natgillin/translations-raw huggingface dataset:
V izjemnih okoliščinah in po ustrezni obrazložitvi se rok lahko podaljša za dodatno obdobje, ki ne presega šestih mesecev.
In exceptional circumstances and following proper justification, the time limit may be extended by up to a further six months .
Dvanajstmesečno obdobje iz odstavka 1 se prekine od dneva izdaje vloge pa do dneva prejema informacij.
The twelve-month period referred to in paragraph 1 shall be suspended from the date of issue of the request until the date the information is received.
Izkušnje so pokazale, da lahko izvedba ocene traja neupravičeno dolgo.
Experience has shown concluding an evaluation procedure could take an unjustifiably long time.
Zato je treba postaviti ustrezne roke, da bi odpravili vrzeli, ki bi lahko po nepotrebnem podaljšale postopek.
It is therefore essential that proper time limits are put in place to avoid loopholes that could protract the procedure unnecessarily.
Imetnik dovoljenja ali njegov zastopnik vloži vlogo za obnovitev nacionalnega dovoljenja pri pristojnem organu prejemniku najmanj 18 mesecev pred potekom dovoljenja.
The authorisation holder or his representative shall submit an application for renewal of a national authorisation to the receiving competent authority at least eighteen months before the expiry date of the authorisation.
Imetnik dovoljenja ali njegov zastopnik vloži vlogo za obnovitev nacionalnega dovoljenja pri pristojnem organu prejemniku najmanj 12 mesecev pred potekom dovoljenja.
The authorisation holder or his representative shall submit an application for renewal of a national authorisation to the receiving competent authority at least twelve months before the expiry date of the authorisation.
Če ni novih podatke za oceno, je 18 mesecev predolgo obdobje za obnovitev dovoljenja za pripravek.
Unless there are new data to be assessed, eighteen months are not required to renew a product authorisation.
Dvanajstmesečno obdobje je ustreznejše.
A twelve month period is more appropriate.
Člen 25 – odstavek 5 – pododstavek 1 a (novo)
Article 25 – paragraph 5 – subparagraph 1 a (new)
V vseh državah članicah, ki so udeležene pri vzajemnem priznavanju, se uporablja enotna številka dovoljenja.
In the event of mutual recognition, a single authorisation number shall be used in all Member States involved.
Kadar se uporabi postopek medsebojnega priznavanja, je treba v vseh državah članicah uporabiti enotno številko dovoljenja.
In the case of a mutual recognition procedure, a single authorisation number should be used in all Member States.
Komisija bo imela nalogo, da sprejme izvedbene ukrepe za dodeljevanje teh številk.
The Commission should be responsible for adopting implementing measures to introduce a single number.
Komisija sprejme izvedbene ukrepe, pri čemer v primeru postopkov medsebojnega priznavanja navede merila in postopke za dodelitev enotne številke dovoljenja v vseh državah članicah.
In the case of mutual recognition procedures, the Commission shall adopt implementing measures laying down the criteria and procedures for assigning a single authorisation number in all Member States concerned.
Komisija po posvetovanju s predlagateljem sprejme odločitev, ali razlogi, ki jih je navedel pristojni organ, upravičujejo zavrnitev priznanja ali omejitev nacionalnega dovoljenja v skladu s postopkom iz člena 72(3).
After consulting the applicant, the Commission shall 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 72(3).
Besedilo uredbe mora vsebovati določilo o časovnem obdobju, v katerem morajo biti spori med državami članicami zaključeni.
Provision is needed in the regulation for a deadline for settling disputes between Member States.
Če Komisija skladno s postopkom iz člena 30 zaprosi agencijo za mnenje, se obdobje treh mesecev prekine, dokler agencija svojega mnenja ne sporoči.
Should the Commission ask the Agency for an opinion under the procedure set out in Article 30, the three ‑month period shall be suspended until the Agency has forwarded its opinion.
Trije meseci so dovolj dolgo časovno obdobje, da lahko Komisija pripravi ustrezen predlog sklepa za utemeljitev nepriznanja ali omejitve dovoljenja.
Three months would seem to be appropriate timing time for the Commission to draw up a proposal for a decision on the refusal, or restriction, of authorisation.
Člen 28 – odstavek 9 – pododstavek 2
Article 28 – paragraph 9 – subparagraph 2
Komisija tri mesece po priglasitvi in po posvetovanju s predlagateljem sprejme odločitev, ali razlogi, ki jih je navedel pristojni organ, upravičujejo zavrnitev priznanja ali omejitev nacionalnega dovoljenja v skladu s postopkom iz člena 72(3).
Within three months following the notification, the Commission shall , after consultation with the applicant, 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 72(3).
V zakonodajnem besedilu bi morali biti jasno določeni roki, da bi bil sistem za reševanje sporov med državami članicami učinkovit.
The legislative text should clearly state the timelines applicable in order to have an efficient system in place to resolve disputes between Member States.
Trije meseci zadostujejo, da Komisija pripravi predlog odločitve na podlagi razlogov, ki upravičujejo zavrnitev priznanja ali omejitev dovoljenja.
Three months is an adequate timing for the Commission to make a proposal for a decision on the grounds justifying the refusal to recognise or restrict authorisations.
Če se Komisija odloči odkloniti razloge , predložene za zavrnitev ali omejitev nacionalnega dovoljenja, pristojni organ, ki predlaga zavrnitev priznanja dovoljenja ali omejitev dovoljenja, nemudoma izda dovoljenje za zadevni biocidni pripravek v skladu z nacionalnim dovoljenjem, ki ga je izdal referenčni pristojni organ .
If the Commission decision dismisses the grounds presented for refusing or restricting the national authorisation the competent authority that proposed to refuse to recognise the authorisation, or to restrict the authorisation, shall without delay authorise the biocidal product concerned in accordance with the national authorisation issued by the reference competent authority .
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 odločitev Komisije potrdi prvotno nacionalno dovoljenje, pristojni organ, ki je predlagal zavrnitev priznanja nacionalnega dovoljenja ali priznanje pod določenimi pogoji, nemudoma izda dovoljenje za zadevni biocidni pripravek v skladu s prvotnim dovoljenjem.
If the Commission decision confirms the initial national authorisation, the competent authority that proposed to refuse to recognise a national authorisation, or to recognise the national authorisation subject to certain conditions, shall without delay authorise the biocidal product concerned in accordance with the initial authorisation .
Če skladno s postopkom iz člena 30 zaprosi agencijo za mnenje, se obdobje treh mesecev prekine, dokler agencija svojega mnenja ne sporoči.
Should the Commission ask the Agency for an opinion under the procedure set out in Article 30, the three ‑month period shall be suspended until the Agency has forwarded its opinion.
Dovoljenje Skupnosti se lahko izda za vse kategorije biocidnih pripravkov.
The Community authorisation may be granted to any category of biocidal products.
Glede na poročilo Komisije o izvajanju te uredbe iz člena 54(4) in glede na izkušnje v zvezi z dovoljenji Skupnosti lahko Komisija doda druge kategorije biocidnih pripravkov v odstavek 1 tega člena.
Following the report of the Commission on the implementation of this Regulation referred to in Article 54(4) and in light of the experience gained with the Community authorisations, the Commission may add other categories of biocidal products in paragraph 1 of this Article.
Vložitev in validacija vloge
Submission and validation of application
Oseba, ki je odgovorna za dajanje biocidnih pripravkov v promet, ali njen zastopnik vloži pri agenciji vlogo za dovoljenje Skupnosti in obvesti agencijo o imenu pristojnega organa države članice, ki ga sam izbere in ki je odgovoren za oceno vloge (v nadaljnjem besedilu: ocenjevalni pristojni organ).
The person responsible for the placing of a biocidal product on the market, or his representative, shall submit an application for a Community authorisation to the Agency and inform the Agency of the name of the competent authority of the Member State of his choice which shall be responsible for the evaluation of the application (hereinafter referred to as 'the evaluating competent authority').
Agencija v enem mesecu po prejemu vloge uradno obvesti ocenjevalni pristojni organ, da je vloga na voljo v zbirki podatkov agencije.
The Agency shall, within one month after the receipt of the application, notify the evaluating competent authority that the application is available in the Agency database.
b) da so bile plačane pristojbine iz člena 70.
b) it is accompanied by the fees payable under Article 70.
Agencija v dveh mesecih po prejemu dodatnih informacij ugotovi, ali predložene dodatne informacije zadostujejo za validacijo vloge.
The Agency shall, within two months from the receipt of the additional information, determine whether the additional information submitted is sufficient to validate the application.
Če predlagatelj vloge ne dopolni v roku, agencija zavrne vlogo in o tem obvesti predlagatelja in pristojni ocenjevalni organ.
The Agency shall reject the application if the applicant fails to complete his application within the deadline and inform the applicant and the evaluating competent authority thereof.
Če agencija na podlagi validacije, opravljene v skladu z odstavkom 2, meni, da je vloga popolna, o tem nemudoma obvesti predlagatelja in ocenjevalni pristojni organ.
If the Agency, on basis of the validation made pursuant to paragraph 2, considers that the application is complete, it shall without delay inform the applicant and the evaluating competent authority thereof.
Po novem členu 22 vložitev in validacijo vlog za nacionalna dovoljenja in dovoljenja Skupnosti urejajo enaka pravila.
Under the new Article 22, the submission and validation of applications for national and Community authorisations are governed by the same rules.
Zato je člen 22 prvotnega predloga odveč.
This renders superfluous Article 22 of the original proposal.
Če se so sestavine, ki jih vsebuje biocidni pripravek, že registrirane za uporabo v biocidnih pripravkih v skladu z Uredbo št. 1907/2006, ocenjevalni pristojni organ ne izvede dodatne ocene.
Should the ingredients contained in the biocidal product have already been registered, in conformity with Regulation (EC) No 1907/2006, for use in biocidal products, the evaluating competent authority shall not duplicate that evaluation.
V izogib nepotrebnemu podvajanju prizadevanj.
Aims to avoid an unnecessary duplication of effort.
Člen 35 – odstavek 2 – pododstavek 1
Article 35 – paragraph 2 - subparagraph 1
Če se pri oceni dokumentacije pokaže, da so potrebne dodatne informacije za izvedbo ocene, ocenjevalni pristojni organ od predlagatelja zahteva, da jih predloži v roku , ki ne presega šestih mesecev .
If, when the dossiers are evaluated, it appears that additional information is necessary to carry out the evaluation, the evaluating competent authority shall ask the applicant to submit such information within a time limit that shall not exceed six months.
Rok devetih mesecev, ki bi ga imela agencija za pripravo in posredovanje mnenja, ki temelji na že razpoložljivi oceni ocenjevalnega pristojnega organa, je predolg.
Nine months is too long a period for the Agency to prepare and submit an opinion based on an already‑available evaluation conducted by the evaluating competent authority.
Trimesečni rok je bolj ustrezen.
Three months is a more appropriate length of time.
Če se z odločitvijo iz odstavka 4 zavrne izdaja dovoljenja Skupnosti za biocidni pripravek, ker ne izpolnjuje meril za biocidni pripravek z manjšim tveganjem v skladu s členom 17, lahko predlagatelj vloži vlogo za dovoljenje Skupnosti v skladu s točko (a) člena 33(1) ali nacionalno dovoljenje v skladu s poglavjem V, če je to primerno.
If the decision referred to in paragraph 4 refuses to grant a Community authorisation to a biocidal product because it does not fulfil the criteria for a low-risk biocidal product in accordance with Article 17, the applicant may apply, if relevant, for a Community authorisation in accordance with point (a) of Article 33(1) or a national authorisation in accordance with Chapter V.
Črtanje odstavka je na mestu, ker se dovoljenje Skupnosti zahteva za vse vrste biocidnih pripravkov.
This paragraph requires deletion as Community authorisation is being requested for all types of biocide.
Dvanajstmesečno obdobje za obnovitev dovoljenja je ustreznejše.
12 months would be a more appropriate length of time for the renewal of an authorisation .
Če ocenjevalni pristojni organ, ki je opravil prvotno oceno vloge za dovoljenje Skupnosti odloči, da popolna ocena vloge ni potrebna, v šestih mesecih po validaciji pripravi in predloži agenciji priporočilo za obnovitev dovoljenja.
If the evaluating competent authority that carried out the initial evaluation of the application for Community authorisation decides that a full evaluation of the application is not necessary, it shall, within six months after the validation, prepare and submit to the Agency a recommendation on the renewal of the authorisation.
V členu 12.2 mora ocenjevalni organ za obnovo vključitve aktivne snovi v Prilogo I priporočilo za obnovo izdati v šestih, ne dvanajstih mesecih, če ni potrebna popolna ocena.
In Article 12.2 for renewal of inclusion of active substance in Annex I, when full evaluation is not necessary it is required that the evaluating authority issues a recommendation for renewal in 6 months not 12.
Poglavje VII a (novo) – Člen 37 a (novo)
Chapter VII a (new) – Article 37 a (new)
POGLAVJE VIIa
CHAPTER VIIa
Lastnik prvega dovoljenja ali vlagatelj vloge za prvo dovoljenje lahko pri agenciji vloži vlogo za izdajo dvojnika dovoljenja za isti biocidni pripravek.
Holders of, or applicants for, a primary authorisation may submit to the Agency a request for a duplicate authorisation for the same biocidal product.
Vlagatelj vloge za dvojnik dovoljenja predloži skupaj z vlogo naslednje informacije in dokumente:
Applicants for a duplicate authorisation must forward the following items and information with their application:
(a) številko prvega dovoljenja, v primeru vloge za izdajo prvega dovoljenja pa številko vloge;
(a) the authorisation number for the primary authorisation or, in the case of an application for primary authorisation, the application number;
(b) kakovostno in količinsko sestavo aktivnih in neaktivnih snovi ob upoštevanju najvišjih dovoljenih koncentracij iz člena 16 in če so ti podatki nujno potrebni za pravilno uporabo biocidnega pripravka;
(b) the qualitative and quantitative composition in terms of active substances and non-active substances, taking into account the concentration limits given in Article 16, insofar as knowledge of this is essential for appropriate use of the biocidal product;
(c) odmerke in navodila za uporabo;
(c) the application doses and instructions for use;
(d) kategorije uporabnikov.
(d) categories of users .
Agencija validira vlogo v skladu z določbami iz člena 22.
The Agency shall validate the application on the basis of the rules laid down in Article 22.
Če agencija na podlagi validacije, opravljene v skladu z odstavkom 3, meni, da je vloga popolna, o tem nemudoma obvesti predlagatelja in ocenjevalni pristojni organ, ki je izdal prvo dovoljenje, v primeru izdaje dvojnika dovoljenja Skupnosti pa Komisijo.
If the Agency considers the application to be complete, on the basis of the validation under paragraph 3, it shall inform forthwith the applicant, the evaluating competent authority granting the primary authorisation or, in the case of duplication of a Community authorisation, the Commission.
V primeru obstoječega prvega dovoljenja mora ocenjevalni pristojni organ, v primeru dvojnika dovoljenja Skupnosti pa Komisija, v mesecu dni po validaciji sprejeti odločitev glede vloge.
In the case of existing primary authorisations, the evaluating competent authority or, in the case of duplication of a Community authorisation, the Commission, shall decide on the application within one month of the validation.
V primeru nerešene prošnje za izdajo dovoljenja mora ocenjevalni pristojni organ, v primeru dvojnika dovoljenja Skupnosti pa Komisija, v mesecu dni po izdaji prvega dovoljenja sprejeti odločitev glede vloge.
In the case of pending applications for authorisation, the evaluating competent authority or, in the case of duplication of a Community authorisation, the Commission, must decide on the application within one month of the granting of the primary authorisation.
Če se pokaže, da so za preverjanje identitete biocidnega pripravka potrebne dodatne informacije, ocenjevalni pristojni organ, v primeru dvojnika dovoljenja Skupnosti pa Komisija, predlagatelja zaprosi za njihovo predložitev.
Should additional information appear to be required to enable the identity of the biocidal product to be established, the evaluating competent authority or, in the case of duplication of a Community authorisation, the Commission, shall request that information from the applicant.
Enomesečno obdobje iz odstavka 5 se prekine od dneva zahteve po dodatnih informacijah do dneva njihovega prejetja.
The one-month period referred to in paragraph 5 shall be suspended from the date of issue of the request until the date the information is received.
Takoj ko pristojni ocenjevalni organ oziroma Komisija, kadar gre za dvojnik dovoljenja Skupnosti, odobri dvojnik prvega dovoljenja, mu dodeli posebno številko, upravni akt pa vnese v register Skupnosti za biocidne pripravke.
As soon as the evaluating competent authority or, in the case of duplication of a Community authorisation, the Commission, has authorised the duplication of a primary authorisation, it shall assign to it a specific authorisation number and record the administrative act in the Community Register of Biocidal Products.
Ne glede na informacije, predložene v skladu z odstavkom 2, tudi za dodatno dovoljenje veljajo pogoji v zvezi z dajanjem v promet in uporabo biocidnega pripravka, ki jih je treba izpolniti za prvo dovoljenje.
Notwithstanding the information submitted pursuant to paragraph 2, in the case of duplicate authorisations the terms and conditions for the placing on the market and use of the biocidal product agreed in the primary authorisation must be applied.
Člen 37 b (novo – drugi člen v novem poglavju VIIa)
Article 37 b (new – second article in the new Chapter VIIa)
Člen 37b
Article 37b
Dodatno dovoljenje se lahko izda na podlagi prvega dovoljenja.
An additional authorisation may be granted on the basis of a primary authorisation.
Če želi predlagatelj zaprositi za dodatno dovoljenje, mora vlogo predložiti agenciji.
Applicants wishing to apply for an additional authorisation must send the application for authorisation to the Agency.
Predlagatelj dodatnega dovoljenja mora skupaj z vlogo predloži naslednje dokumente in informacije:
Applicants for an additional authorisation must forward the following items and information with their application:
(a) številko prvega dovoljenja, v primeru nerešene vloge pa številko vloge;
(a) the authorisation number for the primary authorisation or, in the case of a pending application, the application number;
(b) svoje ime in naslov;
(b) the name and address of the applicant;
(c) pisno privolitev imetnika dovoljenja;
(c) written approval from the holder of the authorisation;
(d) kakovostno in količinsko sestavo aktivnih in neaktivnih snovi ob upoštevanju najvišjih dovoljenih koncentracij iz člena 16 in če so ti podatki nujno potrebni za pravilno uporabo biocidnega pripravka;
(d) the qualitative and quantitative composition in terms of active substances and non-active substances, taking into account the concentration limits given in Article 16, insofar as knowledge of this is essential for appropriate use of the biocidal product;
(e) odmerke in navodila za uporabo;
(e) the application doses and instructions for use;
(f) kategorije uporabnikov.
(f) categories of users .
Če agencija na podlagi validacije, opravljene v skladu z odstavkom 4, meni, da je vloga popolna, o tem nemudoma obvesti predlagatelja in ocenjevalni pristojni organ, ki je izdal prvo dovoljenje, v primeru izdaje dvojnika dovoljenja Skupnosti pa Komisijo.
If the Agency considers the application to be complete, on the basis of the validation under paragraph 4, it shall inform forthwith the applicant, the evaluating competent authority granting the primary authorisation or, in the case of addition of a Community authorisation, the Commission.
V primeru obstoječega prvega dovoljenja ocenjevalni pristojni organ, v primeru dodatnega dovoljenja Skupnosti pa Komisija, v enem mesecu po validaciji sprejme odločitev glede vloge.
In the case of existing primary authorisations, the evaluating competent authority or, in the case of addition of a Community authorisation, the Commission, shall decide on the application within one month of the validation.
V primeru nerešene prošnje za izdajo dovoljenja mora ocenjevalni pristojni organ, v primeru dodatnega dovoljenja Skupnosti pa Komisija, v mesecu dni po izdaji prvega dovoljenja, sprejeti odločitev glede vloge.
In the case of pending applications for authorisation, the evaluating competent authority or, in the case of addition of a Community authorisation, the Commission, must decide on the application within one month of the granting of the primary authorisation.
Če se pokaže, da so za preverjanje identitete biocidnega pripravka potrebne dodatne informacije, ocenjevalni pristojni organ, v primeru dodatnega dovoljenja Skupnosti pa Komisija, predlagatelja zaprosita za njihovo predložitev.
Should additional information appear to be required to enable the identity of the biocidal product to be established, the evaluating competent authority or, in the case of addition of a Community authorisation, the Commission, shall request that information from the applicant.
Enomesečno obdobje iz odstavka 6 se prekine od dneva zahteve po dodatnih informacijah do dneva njihovega prejetja.
The one-month period referred to in paragraph 6 shall be suspended from the date of issue of the request until the date the information is received.
Takoj ko pristojni ocenjevalni organ oziroma Komisija, kadar gre za dodatno dovoljenje Skupnosti, odobri dodatno prvo dovoljenje, mu dodeli posebno številko, upravni akt pa vnese v register Skupnosti za biocidne pripravke.
As soon as the evaluating competent authority or, in case of addition of a Community authorisation, the Commission, has authorised the addition of a primary authorisation, it shall assign to it a specific authorisation number and record the administrative act in the Community Register of Biocidal Products.
Ne glede na informacije, predložene v skladu z odstavkom 3, tudi za dodatno dovoljenje veljajo pogoji v zvezi z dajanjem v promet in uporabo biocidnega pripravka, ki jih je treba izpolniti za prvo dovoljenje.
Notwithstanding the information submitted pursuant to paragraph 3, in the case of additional authorisations the terms and conditions for the placing on the market and use of the biocidal product agreed in the primary authorisation must be applied.
(ca) o spremembah v izvoru ali sestavi aktivne snovi.
(ca) changes in the origin or composition of the active substance.