natgillin/translations-raw huggingface dataset:
Line Metal's first exports of the product under review occurred subsequently to the extension of measures to the Republic of Korea.
Društvo Line Metal počelo je izvoziti proizvod koji je predmet revizije nakon proširenja mjera na Republiku Koreju.
Commission Implementing Regulation (EU) No 490/2014
Provedbena uredba Komisije (EU) br. 490/2014
Commission Regulation (EU) No 491/2014
Uredba Komisije (EU) br. 491/2014
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 ametoctradin, azoxystrobin, cycloxydim, cyfluthrin, dinotefuran, fenbuconazole, fenvalerate, fludioxonil, fluopyram, flutriafol, fluxapyroxad, glufosinate-ammonium, imidacloprid, indoxacarb, MCPA, methoxyfenozide, penthiopyrad, spinetoram and trifloxystrobin in or on certain products
o izmjeni priloga II. i III. Uredbi (EZ) br. 396/2005 Europskog parlamenta i Vijeća u pogledu maksimalnih razina ostataka za ametoktradin, azoksistrobin, cikloksidim, ciflutrin, dinotefuran, fenbukonazol, fenvalerat, fludioksonil, fluopiram, flutriafol, fluksapiroksad, glufosinat amonijak, imidakloprid, indoksakarb, MCPA, metoksifenozid, pentiopirad, spinetoram i trifloksistrobin u određenim proizvodima ili na njima
On 5 July 2013 the Codex Alimentarius Commission (CAC) [2], on proposal of the Codex Committee on Pesticides Residues (CCPR), adopted Codex maximum residue limits (CXLs) for ametoctradin, azoxystrobin, buprofezin, carbofuran, chlorothalonil, cycloxydim, cyfluthrin, cyromazine, dichlorvos, dicofol, diflubenzuron, dinotefuran, esfenvalerate, etofenprox, fenbuconazole, fenvalerate, fludioxonil, fluopyram, flutriafol, fluxapyroxad, glufosinate-ammonium, hexythiazox, imidacloprid, indoxacarb, MCPA, methoxyfenozide, penthiopyrad, phorate, pyraclostrobin, saflufenacil, sedaxane, spinetoram, spirotetramat, sulfoxaflor and trifloxystrobin.
Dana 5. srpnja 2013. Komisija za Codex Alimentarius (CAC) [2], na prijedlog Odbora Codexa za ostatke pesticida (CCPR), utvrdila je maksimalne razine ostataka za potrebe Codexa (CXL) za ametoktradin, azoksistrobin, buprofezin, karbofuran, klorotalonil, cikloksidim, ciflutrin, ciromazin, diklorvos, dikofol, diflubenzuron, dinotefuran, esfenvalerat, etofenproks, fenbukonazol, fenvalerat, fludioksonil, fluopiram, flutriafol, fluksapiroksad, glufosinat amonijak, heksitiazoks, imidakloprid, indoksakarb, MCPA, metoksifenozid, pentiopirad, forat, piraklostrobin, saflufenacil, sedaksan, spinetoram, spirotetramat, sulfoksaflor i trifloksistrobin.
Maximum residue levels (MRLs) are set for those substances in Regulation (EC) No 396/2005 except for dinotefuran, sedaxane and sulfoxaflor.
Maksimalne razine ostataka (MRO) za te su tvari, osim za dinotefuran, sedaksan i sulfoksaflor, utvrđene u Uredbi (EZ) br. 396/2005.
As dinotefuran, sedaxane and sulfoxaflor are not included in Annex IV to Regulation (EC) No 396/2005, the default value of 0,01 mg/kg laid down in Article 18(1)(b) applies.
Budući da dinotefuran, sedaksan i sulfoksaflor nisu uvršteni u Prilog IV. Uredbi (EZ) br. 396/2005, primjenjuje se zadana vrijednost od 0,01 mg/kg utvrđena u članku 18. stavku 1. točki (b).
In accordance with the WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement), MRLs should be adapted to international standards, except where there is a scientific justification to maintain a higher level of protection than provided by an international standard.
U skladu sa Sporazumom WTO-a o primjeni sanitarnih i fitosanitarnih mjera MRO-ove je potrebno prilagoditi međunarodnim normama, osim ako postoji znanstveno opravdanje za zadržavanje više razine zaštite od one koja je predviđena nekom međunarodnom normom.
Accordingly, the Union presented a reservation to the CCPR on the MRLs proposed for the following pesticide/product combinations: ametoctradin (brassica vegetables; leafy vegetables; spring onions); buprofezin (tea); chlorothalonil (all products); cycloxydim (brassica vegetables; eggs); cyromazine (all products); dichlorvos (eggs; poultry (edible offal, fat, meat); rice; wheat); dicofol (tea); diflubenzuron (all products); dinotefuran (brassicas; fruiting vegetables; leafy vegetables except water cress); fenvalerate (Chinese broccoli); fluxapyroxad (stone fruit); glufosinate-ammonium (assorted tropical and subtropical fruits; currants; potatoes; stone fruit); hexythiazox (all products); imidacloprid (celery); methoxyfenozide (cucurbits); penthiopyrad (flowerhead brassicas; stone fruit; leafy vegetables); phorate (all products); saflufenacil (all products); spinetoram (celery; spinach and brassica vegetables); and sulfoxaflor (all products).
U skladu s tim Unija je CCPR-u izrazila rezervu o MRO-ovima predloženima za sljedeće kombinacije pesticida i proizvoda: ametoktradin (kupusnjače; lisnato povrće; mladi luk); buprofezin (čaj); klorotalonil (svi proizvodi); cikloksidim (kupusnjače; jaja); ciromazin (svi proizvodi); diklorvos (jaja; perad (jestive iznutrice, mast, meso); riža; pšenica); dikofol (čaj); diflubenzuron (svi proizvodi); dinotefuran (kupusnjače; plodovito povrće; lisnato povrće osim potočarke); fenvalerat (kineska brokula); fluksapiroksad (koštuničavo voće); glufosinat amonijak (različito tropsko i suptropsko voće; ribiz; krumpir; koštuničavo voće); heksitiazoks (svi proizvodi); imidakloprid (celer); metoksifenozid (tikvenjače); pentiopirad (cvjetne kupusnjače; koštuničavo voće; lisnato povrće); forat (svi proizvodi); saflufenacil (svi proizvodi); spinetoram (celer; špinat i kupusnjače); i sulfoksaflor (svi proizvodi).
CXLs for ametoctradin, azoxystrobin, cycloxydim, cyfluthrin, dinotefuran, fenbuconazole, fenvalerate, fludioxonil, fluopyram, flutriafol, fluxapyroxad, glufosinate-ammonium, imidacloprid, indoxacarb, MCPA, methoxyfenozide, penthiopyrad, spinetoram and trifloxystrobin should therefore be included in Regulation (EC) No 396/2005 as MRLs except where they relate to products which are not set out in Annex I to that Regulation or where they are set at a lower level than the current MRLs.
CXL-ove za ametoktradin, azoksistrobin, cikloksidim, ciflutrin, dinotefuran, fenbukonazol, fenvalerat, fludioksonil, fluopiram, flutriafol, fluksapiroksad, glufosinat amonijak, imidakloprid, indoksakarb, MCPA, metoksifenozid, pentiopirad, spinetoram i trifloksistrobin stoga je potrebno uvrstiti u Uredbu (EZ) br. 396/2005 kao MRO-ove osim ako se odnose na proizvode koji nisu utvrđeni u Prilogu I. toj Uredbi ili ako su utvrđeni na nižoj razini od trenutačnih MRO-ova.
Those CXLs are safe for consumers in the Union [3].
Ti su CXL-ovi sigurni za potrošače u Uniji [3].
As regards fenvalerate and fludioxonil, MRLs were set for several commodities by Commission Regulation (EU) No 79/2014 [4].
U pogledu fenvalerata i fludioksonila utvrđeni su MRO-ovi za pojedine proizvode na temelju Uredbe Komisije (EU) br. 79/2014 [4].
As that Regulation applies as of 19 August 2014, it is appropriate for the MRLs set for fenvalerate and fludioxonil by this Regulation, to apply from the same date.
Budući da se ta Uredba primjenjuje od 19. kolovoza 2014., primjereno je da se MRO-ovi utvrđeni za fenvalerat, fludioksonil na temelju ove Uredbe primjenjuju od istog datuma.
It shall, however, apply from 19 August 2014, as regards the MRLs for fenvalerate and fludioxonil in mangoes with code number 0163030.
Međutim, u pogledu MRO-ova za fenvalerat i fludioksonil u mangu pod brojčanom oznakom 0163030 primjenjuje se od 19. kolovoza 2014.
Done at Brussels, 5 May 2014.
Sastavljeno u Bruxellesu 5. svibnja 2014..
Codex Committee on Pesticide Residues reports available on:http://www.codexalimentarius.org/download/report/799/REP13_PRe.pdfJoint FAO/WHO food standards programme Codex Alimentarius Commission.
Izvješća Odbora Codexa za ostatke pesticida dostupna su na:http://www.codexalimentarius.org/download/report/799/REP13_PRe.pdfZajednički program FAO/WHO za standarde hrane, Komisija za Codex Alimentarius.
Appendices II and III.
Dodaci II. i III.
Thirty-Sixth Session.
Tridesetšesta sjednica.
Rome, Italy, 1-5 July 2013.
Rim, Italija, 1–5. srpnja 2013.
Scientific support for preparing an EU position for the 45th Session of the Codex Committee on Pesticide Residues (CCPR).
Znanstvena potpora za pripremu stajališta EU-a na 45. sjednici Odbora Codexa za ostatke pesticida (CCPR).
EFSA Journal 2013; 11(7):3312 [210 pp.]. doi:10.2903/j.efsa.2013.3312.
EFSA Journal 2013.; 11(7):3312 [210 str.]. doi:10.2903/j.efsa.2013.3312.
Commission Regulation (EU) No 79/2014 of 29 January 2014 amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for bifenazate, chlorpropham, esfenvalerate, fludioxonil and thiobencarb in or on certain products (OJ L 27, 30.1.2014, p. 9).
Uredba Komisije (EU) br. 79/2014 od 29. siječnja 2014. o izmjeni priloga II., III. i V. Uredbi (EZ) br. 396/2005 Europskog parlamenta i Vijeća u pogledu maksimalnih razina ostataka za bifenazat, klorprofam, esfenvalerat, fludioksonil i tiobenkarb u određenim proizvodima ili na njima (SL L 27, 30.1. 2014., str. 9.).
in Annex II, the columns for cyfluthrin, fenvalerate, fludioxonil, indoxacarb, MCPA, methoxyfenozide and trifloxystrobin are replaced by the following:
U Prilogu II. stupci za ciflutrin, fenvalerat, fludioksonil, indoksakarb, MCPA, metoksifenozid i trifloksistrobin zamjenjuju se sljedećima:
Fat soluble’
topiv u masti
Fenvalerate - codes 1011030, 1011040, 1012030, 1012040, 1013030, 1013040, 1014030, 1014040, 1015030, 1015040, 1016030, 1016040, 1017030 and 1017040: sum of fenvalerate (any ratio of constituent isomers including esfenvalerate) and CPIA (chlorophenyl isovaleric acid), expressed as fenvalerate
Fenvalerat – brojčane oznake 1011030, 1011040, 1012030, 1012040, 1013030, 1013040, 1014030, 1014040, 1015030, 1015040, 1016030, 1016040, 1017030 i 1017040: zbroj fenvalerata (bilo koji omjer sastavnih izomera uključujući esfenvalerat) i CPIA-a (klorfenilna izovalerinska kiselina), izražen kao fenvalerat
Fludioxonil - code 1000000 except 1040000: sum of fludioxonil and its metabolites oxidized to metabolite 2,2-difluoro-benzo[1,3]dioxole-4 carboxylic acid
Fludioksonil – brojčana oznaka 1000000 osim 1040000: zbroj fludioksonila i njegovih metabolita oksidiranih do metabolita 2,2-difluoro-benzo[1,3]dioksol-4 karboksilne kiseline
Indoxacarb (sum of indoxacarb and its R enantiomer) (F)
Indoksakarb (zbroj indoksakarba i njegova R enantiomera) (F)
MCPA and MCPB (MCPA, MCPB including their salts, esters and conjugates expressed as MCPA) (F) (R)
MCPA i MCPB (MCPA, MCPB uključujući njihove soli, estere i konjugate izražene kao MCPA) (F) (R)
MCPA and MCPB - code 1000000: MCPA, MCPB and MCPA thioethyl expressed as MCPA
MCPA i MCPB – brojčana oznaka 1000000: MCPA, MCPB i MCPA tioetil izraženi kao MCPA
Trifloxystrobin- code 1000000: the sum of trifloxystrobin and its metabolite (E, E)-methoxyimino- 2-[1-(3-trifluoromethyl-phenyl)-ethylideneamino-oxymethyl]-phenyl-acetic acid (CGA 321113)
Trifloksistrobin – brojčana oznaka 1000000: zbroj trifloksistrobina i njegovog metabolita (E, E)-metoksiimino- 2-[1-(3-trifluorometil-fenil)-etilidenamino-oksimetil]-fenil-octena kiselina (CGA 321113)
Groups and examples of individual products to which the MRLs apply [1]
Skupine i primjeri pojedinačnih proizvoda na koje se odnose maksimalne razine ostataka (MRO [1]
Cyfluthrin (cyfluthrin including other mixtures of constituent isomers (sum of isomers)) (F)
Ciflutrin (ciflutrin uključujući ostale smjese sastavnih izomera (zbroj izomera)) (F)
Methoxyfenozide (F)
Metoksifenozid (F)
in Part A, the columns for ametoctradin, cycloxydim, fenbuconazole, fluopyram, flutriafol, fluxapyroxad, glufosinate-ammonium, imidacloprid, penthiopyrad and spinetoram are replaced by the following:
u dijelu A stupci za ametoktradin, cikloksidim, fenbukonazol, fluopiram, flutriafol, fluksapiroksad, glufosinat amonijak, imidakloprid, pentiopirad i spinetoram zamjenjuju se sljedećima:
Ametoctradin (R)
Ametoktradin (R)
Ametoctradin - code 1000000 except 1040000: Ametoctradin, metabolite 4-(7-amino-5-ethyl [1,2,4]triazolo, [1,5-a]pyrimidin-6-yl) butanoic acid (M650F01) and metabolite 6-(7-amino-5-ethyl [1,2,4]triazolo [1,5-a]pyrimidin-6-yl) hexanoic acid (M650F06), expressed as ametoctradin
Ametoktradin – brojčana oznaka 1000000 osim 1040000: Ametoktradin, metabolit 4-(7-amino-5-etil [1,2,4]triazolo, [1,5-a]pirimidin-6-il) butanske kiseline (M650F01) i metabolit 6-(7-amino-5-etil [1,2,4]triazolo [1,5-a]pirimidin-6-il) heksanske kiseline (M650F06), izražen kao ametoktradin
Cycloxydim including degradation and reaction products which can be determined as 3-(3-thianyl)glutaric acid S-dioxide (BH 517-TGSO2) and/or 3-hydroxy-3-(3-thianyl)glutaric acid S-dioxide (BH 517-5-OH-TGSO2) or methyl esters thereof, calculated in total as cycloxydim
Cikloksidim uključujući degradacijske i reakcijske tvari koje se mogu odrediti kao S-dioksid 3-(3-tianil)glutarne kiseline (BH 517-TGSO2) i/ili S-dioksid 3-hidroksi-3-(3-tianil)glutarne kiseline (BH 517-5-OH-TGSO2) ili njihovi metilni esteri, ukupno izračunani kao cikloksidim
Fluopyram - code 1000000: sum fluopyram and fluopyram-benzamide (M25) expressed as fluopyram
Fluopiram – brojčana oznaka 1000000: zbroj fluopirama i fluopiram-benzamida (M25) izražen kao fluopiram
When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 19 October 2015, or, if that information is not submitted by that date, the lack of it.
Pri preispitivanju MRO-a Komisija će uzeti u obzir informacije iz prve rečenice ako su dostavljene do 19. listopada 2015. ili nedostatak informacija ako nisu dostavljene do tog datuma.
Fluxapyroxad
Fluksapiroksad
Glufosinate-ammonium (sum of glufosinate, its salts, MPP and NAG expressed as glufosinate equivalents)
Glufosinat amonijak (zbroj glufosinata, njegovih soli, MPP-a i NAG-a izraženih kao ekvivalenti glufosinata)
(+) MRL applicable until 31 December 2014, after that date 0,05 [5] will be applicable unless modified by a Regulation.
(+) MRO-ovi koji se primjenjuju do 31. prosinca 2014.; nakon tog datuma primjenjuje se 0,05 [5], osim ako se izmijeni uredbom.
in Part A, the following column for dinotefuran is added:
u dijelu A dodaje se sljedeći stupac za dinotefuran:
in Part B, the columns for azoxystrobin, cyfluthrin, MCPA, methoxyfenozide and trifloxystrobin are replaced by the following:
u dijelu B stupci za azoksistrobin, ciflutrin, MCPA, metoksifenozid i trifloksistrobin zamjenjuju se sljedećima:
Detailed information on supervised field trials to be submitted to the Authority and the European Commission by 30 June 2013 at the latest.
Detaljni podaci o kontroliranim terenskim ispitivanjima moraju se dostaviti Agenciji i Europskoj komisiji najkasnije do 30. lipnja 2013.
Reassessment of data may lead to modification of the MRL.
Nakon ponovne ocjene podataka može doći do izmjene MRO-ova.
Commission Delegated Regulation (EU) No 492/2014
Delegirana uredba Komisije (EU) br. 492/2014
supplementing Regulation (EU) No 528/2012 of the European Parliament and of the Council as regards the rules for the renewal of authorisations of biocidal products subject to mutual recognition
o dopuni Uredbe (EU) br. 528/2012 Europskog parlamenta i Vijeća u pogledu pravila za obnovu odobrenja biocidnih proizvoda koja su predmet međusobnog priznavanja
Having regard to the Treaty on the Functioning of the European Union,
uzimajući o obzir Ugovor o funkcioniranju Europske unije,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products [1], and in particular the first paragraph of Article 40 thereof,
uzimajući u obzir Uredbu (EU) br. 528/2012 Europskog parlamenta i Vijeća od 22. svibnja 2012. o stavljanju na raspolaganje na tržištu i uporabi biocidnih proizvoda [1], a posebno njezin članak 40. prvi stavak,
It is appropriate to lay down supplementary rules for the renewal of national authorisations having been subject to mutual recognition in accordance with Article 4 of Directive 98/8/EC of the European Parliament and of the Council [2] or with Articles 33 and 34 of Regulation (EU) No 528/2012, both in the Member States where the first authorisations were granted and in those Member States having granted authorisations through mutual recognition of the first authorisations.
Prikladno je utvrditi dodatna pravila za obnovu nacionalnih odobrenja koja su predmet međusobnog priznavanja u skladu s člankom 4. Direktive 98/8/EZ Europskog parlamenta i Vijeća [2] ili s člancima 33. i 34. Uredbe (EU) br. 528/2012, kako za državu članicu koja je prva dala odobrenje, tako i za države članice koje su odobrenje dale međusobnim priznavanjem prvog odobrenja.
In order to avoid unnecessary duplication of work and to ensure consistency, renewal of authorisations having been subject to mutual recognition should in the first place be managed by the competent authority of one single reference Member State.
Kako bi se izbjegao nepotreban dvostruki rad i osigurala dosljednost, obnovu odobrenja koja su bila predmet međusobnog priznavanja odmah bi moralo izvršiti nadležno tijelo jedne referentne države članice.
In order to provide flexibility to applicants and competent authorities, the applicant should have the opportunity to choose the reference Member State subject to the latter's agreement.
Kako bi se podnositeljima zahtjeva i nadležnim tijelima osigurala fleksibilnost, podnositelju zahtjeva trebalo bi omogućiti da odabere referentnu državu članicu, pod uvjetom da ona pristane na to.
In order to facilitate the smooth running of the procedure and the tasks to be carried out by the competent authorities, the scope of this Regulation should be limited to those authorisations having, apart from limited exceptions, the same terms and conditions in all the Member States at the time of the application for renewal.
Kako bi nadležna tijela mogla nesmetano provoditi potrebne postupke i zadatke, područje primjene ove Uredbe trebalo bi ograničiti na ona odobrenja na koja se u trenutku podnošenja zahtjeva za obnovu u svim državama članicama primjenjuju jednaki uvjeti, osim ograničenih izuzetaka.
For other national authorisations, an application for renewal should be submitted to the Member State in question in accordance with Article 31 of Regulation (EU) No 528/2012.
Za ostala nacionalna odobrenja zahtjev za obnovu treba podnijeti mjerodavnoj državi članici u skladu s člankom 31. Uredbe (EU) br. 528/2012.
The content of an application for renewal of a national authorisation is specified under Article 31 of Regulation (EU) No 528/2012.
Sadržaj zahtjeva za obnovu nacionalnog odobrenja određen je člankom 31. Uredbe (EU) br. 528/2012.
However, for applications for renewal of national authorisations granted on the basis of mutual recognition, the content of the application should be further specified, in particular to facilitate the work of the Member States involved in the renewal of these authorisations.
Međutim, za zahtjeve za obnovu nacionalnih odobrenja koja su dana na temelju međusobnog priznavanja sadržaj zahtjeva potrebno je detaljnije odrediti, prvenstveno kako bi se olakšao rad državama članicama uključenima u obnovu tih odobrenja.
To take into account the workload associated with the evaluation, the time allowed for processing an application should depend on whether or not a full evaluation needs to be performed.
Kako bi se u obzir uzela količina rada na ocjenjivanju, vrijeme određeno za obradu zahtjeva moralo bi ovisiti o tome mora li se provesti potpuno ocjenjivanje.
In order to provide the same level of protection when an authorisation is renewed as when it is first granted, the maximum validity of the renewed authorisations should not exceed that of the initial authorisations.
Kako bi se pri obnovi odobrenja ostvarila jednaka razina zaštite kao pri njegovom prvom izdavanju, najdulje razdoblje valjanosti obnovljenih odobrenja ne bi smjelo biti dulje od razdoblja za prva odobrenja.
In addition, phasing-out provisions for the existing products on the market of Member States should be set for those authorisations for which an application for renewal is not submitted or is rejected.
Osim toga, potrebno je donijeti odredbe za postupno uklanjanje s tržišta država članica onih proizvoda za koje nije podnesen zahtjev za obnovu odobrenja ili je taj zahtjev odbijen.
It is appropriate to refer any disagreement in the evaluation of renewal applications to the coordination group established under Regulation (EU) No 528/2012 for the purpose of examining disagreements relating to product authorisation, and to allow derogations from mutual recognition based on the general grounds for such derogations laid down in Article 37 of that Regulation.
Prikladno je svako neslaganje u ocjenjivanju zahtjeva za obnovu prijaviti koordinacijskoj skupini utemeljenoj Uredbom (EU) br. 528/2012 u svrhu ispitivanja neslaganja povezanih s odobravanjem proizvoda te odobriti odstupanja od međusobnog priznavanja na temelju općih osnova za takva odstupanja utvrđenih člankom 37. te Uredbe.
In order to bring further predictability, guidelines on the details related to the handling of renewals should be developed by the Agency and regularly updated on the basis of experience and scientific or technical progress,
Kako bi se postigla veća predvidljivost, Agencija bi trebala izraditi smjernice o detaljima povezanim s postupanjem s obnovama te ih redovito ažurirati na temelju iskustva i znanstvenog ili tehnološkog napretka,
This Regulation lays down rules for the renewal of a national authorisation of a biocidal product or a biocidal product family that has been subject to mutual recognition in accordance with Article 4 of Directive 98/8/EC or with Articles 33 and 34 of Regulation (EU) No 528/2012, or of a national authorisation granted through such mutual recognition (hereinafter referred to as an ‘authorisation’).
Ovom Uredbom utvrđuju se pravila za obnovu nacionalnog odobrenja biocidnog proizvoda ili skupine biocidnih proizvoda koje je bilo predmet međusobnog priznavanja u skladu s člankom 4. Direktive 98/8/EZ ili s člancima 33. i 34. Uredbe (EU) br. 528/2012, ili za obnovu nacionalnog odobrenja koje je dano takvim postupkom međusobnog priznavanja (u daljnjem tekstu: „odobrenje”).
This Regulation shall apply to authorisations having the same terms and conditions at the time of the application for renewal in all the Member States where the renewal is sought.
Ova Uredba primjenjuje se na odobrenja na koja se u vrijeme podnošenja zahtjeva za obnovu u svim državama članicama u kojima se zahtijeva obnova primjenjuju jednaki uvjeti.
This Regulation shall also apply to authorisations having different terms and conditions on one or more of the following aspects:
Ova Uredba primjenjuje se i na odobrenja na koja se primjenjuju različiti uvjeti iz najmanje jednog od sljedećih razloga:
concerning merely information which can be the subject of an administrative change in accordance with Commission Implementing Regulation (EU) No 354/2013 [3];
u pogledu informacija koje mogu biti podložne administrativnim izmjenama u skladu s Provedbenom uredbom Komisije (EU) br. 354/2013 [3];
derived from an adjustment of the initial authorisation based on the second and third subparagraphs of Article 4(1) of Directive 98/8/EC;
zbog prilagodbe početnog odobrenja na temelju članka 4. stavka 1. drugog i trećeg podstavka Direktive 98/8/EZ;
established by a Commission Decision adopted either in accordance with Article 4(4) of Directive 98/8/EC or in accordance with Article 37(2)(b) of Regulation (EU) No 528/2012;
na temelju Odluke Komisije koja je donesena u skladu s člankom 4. stavkom 4. Direktive 98/8/EZ ili u skladu s člankom 37. stavkom 2. podstavkom (b) Uredbe (EU) br. 528/2012;
derived from an agreement with the applicant under the first subparagraph of Article 37(2) of Regulation (EU) No 528/2012, or from equivalent agreements reached when implementing the provisions of Article 4 of Directive 98/8/EC.
zbog dogovora s podnositeljem zahtjeva na temelju članka 37. stavka 2. prvog podstavka Uredbe (EU) br. 528/2012 ili jednakih dogovora postignutih pri provedbi odredbi iz članka 4. Direktive 98/8/EZ.