natgillin/translations-raw huggingface dataset:
Če v državi članici ni bila vložena nobena vloga za nacionalno dovoljenje za biocidni proizvod, za katerega je že bilo izdano dovoljenje v drugi državi članici, lahko uradni ali znanstveni organi, vključeni v dejavnosti zatiranja škodljivcev ali varovanje javnega zdravja, po postopku medsebojnega priznavanja dovoljenj iz člena 33 in s soglasjem imetnika dovoljenja v tej drugi državi članici vložijo vlogo za nacionalno dovoljenje za enak biocidni proizvod za enako uporabo in z enakimi pogoji uporabe kot v tej državi članici.
Where no application for a national authorisation has been submitted in a Member State for a biocidal product that is already authorised in another Member State, official or scientific bodies involved in pest control activities or the protection of public health may apply, under the mutual recognition procedure provided for in Article 33 and with the consent of the authorisation holder in that other Member State, for a national authorisation for the same biocidal product, with the same use and the same conditions for use as in that Member State.
Predlagatelj dokaže, da je uporaba takega biocidnega proizvoda v splošnem interesu za navedeno državo članico.
The applicant shall demonstrate that the use of such a biocidal product is of general interest for that Member State.
Ob vložitvi vloge se plačajo tudi pristojbine, ki se plačujejo na podlagi člena 80.
The application shall be accompanied by the fees payable under Article 80.
Kadar pristojni organ zadevne države članice meni, da biocidni proizvod izpolnjuje pogoje iz člena 19 in pogoje iz tega člena, pristojni organ izda dovoljenje za dostopnost biocidnega proizvoda na trgu in za njegovo uporabo.
Where the competent authority of the Member State concerned considers that the biocidal product fulfils the conditions referred to in Article 19 and the conditions under this Article are met, the competent authority shall authorise the making available on the market and use of the biocidal product.
V tem primeru ima organ, ki je vložil vlogo, enake pravice in dolžnosti kot drugi imetniki dovoljenj.
In that case, the body that made the application shall have the same rights and obligations as other authorisation holders.
Podrobna pravila in tehnična navodila
Detailed rules and technical guidance notes
Na Komisijo se prenese pooblastilo za sprejetje delegiranih aktov v skladu s členom 83, ki
The Commission shall be empowered to adopt delegated acts in accordance with Article 83
določajo dodatna
laying down supplementary
pravila za podaljšanje dovoljenj, za katera velja medsebojno priznavanje.
rules for the renewal of authorisations subject to mutual recognition.
Komisija pripravi tudi tehnična navodila za lažje izvajanje tega poglavja, zlasti členov 37 in 39.
The Commission shall also draw up technical guidance notes to facilitate the implementation of this Chapter and, in particular, Articles 37 and 39.
DOVOLJENJA UNIJE ZA BIOCIDNE PROIZVODE
UNION AUTHORISATIONS OF BIOCIDAL PRODUCTS
Izdaja dovoljenj Unije
Granting of Union authorisations
Dovoljenje Unije
Union authorisation
Dovoljenje Unije, ki ga izda Komisija v skladu s tem oddelkom, je veljavno povsod v Uniji, razen če ni določeno drugače.
A Union authorisation issued by the Commission in accordance with this Section shall be valid throughout the Union unless otherwise specified.
Vsaki državi članici podeljuje enake pravice in dolžnosti kot nacionalno dovoljenje.
It shall confer the same rights and obligations in each Member State as a national authorisation.
Vlagatelj lahko za kategorije biocidnih proizvodov iz člena 42(1) namesto vloge za nacionalno dovoljenje in medsebojno priznavanje dovoljenj vloži vlogo za dovoljenje Unije.
For those categories of biocidal products referred to in Article 42(1), the applicant may apply for Union authorisation as an alternative to applying for a national authorisation and mutual recognition.
Biocidni proizvodi, za katere se lahko izda dovoljenje Unije
Biocidal products for which Union authorisation may be granted
Vlagatelji lahko vložijo vlogo za dovoljenje Unije za biocidne proizvode s podobnimi pogoji uporabe v celotni Uniji,
Applicants may apply for Union authorisation for biocidal products which have similar conditions of use across the Union
razen biocidnih proizvodov, ki vsebujejo aktivne snovi iz člena 5, in proizvodov vrste 14, 15, 17, 20 in 21
with the exception of biocidal products that contain active substances that fall under Article 5 and except for those of product-types 14, 15, 17, 20 and 21
od 1. septembra 2013 se lahko dovoljenje Unije izda za biocidne proizvode, ki vsebujejo eno ali več novih aktivnih snovi, in za
from 1 September 2013, the Union authorisation may be granted to biocidal products containing one or more new active substances and
biocidne proizvode vrste
biocidal products of product-types
1, 3, 4, 5, 18 in 19
1, 3, 4, 5, 18 and 19
s 1. januarjem 2017 se lahko dovoljenje Unije izda za biocidne proizvode vrste 2, 6 in 13; in
from 1 January 2017, the Union authorisation may be granted to biocidal products of product-types 2, 6 and 13; and
s 1. januarjem 2020
from 1 January 2020,
se lahko dovoljenje Unije izda za
the Union authorisation may be granted to
biocidnih proizvodov.
biocidal products.
Komisija do ...
The Commission shall by …
UL: vstaviti datum – dan začetka uporabe te uredbe.
OJ: Insert the date - the day of application of this Regulation.
oblikuje smernice za opredelitev „podobnih pogojev uporabe v celotni Uniji“.
draw up guidance documents on the definition of ‘similar conditions of use across the Union’.
To poročilo vsebuje oceno izključitve vrst proizvodov 14, 15, 17, 20 in 21 iz dovoljenja Unije.
This report shall contain an assessment of the exclusion of product-types 14, 15, 17, 20 and 21 from the Union authorisation.
Komisija po
The Commission
potrebi poročilu priloži ustrezne predloge za sprejetje v skladu z rednim zakonodajnim postopkom.
shall, if appropriate, accompany its report with relevant proposals for adoption in accordance with the ordinary legislative procedure.
Vlagatelji, ki želijo vložiti vlogo za dovoljenje Unije v skladu s členom 42(1), vložijo vlogo pri Agenciji, skupaj s potrdilom, da se bo biocidni proizvod uporabljal pod podobnimi pogoji v celotni Uniji, in Agencijo obvestijo o imenu pristojnega organa države članice, ki ga predlagajo za ocenjevanje vloge, ter predložijo pisno potrdilo, da se zadevni pristojni organ s tem strinja.
Applicants wishing to apply for Union authorisation in accordance with Article 42(1) shall submit an application to the Agency, including a confirmation that the biocidal product would have similar conditions of use across the Union, informing the Agency of the name of the competent authority of the Member State that they propose should evaluate the application and providing written confirmation that that competent authority agrees to do so.
Agencija vlagatelja obvesti o pristojbinah, ki se plačujejo na podlagi člena 80(1), in vlogo zavrne, če vlagatelj teh pristojbin ne plača v 30 dneh.
The Agency shall inform the applicant of the fees payable under Article 80(1), and shall reject the application if the applicant fails to pay the fees within 30 days.
Po prejemu pristojbin, ki se plačujejo v skladu s členom 80(1), Agencija validira vlogo in ustrezno obvesti vlagatelja in ocenjevalni pristojni organ.
Upon receipt of the fees payable under Article 80(1), the Agency shall accept the application and inform the applicant and the evaluating competent authority accordingly.
Ocenjevalni pristojni organ vlogo v 30 dneh po njenem sprejetju s strani Agencije validira, če so bile predložene ustrezne informacije iz člena 20.
Within 30 days of the Agency accepting an application, the evaluating competent authority shall validate the application if the relevant information referred to in Article 20 has been submitted.
Potem ko je agencija sprejela vlogo, ocenjevalni pristojni organ čim prej obvesti vlagatelja o pristojbini, ki se plača v skladu s členom 80(2), in zavrne vlogo, če vlagatelj ne plača pristojbine v 30 dneh.
The evaluating competent authority shall, as soon as possible after the Agency has accepted an application, inform the applicant of the fee payable under Article 80(2) and shall reject the application if the applicant fails to pay the fee within 30 days.
Če ocenjevalni pristojni organ meni, da je vloga nepopolna, vlagatelja obvesti o dodatnih informacijah, potrebnih za oceno vloge, in določi razumen rok za predložitev teh informacij.
Where the evaluating competent authority considers that the application is incomplete, it shall inform the applicant what additional information is required for the evaluation of the application and shall set a reasonable time limit for the submission of that information.
Ocenjevalni pristojni organ ob validaciji vloge v skladu z odstavkom 3 ali 4 nemudoma ustrezno obvesti vlagatelja, Agencijo in druge pristojne organe ter navede točen datum validacije.
On validating the application in accordance with paragraph 3 or 4, the evaluating competent authority shall, without delay, inform the applicant, the Agency and other competent authorities accordingly and indicate the exact date of the validation.
Ocenjevalni pristojni organ vlogo v 365 dneh po njeni validaciji oceni v skladu s členom 19, po potrebi pa tudi vse predloge za prilagoditev zahtev glede podatkov, ki so bili predloženi v skladu s členom 21(2), in Agenciji pošlje poročilo o oceni in zaključke ocenjevanja.
The evaluating competent authority shall, within 365 days of the validation of an application, evaluate it in accordance with Article 19, including, where relevant, any proposal to adapt data requirements submitted in accordance with Article 21(2), and send an assessment report and the conclusions of its evaluation to the Agency.
Preden ocenjevalni pristojni organ svoje ugotovitve predloži Agenciji, da vlagatelju možnost, da v 30 dneh predloži pisne pripombe k ugotovitvam ocenjevanja.
Prior to submitting its conclusions to the Agency, the evaluating competent authority shall provide the applicant with the opportunity to provide written comments on the conclusions of the evaluation within 30 days.
Vendar prekinitev skupno ne presega 180 dni, razen v izjemnih primerih in če je to upravičeno zaradi narave zahtevanih podatkov.
However, the suspension shall not exceed 180 days in total other than in exceptional cases and where justified by the nature of the data requested.
V 180 dneh od prejema ugotovitev ocenjevanja Agencija pripravi mnenje o dovoljenju za biocidni proizvod in ga predloži Komisiji.
Within 180 days of receipt of the conclusions of the evaluation, the Agency shall prepare and submit to the Commission an opinion on the authorisation of the biocidal product.
Če Agencija priporoča izdajo dovoljenja za biocidni proizvod, mnenje vsebuje vsaj naslednje elemente:
If the Agency recommends the authorisation of the biocidal product, the opinion shall contain at least the following elements:
izjavo, da so pogoji iz člena 19(1) izpolnjeni, in osnutek povzetka značilnosti biocidnega proizvoda v skladu s členom 22(2);
a statement on whether the conditions laid down in Article 19(1) are fulfilled, and a draft summary of biocidal product characteristics, as referred to in Article 22(2);
po potrebi podrobnosti določil ali pogojev, ki bi jih bilo treba uvesti za dostopnost na trgu ali uporabo biocidnega proizvoda;
where relevant, details of any terms or conditions which should be imposed on the making available on the market or use of the biocidal product;
končno poročilo o oceni biocidnega proizvoda.
the final assessment report on the biocidal product.
Agencija v 30 dneh od predložitve mnenja Komisiji v vseh uradnih jezikih Evropske unije Komisiji posreduje osnutek povzetka značilnosti biocidnega proizvoda, kot je navedeno v členu 22(2), kot je primerno.
Within 30 days of the submission of its opinion to the Commission, the Agency shall transmit to the Commission, in all the official languages of the European Union, the draft summary of the biocidal product characteristics, as referred to in Article 22(2), as applicable.
izvedbeno uredbo o izdaji dovoljenja Unije za biocidne proizvode ali izvedbeno
either an implementing Regulation granting the Union authorisation of the biocidal product or an implementing
neizdaji dovoljenja
stating that
Unije za biocidni proizvod.
the Union authorisation of the biocidal product
Podaljšanje dovoljenj Unije
Renewal of Union authorisations
Vloga s strani ali v imenu imetnika dovoljenja, ki želi podaljšati dovoljenje Unije, se vloži pri Agenciji najmanj 550 dni pred potekom veljavnosti dovoljenja.
An application by or on behalf of an authorisation holder wishing to seek the renewal of a Union authorisation shall be submitted to the Agency at least 550 days before the expiry date of the authorisation.
Ob vložitvi vloge se plačajo tudi pristojbine iz člena 80(1).
The application shall be accompanied by the fees payable under Article 80(1).
po prvotnem dovoljenju ali predhodnem podaljšanju, kakor je primerno in
that it has generated since the initial authorisation or, as appropriate, previous renewal; and
Agencija vlagatelja obvesti o pristojbinah, ki se Agenciji plačujejo na podlagi člena 80(1), in vlogo zavrne, če vlagatelj teh pristojbin ne plača v 30 dneh.
The Agency shall inform the applicant of the fees payable to it under Article 80(1) and shall reject the application if the applicant fails to pay the fees within 30 days.
Po prejemu pristojbin, ki se Agenciji plačujejo v skladu s členom 80(1), Agencija sprejme vlogo in ustrezno obvesti vlagatelja in ocenjevalni pristojni organ.
Upon receipt of the fees payable to it under Article 80(1), the Agency shall accept the application and inform the applicant and the evaluating competent authority accordingly.
Na podlagi ocene razpoložljivih informacij in potrebe po pregledu zaključkov iz prvotnega ocenjevanja vloge za dovoljenje Unije ali predhodnega podaljšanja, kakor je primerno, ocenjevalni pristojni organ v 30 dneh po tem, ko Agencija sprejme vlogo v skladu s členom 45(3), odloči, ali je glede na sedanja znanstvena spoznanja potrebna popolna ocena vloge za podaljšanje.
On the basis of an assessment of the available information and the need to review the conclusions of the initial evaluation of the application for Union authorisation or, as appropriate, the previous renewal, the evaluating competent authority shall, within 30 days of the Agency accepting the application in accordance with Article 45(3), decide whether, in the light of current scientific knowledge, a full evaluation of the application for renewal is necessary.
Če ocenjevalni pristojni organ odloči, da je potrebna popolna ocena vloge, se ocenjevanje opravi v skladu z odstavkoma 1 in 2 člena 44.
Where the evaluating competent authority decides that a full evaluation of the application is necessary, the evaluation shall be carried out in accordance with paragraphs 1 and 2 of Article 44.
Če ocenjevalni pristojni organ odloči, da popolna ocena vloge ni potrebna, v 180 dneh po tem, ko Agencija sprejme vlogo, pripravi priporočilo za podaljšanje dovoljenja in ga predloži Agenciji.
Where the evaluating competent authority decides that a full evaluation of the application is not necessary, it shall, within 180 days of the Agency accepting the application, prepare and submit to the Agency a recommendation on the renewal of the authorisation.
Potem ko je Agencija sprejela vlogo, ocenjevalni pristojni organ čim prej obvesti vlagatelja o pristojbini, ki se plača v skladu s členom 80(2), in zavrne vlogo, če vlagatelj ne plača pristojbin v 30 dneh.
The evaluating competent authority shall, as soon as possible after the Agency has accepted the application, inform the applicant of the fee payable under Article 80(2) and shall reject the application if the applicant fails to pay the fees within 30 days.
V 180 dneh po prejemu priporočila ocenjevalnega pristojnega organa Agencija pripravi mnenje o podaljšanju dovoljenja Unije in ga predloži Komisiji.
Within 180 days of receipt of a recommendation from the evaluating competent authority, the Agency shall prepare and submit to the Commission an opinion on the renewal of the Union authorisation.
Ob prejemu mnenja Agencije Komisija sprejme
On receipt of the opinion of the Agency, the Commission shall adopt
izvedbeno uredbo
either an implementing Regulation
o podaljšanju
to renew
dovoljenja Unije
the Union authorisation
odločitev o zavrnitvi podaljšanja dovoljenja Unije.
to refuse to renew the Union authorisation.
v skladu s postopkom pregleda iz člena 82(3). ▌
in accordance with the examination procedure referred to in Article 82(3). ▌
Komisija obnovi dovoljenje Unije, če so pogoji iz člena 19 še vedno izpolnjeni.
The Commission shall renew a Union authorisation, provided that the conditions set out in Article 19 are still satisfied.
Kadar se zaradi razlogov, na katere imetnik dovoljenja Unije ne more vplivati, odločitev o podaljšanju dovoljenja Unije ne sprejme pred njegovim iztekom veljavnosti, Komisija z izvedbenimi akti odobri podaljšanje dovoljenja Unije za obdobje, ki je potrebno za dokončanje ocenjevanja.
Where, for reasons beyond the control of the holder of the Union authorisation, no decision is taken on the renewal of the authorisation before its expiry, the Commission shall grant the renewal of the Union authorisation for the period necessary to complete the evaluation by means of implementing acts.
RAZVELJAVITEV, PREGLED IN SPREMEMBA DOVOLJENJ
CANCELLATION, REVIEW AND AMENDMENT OF AUTHORISATIONS
Obveznost sporočanja nepričakovanih ali neželenih učinkov
Obligation for notification of unexpected or adverse effects
Ko imetnik dovoljenja izve za informacije v zvezi z dovoljenim biocidnim proizvodom ali v njem vsebovanimi aktivnimi snovmi, ki lahko vplivajo na dovoljenje, jih nemudoma sporoči pristojnemu organu, ki je izdal nacionalno dovoljenje, in Agenciji ali, v primeru dovoljenja Unije, Komisiji in Agenciji.
On becoming aware of information concerning the authorised biocidal product, or the active substance(s) it contains, which may affect the authorisation, the holder of an authorisation shall without delay notify the competent authority that granted the national authorisation and the Agency or, in the case of a Union authorisation, the Commission and the Agency.
novi podatki ali informacije o neželenih učinkih aktivne snovi ali biocidnega proizvoda na človeka, zlasti ranljive skupine, ali okolje;
new data or information on the adverse effects of the active substance or biocidal product for humans, in particular vulnerable groups, or the environment;
kakršni koli podatki, ki kažejo na možnost aktivne snovi, da razvije odpornost;
any data indicating the potential of the active substance for the development of resistance;
novi podatki ali informacije, ki kažejo, da biocidni proizvod ni dovolj učinkovit.
new data or information indicating that the biocidal product is not sufficiently effective.
Pristojni organ, ki je izdal nacionalno dovoljenje, ali, v primeru dovoljenja Unije, Agencija preveri, ali je treba dovoljenje v skladu s členom 48 spremeniti ali preklicati.
The competent authority that granted the national authorisation or, in the case of a Union authorisation, the Agency, shall examine whether the authorisation needs to be amended or cancelled in accordance with Article 48.
Pristojni organ, ki je izdal nacionalno dovoljenje, ali, v primeru dovoljenja Unije, Agencija, nemudoma obvesti pristojne organe drugih držav članic in, kadar je to primerno, Komisijo o vseh takšnih podatkih ali informacijah, ki jih prejme.
The competent authority that granted the national authorisation or, in the case of a Union authorisation, the Agency, shall without delay notify competent authorities of other Member States and, where appropriate, the Commission of any such data or information it receives.
Pristojni organi držav članic, ki so izdali nacionalna dovoljenja za enak biocidni proizvod po postopku medsebojnega priznavanja dovoljenj, preverijo, ali je treba dovoljenje v skladu s členom 48 spremeniti ali preklicati.
Competent authorities of Member States that have issued national authorisations for the same biocidal product under the mutual recognition procedure shall examine whether the authorisation needs to be amended or cancelled in accordance with Article 48.
Preklic ali sprememba dovoljenja
Cancellation or amendment of an authorisation
Brez poseganja v člen 23 pristojni organ države članice ali, v primeru dovoljenja Unije, Komisija kadar koli prekliče ali spremeni dovoljenje, ki ga je izdala, kadar meni, da:
Without prejudice to Article 23, the competent authority of a Member State or, in the case of a Union authorisation, the Commission, shall at any time cancel or amend an authorisation it has granted where it considers that:
pogoji iz člena 19
the conditions referred to in Article 19
ali, kjer je to pomembno, člena 25
, or, where relevant, in Article 25,
niso izpolnjeni;
are not satisfied;
je bilo dovoljenje izdano na podlagi napačnih ali zavajajočih informacij; ali
the authorisation was granted on the basis of false or misleading information; or
imetnik dovoljenja ni izpolnil obveznosti iz dovoljenja ali te uredbe.
the authorisation holder has failed to comply with its obligations under the authorisation or this Regulation.
Kadar namerava pristojni organ ali, v primeru dovoljenja Unije, Komisija preklicati ali spremeniti dovoljenje, o tem obvesti imetnika dovoljenja in mu da možnost, da v določenem roku predloži pripombe ali dodatne informacije.
Where the competent authority or, in the case of a Union authorisation, the Commission, intends to cancel or amend an authorisation, it shall inform the authorisation holder thereof and give it the opportunity to submit comments or additional information within a specified time limit.
Ocenjevalni pristojni organ ali v primeru dovoljenja Unije Komisija te pripombe ustrezno upošteva pri končni odločitvi.
The evaluating competent authority or, in the case of a Union authorisation, the Commission, shall take due account of those comments when finalising its decision.
Kadar pristojni organ ali, v primeru dovoljenja Unije, Komisija v skladu z odstavkom 1 prekliče ali spremeni dovoljenje, o tem nemudoma obvesti imetnika dovoljenja, pristojne organe drugih držav članic in po potrebi Komisijo.
Where the competent authority or, in the case of a Union authorisation, the Commission, cancels or amends an authorisation in accordance with paragraph 1, it shall without delay notify the authorisation holder, the competent authorities of other Member States and, where relevant, the Commission.
Pristojni organi, ki so izdali dovoljenja po postopku medsebojnega priznavanja dovoljenj za biocidne proizvode, za katere je bilo dovoljenje preklicano ali spremenjeno, v 120 dneh od uradnega obvestila prekličejo ali spremenijo dovoljenja in ustrezno obvestijo Komisijo.
Competent authorities that have issued authorisations under the mutual recognition procedure for biocidal products for which the authorisation has been cancelled or amended shall, within 120 days of the notification, cancel or amend the authorisations and shall notify the Commission accordingly.
Preklic dovoljenja na zahtevo imetnika dovoljenja
Cancellation of an authorisation at the request of the authorisation holder
Pristojni organ, ki je izdal nacionalno dovoljenje, ali, v primeru dovoljenja Unije, Komisija na podlagi utemeljene zahteve imetnika dovoljenja prekliče dovoljenje.
At the reasoned request of an authorisation holder, the competent authority that granted the national authorisation or, in the case of Union authorisation, the Commission, shall cancel the authorisation.
Če takšna zahteva zadeva dovoljenje Unije, se vloži pri Agenciji.
Where such a request concerns a Union authorisation, it shall be submitted to the Agency.
Sprememba dovoljenja na zahtevo imetnika dovoljenja
Amendment of an authorisation at the request of the authorisation holder
Določila in pogoje za dovoljenje spremeni le pristojni organ, ki je odobril zadevni biocidni proizvod, ali, v primeru dovoljenja Unije, Komisija.
Amendments to the terms and conditions of an authorisation shall be made only by the competent authority that authorised the biocidal product concerned, or in the case of a Union authorisation, by the Commission.