natgillin/translations-raw huggingface dataset:
In order to provide information on the costs entailed in applying for review and on the need for animal testing for the purposes of compiling the complete dossier, participants may submit to the Rapporteur Member State together with the complete dossiers a breakdown of the costs of the respective actions and studies carried out.
Da bi zagotovili podatke o stroških, ki so nastali zaradi vloge za pregled, in o potrebi po opravljanju poskusov na živalih za namene sestavljanja popolnega dosjeja, lahko udeleženci državi članici poročevalki skupaj s popolnim dosjejem predložijo razčlembo stroškov opravljenih dejavnosti in študij.
The Rapporteur Member State shall communicate that information to the Commission when submitting the competent authority report in accordance with Article 14(4).
Država članica poročevalka Komisiji sporoči navedene podatke ob predložitvi poročila pristojnega organa v skladu s členom 14(4).
Information on the costs entailed in compiling the complete dossier and on the animal testing carried out for that purpose shall be included in the report referred to in Article 18(5) of Directive 98/8/EC together with any appropriate recommendations concerning modifications of data requirements in order to reduce to a minimum the need for testing on vertebrate animals, and to ensure cost-effectiveness and proportionality.
Podatki o stroških, ki so nastali zaradi sestavljanja popolnega dosjeja, in o poskusih na živalih, opravljenih za navedeni namen, so vključeni v poročilo iz člena 18(5) Direktive 98/8/ES, skupaj z morebitnimi primernimi priporočili v zvezi s spremembami zahtevanih podatkov za zmanjšanje potrebe po opravljanju poskusov na vretenčarjih na čim manjšo raven ter za zagotovitev stroškovne učinkovitosti in proporcionalnosti.
Submission of the complete dossier
Predložitev popolnih dosjejev
Unless otherwise indicated by the Rapporteur Member State, a participant shall submit to the Rapporteur Member State one paper and one electronic copy of the complete dossier.
Udeleženec državi članici poročevalki predloži en izvod popolnega dosjeja v papirnati obliki in en izvod v elektronski obliki, razen če država članica poročevalka določi drugače.
The participant shall also, in accordance with Article 13(3), submit one paper and one electronic copy of the summary dossier to the Commission and to each of the other Member States.
V skladu s členom 13(3) udeleženec tudi Komisiji in vsaki od preostalih držav članic predloži po en izvod povzetka dosjeja v papirnati obliki in po en izvod v elektronski obliki.
However, any Member State wishing to receive copies only in electronic format or additional copies shall inform the Commission, which shall make that information publicly available by electronic means.
Vendar pa država članica, ki želi prejeti izvode le v elektronski obliki ali pa želi prejeti dodatne izvode, o tem obvesti Komisijo, ki da te podatke na voljo javnosti prek elektronskih sredstev.
If the Member State subsequently decides otherwise, it shall inform the Commission without undue delay, whereupon the Commission shall update accordingly the information made publicly available.
Če se država članica pozneje odloči drugače, o tem brez neutemeljenega odlašanja obvesti Komisijo, ki nato ustrezno posodobi podatke, ki so dostopni javnosti.
For the existing active substances listed in Annex II, complete dossiers must be received by the competent authority of the Rapporteur Member State within the following periods:
Za obstoječe aktivne snovi iz Priloge II prejmejo pristojni organi države članice poročevalke popolne dosjeje v naslednjih rokih:
for product types 8 and 14, until 28 March 2004;
za vrste pripravkov 8 in 14 do 28. marca 2004;
for product types 16, 18, 19 and 21, from 1 November 2005 until 30 April 2006;
za vrste pripravkov 16, 18, 19 in 21 od 1. novembra 2005 do 30. aprila 2006;
for product types 1, 2, 3, 4, 5, 6 and 13, from 1 February 2007 until 31 July 2007;
za vrste pripravkov 1, 2, 3, 4, 5, 6 in 13 od 1. februarja 2007 do 31. julija 2007;
for product types 7, 9, 10, 11, 12, 15, 17, 20, 22 and 23, from 1 May 2008 until 31 October 2008.
za vrste pripravkov 7, 9, 10, 11, 12, 15, 17, 20, 22 in 23 od 1. maja 2008 do 31. oktobra 2008.
Joining and replacing of participants
Pridružitev udeležencem in zamenjava udeležencev
Where, by mutual agreement, a producer, formulator or association joins or replaces a participant for the purposes of submitting the complete dossier, all parties to the agreement shall jointly inform the Commission and the Rapporteur Member State accordingly, attaching any relevant letter of access.
Kadar se v skladu z medsebojnim sporazumom proizvajalec, formulator ali združenje pridruži udeležencu ali ga zamenja z namenom predložitve popolnega dosjeja, vse stranke sporazuma o tem skupaj obvestijo Komisijo in državo članico poročevalko ter priložijo morebitno ustrezno izjavo o dostopnosti podatkov.
The Commission shall inform accordingly any other participant seeking review of the same active substance in relation to the same product types.
Komisija ustrezno obvesti vsakega drugega udeleženca, ki zahteva pregled iste aktivne snovi v zvezi z isto vrsto pripravka.
Withdrawal of participants
Odstop udeležencev
Where a participant intends to discontinue participation in the review programme, they shall inform the relevant Rapporteur Member State and the Commission accordingly, in writing and without delay, stating the reasons.
Kadar udeleženec namerava prekiniti udeležbo v programu pregledovanja, o tem nemudoma pisno obvesti državo članico poročevalko in Komisijo ter navede razloge.
The Commission shall inform accordingly the other Member States and any other participant seeking review of the same active substance in relation to the same product type(s).
Komisija nato obvesti preostale države članice in vsakega drugega udeleženca, ki zahteva pregled iste aktivne snovi v zvezi z istimi vrstami pripravkov.
Where all the participants have withdrawn as regards a particular existing active substance/product type combination, the Commission shall inform the Member States thereof and shall publish that information electronically.
Kadar v zvezi z določeno kombinacijo obstoječih aktivnih snovi/vrst pripravkov odstopijo vsi udeleženci, Komisija o tem obvesti države članice in ta podatek objavi elektronsko.
Taking over the role of participant
Prevzem vloge udeleženca
Within three months of the electronic publication of the information referred to in Article 11(2), a producer, formulator, association or other person may inform the Commission of their intention to take over the role of participant as regards the existing active substance/product type combination.
V treh mesecih po elektronski objavi podatka iz člena 11(2) lahko proizvajalec, formulator, združenje ali druga oseba obvesti Komisijo o svoji nameri, da prevzame vlogo udeleženca v zvezi s kombinacijo obstoječih aktivnih snovi/vrst pripravkov.
Within the time period referred to in the first subparagraph, a Member State may also indicate to the Commission an interest in taking over the role of participant in order to support the inclusion in Annex I, IA or IB to Directive 98/8/EC of the existing active substance/product type combination, where there are uses which the Member State considers essential, in particular for the protection of human health, animal health or the environment.
V roku iz prvega pododstavka lahko tudi država članica Komisiji izrazi zanimanje za prevzem vloge udeleženca, da bi podprla vključitev kombinacije obstoječih aktivnih snovi/vrst pripravkov v prilogo I, IA ali IB k Direktivi 98/8/ES, kadar gre za vrste uporabe, za katere država članica meni, da so bistvene, zlasti za varovanje zdravja ljudi, varovanje zdravja živali ali varstvo okolja.
The person or Member State wishing to take over the role of the participant who has withdrawn shall, within three months of informing the Commission of their intention, provide evidence to it that work to compile a complete dossier has been commissioned.
V času treh mesecev po obvestilu Komisije oseba ali država članica, ki želi prevzeti vlogo udeleženca, ki je odstopil, zagotovi Komisiji dokaze, da se je začelo delo za pripravo popolnega dosjeja.
On the basis of the evidence referred to in paragraph 2, the Commission shall decide whether or not to allow the interested person or Member State to take over the role of participant.
Na podlagi dokazov iz odstavka 2 Komisija odloči, ali dovoli zainteresirani osebi ali državi članici, da prevzame vlogo udeleženca, ali ne.
Where the Commission allows the interested person or Member State to take over the role of participant, it may decide to extend, if necessary, the relevant period for the submission of a complete dossier specified in Article 9.
Kadar Komisija dovoli zainteresirani osebi ali državi članici, da prevzame vlogo udeleženca, se lahko po potrebi odloči tudi podaljšati rok za predložitev popolnega dosjeja, določenega v členu 9.
The taking over of the role of participant for a given existing active substance/product type combination may be allowed only once.
Prevzem vloge udeleženca za dano kombinacijo obstoječih aktivnih snovi/vrst pripravkov se lahko dovoli samo enkrat.
Where the Commission receives no response pursuant to paragraph 1, it shall take a decision not to include the existing active substance in Annex I, IA or IB to Directive 98/8/EC within the framework of the review programme for the product type(s) concerned.
Kadar Komisija ne prejme nobenega odgovora v skladu z odstavkom 1, odloči, da ne bo vključila obstoječe aktivne snovi v prilogo I, IA ali IB k Direktivi 98/8/ES v okviru programa pregledovanja za zadevne vrste pripravkov.
Completeness check of dossiers
Pregled popolnosti dosjejev
Within three months of receiving the dossier for an existing active substance/product type combination and no later than three months after the end of the relevant time period specified in Article 9(2) of this Regulation, the Rapporteur Member State shall verify whether the dossier is to be accepted as complete in accordance with Article 11(1)(b) of Directive 98/8/EC.
V treh mesecih po prejetju dosjeja za določeno kombinacijo obstoječih aktivnih snovi/vrst pripravkov in najpozneje tri mesece po izteku roka iz člena 9(2) te uredbe država članica poročevalka preveri, ali se dosje lahko sprejme kot popoln v skladu s členom 11(1)(b) Direktive 98/8/ES.
Where the Rapporteur Member State has initiated consultations with other Member States and the Commission in relation to the acceptability of a dossier, the period may be prolonged until consultations have been finalised, up to a maximum of six months from receipt of the dossier.
Kadar država članica poročevalka začne posvet z drugimi državami članicami in Komisijo v zvezi s sprejemljivostjo dosjeja, se rok lahko podaljša, dokler se posvet ne konča, vendar do največ šest mesecev po prejemu dosjeja.
A Rapporteur Member State may require, as a condition for considering a dossier to be complete, proof of advance payment, in full or in part, of the charges payable under Article 25 of Directive 98/8/EC to be provided in the dossier.
Država članica poročevalka lahko kot pogoj za upoštevanje dosjeja kot popolnega zahteva, da se v dosje predloži dokaz o celotnem ali delnem predplačilu za dajatve, plačljive po členu 25 Direktive 98/8/ES.
Where a dossier is considered to be complete, the Rapporteur Member State shall confirm acceptance of the dossier to the participant and agree to the participant forwarding the summary dossier to the Commission and the other Member States within one month of receiving the confirmation.
Kadar se dosje šteje kot popoln, država članica poročevalka udeležencu potrdi sprejem dosjeja ter mu dovoli, da v enem mesecu po prejemu potrdila pošlje povzetek dosjeja Komisiji in preostalim državam članicam.
If a Member State in receipt of a summary dossier has legitimate reason to believe that the dossier is incomplete, it shall without delay communicate its concerns to the Rapporteur Member State, the Commission and the other Member States.
Kadar država članica prejme povzetek dosjeja, za katerega upravičeno meni, da je nepopoln, svoje pomisleke nemudoma sporoči državi članici poročevalki, Komisiji in preostalim državam članicam.
The Rapporteur Member State shall immediately take up consultations with that Member State and the Commission in order to discuss the concern expressed and resolve divergent opinions.
Država članica poročevalka nemudoma začne posvet z navedeno državo članico in Komisijo, da bi proučili izražene pomisleke in razrešili razhajanja mnenj.
In exceptional circumstances, the Rapporteur Member State may establish a new deadline for the submission of information which, for reasons duly substantiated, the participant was unable to submit in due time.
V izjemnih okoliščinah lahko država članica poročevalka postavi nov rok za predložitev podatkov, ki jih udeleženec ni mogel pravočasno predložiti zaradi utemeljenih razlogov.
The participant shall, within three months of being informed of the new deadline, provide evidence to the Rapporteur Member State that work to provide the missing information has been commissioned.
Udeleženec v treh mesecih po obvestilu o novem roku državi članici poročevalki predloži dokaze, da se je delo za zagotovitev manjkajočih podatkov začelo.
If the Rapporteur Member State considers that it has received sufficient evidence, it shall carry out its evaluation in accordance with Article 14 as if the dossier were complete.
Če država članica meni, da je prejela dovolj dokazov, opravi oceno v skladu s členom 14, kakor da je dosje popoln.
Otherwise, the evaluation shall not commence until the missing information is submitted.
Sicer se ocena ne začne opravljati, dokler niso predloženi manjkajoči podatki.
Where a complete dossier is not received within the period specified in Article 9 or by a new deadline established in accordance with paragraph 4, the Rapporteur Member State shall inform the Commission, giving the reasons put forward by the participant by way of justification.
Če popoln dosje ni prejet v roku iz člena 9 ali do izteka morebitnega novega roka, določenega v skladu z odstavkom 4, država članica poročevalka o tem obvesti Komisijo in predloži razloge, ki jih je v opravičilo navedel udeleženec.
The Rapporteur Member State shall also inform the Commission in cases where a participant fails to provide the evidence required in accordance with the second subparagraph of paragraph 4.
Država članica poročevalka obvesti Komisijo tudi, kadar udeleženec ne predloži dokazov, zahtevanih v skladu z drugim pododstavkom odstavka 4.
In the cases referred to in the first and second subparagraphs and if no other dossier concerns the same existing active substance/product type combination, all participants shall be deemed to have withdrawn and Articles 11(2) and 12 shall apply mutatis mutandis.
V primerih iz prvega in drugega pododstavka ter kadar se noben drug dosje ne nanaša na isto kombinacijo obstoječih snovi/vrst pripravkov, se šteje, da so vsi udeleženci odstopili, ter se smiselno uporabljata člena 11(2) in 12.
Evaluation of dossiers by the Rapporteur Member State
Ocena dosjejev, ki jo opravi država članica poročevalka
Where the Rapporteur Member State considers a dossier to be complete, it shall carry out the evaluation within twelve months of accepting the dossier in accordance with Article 11(2) of Directive 98/8/EC and shall prepare a report on that evaluation, hereinafter ‘the competent authority report’.
Država članica poročevalka v primeru dosjeja, za katerega meni, da je popoln, v času 12 mesecev po sprejemu dosjeja opravi oceno v skladu s členom 11(2) Direktive 98/8/ES in o tej oceni pripravi poročilo, v nadaljnjem besedilu „poročilo pristojnega organa“.
Without prejudice to Article 12 of Directive 98/8/EC, the Rapporteur Member State may take into account other relevant technical or scientific information regarding the properties of the active substance, metabolites or residues.
Ne glede na člen 12 Direktive 98/8/ES lahko država članica poročevalka prouči druge ustrezne tehnične ali znanstvene podatke v zvezi z lastnostmi aktivnih snovi, metabolitov ali ostankov.
At the request of a participant, the Rapporteur Member State may take into account additional information relating to an active substance for which the dossier has been accepted as complete only if the following conditions are fulfilled:
Na zahtevo udeleženca lahko država članica poročevalka upošteva dodatne podatke v zvezi z aktivno snovjo, za katero je bil dosje sprejet kakor popoln, le če so izpolnjeni naslednji pogoji:
the participant informed the Rapporteur Member State, at the time of submission of the dossier, that preparation of the additional information was under way;
udeleženec je ob predložitvi dosjeja državo članico poročevalko obvestil, da je priprava dodatnih podatkov v teku;
the additional information is submitted no later than nine months after acceptance of the dossier in accordance with Article 13(3);
dodatni podatki se predložijo najpozneje devet mesecev po sprejetju dosjeja v skladu s členom 13(3);
by comparison with the data originally submitted, the additional information is equally or more reliable owing to the application of the same or higher quality standards;
dodatni podatki so v primerjavi s tistimi, ki so bili prvotno predloženi, enako ali bolj zanesljivi zaradi uporabe istih ali višjih standardov kakovosti;
by comparison with the data originally submitted, the additional information supports a different conclusion concerning the active substance for the purposes of the recommendation under paragraph 6.
dodatni podatki so v primerjavi s tistimi, ki so bili prvotno predloženi, podlaga za drugačen sklep glede aktivne snovi za namene priporočila v odstavku 6.
The Rapporteur Member State shall take into account additional information submitted by persons other than the participant only if that information satisfies the conditions set out in points (b), (c) and (d) of the first subparagraph.
Država članica poročevalka upošteva dodatne podatke, ki jih predložijo osebe, ki niso udeleženci, samo, kadar navedeni podatki izpolnjujejo pogoje, določene v točkah (b), (c) in (d) prvega pododstavka.
Where relevant in the application of paragraph 1, in particular when additional information has been requested by a deadline established by the Rapporteur Member State, the latter may request that the participant submit updated summary dossiers to the Commission and the other Member States when the additional information is received.
Kadar je to primerno pri uporabi odstavka 1, zlasti kadar so bili zahtevani dodatni podatki v roku, ki ga je določila država članica poročevalka, lahko ta od udeleženca zahteva, da Komisiji in preostalim državam članicam predloži posodobljene povzetke dosjejev po prejemu dodatnih podatkov.
All participants shall be deemed to have withdrawn and Articles 11(2) and 12 shall apply mutatis mutandis if:
Šteje se, da so vsi udeleženci odstopili, in ustrezno se uporabita člena 11(2) in 12, če:
the additional information is not received by the deadline;
do izteka roka niso prejeti dodatni podatki;
the participant fails to provide adequate justification for further postponing the deadline;
udeleženec ne zagotovi primernega opravičila za podaljšanje roka;
no other dossier concerns the same existing active substance/product type combination.
noben drug dosje ne obravnava iste kombinacije obstoječih aktivnih snovi/vrst pripravkov.
The Rapporteur Member State shall, without undue delay, send a copy of the competent authority report to the Commission, the other Member States and to the participant.
Država članica poročevalka brez neutemeljenega odlašanja pošlje izvod poročila pristojnega organa Komisiji, preostalim državam članicam in udeležencu.
A Rapporteur Member State may decide to withhold the competent authority report if the charges payable under Article 25 of Directive 98/8/EC have not been paid in full, in which case it shall inform the participant and the Commission accordingly.
Država članica poročevalka se lahko odloči, da zadrži poročilo pristojnega organa, če niso bile v celoti plačane dajatve, plačljive po členu 25 Direktive 98/8/ES, ter v tem primeru o tem obvesti udeleženca in Komisijo.
full payment is not received within three months of the date of receipt of that information;
celotno plačilo ni prejeto v treh mesecih po prejemu tega obvestila;
The competent authority report shall be presented in a format to be recommended by the Commission and shall include one of the following:
Poročilo pristojnega organa se predloži v obliki, ki jo priporoči Komisija, in vključuje eno od naslednjih priporočil:
a recommendation to include the existing active substance in Annex I, IA or IB to Directive 98/8/EC, stating, where appropriate, conditions for inclusion;
priporočilo, da se vključi obstoječa aktivna snov v prilogo I, IA ali IB k Direktivi 98/8/ES, z navedbo, kjer je to primerno, pogojev za vključitev;
a recommendation not to include the existing active substance in Annex I, IA or IB to Directive 98/8/EC, stating the reasons.
priporočilo, da se obstoječa aktivna snov ne vključi v prilogo I, IA ali IB k Direktivi 98/8/ES, z navedbo razlogov.
Commission procedures
Postopki Komisije
When the Commission receives a competent authority report pursuant to Article 14(4) of this Regulation it shall, without undue delay, prepare the draft decision referred to in Article 27 of Directive 98/8/EC.
Kadar Komisija prejme poročilo pristojnega organa v skladu s členom 14(4) te uredbe, nemudoma pripravi predlog za odločitev v skladu s členom 27 Direktive 98/8/ES.
Before preparing the draft decision referred to in paragraph 1, the Commission shall, when necessary in the light of the comments received on the competent authority report, consult with experts from the Member States to address any problems remaining unresolved.
Pred pripravo predloga za odločitev iz odstavka 1 in kadar je to potrebno zaradi prejetih pripomb v zvezi s poročilom pristojnega organa, se Komisija posvetuje s strokovnjaki iz držav članic pri razreševanju vseh nerešenih vprašanj.
Where necessary and upon a request from the Commission, the Rapporteur Member State shall prepare an updated competent authority report.
Kadar je to potrebno in na zahtevo Komisije, država članica poročevalka pripravi posodobljeno poročilo pristojnega organa.
Where an existing active substance, despite a recommendation for inclusion pursuant to Article 14(6) of this Regulation, still gives rise to concern, as referred to in Article 10(5) of Directive 98/8/EC, the Commission may, without prejudice to Article 12 of that Directive, take into account the finalisation of the evaluation of other existing active substances applied for the same use.
Kadar glede aktivne snovi, kljub priporočilu za vključitev v skladu s členom 14(6) te uredbe, še vedno obstajajo pomisleki iz člena 10(5) Direktive 98/8/ES, lahko Komisija ne glede na člen 12 navedene direktive upošteva dokončno oceno drugih obstoječih aktivnih snovi z enako uporabo.
On the basis of the documents and information referred to in Article 27(2) of Directive 98/8/EC, the Rapporteur Member State shall prepare an updated competent authority report, the first part of which shall form the assessment report.
Na podlagi dokumentov in podatkov iz člena 27(2) Direktive 98/8/ES država članica poročevalka pripravi posodobljeno poročilo pristojnega organa, katerega prvi del je poročilo o oceni.
The assessment report shall be reviewed within the Standing Committee on Biocidal Products.
Poročilo o oceni se pregleda v okviru Stalnega odbora za biocidne pripravke.
Where several dossiers have been submitted for the same active substance/product type combination, the Rapporteur Member State shall prepare one assessment report based on the information contained in those dossiers.
Kadar je predloženih več dosjejev za isto kombinacijo aktivnih snovi/vrst pripravkov, država članica poročevalka pripravi eno poročilo o oceni na podlagi podatkov iz teh dosjejev.