natgillin/translations-raw huggingface dataset:
32013 R 0096: Commission Implementing Regulation (EU) No 96/2013 of 1 February 2013 concerning the authorisation of a preparation of Lactobacillus buchneri NCIMB 30139 and of a preparation of Lactobacillus casei ATTC PTA 6135 as feed additives for all animal species (OJ L 33, 2.2.2013, p. 21).
32013 R 0096: Provedbena uredba Komisije (EU) br. 96/2013 od 1. veljače 2013. o odobrenju pripravka od Lactobacillus buchneri NCIMB 30139 i pripravka od Lactobacillus casei ATTC PTA 6135 kao dodataka hrani za životinje za sve životinjske vrste (SL L 33, 2.2.2013., str. 21.).
32013 R 0159: Commission Implementing Regulation (EU) No 159/2013 of 21 February 2013 concerning the authorisation of a preparation of sodium benzoate, propionic acid and sodium propionate as a feed additive for pigs, poultry, bovines, sheep, goats, rabbits and horses and amending Regulations (EC) No 1876/2006 and (EC) No 757/2007 (OJ L 49, 22.2.2013, p. 47).
32013 R 0159: Provedbena uredba Komisije (EU) br. 159/2013 od 21.veljače 2013. o odobrenju pripravka natrijevog benzoata, propionske kiseline i natrijevog propionata kao dodatka hrani za životinje za svinje, perad, goveda, ovce, koze, kuniće i konje i o izmjeni uredbi (EZ) br. 1876/2006 i (EZ) br. 757/2007 (SL L 49, 22.2.2013., str. 47.).
32013 R 0161: Commission Implementing Regulation (EU) No 161/2013 of 21 February 2013 concerning the authorisation of a preparation of sodium hydroxide as a feed additive for cats, dogs and ornamental fish (OJ L 49, 22.2.2013, p. 52).’
32013 R 0161: Provedbena uredba Komisije (EU) br. 161/2013 od 21. veljače 2013. o odobrenju pripravka natrijevog hidroksida kao dodatka hrani za životinje za mačke, pse i ukrasne ribe (SL L 49, 22.2.2013., str. 52.).”
The texts of Implementing Regulations (EU) No 1195/2012, (EU) No 1196/2012, (EU) No 1206/2012, (EU) No 1265/2012, Regulations (EU) No 51/2013, as corrected by OJ L 62, 6.3.2013, p. 36, (EU) No 68/2013, Implementing Regulations (EU) No 95/2013, (EU) No 96/2013, (EU) No 103/2013, (EU) No 105/2013, Regulation (EU) No 107/2013, Implementing Regulations (EU) No 159/2013, (EU) No 160/2013 and (EU) No 161/2013 in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.
Tekstovi provedbenih uredbi (EU) br. 1195/2012, (EU) br. 1196/2012, (EU) br. 1206/2012, (EU) br. 1265/2012, uredbi (EU) br. 51/2013, prema ispravci u SL L 62, 6.3.2013., str. 36., (EU) br. 68/2013, provedbenih uredbi (EU) br. 95/2013, (EU) br. 96/2013, (EU) br. 103/2013, (EU) br. 105/2013, Uredbe (EU) br. 107/2013, provedbenih uredbi (EU) br. 159/2013, (EU) br. 160/2013 i (EU) br. 161/2013 na islandskom i norveškom jeziku, koji se objavljuju u Dodatku o EGP-u Službenom listu Europske unije, vjerodostojni su.
This Decision shall enter into force on 9 October 2013, provided that all the notifications under Article 103(1) of the EEA Agreement have been made [16].
Ova Odluka stupa na snagu 9. listopada 2013., pod uvjetom da su sve obavijesti iz članka 103. stavka 1. Sporazuma o EGP-u podnesene [16].
Done at Brussels, 8 October 2013.
Sastavljeno u Bruxellesu 8. listopada 2013.
OJ L 342, 14.12.2012, p. 23.
SL L 342, 14.12.2012., str. 23.
OJ L 342, 14.12.2012, p. 25.
SL L 342, 14.12.2012., str. 25.
OJ L 347, 15.12.2012, p. 12.
SL L 347, 15.12.2012., str. 12.
OJ L 356, 22.12.2012, p. 61.
SL L 356, 22.12.2012., str. 61.
OJ L 20, 23.1.2013, p. 33.
SL L 20, 23.1.2013., str. 33.
OJ L 29, 30.1.2013, p. 1.
SL L 29, 30.1.2013., str. 1.
OJ L 33, 2.2.2013, p. 19.
SL L 33, 2.2.2013., str. 19.
OJ L 33, 2.2.2013, p. 21.
SL L 33, 2.2.2013., str. 21.
OJ L 34, 5.2.2013, p. 12.
SL L 34, 5.2.2013., str. 12.
OJ L 34, 5.2.2013, p. 15.
SL L 34, 5.2.2013., str. 15.
OJ L 35, 6.2.2013, p. 1.
SL L 35, 6.2.2013., str. 1.
OJ L 49, 22.2.2013, p. 47.
SL L 49, 22.2.2013., str. 47.
OJ L 49, 22.2.2013, p. 50.
SL L 49, 22.2.2013., str. 50.
OJ L 49, 22.2.2013, p. 52.
SL L 49, 22.2.2013., str. 52.
OJ L 159, 17.6.2011, p. 25.
SL L 159, 17.6.2011., str. 25.
Commission Implementing Regulation (EU) No 1012/2012 of 5 November 2012 amending Regulation (EC) No 2074/2005 and Regulation (EC) No 1251/2008 as regards the list of vector species, the health requirements and the certification requirements concerning epizootic ulcerative syndrome and as regards the entry for Thailand in the list of third countries from which imports of certain fish and fishery products into the Union are permitted [1] is to be incorporated into the EEA Agreement.
Provedbenu uredbu Komisije (EU) br. 1012/2012 od 5. studenoga 2012. o izmjeni Uredbe (EZ) br. 2074/2005 i Uredbe (EZ) br. 1251/2008 u pogledu popisa vektorskih vrsta, zdravstvenih zahtjeva i zahtjeva za certificiranje u vezi s epizootskim ulcerativnim sindromom i u pogledu unosa Tajlanda na popis trećih zemalja iz kojih je dopušten uvoz određenih riba i proizvoda ribarstva u Uniju [1] treba uključiti u Sporazum o EGP-u.
Commission Regulation (EU) No 101/2013 of 4 February 2013 concerning the use of lactic acid to reduce microbiological surface contamination on bovine carcases [2] is to be incorporated into the EEA Agreement.
Uredbu Komisije (EU) br. 101/2013 od 4. veljače 2013. o primjeni mliječne kiseline za smanjivanje površinskog mikrobiološkog onečišćenja goveđih trupova [2] treba uključiti u Sporazum o EGP-u.
This Decision concerns legislation regarding veterinary matters, feedingstuffs and foodstuffs.
Ova se odluka odnosi na veterinarska pitanja, hranu i hranu za životinje.
Legislation regarding veterinary matters, 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.
Zakonodavstvo povezano s veterinarskim pitanjima, hranom i hranom za životinje ne primjenjuje se na Lihtenštajn sve dok je primjena Sporazuma između Europske zajednice i Švicarske Konfederacije o trgovini poljoprivrednim proizvodima proširena na Lihtenštajn, kako je utvrđeno sektorskim prilagodbama u Prilogu I. i u uvodu poglavlja XII. Priloga II.
The following indent is added in point 134 (Commission Regulation (EC) No 2074/2005) in Part 1.2 and point 53 (Commission Regulation (EC) No 2074/2005) in Part 6.2:
U dio 1.2 točku 134. (Uredba Komisije (EZ) br. 2074/2005) i dio 6.2 točku 53.
32012 R 1012: Commission Implementing Regulation (EU) No 1012/2012 of 5 November 2012 (OJ L 306, 6.11.2012, p. 1).’
32012 R 1012: Provedbena uredba Komisije (EU) br. 1012/2012 od 5. studenog 2012. (SL L 306, 6.11.2012., str. 1.).”
The following indent is added in point 86 (Commission Regulation (EC) No 1251/2008) in Part 4.2:
U dio 4.2. točku 86. (Uredba Komisije (EZ) br. 1251/2008) dodaje se sljedeća alineja:
The following point is inserted after point 18 (Directive 2004/41/EC of the European Parliament and of the Council) in Part 6.1:
U dio 6.1. točku 18. (Direktiva 2004/41/EZ Europskog parlamenta i Vijeća) umeće se sljedeća točka:
32013 R 0101: Commission Regulation (EU) No 101/2013 of 4 February 2013 concerning the use of lactic acid to reduce microbiological surface contamination on bovine carcases (OJ L 34, 5.2.2013, p. 1).’
32013 R 0101: Uredba Komisije (EU) br. 101/2013 od 4. veljače 2013. o primjeni mliječne kiseline za smanjivanje površinskog mikrobiološkog onečišćenja goveđih trupova (SL L 34, 5.2.2013., str. 1.).”
The following indent is added in point 31k (Commission Regulation (EC) No 2074/2005) of Chapter II of Annex I to the EEA Agreement:
U poglavlje II. Priloga I. točku 31.k Sporazumu o EGP-u (Uredba Komisije (EZ) br. 2074/2005) dodaje se sljedeća alineja:
The following indent is added in point 54zzzk (Commission Regulation (EC) No 2074/2005) of Chapter XII of Annex II to the EEA Agreement:
U poglavlje XII. Priloga II. točku 54.zzzk Sporazumu o EGP-u (Uredba Komisije (EZ) br. 2074/2005) dodaje se sljedeća alineja:
The texts of Implementing Regulation (EU) No 1012/2012 and Regulation (EU) No 101/2013 in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.
Tekstovi Provedbene uredbe (EU) br. 1012/2012 i Uredbe (EU) br. 101/2013 na islandskom i norveškom jeziku, koji se objavljuju u Dodatku o EGP-u Službenom listu Europske unije, vjerodostojni su.
This Decision shall enter into force on 9 October 2013, provided that all the notifications under Article 103(1) of the EEA Agreement have been made [3].
Ova Odluka stupa na snagu 9. listopada 2013., pod uvjetom da su sve obavijesti iz članka 103. stavka 1. Sporazuma o EGP-u podnesene [3].
OJ L 306, 6.11.2012, p. 1.
SL L 306, 6.11.2012., str. 1.
OJ L 34, 5.2.2013, p. 1.
SL L 34, 5.2.2013., str. 1.
Commission Regulation (EU) No 143/2013 of 19 February 2013 amending Directive 2007/46/EC of the European Parliament and of the Council and Commission Regulation (EC) No 692/2008 as regards the determination of CO2 emissions from vehicles submitted to multi-stage type-approval [1] is to be incorporated into the EEA Agreement.
Uredbu Komisije (EU) br. 143/2013 od 19. veljače 2013. o izmjeni Direktive 2007/46/EZ Europskog parlamenta i Vijeća i Uredbe Komisije (EZ) br. 692/2008 u pogledu određivanja emisija CO2 iz vozila u postupku višestupanjske homologacije [1] treba uključiti u Sporazum o EGP-u.
32013 R 0143: Commission Regulation (EU) No 143/2013 of 19 February 2013 (OJ L 47, 20.2.2013, p. 51).’
32013 R 0143: Uredba Komisije (EU) br. 143/2013 od 19. veljače 2013. (SL L 47, 20.2.2013., str. 51.).”
The texts of Regulation (EU) No 143/2013 in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.
Tekstovi Uredbe (EU) br. 143/2013 na islandskom i norveškom jeziku, koji se objavljuju u Dodatku o EGP-u Službenom listu Europske unije, vjerodostojni su.
This Decision shall enter into force on 9 October 2013, provided that all the notifications under Article 103(1) of the EEA Agreement have been made [2].
Ova Odluka stupa na snagu 9. listopada 2013., pod uvjetom da su sve obavijesti iz članka 103. stavka 1. Sporazuma o EGP-u podnesene [2].
OJ L 47, 20.2.2013, p. 51.
SL L 47, 20.2.2013., str. 51.
Commission Directive 2013/8/EU of 26 February 2013 amending, for the purpose of adapting its technical provisions, Directive 2009/144/EC of the European Parliament and of the Council on certain components and characteristics of wheeled agricultural or forestry tractors [1] is to be incorporated into the EEA Agreement.
Direktivu Komisije 2013/8/EU od 26. veljače 2013. o izmjeni, radi prilagodbe njezinih tehničkih odredaba, Direktive 2009/144/EZ Europskog parlamenta i Vijeća o određenim sastavnim dijelovima i značajkama traktora na kotačima za poljoprivredu i šumarstvo [1] treba uključiti u Sporazum o EGP-u.
The following indent is added in point 23 (Directive 2009/144/EC of the European Parliament and of the Council) of Chapter II of Annex II to the EEA Agreement:
U poglavlje II. Priloga II.
32013 L 0008: Commission Directive 2013/8/EU of 26 February 2013 (OJ L 56, 28.2.2013, p. 8).’
32013 L 0008: Direktiva Komisije 2013/8/EU od 26. veljače 2013. (SL L 56, 28.2.2013., str. 8.).”
The text of Directive 2013/8/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.
Tekstovi Direktive 2013/8/EU na islandskom i norveškom jeziku, koji se objavljuju u Dodatku o EGP-u Službenom listu Europske unije, vjerodostojni su.
OJ L 56, 28.2.2013, p. 8.
SL L 56, 28.2.2013., str. 8.
Commission Implementing Regulation (EU) No 1161/2012 of 7 December 2012 amending the Annex to Regulation (EU) No 37/2010 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin, as regards the substance fenbendazole [1] is to be incorporated into the EEA Agreement.
Provedbenu uredbu Komisije (EU) br. 1161/2012 od 7. prosinca 2012. o izmjeni Priloga Uredbi (EU) br. 37/2010 o farmakološki djelatnim tvarima i njihovoj klasifikaciji u odnosu na najveće dopuštene količine rezidua u hrani životinjskog podrijetla u pogledu tvari fenbendazola [1] treba uključiti u Sporazum o EGP-u.
Commission Implementing Regulation (EU) No 1186/2012 of 11 December 2012 amending the Annex to Regulation (EU) No 37/2010 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin, as regards the substance phoxim [2] is to be incorporated into the EEA Agreement.
Provedbenu uredbu Komisije (EU) br. 1186/2012 od 11. prosinca 2012. o izmjeni Priloga Uredbi (EU) br. 37/2010 o farmakološki djelatnim tvarima i njihovoj klasifikaciji u odnosu na najveće dopuštene količine rezidua u hrani životinjskog podrijetla u pogledu tvari foksim [2] treba uključiti u Sporazum o EGP-u.
Commission Implementing Regulation (EU) No 1191/2012 of 12 December 2012 amending the Annex to Regulation (EU) No 37/2010 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin, as regards the substance sodium salicylate [3] is to be incorporated into the EEA Agreement.
Provedbenu uredbu Komisije (EU) br. 1191/2012 od 12. prosinca 2012. o izmjeni Priloga Uredbi (EU) br. 37/2010 o farmakološki djelatnim tvarima i njihovoj klasifikaciji u odnosu na najveće dopuštene količine rezidua u hrani životinjskog podrijetla u pogledu tvari natrijevog salicilata [3] treba uključiti u Sporazum o EGP-u.
The following indents are added in point 13 (Commission Regulation (EU) No 37/2010) of Chapter XIII of Annex II to the EEA Agreement:
U točku 13. (Uredba Komisije (EU) br. 37/2010) u poglavlju XIII. Priloga II.
32012 R 1161: Commission Implementing Regulation (EU) No 1161/2012 of 7 December 2012 (OJ L 336, 8.12.2012, p. 14),
32012 R 1161: Provedbena uredba Komisije (EU) br. 1161/2012 od 7. prosinca 2012. (SL L 336, 8.12.2012., str. 14.),
32012 R 1186: Commission Implementing Regulation (EU) No 1186/2012 of 11 December 2012 (OJ L 338, 12.12.2012, p. 20),
32012 R 1186: Provedbena uredba Komisije (EU) br. 1186/2012 od 11. prosinca 2012. (SL L 338, 12.12.2012., str. 20.),
32012 R 1191: Commission Implementing Regulation (EU) No 1191/2012 of 12 December 2012 (OJ L 340, 13.12.2012, p. 35).’
32012 R 1191: Provedbena uredba Komisije (EU) br. 1191/2012 od 12. prosinca 2012. (SL L 340, 13.12.2012., str. 35.).”
The texts of Implementing Regulations (EU) No 1161/2012, (EU) No 1186/2012 and (EU) No 1191/2012 in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.
Tekstovi provedbenih uredbi (EU) br. 1161/2012, (EU) br. 1186/2012 i (EU) br. 1191/2012 na islandskom i norveškom jeziku, koji se objavljuju u Dodatku o EGP-u Službenom listu Europske unije, vjerodostojni su.
This Decision shall enter into force on 9 October 2013, provided that all the notifications under Article 103(1) of the EEA Agreement have been made [4].
Ova Odluka stupa na snagu 9. listopada 2013., pod uvjetom da su sve obavijesti iz članka 103. stavka 1. Sporazuma o EGP-u podnesene [4].
OJ L 336, 8.12.2012, p. 14.
SL L 336, 8.12.2012., str. 14.
OJ L 338, 12.12.2012, p. 20.
SL L 338, 12.12.2012., str. 20.
OJ L 340, 13.12.2012, p. 35.
SL L 340, 13.12.2012., str. 35.
Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products [1], as corrected by OJ L 201, 27.7.2012, p. 138, is to be incorporated into the EEA Agreement.
Uredbu (EU) br. 1235/2010 Europskog parlamenta i Vijeća od 15. prosinca 2010. o izmjeni Uredbe (EZ) br. 726/2004 o utvrđivanju postupaka Zajednice za odobravanje primjene i postupaka nadzora nad primjenom lijekova koji se rabe u humanoj i veterinarskoj medicini, te uspostavi Europske agencije za lijekove i Uredbe (EZ) br. 1394/2007 o lijekovima za naprednu terapiju [1], u vezi s farmakovigilancijom lijekova za primjenu kod ljudi, kako je ispravljena u SL L 201, 27.7.2012., str. 138., treba uključiti u Sporazum o EGP-u.
Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use [2], as corrected by OJ L 21, 25.1.2011, p. 8 and OJ L 276, 21.10.2011, p. 63, is to be incorporated into the EEA Agreement.
Direktivu 2010/84/EU Europskog parlamenta i Vijeća od 15. prosinca 2010. o izmjeni, u pogledu farmakovigilancije, Direktive 2001/83/EZ o zakoniku Zajednice o lijekovima za humanu primjenu [2], kako je ispravljena u SL L 21, 25.1.2011., str. 8. i SL L 276, 21.10.2011., str. 63. treba uključiti u Sporazum o EGP-u.
Chapter XIII of Annex II to the EEA Agreement shall be amended as follows:
Poglavlje XIII. Priloga II. Sporazumu o EGP-u mijenja se kako slijedi:
The following text is inserted after the words ‘Committee on Orphan Medicinal Products (COMP)’ in the 13th paragraph of the introductory text:
U trinaesti stavak uvodnog teksta nakon riječi „Odbora za lijekove za rijetke bolesti” umeće se sljedeći tekst:
‘, the Pharmacovigilance Risk Assessment Committee (PRAC)’
„, Odbora za procjenu rizika u području farmakovigilancije”.
Point 15q (Directive 2001/83/EC of the European Parliament and of the Council) shall be amended as follows:
Točka 15.q (Direktive 2001/83/EZ Europskog parlamenta i Vijeća) mijenja se kako slijedi:
The following indent is added:
i. Dodaje se sljedeća alineja:
32010 L 0084: Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 (OJ L 348, 31.12.2010, p. 74), as corrected by OJ L 21, 25.1.2011, p. 8 and OJ L 276, 21.10.2011, p. 63.’
32010 L 0084: Direktiva 2010/84/EU Europskog parlamenta i Vijeća od 15. prosinca 2010. (SL L 348, 31.12.2010., str. 74.), kako je ispravljena u SL L 21, 25.1.2011., str. 8. i SL L 276, 21.10.2011., str. 63.”
The adaptation text is replaced by the following:
Tekst prilagodbe zamjenjuje se sljedećim:
‘The provisions of the Directive shall, for the purposes of this Agreement, be read with the following adaptations:
„Odredbe Direktive, u smislu ovog Sporazuma, sadrže sljedeće prilagodbe:
Liechtenstein shall not be obliged to participate in the decentralised procedure (DCP) and in the mutual recognition procedure (MRP) and shall, therefore, not be obliged to issue the corresponding marketing authorisations.
Lihtenštajn nije obvezan sudjelovati u decentraliziranom postupku i u postupku uzajamnog priznavanja te stoga nije obvezan izdati odgovarajuća odobrenja za stavljanje lijeka u promet.
Instead, Austrian marketing authorisations within the DCP and the MRP shall be valid for Liechtenstein upon request of a marketing authorisation applicant.
Umjesto toga, austrijska odobrenja za stavljanje lijeka u promet unutar decentraliziranog postupka i postupka uzajamnog priznavanja vrijede za Lihtenštajn nakon podnošenja zahtjeva za odobrenje za stavljanje lijeka u promet.
The EFTA States may initiate the urgent Union procedure pursuant to Section 4 of Chapter 3 of Title IX of the Directive.
Države EFTA-e mogu započeti hitan postupak Unije u skladu s odjeljkom 4. poglavlja 3. glave IX. ove Direktive.
With respect to Title IX, the obligations of Liechtenstein will be executed by Austria.
S obzirom na glavu IX., obveze Lihtenštajna će izvršiti Austrija.
Liechtenstein will however, as far as applicable to Liechtenstein:
Lihtenštajn će, koliko je to primjenljivo za Lihtenštajn:
operate a pharmacovigilance system in accordance with Article 101(1);
upravljati sustavom farmakovigilancije u skladu s člankom 101. stavkom 1.,
perform a regular audit of its pharmacovigilance system in accordance with Article 101(2);
upravljati redovnim revizijama sustava farmakovigilancije u skladu s člankom 101. stavkom 2.,
designate a competent authority for the performance of its pharmacovigilance tasks in accordance with Article 101(3),
odrediti nadležno tijelo za izvođenje zadataka farmakovigilancije u skladu s člankom 101. stavkom 3.,
take all appropriate measures to encourage patients, doctors, pharmacists and other healthcare professionals to report suspected adverse reactions to the national competent authority in accordance with Article 102(a);
poduzeti sve odgovarajuće mjere kako bi se potaknulo pacijente, liječnike, farmaceute i ostale zdravstvene djelatnike da prijave sumnje na nuspojave državnim nadležnim tijelima u skladu s člankom 102. točkom (a),
facilitate patient reporting through the provision of alternative reporting formats in addition to web-based formats in accordance with Article 102(b);
olakšati izvješćivanje pacijenta omogućivanjem alternativnih oblika izvješćivanja uz obrasce kojima se pristupa putem interneta u skladu s člankom 102. točkom (b),
impose an obligation on a marketing authorisation holder to operate a risk management system, as referred to in Article 104(3)(c), if there are concerns about the risks affecting the risk-benefit balance of an authorised medicinal product in accordance with Article 104a(2).
nametnuti obvezu nositelju odobrenja za stavljanje lijeka u promet da upravlja sustavom za upravljanje rizikom, kako je navedeno u članku 104. stavku 3. točki (c), ako postoji sumnja u rizik koji bi mogao utjecati na odnos rizika i koristi dopuštenog lijeka u skladu s člankom 104.a stavkom 2.
For the imposition of such obligation Liechtenstein will base itself on a corresponding decision of the Austrian authorities;
Za nametanje te obveze Lihtenštajn se oslanja na odgovarajuću odluku austrijskih vlasti,
set up and maintain a national medicines web-portal which shall be linked to the European medicines web-portal in accordance with Article 106;
uspostaviti održavati državni web-portal za lijekove koji se povezuje s europskim web-portalom za lijekove u skladu s člankom 106.,
record all suspected adverse reactions that occur in its territory which are brought to its attention from healthcare professionals and patients and ensure that reports of such reactions may be submitted by means of the national medicines web-portals or by other means in accordance with Article 107a(1), and
bilježiti sve sumnjive nuspojave koje se pojave na njegovu području na koje mu ukažu zdravstveni djelatnici i pacijenti te osigurati da se izvješća o takvim reakcijama mogu predati putem državnog web-portala za lijekove ili drugim sredstvima u skladu s člankom 107.a stavkom 1. i
submit reports in accordance with Article 107a(4).
predati izvješća u skladu s člankom 107.a stavkom 4.
The following subparagraph shall be added to Article 107c(5):
Članku 107.c stavku 5. dodaje se sljedeći podstavak:
“Swiss marketing authorisation for a medicinal product taking effect in Liechtenstein by virtue of Liechtenstein law on the basis of the Customs Union between the Principality of Liechtenstein and the Swiss Confederation shall not be considered as a first authorisation to place a product on the market for the purposes of this paragraph.” ’
‚Švicarsko odobrenje za stavljanje lijeka u promet koje stupa na snagu u Lihtenštajnu zbog lihtenštajnskog zakona na temelju carinske unije između Kneževine Lihtenštajn i Švicarske Konfederacije ne smatra se prvim odobrenjem za stavljanje lijeka u promet u smislu ovog stavka.’ ”
The following indent is added in point 15zb (Regulation (EC) No 726/2004 of the European Parliament and of the Council):
U točki 15.zb (Uredba (EZ) br. 726/2004 Europskog parlamenta i Vijeća) dodaje se sljedeća alineja:
32010 R 1235: Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 (OJ L 348, 31.12.2010, p. 1), as corrected by OJ L 201, 27.7.2012, p. 138.’
32010 R 1235: Uredbom (EU) br. 1235/2010 Europskog parlamenta i Vijeća od 15. prosinca 2010. (SL L 348, 31.12.2010., str. 1.), kako je ispravljena u SL L 201, 27.7.2012., str. 138.”