natgillin/translations-raw huggingface dataset:
področja znanstvene uporabe, za katero se bo žival uporabila;
the areas of scientific use for which animals will be used;
oblikovanja poskusov, vključno s statistiko, kadar je to primerno;
experimental design, including statistics where appropriate;
veterinarske prakse s področja znanosti o laboratorijskih živalih ali prakse s področja veterine prostoživečih živali, kadar je to primerno;
veterinary practice in laboratory animal science or wildlife veterinary practice where appropriate;
reje in oskrbe živali v zvezi z vrsto, ki se namerava uporabiti;
animal husbandry and care, in relation to the species that are intended to be used;
praktične uporabe zahtev za nadomestitev, zmanjšanje in izboljšanje;
practical application of the requirement of replacement, reduction and refinement;
uporabne etike;
applied ethics;
ekologije, kadar je to primerno.
environmental science, where appropriate.
Etično vrednotenje se izvaja pregledno z vključevanjem
Ethical evaluation shall be performed in a transparent manner║ by integrating ▌independent
neodvisnega strokovnega znanja, ob varovanju intelektualne lastnine in zaupnih informacij ter varnosti za blago in ljudi
expertise whilst safeguarding intellectual property and confidential information as well as the safety of goods and persons
Naknadna ocena
Retrospective assessment
na podlagi analize škode in koristi iz točke (d)
ethical evaluation shall determine, on the basis of the harm-benefit analysis referred to in point
Če se naknadna ocena zdi primerna, se z etičnim vrednotenjem v zvezi z zadevnim projektom opredeli rok, do katerega je treba izvesti naknadno oceno.
If a retrospective assessment is deemed appropriate, the ethical evaluation shall determine, in relation to the project concerned, the deadline by which the retrospective assessment is to take place.
Z naknadno oceno se
Retrospective assessment shall
ali so bili cilji projekta doseženi;
whether the objectives of the project were achieved;
škoda, ki je bila povzročena živalim, vključno s številom in vrsto uporabljenih živali in težo posledic postopkov;
harm inflicted on animals including the numbers and species of animals used and the severity of the procedures;
ali obstajajo
whether there are
elementi, ki lahko prispevajo k nadaljnji uporabi zahtev za nadomestitev, zmanjšanje in izboljšanje.
elements that may contribute to the further implementation of the requirement of replacement, reduction and refinement.
Naknadna ocena se izvede za vse projekte, v katerih so uporabljeni primati razen človeka.
All projects using non-human primates shall undergo a retrospective assessment.
Dokumentacija o etičnem vrednotenju
Records of ethical evaluation
Enota hrani dokumentacijo o etičnem vrednotenju vsaj tri leta od poteka odobritve projekta in to dokumentacijo na zahtevo predloži pristojnemu organu.
The establishment shall keep records of ethical evaluation for at least three years from the expiry date of authorisation of the project and shall submit those records to the competent authority upon request.
Kljub temu se dokumentacija o etičnem vrednotenju za projekte, ki bodo naknadno ocenjeni, hrani do konca naknadnega ocenjevanja.
However, records of ethical evaluation for projects which have to undergo retrospective assessment shall be kept until the retrospective assessment has been completed.
Netehnični povzetki projekta
Non-technical project summaries
Ob upoštevanju varovanja zaupnih podatkov
Subject to safeguarding confidential information,
ter podrobnosti o enoti in osebju
establishment and personnel details,
netehnični povzetek projekta vsebuje:
the non-technical project summary shall provide the following:
podatke o ciljih projekta, vključno z verjetnostjo, da se dosežejo, morebitno škodo in podrobnostmi o številu in vrstah živali, ki bodo uporabljene;
information on the objectives of the project, including the likelihood of achieving them, the potential harm, and details of the number and types of animals to be used;
, da so upoštevana načela
that the principles
nadomestitve, zmanjšanja in izboljšanja
of replacement, reduction and refinement
, kjer je to izvedljivo
have been observed where practicable
Na podlagi rezultatov etičnega vrednotenje uporabniška enota v netehničnem povzetku projekta navede, ali naj se projekt naknadno oceni in do katerega roka naj se naknadna ocena izvede.
On the basis of the results of the ethical evaluation, the user establishment shall specify in the non-technical project summary whether a project is to undergo a retrospective assessment and by which deadline.
Uporabniška enota netehnični povzetek projekta posodobi z rezultati naknadne ocene.
The user establishment shall update the non-technical project summary with the results of retrospective assessment.
Države članice dajo javnosti na voljo
Member States shall make publicly available
anonimne različice netehničnih povzetkov
anonymous versions of
odobrenih projektov in njihove morebitne posodobitve.
the non-technical project summaries of authorised projects and any updates to them.
Ob upoštevanju varovanja zaupnih in osebnih podatkov države članice javno objavijo neosebne podatke o kršitvah te direktive, nacionalne zakonodaje in dovoljenj.
Subject to the safeguarding of confidential and personal information, Member States shall make publicly available non-personal information regarding infringements of this Directive, national laws and authorisations.
Odobritev projekta
Granting of project authorisation
Odobritev projektov je omejena na postopke, ki so bili etično ovrednoteni in razvrščeni glede na težo njihovih posledic.
The project authorisation shall be limited to the procedures which have been subject to an ethical evaluation and to the severity classifications assigned to those procedures.
Z odobritvijo projekta se opredelijo:
The project authorisation shall identify the following:
osebe v enoti, ki so odgovorne za celotno izvajanje projekta;
the persons in the establishment responsible for the overall implementation of the project;
uporabniške enote, v katerih se bo projekt izvajal;
the user establishments in which the project will be undertaken;
pri terenskih študijah uporabniška enota, ki je odgovorna za projekt;
in the case of field studies, the user establishment which is responsible for the project;
vsaj ena oseba, ki ima posebno znanje o vrsti.
at least one person demonstrating species specific knowledge.
Odobritve projektov se dodelijo za obdobje, ki ne presega
Project authorisations shall be granted for a period not exceeding
Države članice lahko dovolijo odobritev več projektov, kadar se ti projekti zahtevajo z zakonom
Member States may allow the authorisation of multiple projects when those projects are required by law
ali kadar se uporabljajo standardizirani postopki, ki so že bili pozitivno ocenjeni pri etični presoji
, or when standardised procedures are applied, the ethical evaluation of which has already produced a positive result
Uporabniške enote hranijo dokumentacijo o vseh odobritvah projektov vsaj tri leta po poteku odobritve in to dokumentacijo na zahtevo predložijo organu.
User establishments shall keep records of all project authorisations for at least three years from the expiry date of the authorisation and shall submit those records to the authority upon request.
Sprememba, podaljšanje in preklic odobritve projekta
Amendment, renewal and withdrawal of a project authorisation
Vsaka sprememba ali podaljšanje odobritve projekta je odvisno od dodatnega ▌ etičnega ovrednotenja.
Any amendment or renewal of a project authorisation shall be subject to a further ▌ethical evaluation.
Spremembe blagih ali zmernih postopkov, zaradi katerih se ne poveča teža posledic postopka, lahko izvede stalni organ za etično presojo, vendar mora o tem obvestiti pristojni organ v enem tednu po taki spremembi.
Amendments to mild or moderate procedures that do not increase the severity of the procedure may be made by the permanent ethical review body but must be communicated to the competent authority within one week of such change.
Pristojni organ lahko prekliče odobritev projekta, kadar se projekt ne izvaja v skladu z odobritvijo projekta
The competent authority may withdraw the project authorisation where the project is not carried out in accordance with the project authorisation
in lahko povzroči poslabšanje standardov za dobro počutje živali
and may cause a deterioration in animal welfare standards
Kadar se odobritev projekta prekliče, to ne vpliva neugodno na dobro počutje živali, ki se uporabljajo ali so se nameravale uporabiti v projektu.
Where a project authorisation is withdrawn, the welfare of the animals used or intended to be used in the project shall not be adversely affected.
Države članice opredelijo in objavijo podrobne pogoje za spremembo in podaljšanje odobritev projektov.
Member States shall establish and publish detailed conditions for amendment and renewal of project authorisations.
Odločbe o odobritvi
Authorisation decisions
║ Države članice zagotovijo, da se odločba o izdaji odobritve sprejme in sporoči uporabniški enoti najpozneje v 30 dneh od predložitve vloge.
║ Member States shall ensure that the decision to grant an authorisation is taken and communicated to the user establishment at the latest within 30 days from the submission of the application.
IZOGIBANJE PODVOJEVANJU IN ALTERNATIVNI PRISTOPI
AVOIDANCE OF DUPLICATION AND ALTERNATIVE APPROACHES
Nepotrebno podvajanje postopkov
Unnecessary duplication of procedures
Vsaka država članica
Each Member State shall accept
iz druge države članice
from another Member State
sprejme podatke ▌, ki so ▌ pridobljeni s postopki, ki
data that are ▌ generated by procedures recognised by
so priznani
, or which take place under,
z zakonodajo Skupnosti
Community legislation ▌.
Države članice ob upoštevanju varovanja zaupnih podatkov zagotovijo souporabo podatkov, pridobljenih s postopki, tudi s tistimi, ki so bili izvedeni v Evropski uniji pred začetkom veljavnosti te direktive.
Subject to the safeguarding of confidential information, Member States shall ensure the sharing of data generated by procedures, including those which have taken place in the European Union prior to the coming into force of the Directive.
Kdor želi uporabiti podatke v lasti nekoga drugega, prispeva k notranjim stroškom takih podatkov, kjer je to ustrezno.
A person seeking to rely on data owned by another shall where appropriate contribute towards the intrinsic cost of producing such data.
Preden oseba, ki namerava izvesti postopek, zaprosi za odobritev projekta, naredi vse potrebno, da ugotovi, ali že obstajajo podatki, ki zadevajo predlagani projekt, in jih v tem primeru pridobi, (to vključuje tudi prispevek k stroškom); ravno tako države članice pred odobritvijo preverijo, ali taki podatki obstajajo.
Before applying for a project authorisation, a person intending to carry out a procedure must take all reasonable steps to ascertain whether data relevant to the proposed project already exists and, if so, to access such data (including contributing towards the cost thereof), and Member States shall similarly verify whether such data exists before granting an authorisation.
Države članice ne odobrijo postopka, kadar oseba ne stori vsega potrebnega za izpolnitev zahtev odstavka 3
Member States shall not authorise a procedure where a person has not taken reasonable steps to comply with paragraph 3
Če so ustrezni podatki dostopni pod razumnimi pogoji, države članice projekt odobrijo le, kadar je to potrebno za varovanje javnosti.
Where relevant data is reasonably available, Member States shall only grant authorisation for a project where this is necessary for the protection of the public.
Alternativni pristopi
Alternative approaches
Komisija in države članice
The Commission and Member States shall contribute
finančno in drugače
financially and otherwise
prispevajo k razvoju in
to the development and
, kjer je to potrebno, k znanstvenemu
, where appropriate, the scientific
potrjevanju alternativnih pristopov,
validation of alternative approaches
podatkov, kot je pridobljena pri postopkih, v katerih so uporabljene živali, ampak ne vključujejo uporabe živali ali jih uporabljajo manj ali pa vključujejo manj boleče postopke, ter bodo naredile take druge korake, za katere menijo, da so primerni za spodbujanje raziskav na tem področju.
level of information as that obtained in procedures using animals but that do not involve the use of animals or use fewer animals or that entail less painful procedures and shall take such other steps as they consider appropriate to encourage research in this field.
Primerno je ustanoviti veterinarske biobanke velikega obsega, da bi podprli načela nadomestitve, zmanjšanja in izboljšanja z uporabo odvečnega tkiva, odvzetega med kliničnimi postopki.
It is appropriate to establish large-scale veterinary biobanks to support the principles of replacement, reduction and refinement using surplus tissue taken as part of clinical procedures.
Evropski center za validacijo alternativnih metod
European Centre for the Validation of Alternative Methods
usklajevanje raziskav v nacionalnih centrih za alternativne metode iz člena 49, s katerimi bi olajšali razvoj alternativ postopkom na živalih;
coordinate research undertaken to facilitate the development of alternatives to animal procedures by the National Centres for Alternative Methods described in Article 49;
izvajanje raziskav, s katerimi bi omogočili razvoj alternativ postopkom na živalih;
conduct research to facilitate the development of alternatives to animal procedures;
naročanje raziskav na področjih, kjer bi verjetno pridobili informacije, s katerimi bi pospešili nadomestitev, zmanjšanje ali izboljšanje postopkov na živalih;
commission research in fields likely to yield information that will facilitate the replacement, reduction or refinement of animal procedures;
oblikovanje in izvajanje strategij za nadomestitev, zmanjšanje in izboljšanje postopkov na živalih v posvetovanju z ustreznimi zainteresiranimi stranmi;
in consultation with relevant stakeholders, create and implement strategies to replace, reduce and refine animal procedures;
zagotavljanje informacij o alternativah postopkom na živalih prek rednega poročanja javnosti, zainteresiranim stranem in organom držav članic;
make available information on alternatives to animal procedures through regular reporting to the public, to stakeholders and to Member State authorities;
zagotavljanje baz podatkov za lažjo izmenjavo pomembnih informacij, vključno z informacijami o alternativnih metodah in informacijami, ki so jih prostovoljno prispevali raziskovalci in bi bile sicer neobjavljene, vendar bi lahko z njimi preprečili podvajanje neuspešnih študij na živalih;
provide databases to facilitate the exchange of relevant information including information on available alternative methods and information contributed voluntarily by researchers which would otherwise remain unpublished, but which could prevent duplication of unsuccessful animal studies;
usklajevanje študij predhodnega potrjevanja in potrjevanja, ki jih izvajajo nacionalni centri za alternativne metode v skladu s členom 49 te direktive;
coordinate pre-validation and validation studies undertaken by the National Centres for Alternative Methods in accordance with Article 49 of this Directive;
izvajanje študij potrjevanja in predhodnega potrjevanja, kjer je ustrezno;
conduct validation and pre-validation studies where appropriate;
v posvetovanju z ustreznimi regulativnimi organi in zainteresiranimi stranmi oblikovanje in izvajanje strategij za nadomestitev, zmanjšanje in izboljšanje poskusov na živalih, ki se uporabljajo za regulativne namene;
in consultation with relevant regulatory bodies and stakeholders, create and implement strategies to replace, reduce and refine animal tests used for regulatory purposes;
pospeševanje znanstvenega potrjevanja in regulativnega sprejemanja alternativ poskusom na živalih, ki se uporabljajo za regulativne namene;
facilitate the scientific endorsement and regulatory acceptance of alternatives to animal tests used for regulatory purposes;
obveščanje ustreznih regulativnih organov o začetku študij predhodnega potrjevanja in potrjevanja ter o znanstveni potrditvi in regulativnem sprejetju alternativnih metod poskusov, ter omogočanje dostopa javnosti in zainteresiranih strani do teh informacij na posebnih spletnih straneh.
inform relevant regulatory authorities when pre-validation and validation studies begin, and when alternative test methods achieve scientific endorsement and regulatory acceptance, and make this information available to the public and stakeholders through dedicated websites.
Nacionalni referenčni laboratoriji za alternativne metode
National reference laboratories for alternative methods
Nacionalni referenčni laboratoriji izpolnjujejo naslednje zahteve:
The national reference laboratories shall fulfil the following requirements:
imajo primerno usposobljeno osebje z ustrezno izobrazbo na področju alternativnih metod in postopka potrjevanja ter tehnik, ki se uporabljajo na njihovem področju pristojnosti;
they shall have suitably qualified staff with adequate training in alternative methods and validation process and techniques applied in their area of competence;
imajo opremo in izdelke, ki so potrebni za izvajanje osebju dodeljenih nalog;
they shall possess the equipment and products needed to carry out the tasks assigned to them;
imajo primerno upravno infrastrukturo;
they shall have an appropriate administrative infrastructure;
zagotavljajo, da njihovo osebje spoštuje predpise o zaupnosti.
they shall ensure that their staff respect the rules on confidentiality.
Nacionalni referenčni laboratoriji izvajajo naslednje naloge:
The national reference laboratories shall perform the following functions:
sodelujejo s Komisijo na svojem področju pristojnosti
cooperate with the Commission in their area of competence
sodelujejo pri predhodnem potrjevanju in potrjevanju alternativnih metod
participate in pre-validation and validation of alternative methods
, kjer je ustrezno,
, where appropriate,
pod usklajevanjem Komisije;
under the co-ordination of the Commission;
ustreznim organom držav članic sporočajo podatke o dosegljivosti in uporabi alternativnih metod, ki jih prejmejo od Komisije;
communicate information on the availability and application of alternative methods received from the Commission to the relevant authorities of the Member State;
ustreznim organom
provide scientific and technical assistance to the relevant authorities
osebam iz
provide training on the use of alternative methods to persons referred to in
člena 22(1)
Article 22(1)
in, če se zahteva, uporabniškim enotam
and, if required, to user establishments
sporočajo o razvoju alternativnih metod in javnost obveščajo o pozitivnih in negativnih rezultatih.
communicate developments on alternative methods and inform the public of positive and negative outcomes.
Nacionalni centri sodelujejo z vsemi ustreznimi zainteresiranimi stranmi in tako podprejo cilj za nadomestitev vseh postopkov na živalih.
The national centres shall work with all relevant stakeholders to further the aim of replacing all animal procedures.
Nacionalni referenčni laboratoriji podajo izjavo o kakršnem koli navzkrižju interesov pri nalogah, ki jih izvajajo.
National reference laboratories shall declare any conflict of interest on any task being undertaken.
Vsa država članica sporoči Komisiji imena in naslove svojih referenčnih laboratorijev.
Each Member State shall communicate the name and address of their reference laboratory to the Commission.
Komisija seznam nacionalnih referenčnih laboratorijev javno objavi.
The Commission shall make publicly available the list of national reference laboratories.
Po posvetu z nacionalnimi referenčnimi laboratoriji Komisija določi prednostne naloge za validacijske študije in med te laboratorije razdeli sredstva za izvajanje teh študij.
After consulting the national reference laboratories, the Commission shall set the priorities for the validation studies and allocate the tasks between those laboratories for carrying out those studies.
Nacionalni odbor za dobro počutje živali in etiko
National animal welfare and ethics committee
Vsaka država članica ustanovi nacionalni odbor za dobro počutje živali in etiko, ki svetuje pristojnim organom in stalnim organom za etično presojo pri zadevah, v katerih se obravnavajo pridobivanje, vzreja, namestitev, oskrba in uporaba živali v postopkih, ter zagotavljajo izmenjevanje najboljših praks.
Each Member State shall establish a national animal welfare and ethics committee that shall advise the competent authorities and permanent ethical review bodies in matters dealing with the acquisition, breeding, accommodation, care and use of animals in procedures and ensure sharing of best practices.
Nacionalni odbori za dobro počutje živali in etiko si izmenjujejo podatke o delovanju stalnih organov za etično presojo in etičnem vrednotenju ter najboljše prakse znotraj Skupnosti.
The national animal welfare and ethics committees shall exchange information on the operation of permanent ethical review bodies and ethical evaluation and share best practices within the Community.
Prilagoditve prilog tehničnemu napredku
Adaptation of annexes to technical progress
Komisija lahko priloge od II do
The Commission may adapt Annexes II to
prilagodi tehničnemu in znanstvenemu napredku.
to technical and scientific progress.
člena 54(4)
Article 54(4)
Najpozneje šest let po datumu prenosa v zakonodajo.
Six years after the transposition date.
in vsakih pet let po tem Komisiji pošljejo podatke o izvajanju te direktive in zlasti
, and every five years thereafter, send the information on the implementation of this Directive and in particular
členov 11(1), 27, 29, 35, 39, 40, 42
Articles 11(1), 27, 29, 35, 39, 40, 42
te direktive.
thereof to the Commission.
Države članice letno zberejo in javno objavijo statistične podatke o uporabi živali v postopkih, vključno s podatki o dejanski teži postopkov ter izvoru in vrstah primatov razen človeka, ki se uporabljajo v postopkih.
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.
te statistične podatke objavijo in jih
publicly available and submit it
predložijo Komisiji te statistične podatke do ...
to the Commission by ... **
v presledkih, ki niso daljši od dveh let
at intervals not exceeding two years
Najpozneje 18 mesecev po začetku veljavnosti te direktive
18 months after the entry into force of this Directive.
člena 54(2)
Article 54(2)
Če ima država članica upravičene razloge, da verjame, da je ukrepanje bistveno za ohranitev vrst ali v zvezi z nepričakovanim izbruhom smrtno nevarnih ali izčrpavajočih kliničnih stanj pri človeku, lahko odobri uporabo velikih opic v postopkih, ki imajo enega od namenov iz člena 5(2)(a), (3) ali
Where a Member State has justifiable grounds for believing that action is essential for the preservation of the species or in relation to an unexpected outbreak of a life-threatening or debilitating clinical condition in human beings, it may authorise the use of great apes in procedures having one of the purposes referred to in Article 5(2)(a), (3) or
, če namena postopka ni mogoče doseči z uporabo drugih vrst razen velikih opic ali z uporabo alternativnih metod.
; provided that the purpose of the procedure cannot be achieved by the use of other species than great apes or by the use of alternative methods.
Vendar sklic na člen 5(2)(a) ne vključuje živali ali rastlin.
However, the reference to Article 5(2)(a) shall not be taken to include the reference to animals or plants.
Država članica o tem takoj obvesti Komisijo in druge države članice, navede razloge za svojo odločitev in predloži dokaze o stanju, kakor je opisano v odstavku 1, na katerih temelji začasni ukrep.
The Member State shall immediately inform the Commission and the other Member States thereof, giving reasons for its decision and submitting evidence of the situation as described in paragraph 1 on which the provisional measure is based.
Komisija sprejme odločbo v skladu
The Commission shall take a decision in accordance with the