o lijekovima za pedijatrijsku upotrebu treba se uključiti u Sporazum o EGP-u.
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.
Uredba (EZ) br. 469/2009 Europskog parlamenta i Vijeća od 6. svibnja 2009. o svjedodžbi o dodatnoj zaštiti za lijekove treba se uključiti u Sporazum o EGP-u.
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 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, kako je ispravljena u SL L 338, 12.12.2012., str. 44., treba se uključiti u Sporazum o EGP-u.
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.
Uredbom (EZ) br. 469/2009 stavlja se izvan snage Uredba Vijeća (EEZ) br. 1768/92, koja je uključena u Sporazum o EGP-u i koja se stoga treba isključiti iz njega.
Once the Commission has granted a marketing authorisation, the EFTA States should simultaneously take corresponding decisions within 30 days from the grant.
Uredbom Komisije (EZ) br. 658/2007 utvrđuju se pravila za primjenu novčanih kazni za nositelje odobrenja za stavljanje u promet danih u skladu s Uredbom (EZ) br. 726/2004 Europskog parlamenta i Vijeća.
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.
Kad Komisija da odobrenje za stavljanje u promet, države EFTA-e trebale bi istodobno, u roku od 30 dana od izdavanja odobrenja, donijeti odgovarajuće odluke.
Annexes II and XVII to the EEA Agreement should therefore be amended accordingly,
Zbog posebnih okolnosti, posebice činjenica da Komisija daje odobrenja za stavljanje u promet, da povrede utječu na Uniju i njezine interese te da su postupci zbog povrede složene i tehničke prirode, Nadzorno tijelo EFTA-e trebalo bi usko surađivati s Komisijom te pričekati Komisijinu procjenu i njezin prijedlog djelovanja prije odlučivanja o novčanim kaznama za nositelje odobrenja za stavljanje u promet koji imaju poslovni nastan u jednoj od država EFTA-e.
HAS ADOPTED THIS DECISION:
Priloge II. i XVII.
The following text is inserted after the words ‘Committee on Orphan Medicinal Products (COMP)’ in the 13th paragraph of the introductory text:
Članak 1.
‘, the Paediatric Committee’.
Poglavlje XIII.
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):
Priloga II.
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).’
Sporazumu o EGP-u mijenja se kako slijedi:
The adaptation text of point 15zb (Regulation (EC) No 726/2004 of the European Parliament and of the Council) is replaced by the following:
U 13. odlomku uvodnog teksta nakon riječi „Odbora za gotove lijekove za rijetke bolesti (COMP)” umeće se sljedeći tekst:
‘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.
„,Odbora za pedijatrijske lijekove”.
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 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:
The text of point 15zj (Commission Regulation (EC) No 658/2007) is replaced by the following:
32006 R 1901: Uredbom (EZ) br. 1901/2006 Europskog parlamenta i Vijeća od 12. prosinca 2006.
‘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:
(SL L 378, 27.12.2006., str. 1.).”
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.
Tekst prilagodbe u točki 15.zb (Uredba (EZ) br. 726/2004 Europskog parlamenta i Vijeća) zamjenjuje se sljedećim:
The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following adaptation:
„Ako nositelj odobrenja za stavljanje u promet ima poslovni nastan u jednoj od država EFTA-e, ovlasti koje Europska komisija ima u vezi s postupkom zbog povrede kako je predviđeno člankom 84. stavkom 3., uključujući ovlast za izricanje novčanih kazni nositeljima odobrenja za stavljanje u promet, izvršava Nadzorno tijelo EFTA-e u bliskoj suradnji s Komisijom.
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.
Prije nego što Nadzorno tijelo EFTA-e donese odluku o novčanim kaznama, Komisija mu dostavlja svoju procjenu i prijedlog djelovanja.”
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.’
Tekst točke 15.zj (Uredba Komisije (EZ) br. 658/2007) zamjenjuje se sljedećim:
The following point is inserted after point 15zq (Commission Implementing Regulation (EU) No 520/2012):
„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:
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:
32012 R 0488: Uredbom Komisije (EU) br. 488/2012 od 8. lipnja 2012.
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).
(SL L 150, 9.6.2012., str. 68.), kako je ispravljena u SL L 338, 12.12.2012., str. 44.
The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following adaptations:
Za potrebe ovog Sporazuma odredbe Uredbe sadržavaju sljedeću prilagodbu:
The application of Article 36(3) shall not be made dependent on an authorisation of the medicinal product in Liechtenstein.
Ako nositelj odobrenja za stavljanje u promet ima poslovni nastan u jednoj od država EFTA-e, ovlasti koje Europska komisija ima u vezi s postupkom zbog povrede, uključujući ovlast za izricanje novčanih kazni nositeljima odobrenja za stavljanje u promet, izvršava Nadzorno tijelo EFTA-e u bliskoj suradnji s Komisijom.
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.
Prije nego što Nadzorno tijelo EFTA-e donese odluku o novčanim kaznama, Komisija mu dostavlja svoju procjenu i prijedlog djelovanja.”
Article 2
Nakon točke 15.zq (Provedbena uredba Komisije (EU) br. 520/2012) umeće se sljedeća točka:
The text of point 6 (Council Regulation (EEC) No 1768/92) of Annex XVII to the EEA Agreement is replaced by the following:
32006 R 1901: 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.), kako je izmijenjena:
‘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).
32006 R 1902: Uredbom (EZ) br. 1902/2006 Europskog parlamenta i Vijeća od 20. prosinca 2006.
The following paragraphs shall be added to Article 7:
Za potrebe ovog Sporazuma odredbe Uredbe sadržavaju sljedeće prilagodbe:
Paragraph 5 shall not apply to the EFTA States.
Primjena članka 36. stavka 3. ne ovisi o odobrenju lijeka u Lihtenštajnu.
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.”
Ako nositelj odobrenja za stavljanje u promet ima poslovni nastan u jednoj od država EFTA-e, ovlasti koje Europska komisija ima u vezi s postupkom zbog povrede kako je predviđeno člankom 49. stavkom 3., uključujući ovlast za izricanje novčanih kazni nositeljima odobrenja za stavljanje u promet, izvršava Nadzorno tijelo EFTA-e u bliskoj suradnji s Komisijom.
The following paragraphs shall be added to Article 21:
Članak 2.
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.
Tekst točke 6.(Uredba Vijeća (EEZ) br. 1768/92) Priloga XVII.
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.
Sporazumu o EGP-u zamjenjuje se sljedećim:
However, paragraph 3 of Article 13 shall apply as to the calculation of the duration of the extension.
„32009 R 0469: Uredba (EZ) br. 469/2009 Europskog parlamenta i Vijeća od 6. svibnja 2009. o svjedodžbi o dodatnoj zaštiti za lijekove (kodificirana verzija) (SL L 152, 16.6.2009., str. 1.).
Notwithstanding paragraph 7 of Article 7, in cases where a certificate expires earlier than seven months after 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 shall be lodged no later than one month after such entry into force in the EFTA state concerned.
U članku 7. dodaju se sljedeći stavci: