natgillin/translations-raw huggingface dataset:
Within 365 days of validating an application, the reference Member State shall evaluate the application and draft an assessment report in accordance with Article 30(3) and shall send its assessment report and the summary of biocidal product characteristics to the Member States concerned and to the applicant.
Referenčna država članica v 365 dneh od validacije vloge v skladu z členom 30(3) oceni vlogo in sestavi poročilo o oceni ter ga skupaj s povzetkom značilnosti biocidnega proizvoda pošlje zadevnim državam članicam in vlagatelju.
Within 90 days of receipt of the documents referred to in paragraph 4, and subject to Articles 35, 36 and 37, the Member States concerned shall agree on the summary of biocidal product characteristics, and shall record their agreement in the Register for Biocidal Products.
Zadevne države članice se v 90 dneh po prejemu dokumentov iz odstavka 4 in ob upoštevanju členov 35, 36 in 37 dogovorijo o povzetku značilnosti biocidnega proizvoda, dogovor pa vnesejo v register biocidnih proizvodov.
The reference Member State shall enter the agreed summary of biocidal product characteristics and the final assessment report in the Register for Biocidal Products, together with any agreed terms or conditions imposed on the making available on the market or use of the biocidal product.
Referenčna država članica vnese dogovorjen povzetek značilnosti biocidnega proizvoda in končno poročilo o oceni v register biocidnih proizvodov, skupaj z morebitnimi dogovorjenimi določili ali pogoji glede dostopnosti na trgu ali uporabe biocidnega proizvoda.
Within 30 days of reaching agreement, the reference Member State and each of the Member States concerned shall authorise the biocidal product in conformity with the agreed summary of biocidal product characteristics.
V 30 dneh po doseženem dogovoru referenčna država članica in vsaka zadevna država članica izda dovoljenje za biocidni proizvod v skladu z dogovorjenim povzetkom značilnosti biocidnega proizvoda.
Without prejudice to Articles 35, 36, and 37, if no agreement is reached within the 90-day period referred to in paragraph 5, each Member State that agrees to the summary of biocidal product characteristics referred to in paragraph 5 may authorise the product accordingly.
Če v 90-dnevnem obdobju iz odstavka 5 ni dosežen dogovor, lahko vsaka država članica, ki se strinja s povzetkom značilnosti biocidnega proizvoda iz odstavka 5, brez poseganja v člene 35, 36 in 37 izda dovoljenje za proizvod.
Referral of objections to the coordination group
Predložitev ugovorov koordinacijski skupini
A coordination group shall be set up to examine any question, other than matters referred to in Article 37, relating to whether a biocidal product for which an application for mutual recognition has been made in accordance with Article 33 or 34 meets the conditions for granting an authorisation laid down in Article 19.
Ustanovi se koordinacijska skupina, zadolžena za preučevanje vseh vprašanj, razen zadev iz člena 37, ki so povezana z ugotavljanjem, ali biocidni proizvod, za katerega je bila v skladu s členom 33 ali členom 34 vložena vloga za medsebojno priznavanje, izpolnjuje pogoje za izdajo dovoljenja iz člena 19.
All Member States and the Commission shall be entitled to participate in the work of the coordination group.
Pri delu koordinacijske skupine imajo pravico sodelovati vse države članice in Komisija.
The Agency shall provide the secretariat of the coordination group.
Agencija koordinacijski skupini zagotovi sekretariat.
The coordination group shall establish its rules of procedure.
Koordinacijska skupina sprejme svoj poslovnik.
If any of the Member States concerned considers that a biocidal product assessed by the reference Member State does not meet the conditions laid down in Article 19, it shall send a detailed explanation of the points of disagreement and the reasons for its position to the reference Member State, the other Member States concerned, the applicant, and, where applicable, to the authorisation holder.
Če katera koli od zadevnih držav članic meni, da biocidni proizvod, ki ga oceni referenčna država članica, ne izpolnjuje pogojev iz člena 19, referenčni državi članici, drugim zadevnim državam članicam, vlagatelju in po potrebi imetniku dovoljenja pošlje podrobno obrazložitev spornih točk in razloge za svoje stališče.
The points of disagreement shall be referred without delay to the coordination group.
Sporne točke se nemudoma predložijo koordinacijski skupini.
Within the coordination group, all Member States referred to in paragraph 2 of this Article shall use their best endeavours to reach agreement on the action to be taken.
V koordinacijski skupini si vse države članice iz odstavka 2 tega člena po svojih najboljših močeh prizadevajo za dosego dogovora o ukrepu, ki ga je treba sprejeti.
They shall allow the applicant the opportunity to make its point of view known.
Vlagatelju dajo možnost, da izrazi svoje stališče.
Where they reach agreement within 60 days of the referral of the points of disagreement referred to in paragraph 2 of this Article, the reference Member State shall record the agreement in the Register for Biocidal Products.
Če dosežejo dogovor v 60 dneh po predložitvi spornih točk iz odstavka 2 tega člena, referenčna država članica to vnese v register biocidnih proizvodov.
The procedure shall then be considered to be closed and the reference Member State and each of the Member States concerned shall authorise the biocidal product in accordance with Article 33(4) or Article 34(6) as appropriate.
Postopek se nato šteje za končanega ter referenčna država članica in vsaka zadevna država članica izda dovoljenje v skladu s členom 33(4) ali členom 34(6), kot je to ustrezno.
Referral of unresolved objections to the Commission
Predložitev nerešenih ugovorov Komisiji
If the Member States referred to in Article 35(2) fail to reach agreement within the 60-day period laid down in Article 35(3), the reference Member State shall immediately inform the Commission, and provide it with a detailed statement of the matters on which Member States have been unable to reach agreement and the reasons for their disagreement.
Če države članice iz člena 35(2) ne dosežejo dogovora v 60-dnevnem roku iz člena 35(3), referenčna država članica nemudoma obvesti Komisijo in ji predloži podroben opis zadev, o katerih niso mogle doseči dogovora, ter razloge za njihovo nestrinjanje.
A copy of that statement shall be forwarded to the Member States concerned, the applicant and, where applicable, the authorisation holder.
Izvod tega opisa se pošlje zadevnim državam članicam, vlagatelju in po potrebi imetniku dovoljenja.
The Commission may ask the Agency for an opinion on scientific or technical questions raised by Member States.
Komisija lahko zaprosi Agencijo za mnenje o znanstvenih ali tehničnih vprašanjih, ki so jih zastavile države članice.
Where the Commission does not ask the Agency for an opinion it shall provide the applicant and, where applicable, the authorisation holder with the opportunity to provide written comments within 30 days.
Če Komisija Agencije ne zaprosi za mnenje, da vlagatelju in po potrebi imetniku dovoljenja možnost, da v 30 dneh pisno predloži pripombe.
The Commission shall adopt, by means of implementing acts, a decision on the matter referred to it.
Komisija z izvedbenimi akti sprejme sklep o predloženi zadevi.
The decision referred to in paragraph 3 shall be addressed to all Member States and reported for information to the applicant and, where applicable, the authorisation holder.
Sklep iz odstavka 3 se naslovi na vse države članice ter pošlje v vednost vlagatelju in po potrebi imetniku dovoljenja.
The Member States concerned and the reference Member State shall, within 30 days of notification of the decision, either grant, refuse to grant or cancel the authorisation, or vary its terms and conditions as necessary to comply with the decision.
Zadevne države članice in referenčna država članica v 30 dneh po uradnem obvestilu o odločitvi po potrebi bodisi izdajo, zavrnejo izdajo dovoljenja ali ga prekličejo bodisi spremenijo določila in pogoje, da bi tako upoštevale sklep.
Derogations from mutual recognition
Odstopanja od medsebojnega priznavanja dovoljenj
By way of derogation from Article 32(2), any of the Member States concerned may propose to refuse to grant an authorisation or to adjust the terms and conditions of the authorisation to be granted, provided that such a measure can be justified on grounds of:
Z odstopanjem od člena 32(2) lahko katera koli od zadevnih držav članic predlaga, da se zavrne izdaja dovoljenja ali prilagodijo določila in pogoji za dovoljenje, ki bo izdano, pod pogojem, da je tak ukrep utemeljen z naslednjimi razlogi:
the protection of the environment;
varstvo okolja;
public policy or public security;
javni red in javna varnost;
the protection of health and life of humans, particularly of vulnerable groups, or of animals or plants;
varovanje zdravja in življenja ljudi, zlasti ranljivih skupin, ali živali ali rastlin;
the protection of national treasures possessing artistic, historic or archaeological value; or
varstvo nacionalnega bogastva umetniške, zgodovinske ali arheološke vrednosti ali
the target organisms not being present in harmful quantities.
ciljni organizmi niso prisotni v škodljivih količinah.
Any of the Member States concerned may, in particular, propose in accordance with the first subparagraph to refuse to grant an authorisation or to adjust the terms and conditions of the authorisation to be granted for a biocidal product containing an active substance to which Article 5(2) or Article 10(1) applies.
Katera koli od zadevnih držav članic lahko v skladu s prvim pododstavkom zlasti predlaga, da se zavrne izdaja dovoljenja ali da se prilagodijo določila in pogoji za izdajo dovoljenja za biocidni proizvod, ki vsebuje aktivno snov, za katero se uporablja člen 5(2) ali člen 10(1).
The Member State concerned shall communicate to the applicant a detailed statement of the grounds for seeking a derogation pursuant to paragraph 1 and shall seek to reach an agreement with the applicant on the proposed derogation.
Zadevna država članica vlagatelju pošlje podroben opis razlogov, zaradi katerih je zaprosila za odstopanje na podlagi odstavka 1, in si prizadeva za dosego dogovora z vlagateljem o predlaganem odstopanju.
If the Member State concerned is unable to reach agreement with the applicant or receives no reply from the applicant within 60 days of that communication it shall inform the Commission.
Če zadevna država članica ne more doseči dogovora z vlagateljem ali če v 60 dneh po poslanem sporočilu od vlagatelja ne prejme odgovora, o tem obvesti Komisijo.
In that case, the Commission:
Komisija v tem primeru:
may ask the Agency for an opinion on scientific or technical questions raised by the applicant or the Member State concerned;
lahko zaprosi Agencijo za mnenje o znanstvenih in tehničnih vprašanjih, ki jih je zastavil vlagatelj ali zadevna država članica;
shall adopt a decision on the derogation in accordance with the examination procedure referred to in Article 82(3).
sprejme sklep o odstopanju v skladu s postopkom pregleda iz člena 82(3).
The Commission’s decision shall be addressed to the Member State concerned and the Commission shall inform the applicant thereof.
Komisija svoj sklep naslovi na zadevno državo članico in Komisija o njej obvesti vlagatelja.
The Member State concerned shall take necessary measures to comply with the Commission’s decision within 30 days of its notification.
Zadevna država članica v 30 dneh po uradnem obvestilu o sklepu Komisije sprejme ukrepe, potrebne za upoštevanje tega sklepa.
If the Commission has not adopted a decision pursuant to paragraph 2 within 90 days of being informed in accordance with the second subparagraph of paragraph 2, the Member State concerned may implement the derogation proposed pursuant to paragraph 1.
Če Komisija v skladu z odstavkom 2 ne sprejme sklepa v roku 90 dni od datuma, ko je bila obveščena v skladu z drugim pododstavkom odstavka 2, lahko zadevna država članica izvede predlagano odstopanje v skladu z odstavkom 1.
While the procedure under this Article is ongoing, the Member States’ obligation to authorise a biocidal product within two years of the date of approval, referred to in the first subparagraph of Article 89(3), shall be temporarily suspended.
V času trajanja postopka iz tega člena obveznost države članice, da izda dovoljenje za biocidni proizvod v dveh letih od dneva odobritve iz prvega pododstavka člena 89(3), začasno miruje.
By way of derogation from Article 32(2), a Member State may refuse to grant authorisations for product-types 15, 17 and 20 on grounds of animal welfare.
Z odstopanjem od člena 32(2) lahko država članica iz razlogov varstva dobrega počutja živali zavrne izdajo dovoljenj za proizvode vrste 15, 17 in 20.
Member States shall without delay inform other Member States and the Commission of any decision taken in this respect and its justification.
Države članice nemudoma obvestijo druge države članice in Komisijo o vsakem takem sklepu in o njegovi utemeljitvi.
Opinion of the Agency
Mnenje Agencije
If so requested by the Commission pursuant to Article 36(2) or Article 37(2), the Agency shall issue an opinion within 120 days from the date on which the matter in question was referred to it.
Agencija na zahtevo Komisije v skladu s členom 36(2) ali členom 37(2) izda mnenje v 120 dneh od datuma, ko ji je bila zadeva predložena.
Before issuing its opinion, the Agency shall provide the applicant and, where applicable, the authorisation holder with an opportunity to provide written comments within a specified time limit not exceeding 30 days.
Preden Agencija izda mnenje, da vlagatelju in po potrebi imetniku dovoljenja možnost, da v določenem roku, ki ni daljši od 30 dni, pisno predloži pripombe.
The Agency may suspend the time limit referred to in paragraph 1 to allow the applicant or the authorisation holder to prepare the comments.
Agencija lahko začasno prekine rok iz odstavka 1, da vlagatelju ali imetniku dovoljenja omogoči pripravo pripomb.
Application for mutual recognition by official or scientific bodies
Vloga za medsebojno priznavanje dovoljenj, ki jo vložijo uradni ali znanstveni organi
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.
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.
The applicant shall demonstrate that the use of such a biocidal product is of general interest for that Member State.
Predlagatelj dokaže, da je uporaba takega biocidnega proizvoda v splošnem interesu za navedeno državo članico.
The application shall be accompanied by the fees payable under Article 80.
Ob vložitvi vloge se plačajo tudi pristojbine, ki se plačujejo v skladu s členom 80.
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.
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.
In that case, the body that made the application shall have the same rights and obligations as other authorisation holders.
V tem primeru ima organ, ki je vložil vlogo, enake pravice in dolžnosti kot drugi imetniki dovoljenj.
Supplementary rules and technical guidance notes
Dopolnilna pravila in tehnična navodila
The Commission shall be empowered to adopt delegated acts in accordance with Article 83 laying down supplementary rules for the renewal of authorisations subject to mutual recognition.
Na Komisijo se prenese pooblastilo za sprejetje delegiranih aktov v skladu s členom 83, ki določijo dodatna pravila za podaljšanje dovoljenj, za katera velja medsebojno priznavanje.
The Commission shall also draw up technical guidance notes to facilitate the implementation of this Chapter and, in particular, Articles 37 and 39.
Komisija pripravi tudi tehnična navodila za lažje izvajanje tega poglavja in zlasti členov 37 in 39.
UNION AUTHORISATIONS OF BIOCIDAL PRODUCTS
DOVOLJENJA UNIJE ZA BIOCIDNE PROIZVODE
Granting of Union authorisations
Izdaja dovoljenj Unije
Union authorisation
Dovoljenje Unije
A Union authorisation issued by the Commission in accordance with this Section shall be valid throughout the Union unless otherwise specified.
Dovoljenje Unije, ki ga izda Komisija v skladu s tem oddelkom, je veljavno povsod v Uniji, razen če ni določeno drugače.
It shall confer the same rights and obligations in each Member State as a national authorisation.
Vsaki državi članici podeljuje enake pravice in dolžnosti kot nacionalno dovoljenje.
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.
Vlagatelj lahko za kategorije biocidnih proizvodov iz člena 42(1) namesto vloge za nacionalno dovoljenje in medsebojno priznavanje dovoljenj vloži vlogo za dovoljenje Unije.
Biocidal products for which Union authorisation may be granted
Biocidni proizvodi, za katere se lahko izda dovoljenje Unije
Applicants may apply for Union authorisation for biocidal products which have similar conditions of use across the Union with the exception of biocidal products that contain active substances that fall under Article 5 and those of product-types 14, 15, 17, 20 and 21.
Vlagatelji lahko vložijo vlogo za dovoljenje Unije za biocidne proizvode s podobnimi pogoji uporabe v celotni Uniji, razen biocidnih proizvodov, ki vsebujejo aktivne snovi, ki spadajo v člen 5, in aktivne snovi iz proizvodov vrste 14, 15, 17, 20 in 21.
The Union authorisation may be granted:
Dovoljenje Unije se lahko izda:
from 1 September 2013, to biocidal products containing one or more new active substances and biocidal products of product-types 1, 3, 4, 5, 18 and 19;
od 1. septembra 2013 za biocidne proizvode, ki vsebujejo eno ali več novih aktivnih snovi, in za biocidne proizvode vrste 1, 3, 4, 5, 18 in 19;
from 1 January 2017, to biocidal products of product-types 2, 6 and 13; and
s 1. januarjem 2017 za biocidne proizvode vrste 2, 6 in 13 in
from 1 January 2020, to biocidal products of all remaining product-types.
s 1. januarjem 2020 za biocidne proizvode vseh ostalih vrst.
The Commission shall by 1 September 2013 draw up guidance documents on the definition of ‘similar conditions of use across the Union’.
Komisija do 1. septembra 2013 oblikuje smernice za opredelitev „podobnih pogojev uporabe v celotni Uniji“.
The report shall, if appropriate, be accompanied by relevant proposals for adoption in accordance with the ordinary legislative procedure.
Poročilu se po potrebi priloži ustrezne predloge za sprejetje v skladu z rednim zakonodajnim postopkom.
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.
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.
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.
Agencija vlagatelja obvesti o pristojbinah, ki se plačujejo v skladu s členom 80(1), in vlogo zavrne, če vlagatelj teh pristojbin ne plača v 30 dneh.
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, indicating the date of acceptance.
Po prejemu pristojbin, ki se plačujejo v skladu s členom 80(1), Agencija sprejme vlogo in obvesti vlagatelja in ocenjevalni pristojni organ ter navede datum sprejema.
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.
Ocenjevalni pristojni organ vlogo v 30 dneh po sprejemu vloge s strani Agencije vlogo validira, če so bile predložene ustrezne informacije iz člena 20.
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.
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.
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, indicating the date of the validation.
Ocenjevalni pristojni organ ob validaciji vloge v skladu z odstavkom 3 ali 4 nemudoma obvesti vlagatelja, Agencijo in druge pristojne organe ter navede datum validacije.
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.
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.
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.
Preden ocenjevalni pristojni organ svoje ugotovitve predloži Agenciji, da vlagatelju možnost, da v 30 dneh predloži pisne pripombe k ugotovitvam ocenjevanja.
However, the suspension shall not exceed 180 days in total other than in exceptional cases and where justified by the nature of the information requested.
Vendar prekinitev skupno ne presega 180 dni, razen v izjemnih primerih in če je to upravičeno zaradi narave zahtevanih podatkov.
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.
V 180 dneh od prejema ugotovitev ocenjevanja Agencija pripravi mnenje o dovoljenju za biocidni proizvod in ga predloži Komisiji.