natgillin/translations-raw huggingface dataset:
Šestmesečno obdobje iz odstavka 6 se prekine od dneva izdaje vloge, pa do dneva prejema informacij.
The six-month period referred to in paragraph 6 shall be suspended from the date of the request until the date the information is received.
Kadar se zaradi razlogov, na katere imetnik nacionalnega dovoljenja ne more vplivati, odločitev o obnovitvi nacionalnega dovoljenja ne sprejme pred njegovim potekom, pristojni organ prejemnik odobri obnovitev nacionalnega dovoljenja za obdobje, ki je potrebno za zaključitev ocene.
Where, for reasons beyond the control of the holder of the national authorisation, no decision is taken on the renewal of the national authorisation before its expiry, the receiving competent authority shall grant the renewal of the national authorisation for the period necessary to complete the evaluation.
Ob sprejetju odločitve o obnovitvi nacionalnega dovoljenja pristojni organ, ki je izdal tako odločitev, vnese informacije iz člena 23(5) v Register biocidnih pripravkov Unije.
As soon as the competent authority has taken a decision concerning the renewal of a national authorisation, it shall enter the information referred to in Article 23(5) in the Union Register of Biocidal Products.
Imetnik nacionalnega dovoljenja za biocidni pripravek, ki ga je pristojni organ izdal v skladu s členom 15 (v nadaljnjem besedilu: referenčni pristojni organ), lahko vloži vlogo za nacionalno dovoljenje za biocidni pripravek v drugi državi članici v okviru postopka zaporednega medsebojnega priznavanja.
The holder of a national authorisation for a biocidal product granted by a competent authority in accordance with Article 15 (hereinafter the ‘reference competent authority’) may apply for a national authorisation of the biocidal product in another Member State under the procedure for mutual recognition in sequence.
Vlogi za medsebojno priznavanje je treba priložiti:
The application for mutual recognition shall be accompanied by:
sklic na nacionalno dovoljenje, ki ga je izdal referenčni pristojni organ;
a reference to the national authorisation granted by the reference competent authority;
elektronski povzetek dokumentacije, ki izpolnjuje zahteve iz Priloge III;
an electronic summary of the dossier satisfying the requirements set out in Annex III;
sklic na poročilo referenčnega pristojnega organa, v katerem so povzete ugotovitve ocene in razlogi za izdajo dovoljenja za biocidni pripravek.
a reference to the report of the reference competent authority summarising the conclusions of its assessment and the reasons for authorising the biocidal product.
Pristojni organ prejemnik lahko zahteva prevod nacionalnega dovoljenja in vloge v enega ali več uradnih jezikov države članice, kjer ima ta pristojni organ svoj sedež.
The receiving competent authority may require a translation of the national authorisation and application into one ▌of the official languages of the Member State where that competent authority is situated.
Vloge za nacionalno dovoljenje, ki vključujejo postopek vzajemnega priznavanja, vključno z dokumenti iz člena 18, je mogoče vložiti pri pristojnem organu v angleščini.
Applications for a national authorisation which involve a mutual recognition procedure, including the documents referred to in Article 18, may be submitted to the competent authority in English.
Pristojni organ prejemnik o vlogi odloča v štirih mesecih od prejema vloge.
The receiving competent authority shall decide on the application within four months of receipt of the application.
Pristojni organ prejemnik izda dovoljenje za zadevni biocidni pripravek pod enakimi pogoji kot referenčni pristojni organ
The receiving competent authority shall authorise the biocidal product concerned under the same conditions as the reference competent authority
, razen če je odstopanje utemeljeno s posebnimi nacionalnimi okoliščinami v skladu s členom 29
, unless specific national circumstances justify a deviation according to Article 29
Komisija sprejme ukrepe z delegiranimi akti v skladu s členom 73 in pod pogoji iz členov 74 in 75, pri čemer navede merila in postopke za dodeljevanje enotne številke dovoljenja iz odstavka 5.
The Commission shall adopt, by means of delegated acts in accordance with Article 73 and subject to the conditions of Articles 74 and 75, measures specifying the criteria and procedures for assigning the single authorisation number referred to in paragraph 5.
Vloga za medsebojno priznavanje, ki jo vložijo organi za zatiranje škodljivcev
Article 26 Application for mutual recognition by pest control bodies
Če ni bila v državi članici vložena nobena vloga za nacionalno dovoljenje za biocidni pripravek, za katerega je že izdano dovoljenje v drugi državi članici, lahko uradni ali znanstveni organi, vključeni v dejavnosti zatiranja škodljivcev, ali strokovne organizacije ob soglasju imetnika dovoljenja v drugi državi članici zahtevajo nacionalno dovoljenje za enak biocidni pripravek, enako uporabo in pod enakimi pogoji za uporabo v navedeni državi članici po postopku medsebojnega priznavanja iz člena 25.
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 professional organisations may apply, with the consent of the authorisation holder in another Member State, for a national authorisation for the same biocidal product, the same use and under the same conditions for use in that Member State under the mutual recognition procedure provided for in Article 25.
Predlagatelj dokaže, da je uporaba takega biocidnega pripravka 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.
Ne glede na odstavek 1 lahko predlagatelj, če imetnik dovoljenja ne soglaša, to navede v vlogi in pristojni organ zadevne države članice lahko sprejme vlogo na podlagi javnega interesa.
By way of derogation from paragraph 1, where the authorisation holder does not give his consent, the applicant may indicate that in the application and the competent authority of the Member State concerned may accept the application on grounds of public interest.
Če pristojni organ zadevne države članice meni, da biocidni pripravek izpolnjuje pogoje iz člena 16 in je v skladu s pogoji iz tega člena, pristojni organ izda dovoljenje za dajanje biocidnega pripravka v promet.
If the competent authority of the Member State concerned considers that the biocidal product fulfils the conditions referred to in Article 16 and the conditions under this Article are complied with, the competent authority shall authorise the placing of the biocidal product on the market.
Uradni ali znanstveni organi, vključeni v dejavnosti zatiranja škodljivcev, ali strokovne organizacije morajo imeti pravice in dolžnosti imetnika dovoljenja.
The official or scientific bodies involved in pest control activities or professional organisations shall have the rights and obligations of the authorisation holder.
Če pristojni organ v štirih mesecih po vlogi za medsebojno priznavanje meni, da biocidni pripravek, za katerega je bilo izdano dovoljenje v drugi državi članici, ne izpolnjuje zahtev iz člena 16, mora nemudoma uradno obvestiti Komisijo, pristojne organe v drugih državah članicah in predlagatelja, ter jim predložiti obrazložitveni dokument, ki opredeljuje biocidni pripravek in njegove specifikacije ter določa razloge, zaradi katerih predlaga zavrnitev priznanja ali omejitev nacionalnega dovoljenja.
Where, within four months of receipt of the application for mutual recognition, the competent authority considers that a biocidal product, which has been authorised in another Member State, does not satisfy the requirements of Article 16, it shall without delay notify the Commission, the competent authorities of the other Member States and the applicant thereof, and shall provide them with an explanatory document identifying the biocidal product and its specifications and setting out the grounds on which it proposes to refuse to recognise or to restrict the national authorisation.
po posvetovanju s predlagateljem
, after consultation with the applicant,
sprejme odločitev, ali razlogi, ki jih je navedel pristojni organ, upravičujejo zavrnitev priznanja ali omejitev nacionalnega dovoljenja v skladu s postopkom iz člena 76(3).
adopt a decision on whether the grounds set out by the competent authority justify refusal to recognise, or restriction of, the national authorisation in accordance with the procedure referred to in Article 76(3).
Komisija pripravi predlog sklepa v treh mesecih od prejetja obvestila.
Within three months of receipt of the notification, the Commission shall make a proposal for a decision.
Če odločitev Komisije potrdi navedene razloge za zavrnitev ali omejitev poznejšega dovoljenja, pristojni organ, ki je predhodno izdal dovoljenje za biocidni pripravek, nemudoma preveri svoje nacionalno dovoljenje, da bo v skladu z navedeno odločitvijo.
If the Commission decision confirms the grounds presented for refusing or restricting the subsequent authorisation, the competent authority that had previously authorised the biocidal product shall without delay review its national authorisation to comply with that decision.
Če želi predlagatelj dobiti nacionalna dovoljenja za biocidni pripravek hkrati v več kot eni državi članici, vloži pri referenčnem pristojnem organu, ki ga sam izbere, vlogo, ki vsebuje:
If the applicant seeks to receive national authorisations for a biocidal product in more than one Member State in parallel, he shall submit to a reference competent authority of his choice an application containing:
dokumente iz člena 18;
the documents referred to in Article 18;
seznam vseh drugih držav članic, v katerih želi pridobiti nacionalno dovoljenje (v nadaljnjem besedilu: druge zadevne države članice).
a list of all other Member States where a national authorisation is sought (hereinafter the ‘other Member States concerned’).
Referenčni pristojni organ je odgovoren za oceno vloge.
The reference competent authority shall be responsible for the evaluation of the application.
Predlagatelj vloži pri pristojnih organih drugih zadevnih držav članic vlogo za medsebojno priznavanje dovoljenja, za katero je vložil vlogo pri referenčnem pristojnem organu.
The applicant shall submit to the competent authorities of the other Member States concerned an application for mutual recognition of the authorisation for which it has applied to the reference competent authority.
Ta vloga vsebuje:
This application shall contain:
elektronski povzetek dokumentacije v skladu s Prilogo III;
an electronic summary of the dossier as required in Annex III;
imena referenčnega pristojnega organa in drugih zadevnih držav članic.
the names of the reference competent authority and of the other Member States concerned.
Referenčni pristojni organ v enem mesecu po prejemu vloge iz odstavka 1 preveri, ali je vloga v skladu z naslednjimi zahtevami:
The reference competent authority shall, within one month after receipt of an application referred to in paragraph 1, validate the application if it complies with the following requirements:
da so bile predložene informacije iz odstavka 1;
the information referred to in paragraph 1 has been submitted;
Če referenčni pristojni organ 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 reference competent authority 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.
Referenčni pristojni organ obvesti tudi druge zadevne države članice.
The reference competent authority shall also inform the other Member States concerned.
Referenčni pristojni organ v enem mesecu po prejemu dodatnih informacij določi, ali predložene dodatne informacije zadostujejo za validacijo vloge.
The reference competent authority shall, within one month after receipt of the additional information, determine whether the additional information submitted is sufficient to validate the application.
Če predlagatelj zahtevanih informacij ne predloži v roku, referenčni pristojni organ zavrne vlogo in o tem obvesti predlagatelja ter druge zadevne države članice.
The reference competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant and the other Member States concerned thereof.
Če referenčni pristojni organ na podlagi validacije, opravljene v skladu z odstavkom 3, meni, da je vloga popolna, o tem nemudoma obvesti predlagatelja in druge zadevne države članice.
If the reference competent authority considers, on the basis of the validation made pursuant to paragraph 3, that the application is complete, it shall without delay inform the applicant and the other Member States concerned.
Referenčni pristojni organ v dvanajstih mesecih po prejemu veljavne vloge oceni informacije iz odstavka 1 in pripravi poročilo, ki povzema ugotovitve njegove ocene in osnutek povzetka značilnosti biocidnega pripravka ter pošlje poročilo in osnutek povzetka pristojnim organom drugih zadevnih držav članic in predlagatelju.
The reference competent authority shall evaluate the information referred to in paragraph 1 and prepare a report summarising the conclusions of its assessment and a draft of the summary of the biocidal product characteristics within 12 months from the receipt of a valid application and shall communicate the report and the draft summary to the competent authorities of other Member States concerned and the applicant.
Referenčni pristojni organ pošlje osnutek poročila o oceni predlagatelju, ki mora imeti priložnost, da v enem mesecu v pisni ali ustni obliki predloži opombe.
The reference competent authority shall send the draft assessment report to the applicant who shall be provided with the opportunity to submit oral or written comments within one month.
Referenčni pristojni organ te opombe ustrezno upošteva pri zaključevanju svoje ocene.
The reference competent authority shall take due account of these comments when finalising its assessment.
V štirih mesecih po prejemu dokumentov iz odstavka 6 pristojni organi drugih zadevnih držav članic odobrijo poročilo o oceni in povzetek značilnosti pripravka ter o tem obvestijo referenčni pristojni organ.
Within four months after receipt of the documents referred to in paragraph 6, the competent authorities of other Member States concerned shall approve the assessment report and the summary of the product characteristics, and shall inform the reference competent authority accordingly.
Referenčni pristojni organ in pristojni organi drugih zadevnih držav članic v enem mesecu po izteku obdobja iz odstavka 7 izdajo dovoljenje za biocidni pripravek na podlagi odobrenega poročila o oceni in povzetka značilnosti biocidnega pripravka.
The reference competent authority and the competent authorities of the other Member States concerned shall authorise the biocidal product on the basis of the approved assessment report and the summary of the biocidal product characteristics within one month after the end of the period referred to in paragraph 7.
Komisija sprejme ukrepe z delegiranimi akti v skladu s členom 73 in pod pogoji iz členov 74 in 75, pri čemer navede merila in postopke za dodeljevanje enotne številke dovoljenja.
The Commission shall adopt, by means of delegated acts in accordance with Article 73 and subject to the conditions of Articles 74 and 75, measures specifying the criteria and procedures for assigning the single authorisation number.
Če eden ali več pristojnih organov drugih zadevnih držav članic v štirih mesecih po prejemu dokumentov iz odstavka 6 ni odobril poročila o oceni in povzetka značilnosti biocidnega pripravka, o tem uradno obvesti Komisijo, predlagatelja, referenčni pristojni organ in pristojne organe drugih zadevnih držav članic ter jim predloži obrazložitveni dokument, ki opredeljuje biocidni pripravek in njegove specifikacije ter določa razloge, zaradi katerih predlagajo zavrnitev priznanja ali omejitev nacionalnega dovoljenja.
If one or more competent authorities of other Member States concerned have not approved the assessment report and the summary of the biocidal product characteristics within four months after receipt of the documents referred to in paragraph 6, they shall notify the Commission, the applicant, the reference competent authority and the competent authorities of other Member States concerned and shall provide them with an explanatory document identifying the biocidal product and its specifications and setting out the grounds on which they propose to refuse to recognise, or to restrict, the national authorisation.
po predhodnem posvetovanju s predlagateljem
, following consultation of the applicant,
Ta odločitev se sprejme v treh mesecih od sporočila pristojnega organa iz prvega pododstavka.
This decision shall be taken within three months of the notification by the competent authority referred to in the first subparagraph.
razloge ▌za zavrnitev ali omejitev
the grounds presented for refusing or restricting the
dovoljenja, pristojni organ, ki
authorisation, the competent authority that
je predhodno izdal
shall without delay
, nemudoma preveri svoje nacionalno dovoljenje, da bo v skladu z navedeno odločitvijo
to comply with that decision
Ob sprejetju odločitev o vlogi za hkratno nacionalno dovoljenje v več kot eni državi članici vnesejo pristojni organi držav članic, ki so sprejele odločitev, informacije iz člena 23(5) v Register biocidnih pripravkov Unije, če je to primerno.
As soon as the competent authorities have taken a decision on an application for a national authorisation in more than one Member State in parallel, they shall enter information referred to in Article 23(5), where applicable, in the Union Register of Biocidal Products.
Pristojni organ, ki je prejel vlogo za medsebojno priznavanje v skladu s členom 25 ali 28, lahko v dveh mesecih po prejemu vloge predlagatelju predlaga, da se nekateri pogoji iz točk
The competent authority that has received an application for mutual recognition in accordance with Articles 25 or 28 may, within two months from the receipt of the application, propose to the applicant that certain conditions referred to in points
in (n) člena 58(2) v dovoljenju prilagodijo lokalnim okoliščinam, da bodo tako izpolnjeni pogoji za izdajo dovoljenja iz člena 16, ter o tem obvesti Komisijo, če ugotovi, da je na njegovem ozemlju izpolnjen eden izmed naslednjih pogojev:
and (n) of Article 58(2) in the authorisation be adjusted to local circumstances, so that conditions for issue of an authorisation laid down in Article 16 are satisfied, and shall inform the Commission thereof, if it establishes that, in its territory, one of the following conditions is met:
ciljna vrsta ni prisotna v škodljivih količinah;
the target species is not present in harmful quantities;
je dokazana nesprejemljiva toleranca ali odpornost ciljnega organizma na biocidni pripravek;
unacceptable tolerance or resistance of the target organism to the biocidal product is demonstrated;
Pristojni organi sporočijo Komisiji vse predloge v zvezi s prilagoditvijo pogojev za nacionalna dovoljenja lokalnim okoliščinam ter razloge za predlaganje prilagoditve.
The competent authorities shall communicate to the Commission all proposals concerning adjustment of conditions in national authorisations to local circumstances and the reasons for proposing adjustment.
Ob upoštevanju prava Unije je mogoče uvesti ustrezne pogoje v skladu z zahtevami iz člena 15 ter druge ukrepe za zmanjšanje tveganja, ki izhajajo iz posebnih pogojev uporabe.
Subject to Union law, appropriate conditions may be imposed with respect to the requirements referred to in Article 15 and other risk-mitigation measures deriving from specific conditions of use.
Če v dveh mesecih ni dosežen sporazum o predlaganih prilagoditvah med predlagateljem in pristojnim organom, ki je prejel vlogo za medsebojno priznanje, pristojni organ o tem nemudoma obvesti Komisijo in predloži obrazložitveni dokument o predlaganih prilagoditvah, ki opredeljuje biocidni pripravek in njegove specifikacije ter določa razloge, zaradi katerih predlaga prilagoditev pogojev za nacionalno dovoljenje.
If, within 2 months, an agreement on the proposed adjustments is not reached between the applicant and the competent authority that has received an application for mutual recognition, that competent authority shall without delay inform the Commission thereof and provide an explanatory document on the proposed adjustments identifying the biocidal product and its specifications and setting out the grounds on which it proposes to adjust the conditions of the national authorisation.
Komisija lahko zaprosi agencijo za mnenje o znanstvenih ali tehničnih vprašanjih, ki jih postavi država članica, ki ugovarja medsebojnemu priznanju nacionalnega dovoljenja ali želi prilagoditi dovoljenje lokalnim okoliščinam.
The Commission may ask the Agency for an opinion on scientific or technical matters raised by a Member State objecting to the mutual recognition of a national authorisation or seeking to adjust the authorisation to local circumstances.
Agencija izda mnenje v šestih mesecih od datuma, ko je prejela vprašanje.
The Agency shall issue an opinion within six months from the date on which the matter was referred to it.
Preden agencija izda svoje mnenje, da predlagatelju ali imetniku dovoljenja možnost, da v določenem roku, ki ne presega enega meseca, predloži pisno ali ustno obrazložitev.
Before issuing its opinion, the Agency shall provide the applicant or the authorisation holder with an opportunity to present written or oral explanations within a specified time limit not exceeding one month.
Agencija lahko začasno prekine rok iz odstavka 1, da predlagatelju 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.
aktivnimi snovmi ali
active substances or
člene 25–29
Articles 25 to 29
lahko pristojni organi držav članic zavrnejo medsebojno priznavanje nacionalnih dovoljenj, izdanih za
, competent authorities of Member States may refuse mutual recognition of national authorisations granted for
biocidne pripravke, ki vsebujejo aktivne snovi iz členov 5 in 9, ter za
biocidal products containing active substances referred to in Articles 5 and 9 and for
pripravke vrst 15, 17 in 23 Priloge V, če se take zavrnitve lahko upravičijo z zaščito zdravja ljudi,
product types 15, 17 and 23 of Annex V, provided that such a refusal can be justified on grounds of the protection of health of humans,
zlasti zdravja ranljivih skupin, z zaščito zdravja
particularly the health of vulnerable groups, the protection of the health of
živali ali rastlin, varstvom
animals or plants, the protection of
nacionalnega bogastva umetniške, zgodovinske ali arheološke vrednosti ali varstvom industrijske in poslovne lastnine.
national treasures possessing artistic, historic or archaeological value, or the protection of industrial and commercial property.
To dovoljenje podeljuje enake pravice in dolžnosti vsaki državi članici kot dovoljenje, ki ga je izdal pristojni organ navedene države članice.
It shall confer the same rights and obligations in each of the Member States as an authorisation issued by the competent authority of that Member State.
Od leta 2013
From 2013,
se dovoljenje Unije lahko izda za naslednje kategorije biocidnih pripravkov:
the Union authorisation may be granted to the following categories of biocidal products:
biocidne pripravke, ki vsebujejo eno ali več novih aktivnih snovi;
biocidal products containing one or more new active substances;
biocidne pripravke z manjšim tveganjem.
low-risk biocidal products.