natgillin/translations-raw huggingface dataset:
all relevant supporting documents to demonstrate that the proposed change would not adversely affect the conclusions previously reached concerning the compliance with the conditions set out in Article 19 or 25 of Regulation (EU) No 528/2012;
Vso relevantno gradivo, ki dokazuje, da predlagana sprememba ne bi negativno vplivala na predhodne ugotovitve glede skladnosti s pogoji iz člena 19 ali 25 Uredbe (EU) št. 528/2012.
where relevant, the opinion issued by the Agency in accordance with Article 3 of this Regulation.
Po potrebi mnenje, ki ga izda Agencija v skladu s členom 3 te uredbe.
CHANGES OF PRODUCTS AUTHORISED BY MEMBER STATES
SPREMEMBE PROIZVODOV, KI JIH ODOBRIJO DRŽAVE ČLANICE
Notification procedure for administrative changes of products
Postopek obveščanja za upravne spremembe proizvodov
The authorisation holder, or its representative, shall submit simultaneously to all Member States concerned a notification complying with Article 5 and, in each of those Member States, pay the fee payable in accordance with Article 80(2) of Regulation (EU) No 528/2012.
Imetnik dovoljenja ali njegov zastopnik vsem zadevnim državam članicam hkrati predloži obvestilo, ki je v skladu s členom 5, in vsaki od teh držav članic plača pristojbino, ki se plača na podlagi člena 80(2) Uredbe (EU) št. 528/2012.
Without prejudice to the second subparagraph, the notification shall be submitted within 12 months following the implementation of the change.
Brez poseganja v drugi pododstavek se obvestilo predloži v dvanajstih mesecih po začetku izvajanja spremembe.
In case of a change referred to in Section 1 of Title 1 of the Annex to this Regulation, the notification shall be submitted before the implementation of the change.
V primeru spremembe iz oddelka 1 naslova 1 Priloge k tej uredbi se obvestilo predloži pred začetkom izvajanja spremembe.
Within 30 days following receipt of the notification, where one of the Member States concerned disagrees with the change or the relevant fee has not been paid, that Member State shall inform the authorisation holder, or its representative, and the other Member States concerned that the change is rejected and the grounds for the rejection.
Kadar se ena od zadevnih držav članic ne strinja s spremembo ali kadar ustrezna pristojbina ni bila plačana, ta država članica imetnika dovoljenja ali njegovega zastopnika in druge zadevne države članice v 30 dneh po prejemu obvestila obvesti, da je sprememba zavrnjena, in navede razloge za zavrnitev.
If, within 30 days following receipt of the notification, a Member State concerned has not expressed its disagreement, that Member State shall be deemed to have agreed with the change.
Če zadevna država članica v 30 dneh po prejemu obvestila ne izrazi nestrinjanja, se šteje, da se strinja s spremembo.
Each of the Member States concerned which has not rejected the change in accordance with paragraph 3 shall, where relevant, amend the authorisation of the biocidal product in conformity with the agreed change.
Vsaka od zadevnih držav članic, ki ni zavrnila spremembe v skladu z odstavkom 3, po potrebi spremeni dovoljenje za biocidni proizvod v skladu z dogovorjeno spremembo.
Procedure for minor changes of products
Postopek za manjše spremembe proizvodov
The authorisation holder, or its representative, shall submit simultaneously to all Member States concerned an application complying with Article 5.
Imetnik dovoljenja ali njegov zastopnik vsem zadevnim državam članicam hkrati predloži vlogo, ki je v skladu s členom 5.
Each Member State concerned shall inform the applicant of the fee payable in accordance with Article 80(2) of Regulation (EU) No 528/2012.
Vsaka od zadevnih držav članic vlagatelja obvesti o pristojbini, ki se plača na podlagi člena 80(2) Uredbe (EU) št. 528/2012.
If the applicant fails to pay the fee within 30 days, the Member State concerned shall reject the application and inform the applicant and the other Member States concerned accordingly.
Če je vlagatelj ne plača v 30 dneh, zadevna država članica vlogo zavrne ter o tem obvesti vlagatelja in druge zadevne države članice.
Upon receipt of the fee, the Member State concerned shall accept the application and inform the applicant accordingly indicating the date of acceptance.
Zadevna država članica ob prejemu pristojbine sprejme vlogo in o tem obvesti vlagatelja, pri čemer navede datuma sprejetja.
The reference Member State shall validate the application within 30 days of its acceptance, if it complies with the requirements laid down in Article 5 and inform the applicant and the Member States concerned accordingly.
Referenčna država članica vlogo validira v 30 dneh po njenem sprejetju, če izpolnjuje zahteve iz člena 5, in o tem obvesti vlagatelja in zadevne države članice.
In the context of the validation referred to in the first subparagraph, the reference Member State shall not make an assessment of the quality or the adequacy of the data or justifications submitted.
Referenčna država članica v okviru validacije iz prvega pododstavka ne opravi ocene kakovosti ali ustreznosti predloženih podatkov ali utemeljitev.
Where the reference Member State considers that the application is incomplete, it shall inform the applicant as to what additional information is required for the application to be completed and shall set a reasonable time limit for the submission of that information.
Če referenčna država članica meni, da je vloga nepopolna, vlagatelja obvesti, katere dodatne informacije so potrebne za popolnost vloge, in določi razumen rok za predložitev teh informacij.
That time limit shall not normally exceed 45 days.
Ta rok običajno ne presega 45 dni.
The reference Member State shall, within 30 days of receipt of the additional information, validate the application if the additional information submitted is sufficient to comply with the requirements laid down in Article 5.
Referenčna država članica v 30 dneh po prejemu dodatnih informacij validira vlogo, če predložene dodatne informacije zadostujejo za izpolnitev zahtev iz odstavka 5.
The reference Member State shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant and the Member States concerned accordingly.
Če vlagatelj zahtevanih informacij ne predloži v roku, referenčna država članica zavrne vlogo ter o tem obvesti vlagatelja in zadevne države članice.
Within 90 days of validating an application, the reference Member State shall evaluate the application and draft an assessment report and shall send its assessment report and, where relevant, the revised summary of the biocidal product characteristics to the Member States concerned and to the applicant.
Referenčna država članica v 90 dneh po validaciji vloge slednjo oceni in pripravi povzetek poročila o oceni ter ga, po potrebi skupaj z revidiranim povzetkom značilnosti biocidnega proizvoda, pošlje zadevnim državam članicam in vlagatelju.
Where it appears that additional information is necessary to carry out the evaluation, the reference Member State shall ask the applicant to submit such information within a specified time limit.
Če se izkaže, da so za izvedbo ocene potrebne dodatne informacije, referenčna država članica od vlagatelja zahteva, da jih predloži v določenem roku.
The period referred to in paragraph 4, shall be suspended from the date of the request until the date the information is received.
Obdobje iz odstavka 4 se prekine od dneva zahteve do dneva prejema informacij.
The time limit given to the applicant shall not exceed 45 days in total unless justified by the nature of the data requested or by exceptional circumstances.
Rok, ki ga ima na voljo vlagatelj, ne presega skupno 45 dni, razen če je to upravičeno zaradi narave zahtevanih podatkov ali izrednih okoliščin.
If, within 45 days of receipt of the assessment report and, where relevant, of the revised summary of the biocidal product characteristics, the Member States concerned express no disagreement in accordance with Article 10, those Member States shall be deemed to have agreed with the conclusions of the assessment report and, where relevant, the revised summary of the biocidal product characteristics.
Če zadevne države članice v 45 dneh po prejemu poročila o oceni in po potrebi revidiranega povzetka značilnosti biocidnih proizvodov ne izrazijo nestrinjanja v skladu s členom 10, se šteje, da se strinjajo z ugotovitvami poročila o oceni in po potrebi revidiranim povzetkom značilnosti biocidnega proizvoda.
Within 30 days of reaching agreement, the reference Member State shall inform the applicant of the agreement and make it available in the Register for Biocidal Products referred to in Article 71 of Regulation (EU) No 528/2012.
Referenčna država članica v 30 dneh po dosegu soglasja vlagatelja obvesti o soglasju in ga da na voljo v registru biocidnih proizvodov iz člena 71 Uredbe (EU) št. 528/2012.
The reference Member State and each of the Member States concerned shall, where relevant, amend the authorisations of the biocidal product in conformity with the agreed change.
Referenčna država članica in vsaka od zadevnih držav članic po potrebi spremeni dovoljenja za biocidni proizvod v skladu z dogovorjeno spremembo.
Procedure for major changes of products
Postopek za večje spremembe proizvodov
The reference Member State shall validate the application within 30 days of its acceptance if it complies with the requirements laid down in Article 5 and inform the applicant and the Member States concerned accordingly.
Referenčna država članica vlogo validira v 30 dneh po njenem sprejetju, če izpolnjuje zahteve iz člena 5, ter o tem obvesti vlagatelja in zadevne države članice.
Where the reference Member State considers that the application is incomplete, it shall inform the applicant as to 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 referenčna država članica meni, da vloga ni popolna, vlagatelja obvesti, katere dodatne informacije so potrebne za validacijo vloge, ter določi razumen rok za predložitev teh informacij.
The reference Member State shall, within 30 days of receipt of the additional information, validate the application if it determines that the additional information submitted is sufficient to comply with the requirements laid down in Article 5.
Referenčna država članica v 30 dneh po prejemu dodatnih informacij validira vlogo, če odloči, da predložene dodatne informacije zadostujejo za izpolnitev zahtev iz člena 5.
Within 180 days of validating an application, the reference Member State shall evaluate the application and draft an assessment report and shall send its assessment report and, where relevant, the revised summary of the biocidal product characteristics to the Member States concerned and to the applicant.
Referenčna država članica v 180 dneh po validaciji vloge slednjo oceni in pripravi povzetek poročila o oceni ter ga, po potrebi skupaj z revidiranim povzetkom značilnosti biocidnega proizvoda, pošlje zadevnim državam članicam in vlagatelju.
The period referred to in paragraph 4 shall be suspended from the date of the request until the date on which the information is received.
Obdobje iz odstavka 4 se prekine od dneva zahteve do dneva prejema informacij.
The time limit given to the applicant shall not exceed 90 days in total unless justified by the nature of the data requested or by exceptional circumstances.
Rok, ki ga ima na voljo vlagatelj, ne presega skupno 90 dni, razen če je to upravičeno zaradi narave zahtevanih podatkov ali izrednih okoliščin.
If, within 90 days of receipt of the assessment report and, where relevant, of the revised summary of the biocidal product characteristics, the Member States concerned express no disagreement in accordance with Article 10, those Member States shall be deemed to agree with the conclusions of the assessment report and, where appropriate, the revised summary of the biocidal product characteristics.
Če zadevne države članice v 90 dneh po prejemu poročila o oceni in po potrebi revidiranega povzetka značilnosti biocidnih proizvodov ne izrazijo nestrinjanja v skladu s členom 10, se šteje, da se strinjajo z ugotovitvami poročila o oceni in po potrebi revidiranim povzetkom značilnosti biocidnega proizvoda.
Within 30 days of reaching agreement, the reference Member State shall inform the applicant of the agreement, and the reference Member State and each of the Member States concerned shall, where relevant, amend the authorisations of the biocidal product in conformity with the agreed change.
Referenčna država članica v 30 dneh po dosegu soglasja vlagatelja obvesti o soglasju, referenčna država članica in vsaka od zadevnih držav članic pa po potrebi spremeni dovoljenja za biocidni proizvod v skladu z dogovorjeno spremembo.
Biocidal products authorised in accordance with Article 26 of Regulation (EU) No 528/2012
Biocidni proizvodi, odobreni v skladu s členom 26 Uredbe (EU) št. 528/2012
Where the authorisation has been granted in accordance with Article 26 of Regulation (EU) No 528/2012, the authorisation holder or its representative shall notify each Member State, on the territory of which the biocidal product is made available, of notifications or applications made to the reference Member State in accordance with Article 6, 7 or 8 of this Regulation.
Kadar je bilo dovoljenje odobreno v skladu s členom 26 Uredbe (EU) št. 528/2012, imetnik dovoljenja ali njegov zastopnik obvesti vsako državo članico, na ozemlju katere je biocidni proizvod na voljo, o obvestilih ali vlogah, predloženih referenčni državi članici v skladu s členom 6, 7 ali 8 te uredbe.
Where a reference Member State has agreed with a revised summary of the biocidal product characteristics, the authorisation holder or its representative shall submit the revised summary to each Member State on the territory of which the biocidal product is made available in the official language(s) of that Member State.
Kadar se referenčna država članica strinja z revidiranim povzetkom značilnosti biocidnega proizvoda, imetnik dovoljenja ali njegov zastopnik vsaki državi članici, na ozemlju katere je biocidni proizvod na voljo, predloži revidirani povzetek v njenih uradnih jezikih.
Procedure for changes already agreed by other Member States
Postopek pri spremembah, s katerimi so se druge države članice že strinjale
Where an administrative change has already been agreed in one or more Member States and the authorisation holder seeks the same administrative change in an additional Member State concerned, the authorisation holder or its representative shall submit a notification in accordance with Article 6(1) to the additional Member State concerned.
Kadar se je ena ali več držav članic že strinjalo s kako upravno spremembo in želi imetnik dovoljenja isto upravno spremembo uvesti v dodatni zadevni državi članici, ji imetnik dovoljenja ali njegov zastopnik predloži obvestilo v skladu s členom 6(1).
Where a minor or a major change has already been agreed in one or more Member States and the authorisation holder seeks the same minor or major change in an additional Member State concerned, the authorisation holder, or its representative, shall submit an application complying with Article 5 to the additional Member State concerned.
Kadar se je ena ali več držav članic že strinjalo z manjšo ali večjo spremembo in želi imetnik dovoljenja isto manjšo ali večjo spremembo uvesti v dodatni zadevni državi članici, ji imetnik dovoljenja ali njegov zastopnik predloži vlogo v skladu s členom 5.
The Member State concerned shall inform the applicant of the fee payable in accordance with Article 80(2) of Regulation (EU) No 528/2012.
Zadevna država članica vlagatelja obvesti o pristojbini, ki se plača na podlagi člena 80(2) Uredbe (EU) št. 528/2012.
If within 45 days in the case of a minor change, or 90 days in the case of a major change, of the date of acceptance, the Member State concerned express no disagreement in accordance with Article 10, it shall be deemed to agree with the conclusions of the assessment report and, where appropriate, the revised summary of the biocidal product characteristics.
Če zadevna država članica v 45 dneh v primeru manjše spremembe ali v 90 dneh v primeru večje spremembe po datumu sprejetja ne izrazi nestrinjanja v skladu s členom 10, se šteje, da se strinja z ugotovitvami poročila o oceni in po potrebi revidiranim povzetkom značilnosti biocidnega proizvoda.
Within 30 days of the agreement referred to in paragraph 4, the Member State concerned shall inform the applicant of the agreement, and, where relevant, amend the authorisation of the biocidal product in conformity with the agreed change.
Zadevna država članica v 30 dneh po dosegu soglasja iz odstavka 4 vlagatelja obvesti o soglasju in po potrebi spremeni dovoljenje za biocidni proizvod v skladu z dogovorjeno spremembo.
Coordination group, arbitration and derogation from mutual recognition
Koordinacijska skupina, arbitraža in odstopanje od vzajemnega priznanja
A Member State concerned may propose to refuse to grant an authorisation or to adjust the terms and conditions of the authorisation in accordance with Article 37 of Regulation (EU) No 528/2012.
Zadevna država članica lahko predlaga zavrnitev odobritve dovoljenja ali prilagoditve pogojev dovoljenja v skladu s členom 37 Uredbe (EU) št. 528/2012.
Where, regarding matters other than those referred to in paragraph 1, the Member States concerned do not reach an agreement on the conclusions of the assessment report or, where relevant, on the revised summary of the biocidal product characteristics in accordance with Article 7(6) or 8(6), or a Member State concerned has disagreed in accordance with Article 6(3), the reference Member State shall refer the matter to the coordination group referred to in Article 35 of Regulation (EU) No 528/2012.
Kadar zadevne države članice glede zadev, ki niso navedene v odstavku 1, ne dosežejo soglasja glede ugotovitev poročila o oceni ali po potrebi revidiranega povzetka značilnosti biocidnih proizvodov v skladu s členom 7(6) ali 8(6) ali je zadevna država članica izrazila nestrinjanje v skladu s členom 6(3), referenčna država članica zadevo predloži koordinacijski skupini iz člena 35 Uredbe (EU) št. 528/2012.
Where a Member State concerned is in disagreement with the reference Member State, the former shall give a detailed statement of the reasons for its position to all Member States concerned and to the applicant.
Kadar se zadevna država članica ne strinja z referenčno državo članico, vsem zadevnim državam članicam in vlagatelju predloži podrobno izjavo o razlogih za svoje stališče.
Articles 35 and 36 of Regulation (EU) No 528/2012 shall apply to matters of disagreement referred to in paragraph 2.
Člena 35 in 36 Uredbe (EU) št. 528/2012 se uporabljata v primeru nesoglasja iz odstavka 2.
CHANGES OF PRODUCTS AUTHORISED BY THE COMMISSION
SPREMEMBE PROIZVODOV, KI JIH ODOBRI KOMISIJA
The authorisation holder, or its representative, shall submit to the Agency a notification complying with Article 5 and pay the fee referred to in Article 80(1)(a) of Regulation (EU) No 528/2012.
Imetnik dovoljenja ali njegov zastopnik Agenciji predloži obvestilo, ki je v skladu s členom 5, in plača pristojbino iz člena 80(1)(a) Uredbe (EU) št. 528/2012.
Without prejudice to the second subparagraph, that notification shall be submitted within 12 months following implementation of the change.
Obvestilo se brez poseganja v drugi pododstavek predloži v dvanajstih mesecih po začetku izvajanja spremembe.
Within 30 days following receipt of the notification and subject to the payment of the relevant fee, the Agency shall prepare and submit to the Commission an opinion on the proposed change.
Agencija v 30 dneh po prejemu obvestila in ob plačilu ustrezne pristojbine pripravi in Komisiji predloži mnenje o predlagani spremembi.
If, within 30 days following receipt of the notification, the relevant fee has not been paid, the Agency shall reject the application and inform the applicant accordingly.
Če ustrezna pristojbina v 30 dneh po prejemu obvestila ni bila plačana, Agencija zavrne vlogo in o tem obvesti vlagatelja.
An appeal may be brought, in accordance with Article 77 of Regulation (EU) No 528/2012, against Agency decisions under this paragraph.
V skladu s členom 77 Uredbe (EU) št. 528/2012 se lahko proti odločitvam Agencije na podlagi tega odstavka vloži pritožba.
The Agency shall inform the applicant of its opinion and shall, where relevant, request the applicant to submit in all the official languages of the Union, a draft revised summary of the biocidal product characteristics.
Agencija obvesti vlagatelja o svojem mnenju in po potrebi od njega zahteva, da v vseh uradnih jezikih Unije predloži osnutek revidiranega povzetka značilnosti biocidnega proizvoda.
Within 30 days of the submission of its opinion to the Commission, the Agency shall, where relevant, transmit to the Commission, in all the official languages of the Union, the revised summary of the biocidal product characteristics, as referred to in Article 22(2) of Regulation (EU) No 528/2012.
Agencija v 30 dneh po predložitvi svojega mnenja Komisiji slednji v vseh uradnih jezikih Unije posreduje revidiran povzetek značilnosti biocidnega proizvoda, kot je navedeno v členu 22(2) Uredbe (EU) št. 528/2012.
The authorisation holder, or its representative, shall submit to the Agency an application complying with the Article 5.
Imetnik dovoljenja ali njegov zastopnik Agenciji predloži vlogo, ki je v skladu s členom 5.
The Agency shall inform the applicant of the fee payable under Article 80(1)(a) of Regulation (EU) No 528/2012, and shall reject the application if the applicant fails to pay the fee within 30 days.
Agencija vlagatelja obvesti o pristojbini, ki se plača na podlagi člena 80(1)(a) Uredbe (EU) št. 528/2012, in vlogo zavrne, če je vlagatelj ne plača v 30 dneh.
It shall inform the applicant accordingly.
O tem obvesti vlagatelja.
Upon receipt of the fee, the Agency shall accept the application and inform the applicant accordingly.
Agencija ob prejemu pristojbine sprejme vlogo in o tem obvesti vlagatelja.
The Agency shall validate the application within 30 days of the date of acceptance if it complies with the requirements laid down in Article 5.
Agencija vlogo validira v 30 dneh po datumu sprejetja, če izpolnjuje zahteve iz člena 5.
In the context of the validation referred to in the first subparagraph, the Agency shall not make an assessment of the quality or the adequacy of the data or justifications submitted.
Agencija v okviru validacije iz prvega pododstavka ne opravi ocene kakovosti ali ustreznosti predloženih podatkov ali utemeljitev.
Where the Agency considers that the application is incomplete, it shall inform the applicant as to what additional information is required for the completeness of the application and shall set a reasonable time limit for the submission of that information.
Če Agencija meni, da je vloga nepopolna, vlagatelja obvesti, katere dodatne informacije so potrebne za popolnost vloge, in določi razumen rok za predložitev teh informacij.
The Agency shall, within 30 days of receipt of the additional information, validate the application if it determines that the additional information submitted is sufficient to comply with the requirements laid down in Article 5.
Agencija v 30 dneh po prejemu dodatnih informacij validira vlogo, če odloči, da predložene dodatne informacije zadostujejo za izpolnitev zahtev iz člena 5.
The Agency shall reject the application if the applicant fails to submit the requested information within the deadline and inform the applicant accordingly.
Če vlagatelj zahtevanih informacij ne predloži v roku, Agencija vlogo zavrne ter o tem obvesti vlagatelja.
In such cases, part of the fee paid in accordance with paragraph 2 shall be reimbursed.
V takšnem primeru se del pristojbine, plačane v skladu s členom 2, povrne.
Within 90 days of accepting an application as valid, the Agency shall prepare and submit to the Commission an opinion on the proposed change.
Agencija v 90 dneh po sprejetju vloge kot veljavne pripravi mnenje o predlagani spremembi in ga predloži Komisiji.