natgillin/translations-raw huggingface dataset:
Od leta 2017 se dovoljenje Unije lahko izda za vse kategorije biocidnih pripravkov, razen za tiste, ki vsebujejo aktivne snovi iz člena 5
From 2017, the Union authorisation may be granted to all categories of biocidal products with the exception of biocidal products that contain active substances that fall under Article 5
Oseba, ki je odgovorna za dajanje biocidnih pripravkov v promet, ali njen zastopnik vloži pri agenciji vlogo za dovoljenje Unije in obvesti agencijo o imenu pristojnega organa države članice, ki ga sam izbere in ki je odgovoren za oceno vloge (v nadaljnjem besedilu: ocenjevalni pristojni organ).
The person responsible for the placing of a biocidal product on the market, or his representative, shall submit an application for a Union authorisation to the Agency and inform the Agency of the name of the competent authority of the Member State of his choice which shall be responsible for the evaluation of the application (hereinafter the ‘evaluating competent authority’).
Agencija v enem mesecu po prejemu vloge uradno obvesti ocenjevalni pristojni organ, da je vloga na voljo v zbirki podatkov agencije.
The Agency shall, within one month after receipt of the application, notify the evaluating competent authority that the application is available in the Agency database.
Agencija v dveh mesecih po prejemu vloge preveri, če vloga izpolnjuje naslednje zahteve:
Within two months after receipt of an application, the Agency shall validate the application if it complies with the following requirements:
da so bili predloženi dokumentiiz člena 18;
the documents referred to in Article 18 has been submitted;
Če agencija meni, da vloga ni popolna, predlagatelja obvesti, katere dodatne informacije so potrebne za validacijo vloge ter določi razumen rok za predložitev navedenih informacij.
If the Agency considers that the application is incomplete, it shall inform the applicant what additional information is required for the validation of the application and shall set a reasonable time limit for the submission of that information.
Če predlagatelj vloge ne dopolni v roku, agencija zavrne vlogo in o tem obvesti predlagatelja in pristojni ocenjevalni organ.
The Agency shall reject the application if the applicant fails to complete the application within the deadline and shall inform the applicant and the evaluating competent authority thereof.
Na podlagi člena 68 se lahko proti odločitvam agencije na podlagi tretjega pododstavka odstavka 3 tega člena vloži pritožba.
An appeal may be brought, in accordance with Article 68, against Agency decisions under the third subparagraph of paragraph 3 of this Article.
Če agencija na podlagi validacije, opravljene v skladu z odstavkom 2, meni, da je vloga popolna, o tem nemudoma obvesti predlagatelja in ocenjevalni pristojni organ.
If the Agency considers, on the basis of the validation made pursuant to paragraph 2, that the application is complete, it shall without delay inform the applicant and the evaluating competent authority thereof.
Ocenjevalni pristojni organ v dvanajstih mesecih po validaciji oceni dokumentacijo v skladu s členom 16, vključno z vsemi predlogi za prilagoditev zahtevanih podatkov, ki so bili predloženi v skladu s členom 19(2), če je to primerno.
The evaluating competent authority shall, within twelve months after the validation, evaluate the dossiers in accordance with Article 16 including, where relevant, any proposal to adapt data requirements submitted in accordance with Article 19(2).
Ocenjevalni pristojni organ da predlagatelju možnost, da v enem mesecu v pisni ali ustni obliki predloži opombe v zvezi z ugotovitvami ocene.
The evaluating competent authority shall provide the applicant with an opportunity to provide written or oral comments on the conclusions of the evaluation within one month.
Ocenjevalni pristojni organ pošlje agenciji ugotovitve ocene in poročilo o oceni.
The evaluating competent authority shall send the conclusions of the assessment and the assessment report to the Agency.
Če se pri oceni dokumentacije pokaže, da so potrebne dodatne informacije za izvedbo ocene, ocenjevalni pristojni organ od predlagatelja zahteva, da v določenem roku predloži te informacije in o tem obvesti agencijo.
If, when the dossiers are evaluated, it appears that additional information is necessary to carry out the evaluation, the evaluating competent authority shall ask the applicant to submit such information within a specified time limit, and shall inform the Agency thereof.
Dvanajstmesečno obdobje iz odstavka 1 se prekine od dneva izdaje vloge, pa do dneva prejema informacij.
The twelve-month period referred to in paragraph 1 shall be suspended from the date of issue of the request until the date the information is received.
mesecih od prejema zaključkov ocene agencija pripravi in predloži Komisiji mnenje o dovoljenju za biocidni pripravek.
months from 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 pripravek, 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 točk (b), (c) in (d) člena 16(1) izpolnjeni, ter osnutek povzetka značilnosti biocidnega pripravka v skladu s členom 20(2);
a statement on whether the conditions of points (b), (c) and (d) of Article 16(1) are fulfilled, and a draft summary of the biocidal product characteristics, as referred to in Article 20(2);
podrobnosti vseh pogojev, ki jih je treba uvesti za dajanje v promet ali uporabo biocidnega pripravka, če je to primerno;
where relevant, details of any terms or conditions which should be imposed on the placing on the market or use of the biocidal product;
zaključno poročilo o oceni biocidnega pripravka.
the final assessment report on the biocidal product.
Po prejemu mnenja agencije sprejme Komisija odločitev o dovoljenju Unije za biocidni pripravek v skladu s postopkom iz člena 76(3).
On receipt of the opinion of the Agency, the Commission shall adopt a decision on the Union authorisation of the biocidal product in accordance with the procedure referred to in Article 76(3).
Država članica obvesti Komisijo, če omeji ali prepove
shall notify the Commission where it restricts or prohibits
dovoljenje Unije za biocidni pripravek vrste 15, 17 ali 23 Priloge V ▌na ozemlju
the Union authorisation ▌for a biocidal product of the product-types 15, 17 or 23 of Annex V
zlasti zdravja ranljivih skupin, ali
particularly the health of vulnerable groups,
industrijske in poslovne lastnine.
industrial and commercial property.
Če se država članica
If a Member State decides
odloči, da je treba ▌dovoljenje Unije prilagoditi različnim lokalnim okoliščinam v navedeni državi članici v skladu s členom 29, o tem
that ▌the Union authorisation should be adjusted to the different local circumstances in that Member State in accordance with Article 29
obvesti Komisijo
, it shall inform the Commission thereof
Če se z odločitvijo iz prvega pododstavka odstavka 4 zavrne izdaja dovoljenja Unije za biocidni pripravek, ker ne izpolnjuje meril za biocidni pripravek z manjšim tveganjem v skladu s členom 17, lahko predlagatelj vloži vlogo za dovoljenje Unije v skladu s točko (a) člena 33(1) ali nacionalno dovoljenje v skladu s poglavjem V, če je to primerno.
If the decision referred to in the first subparagraph of paragraph 4 is to refuse to grant a Union authorisation to a biocidal product because it does not fulfil the criteria for a low-risk biocidal product in accordance with Article 17, the applicant may apply, if relevant, for a Union authorisation in accordance with point (a) of Article 33(1) or a national authorisation in accordance with Chapter V.
Pristojni organ, ki je bil uradno obveščen o vlogi za oceno iz člena 34(1), lahko pri Komisiji v enem mesecu od prejema uradnega obvestila vloži ustrezno utemeljeno vlogo za imenovanje drugega ocenjevalnega pristojnega organa.
The competent authority that has been notified of the application for the evaluation as referred to in Article 34(1) may, within one month after receipt of the notification, submit a duly substantiated request to the Commission to appoint another evaluating competent authority.
Komisija sprejme odločitev v skladu s postopkom iz člena 76(2).
The Commission shall take a decision in accordance with the procedure referred to in Article 76(2).
Imetnik dovoljenja ali njegov zastopnik vloži vlogo za obnovitev dovoljenja Skupnosti agenciji najmanj
The authorisation holder or his representative shall submit an application for renewal of a Union authorisation to the Agency at least
pred iztekom dovoljenja.
before the expiry date of the authorisation.
Agencija v enem mesecu po prejemu vloge obvesti ocenjevalni pristojni organ, ki je opravil prvotno oceno vloge za dovoljenje Unije, da je vloga na voljo v zbirki podatkov agencije.
The Agency shall, within one month after receipt of the application, notify the evaluating competent authority that carried out the initial evaluation of the application for Union authorisation that the application is available in the Agency database.
Komisija obnovi dovoljenje Unije, če so pogoji iz člena 16 še vedno izpolnjeni.
The Commission shall renew a Union authorisation, provided that the conditions set out in Article 16 are still satisfied.
Ko zaprosi za obnovitev, predlagatelj predloži seznam vseh podatkov v zvezi z biocidnim pripravkom, ki so bili pridobljeni po prejšnjem dovoljenju, ter utemeljitev, zakaj še veljajo zaključki iz prvotne ocene biocidnega pripravka.
When applying for renewal, the applicant shall submit a list of all data relating to the biocidal product that have been generated since the previous authorisation and a justification as to whether the conclusions of the initial assessment of the biocidal product are still valid.
Ocenjevalni pristojni organ, ki je opravil prvotno oceno, lahko od predlagatelja kadarkoli zahteva, da predloži podatke s seznama.
The evaluating competent authority that carried out the initial evaluation may require the applicant to submit the data referred to in the list at any time.
V dveh mesecih po prejemu vloge agencija validira vlogo, če so izpolnjene naslednje zahteve:
Within two months after receipt of an application, the Agency shall validate the application if it complies with the following requirements:
dokumenti iz odstavka 4 so predloženi;
the documents referred to paragraph 4 has been submitted;
Če agencija meni, da je vloga nepopolna, predlagatelja obvesti, katere dodatne informacije so potrebne za validacijo vloge ter določi razumen rok za predložitev navedenih informacij.
If the Agency considers that the application is incomplete, it shall inform the applicant what additional information is required for the validation of the application and shall set a reasonable time limit for the submission of that information.
Če predlagatelj zahtevanih informacij ne predloži v roku, agencija vlogo zavrne ter o tem obvesti predlagatelja.
The Agency shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant thereof.
Na podlagi člena 68 se lahko proti odločitvam agencije na podlagi tretjega pododstavka odstavka 6 tega člena vloži pritožba.
An appeal may be brought, in accordance with Article 68, against Agency decisions under the third subparagraph of paragraph 6 of this Article.
Če agencija na podlagi validacije, opravljene v skladu z odstavkom 5, meni, da je vloga popolna, o tem nemudoma obvesti predlagatelja in ocenjevalni pristojni organ.
If the Agency, on basis of the validation made pursuant to paragraph 5, considers that the application is complete, it shall without delay inform the applicant and the evaluating competent authority thereof.
Na podlagi razpoložljivih informacij in potrebe po pregledu sklepov prvotne ocene vloge za dovoljenje Unije, ocenjevalni pristojni organ, ki je opravil prvotno oceno vloge za dovoljenje Unije, v enem mesecu po validaciji iz člena 36(5) odloči, ali je potrebna popolna ocena vloge za obnovitev.
On the basis of the available information and a need to review the conclusions of the initial assessment of the application for Union authorisation, the evaluating competent authority that carried out the initial evaluation of the application for Union authorisation shall, within one month after the validation referred to in Article 36(5), decide whether a full evaluation of the application for renewal is necessary.
Če se ocenjevalni pristojni organ odloči, da je potrebna popolna ocena vloge, se ocenjevanje opravi v skladu z odstavki 1 do 3 člena 35.
If 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 to 3 of Article 35.
Odločitev o vlogi se sprejme v skladu z odstavkom 5 tega člena.
The decision on the application shall be adopted in accordance with paragraph 5 of this Article.
Če ocenjevalni pristojni organ, ki je opravil prvotno oceno vloge za dovoljenje Unije odloči, da popolna ocena vloge ni potrebna, v
If the evaluating competent authority that carried out the initial evaluation of the application for Union authorisation decides that a full evaluation of the application is not necessary, it shall, within
po validaciji pripravi in predloži agenciji priporočilo za obnovitev dovoljenja.
after the validation, prepare and submit to the Agency a recommendation on the renewal of the authorisation.
Preden se predložijo priporočila agenciji, da ocenjevalni pristojni organ predlagatelju možnost, da v enem mesecu v pisni ali ustni obliki predloži opombe k priporočilu.
Prior to submitting the recommendation to the Agency, the evaluating competent authority shall provide the applicant with an opportunity to provide written or oral comments on the recommendation within one month.
Ko agencija prejme priporočilo s strani ocenjevalnega pristojnega organa, ga da na voljo pristojnim organom drugih držav članic in predlagatelju ter jim da na voljo tri mesece za predložitev pisnih opomb.
On receipt of the recommendation from the evaluating competent authority, the Agency shall make it available to the competent authorities of other Member States and the applicant and allow a period of three months during which they may submit written comments to it.
Ob koncu obdobja iz odstavka 3 ali ob prejemu mnenja agencije Komisija sprejme odločitev o obnovitvi ali zavrnitvi obnovitve dovoljenja Unije v skladu s postopkom iz člena 76(3).
At the end of the period referred to in paragraph 3 or on receipt of the opinion of the Agency, the Commission shall adopt a decision to renew, or to refuse to renew, the Union authorisation in accordance with the procedure referred to in Article 76(3).
Komisija po sprejemu odločitve nemudoma posodobi informacije iz člena 23(5) v Registru biocidnih pripravkov Unije.
As soon as the Commission has taken a decision, it shall update the information referred to in Article 23(5) in the Union Register of Biocidal Products.
Kadar se zaradi razlogov, na katere imetnik dovoljenja Unije ne more vplivati, odločitev o obnovitvi dovoljenja ne sprejme pred njegovim iztekom, Komisija odobri obnovitev dovoljenja Unije za obdobje, ki je potrebno za zaključitev ocene v skladu s postopkom iz člena 76(2).
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 in accordance with the procedure referred to in Article 76(2).
Če imetnik dovoljenja izve za informacije v zvezi z dovoljenim biocidnim pripravkom ali aktivnimi snovmi, ki jih vsebuje in ki lahko vplivajo na dovoljenje, jih mora nemudoma sporočiti pristojnemu organu, ki je izdal nacionalno dovoljenje, in agenciji ali, v primeru dovoljenja Unije, Komisiji in Agenciji.
If the authorisation holder becomes aware of information concerning the authorised biocidal product or the active substance(s) it contains which may affect the authorisation, he 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.
Zlasti se sporoči naslednje:
In particular, the following shall be notified:
nova spoznanja ali podatki o učinkih aktivne snovi ali biocidnega pripravka na človeka
new knowledge or information on the effects of the active substance or biocidal product for humans
, zlasti na ranljive skupine
, especially for vulnerable groups,
ali okolje;
or the environment;
podatki, ki kažejo na možnost aktivne snovi, da razvije odpornost;
data indicating the potential of the active substance for the development of resistance;
Pristojni organ, ki je izdal nacionalno dovoljenje, ali, v primeru dovoljenja Unije, Agencija preveri, ali je treba dovoljenje v skladu s členom 39 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 39.
Pristojni organ, ki je izdal nacionalno dovoljenje, ali, v primeru dovoljenja Skupnosti, Agencija, nemudoma obvesti pristojne organe drugih držav članic in, kjer je to primerno, Komisijo o vseh takšnih 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 information it received.
Pristojni organi države članice, ki so izdali nacionalna dovoljenja za isti biocidni pripravek po postopku medsebojnega priznavanja, preverijo, ali je treba dovoljenje spremeniti ali preklicati v skladu s členom 39.
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 39.
Pristojni organ države članice ali v primeru dovoljenja Unije, Komisija, lahko kadar koli prekliče ali spremeni dovoljenje, ki ga je izdal, in sicer v naslednjih primerih:
The competent authority of a Member State or, in the case of a Union authorisation, the Commission, may at any time cancel or amend an authorisation it has granted in the following cases:
če niso izpolnjene
where there is failure to comply with
zahteve iz člena 16 ali
the requirements referred to in Article 16
standardi Unije za varstvo zdravja ljudi in okolja, določeni zlasti v Direktivi 2008/56/ES Evropskega parlamenta in Sveta z dne 17. junija 2008 o določitvi okvira za ukrepe Skupnosti na področju politike morskega okolja (Okvirna direktiva o morski strategiji)
or with Union standards for the protection of human health and the environment, particularly those laid down in Directive 2008/56/EC of the European Parliament and of the Council of 17 June 2008 establishing a framework for Community action in the field of marine environmental policy (Marine Strategy Framework Directive)
, Direktivi 2006/118/ES Evropskega parlamenta in Sveta z dne 12. decembra 2006 o varstvu podzemne vode pred onesnaževanjem in poslabšanjem
, Directive 2006/118/EC of the European Parliament and of the Council of 12 December 2006 on the protection of groundwater against pollution and deterioration
, Direktivi 2000/60/ES, Direktivi 98/83/ES in Direktivi 2008/1/ES Evropskega parlamenta in Sveta z dne 15. januarja 2008 o celovitem preprečevanju in nadzorovanju onesnaževanja
, Directive 2000/60/EC, Directive 98/83/EC and Directive 2008/1/EC of the European Parliament and of the Council of 15 January 2008 concerning integrated pollution prevention and control
predložene so bile napačne ali zavajajoče informacije o dejstvih, na podlagi katerih je bilo dovoljenje izdano;
false or misleading information was supplied concerning the facts on the basis of which the authorisation was granted;
pogoj iz dovoljenja ni bil izpolnjen;
a condition included in the authorisation has not been complied with;
Kadar pristojni organ ali v primeru dovoljenja Unije Komisija načrtuje preklic ali spremembo dovoljenja, o tem obvesti imetnika dovoljenja in mu da možnost, da v določenem roku predloži pisne ali ustne opombe 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 him the opportunity to submit written or oral comments or additional information within a specified time limit.
Ocenjevalni pristojni organ te opombe ustrezno upošteva pri zaključevanju svoje odločitve.
The evaluating competent authority shall take due account of these comments when finalising its decision.
Kadar pristojni organ ali, v primeru dovoljenja Unije, Komisija prekliče ali spremeni dovoljenje v skladu z odstavkom 1, o tem nemudoma obvesti imetnika dovoljenja, pristojne organe drugih držav članic in, kjer je to potrebno, 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 za isti biocidni pripravek po postopku medsebojnega priznavanja, v štirih mesecih ustrezno prekličejo ali spremenijo dovoljenja, pri čemer upoštevajo lokalne okoliščine, in o tem obvestijo Komisijo.
Competent authorities which have issued authorisations for the same biocidal product under the mutual recognition procedure shall, within four months, cancel or amend the authorisations accordingly, taking into account local circumstances, and shall notify the Commission thereof.
Ob sprejetju odločitve za preklic ali spremembo dovoljenja pristojni organ ali v primeru pripravka, ki ga odobri Unija, Komisija v Registru biocidnih pripravkov Unije nemudoma posodobi informacije iz člena 23(5) v zvezi z zadevnim biocidnim pripravkom.
As soon as the competent authority or the Commission in the case of a Union authorisation, has taken a decision to cancel or amend an authorisation, it shall update the information referred to in Article 23(5) relating to the biocidal product concerned in the Union Register of Biocidal Products.
Člen 40
Article 40 Cancellation of an authorisation at the request of the authorisation holder
Če takšna zahteva zadeva dovoljenje Unije, se vloži pri Agenciji.
If such a request concerns a Union authorisation, it shall be submitted to the Agency.
Ob sprejetju odločitve za preklic dovoljenja pristojni organ ali, v primeru pripravka, odobrenega na ravni Skupnosti, Komisija v Registru biocidnih pripravkov Unije posodobi informacije iz člena 23(5) v zvezi z zadevnim biocidnim pripravkom.
As soon as the competent authority or the Commission in the case of a Union authorisation, has taken a decision to cancel an authorisation, it shall update the information referred to in Article 23(5) information relating to the biocidal product concerned in the Union Register of Biocidal Products.
Pogoji za dovoljenje se ne spremenijo, razen če dovoljenje spremeni pristojni organ, ki je prej odobril zadevni biocidni pripravek, ali, v primeru dovoljenja Unije, Komisija.
The terms and conditions of an authorisation shall not be changed unless the authorisation has been amended by the competent authority which has previously authorised the biocidal product concerned, or in the case of a Union authorisation, by the Commission.