natgillin/translations-raw huggingface dataset:
The Commission shall ensure that the Union antigen, vaccine and diagnostic reagent banks provided for in paragraph 1:
imajo dovolj zalog ustreznih tipov antigenov, cepiv, izhodiščnih sevov cepnih virusov in diagnostičnih reagentov za zadevno določeno bolezen s seznama, ob upoštevanju potreb držav članic, ocenjenih v okviru načrtov ukrepov iz člena 43(1);
store sufficient stocks of the appropriate type of antigens, vaccines, vaccine master seed–stocks and diagnostic reagents for the specific listed disease in question, taking into account the needs of Member States estimated in the context of the contingency plans provided for in Article 43(1);
redno prejemajo in pravočasno menjajo antigene, cepiva, izhodiščne seve cepnih virusov in diagnostične reagente;
receive regular supplies and timely replacements of antigens, vaccines, vaccine master seed–stocks and diagnostic reagents;
se upravljajo in premikajo v skladu z ustreznimi zahtevami za biološko zaščito, biološko varnost in biološko zadrževanje, določenimi v členu 16(1), in v skladu z delegiranimi akti, sprejetimi na podlagi člena 16(2).
are maintained and moved in conformity with the appropriate biosecurity, biosafety and bio–containment requirements laid down in Article 16(1) and in accordance with delegated acts adopted pursuant to Article 16(2);
upravljanjem, shranjevanjem in menjavo zalog v bankah antigenov, cepiv in diagnostičnih reagentov Unije, kot je določeno v odstavkih 1 in 2 tega člena;
the management, storage and replacement of stocks of the Union antigen, vaccine and diagnostic reagent banks as provided for in paragraphs 1 and 2 of this Article;
zahtevami za biološko zaščito, biološko varnost in biološko zadrževanje pri delovanju teh bank, ob upoštevanju zahtev iz člena 16(1) in delegiranih aktov, sprejetih na podlagi člena 16(2).
the biosecurity, biosafety and bio–containment requirements for the operation of those banks, respecting the requirements provided for in Article 16(1) and taking into account the delegated acts adopted pursuant to Article 16(2).
Člen 49
Article 49
Dostop do bank antigenov, cepiv in diagnostičnih reagentov Unije
Access to the Union antigen, vaccine and diagnostic reagent banks
Komisija na zahtevo zagotovi, da se biološki proizvodi iz člena 48(1), če so na zalogi, iz bank antigenov, cepiv in diagnostičnih reagentov Unije dostavijo:
The Commission shall, upon request, provide for the delivery of the biological products referred to in Article 48(1) from the Union antigen, vaccine and diagnostic reagent banks, provided that stocks are available, to:
najprej državam članicam ter
in the first place, Member States; and
tretjim državam ali ozemljem, če je taka dostava prvenstveno namenjena preprečevanju širjenja bolezni v Unijo.
third countries or territories, provided that such delivery is primarily intended to prevent the spread of a disease into the Union.
Komisija v primeru omejene razpoložljivosti zalog pripravi prednostni vrstni red dostopa do zalog, ki se dostavijo v skladu z odstavkom 1, in sicer na podlagi:
The Commission shall, in the event of the limited availability of stocks, prioritise access to the stocks to be delivered pursuant to paragraph 1 based on:
okoliščin, povezanih z boleznijo, na podlagi katerih je bil vložen zahtevek;
the disease circumstances under which the request is made;
obstoja nacionalne banke antigenov, cepiv in diagnostičnih reagentov v državi članici ali v tretji državi ali na ozemlju, ki vloži zahtevek;
the existence of a national antigen, vaccine and diagnostic reagent bank in the requesting Member State or third country or territory;
obstoja ukrepov Unije za obvezno cepljenje, določenih v delegiranih aktih, sprejetih na podlagi člena 47.
the existence of Union measures for compulsory vaccination laid down in delegated acts adopted pursuant to Article 47.
Člen 50
Article 50
Izvedbena pooblastila glede bank antigenov, cepiv in diagnostičnih reagentov Unije
Implementing powers concerning the Union antigen, vaccine and diagnostic reagent banks
Komisija z izvedbenimi akti določi pravila za banke antigenov, cepiv in diagnostičnih reagentov Unije ter za biološke proizvode iz člena 48(1) navede:
The Commission shall, by means of implementing acts, lay down rules for Union antigen, vaccine and diagnostic reagent banks, specifying for the biological products referred to in Article 48(1):
katere izmed navedenih bioloških proizvodov je treba hraniti v bankah antigenov, cepiv in diagnostičnih reagentov Unije ter za katere bolezni s seznama iz točke (a) člena 9(1);
which of those biological products are to be included in the Union antigen, vaccine and diagnostic reagent banks and for which of the listed diseases referred to in point (a) of Article 9(1);
katere tipe navedenih bioloških proizvodov je treba hraniti v bankah antigenov, cepiv in diagnostičnih reagentov Unije ter njihove količine za vsako določeno bolezen s seznama iz točke (a) člena 9(1), za katere obstaja zadevna banka;
the types of those biological products that are to be included in the Union antigen, vaccine and diagnostic reagent banks and in what quantities for each specific listed disease referred to in point (a) of Article 9(1) for which the bank in question exists;
zahteve v zvezi z dobavo, shranjevanjem in menjavo teh bioloških proizvodov;
the requirements concerning the supply, storage and replacement of those biological products;
dostavo navedenih bioloških proizvodov iz bank antigenov, cepiv in diagnostičnih reagentov Unije državam članicam ter tretjim državam in ozemljem;
the delivery of those biological products from the Union antigen, vaccine and diagnostic reagent banks to the Member States and to third countries and territories;
postopkovne in tehnične zahteve za shranjevanje bioloških proizvodov v bankah antigenov, cepiv in diagnostičnih reagentov Unije ter za zahtevanje dostopa do njih.
procedural and technical requirements for the inclusion of those biological products in the Union antigen, vaccine and diagnostic reagent banks and for requesting access to them.
V izredno nujnih ustrezno utemeljenih primerih v zvezi z boleznijo s seznama iz točke (a) člena 9(1), pri kateri so možne zelo hude posledice, sprejme Komisija v skladu s postopkom iz člena 266(3) izvedbene akte, ki se začnejo uporabljati takoj.
On duly justified imperative grounds of urgency relating to a listed disease referred to in point (a) of Article 9(1) representing a risk of a highly significant impact, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure provided for in Article 266(3).
Člen 51
Article 51
Zaupnost informacij glede bank antigenov, cepiv in diagnostičnih reagentov Unije
Confidentiality of information concerning the Union antigen, vaccine and diagnostic reagent banks
Komisija informacije o količinah in podtipih bioloških proizvodov iz člena 48(1), shranjenih v bankah antigenov, cepiv in diagnostičnih reagentov Unije, obravnava kot zaupne in te informacije se ne objavijo.
Information on the quantities and subtypes of the biological products referred to in Article 48(1) stored in the Union antigen, vaccine and diagnostic reagent banks shall be treated by the Commission as classified information and shall not be published.
Člen 52
Article 52
Nacionalne banke antigenov, cepiv in diagnostičnih reagentov
National antigen, vaccine and diagnostic reagent banks
Države članice, ki so vzpostavile nacionalne banke antigenov, cepiv in diagnostičnih reagentov za bolezni s seznama iz točke (a) člena 9(1), za katere obstajajo banke antigenov, cepiv in diagnostičnih reagentov Unije, zagotovijo, da so njihove nacionalne banke antigenov, cepiv in diagnostičnih reagentov skladne z zahtevami za biološko zaščito, biološko varnost in biološko zadrževanje, določenimi v točki (a) člena 16(1) in delegiranih aktih, sprejetih na podlagi člena 16(2) in točke (b) člena 48(3).
Member States that have established national antigen, vaccine and diagnostic reagent banks for listed diseases referred to in point (a) of Article 9(1) for which Union antigen, vaccine and diagnostic reagent banks exist, shall ensure that their national antigen, vaccine and diagnostic reagent banks comply with the biosecurity, biosafety and bio–containment requirements laid down in point (a) of Article 16(1) and in delegated acts adopted in accordance with Article 16(2) and point (b) of Article 48(3).
Države članice Komisiji predložijo posodobljene informacije o:
Member States shall provide the Commission with up–to–date information on:
obstoju ali vzpostavitvi nacionalnih bank antigenov, cepiv in diagnostičnih reagentov iz odstavka 1;
the existence or the establishment of the national antigen, vaccine and diagnostic reagent banks referred to paragraph 1;
tipih in količinah antigenov, cepiv, zalog izhodiščnih sevov cepnih virusov in diagnostičnih reagentov v takšnih bankah;
the types of antigens, vaccines, vaccine master-seed stocks and diagnostic reagents and the quantities thereof held in such banks;
kakršnih koli spremembah delovanja takšnih bank.
any changes in the operation of such banks.
Komisija takšne informacije obravnava kot zaupne in te informacije se ne objavijo.
That information shall be treated as classified information by the Commission and shall not be published.
Komisija lahko z izvedbenimi akti določi pravila o vsebini, pogostosti in obliki predložitve informacij iz odstavka 2.
The Commission may, by means of implementing acts, lay down rules specifying the content, frequency and format of the submission of the information provided for in paragraph 2.
NASLOV II
TITLE II
UKREPI ZA OBVLADOVANJE BOLEZNI
DISEASE CONTROL MEASURES
Ukrepi za obvladovanje bolezni s seznama iz točke (a) člena 9(1)
Disease control measures for listed diseases as referred to in point (a) of Article 9(1)
Ukrepi za obvladovanje bolezni ob sumu bolezni s seznama pri gojenih živalih
Disease control measures in the event of suspicion of a listed disease in kept animals
Člen 53
Article 53
Obveznosti izvajalcev dejavnosti in drugih zadevnih ustreznih fizičnih in pravnih oseb
Obligations on operators and other relevant natural and legal persons concerned
Države članice ob sumu bolezni s seznama iz točke (a) člena 9(1) pri gojenih živalih – še preden ukrepe za obvladovanje bolezni v skladu s členoma 54(1) in 55(1) sprejme pristojni organ – poleg upoštevanja dolžnosti prijave, določene v členu 18(1), sprejmejo ukrepe, s katerimi zagotovijo, da izvajalci dejavnosti in druge zadevne ustrezne fizične in pravne osebe sprejmejo ustrezne ukrepe za obvladovanje bolezni iz točk (c), (d) in (e) člena 55(1) za preprečitev širjenja te bolezni s seznama s prizadetih živali, obratov in lokacij, za katere so odgovorni, na druge neprizadete živali ali na ljudi.
In the event of suspicion of a listed disease as referred to in point (a) of Article 9(1) in kept animals, in addition to complying with the notification obligation laid down in Article 18(1) and pending any disease control measures being taken by the competent authority in accordance with Articles 54(1) and 55(1), Member States shall take measures to ensure that operators and other relevant natural and legal persons concerned take the appropriate disease control measures provided for in points (c), (d) and (e) of Article 55(1), to prevent the spread of that listed disease from the affected animals, establishments and locations under their responsibility to other unaffected animals or to humans.
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 264 v zvezi s podrobnimi pravili, ki dopolnjujejo ukrepe za obvladovanje bolezni iz odstavka 1 tega člena.
The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning detailed rules for supplementing the disease control measures provided for in paragraph 1 of this Article.
Člen 54
Article 54
Preiskava, ki jo opravi pristojni organ ob sumu bolezni s seznama
Investigation by the competent authority in the event of suspicion of a listed disease
Pristojni organ ob sumu bolezni s seznama iz točke (a) člena 9(1) pri gojenih živalih nemudoma opravi preiskavo, s katero potrdi ali izključi prisotnost te bolezni s seznama.
In the event of suspicion of a listed disease as referred to in point (a) of Article 9(1) in kept animals, the competent authority shall conduct without delay an investigation to confirm or rule out the presence of that listed disease.
Za namen preiskave iz odstavka 1 pristojni organ po potrebi zagotovi, da:
For the purpose of the investigation provided for in paragraph 1, the competent authority shall, when appropriate, ensure that:
uradni veterinarji opravijo klinični pregled reprezentativnega vzorca gojenih živali iz vrst s seznama za zadevno bolezen s seznama;
official veterinarians carry out a clinical examination of a representative sample of the kept animals of listed species for the listed disease in question;
uradni veterinarji navedenim gojenim živalim iz vrst s seznama odvzamejo ustrezne vzorce in druge vzorce za preiskavo v laboratorijih, ki jih v ta namen določi pristojni organ;
official veterinarians take appropriate samples from those kept animals of listed species and other samples for examination in laboratories designated for that purpose by the competent authority;
takšni določeni laboratoriji opravijo preiskave za potrditev ali izključitev prisotnosti zadevne bolezni s seznama.
such designated laboratories carry out examinations to confirm or rule out the presence of the listed disease in question.
Komisija sprejme delegirane akte v skladu s členom 264 v zvezi s podrobnimi pravili, ki dopolnjujejo pravila za preiskave, ki jih opravijo pristojni organi, kot je določeno v odstavku 1 tega člena.
The Commission shall adopt delegated acts in accordance with Article 264 concerning detailed rules supplementing the rules for investigations by competent authorities as provided for in paragraph 1 of this Article.
Člen 55
Article 55
Predhodni ukrepi za obvladovanje bolezni, ki jih sprejmejo pristojni organi
Preliminary disease control measures by competent authorities
Če pristojni organ sumi na prisotnost bolezni s seznama iz točke (a) člena 9(1) pri gojenih živalih, ob upoštevanju nacionalnih zahtev za pridobitev dostopa do zasebnih bivališč, še preden so na voljo rezultati preiskave iz člena 54(1) in še preden se začnejo izvajati ukrepi za obvladovanje bolezni iz člena 61(1), izvede naslednje predhodne ukrepe za obvladovanje bolezni:
The competent authority shall, in the event that it suspects the presence of a listed disease as referred to in point (a) of Article 9(1) in kept animals, carry out the following preliminary disease control measures, subject to national requirements for gaining access to private residences, pending the results of the investigation provided for in Article 54(1) and the carrying-out of the disease control measures provided for in Article 61(1):
uvede uradno spremljanje zadevnega obrata, obrata živilske dejavnosti in dejavnosti poslovanja s krmo ali živalskimi stranskimi proizvodi ali katere koli druge lokacije, na kateri se pojavi sum bolezni, tudi tistih lokacij, iz katerih bi lahko izvirala domnevna bolezen;
place the establishment, food and feed business or animal by–products establishment concerned, or any other location where the disease is suspected of having occurred, including locations where the suspected disease may have originated, under official surveillance;
naredi popis:
compile an inventory of:
gojenih živali v zadevnem obratu, obratu živilske dejavnosti in dejavnosti poslovanja s krmo ali živalskimi stranskimi proizvodi ali na kateri koli drugi lokaciji;
the kept animals in the establishment, food and feed business, or animal by–products establishment concerned, or in any other location;
proizvodov v tem obratu, obratu živilske dejavnosti in dejavnosti poslovanja s krmo ali živalskimi stranskimi proizvodi ali na kateri koli drugi lokaciji, če je to potrebno zaradi širjenja te bolezni s seznama;
the products in that establishment, food and feed business, or animal by–products establishment, or in any other location, where relevant for the spread of that listed disease;
zagotovi izvajanje ustreznih ukrepov za biološko zaščito, da se prepreči širjenje povzročitelja te bolezni s seznama na druge živali ali ljudi;
ensure that appropriate biosecurity measures are applied to prevent the spreading of that listed disease agent to other animals or to humans;
kadar je to ustrezno za preprečevanje nadaljnjega širjenja povzročitelja bolezni, zagotovi, da se gojene živali iz vrst s seznama za to bolezen s seznama osamijo ter se prepreči njihov stik z divjimi živalmi;
when appropriate to prevent the further spread of the disease agent, ensure that the kept animals of listed species for that listed disease are isolated, and that they are prevented from coming into contact with wildlife;
omeji premike gojenih živali, proizvodov in, če je to ustrezno, ljudi, vozil in katerega koli materiala ali drugih sredstev, s katerimi bi se lahko povzročitelj bolezni razširil v obrat, obrate živilske dejavnosti in dejavnosti poslovanja s krmo ali živalskimi stranskimi proizvodi ali iz njih ali na katere koli druge lokacije, na katerih se pojavi sum navedene bolezni s seznama, ali z njih, kolikor je to potrebno, da se prepreči širjenje te bolezni;
restrict the movements of kept animals, products and, if appropriate, people, vehicles and any material or other means by which the disease agent could have spread to or from the establishment, food and feed business or animal by–products establishment, or from any other location where that listed disease is suspected, as far as necessary to prevent its spread;
sprejme vse druge potrebne ukrepe za obvladovanje bolezni, pri čemer upošteva ukrepe za obvladovanje bolezni iz oddelka 4 tega poglavja, v zvezi z:
take any other necessary disease control measures, taking into account the disease control measures provided for in Section 4 of this Chapter, concerning:
izvajanjem preiskave, ki jo opravi pristojni organ v skladu s členom 54(1), in ukrepov za obvladovanje bolezni iz točk (a) do (d) tega odstavka v drugih obratih, obratih živilske dejavnosti in dejavnosti poslovanja s krmo ali živalskimi stranskimi proizvodi ali na kateri koli drugi lokaciji;
the application of the investigation by the competent authority provided for in Article 54(1) and disease control measures provided for in points (a) to (d) of this paragraph to other establishments, food and feed businesses, or animal by–products establishments, or to any other location;
vzpostavitvijo začasnih območij z omejitvami, ustreznimi glede na profil bolezni;
the establishment of any temporary restricted zones which are appropriate, taking into account the disease profile;
sproži epidemiološko poizvedbo iz člena 57(1).
initiate the epidemiological enquiry provided for in Article 57(1).
Komisija sprejme delegirane akte v skladu s členom 264 v zvezi s podrobnimi pravili, ki dopolnjujejo pravila iz odstavka 1 tega člena, glede posebnih in podrobnih ukrepov za obvladovanje bolezni, ki se sprejmejo glede na bolezen s seznama iz točke (a) člena 9(1), na podlagi tveganj za:
The Commission shall adopt delegated acts in accordance with Article 264 concerning detailed rules supplementing those laid down in paragraph 1 of this Article as regards the specific and detailed disease control measures to be taken depending on the listed disease referred to in point (a) of Article 9(1), based on the risks involved for:
vrsto ali kategorijo zadevnih živali;
the species or category of animals concerned;
vrsto zadevne proizvodnje.
the type of production concerned.
Člen 56
Article 56
Pregled in razširitev predhodnih ukrepov za obvladovanje bolezni
Review and extension of the preliminary disease control measures
Ukrepe za obvladovanje bolezni iz člena 55(1):
The disease control measures provided for in Article 55(1) shall be:
pregleda pristojni organ, kadar je ustrezno in na podlagi ugotovitev:
reviewed by the competent authority, as appropriate, following the findings of:
preiskave iz člena 54(1);
the investigation provided for in Article 54(1);
epidemiološke poizvedbe iz člena 57(1);
the epidemiological enquiry provided for in Article 57(1);
se po potrebi razširi na druge lokacije iz točke (a) člena 55(1).
further extended to other locations as referred to in point (a) of Article 55(1), where necessary.
Epidemiološka poizvedba
Epidemiological enquiry
Člen 57
Article 57
Pristojni organ opravi epidemiološko poizvedbo, kadar je bolezen s seznama iz točke (a) člena 9(1) pri živalih potrjena.
The competent authority shall carry out an epidemiological enquiry in the event of the confirmation of a listed disease as referred to in point (a) of Article 9(1) in animals.
Cilji epidemiološke poizvedbe iz odstavka 1 so:
The epidemiological enquiry provided for in paragraph 1 shall aim to:
opredeliti verjetni vir zadevne bolezni s seznama in način njenega širjenja;
identify the likely origin of the listed disease in question and the means of its spread;
izračunati verjetno obdobje prisotnosti bolezni s seznama;
calculate the likely length of time that the listed disease has been present;
opredeliti obrate in njihove epidemiološke enote, obrate živilske dejavnosti in dejavnosti poslovanja s krmo ali živalskimi stranskimi proizvodi ali druge lokacije, na katerih bi se živali iz vrst s seznama za zadevno bolezen s seznama lahko okužile, infestirale ali kontaminirale;
identify establishments and epidemiological units therein, food and feed businesses or animal by–products establishments, or other locations, where animals of listed species for the suspected listed disease may have become infected, infested or contaminated;
pridobiti informacije o premikih gojenih živali, oseb, proizvodov, vozil, katerega koli materiala ali drugih sredstev, s katerimi bi se lahko povzročitelj bolezni razširil v ustreznem obdobju pred prijavo suma ali potrditvijo bolezni s seznama;
obtain information on the movements of kept animals, persons, products, vehicles, any material or other means by which the disease agent could have been spread during the relevant period preceding the notification of the suspicion or confirmation of the listed disease;
pridobiti informacije o verjetnem širjenju bolezni s seznama v okolico, vključno s prisotnostjo in porazdelitvijo vektorjev bolezni.
obtain information on the likely spread of the listed disease in the surrounding environment, including the presence and distribution of disease vectors.
Potrditev bolezni pri gojenih živalih
Disease confirmation in kept animals
Člen 58
Article 58
Uradna potrditev bolezni s seznama iz točke (a) člena 9(1) s strani pristojnega organa
Official confirmation by the competent authority of a listed disease as referred to in point (a) of Article 9(1)
Pristojni organ pri uradni potrditvi bolezni s seznama iz točke (a) člena 9(1) upošteva naslednje informacije:
The competent authority shall base an official confirmation of a listed disease as referred to in point (a) of Article 9(1) on the following information:
rezultate kliničnih in laboratorijskih preiskav iz člena 54(2);
the results of the clinical and laboratory examinations provided for in Article 54(2);
predhodne ali končne rezultate epidemiološke poizvedbe iz člena 57(1);
the preliminary or final results of the epidemiological enquiry provided for in Article 57(1);
druge razpoložljive epidemiološke podatke.
other available epidemiological data.
Komisija sprejme delegirane akte v skladu s členom 264 v zvezi z zahtevami, ki morajo biti izpolnjene za uradno potrditev iz odstavka 1 tega člena.
The Commission shall adopt delegated acts in accordance with Article 264 concerning the requirements to be fulfilled for the official confirmation referred to in paragraph 1 of this Article.
Člen 59
Article 59
Odprava predhodnih ukrepov za obvladovanje bolezni, kadar je bila prisotnost bolezni s seznama izključena
Lifting of preliminary disease control measures where the presence of the listed disease has been ruled out
Pristojni organ izvaja predhodne ukrepe za obvladovanje bolezni iz člena 55(1) in člena 56, vse dokler prisotnost zadevne bolezni s seznama iz točke (a) člena 9(1) ni bila izključena na podlagi informacij iz člena 58(1) ali pravil, sprejetih na podlagi člena 58(2).