natgillin/translations-raw huggingface dataset:
If the Agency recommends the authorisation of the biocidal product, the opinion shall contain at least the following elements:
Če Agencija priporoča izdajo dovoljenja za biocidni proizvod, mnenje vsebuje vsaj naslednje elemente:
a statement on whether the conditions laid down in Article 19(1) are fulfilled, and a draft summary of biocidal product characteristics, as referred to in Article 22(2);
izjavo, da so pogoji iz člena 19(1) izpolnjeni, in osnutek povzetka značilnosti biocidnega proizvoda v skladu s členom 22(2);
where relevant, details of any terms or conditions which should be imposed on the making available on the market or use of the biocidal product;
po potrebi podrobnosti določil ali pogojev, ki bi jih bilo treba uvesti za dostopnost na trgu ali uporabo biocidnega proizvoda;
the final assessment report on the biocidal product.
končno poročilo o oceni biocidnega proizvoda.
Within 30 days of submitting its opinion to the Commission, the Agency shall transmit to the Commission, in all the official languages of the Union, the draft summary of the biocidal product characteristics, as referred to in Article 22(2), where applicable.
Agencija v 30 dneh od predložitve svojega mnenja Komisiji slednji v vseh uradnih jezikih Unije posreduje osnutek povzetka značilnosti biocidnega proizvoda, kot je navedeno v členu 22(2), kot je primerno.
On receipt of the opinion of the Agency, the Commission shall adopt either an implementing regulation granting the Union authorisation to the biocidal product or an implementing decision stating that the Union authorisation of the biocidal product has not been granted.
Komisija po prejemu mnenja Agencije sprejme bodisi izvedbeno uredbo o izdaji dovoljenja Unije za biocidni proizvod bodisi izvedbeni sklep o neizdaji dovoljenja Unije za biocidni proizvod.
The Commission shall, at the request of a Member State, decide to adjust certain conditions of a Union authorisation specifically for the territory of that Member State or decide that a Union authorisation shall not apply in the territory of that Member State, provided that such a request can be justified on one or more of the grounds referred to in Article 37(1).
Komisija na zahtevo države članice odloči, da bo posebej za ozemlje te države članice prilagodila določene pogoje za dovoljenje Unije ali da dovoljenje Unije ne velja na ozemlju te države članice, če se taka zahteva lahko upraviči z enim ali več razlogi iz člena 37(1).
Renewal of Union authorisations
Podaljšanje dovoljenj Unije
An application by or on behalf of an authorisation holder wishing to seek the renewal of a Union authorisation shall be submitted to the Agency at least 550 days before the expiry date of the authorisation.
Vloga s strani ali v imenu imetnika dovoljenja, ki želi podaljšati dovoljenje Unije, se vloži pri Agenciji najmanj 550 dni pred potekom veljavnosti dovoljenja.
The application shall be accompanied by the fees payable under Article 80(1).
Ob vložitvi vloge se plačajo tudi pristojbine, ki se plačujejo v skladu s členom 80(1).
The Agency shall inform the applicant of the fees payable to it under Article 80(1) and shall reject the application if the applicant fails to pay the fees within 30 days.
Agencija vlagatelja obvesti o pristojbinah, ki se Agenciji plačujejo v skladu s členom 80(1), in vlogo zavrne, če vlagatelj teh pristojbin ne plača v 30 dneh.
Upon receipt of the fees payable to it under Article 80(1), the Agency shall accept the application and inform the applicant and the evaluating competent authority accordingly, indicating the date of acceptance.
Po prejemu pristojbin, ki se Agenciji plačujejo v skladu s členom 80(1), Agencija sprejme vlogo in obvesti vlagatelja in ocenjevalni pristojni organ ter navede datum sprejema.
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 Union authorisation or, as appropriate, the previous renewal, the evaluating competent authority shall, within 30 days of the Agency accepting the application in accordance with Article 45(3), decide whether, in the light of current scientific knowledge, a full evaluation of the application for renewal is necessary.
Na podlagi ocene razpoložljivih informacij in potrebe po pregledu zaključkov iz prvotnega ocenjevanja vloge za dovoljenje Unije ali predhodnega podaljšanja, kakor je primerno, ocenjevalni pristojni organ v 30 dneh po tem, ko Agencija sprejme vlogo v skladu s členom 45(3), odloči, ali je glede na sedanja znanstvena spoznanja potrebna popolna ocena vloge za podaljšanje.
Where the evaluating competent authority decides that a full evaluation of the application is necessary, the evaluation shall be carried out in accordance with paragraphs 1 and 2 of Article 44.
Če ocenjevalni pristojni organ odloči, da je potrebna popolna ocena vloge, se ocenjevanje opravi v skladu z odstavkoma 1 in 2 člena 44.
Where the evaluating competent authority decides that a full evaluation of the application is not necessary, it shall, within 180 days of the Agency accepting the application, prepare and submit to the Agency a recommendation on the renewal of the authorisation.
Če ocenjevalni pristojni organ odloči, da popolna ocena vloge ni potrebna, v 180 dneh po tem, ko Agencija sprejme vlogo, pripravi priporočilo za podaljšanje dovoljenja in ga predloži Agenciji.
The evaluating competent authority shall, as soon as possible after the Agency has accepted the application, inform the applicant of the fees payable under Article 80(2) and shall reject the application if the applicant fails to pay the fees within 30 days.
Potem ko je Agencija sprejela vlogo, ocenjevalni pristojni organ čim prej obvesti vlagatelja o pristojbinah, ki se plačujejo v skladu s členom 80(2), in zavrne vlogo, če vlagatelj pristojbin ne plača v 30 dneh.
Within 180 days of receipt of a recommendation from the evaluating competent authority, the Agency shall prepare and submit to the Commission an opinion on the renewal of the Union authorisation.
V 180 dneh po prejemu priporočila ocenjevalnega pristojnega organa Agencija pripravi mnenje o podaljšanju dovoljenja Unije in ga predloži Komisiji.
On receipt of the opinion of the Agency, the Commission shall adopt either an implementing Regulation to renew the Union authorisation or an implementing decision to refuse to renew the Union authorisation.
Ob prejemu mnenja Agencije Komisija sprejme bodisi izvedbeno uredbo o podaljšanju dovoljenja Unije bodisi izvedbeni sklep o zavrnitvi podaljšanja dovoljenja Unije.
The Commission shall renew a Union authorisation, provided that the conditions set out in Article 19 are still satisfied.
Komisija obnovi dovoljenje Unije, če so pogoji iz člena 19 še vedno izpolnjeni.
Where, for reasons beyond the control of the holder of the Union authorisation, no decision is taken on the renewal of the authorisation before its expiry, the Commission shall grant the renewal of the Union authorisation for the period necessary to complete the evaluation by means of implementing acts.
Kadar se zaradi razlogov, na katere imetnik dovoljenja Unije ne more vplivati, odločitev o podaljšanju dovoljenja Unije ne sprejme pred njegovim iztekom veljavnosti, Komisija z izvedbenimi akti odobri podaljšanje dovoljenja Unije za obdobje, ki je potrebno za dokončanje ocenjevanja.
CANCELLATION, REVIEW AND AMENDMENT OF AUTHORISATIONS
RAZVELJAVITEV, PREGLED IN SPREMEMBA DOVOLJENJ
Obligation for notification of unexpected or adverse effects
Obveznost sporočanja nepričakovanih ali neželenih učinkov
On becoming aware of information concerning the authorised biocidal product, or the active substance(s) it contains, that may affect the authorisation, the holder of an authorisation shall without delay notify the competent authority that granted the national authorisation and the Agency or, in the case of a Union authorisation, the Commission and the Agency.
Ko imetnik dovoljenja izve za informacije v zvezi z dovoljenim biocidnim proizvodom ali v njem vsebovano aktivno oziroma aktivnimi snovmi, ki lahko vplivajo na dovoljenje, o tem nemudoma obvesti pristojni organ, ki je izdal nacionalno dovoljenje, in Agenciji ali, v primeru dovoljenja Unije, Komisiji in Agenciji.
In particular, the following shall be notified:
Zlasti se sporoči naslednje:
new data or information on the adverse effects of the active substance or biocidal product for humans, in particular vulnerable groups, animals or the environment;
novi podatki ali informacije o neželenih učinkih aktivne snovi ali biocidnega proizvoda na ljudi, zlasti ranljive skupine, živali ali okolje;
any data indicating the potential of the active substance for the development of resistance;
kakršni koli podatkih, ki kažejo na možnost aktivne snovi, da razvije odpornost;
new data or information indicating that the biocidal product is not sufficiently effective.
novi podatki ali informacije, ki kažejo, da biocidni proizvod ni dovolj učinkovit.
The competent authority that granted the national authorisation or, in the case of a Union authorisation, the Agency, shall examine whether the authorisation needs to be amended or cancelled in accordance with Article 48.
Pristojni organ, ki je izdal nacionalno dovoljenje, ali, v primeru dovoljenja Unije, Agencija preveri, ali je treba dovoljenje v skladu s členom 48 spremeniti ali preklicati.
The competent authority that granted the national authorisation or, in the case of a Union authorisation, the Agency, shall without delay notify competent authorities of other Member States and, where appropriate, the Commission of any such data or information it receives.
Pristojni organ, ki je izdal nacionalno dovoljenje, ali, v primeru dovoljenja Unije, Agencija, nemudoma uradno obvesti pristojne organe drugih držav članic in, kadar je to primerno, Komisijo o vseh takšnih podatkih ali informacijah, ki jih prejme.
Competent authorities of Member States that have issued a national authorisation for the same biocidal product under the mutual recognition procedure shall examine whether the authorisation needs to be amended or cancelled in accordance with Article 48.
Pristojni organi držav članic, ki so izdali nacionalno dovoljenje za enak biocidni proizvod po postopku medsebojnega priznavanja dovoljenj, preverijo, ali je treba dovoljenje v skladu s členom 48 spremeniti ali preklicati.
Cancellation or amendment of an authorisation
Preklic ali sprememba dovoljenja
Without prejudice to Article 23, the competent authority of a Member State or, in the case of a Union authorisation, the Commission shall at any time cancel or amend an authorisation it has granted where it considers that:
Brez poseganja v člen 23 pristojni organ države članice ali, v primeru dovoljenja Unije, Komisija kadar koli prekliče ali spremeni dovoljenje, ki ga je izdala, kadar meni, da:
the conditions referred to in Article 19 or, where relevant, in Article 25 are not satisfied;
niso izpolnjeni pogoji iz člena 19 ali, kjer je to pomembno, člena 25;
the authorisation was granted on the basis of false or misleading information; or
je bilo dovoljenje izdano na podlagi napačnih ali zavajajočih informacij ali
the authorisation holder has failed to comply with its obligations under the authorisation or this Regulation.
imetnik dovoljenja ni izpolnil obveznosti iz dovoljenja ali te uredbe.
Where the competent authority or, in the case of a Union authorisation, the Commission, intends to cancel or amend an authorisation, it shall inform the authorisation holder thereof and give it the opportunity to submit comments or additional information within a specified time limit.
Kadar namerava pristojni organ ali, v primeru dovoljenja Unije, Komisija preklicati ali spremeniti dovoljenje, o tem obvesti imetnika dovoljenja in mu da možnost, da v določenem roku predloži pripombe ali dodatne informacije.
The evaluating competent authority or, in the case of a Union authorisation, the Commission, shall take due account of those comments when finalising its decision.
Ocenjevalni pristojni organ ali, v primeru dovoljenja Unije, Komisija te pripombe ustrezno upošteva pri končni odločitvi.
Where the competent authority or, in the case of a Union authorisation, the Commission, cancels or amends an authorisation in accordance with paragraph 1, it shall without delay notify the authorisation holder, the competent authorities of other Member States and, where relevant, the Commission.
Kadar pristojni organ ali, v primeru dovoljenja Unije, Komisija v skladu z odstavkom 1 prekliče ali spremeni dovoljenje, o tem nemudoma uradno obvesti imetnika dovoljenja, pristojne organe drugih držav članic in po potrebi Komisijo.
Competent authorities that have issued authorisations under the mutual recognition procedure for biocidal products for which the authorisation has been cancelled or amended shall, within 120 days of the notification, cancel or amend the authorisations and shall notify the Commission accordingly.
Pristojni organi, ki so izdali dovoljenja po postopku medsebojnega priznavanja dovoljenj za biocidne proizvode, za katere je bilo dovoljenje preklicano ali spremenjeno, v 120 dneh od uradnega obvestila prekličejo ali spremenijo dovoljenja in ustrezno uradno obvestijo Komisijo.
In the case of disagreement between competent authorities of certain Member States concerning national authorisations subject to mutual recognition the procedures laid down in Articles 35 and 36 shall apply mutatis mutandis.
Če se pristojni organi določenih držav članic med seboj ne strinjajo glede nacionalnih dovoljenj, za katere velja medsebojno priznanje, se smiselno uporabljajo postopki iz členov 35 in 36.
Cancellation of an authorisation at the request of the authorisation holder
Preklic dovoljenja na zahtevo imetnika dovoljenja
At the reasoned request of an authorisation holder, the competent authority that granted the national authorisation or, in the case of Union authorisation, the Commission shall cancel the authorisation.
Pristojni organ, ki je izdal nacionalno dovoljenje, ali, v primeru dovoljenja Unije, Komisija na podlagi utemeljene zahteve imetnika dovoljenja prekliče dovoljenje.
Where such a request concerns a Union authorisation, it shall be submitted to the Agency.
Če takšna zahteva zadeva dovoljenje Unije, se vloži pri Agenciji.
Amendment of an authorisation at the request of the authorisation holder
Sprememba dovoljenja na zahtevo imetnika dovoljenja
Amendments to the terms and conditions of an authorisation shall be made only by the competent authority that authorised the biocidal product concerned, or in the case of a Union authorisation, by the Commission.
Določila in pogoje za dovoljenje spremeni le pristojni organ, ki je odobril zadevni biocidni proizvod, ali, v primeru dovoljenja Unije, Komisija.
An authorisation holder seeking to change any of the information submitted in relation to the initial application for authorisation of the product shall apply to the competent authorities of relevant Member States having authorised the biocidal product concerned, or in the case of a Union authorisation, the Agency.
Imetnik dovoljenja, ki želi spremeniti informacije, predložene v zvezi s prvotno vlogo za izdajo dovoljenja za proizvod, vloži vlogo pri pristojnih organih ustreznih držav članic, ki so odobrile zadevni biocidni proizvod, ali, v primeru dovoljenja Unije, pri Agenciji.
Those competent authorities shall decide, or, in the case of a Union authorisation, the Agency shall examine and the Commission decide whether the conditions of Article 19 or, where relevant, Article 25 are still met and whether the terms and conditions of the authorisation need to be amended.
Ti pristojni organi odločijo ali, v primeru dovoljenja Unije, Agencija preuči in Komisija odloči, ali so pogoji iz člena 19 ali, kjer je pomembno, člena 25 še vedno izpolnjeni in ali je treba spremeniti določila in pogoje za izdajo dovoljenja.
The application shall be accompanied by the fees payable under Article 80(1) and (2).
Ob vložitvi vloge se plačajo tudi pristojbine, ki se plačujejo v skladu s členom 80(1) in (2).
An amendment to an existing authorisation shall fall under one of the following categories of changes:
Sprememba obstoječega dovoljenja spada v eno od naslednjih kategorij sprememb:
administrative change;
upravna sprememba;
minor change; or
manjša sprememba ali
major change.
večja sprememba.
In order to ensure a harmonised approach to the cancellation and amendment of authorisations, the Commission shall lay down detailed rules for the application of Articles 47 to 50 by means of implementing acts.
Za zagotovitev usklajenega pristopa pri preklicu in spremembi dovoljenj Komisija z izvedbenimi akti določi podrobna pravila za uporabo členov 47 do 50.
The rules referred to in the first paragraph of this Article shall be based, inter alia, on the following principles:
Pravila iz prvega odstavka tega člena temeljijo med drugim na naslednjih načelih:
a simplified notification procedure shall be applied for administrative changes;
za upravne spremembe se uporablja poenostavljeni postopek priglasitve;
a reduced evaluation period shall be established for minor changes;
za manjše spremembe se določi krajše obdobje ocenjevanja;
in the case of major changes, the evaluation period shall be proportionate to the extent of the proposed change.
v primeru večjih sprememb je obdobje ocenjevanja sorazmerno z obsegom predlagane spremembe.
Notwithstanding Article 89, where the competent authority or, in the case of a biocidal product authorised at Union level, the Commission, cancels or amends an authorisation or decides not to renew it, it shall grant a period of grace for the disposal, making available on the market and use of existing stocks, except in cases where continued making available on the market or use of the biocidal product would constitute an unacceptable risk to human health, animal health or the environment.
Kadar pristojni organ ali, v primeru biocidnega proizvoda, odobrenega na ravni Unije, Komisija prekliče ali spremeni dovoljenje ali odloči, da ga ne bo obnovila, ne glede na člen 89 odobri prehodno obdobje za odstranitev, dostopnost na trgu in uporabo obstoječih zalog, razen v primerih, kadar bi nadaljnja dostopnost na trgu ali uporaba biocidnega proizvoda pomenila nesprejemljivo tveganje za zdravje človeka, zdravje živali ali okolje.
The period of grace shall not exceed 180 days for the making available on the market and an additional maximum period of 180 days for the disposal and use of existing stocks of the biocidal products concerned.
Prehodno obdobje ne sme biti daljše od 180 dni za dostopnost na trgu in od dodatnih največ 180 dni za odstranitev in uporabo obstoječih zalog zadevnih biocidnih proizvodov.
PARALLEL TRADE
VZPOREDNO TRGOVANJE
A competent authority of a Member State (‘Member State of introduction’) shall, at the request of the applicant, grant a parallel trade permit for a biocidal product that is authorised in another Member State (‘Member State of origin’) to be made available on the market and used in the Member State of introduction, if it determines in accordance with paragraph 3 that the biocidal product is identical to a biocidal product already authorised in the Member State of introduction (‘the reference product’).
Pristojni organ države članice (v nadaljnjem besedilu: država članica vnosa) na zahtevo vlagatelja izda dovoljenje za vzporedno trgovanje z biocidnim proizvodom, za katerega je bilo izdano dovoljenje v drugi državi članici (v nadaljnjem besedilu: država članica porekla), zaradi dostopnosti na trgu in uporabe v državi članici vnosa, če v skladu z odstavkom 3 ugotovi, da je biocidni proizvod identičen biocidnemu proizvodu, ki je že dovoljen v državi članici vnosa (v nadaljnjem besedilu: referenčni proizvod).
The applicant who intends to place the biocidal product on the market in the Member State of introduction shall submit the application for a parallel trade permit to the competent authority of the Member State of introduction.
Vlagatelj, ki namerava dati biocidni proizvod na trg v državi članici vnosa, vloži vlogo za dovoljenje za vzporedno trgovanje pri pristojnemu organu države članice vnosa.
The application shall be accompanied by the information referred to in paragraph 4 and all other information necessary to demonstrate that the biocidal product is identical to the reference product as defined in paragraph 3.
Vlogi se priložijo informacije iz odstavka 4 in vse druge informacije, ki so potrebne, da se dokaže, da je biocidni proizvod identičen referenčnemu proizvodu, določenemu v odstavku 3.
Where the competent authority of the Member State of introduction determines that a biocidal product is identical to the reference product, it shall grant a parallel trade permit within 60 days of receipt of the fees payable under Article 80(2).
Če pristojni organ države članice vnosa ugotovi, da je biocidni proizvod identičen referenčnemu proizvodu, izda dovoljenje za vzporedno trgovanje v 60 dneh po prejemu pristojbin, ki se plačujejo v skladu s členom 80(2).
The competent authority of the Member State of introduction may request from the competent authority of the Member State of origin additional information necessary to determine whether the product is identical to the reference product.
Pristojni organ države članice vnosa lahko od pristojnega organa države članice porekla zahteva dodatne informacije, ki so potrebne za ugotovitev, ali je proizvod identičen referenčnemu proizvodu.
The competent authority of the Member State of origin shall provide the requested information within 30 days of receiving the request.
Pristojni organ države članice porekla zagotovi zahtevane informacije v 30 dneh po prejemu zahteve.
A biocidal product shall be considered as identical to the reference product only if all the following conditions are met:
Biocidni proizvod se šteje za identičnega referenčnemu proizvodu le, če so izpolnjeni vsi naslednji pogoji:
they have been manufactured by the same company, by an associated undertaking or under license in accordance with the same manufacturing process;
proizvedla ju je ista družba, povezano podjetje ali pa sta bila proizvedena po licenci v skladu z enakim proizvodnim postopkom;
they are identical in specification and content in respect of the active substances and the type of formulation;
identična sta po specifikaciji in vsebini, kar zadeva aktivne snovi, ter po vrsti formulacije;
they are the same in respect of the non-active substances present; and
sta enaka glede na vsebnost neaktivnih snovi in
they are either the same or equivalent in packaging size, material or form, in terms of the potential adverse impact on the safety of the product with regard to human health, animal health or the environment.
sta enaka ali enakovredna glede velikosti, materiala ali oblike embalaže v smislu možnega neželenega vpliva na varnost proizvoda, kar zadeva zdravje človeka, zdravje živali ali okolje.
An application for a parallel trade permit shall include the following information and items:
Vloga za dovoljenje za vzporedno trgovanje vsebuje naslednje informacije in točke:
name and authorisation number of the biocidal product in the Member State of origin;
ime in številko dovoljenja za biocidni proizvod v državi članici porekla;
name and address of the competent authority of the Member State of origin;
naziv in naslov pristojnega organa države članice porekla;
name and address of the authorisation holder in the Member State of origin;
ime in naslov imetnika dovoljenja v državi članici porekla;
original label and instructions for use with which the biocidal product is distributed in the Member State of origin if it is considered as necessary for the examination by the competent authority of the Member State of introduction;
izvirno oznako in navodila za uporabo, ki se priložijo biocidnemu proizvodu za prodajo v državi članici porekla, če pristojni organ države članice vnosa meni, da so potrebni za preučitev;
name and address of the applicant;
ime in naslov vlagatelja;
name to be given to the biocidal product to be distributed in the Member State of introduction;
ime, ki se podeli biocidnemu proizvodu za prodajo v državi članici vnosa;