natgillin/translations-raw huggingface dataset:
Sprememba obstoječega dovoljenja spada v eno od spodnjih kategorij, navedenih v točkah (ua), (ub) in (uc) člena 3:
An amendment to an existing authorisation should fall under one of the following categories referred to in points (ua), (ub) and (uc) of Article 3:
(a) upravna sprememba,
(a) Administrative change,
(b) manjša sprememba ali
(b) Minor change or
(c) večja sprememba.
(c) Major change.
V zakonodajnem besedilu bi morala biti jasno izražena glavna načela, ki se uporabljajo pri spreminjanju dovoljenj, podrobnosti glede postopkov pa je mogoče določiti v izvedbenih ukrepih.
The legislative text should clearly outline the main principles which shall be applied when amending authorisations, although the details of the procedures can be specified in the implementing measures.
Zlasti je treba opredeliti vrste sprememb, ki so možne pri obstoječih dovoljenjih za pripravke.
In particular, it is necessary to specify the types of changes that can be made to existing product authorisations.
Člen 42 – odstavek 1 a (novo)
Article 42 – paragraph 1 a (new)
Merila in postopki iz odstavka 1 temeljijo na naslednjih načelih, vendar nanje niso omejeni:
The criteria and the procedures referred to in paragraph 1 shall be based on, but not limited to, the following principles:
(a) za upravne spremembe dovoljenja obveščanja se bo zahteval poenostavljen postopek,
(a) a simplified notification procedure shall be applied for administrative changes to the authorisation;
(b) za oceno manjših sprememb dovoljenja se bo določilo krajše obdobje,
(b) a reduced evaluation period shall be established for minor changes to the authorisation;
(c) v primeru pomembnih sprememb se bo določilo obdobje glede na obsežnost sprememb.
(c) a period of time proportional to the size of the variations requested in the event of significant variations.
Čeprav se lahko podrobnosti postopka opišejo v izvedbenih ukrepih, mora zakonodajno besedilo jasno opredeliti temeljna načela, ki se bodo uporabila pri različnih tipih sprememb, ki se lahko opravijo na obstoječih proizvodih.
While the details of procedures can be specified in the implementing measures, the legislative text should clearly define the fundamental principles to be applied to the different types of change that may be made to the authorisations for existing products.
Člen 44 – odstavek 1– pododstavek 1
Article 44 – paragraph 1 – subparagraph 1
Pristojni organ lahko izda dovoljenje za vzporedno trgovanje za biocidni pripravek, ki je odobren v drugi državi članici (v nadaljnjem besedilu država članica porekla), za dajanje v promet in uporabo v tej državi članici (v nadaljnjem besedilu država članica vnosa), če pristojni organ te države članice ugotovi, da je biocidni pripravek po sestavinah zelo podoben biocidnemu pripravku, ki je že dovoljen na njenem ozemlju (v nadaljnjem besedilu referenčni pripravek).
A competent authority of a Member State (hereinafter referred to as 'Member State of introduction') may grant a parallel trade permit for a biocidal product that is authorised in another Member State (hereinafter referred to as 'Member State of origin') to be placed on the market and used in the Member State of introduction, if it determines that the biocidal product is substantially identical in composition to a biocidal product already authorised in that Member State (hereinafter referred to as 'the reference product') .
Da bi se doseglo razumno ravnovesje med prosto trgovino dobrin in varnim tržnim okoljem, je treba dovoljenja iz vzporednega trga omejiti na enake proizvode, ki temeljijo na istem viru aktivnih snovi in sestavin.
Parallel trade permits should be restricted to identical products based on the same source of active substances and co-formulants in order to achieve a reasonable balance between free trade in goods and a safe market environment.
Biocidni pripravek se šteje za identičnega referenčnemu biocidnemu pripravku, če:
A biocidal product shall be considered as identical to the reference product if:
(a) vir aktivnih snovi, ki jih vsebuje, je isti, kar zadeva proizvajalca in lokacijo proizvodnega obrata;
(a) the source of the active substances it contains is the same in terms of manufacturer and location of the production plant;
(a) ga je proizvedel isti proizvajalec ali z njim povezan proizvajalec ali pod licenčno pogodbo z enakim proizvodnim postopkom,
(a) it has been produced by the same manufacturer or a manufacturer associated with him or under licence, on the basis of the same manufacturing process;
(b) je enak po vsebini aktivnih snovi in po tipu formulacije, ter
(b) it is the same with regard to the specifications and content of the active substances and the type of formulation; and
(c) je enak ali enakovreden po prisotnih sestavinah in po formatu, po materialu in obliki embalaže, po možnosti negativnega vpliva na varnost proizvoda za zdravje ljudi in živali ali za okolje.
(c) it is the same or equivalent in the co-formulants present and the packaging size, material or form, in terms of the potential adverse impact on the safety of the product with regard to human or animal health or the environment.
Zaradi skladnosti je treba pogoje, predvidene za zelo podoben proizvod, zamenjati s pogoji za enak proizvod.
For the purpose of consistency, the conditions relating a substantially identical product should be replaced with those for an identical product.
Člen 44 – odstavek 4 – točka a a (novo)
Article 44 – paragraph 4 – point a a (new)
(aa) številka vključitve aktivnih snovi v proizvodu je in, kjer je to primerno, izjava o dostopnosti predlagatelja v skladu s členom 50.
(aa) registration number of the active substances contained in the product and, where appropriate, the applicant's letter of access in accordance with Article 50;
Zaradi skladnosti s členom 8(5)(a) in da bi zagotovili, da ima predlagatelj potreben dokument za dostop do podatkov.
To be consistent with Article 8(5a) and to ensure that the applicant has the document required for access to the data.
Člen 44 – odstavek 4 – točka c
Article 44 – paragraph 4 – point c
(c) ime in naslov imetnika dovoljenja za biocidni pripravek v državi članici porekla in, kjer je to primerno, izjavo o dostopnosti do podatkov v skladu s členom 50 ;
(c) name and address of the authorisation holder in the Member State of origin and, where appropriate, the letter of access in accordance with Article 50 ;
Da bi zagotovili, da predlagatelj ima potreben dokument za dostop do podatkov.
To ensure that the applicant has the document required for access to the data.
Ne glede na člen 15 se lahko poskus ali preskus, namenjen za razvoj ali raziskave, ki vključujejo dajanje še nedovoljenega biocidnega pripravka v promet, ali dajanje aktivne snovi v promet, ki je namenjena izključno za uporabo v biocidnem pripravku, izvedejo le, če gre za znanstveni razvoj in raziskave ali v pripravek in proces usmerjene raziskave in razvoj ter pod pogoji iz drugega in tretjega pododstavka.
By way of derogation from Article 15, an experiment or a test for the purposes of research or development involving the placing on the market of an unauthorised biocidal product or an active substance intended exclusively for use in a biocidal product may only take place in the case of scientific research and development or in the case of product and process-oriented research and development, and under the conditions laid down in the second and third subparagraphs.
V primeru znanstvenega razvoja in raziskav oseba, ki namerava izvesti poskus ali preskus, pred začetkom izvajanja o tem obvesti pristojni organ.
In the case of scientific research and development, the person who intends to carry out the experiment or the test shall notify the competent authority prior to the start.
Oseba sestavi in hrani pisno evidenco, ki vsebuje podroben opis biocidnega pripravka ali aktivne snovi, podatke o označevanju, dobavljene količine ter imena in naslove prejemnikov biocidnega pripravka ali aktivne snovi, ter zbere dokumentacijo, ki vsebuje vse razpoložljive podatke o možnih učinkih na zdravje človeka ali živali, ali vplivu na okolje.
The person shall draw up and maintain written records detailing the identity of the biocidal product or active substance, labelling data , quantities supplied and the names and addresses of those persons receiving the biocidal product or active substance , and shall compile a dossier containing all available data on possible effects on human or animal health or impact on the environment.
Zadevna oseba mora te podatke dati na voljo pristojnemu organu, če jih zahteva.
The persons concerned shall, if requested, make this information available to the competent authority.
V primeru znanstvenega razvoja in raziskav oseba, ki namerava izvesti poskus ali preskus, pred začetkom izvajanja o tem obvesti pristojni organ , če količine aktivnih snovi ali biocidnih pripravkov, ki se jih sme sprostiti med poskusi ali preskusi, ne presegajo ene tone na leto.
In the case of scientific research and development, the person who intends to carry out the experiment or the test shall notify the competent authority prior to the start , provided that the quantities of active substances or biocidal products that may be released during the experiment or test do not exceed one tonne per year.
Oseba sestavi in hrani pisno evidenco, ki vsebuje podroben opis biocidnega pripravka ali aktivne snovi, podatke o označevanju in dobavljene količine, ter zbere dokumentacijo, ki vsebuje vse razpoložljive podatke o možnih učinkih na zdravje človeka ali živali, ali vplivu na okolje.
The person shall draw up and maintain written records detailing the identity of the biocidal product or active substance, labelling data and quantities supplied, and shall compile a dossier containing all available data on possible effects on human or animal health or impact on the environment.
Če gre za v pripravek in uporabo usmerjena raziskovanje in razvoj, oseba, ki namerava izvesti poskus ali preskus, pred dajanjem biocidnega pripravka ali aktivne snovi v promet pristojnemu organu države članice, kjer se dajanje v promet izvede, sporoči informacije, zahtevane v drugem pododstavku.
In the case of product and process-oriented research and development, the person who intends to carry out the experiment or the test shall, prior to the placing of the biocidal product or the active substance on the market, notify the information required in the second subparagraph to the competent authority of the Member State where the placing on the market occurs.
Nedovoljeni biocidni pripravek ali aktivna snov za izključno uporabo v biocidnem pripravku se ne sme dajati v promet za namen kakršnega koli poskusa ali preskusa, ki lahko vključuje ali ima za posledico sproščanje v okolje, razen če pristojni organ oceni podatke, ki jih je predložila oseba, ki želi dati tak pripravek v promet, in izda nacionalno dovoljenje za ta namen, ki omejuje uporabljene količine ter površine, ki se bodo tretirale, in lahko naloži še druge pogoje.
An unauthorised biocidal product or an active substance for exclusive use in a biocidal product shall not be placed on the market for the purpose of any experiment or test which may involve, or result in, release of the biocidal product into the environment unless the competent authority has assessed the data submitted by the person interested in the placing of such product on the market and issued a national authorisation for this purpose which limits the quantities to be used and the areas to be treated and which may impose further conditions.
Pristojni organ nemudoma obvesti Komisijo in druge pristojne organe o izdanem nacionalnem dovoljenju.
The competent authority shall without delay inform the Commission and other competent authorities about the issued national authorisation .
Nedovoljeni biocidni pripravek ali aktivna snov za izključno uporabo v biocidnem pripravku se ne sme dajati v promet za namen kakršnega koli poskusa ali preskusa, ki lahko vključuje ali ima za posledico sproščanje v okolje, razen če pristojni organ oceni podatke, ki jih je predložila oseba, ki želi dati tak pripravek v promet, in izda pozitivno mnenje za ta namen, v katerem lahko naloži še druge pogoje.
An unauthorised biocidal product or an active substance for exclusive use in a biocidal product shall not be placed on the market for the purpose of any experiment or test which may involve, or result in, release of the biocidal product into the environment unless the competent authority has assessed the data submitted by the person interested in the placing of such product on the market and issued a positive opinion for this purpose which may impose further conditions.
Če pristojni organ v tridesetih dneh po priglasitvi informacij iz odstavka 1 ne predloži mnenja, je biocidni pripravek ali aktivno snov mogoče dati v promet za namen napovedanega preskusa ali poskusa.
In the absence of an opinion from the competent authority within 30 days of the notification of the information required in paragraph 1, the biocidal product or active substance may be placed on the market for the purpose of the notified experiment or test .
Kadar se poskus ali preskus izvaja v državi članici, kjer se biocidni pripravek ne daje v promet, predlagatelj pridobi dovoljenje za poskus ali preskus od pristojnega organa tiste države članice, na ozemlju katere se bodo poskusi ali preskusi izvajali.
Where any experiment or test takes place in a Member State other than the Member State where placing on the market of the biocidal product occurs, the applicant shall obtain experiment or test authorisation from the competent authority of the Member State in the territory of which the experiments or tests are to be conducted.
Kadar se poskus ali preskus izvaja v državi članici, kjer se biocidni pripravek ne daje v promet, predlagatelj obvesti pristojni organ tiste države članice, na ozemlju katere se bodo poskusi ali preskusi izvajali.
Where any experiment or test takes place in a Member State other than the Member State where placing on the market of the biocidal product occurs, the applicant shall notify the competent authority of the Member State in the territory of which the experiments or tests are to be conducted.
Predlagatelj sestavi in hrani pisno evidenco, ki vsebuje podroben opis biocidnega pripravka ali aktivne snovi, podatke o označevanju in dobavljene količine, ter zbere dokumentacijo, ki vsebuje vse razpoložljive podatke o možnih učinkih na zdravje človeka ali živali ali vplivu na okolje.
The applicant shall draw up and maintain written records detailing the identity of the biocidal product or active substance, labelling data and quantities supplied, and shall compile a dossier containing all available data on possible effects on human or animal health or impact on the environment.
Predlagatelj mora te podatke na zahtevo dati na voljo pristojnemu organu.
The applicant shall, if requested, make this information available to the competent authority.
Tretirani izdelki ali snovi se označijo z naslednjimi informacijami:
Treated articles or materials shall be labelled with the following information:
Tretirani izdelki ali snovi , ki vsebujejo enega ali več biocidnih pripravkov, ki bi lahko bili pod običajnimi ali predvidljivimi pogoji uporabe izpuščeni v okolje ali bi prišli v neposredni stik s človekom, se označijo z naslednjimi informacijami:
Treated articles or materials that incorporate one or more biocidal products that might , under normal and foreseeable conditions of use, be released into the environment or come into direct contact with humans, shall be labelled with the following information:
(a) imena vseh aktivnih snovi, uporabljenih za tretiranje ali iz katerih so izdelki ali snovi sestavljene , pri čemer se, kjer je to mogoče, uporabi mednarodno priznana nomenklatura;
(a) the name of all active substances that were used for the treatment or were incorporated in the articles or materials , using, where possible, internationally recognised nomenclature ;
(b) biocidna lastnost tretiranega izdelka ali snovi, kjer je potrebno;
(b) where relevant, the biocidal property attributed to treated articles or materials;
(c) številke dovoljenj vseh biocidnih pripravkov, ki so bili uporabljeni za tretiranje ali so vključeni v izdelke ali snovi.
(c) the authorisation number of all biocidal products that were used for the treatment or were incorporated in the articles or materials;
(c) stavki o nevarnosti ali previdnostni stavki, navedeni v dovoljenju za biocidni pripravek.
(c) any hazard statement or precautionary statement set out in the authorisation for the biocidal product.
Označba mora biti jasno vidna, čitljiva in primerno obstojna.
The labelling shall be clearly visible, easily legible and appropriately durable.
Označba se lahko natisne na tretiran izdelek ali snov, na embalažo, na navodila za uporabo ali na garancijo tretiranega izdelka ali snovi, pogoj pa je , da je jasno vidna, čitljiva in ustrezno odporna.
The labelling may be printed on the treated article or material, on the packaging, on the instructions for use or on the warranty of the treated article or material, provided that it is clearly visible, easily legible and appropriately durable.
Ta odstavek ne posega v zahteve glede označevanja ali obveščanja iz sektorsko specifične zakonodaje, ki se uporablja za tretirane izdelke ali snovi.
This paragraph shall be without prejudice to labelling or information requirements laid down in sector specific legislation applicable to treated articles and materials.
(a) poznejši predlagatelj je od prvega predlagatelja pridobil pisni dogovor v obliki izjave o dostopnosti , v katerem mu dovoljuje uporabo navedenih informacij ;
(a) the subsequent applicant has written agreement in the form of a letter of access from the first applicant that he can use that information ,
(a) poznejši predlagatelj je od prvega predlagatelja pridobil pisni dogovor v obliki izjave o dostopnosti v skladu s členom 50 ;
(a) the subsequent applicant has written agreement in the form of a letter of access , as provided for by Article 50 ,
Treba je dopustiti možnost, da je kot rezultat delitve in skupnega razvoja solastnik podatkov drugi predlagatelj ali da to lahko postane.
The option must also be allowed for a second applicant to be or become the co-owner of the information, as a result of sharing or joint development of the information.
(ba) naslednji predlagatelj se tudi obravnava kot lastnik podatkov;
(ba) the subsequent applicant is also regarded as an owner of the information.
Treba je dopustiti možnost, da je kot rezultat delitve in skupnega razvoja solastnik podatkov drugi predlagatelj ali da to lahko postane.
The option must also be allowed for a second applicant or business to be or become the co-owner of the information, as a result of sharing or joint development of the information.
Agencija vse informacije s seznama iz odstavka 2 , označene z enotno kodo, vnese v register za izmenjavo podatkov o biocidih , ki vsebuje vse prepoznavne podrobnosti, povezane z identiteto prvega predlagatelja in lastnika podatkov .
All information contained in the list referred to in paragraph 2 shall be entered by the Agency in the Biocides Data Sharing Register , identified by a single code and complete with all identifying details and with a link to the identity of the first applicant and of the owner of the information.
Register mora vsebovati vse delne informacije in dokumente s seznama.
All parts of the items of information and documents that are on the list must be contained in the register.
Številčna identifikacija je primernejša za vse poslane dokumente, saj se tako izognemo zmedi ob pošiljanju imen ali popravkov študij s podobnimi imeni.
It is preferable to identify numerically each document sent in order to avoid confusion when titles or corrections to studies with similar names are sent.
Povezava z lastnikom podatkov in predlagateljem zagotavlja, da se spoštujejo lastninske pravice.
Linking the items of information to the information owners and applicants will ensure that property rights are respected.
Informacije, predložene za namen te Direktive 98/8 ali te uredbe, bodo varovane v skladu s pogoji iz tega člena.
Information submitted for the purposes of Directive 98/8/EC or of this Regulation shall benefit from data protection under the conditions laid down in this Article.
Obdobje varovanja teh informacij se začne ob predložitvi podatkov.
The protection period for this information shall start when the information is submitted.
Datum pošiljanja se dodeli vsakemu dokumentu, ki ima enotno kodo v skladu s členom 48(4).
A date of submission shall be assigned separately to each document, identified with the single code pursuant to Article 48(4).
Informacije, varovane v skladu z Direktivo 98/8/ES ali tem členom ali za katere obdobje varovanja poteče v skladu z Direktivo 98/8/ES ali tem členom, se ponovno ne zavarujejo.
Information protected under Directive 98/8/EC or under this Article or for which the protection period expired under Directive 98/8/EC or under this Article shall not be protected again.
Zahteve po zaščiti podatkov nikoli niso bile jasno opredeljene v Direktivi 98/8/ES.
Data protection requirements were never unequivocally established by Directive 98/8/EC.
Ker datum pošiljanja dokumentacije ne more biti enak datumu pošiljanja vseh informacij, se datumi dodelijo ločeno pri vsakem pošiljanju.
As the date on which a dossier is submitted may not be the date of submission of all the information, submission dates are to be assigned individually when each subsequent submission of information is made.
Zaščita posameznih podatkov bolje odraža realno stanje, saj je vsak poseben podatek rezultat naložbe lastnika.
Protecting the individual items of information reflects the real situation more faithfully in that each individual item of information is the result of investment by its owner.
Ne glede na prvi pododstavek odstavka 2 se obdobje varovanja informacij, predloženih državi članici v okviru nacionalnih sistemov ali praks za odobritev biocidnih pripravkov, preden so bile predložene za namene Direktive 98/8/ES ali te uredbe, konča ob izteku preostalega obdobja, predpisanega z nacionalnimi predpisi, ali 14. maja 2014, če to nastopi prej, razen če so bile te informacije pridobljene pred 14. majem 2000.
By way of derogation from the first subparagraph of paragraph 2, the protection period for information submitted to a Member State under national systems or practices for the approval of biocidal products, before it was submitted for the purposes of Directive 98/8/EC or of this Regulation, shall end at the expiry of any remaining period provided for under national rules or on 14 May 2014, whichever is the earlier, unless this information has been generated after 14 May 2000.
Tudi če ta člen izboljšuje opredelitev varovanja podatkov iz Direktive 98/8/ES, ni razloga za razlikovanje novih in obstoječih podatkov.
Even if this article represents an improvement in comparison with the provisions of Directive 98/8/EC as regards data protection, there is no justification for distinguishing between new and existing information.
To pa zato, ker nacionalni zakonodajni sistemi pokrivajo samo majhen del trga z biocidnimi pripravki.
This is because national legislative frameworks cover only a small fraction of the biocides market.
Nekatere države članice jih namreč niso uporabile niti tam, kjer ti sistemi obstajajo.
Where such frameworks exist, some Member States have not in fact applied them.
Poleg tega je odprava tega razlikovanja približalo določbe te uredbe uredbi REACH.
Moreover, eliminating this distinction would bring the provisions of the present Regulation more into line with REACH.
Člen 52 – odstavek 3
Article 52 – paragraph 3
Če se dogovor ne sprejme v dveh mesecih po vložitvi zahtevka v skladu s členom 51(2), bodoči predlagatelj o tem nemudoma obvesti agencijo in lastnika informacij .
Where no such agreement is reached two months after the request was made according to Article 51(2), the prospective applicant shall without delay inform the Agency and the owner of the information thereof.