natgillin/translations-raw huggingface dataset:
Na zahtevo države članice, ki preučuje vlogo, druge države članice v isti coni, katerim je bila vloga predložena, sodelujejo, da se zagotovi pravična razdelitev delovne obremenitve.
At the request of the Member State examining the application, the other Member States in the same zone to which an application has been submitted shall cooperate to ensure a fair division of the workload.
Na zahtevo države članice, ki preučuje vlogo, druge države članice sodelujejo, da se zagotovi pravična razdelitev delovne obremenitve.
At the request of the Member State examining the application, the other Member States shall cooperate to ensure a fair division of the workload.
Druge države članice znotraj cone, katerim je bila predložena vloga, prenehajo preučevati vlogo, dokler država članica, ki preučuje vlogo, ne predloži ocene.
The other Member States within the zone to which an application has been submitted shall refrain from proceeding with the file pending assessment by the Member State examining the application.
Če se vloga vloži v več kot eni coni, se države članice, ki vlogo ocenjujejo, sporazumejo o oceni podatkov, ki niso povezani z okoljskimi in kmetijskimi razmerami.
In case an application has been made in more than one zone, Member States evaluating the application shall agree on the evaluation of data which are not related to the environmental and agricultural conditions.
Države članice, ki vlogo ocenjujejo, se sporazumejo o oceni podatkov, ki niso povezani z okoljskimi in kmetijskimi razmerami.
Member States evaluating the application shall agree on the evaluation of data which are not related to the environmental and agricultural conditions.
Člen 35a
Article 3 5 a
Ko je obveščen o tem, katera država članica bo preučila zahtevek, vlagatelj nemudoma posreduje Agenciji popolno dokumentacijo in njen povzetek iz člena 33(3)(a) in (b) ter informacije iz člena 33(3)(c).
Upon being informed which Member State will examine the application, the applicant shall immediately forward to the Authority the complete and the summary dossiers referred to in Article 3 3 (3)(a) and (b) and the information referred to in Article 3 3 (3)(c).
Agencija brez odlašanja zagotovi, da je povzetek dokumentacije dostopen za javnost, razen kakršnih koli zaupnih podatkov iz člena 63 ter podatkov iz člena 33(3)(c).
The Authority shall without delay make available to the public the summary dossiers, excluding any information which is confidential under Article 63 , and the information referred to in Article 3 3 (3)(c).
Zaradi lažje izmenjave podatkov je treba vzpostaviti osrednjo bazo podatkov, ki bi jo vodila Agencija in bi obsegala vse informacije o preskusih in študijah, ki so bili predhodno izvedeni za namene te uredbe.
In order to facilitate data sharing it is necessary to establish one central database with all the information on tests and studies carried out previously for the purposes of this Regulation, managed by the Authority.
Zaradi zagotavljanja preglednosti glede prizadevanja vlagateljev za preprečevanje preskusov na živalih bi morale biti tudi informacije iz člena 32(3)(c) javno dostopne.
The information referred to in Article 32(3)(c) should also be publicly available to ensure transparency in relation to the steps taken by applicants to avoid animal testing.
Ponovna vložitev predloga spremembe 135 s prve obravnave.
Reinstating first reading Amendment 135.
Država članica, ki preučuje vlogo, opravi neodvisno, objektivno in pregledno oceno ob upoštevanju trenutnih znanstvenih in tehničnih spoznanj in s pomočjo smernic, ki so na voljo v času vloge.
The Member State examining the application shall make an independent, objective and transparent assessment in the light of current scientific and technical knowledge using guidance documents available at the time of application.
Vsem državam na istem območju omogoči, da dajo pripombe, ki se bodo upoštevale pri oceni.
It shall give all Member States in the same zone the opportunity to submit comments to be considered in the assessment.
Vsem državam članicam omogoči, da dajo pripombe, ki se bodo upoštevale pri oceni.
It shall give all Member States the opportunity to submit comments to be considered in the assessment.
Uporabi enotna načela za oceno in registracijo fitofarmacevtskih sredstev iz člena 29(6), da – kolikor je to mogoče – določi, ali fitofarmacevtsko sredstvo izpolnjuje zahteve iz člena 29 v isti coni , kadar se uporablja v skladu s členom 55 in v skladu z realnimi pogoji za uporabo.
It shall apply the uniform principles for evaluation and authorisation of plant protection products, referred to in Article 29(6), to establish, as far as possible, whether the plant protection product meets the requirements provided for in Article 29 in the same zone , where used in accordance with Article 55, and under realistic conditions of use.
Uporabi enotna načela za oceno in registracijo fitofarmacevtskih sredstev iz člena 29(6), da – kolikor je to mogoče – določi, ali fitofarmacevtsko sredstvo izpolnjuje zahteve iz člena 29, kadar se uporablja v skladu s členom 55 in v skladu z realnimi pogoji za uporabo.
It shall apply the uniform principles for evaluation and authorisation of plant protection products, referred to in Article 29(6), to establish, as far as possible, whether the plant protection product meets the requirements provided for in Article 29, where used in accordance with Article 55, and under realistic conditions of use.
Država članica, ki preučuje vlogo, da svojo oceno na voljo drugim državam članicam znotraj iste cone .
The Member State examining the application shall make available its assessment to the other Member States within the same zone .
Oblika osnutka poročila o oceni se določi v skladu s svetovalnim postopkom iz člena 79(2) .
The format of the assessment report shall be established in accordance with the advisory procedure referred to in Article 79(2).
Država članica, ki preučuje vlogo, da svojo oceno na voljo drugim državam članicam.
The Member State examining the application shall make available its assessment to the other Member States.
Oblika osnutka poročila o oceni se določi v skladu z regulativnim postopkom iz člena 79(3) .
The format of the assessment report shall be established in accordance with the regulatory procedure referred to in Article 79(3).
Zadevne države članice ustrezno izdajo ali zavrnejo registracijo na podlagi sklepov ocene države članice, ki preuči vlogo, kakor je določeno v členih 31 in 32.
The Member States concerned shall grant or refuse authorisations accordingly on the basis of the conclusions of the assessment of the Member State examining the application as provided for in Articles 31 and 32 .
Zadevne države članice v 180 dneh izdajo ali zavrnejo registracijo na podlagi sklepov ocene države članice, ki preuči vlogo, kakor je določeno v členih 31 in 32 , ter na podlagi dodatnih ocen, preskusov in študij, povezanih s posebnimi razmerami v državah članicah .
Within 180 days, the Member States concerned shall grant or refuse authorisations on the basis of the conclusions of the assessment of the Member State examining the application as provided for in Articles 31 and 32, and on the basis of any additional assessments, tests, and studies related to specific conditions in the Member States.
Obdobja 180 dni ni mogoče podaljšati.
The 180-day period cannot be extended.
Člen 36 – odstavek 2 a (novo)
Article 36 – paragraph 2 a (new)
Člen 36 – odstavek 3
Article 36 – paragraph 3
Z odstopanjem od odstavka 2 in v skladu z zakonodajo Skupnosti se lahko določijo ustrezni pogoji v zvezi z zahtevami iz člena 31(3)(a) in (b) ter drugi ukrepi za zmanjšanje tveganja, ki se sprejmejo zaradi posebnih pogojev uporabe.
By way of derogation from paragraph 2 and subject to Community law , appropriate conditions may be imposed with respect to the requirements referred to in points (a) and (b) of Article 31(3) and other risk mitigation measures deriving from specific conditions of use.
Države članice lahko z odstopanjem od odstavka 2 in v skladu z zakonodajo Skupnosti določijo ustrezne pogoje v zvezi z zahtevami iz člena 31(3) ter druge ukrepe za zmanjšanje tveganja, ki se sprejmejo zaradi posebnih pogojev uporabe.
By way of derogation from paragraph 2 and subject to Community law , Member States may impose appropriate conditions with respect to the requirements referred to in Article 31(3) and other risk mitigation measures deriving from specific conditions of use.
Če se pomisleki držav članic glede zdravja ljudi ali živali ter varovanja okolja ne morejo nadzirati z uvedbo nacionalnih ukrepov za zmanjšanje tveganja iz prvega pododstavka, lahko država članica v skrajnem primeru zavrne registracijo fitofarmacevtskih sredstev na svojem območju, če zaradi zelo specifičnih okoljskih ali kmetijskih pogojev utemeljeno meni, da zadevno sredstvo predstavlja resno tveganje zdravju ljudi ali živali ali okolju.
Where the concerns of a Member State related to human or animal health or the environment cannot be controlled by the establishment of national risk mitigation measures referred to in the first subparagraph, a Member State may as a last resort refuse authorisation of the plant protection product in its territory if, due to its very specific environmental or agricultural circumstances, it has substantiated reasons to consider that the product in question poses a serious risk to human or animal health or the environment.
O svoji odločitvi nemudoma obvesti vlagatelja in Komisijo ter jo podpre s tehničnimi ali znanstvenimi dokazi.
It shall immediately inform the applicant and the Commission of its decision and provide a technical or scientific justification therefore.
Države članice zagotovijo, da se lahko odločitve o zavrnitvi registracije takšnega sredstva izpodbija pred nacionalnim sodiščem ali drugimi organi za pritožbe.
Member States shall provide for a possibility to challenge decision refusing the authorisation of such product before the national courts or other instances of appeal.
Države članice zagotovijo, da lahko katerakoli zainteresirana stran odločitve o odobritvi ali zavrnitvi registracije takšnega sredstva izpodbija pred nacionalnim sodiščem ali drugimi organi za pritožbe.
Member States shall provide for a possibility to challenge a decision accepting or refusing the authorisation of such product by any stakeholder before the national courts or other instances of appeal.
Člen 37 – odstavek 4
Article 37 – paragraph 4
Druge zadevne države članice najpozneje v 90 dneh od prejema poročila o oceni in kopije registracije, ki jo je izdala država članica, ki je preučila vlogo, odločijo o tej vlogi v skladu s členom 36(2) in (3).
The other Member States concerned shall at the latest within 90 days of the receipt of the assessment report and the copy of the authorisation of the Member State examining the application decide on the application as referred to in Article 36(2) and (3).
Črtanje novega besedila Sveta v skladu z mnenjem Parlamenta, da se načelo con črta.
Deletion of new wording introduced by Council in line with Parliament's position to delete the concept of zones.
Člen 39 – odstavek 1 – pododstavek 1 a (novo)
Article 39 – paragraph 1 – subparagraph 1 a (new)
*12 mesecev po začetku veljavnosti te uredbe.
* 12 months after the entry into force of this Regulation.
Treba bi bilo uvesti sistem delitve dela, ki bi pospešil postopek odločanja držav članic, ki registrirajo isto sredstvo v EU.
A system of work sharing should be put in place to facilitate the decision making process of Member States that authorise the same product within the EU.
Ponovna vložitev predloga spremembe 143 s prve obravnave.
Reinstating first reading Amendment 143.
Člen 39 – odstavek 1 a (novo)
Article 39 – paragraph 1 a (new)
Države članice Agenciji nemudoma zagotovijo dosje z dokumentacijo iz točk (a), (b) in (c) odstavka 1.
Member States shall, without delay, make available to the Authority a file containing the documentation provided for in points (a), (b) and (c) of paragraph 1.
Ponovna vložitev predloga spremembe 144 s prve obravnave.
Reinstating first reading Amendment 144.
Člen 39 – odstavek 2 a (novo)
Article 39 – paragraph 2 a (new)
Države članice v 12 tednih po odločitvi o registraciji fitofarmacevtskega sredstva na javni spletni strani omogočijo dostop do evidence upravnih odločitev iz točke (c) odstavka 1.
Within 12 weeks of a decision on the authorisation of a plant protection product, Member States shall make available a record of the administrative decision s as referred to in point (c) of paragraph 1 on a public website.
Ponovna vložitev predloga spremembe 146 s prve obravnave.
Reinstating first reading Amendment 146.
Člen 40 – odstavek 1
Article 40 – paragraph 1
Imetnik registracije, izdane v skladu s členom 29, lahko zaprosi za registracijo istega fitofarmacevtskega sredstva, enako uporabo in v okviru primerljivih kmetijskih praks v drugi državi članici v skladu s postopkom vzajemnega priznavanja iz tega pododdelka , če:
The holder of an authorisation granted in accordance with Article 29 may apply for an authorisation for the same plant protection product, the same use and under the comparable agricultural practices in another Member State under the mutual recognition procedure, provided for in this subsection , in the following cases:
Imetnik registracije, izdane v skladu s členom 29, lahko zaprosi za registracijo istega fitofarmacevtskega sredstva, enako uporabo in v okviru primerljivih kmetijskih praks v drugi državi članici v skladu s postopkom vzajemnega priznavanja iz tega pododdelka .
The holder of an authorisation granted in accordance with Article 29 may apply for an authorisation for the same plant protection product, the same use and under the comparable agricultural practices in another Member State under the mutual recognition procedure provided for in this subsection.
(a) je registracijo izdala država članica (referenčna država članica), ki spada v isto cono;
(a) the authorisation was granted by a Member State (reference Member State ) which belongs to the same zone;
(b) je registracijo izdala država članica (referenčna država članica), ki spada v drugo cono, če se zaprošena registracija ne uporabi za potrebe vzajemnega priznavanja v drugi državi članici iz iste cone;
(b) the authorisation was granted by a Member State (reference Member State ) which belongs to a different zone provided that the authorisation for which the application was made is not used for the purpose of mutual recognition in another Member State within the same zone;
( c) je registracijo izdala država članica za uporabo v rastlinjakih, ali za tretiranje po spravilu, ali za tretiranje praznih prostorov ali shramb za skladiščenje rastlin ali rastlinskih proizvodov, ali za tretiranje semen, ne glede na cono, v katero spada referenčna država članica.
( c) the authorisation was granted by a Member State for use in greenhouses, or as post-harvest treatment, or for treatment of empty rooms or containers used for storing plant or plant products, or for seed treatment, regardless of the zone to which the reference Member State belongs.
Država članica, ki ji je predložena vloga v skladu s členom 40, registrira zadevno fitofarmacevtsko sredstvo pod enakimi pogoji kot država članica, ki je preučila vlogo, razen če se uporablja člen 36(3) .
The Member State to which an application under Article 40 is submitted shall authorise the plant protection product concerned under the same conditions as the Member State examining the application except where Article 36(3) applies.
Država članica, ki ji je predložena vloga v skladu s členom 40, preuči oceno države članice, ki je registracijo izdala (referenčne države članice), v primerjavi z okoliščinami na svojem ozemlju ter v 180 dneh registrira zadevno fitofarmacevtsko sredstvo pod enakimi pogoji kot država članica, ki je preučila vlogo, ali uporabi člen 36(2a) ali (3) .
The Member State to which an application under Article 40 is submitted shall examine the assessment undertaken by the Member State where the authorisation was granted ( reference Member State ) against the circumstances in its own territory and shall within 180 days authorise the plant protection product concerned under the same conditions as the Member State examining the application or apply Article 36 (2a) or (3).
Člen 41 – odstavek 1 a (novo)
Article 41 – paragraph 1 a (new)
Kadar država članica zavrne registracijo fitofarmacevtskega sredstva v skladu s členom 36(2a), o tem v 15 dneh po svoji odločitvi obvesti Komisijo, druge države članice in vlagatelja, ter to odločitev tudi utemelji.
Where a Member State refuses the authorisation of a plant protection product in accordance with A rticle 36(2a), it shall notify the Commission, the other Member States and the applicant within 15 days of its decision and its substantiated reasons for that decision .
Z odstopanjem od odstavka 1 lahko država članica registrira fitofarmacevtsko sredstvo, če:
By way of derogation from paragraph 1, the Member State may authorise the plant protection product where:
(a) se je registracija zaprosila v skladu s členom 40(1)(b);
(a) an authorisation under point (b) of Article 40(1) was applied for;
(b) vsebuje snov za zamenjavo;
(b) it contains a candidate of substitution;
(a) vsebuje snov za zamenjavo;
(a) it contains a candidate of substitution;
(c) se je uporabljal člen 30; ali
(c) Article 30 has been applied; or
(b) se je uporabljal člen 30; ali
(b) Article 30 has been applied; or
(d) vsebuje snov, odobreno v skladu s členom 4(7).
(d) it contains a substance approved in accordance with Article 4(7).
(c) vsebuje snov, odobreno v skladu s členom 4(7).
(c) it contains a substance approved in accordance with Article 4(7).
Država članica lahko tudi zavrne registracijo fitofarmacevtskega sredstva na svojem ozemlju, če utemeljeno meni, da bi bila registracija tega sredstva v nasprotju s cilji njenega nacionalnega akcijskega načrta.
A Member State may also refuse authorisation of the plant protection product in its territory if it has substantiated reasons to consider that the authorisation of this product would counteract the objectives of its national action plan.
Člen 42 – odstavek 1 – točka a
Article 42 – paragraph 1 - point a
(a) kopija registracije, ki jo je izdala referenčna država članica, ter prevod registracije v uradni jezik države članice, ki prejme vlogo;
(a) a copy of the authorisation granted by the reference Member State as well as a translation of the authorisation into an official language of the Member State receiving the application;
(a) kopija registracije, ki jo je izdala referenčna država članica, na zahtevo pa tudi prevod registracije v uradni ali nacionalni jezik države članice, ki prejme vlogo;
(a) a copy of the authorisation granted by the reference Member State as well as, where requested, a translation of the authorisation into an official or national language of the Member State receiving the application;
Pojasnilo zaradi skladnosti z zahtevami glede prevoda iz člena 33(5).
Clarification to achieve consistency with translation requirements in Article 33(5).
Splošna zahteva po prevajanju zmanjšuje učinkovitost postopka.
A general translation requirement without request undermines the efficiency of the process.
Država članica, ki ji je vloga predložena v skladu s členom 40, se v 90 dneh odloči o vlogi.
The Member State to which an application under Article 40 is submitted shall decide on the application within 90 days.
Država članica, ki ji je vloga predložena v skladu s členom 40, se v 180 dneh odloči o vlogi.
The Member State to which an application under Article 40 is submitted shall decide on the application within 180 days .
Ponovna vložitev predloga spremembe 154 s prve obravnave.
Reinstating first reading Amendment 154.
Člen 43 – odstavek 3 – pododstavek 2
Article 43 – paragraph 3 – subparagraph 2
Država članica iz člena 35 znotraj vsake cone usklajuje izvajanje preverjanj skladnosti in ocenjevanja informacij za vse države članice znotraj te cone .
The Member State referred to in Article 35 within each zone shall coordinate the compliance check and assessment of the information submitted for all Member States within that zone .
Država članica iz člena 35 usklajuje izvajanje preverjanj skladnosti in ocenjevanja informacij , predloženih vsem državam članicam, ki so prejele zahtevek .
The Member State referred to in Article 35 shall coordinate the compliance check and assessment of the information submitted to all Member States that received an application .
Člen 43 – odstavek 4
Article 43 – paragraph 4
Navodila za registracijo preverjanj skladnosti se lahko določijo v skladu s svetovalnim postopkom iz člena 79(2) .
Guidelines on the authorisation of compliance checks may be established in accordance with the advisory procedure referred to in Article 79(2).
Navodila za registracijo preverjanj skladnosti se lahko določijo v skladu z regulativnim postopkom iz člena 79(3) .
Guidelines on the authorisation of compliance checks may be established in accordance with the regulatory procedure referred to in Article 79 (3).
Kompromisni predlog spremembe temelji na predlogu spremembe 158 iz prve obravnave.
Compromise proposal based on amendment 158 from first reading.
Člen 44 – odstavek 3 – točka c a (novo)
Article 44 – paragraph 3 – point (c a ) (new)
(ca) na podlagi znanstvenega in tehničnega razvoja se lahko spremenijo uporabljeni odmerki in način njihove uporabe;
(ca) on the basis of developments in scientific and technical knowledge the manner of use and amounts used can be modified ;
Predlagano besedilo ne vsebuje pomembne določbe iz člena 4(6) Direktive 91/414.
In the proposed text an important provision from Directive 91/414 Article 4(6) is missing.
Ponovna vložitev predloga spremembe 160 s prve obravnave.
Reinstating first reading Amendment 160.
Člen 44 – odstavek 4
Article 44 – paragraph 4
Če država članica prekliče ali spremeni registracijo v skladu z odstavkom 3, o tem nemudoma obvesti imetnika registracije, druge države članice, Agencijo in Komisijo.
Where a Member State withdraws or amends an authorisation in accordance with paragraph 3, it shall immediately inform the holder of the authorisation, the other Member States, the Commission and the Authority.
Druge države članice , ki sodijo v isto cono, registracijo ustrezno spremenijo ali prekličejo, pri tem pa upoštevajo nacionalne pogoje in ukrepe za zmanjšanje tveganja, razen v primerih, kadar sta bila uporabljena drugi in četrti pododstavek člena 36(3) .
The other Member States belonging to the same zone shall withdraw or amend the authorisation accordingly taking into account national conditions and risk mitigation measures except for cases where second to fourth subparagraphs of Article 36(3) have been applied.
Člen 46 se uporablja po potrebi.
Article 46 shall apply where appropriate.
Druge države članice registracijo ustrezno spremenijo ali prekličejo, pri tem pa upoštevajo nacionalne pogoje in ukrepe za zmanjšanje tveganja, razen v primerih, kadar se uporabi člen 36(2a) .
The other Member States shall withdraw or amend the authorisation accordingly taking into account national conditions and risk mitigation measures except for cases where Article 36(2a) has been applied.
Kadar razlogi za preklic, spremembo ali zavrnitev podaljšanja registracije to dovoljujejo, je prehodno obdobje omejeno in ni daljše od šestih mesecev za dajanje v promet in dodatnega, največ leta za odstranjevanje, shranjevanje in uporabo obstoječih zalog zadevnih fitofarmacevtskih sredstev .
Where the reasons for withdrawal, amendment or not renewing the authorisation permit it the grace period shall be limited and not exceed six months for the placing on the market and an additional maximum of one year for the disposal, storage, and use of existing stocks of the plant protection products concerned.
Kadar razlogi za preklic, spremembo ali zavrnitev podaljšanja registracije niso povezani z varovanjem zdravja ljudi in živali ter okolja, rok za porabo zalog zadevnih fitofarmacevtskih sredstev ni daljši od ene sezone .
Where the reasons for withdrawal, amendment or not renewing the authorisation are not related to the protection of human and animal health or the environment, grace periods for using up stocks of the plant protection products concerned shall be granted for a period not longer than one season.