natgillin/translations-raw huggingface dataset:
Pristojni organ prejemnik podaljša nacionalno dovoljenje, če so pogoji iz člena 19 še vedno izpolnjeni.
The receiving competent authority shall renew the national authorisation, provided that the conditions set out in Article 19 are still satisfied.
Ob vložitvi vloge za podaljšanje vlagatelj predloži:
When applying for renewal, the applicant shall submit:
po prvotnem dovoljenju ali predhodnem podaljšanju, kakor je primerno, in
that it has generated since the initial authorisation or, as appropriate, previous renewal; and
svojo oceno o tem, ali so ugotovitve iz prvotne ali predhodne ocene biocidnega proizvoda še naprej veljavne, in ustrezna dokazila.
its assessment of whether the conclusions of the initial or previous assessment of the biocidal product remain valid and any supporting information.
, in vlogo zavrne, če vlagatelj teh pristojbin ne plača v 30 dneh.
and shall reject the application if the applicant fails to pay the fees within 30 days.
, pristojni organ prejemnik sprejme vlogo in vlagatelja ustrezno obvesti o datumu sprejetja.
, the receiving competent authority shall accept the application and inform the applicant accordingly, indicating the date of the acceptance.
Na podlagi ocene razpoložljivih informacij in potrebe po pregledu ugotovitev iz prvotne ocene vloge za dovoljenje ali predhodnega podaljšanja, kakor je primerno, pristojni organ prejemnik v 90 dneh po sprejetju vloge v skladu z odstavkom 4 odloči, ali je glede na sedanja znanstvena spoznanja potrebna popolna ocena vloge za podaljšanje, ob upoštevanju vseh vrst proizvodov, za katere se zahteva 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 authorisation or, as appropriate, the previous renewal, the receiving competent authority shall, within 90 days of accepting an application in accordance with paragraph 4, decide whether, in the light of current scientific knowledge, a full evaluation of the application for renewal is necessary taking account of all product types for which renewal is requested.
Če pristojni organ prejemnik odloči, da je potrebna popolna ocena vloge, odločitev o podaljšanju dovoljenja sprejme po izvedbi ocene vloge v skladu z odstavki 1, 2 in 3 člena 30.
Where the receiving competent authority decides that a full evaluation of the application is necessary, it shall decide on the renewal of the authorisation after carrying out an evaluation of the application in accordance with paragraphs 1, 2 and 3 of Article 30.
Če pristojni organ prejemnik odloči, da popolna ocena vloge ni potrebna, odločitev o podaljšanju dovoljenja sprejme v 180 dneh po sprejetju vloge v skladu z odstavkom 4 tega člena.
Where the receiving competent authority decides that a full evaluation of the application is not necessary, it shall decide on the renewal of the authorisation within 180 days of accepting the application in accordance with paragraph 4 of this Article.
Kadar se zaradi razlogov, na katere imetnik nacionalnega dovoljenja ne more vplivati, odločitev o podaljšanju tega dovoljenja ne sprejme pred njegovim iztekom veljavnosti, pristojni organ prejemnik odobri podaljšanje za obdobje, ki je potrebno za dokončanje ocene.
Where, for reasons beyond the control of the holder of a national authorisation, no decision is taken on the renewal of that authorisation before its expiry, the receiving competent authority shall grant a renewal for the period necessary to complete the evaluation.
POSTOPKI MEDSEBOJNEGA PRIZNAVANJA DOVOLJENJ
MUTUAL RECOGNITION PROCEDURES
Izdaja dovoljenja na podlagi medsebojnega priznavanja dovoljenj
Authorisation through mutual recognition
Vloge za medsebojno priznavanje nacionalnih dovoljenj so vložene v skladu s postopki iz člena 33 (zaporedno medsebojno priznavanje dovoljenj) ali člena 34 (vzporedno medsebojno priznavanje dovoljenj).
Applications for mutual recognition of a national authorisation shall be made in accordance with the procedures set out in Article 33 (mutual recognition in sequence) or Article 34 (mutual recognition in parallel).
Brez poseganja v člen 37 vse države članice, ki prejmejo vloge za medsebojno priznavanje nacionalnega dovoljenja za biocidni proizvod, v skladu s tem poglavjem in ob upoštevanju postopkov iz tega poglavja izdajo dovoljenje za biocidni proizvod pod enakimi določili in pogoji.
Without prejudice to Article 37, all Member States receiving applications for mutual recognition of a national authorisation for a biocidal product shall, in accordance with and subject to the procedures set out in this Chapter, authorise the biocidal product under the same terms and conditions.
Zaporedno medsebojno priznavanje dovoljenj
Mutual recognition in sequence
Vlagatelji, ki želijo v eni ali več državah članicah (v nadaljnjem besedilu: zadevne države članice) zaprositi za zaporedno medsebojno priznanje nacionalnega dovoljenja za biocidni proizvod, za katerega je druga država članica že izdala dovoljenje v skladu s členom 15 (v nadaljnjem besedilu: referenčna država članica), pri pristojnih organih vsake od zadevnih držav članic vložijo vlogo, ki v vsakem primeru vsebuje
Applicants wishing to seek the mutual recognition in sequence in one or more Member States (‘the Member States concerned’) of the national authorisation of a biocidal product already granted in another Member State in accordance with Article 17 (‘the reference Member State’) shall submit an application to each of the competent authorities of the Member States concerned containing, in each case,
prevode nacionalnega dovoljenja, ki ga je izdala referenčna država članica, v takšne uradne jezike zadevne države članice, kot ta to lahko zahteva.▌
a translation of the national authorisation granted by the reference Member State, into such official languages of the Member State concerned as it may require.▌
Pristojni organi zadevnih držav članic vlagatelja obvestijo o pristojbinah, ki se plačujejo na podlagi člena 80, in vlogo zavrnejo, če vlagatelj teh pristojbin ne plača v 30 dneh.
The competent authorities of the Member States concerned shall inform the applicant of the fees payable under Article 80 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, pristojni organ zadevnih držav članic sprejme vlogo in vlagatelja obvesti o datumu sprejetja.
Upon receipt of the fees payable under Article 80, the competent authority of the Member States concerned shall accept the application and inform the applicant indicating the date of acceptance.
Zadevne države članice v 30 dneh po sprejetju iz odstavka 1 validirajo vlogo in vlagatelja ustrezno obvestijo o datumu validacije.
Within 30 days of acceptance referred to in paragraph 1, the Member States concerned shall validate the application and inform the applicant accordingly, indicating the date of the validation.
Zadevne države članice se v 90 dneh po validaciji vloge in ob upoštevanju členov 35, 36 in 37 dogovorijo o povzetku značilnosti biocidnega proizvoda, njihov dogovor pa vnesejo v register biocidnih proizvodov.
Within 90 days of validating the application, 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.
V 30 dneh po
Within 30 days of
doseženem dogovoru
reaching agreement
vsaka zadevna država članica izda dovoljenje za biocidni proizvod v skladu z dogovorjenim povzetkom značilnosti biocidnega proizvoda.
, each of the Member States concerned shall authorise the biocidal product in conformity with the agreed summary of biocidal product characteristics.
Če v 90-dnevnem obdobju iz odstavka 2 ni dosežen dogovor, lahko vsaka zadevna država članica, ki se dogovori o povzetku značilnosti biocidnega proizvoda iz odstavka 2, brez poseganja v člene 35, 36 in 37 v skladu s tem izda dovoljenje za proizvod.
Without prejudice to Articles 35, 36, and 37, if no agreement is reached within the 90 day period referred to in the paragraph 2, each Member State concerned, which agrees to the summary of biocidal product characteristics referred to in paragraph 2, may authorise the product accordingly.
Vzporedno medsebojno priznavanje dovoljenj
Mutual recognition in parallel
Vlagatelji, ki želijo zaprositi za vzporedno medsebojno priznanje biocidnega proizvoda, za katerega v skladu s členom 17 še ni bilo izdano dovoljenje v nobeni državi članici, pri pristojnemu organu države članice, ki jo sami izberejo (v nadaljnjem besedilu: referenčna država članica), vložijo vlogo, ki vsebuje:
Applicants wishing to seek the mutual recognition in parallel of a biocidal product which has not yet been authorised in accordance with Article 17 in any Member State shall submit to the competent authority of the Member State of its choice (‘the reference Member State’) an application containing:
informacije iz člena 20;
the information referred to in Article 20;
seznam vseh drugih držav članic, v katerih želijo pridobiti nacionalno dovoljenje (za namen tega člena: zadevne države članice).
a list of all other Member States where a national authorisation is sought (‘the Member States concerned’).
Referenčna država članica je pristojna za oceno vloge.
The reference Member State shall be responsible for the evaluation of the application.
Vlagatelj ob vložitvi vloge v referenčni državi članici v skladu z odstavkom 1 hkrati pri pristojnih organih vseh zadevnih držav članic vloži vlogo za medsebojno priznanje dovoljenja, za katero je vložil vlogo pri referenčni državi članici.
The applicant shall, at the same time as submitting the application to the reference Member State in accordance with paragraph 1, submit to the competent authorities of each of the Member States concerned an application for mutual recognition of the authorisation for which it has applied to the reference Member State.
imena referenčne države članice in držav članic priznanja;
the names of the reference Member State and of the Member States concerned;
predlog povzetka značilnosti biocidnega proizvoda iz člena 20(1)(a)(ii) v zahtevanih uradnih jezikih zadevnih držav članic, kot te to lahko zahtevajo.
the summary of biocidal product characteristics referred to in Article 20(1)(a)(ii) in such official languages of the Member States concerned as they may require.
Pristojni organi referenčne države članice in zadevnih držav članic vlagatelja obvestijo o pristojbinah, ki se plačujejo v skladu s členom 80, in vlogo zavrnejo, če vlagatelj teh pristojbin ne plača v 30 dneh.
The competent authorities of the reference Member State and of the Member States concerned shall inform the applicant of the fees payable in accordance with Article 80 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, pristojni organi referenčne države članice in zadevnih držav članic sprejmejo vlogo ter vlagatelja ustrezno obvestijo in navedejo datum sprejetja.
Upon receipt of the fees payable under Article 80, the competent authorities of the reference Member State and of the Member States concerned shall accept the application and inform the applicant accordingly indicating the date of acceptance.
Referenčna država članica validira vlogo v skladu s členom 29(2) in (3) ter ustrezno obvesti vlagatelja in zadevne države članice.
The reference Member State shall validate the application in accordance with Article 29(2) and (3) and inform the applicant and the Member States concerned accordingly.
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 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.
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.
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.
Referenčna država članica vnese dogovorjen povzetek značilnosti biocidnega proizvoda in končno poročilo o oceni v register biocidnih proizvodov, skupaj z morebitnimi pogoji glede dostopnosti na trgu ali uporabe biocidnega proizvoda.
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.
doseženem sporazumu
reaching agreement
referenčna država članica in vsaka zadevna država članica izda dovoljenje za biocidni proizvod v skladu z dogovorjenim povzetkom značilnosti biocidnega proizvoda.
, 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.
Če v 90-dnevnem obdobju iz odstavka 5 ni dosežen dogovor, lahko vsaka država članica, ki se dogovori o povzetku značilnosti biocidnega proizvoda iz odstavka 2, brez poseganja v člene 35, 36 in 37 v skladu s tem izda dovoljenje za proizvod.
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, which agrees to the summary of biocidal product characteristics referred to in paragraph 2, may authorise the product accordingly.
Predložitev ugovorov koordinacijski skupini
Referral of objections to the coordination group
Ustanovi se koordinacijska skupina, zadolžena za preučevanje vseh vprašanj, razen zadev iz člena 36, 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.
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 Article 34 meets the conditions for granting an authorisation laid down in Article 19.
Pri delu koordinacijske skupine imajo pravico sodelovati vse države članice in Komisija.
All Member States and the Commission shall be entitled to participate in the work of the coordination group.
Agencija koordinacijski skupini zagotovi sekretariat.
The Agency shall provide the secretariat of the coordination group.
Koordinacijska skupina sprejme svoj poslovnik.
The coordination group shall establish its rules of procedure.
meni, da biocidni proizvod, ki ga
any of the Member States concerned considers that a biocidal product
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.
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.
Sporne točke se nemudoma predložijo koordinacijski skupini.
The points of disagreement shall be referred without delay to the coordination group.
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.
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.
Vlagatelju dajo možnost, da izrazi svoje stališče.
They shall allow the applicant the opportunity to make its point of view known.
Če dosežejo dogovor v 60 dneh po predložitvi spornih točk iz odstavka 2 tega člena, referenčna država članica to vnese v register biocidnih proizvodov.
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.
Postopek se nato šteje za končanega ter referenčna država članica in vsaka zadevna država članica izda dovoljenje v skladu s členom 33(4) ali 34(6), kot je to ustrezno.
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 34(6) as appropriate.
Predložitev nerešenih ugovorov Komisiji
Referral of unresolved objections to the Commission
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.
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.
Izvod tega opisa se pošlje zadevnim državam članicam, vlagatelju in po potrebi imetniku dovoljenja.
A copy of that statement shall be forwarded to the Member States concerned, the applicant and, where applicable, the authorisation holder.
Komisija lahko zaprosi Agencijo za mnenje o znanstvenih ali tehničnih vprašanjih, ki so jih zastavile države članice.
The Commission may ask the Agency for an opinion on scientific or technical questions raised by Member States.
Če Komisija Agencije ne zaprosi za mnenje, da vlagatelju in po potrebi imetniku dovoljenja možnost, da v 30 dneh pisno predloži pripombe.
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.
Komisija z izvedbenimi akti sprejme sklep o predloženi zadevi.
The Commission shall adopt, by means of implementing acts, a decision on the matter referred to it.
Sklep iz odstavka 3 se naslovi na vse države članice ter pošlje v vednost vlagatelju in po potrebi imetniku dovoljenja.
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.
Zadevne države članice in referenčna država članica v 30 dneh po obvestilu o odločitvi po potrebi bodisi izdajo, zavrnejo izdajo ali prekličejo dovoljenje bodisi spremenijo določila in pogoje, da bi tako upoštevale sklep.
The Member States concerned and the reference Member State shall, within 30 days of notification of the decision, either grant, refuse to grant or revoke the authorisation, or vary its terms and conditions as necessary to comply with the decision.
Odstopanje od medsebojnega priznavanja dovoljenj
Derogations from mutual recognition
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:
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:
varstvo okolja;
the protection of the environment;
javni red in javna varnost;
public policy or public security;
varovanje zdravja in življenja ljudi,
the protection of health and life of humans,
zlasti ranljivih skupin, ali
particularly of vulnerable groups, or of
živali ali rastlin;
animals or plants;
varstvo nacionalnega bogastva umetniške, zgodovinske ali arheološke vrednosti; ali
the protection of national treasures possessing artistic, historic or archaeological value; or
ciljni organizmi niso prisotni v škodljivih količinah.
the target organisms not being present in harmful quantities.
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.
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.
lahko zaprosi Agencijo za mnenje o znanstvenih in tehničnih vprašanjih, ki jih je zastavil vlagatelj ali zadevna država članica;
may ask the Agency for an opinion on scientific or technical questions raised by the applicant or the Member State concerned;
sprejme sklep o odstopanju v skladu s postopkom pregleda iz člena 82(3).
shall adopt a decision on the derogation in accordance with the examination procedure referred to in Article 82(3).
Če Komisija v skladu z odstavkom 2 ne sprejme odločitve v roku 90 dni od datuma, ko je bila obveščena v skladu z drugim pododstavkom odstavka 2, lahko zadevna država članica izvaja predlagano odstopanje iz odstavka 1.
If the Commission has not adopted a decision pursuant to paragraph 2 within 90 days of having been informed in accordance with the second sub-paragraph of paragraph 2, the Member State concerned may implement the derogation proposed pursuant to paragraph 1.
V času trajanja tega postopka se obveznost države članice, da biocidni proizvod odobri v dveh letih od dneva odobritve iz člena 89(3), začasno prekine.
While this procedure is ongoing, the Member States' obligation to authorise a biocidal product within two years of the date of approval, referred to in Article 89 paragraph 3, shall be temporarily suspended.
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.
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.
Države članice nemudoma obvestijo druge države članice in Komisijo o vsakem takem sklepu in o njegovi utemeljitvi.
Member States shall without delay inform other Member States and the Commission of any decision taken in this respect and its justification.
Agencija na zahtevo Komisije v skladu s členom 36(2) ali 37(2) izda mnenje v 120 dneh od datuma, ko ji je bila zadeva predložena.
If so requested by the Commission pursuant to Article 36(2) or 37(2), the Agency shall issue an opinion within 120 days from the date on which the matter in question was referred to it.
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.
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.
Agencija lahko začasno prekine rok iz odstavka 1, da vlagatelju ali imetniku dovoljenja omogoči pripravo obrazložitev.
The Agency may suspend the time limit referred to in paragraph 1 to allow the applicant or the authorisation holder to prepare the explanations.
Vloga za medsebojno priznavanje dovoljenj, ki jo vložijo uradni ali znanstveni organi
Application for mutual recognition by official or scientific bodies