natgillin/translations-raw huggingface dataset:
Osebe, ki izvajajo naloge iz točke (b) odstavka 1, morajo prejeti navodila iz znanstvene vede, ki je v zvezi z izvajanim delom, in morajo biti sposobne ravnati z zadevnimi vrstami in skrbeti zanje.
Persons carrying out the functions referred to in point (b) of paragraph 1 shall have received instruction in a scientific discipline relevant to the work being undertaken and shall be capable of handling and taking care of the species concerned.
Osebe se odobrijo za določen čas, ki ne sme presegati petih let.
All authorisations of persons shall be granted for a limited period ▌, not exceeding five years.
Države članice zagotovijo, da se podaljšanje dovoljenja oseb odobri samo na podlagi
Member States shall ensure that the renewal of an authorisation of persons is only granted on the basis of
Države članice na podlagi elementov iz
Member States shall publish, on the basis of the elements set out in
Priloge VII
Annex VII,
objavijo minimalne zahteve v zvezi z izobrazbo, usposobljenostjo in zahtevami za pridobitev, vzdrževanje in dokazovanje potrebnega strokovnega znanja.
minimum requirements with regard to education, training and requirements for obtaining, maintaining and demonstrating requisite competence.
Zahteve za enote
Requirements for establishments
Odobritev enot
Authorisation of establishments
Države članice zagotovijo, da pristojni organ odobri in registrira vse vzrejne, dobavne in uporabniške enote.
Member States shall ensure that all breeding, supplying and user establishments are authorised by and registered with the competent authority.
Enota dobi pooblastilo samo, če jo je pristojni organ pregledal in ugotovil, da izpolnjuje zahteve te direktive.
An authorisation shall be given to an establishment only if it has been inspected by the competent authority and found to comply with the requirements of this Directive.
V odobritvi sta navedeni vrsta enote in oseba, ki je odgovorna za enoto in skladnost z določbami te direktive.
The authorisation shall specify the type of establishment and the person responsible for the establishment and for compliance with the provisions of this Directive.
Mirovanje in umik odobritve
Suspension and withdrawal of authorisation
začasno prekliče ali umakne njeno odobritev
suspend or withdraw its authorisation
, sprejme ustrezne popravne ukrepe ali zahteva, da se takšni ukrepi izvedejo
, or take appropriate remedial action or require such action to be taken.
Države članice zagotovijo, da kadar je odobritev začasno preklicana ali umaknjena, to ne vpliva neugodno na dobro počutje živali, ki so nastanjene v enoti.
Member States shall ensure that, where the authorisation is suspended or withdrawn, the welfare of the animals housed in the establishment is not adversely affected.
Zahteve za objekte in opremo
Requirements for installations and equipment
Države članice zagotovijo, da imajo vse vzrejne, dobavne in uporabniške enote objekte in opremo, ki so primerni za nastanjeno vrsto živali, v enotah, v katerih se izvajajo postopki, pa tudi za izvajanje postopkov.
Member States shall ensure that all breeding, supplying and user establishments have installations and equipment suited to the species of animals housed and, where procedures are carried out, to the performance of the procedures.
Oblika, zgradba in delovanje naprav in opreme iz odstavka 1 zagotavljajo čim učinkovitejše izvajanje postopkov ▌ z najmanjšim številom živali in najnižjo stopnjo bolečine, trpljenja, stiske ali trajnih poškodb.
The design, construction and method of functioning of the installations and equipment referred to in paragraph 1 shall ensure that the procedures are carried out as effectively as possible, ▌with the minimum number of animals and the minimum degree of pain, suffering, distress or lasting harm.
Zahteve za osebje in enote
Requirements for personnel in establishments
Vsaka vzrejna, dobavna in uporabniška enota mora imeti zadostno število usposobljenega osebja, vključno z najmanj:
Each breeding, supplying and user establishment shall have sufficient trained staff, including as a minimum:
osebami, ki so na kraju samem odgovorne za dobro počutje in oskrbo živali, ki se redijo, so nastanjene ali se uporabljajo v enoti, ter zagotovijo, da:
persons responsible on site for the welfare and care of the animals bred, kept or used in the establishment, who shall ensure the following:
ima osebje, ki dela z živalmi, dostop do podatkov, ki so značilni za vrsto, nastanjeno v enoti;
the staff dealing with animals have access to the information specific to the species housed in the establishment;
se projekti izvajajo v skladu z odobritvijo projekta;
the projects are carried out in accordance with the project authorisation;
se vsak postopek, med katerim se živali povzroča nepotrebna stiska, bolečina ali trpljenje, ustavi;
any procedure in the course of which any unnecessary distress, pain or suffering is being inflicted on an animal is stopped;
se v primeru neskladnosti z odobritvijo projekta sprejmejo ustrezni ukrepi za odpravljanje neskladnosti, se zapišejo in sporočijo stalnemu organu za etično presojo.
in the event of non-compliance with the project authorisation, the appropriate measures to rectify the non-compliance are taken, recorded and reported to the permanent ethical review body.
imenovanim veterinarjem s strokovnim znanjem na področju medicine laboratorijskih živali, ki je odgovoren za svetovanje v zvezi z dobrim počutjem in zdravljenjem živali.
a designated veterinarian with expertise in laboratory animal medicine charged with advisory duties in relation to the well-being and treatment of the animals.
Brez poseganja v splošnost točke 1, vsaka vzrejna, dobavna ali uporabniška enota zagotovi, da je vedno na voljo vsaj ena usposobljena oseba, ki skrbi za dobro počutje živali.
Without prejudice to the generality of point 1, each breeding, supplying and user establishment shall ensure that there is at least one trained person available at all times to look after the animals' welfare.
Stalni organ za etično presojo
Permanent ethical review body
Države članice zagotovijo, da vsaka vzrejna, dobavna in uporabniška enota ustanovi stalni organ za etično presojo.
Member States shall ensure that each breeding, supplying and user establishment sets up a permanent ethical review body.
Stalni organ za etično presojo vključuje
The permanent ethical review body shall include
imenovanega veterinarja, osebo ali osebe, odgovorne za dobro počutje in oskrbo živali v enoti, ter v uporabniški enoti tudi znanstvenika
the designated veterinarian, the person(s) responsible for the welfare and care of the animals in the establishment and, in the case of a user establishment, a scientific member
in izvedenca za izvajanje načel nadomestitve, zmanjšanja in izboljšanja
and a person with expertise in the application of the principles of replacement, reduction and refinement
Naloge stalnega organa za etično presojo
Tasks of permanent ethical review body
Ob upoštevanju ciljev te direktive, zlasti člena 4, opravlja
Having regard to the objectives of this Directive, and in particular Article 4,
osebju, ki dela z živalmi,, zagotavlja etično svetovanje o zadevah, ki so povezane z dobrim počutjem živali v zvezi z njihovim pridobivanjem, namestitvijo, oskrbo in uporabo;
provide ethical advice to the staff dealing with animals on matters related to the welfare of animals in relation to their acquisition, accommodation, care and use;
osebju enote svetuje o uporabi zahtev za nadomestitev, zmanjšanje in izboljšanje ter ga obvešča o najnovejših tehničnih in znanstvenih dognanjih o uporabi teh zahtev;
advise the staff of the establishment on the application of the requirement of replacement, reduction and refinement and keep it informed on the latest technical and scientific developments on the application of those requirements;
uvaja in pregleduje notranje delovne postopke za spremljanje, poročanje in naknadno ukrepanje v zvezi z dobrim počutjem živali, ki so nastanjene ali se uporabljajo v enoti;
establish and review internal operational processes as regards monitoring, reporting and follow up in relation to the welfare of animals housed or used in the establishment;
enkrat na leto pregleda vse projekte,
review annually all projects
ki so razvrščeni kot "hudi" ali vključujejo primate razen človeka, ter enkrat na tri leta vse ostale projekte,
classified as "severe" or those on non-human primates, and every three years all other projects
ki trajajo več kot 12 mesecev, pri tem se pa posebej osredotoči na:
which are of more than 12 months duration, focusing in particular on:
število, vrste in razvojne stopnje živali, ki so bile uporabljene v prejšnjem letu;
the numbers, species and life stages of animals used in the preceding year;
utemeljitev števila, vrst in razvojnih stopenj živali, ki so potrebne za naslednje leto;
the justification for the numbers, species and life stages of animals needed for the subsequent year;
znanstveni napredek projekta;
the scientific progress of the project;
uporabo humanih metod ubijanja in na to, kako so bili upoštevani novi razvojni dosežki v zvezi z uporabo živali v postopkih;
the use of humane methods of killing and how new developments in relation to the use of animals in procedures have been taken into account;
na podlagi pregleda iz točke (d) ali v primeru odstopanj od odobritve projekta preuči, ali mora biti odobritev projekta predložena za spremembo ali podaljšanje;
based on the review referred to in point (d) or, in the case of deviations from the project authorisation, examine whether the project authorisation needs to be submitted for amendment or renewal;
svetuje o shemah za vnovično nastanitev v domovih, zlasti v zvezi s primerno socializacijo živali, ki bodo znova nastanjene v domovih.
advise on re-homing schemes, in particular in relation to the appropriate socialisation of the animals to be re-homed.
pristojnemu organu.
to the competent authority upon request.
Strategija za vzrejo primatov razen človeka
Breeding strategy for non-human primates
Države članice zagotovijo, da imajo enote za vzrejo in dobavo primatov razen človeka
Member States shall ensure that
vzpostavljeno strategijo za povečevanje deleža živali, ki so potomke primatov razen človeka, vzrejenih v ujetništvu.
breeding and supplying establishments of non-human primates have a strategy in place for increasing the proportion of animals that are the offspring of non-human primates that have been bred in captivity.
Kadar je odobrena uporaba primatov razen človeka, Komisija in države članice sprejmejo vse potrebne ukrepe za zagotovitev ustreznih pogojev pri prevozu.
Where the use of non-human primates is authorised, the Commission and the Member States shall take all necessary measures to ensure appropriate transport conditions.
, ki pridobivajo primate razen človeka, pristojnemu organu na zahtevo predložijo dokaze, da ima enota, iz katere so bile živali pridobljene, vzpostavljeno strategijo za vzrejo.
establishments acquiring non-human primates shall supply proof to the competent authority, on request, that the establishment from which animals have been acquired have a breeding strategy in place.
Shema za vnovično nastanitev v domovih
Re-homing scheme
Kadar države članice dovoljujejo vnovično nastanitev v domovih, kot je navedeno v
Where Member States allow re-homing as referred to in
, mora imeti vzrejna, dobavna ali uporabniška enota, iz katere naj bi se živali znova nastanile v domovih, vzpostavljeno shemo za vnovično nastanitev v domovih, s katero se zagotavlja socializacija živali, ki bodo znova nastanjene v domovih.
, the breeding, supplying and user establishments from which animals are intended to be re-homed shall have a re-homing scheme in place that ensures socialisation of the animals that are re-homed.
Dokumentacija o živalih
Records on animals
zagotovijo, da vse vzrejne, dobavne in uporabniške enote hranijo dokumentacijo o:
ensure that all breeding, supplying and user establishments keep records of the following:
izvoru živali, vključno s podatkom o tem, ali se redijo za uporabo v postopkih;
the origin of the animals, including whether they are bred for use in procedures;
datumih, na katere so bile živali pridobljene, dobavljene, spuščene ali znova nastanjene v domovih;
the dates on which the animals are acquired, supplied, released or re-homed;
imenu in naslovu dobavne enote in datumu prihoda živali;
the name and address of the supplying establishment and the date of their arrival;
imenu in naslovu
the name and address of the
enote, ki prejme
the establishment receiving the
številu in vrstah živali, ki so poginile ali so bile ubite s humano metodo v enoti.
the number and species of animals which have died or have been killed using a humane method in the establishment.
Dokumentacija iz odstavka 1 se hrani najmanj tri leta in se na zahtevo predloži pristojnemu organu.
The records referred to in paragraph 1 shall be kept for a minimum of three years and shall be submitted to the competent authority upon request.
Podatki o psih, mačkah in primatih razen človeka
Information on dogs, cats and non-human primates
Države članice zagotovijo, da vse vzrejne, dobavne in uporabniške enote hranijo naslednje podatke o vsakem psu, mački in primatu razen človeka:
Member States shall ensure that all breeding, supplying and user establishments keep the following information on each dog, cat and non-human primate:
kraju rojstva;
place of birth;
ali je žival vzrejena za uporabo v postopkih;
whether it is bred for use in procedures;
v primeru primata razen človeka, ali je potomec primatov, ki sta bila vzrejena v ujetništvu.
in the case of a non-human primate, whether it is the offspring of non-human primates that have been bred in captivity.
pes, mačka in
dog, cat and
primat ima osebno kartoteko o zgodovini, v kateri živali se sledi skozi vse njeno življenje.
non-human primate shall have an individual history file, which follows the animal throughout its life.
Države članice morajo zagotoviti primerno in skladno izvajanje te direktive.
Member States shall ensure the adequate and consistent implementation of this Directive.
Kartoteka se ustvari ob rojstvu in vsebuje
The file shall be established at birth and shall cover
vse pomembne
any relevant
reproduktivne, medicinske in socialne podatke o posamezni živali.
reproductive, medical and social information on the individual animal.
Podatki iz odstavka 1 se hranijo najmanj tri leta po smrti živali in se na zahtevo predložijo pristojnemu organu.
The information referred to in paragraph 1 shall be kept for a minimum of three years after the death of the animal and shall be submitted to the competent authority upon request.
Kadar je iz ene enote v drugo prestavljen neki pes, mačka ali primat razen človeka, še preden je odstavljen, in ni izvedljivo, da bi ga vnaprej označili, mora enota, ki ga je sprejela, do tedaj, ko ga je mogoče označiti, vzdrževati popolno dokumentacijo, ki še zlasti navaja njegovo mater.
Where a dog, cat or non-human primate is transferred from one establishment to another before it is weaned, and it is not practicable to mark it beforehand, a full documentary record, specifying in particular its mother, must be maintained by the receiving establishment until it is so marked.
Kadar je v enoto sprejet neoznačen pes, mačka ali primat razen človeka prvič, ga je treba označiti, kakor hitro je mogoče.
Where an unmarked dog, cat or non-human primate is taken into an establishment for the first time it shall be marked as soon as possible.
Enota na zahtevo pristojnega organa poda razloge, zakaj žival ni označena.
The establishment shall provide, on request by the competent authority, reasons for the animal being unmarked.
Oskrba in namestitev
Care and accommodation
in ki jim omogočajo, da zadovoljijo svoje etološke in telesne potrebe
and which allow them to satisfy their ethological as well as physical needs
vse omejitve na obseg, do katerega lahko žival zadovolji svoje fiziološke in etološke potrebe, so zmanjšane na minimum;
any restrictions on the extent to which an animal can satisfy its physiological and ethological needs are limited to a minimum;
okoljske razmere, v katerih se živali redijo, so nastanjene ali se uporabljajo, se dnevno preverjajo;
the environmental conditions in which animals are bred, kept or used are checked daily;
dobro počutje in zdravstveno stanje živali
the well-being and state of health of animals are observed by a competent person
vsaj enkrat dnevno
at least once a day
nadzoruje pristojna oseba, da se preprečijo bolečine ali trpljenje, stiska ali trajne poškodbe, ki se jim je mogoče izogniti;
to prevent pain or avoidable suffering, distress or lasting harm;
zagotovi se, da se morebitne odkrite napake ali trpljenje
arrangements are made to ensure that any
kar najhitreje odpravijo.
defect or suffering discovered is eliminated as quickly as possible.
dovolijo izjeme od določb odstavka 2.
Member States may allow exemptions to paragraph 2 for
V postopkih, katerih namen je opisan v členu 5(2)(c), se vrste agronomskega interesa, naštete v Prilogi V, lahko nastanijo v običajni vzreji, kot je opredeljena v skladu s sedanjimi kmetijskimi praksami v državah članicah in veljavnimi predpisi.
In those procedures whose purpose is described in Article 5(2)(c), the animal species of agricultural interest listed in Annex V may be housed in normal breeding conditions as defined by the current agricultural practices of the Member States and the applicable rules.
Nacionalni pregledi
National inspections
Države članice zagotovijo, da se v vseh vzrejnih, dobavnih in uporabniških enotah opravljajo pregledi skladnosti teh enot s to direktivo.
Member States shall ensure that all breeding, supplying and user establishments are subject to inspections on the compliance of those establishments with this Directive.
Nacionalne preglede izvaja pristojni organ
National inspections shall be carried out by the competent authority
povprečno enkrat
on average once
na leto
a year
, pri čemer pristojni organ prilagodi pogostost pregledov analizi tveganja za vsako enoto
, with the competent authority adapting the frequency of inspection on the basis of a risk analysis for each establishment
Vsaj en pregled je nenapovedan.
At least one of the inspections shall be unannounced.
Dokumentacija o vseh pregledih
Records of all inspections
, vključno z dokumentacijo o kakršnem koli nespoštovanju zahtev iz te direktive,
, including details of any failure to meet the requirements of this Directive,
se hrani
shall be kept
s strani pristojnega organa vsake države članice
by each Member State's competent authority
najmanj pet let.
for at least five years.
Države članice zagotovijo, da je vzpostavljena primerna infrastruktura z zadostnim številom usposobljenih inšpektorjev, ki izvajajo preglede.
Member States shall ensure that an appropriate infrastructure with sufficient numbers of trained inspectors is in place to carry out inspections.
Države članice oblikujejo programe za skupne preglede, ki jih izvajajo države članice.
Member States shall establish programmes for joint inspections by Member States.
Nadzor nad nacionalnimi pregledi
Controls of national inspections
ter pravilno uporabo razvrstitve teže posledic
as well as of the correct application of severity classifications
v državah članicah.
in Member States.
V ta namen Komisija vzpostavi sistem, po katerem spremlja preglede in izvajanje te direktive v vseh državah članicah povprečno enkrat na tri leta, kar bo zagotovilo uskladitev prakse za uporabo in oskrbo živali, ki se uporabljajo pri znanstvenih poskusih ali so temu namenjene.
To that end, the Commission shall set up a system to monitor each Member State's inspections and enforcement of this Directive on average once every three years, ensuring harmonised practices for the use and the care of animals used or intended to be used in scientific procedures.
Država članica na območju, na katerem se izvaja nadzor, strokovnjakom Komisije pri izvajanju njihovih nalog zagotovi vso potrebno pomoč.
The Member State in the territory of which the control is being carried out shall give all necessary assistance to the experts of the Commission in carrying out their duties.
Komisija obvesti pristojni organ zadevne države članice o rezultatu nadzora.
The Commission shall inform the competent authority of the Member State concerned of the results of the control.
Pristojni organ zadevne države članice sprejme vse ukrepe za upoštevanje rezultatov nadzora.
The competent authority of the Member State concerned shall take measures to take account of the results of the control.
Zahteve za projekte
Requirements for projects
Odobritev projektov
Authorisation of projects
Države članice zagotovijo, da se projekti
Member States shall ensure that projects
z oznako "zmerni" ali "hudi" ali projekti, ki vključujejo primate razen človeka,
classified as "moderate" or "severe" or any projects involving non-human primates
ne izvajajo brez predhodne odobritve pristojnega organa.
are not carried out without a prior authorisation by the competent authority.
Za izdajo odobritve je potrebna ugodna
Granting of authorisation shall be subject to favourable
in znanstvena
and scientific
ocena pristojnega organa.
evaluation by the competent authority.
Vloga za odobritev projekta
Application for the project authorisation
Uporabniška enota
When required,
ali oseba, ki je znanstveno odgovorna za projekt, na zahtevo
or the person scientifically responsible for the project
predloži vlogo za odobritev projekta, ki vključuje:
shall submit an application for the project authorisation, which shall include the following:
predlog projekta;
project proposal;
netehnični povzetek projekta;
non-technical project summary;
podatke o elementih iz
information on the elements set out in
znanstveno utemeljeno obrazložitev, da je raziskovalni projekt nujen in etično sprejemljiv ter da njegovega namena ni mogoče doseči z drugimi metodami ali postopki.
a scientifically justified statement that the research project is indispensable and ethically defensible and that the purposes of the project cannot be achieved using other methods or procedures.
Države članice lahko odstopijo od zahteve iz odstavka 1(b) in uporabniški enoti dovolijo, da predloži skrajšan predlog projekta, ki zajema samo etično vrednotenje in elemente iz
Member States may waive the requirement in paragraph 1(b) and permit the user establishment to submit a reduced project proposal covering only the ethical evaluation and elements listed in
člena 43(2)
Article 43(2)
Etično vrednotenje
Ethical evaluation
Pri etičnem vrednotenju se preveri, da projekt izpolnjuje naslednja merila:
The ethical evaluation shall verify that the project meets the following criteria:
projekt je znanstveno utemeljen
the project is scientifically justified
, nujen in etično sprejemljiv
, indispensable and ethically defensible
nameni projekta upravičujejo uporabo živali
the purposes of the project justify the use of animals
in jih ni mogoče doseči z drugimi metodami ali postopki
and cannot be achieved through other methods or procedures
projekt je zasnovan tako, da
the project is designed so as to enable procedures to be carried out
se pri izvajanju postopkov v največji možni meri upoštevajo zaščita živali in okoljski vidiki
with maximum respect for animal welfare
Etično vrednotenje zlasti vključuje:
The ethical evaluation shall consider in particular the following:
vrednotenje ciljev projekta, predvidenih znanstvenih koristi ali izobraževalne vrednosti;
an evaluation of the objectives of the project, the predicted scientific benefits or educational value;
oceno skladnosti projekta z zahtevami nadomestitve, zmanjšanja in izboljšanja;
an assessment of compliance of the project with the requirement of replacement, reduction and refinement;
oceno razvrstitve glede na težo posledic postopkov;
an assessment of the classification of the severity of procedures;
, etično sprejemljiva glede na
ethically defensible in light of
pričakovani napredek znanosti, ki
the expected advancement of science that
Pristojni organ, ki izvaja etično vrednotenje, vključi
The competent authority carrying out the ethical evaluation shall consider
ustrezno strokovno znanje
corresponding expertise
zlasti z naslednjih področij:
in particular in the following areas: