natgillin/translations-raw huggingface dataset:
In case of a favourable opinion, the Agency shall indicate whether the proposed change would require an amendment of the authorisation.
Agencija v primeru ugodnega mnenja navede, ali bi bila zaradi predlagane spremembe potrebna sprememba dovoljenja.
The Agency shall inform the applicant of its opinion and make it available in the Register for Biocidal Products referred to in Article 71 of Regulation (EU) No 528/2012, 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 ga da na voljo v registru biocidnih proizvodov iz člena 71 Uredbe (EU) št. 528/2012 ter po potrebi od vlagatelja zahteva, da v vseh uradnih jezikih Unije predloži osnutek revidiranega povzetka značilnosti biocidnega proizvoda.
Where it appears that additional information is necessary to carry out the evaluation, the Agency shall ask the applicant to submit such information within a specified time limit.
Če se izkaže, da so za izvedbo ocene potrebne dodatne informacije, Agencija 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 authorisation holder, or its representative, shall submit to the Agency an application complying with Article 5.
Imetnik dovoljenja ali njegov zastopnik Agenciji predloži vlogo, ki je v skladu s členom 5.
It shall inform the applicant and the competent authority of the Member State referred to in Article 5(1)(d) (hereinafter referred to as the ‘evaluating competent authority’) accordingly.
O tem obvesti vlagatelja in pristojni organ države članice iz člena 5(1)(d) (v nadaljnjem besedilu: ocenjevalni pristojni organ).
Upon receipt of the fee, the Agency shall accept the application and inform the applicant and the evaluating competent authority accordingly.
Agencija ob prejemu pristojbine sprejme vlogo ter o tem obvesti vlagatelja in ocenjevalni pristojni organ.
An appeal may be brought, in accordance with Article 77 of Regulation (EU) No 528/2012, against decisions of the Agency under this paragraph.
V skladu s členom 77 Uredbe (EU) št. 528/2012 se lahko proti odločitvam Agencije na podlagi tega odstavka vloži pritožba.
Within 30 days of the Agency accepting an application, the evaluating competent authority shall validate the application if it complies with the requirements laid down in Article 5.
Ocenjevalni pristojni organ vlogo v 30 dneh, ko jo je Agencija sprejela, validira, če izpolnjuje zahteve iz člena 5.
The evaluating competent authority shall, within 15 days from the Agency’s acceptance of an application, inform the applicant of the fee payable under Article 80(2) of Regulation (EU) No 528/2012 and shall reject the application if the applicant fails to pay the fee within 30 days.
Ocenjevalni pristojni organ v 15 dneh, ko Agencija sprejme vlogo, vlagatelja obvesti o pristojbini, ki se plača na podlagi člena 80(2) Uredbe (EU) št. 528/2012, in vlogo zavrne, če je vlagatelj ne plača v 30 dneh.
Where the evaluating competent authority 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.
Kadar ocenjevalni pristojni organ meni, da je vloga nepopolna, vlagatelja obvesti, katere dodatne informacije so potrebne za popolnost vloge, in določi razumen rok za predložitev teh informacij.
The evaluating competent authority 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.
Ocenjevalni pristojni organ v 30 dneh po prejemu dodatnih informacij validira vlogo, če odloči, da predložene dodatne informacije zadostujejo za izpolnitev zahtev iz člena 5.
The evaluating 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 Agency accordingly.
Če vlagatelj zahtevanih informacij ne predloži v roku, ocenjevalni pristojni organ vlogo zavrne ter o tem obvesti vlagatelja in Agencijo.
The evaluating competent authority shall, within 180 days of the validation of an application, evaluate it and send an assessment report and the conclusions of its evaluation, including, where relevant, a draft revised summary of the product characteristics, to the Agency.
Ocenjevalni pristojni organ v 180 dneh po validaciji vloge slednjo oceni ter Agenciji pošlje poročilo o oceni in ugotovitve ocene ter po potrebi osnutek revidiranega povzetka značilnosti biocidnega proizvoda.
Prior to submitting its conclusions to the Agency, the evaluating competent authority shall provide the applicant with the opportunity to provide written comments on the conclusions of the evaluation within 30 days.
Preden ocenjevalni pristojni organ svoje ugotovitve predloži Agenciji, da vlagatelju možnost, da v 30 dneh k ugotovitvam ocene predloži pisne pripombe.
Where 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 specified time limit, and shall inform the Agency accordingly.
Če se izkaže, da so za izvedbo ocene potrebne dodatne informacije, ocenjevalni pristojni organ od vlagatelja zahteva, da te predloži v določenem roku, in o tem obvesti Agencijo.
The period referred to in paragraph 5 shall be suspended from the date of the request until the date the information is received.
Obdobje iz odstavka 5 se prekine od dneva zahteve do dneva prejema informacij.
Within 90 days of receipt of the conclusions of the evaluation, the Agency shall prepare and submit to the Commission an opinion on the proposed change.
Agencija v 90 dneh od prejema ugotovitev ocene pripravi mnenje o predlagani spremembi in ga predloži Komisiji.
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, naj 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 draft 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 osnutek revidiranega povzetka značilnosti biocidnega proizvoda, kot je navedeno v členu 22(2) Uredbe (EU) št. 528/2012.
IMPLEMENTATION OF CHANGES
IZVAJANJE SPREMEMB
Administrative changes of products
Upravne spremembe proizvodov
Administrative changes referred to in Section 2 of Title 1 of the Annex may be implemented any time before completion of the procedures laid down in Articles 6 and 11.
Upravne spremembe iz oddelka 2 naslova 1 Priloge se lahko izvedejo kadar koli pred končanjem postopkov iz členov 6 in 11.
Administrative changes referred to in Section 1 of Title 1 of the Annex may be implemented at the earliest on the date when the Member State or, in the case of changes of a product authorised by Union authorisation, the Commission explicitly agrees with the change, or 45 days following receipt of the notification submitted in accordance with Articles 6 and 11, whichever is earliest.
Upravne spremembe iz oddelka 1 naslova 1 Priloge se lahko izvedejo najprej na dan, ko se država članica ali, v primeru sprememb proizvoda, odobrenih z dovoljenjem Unije, Komisija izrecno strinja s spremembo, ali 45 dni po prejemu obvestila, predloženega v skladu s členoma 6 in 11, kar je prej.
Where one of the changes referred to in paragraph 1 is rejected, the authorisation holder shall cease to apply the concerned change within 30 days following notification of the decision of the relevant Member States or, in the case of changes of a product authorised by Union authorisation, the Commission.
Kadar se ena od sprememb iz odstavka 1 zavrne, imetnik dovoljenja preneha izvajati zadevno spremembo v 30 dneh po prejemu obvestila o odločitvi zadevnih držav članic ali, v primeru sprememb proizvoda, ki jih odobri Unija, Komisije.
Minor changes
Manjše spremembe proizvodov, odobrene z dovoljenjem Unije
Subject to a favourable opinion from the Agency, minor changes of a product authorised by Union authorisation may be implemented any time after the Agency’s opinion has been made available in the Register for Biocidal Products in accordance with Article 12(4).
Ob ugodnem mnenju Agencije se lahko manjše spremembe proizvoda, odobrene z dovoljenjem Unije, izvedejo kadar koli potem, ko je bilo mnenje Agencije dano na voljo v registru biocidnih proizvodov v skladu členom 12(4).
Where the proposed minor change of the product is rejected by the Commission in accordance with Article 50(2) of Regulation (EU) No 528/2012, the authorisation holder shall cease to apply the proposed change within 30 days following notification of the decision of the Commission.
Kadar predlagano manjšo spremembo proizvoda Komisija zavrne v skladu s členom 50(2) Uredbe (EU) št. 528/2012, imetnik dovoljenja preneha izvajati predlagano spremembo v 30 dneh po prejemu obvestila o odločitvi Komisije.
Minor changes of a product authorised by Member States may be implemented any time after the reference Member State has made the agreement available in the Register for Biocidal Products in accordance with Article 7(7).
Manjše spremembe proizvoda, ki jih odobrijo države članice, se lahko izvedejo kadar koli potem, ko je referenčna država članica dala soglasje na voljo v registru biocidnih proizvodov v skladu s členom 7(7).
Major changes
Večje spremembe
Major changes may only be implemented after the concerned Member States have or, in the case of changes of a product authorised by Union authorisation, the Commission has agreed with the change and, where relevant, amended the decision granting the authorisation by the decision referred to in Article 50(2) of Regulation (EU) No 528/2012.
Večje spremembe se lahko izvedejo šele potem, ko so se ustrezne države članice ali, v primeru sprememb proizvoda, odobrenih z dovoljenjem Unije, Komisija strinjale s spremembo in po potrebi spremenile odločitev o odobritvi dovoljenja z odločitvijo iz člena 50(2) Uredbe (EU) št. 528/2012.
Continuous monitoring of implementation of changes
Stalno spremljanje izvajanja sprememb
Where requested by a Member State, the Agency or the Commission and for the purpose of monitoring biocidal products placed on the market, authorisation holders shall without delay supply the requesting authority with any information related to the implementation of a given change.
Kadar država članica, Agencija ali Komisija tako zahteva ali za namene spremljanja biocidnih proizvodov, danih na trg, imetnik dovoljenja organu, ki zahteva informacije v zvezi z izvajanjem določene spremembe, te nemudoma zagotovi.
CLASSIFICATION OF CHANGES OF PRODUCTS
RAZVRSTITEV SPREMEMB PROIZVODOV
An administrative change of a product is a change following which any change of the existing authorisation can be expected to be only administrative within the meaning of Article 3(1)(aa) of Regulation (EU) No 528/2012.
Upravna sprememba proizvoda je sprememba, na podlagi katere se lahko od katere koli spremembe obstoječega dovoljenja pričakuje, da je zgolj upravna v smislu člena 3(1)(aa) Uredbe (EU) št. 528/2012.
Administrative changes of products requiring prior notification before implementation
Upravne spremembe proizvodov, za katere je pred izvajanjem potrebno predhodno obvestilo
An administrative change of a product requiring prior notification before implementation is an administrative change, the knowledge of which is important for purposes of control and enforcement.
Upravna sprememba proizvoda, za katero je pred izvajanjem potrebno predhodno obvestilo, je upravna sprememba, ki jo je treba poznati za namene nadzora in izvrševanja.
Such changes include those listed in the following table, provided that the conditions therein are met:
Takšne spremembe vključujejo spremembe iz naslednje razpredelnice, če so izpolnjeni v njej navedeni pogoji:
Name of the biocidal product
Ime biocidnega proizvoda
Changes of the name of the biocidal product where there is no risk of confusion with the names of other biocidal products.
Spremembe imena biocidnega proizvoda, kadar ni tveganja, da bi prišlo do zamenjave z imeni drugih biocidnih proizvodov.
Addition of a name for the biocidal product where there is no risk of confusion with the names of other biocidal products.
Dodajanje imena za biocidni proizvod, kadar ni tveganja, da bi prišlo do zamenjave z imeni drugih biocidnih proizvodov.
Transfer of the authorisation to a new holder established in the European Economic Area (EEA).
Prenos dovoljenja na novega imetnika s sedežem v Evropskem gospodarskem prostoru (EGP).
Change in the name or address of the authorisation holder, which remains in the EEA.
Sprememba imena ali naslova imetnika dovoljenja, ki ostaja v EGP.
Manufacturer(s) of the active substance(s)
Proizvajalci aktivnih snovi
Addition of a manufacturer of the active substance or change in the manufacturer’s identity or in manufacturing location or process, where the technical equivalence between the substances from the two manufacturers, manufacturing locations and processes has been established by the Agency in accordance with Article 54 of Regulation (EU) No 528/2012, and the manufacturer or importer is listed in accordance with Article 95(2) of Regulation (EU) No 528/2012.
Dodajanje proizvajalca aktivne snovi ali sprememba identitete proizvajalca, kraja ali postopka proizvodnje, kadar je Agencija v skladu s členom 54 Uredbe (EU) št. 528/2012 ugotovila tehnično ekvivalenco snovi obeh proizvajalcev, krajev in postopkov proizvodnje in je proizvajalec ali uvoznik naveden na seznamu iz člena 95(2) Uredbe (EU) št. 528/2012.
Biocidal product family
Družina biocidnih proizvodov
Authorisation as a biocidal product family of a number of authorised products falling within the specifications of a frame-formulation established in accordance with Directive 98/8/EC in accordance with the same terms and conditions.
Več odobrenih proizvodov, ki izpolnjujejo specifikacije okvirne formulacije, določene v skladu z Direktivo 98/8/ES, pridobi dovoljenje kot družina biocidnih proizvodov v skladu z istimi pogoji.
Administrative changes of products which can be notified after implementation
Upravne spremembe proizvodov, ki se lahko priglasijo po izvajanju
An administrative change of a product which can be notified after implementation is an administrative change, the knowledge of which is not important for purposes of control and enforcement.
Upravna sprememba proizvoda, ki se lahko priglasi po izvajanju, je upravna sprememba, ki je ni treba poznati za namene nadzora in izvrševanja.
Change in other administrative details of the authorisation holder than the name and address.
Sprememba upravnih podrobnosti imetnika dovoljenja, ki niso ime in naslov.
Formulator(s) of the biocidal product
Formulatorji biocidnega proizvoda
Change in the name, the administrative details or the formulating location of the biocidal product formulator, where the biocidal product composition and the formulating process remain unchanged.
Sprememba imena, upravnih podrobnosti ali kraja formulacije formulatorja biocidnega proizvoda, kadar sestava biocidnega proizvoda in njegov postopek formulacije ostaneta nespremenjena.
Deletion of a formulating location or a formulator of the biocidal product
Izbris kraja formulacije ali formulatorja biocidnega proizvoda.
Addition of a formulator of the biocidal product, where the biocidal product composition and the formulating process remain unchanged.
Dodajanje formulatorja biocidnega proizvoda, kadar sestava biocidnega proizvoda in postopek formulacije ostaneta nespremenjena.
Change in the name or the administrative details of a manufacturer of the active substance, where the manufacturing location and process remain unchanged and the manufacturer remains listed in accordance with Article 95(2) of Regulation (EU) No 528/2012
Sprememba imena ali upravnih podrobnosti proizvajalca aktivne snovi, kadar kraj in postopek proizvodnje ostaneta nespremenjena in proizvajalec ostane naveden na seznamu iz člena 95(2) Uredbe (EU) št. 528/2012.
Deletion of a manufacturer or a manufacturing location of the active substance
Izbris proizvajalca ali kraja proizvodnje aktivne snovi.
More precise instructions for use, where only wording but not content of instructions are changed.
Natančnejša navodila za uporabo, kadar je spremenjena le dikcija in ne vsebina navodil.
Removal of a particular claim, such as a specific target organism or a specific use.
Odstranitev kake navedbe, npr. posebnega ciljnega organizma ali posebne uporabe.
Removal of a category of users.
Odstranitev kategorije uporabnikov.
Addition, replacement or modification of a measuring or administration device not relevant for the risk assessment and not regarded as a risk mitigation measure.
Dodajanje, nadomestitev ali sprememba merilne ali upravne naprave, ki ni pomembna za oceno tveganja in ne velja za ukrep za zmanjšanje tveganja.
Change to the classification and labelling, where the change is limited to what is necessary to comply with newly applicable requirements of Regulation (EC) No 1272/2008 of the European Parliament and of the Council [1].
Sprememba razvrščanja in označevanja, kadar je sprememba omejena na to, kar je potrebno za izpolnjevanje na novo veljavnih zahtev Uredbe (ES) št. 1272/2008 Evropskega parlamenta in Sveta [1].
Minor changes of products
Manjše spremembe proizvodov
A minor change of a product is a change, following which any change of the existing authorisation can be expected to be minor within the meaning of Article 3(1)(ab) of Regulation (EU) No 528/2012, since the change of the product is not expected to affect the conclusion with regard to the fulfilment of the conditions of Article 19 or 25 of that Regulation.
Manjša sprememba proizvoda je sprememba, na podlagi katere se lahko od katere koli spremembe obstoječega dovoljenja pričakuje, da je manjša v smislu člena 3(1)(ab) Uredbe (EU) št. 528/2012, ker naj sprememba proizvoda ne bi vplivala na ugotovitev glede izpolnjevanja pogojev iz člena 19 ali 25 navedene uredbe.
Such changes include the changes listed in the following table, provided that the conditions therein are met:
Takšne spremembe vključujejo spremembe iz naslednje razpredelnice, če so izpolnjeni v njej navedeni pogoji:
Increase or reduction, addition, deletion or replacement of a non-active substance intentionally incorporated in the product, where:
Povečanje ali zmanjšanje, dodajanje ali izbris ali nadomestitev neaktivne snovi, ki je namerno vključena v proizvod, če:
The added or increased non active-substance is not a substance of concern.
dodana ali povečana neaktivna snov ni pogojno nevarna snov,
The deletion or reduction of the non-active substance does not lead to an increase of an active substance or a substance of concern.
izbris ali zmanjšanje neaktivne snovi ne povzroča povečanja aktivne ali pogojno nevarne snovi,
The physical-chemical properties and the shelf-life of the product are expected to remain the same.
se pričakuje, da bodo fizikalno-kemijske lastnosti in rok uporabe proizvoda ostali enaki,
The risk and efficacy profile are expected to remain the same.
se pričakuje, da bosta tveganje in učinkovitost ostala enaka,
A new quantitative risk assessment is not expected to be necessary
se pričakuje, da nova kvantitativna ocena tveganja ne bo potrebna.
Increase, reduction, addition or deletion, or replacement of a non-active substance intentionally incorporated in a biocidal product family outside the authorised range, where:
Povečanje ali zmanjšanje, dodajanje ali izbris ali nadomestitev neaktivne snovi, ki je namerno vključena v družino biocidnih proizvodov zunaj odobrenega niza, če:
The added or increased non-active substance is not a substance of concern.
dodana ali povečana neaktivna snov ni pogojno nevarna snov,
The physical-chemical properties and the shelf-life of the products of the biocidal product family remain the same.
fizikalno-kemijske lastnosti in rok uporabe proizvodov iz družine biocidnih proizvodov ostanejo enaki,
A new quantitative risk assessment is not expected to be necessary.
se pričakuje, da nova kvantitativna ocena tveganja ne bo potrebna.
Changed instructions for use, where the changes do not adversely affect the exposure
Spremenjena navodila za uporabo, kadar spremembe ne vplivajo negativno na izpostavljenost.
Addition, replacement or modification of a measuring or administration device relevant for the risk assessment and regarded as a risk mitigation measure, where:
Dodajanje, nadomestitev ali sprememba merilne ali upravne naprave, ki je pomembna za oceno tveganja in velja za ukrep za zmanjšanje tveganja, če:
The new device accurately delivers the required dose for the biocidal product concerned in line with the approved conditions of use.
nova naprava natančno odmerja potrebni odmerek zadevnega biocidnega proizvoda v skladu z odobrenimi pogoji uporabe,
The new device is compatible with the biocidal product.
je nova naprava skladna z biocidnim proizvodom,
The change is not expected to adversely affect the exposure.
naj sprememba ne bi negativno vplivala na izpostavljenost.
Shelf-life and conditions of storage
Rok uporabe in pogoji skladiščenja
Change in the shelf-life.
sprememba roka uporabe
Change in the conditions of storage
sprememba pogojev skladiščenja
Pack size
Velikost embalaže
Change in the pack size range, where:
Sprememba obsega velikosti embalaže, kadar:
New range is consistent with the dose rate and instructions for use as approved in the summary of the biocidal product characteristics.
je nov obseg skladen s stopnjo odmerka in navodili za uporabo, kakor so odobreni v povzetku značilnosti biocidnega proizvoda,
No change of user category.
se kategorija uporabnikov ne spremeni,
The same risk-mitigation measures apply.
veljajo enaki ukrepi za zmanjšanje tveganja.
Major changes of products
Večje spremembe proizvodov
A major change of a product is a change, following which any change of the existing authorisation can be expected to be major within the meaning of Article 3(1)(ac) of Regulation (EU) No 528/2012, since the change of the product can be expected to affect the conclusion with regard to the fulfilment of the conditions of Article 19 or 25 of that Regulation.
Večja sprememba proizvoda je sprememba, na podlagi katere se lahko od katere koli spremembe obstoječega dovoljenja pričakuje, da je večja v smislu člena 3(1)(ac) Uredbe (EU) št. 528/2012, ker naj bi sprememba proizvoda vplivala na ugotovitev glede izpolnjevanja pogojev iz člena 19 ali 25 navedene uredbe.
Commission Implementing Regulation (EU) No 355/2013
Izvedbena uredba Komisije (EU) št. 355/2013
approving the active substance maltodextrin, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
o odobritvi aktivne snovi maltodekstrin v skladu z Uredbo (ES) št. 1107/2009 Evropskega parlamenta in Sveta o dajanju fitofarmacevtskih sredstev v promet in spremembi Priloge k Izvedbeni uredbi Komisije (EU) št. 540/2011