natgillin/translations-raw huggingface dataset:
Member States shall ensure that when determined in accordance with Article 38(2)(f), the retrospective assessment shall be carried out by the competent authority which shall, on the basis of the necessary documentation submitted by the user, evaluate the following:
Države članice zagotovijo, da ob določitvi v skladu s členom 38(2)(f) retrospektivno oceno izvede pristojni organ, ki na podlagi potrebne dokumentacije, ki jo zagotovi uporabnik, oceni naslednje:
whether the objectives of the project were achieved;
ali so bili cilji projekta doseženi;
the harm inflicted on animals, including the numbers and species of animals used, and the severity of the procedures; and
škodo, ki je bila povzročena živalim, vključno s številom in živalskimi vrstami uporabljenih živali ter težavnostjo postopkov, in
any elements that may contribute to the further implementation of the requirement of replacement, reduction and refinement.
kakršne koli elemente, ki lahko prispevajo k nadaljnjemu izvajanju zahteve za zamenjavo, zmanjšanje in izboljšanje.
All projects using non-human primates and projects involving procedures classified as ‘severe’, including those referred to in Article 15(2), shall undergo a retrospective assessment.
Retrospektivna ocena se izvede za vse projekte, v katerih se uporabljajo primati razen človeka in projekte, ki vključujejo postopke, ki so razvrščeni kot „težavni“, vključno s tistimi iz člena 15(2).
Without prejudice to paragraph 2 and by way of derogation from Article 38(2)(f), Member States may exempt projects involving only procedures classified as ‘mild’ or ‘non-recovery’ from the requirement for a retrospective assessment.
Brez poseganja v odstavek 2 in z odstopanjem od člena 38(2)(f) lahko države članice iz zahteve po retrospektivni oceni izvzamejo projekte, ki vključujejo samo postopke, ki so razvrščeni kot „blagi“ ali „nepovratni“.
Granting of project authorisation
Odobritev projekta
The project authorisation shall be limited to procedures which have been subject to:
Odobritev projekta je omejena na postopke, ki so bili predmet:
a project evaluation; and
ocene projekta in
the severity classifications assigned to those procedures.
razvrstitve glede na težavnost teh postopkov.
The project authorisation shall specify the following:
V odobritvi projekta se določi:
the user who undertakes the project;
uporabnika, ki izvaja projekt;
the persons responsible for the overall implementation of the project and its compliance with the project authorisation;
osebe, ki so odgovorne za celotno izvajanje projekta in njegovo skladnost z odobritvijo projekta;
the establishments in which the project will be undertaken, where applicable; and
po potrebi ustanove, v katerih se bo projekt izvajal, in
any specific conditions following the project evaluation, including whether and when the project shall be assessed retrospectively.
kakršne koli posebne pogoje, ki izhajajo iz ocene projekta, vključno s tem ali in kdaj se izvede retrospektivna ocena projekta.
Project authorisations shall be granted for a period not exceeding 5 years.
Odobritve projektov se dodelijo za obdobje, ki ne presega petih let.
Member States may allow the authorisation of multiple generic projects carried out by the same user if such projects are to satisfy regulatory requirements or if such projects use animals for production or diagnostic purposes with established methods.
Države članice lahko dovolijo odobritev večkratnih generičnih projektov, ki jih izvaja isti uporabnik, če takšni projekti izpolnjujejo regulativne zahteve ali če se v takšnih projektih uporabljajo živali za proizvodnjo ali diagnostične namene po uveljavljenih metodah.
Authorisation decisions
Odločitev o odobritvi
Member States shall ensure that the decision regarding authorisation is taken and communicated to the applicant 40 working days at the latest from the receipt of the complete and correct application.
Države članice zagotovijo, da se odločitev o odobritvi sprejme in sporoči vlagatelju najpozneje v 40 delovnih dneh od prejema popolne in pravilne vloge.
This period shall include the project evaluation.
To obdobje vključuje oceno projekta.
When justified by the complexity or the multi-disciplinary nature of the project, the competent authority may extend the period referred to in paragraph 1 once, by an additional period not exceeding 15 working days.
Kadar je to utemeljeno zaradi kompleksnosti in večdisciplinarnosti projekta, lahko pristojni organ enkrat podaljša rok iz odstavka 1 za dodatno obdobje, ki ni daljše od 15 delovnih dni.
The extension and its duration shall be duly motivated and shall be notified to the applicant before the expiry of the period referred to in paragraph 1.
Podaljšanje in trajanje podaljšanja se ustrezno utemelji ter o njem uradno obvesti vlagatelja pred iztekom roka iz odstavka 1.
Competent authorities shall acknowledge to the applicant all applications for authorisations as quickly as possible, and shall indicate the period referred to in paragraph 1 within which the decision is to be taken.
Pristojni organ vlagatelju čim prej potrdi prejem vseh vlog za odobritev in določi rok iz odstavka 1, v okviru katerega je treba sprejeti odločitev.
In the case of an incomplete or incorrect application, the competent authority shall, as quickly as possible, inform the applicant of the need to supply any additional documentation and of any possible effects on the running of the applicable time period.
V primeru nepopolne ali nepravilne vloge pristojni organ čim prej obvesti vlagatelja o potrebi po predložitvi morebitne dodatne dokumentacije in o možnih učinkih na nadaljnji potek.
Simplified administrative procedure
Poenostavljen upravni postopek
Member States may decide to introduce a simplified administrative procedure for projects containing procedures classified as ‘non-recovery’, ‘mild’ or ‘moderate’ and not using non-human primates, that are necessary to satisfy regulatory requirements, or which use animals for production or diagnostic purposes with established methods.
Države članice lahko odločijo, da bodo uvedle poenostavljen upravni postopek za projekte, ki vključujejo postopke, razvrščene kot „nepovratne“, „blage“ ali „zmerne“ in v katerih niso uporabljeni primati razen človeka ter so potrebni za izpolnitev regulativnih zahtev ali v katerih se uporabljajo živali za proizvodnjo ali diagnostične namene z uveljavljenimi metodami.
When introducing a simplified administrative procedure, Member States shall ensure that the following provisions are met:
Pri uvedbi poenostavljenega upravnega postopka države članice zagotovijo, da so izpolnjeni naslednji pogoji:
the application specifies elements referred to in Article 40(2)(a), (b) and (c);
v vlogi so opredeljeni elementi iz člena 40(2)(a), (b) in (c);
a project evaluation is performed in accordance with Article 38; and
ocena projekta se izvede v skladu s členom 38 in
that the period referred to in Article 41(1) is not exceeded.
rok iz člena 41(1) ni potekel.
If a project is changed in a way that may have a negative impact on animal welfare, Member States shall require an additional project evaluation with a favourable outcome.
Če se projekt spremeni na način, ki ima lahko negativne učinke na dobro počutje živali, države članice zahtevajo dodatno oceno projekta z ugodnim izidom.
Article 40(3) and (4), Article 41(3) and Article 44(3), (4) and (5) shall apply mutatis mutandis to projects that are allowed to be carried out in accordance with this Article.
Člen 40(3) in (4), člen 41(3) in člen 44(3), (4) in (5) se smiselno uporabljajo za projekte, katerih izvajanje je v skladu s tem členom dovoljeno.
Non-technical project summaries
Netehnični povzetki projekta
Subject to safeguarding intellectual property and confidential information, the non-technical project summary shall provide the following:
Ob upoštevanju varovanja intelektualne lastnine in zaupnih podatkov netehnični povzetek projekta vsebuje:
information on the objectives of the project, including the predicted harm and benefits and the number and types of animals to be used;
podatke o ciljih projekta, vključno s predvideno škodo in predvidenimi koristmi, ter številom in vrstami živali, ki bodo uporabljene;
a demonstration of compliance with the requirement of replacement, reduction and refinement.
dokaz o skladnosti z zahtevo zamenjave, zmanjšanja in izboljšanja.
The non-technical project summary shall be anonymous and shall not contain the names and addresses of the user and its personnel.
Netehnični povzetek projekta je anonimen ter ne vsebuje imen in naslovov uporabnika ali njegovega osebja.
Member States may require the non-technical project summary to specify whether a project is to undergo a retrospective assessment and by what deadline.
Države članice lahko zahtevajo, da se v netehničnem povzetku projekta navede, ali naj se projekt naknadno oceni in do katerega roka naj se retrospektivna ocena izvede.
In such a case, Member States shall ensure that the non-technical project summary is updated with the results of any retrospective assessment.
V takšnem primeru države članice zagotovijo, da se netehnični povzetek projekta posodobi z rezultati morebitne retrospektivne ocene.
Member States shall publish the non-technical project summaries of authorised projects and any updates thereto.
Države članice objavijo netehnične povzetke odobrenih projektov in morebitne posodobitve teh projektov.
Amendment, renewal and withdrawal of a project authorisation
Sprememba, podaljšanje in preklic odobritve projekta
Member States shall ensure that amendment or renewal of the project authorisation is required for any change of the project that may have a negative impact on animal welfare.
Države članice zagotovijo, da je za kakršno koli spremembo projekta, ki lahko negativno vpliva na dobro počutje živali, potrebna sprememba ali podaljšanje odobritve projekta.
Any amendment or renewal of a project authorisation shall be subject to a further favourable outcome of the project evaluation.
Kakršna koli sprememba ali podaljšanje odobritve projekta je odvisno od dodatnega ugodnega rezultata ocene projekta.
The competent authority may withdraw the project authorisation where the project is not carried out in accordance with the project authorisation.
Pristojni organ lahko odobritev projekta prekliče, kadar se projekt ne izvaja v skladu z odobritvijo projekta.
Where a project authorisation is withdrawn, the welfare of the animals used or intended to be used in the project must not be adversely affected.
Kadar se odobritev projekta prekliče, to ne sme neugodno vplivati na dobro počutje živali, ki se uporabljajo ali so se nameravale uporabiti v projektu.
Member States shall establish and publish conditions for amendment and renewal of project authorisations.
Države članice opredelijo in objavijo pogoje za spremembo in podaljšanje odobritev projektov.
Member States shall ensure that all relevant documentation, including project authorisations and the result of the project evaluation is kept for at least 3 years from the expiry date of the authorisation of the project or from the expiry of the period referred to in Article 41(1) and shall be available to the competent authority.
Države članice zagotovijo, da se vsa zadevna dokumentacija, vključno z odobritvami projektov in rezultatom ocene projekta, hrani vsaj tri leta po poteku datuma veljavnosti odobritve projekta ali po poteku roka iz člena 41(1) in je na voljo pristojnemu organu.
Without prejudice to paragraph 1, the documentation for projects which have to undergo retrospective assessment shall be kept until the retrospective assessment has been completed.
Brez poseganja v odstavek 1 se dokumentacija za projekte, za katere se zahteva retrospektivna ocena, hrani do dokončanja navedene ocene.
AVOIDANCE OF DUPLICATION AND ALTERNATIVE APPROACHES
IZOGIBANJE PODVOJEVANJU IN ALTERNATIVNI PRISTOPI
Avoidance of duplication of procedures
Izogibanje podvajanju postopkov
Each Member State shall accept data from other Member States that are generated by procedures recognised by the legislation of the Union, unless further procedures need to be carried out regarding that data for the protection of public health, safety or the environment.
Vsaka država članica sprejme podatke iz drugih držav članic, ki so pridobljeni s postopki, ki se priznavajo z zakonodajo Unije, razen če je treba za zaščito javnega zdravja, zaradi varnosti ali zaradi okolja izvesti nadaljnje postopke v zvezi s temi podatki.
Alternative approaches
Alternativni pristopi
The Commission and the Member States shall contribute to the development and validation of alternative approaches which could provide the same or higher levels of information as those obtained in procedures using animals, but which do not involve the use of animals or use fewer animals or which entail less painful procedures, and they shall take such other steps as they consider appropriate to encourage research in this field.
Komisija in države članice prispevajo k razvoju in validaciji alternativnih pristopov, ki bi lahko zagotovili enake ali višje ravni podatkov, kot so pridobljeni pri postopkih, v katerih so uporabljene živali, vendar ki ne vključujejo uporabe živali ali uporabljajo manj živali ali ki vključujejo manj boleče postopke, ter sprejmejo druge take ukrepe, za katere menijo, da so primerni za spodbujanje raziskav na tem področju.
Member States shall assist the Commission in identifying and nominating suitable specialised and qualified laboratories to carry out such validation studies.
Države članice Komisiji pomagajo pri določanju in imenovanju ustreznih specializiranih in kvalificiranih laboratorijev za opravljanje takšnih študij validacije.
After consulting the Member States, the Commission shall set the priorities for those validation studies and allocate the tasks between the laboratories for carrying out those studies.
Po posvetovanju z državami članicami Komisija določi prednostne naloge za navedene študije validacije in med te laboratorije razdeli naloge za izvajanje teh študij.
Member States shall, at national level, ensure the promotion of alternative approaches and the dissemination of information thereon.
Države članice na nacionalni ravni zagotovijo spodbujanje alternativnih pristopov in razširjanje informacij o teh alternativnih pristopih.
Member States shall nominate a single point of contact to provide advice on the regulatory relevance and suitability of alternative approaches proposed for validation.
Države članice določijo enotno kontaktno točko za svetovanje glede regulativne ustreznosti in primernosti alternativnih pristopov, ki so predlagani v potrjevanje.
The Commission shall take appropriate action with a view to obtaining international acceptance of alternative approaches validated in the Union.
Komisija sprejme ustrezne ukrepe z namenom pridobitve mednarodnega priznanja alternativnih pristopov, validiranih v Uniji.
Union Reference Laboratory
Referenčni laboratorij Unije
The Union Reference Laboratory and its duties and tasks shall be those referred to in Annex VII.
Referenčni laboratorij Unije ter njegove dolžnosti in naloge so navedeni v Prilogi VII.
The Union Reference Laboratory may collect charges for the services it provides that do not directly contribute to the further advancement of replacement, reduction and refinement.
Referenčni laboratorij Unije lahko zahteva pristojbine za storitve, ki jih zagotavlja in ki neposredno ne prispevajo k nadaljnjemu razvoju zamenjave, zmanjšanja in izboljšanja.
Detailed rules necessary for the implementation of paragraph 2 of this Article and Annex VII may be adopted in accordance with the regulatory procedure referred to in Article 56(3).
Podrobne določbe, potrebne za izvajanje odstavka 2 tega člena in Priloge VII, se lahko sprejmejo v skladu z regulativnim postopkom iz člena 56(3).
National committees for the protection of animals used for scientific purposes
Nacionalni odbor za zaščito živali, ki se uporabljajo v znanstvene namene
Each Member State shall establish a national committee for the protection of animals used for scientific purposes.
Vsaka država članica ustanovi nacionalni odbor za zaščito živali, ki se uporabljajo v znanstvene namene.
It shall advise the competent authorities and animal-welfare bodies on matters dealing with the acquisition, breeding, accommodation, care and use of animals in procedures and ensure sharing of best practice.
Odbor svetuje pristojnim organom in organom za dobro počutje živali pri zadevah povezanih s pridobivanjem, vzrejo, nastanitvijo, oskrbo in uporabo živali v postopkih, ter zagotavljajo izmenjavo najboljših praks.
The national committees referred to in paragraph 1 shall exchange information on the operation of animal-welfare bodies and project evaluation and share best practice within the Union.
Nacionalni odbori iz odstavka 1 si izmenjujejo podatke o delovanju organov za dobro počutje živali in oceni projektov ter najboljših praksah znotraj Unije.
Adaptation of Annexes to technical progress
Prilagoditev prilog tehničnemu napredku
In order to ensure that the provisions of Annexes I and III to VIII reflect the state of technical or scientific progress, taking into account the experience gained in the implementation of this Directive, in particular through the reporting referred to in Article 54(1), the Commission may adopt, by means of delegated acts in accordance with Article 51 and subject to the conditions laid down in Articles 52 and 53, modifications of those Annexes, with the exception of provisions of Sections I and II of Annex VIII.
Da bi se zagotovilo, da priloge I in III do VIII odražajo stanje tehničnega ali znanstvenega napredka, ob upoštevanju izkušenj pridobljenih pri izvajanju te direktive, zlasti preko poročanja iz člena 54(1), lahko Komisija z delegiranimi akti v skladu s členom 51 in ob upoštevanju pogojev iz členov 52 in 53 te priloge spremeni, z izjemo določb oddelkov I in II Priloge VIII.
The dates referred to in Section B of Annex III shall not be brought forward.
Datumov iz oddelka B Priloge III se ne sme premakniti naprej.
When adopting such delegated acts, the Commission shall act in accordance with the relevant provisions of this Directive.
Komisija pri sprejemanju navedenih delegiranih aktov ravna v skladu z zadevnimi določbami te direktive.
The delegation of power shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 52.
Prenos pooblastila se samodejno podaljša za enako obdobje, razen če Evropski parlament ali Svet pooblastilo prekliče v skladu s členom 52.
The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in Articles 52 and 53.
Pooblastilo za sprejemanje delegiranih aktov je prenešeno na Komisijo pod pogoji, določenimi v členih 52 in 53.
The delegation of power referred to in Article 50 may be revoked at any time by the European Parliament or by the Council.
Pooblastilo iz člena 50 lahko kadar koli prekliče Evropski parlament ali Svet.
The institution which has commenced an internal procedure for deciding whether to revoke the delegation of power shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated power which could be subject to revocation and possible reasons for a revocation.
Institucija, ki je začela notranji postopek o morebitnem preklicu pooblastila, si prizadeva o tem obvestiti drugo institucijo in Komisijo v razumnem roku pred sprejetjem končne odločitve ter pri tem navede pooblastila, ki bi se lahko preklicala, in možne razloge za preklic.
The decision of revocation shall put an end to the delegation of the power specified in that decision.
Z odločitvijo o preklicu pooblastil prenehajo veljati pooblastila, navedena v tej odločitvi.
The European Parliament or the Council may object to a delegated act within a period of 2 months from the date of notification.
1. Evropski parlament ali Svet lahko nasprotuje delegiranemu aktu v dveh mesecih od datuma uradnega obvestila.
At the initiative of the European Parliament or the Council this period shall be extended by 2 months.
Na pobudo Evropskega parlamenta ali Sveta se navedeni rok podaljša za dva meseca.
If, on expiry of that period, neither the European Parliament nor the Council has objected to the delegated act, it shall be published in the Official Journal of the European Union and shall enter into force at the date stated therein.
Če do izteka navedenega roka niti Evropski parlament niti Svet ne nasprotuje delegiranemu aktu, se akt objavi v Uradnem listu Evropske unije in začne veljati na dan, ki je v njem določen.
Member States shall by 10 November 2018, and every 5 years thereafter, send the information on the implementation of this Directive and in particular Articles 10(1), 26, 28, 34, 38, 39, 43 and 46 to the Commission.
Države članice do 10. novembra 2018 in vsakih pet let po tem Komisiji pošljejo podatke o izvajanju te direktive in zlasti členov 10(1), 26, 28, 34, 38, 39, 43 in 46.
Member States shall collect and make publicly available, on an annual basis, statistical information on the use of animals in procedures, including information on the actual severity of the procedures and on the origin and species of non-human primates used in procedures.
Države članice letno zberejo in javno objavijo statistične podatke o uporabi živali v postopkih, vključno s podatki o dejanski težavnosti postopkov ter o izvoru in živalskih vrstah primatov razen človeka, ki se uporabljajo v postopkih.
Member States shall submit that statistical information to the Commission by 10 November 2015 and every year thereafter.
Države članice Komisiji predložijo navedene statistične podatke do 10. novembra 2015 in nato vsako leto po tem.
Member States shall submit to the Commission, on annual basis, detailed information on exemptions granted under Article 6(4)(a).
Države članice Komisiji vsako leto predložijo podrobne informacije o izjemah, dodeljenih na podlagi člena 6(4)(a).
The Commission shall by 10 May 2012 establish a common format for submitting the information referred to in paragraphs 1, 2, and 3 of this Article in accordance with the regulatory procedure referred to in Article 56(3).
Komisija do 10. maja 2012 uvede enotni obrazec za predložitev podatkov iz odstavkov 1, 2 in 3 tega člena v skladu z regulativnim postopkom iz člena 56(3).
Where a Member State has scientifically justifiable grounds for believing it is essential to use non-human primates for the purposes referred to in Article 8(1)(a)(i) with regard to human beings, but where the use is not undertaken with a view to the avoidance, prevention, diagnosis or treatment of debilitating or potentially life-threatening clinical conditions, it may adopt a provisional measure allowing such use, provided the purpose cannot be achieved by the use of species other than non-human primates.
Kadar obstajajo znanstveno utemeljeni razlogi, zaradi katerih država članica meni, da je treba primate razen človeka uporabiti za namene, navedene v členu 8(1)(a)(i) v zvezi z ljudmi, vendar kadar se uporaba ne izvaja za odvračanje, preprečevanje, diagnosticiranje ali zdravljenje stanj splošne oslabelosti ali potencialno življenje ogrožajočih kliničnih stanj pri človeku, lahko ta država članica sprejme začasni ukrep in z njim dovoli tako uporabo, če namena ni mogoče doseči z uporabo drugih živalskih vrst, ki niso primati razen človeka.