natgillin/translations-raw huggingface dataset:
the criteria to be used, and the evidence required, to substantiate claims that a disease agent or vector is not able to survive, as provided for in points (b) and (c) of Article 36(1);
meril in pogojev, ki se uporabljajo za ugotovitev statusa prost zadevne bolezni v skladu s točko (d) člena 36(1);
the criteria to be used, and the conditions to be applied, to determine freedom from the disease in question, as referred to in point (d) of Article 36(1);
omejitev in pogojev za cepljenje v državah članicah prostih bolezni in na njihovih območjih;
restrictions and conditions for vaccination in disease-free Member States and zones thereof;
vzpostavitve območij, ki ločujejo območja prosta bolezni ali območja, na katerih se izvaja program izkoreninjenja, od območij z omejitvami („varovalni pasovi“);
the establishment of zones separating disease–free zones or zones under the eradication programme from restricted zones (‘buffer zones’);
območij, ki se nahajajo na ozemlju več kot ene države članice;
zones which are located in the territory of more than one Member State;
odstopanji od zahteve, da Komisija odobri statusa prost bolezni glede ene ali več bolezni s seznama iz točk (b) in (c) člena 9(1), kot je določeno v členu 36(1), če takšna odobritev ni potrebna zaradi podrobnih pravil glede statusa prost bolezni, določenih v pravilih, sprejetih v skladu s točko (a) tega člena;
derogations from the requirement for approval by the Commission of disease–free status for one or more listed diseases referred to in points (b) and (c) of Article 9(1), as laid down in Article 36(1), where such approval is not necessary on account of detailed rules for freedom from disease having been laid down in rules adopted pursuant to point (a) of this Article;
informacijami, ki jih morajo države članice predložiti Komisiji in ostalim državam članicam za utemeljitev izjav o statusu prost bolezni, brez sprejetja izvedbenega akta v skladu s členom 36(4), kot je določeno v točki (b) tega člena.
the information to be provided by Member States to the Commission and the other Member States to substantiate declarations of disease–free status, without the adoption of an implementing act in accordance with Article 36(4), as provided for in point (b) of this Article.
Člen 40
Article 40
Komisija z izvedbenimi akti določi podrobne zahteve glede informacij, ki jih morajo države članice predložiti Komisiji in ostalim državam članicam za utemeljitev izjav o statusu prost bolezni na ozemljih, območjih in v kompartmentih v skladu s členi 36 do 39, ter oblike in postopkov za:
The Commission shall, by means of implementing acts, lay down detailed requirements concerning the information to be provided by Member States to the Commission and the other Member States to substantiate declarations of disease–free status of territories, zones and compartments in accordance with Articles 36 to 39, and the format and procedures for:
vloge za priznanje statusa prost bolezni na celotnem ozemlju zadevne države članice ali na njegovih območjih in kompartmentih;
applications for recognition of disease–free status of the entire territory of the Member State concerned, or zones and compartments thereof;
izmenjavo informacij med državami članicami in Komisijo o državah članicah ali njenih območjih in kompartmentih prostih bolezni.
exchanges of information between the Member States and the Commission on disease-free Member States, or zones and compartments thereof.
Člen 41
Article 41
Ohranitev statusa prost bolezni
Maintenance of disease–free status
Države članice ohranijo status prost bolezni na svojih ozemljih ali na njihovih območjih ali kompartmentih le, če:
Member States shall only maintain disease–free status for their territories, or zones or compartments thereof, as long as:
so še naprej izpolnjeni pogoji za status prost bolezni, določeni v členu 36(1) ter v členu 37(1) in (2), pa tudi pravila, določena v skladu z odstavkom 3 tega člena in členom 39;
the conditions for disease–free status laid down in Article 36(1) and Article 37(1) and (2), and rules laid down pursuant to paragraph 3 of this Article and Article 39, continue to be fulfilled;
se izvaja spremljanje ob upoštevanju zahtev, določenih v členu 27, da se preveri, ali je zadevno ozemlje, območje ali kompartment še naprej prosto bolezni s seznama, v zvezi s katero mu je bil odobren ali priznan status prost bolezni;
surveillance, taking into account the requirements provided for in Article 27, is undertaken to verify that the territory, zone or compartment concerned continues to be free of the listed disease for which it was approved or recognised as having disease–free status;
veljajo omejitve za premike vrst s seznama za bolezen s seznama, v zvezi s katero je bil odobren ali priznan status prost bolezni, in, kadar je to primerno, od njih pridobljenih proizvodov, na zadevno ozemlje, območje ali v kompartment v skladu s pravili, določenimi v delih IV in V;
restrictions are applied on movements of animals, and where relevant products derived therefrom, of listed species for the listed disease for which the disease–free status was approved or recognised, into the territory, zone or compartment concerned, in accordance with the rules laid down in Parts IV and V;
se uporabljajo drugi ukrepi za biološko zaščito, da se prepreči vnos bolezni s seznama, v zvezi s katero je bil odobren ali priznan status prost bolezni.
other biosecurity measures are applied to prevent the introduction of the listed disease for which it was approved or recognised as having disease–free status.
Države članice nemudoma obvestijo Komisijo, če pogoji iz odstavka 1 za ohranitev statusa prost bolezni niso več izpolnjeni.
A Member State shall immediately inform the Commission if the conditions referred to in paragraph 1 for maintaining disease–free status are no longer met.
Komisija sprejme delegirane akte v skladu s členom 264 v zvezi z naslednjimi pogoji za ohranitev statusa prost bolezni:
The Commission shall adopt delegated acts in accordance with Article 264 concerning the following conditions for maintaining disease–free status:
spremljanjem, kot je določeno v točki (b) odstavka 1;
surveillance as provided for in point (b) of paragraph 1;
ukrepi za biološko zaščito, kot so določeni v točki (d) odstavka 1.
biosecurity measures as provided for in point (d) of paragraph 1.
Člen 42
Article 42
Začasni preklic, odvzem in ponovna pridobitev statusa prost bolezni
Suspension, withdrawal and restoration of disease–free status
Če država članica ugotovi ali ima razlog za sum, da je bil kršen kateri od pogojev za ohranitev njenega statusa ali statusa njenega območja ali kompartmenta prost bolezni, potem nemudoma:
Where a Member State becomes aware, or has reason to suspect, that any of the conditions for maintaining its status as a disease–free Member State or zone or compartment thereof, have been breached, it shall immediately:
kadar je to primerno, odvisno od tveganja, začasno prekliče ali omeji premike vrst s seznama za bolezen s seznama, za katero je bil odobren ali priznan status prost bolezni, v druge države članice, območja ali kompartmente z višjim zdravstvenim statusom glede te bolezni s seznama;
where relevant, depending on the risk, suspend or restrict movements of the listed species, for the listed disease for which it was approved or recognised as having disease-free status, to other Member States, zones or compartments with a higher health status for that listed disease;
sprejme ukrepe za obvladovanje bolezni iz naslova II dela III, če je to relevantno za preprečevanje širjenja bolezni s seznama, za katero je bil odobren ali priznan status prost bolezni.
where relevant for the prevention of the spread of a listed disease for which disease–free status has been approved or recognised, apply the disease control measures provided for in Title II of Part III.
Ukrepi iz odstavka 1 se odpravijo, če se med nadaljnjo preiskavo potrdi, da:
The measures provided for in paragraph 1 shall be lifted where further investigation confirms that:
do domnevne kršitve ni prišlo ali
the suspected breach has not taken place; or
domnevna kršitev ni imela hudih posledic in lahko zadevna država članica da zagotovila, da ponovno izpolnjuje pogoje za ohranitev statusa prost bolezni.
the suspected breach has not had a significant impact and the Member State concerned can provide assurances that the conditions for maintaining its disease–free status are again fulfilled.
Če se med nadaljnjo preiskavo, ki jo izvede zadevna država članica, potrdi izbruh bolezni s seznama, za katero je država članica pridobila status prost bolezni, ali pojav druge pomembne kršitve pogojev za ohranitev statusa prost bolezni iz člena 41(1) ali je velika verjetnost, da se je to zgodilo, država članica o tem nemudoma obvesti Komisijo.
Where further investigation by the Member State concerned confirms that there has been an outbreak of the listed disease for which it obtained disease–free status, or that other significant breaches of the conditions for maintaining disease–free status as referred to in Article 41(1) have occurred, or where there is a significant likelihood of this having occurred, the Member State shall immediately inform the Commission thereof.
Komisija z izvedbenimi akti brez nepotrebnega odlašanja prekliče odobritev statusa države članice ali območja prostega bolezni, ki je bil podeljen v skladu s členom 36(4), ali priznanje statusa kompartmenta prost bolezni, ki je bil podeljen v skladu s členom 37(4), ko od zadevne države članice pridobi informacije, da pogoji za ohranitev statusa prost bolezni niso več izpolnjeni.
The Commission shall, by means of implementing acts, withdraw without undue delay the approval of the disease–free status of a Member State or zone granted in accordance with Article 36(4) or the recognition of the disease–free status of a compartment granted in accordance with Article 37(4) after obtaining the information from the Member State concerned that the conditions for maintaining the disease–free status are no longer met.
V izredno nujnih ustrezno utemeljenih primerih, ko se bolezen s seznama iz odstavka 3 tega člena hitro širi, hkrati pa so pri njej možne zelo hude posledice za zdravje živali ali javno zdravje, gospodarstvo ali družbo, sprejme Komisija v skladu s postopkom iz člena 266(3) izvedbene akte, ki se začnejo uporabljati takoj.
On duly justified imperative grounds of extreme urgency, where the listed disease referred to in paragraph 3 of this Article spreads in a rapid manner, carrying with it the risk of a highly significant impact on animal or public health, the economy or society, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure provided for in Article 266(3).
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 264 v zvezi z določbami, ki dopolnjujejo pravila za začasni preklic, odvzem in ponovno pridobitev statusa prost bolezni, določena v odstavkih 1 in 2 tega člena.
The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning provisions supplementing the rules for the suspension, withdrawal and restoration of disease–free status set out in paragraphs 1 and 2 of this Article.
DEL III
PART III
OZAVEŠČANJE O BOLEZNIH, PRIPRAVLJENOST NANJE IN NJIHOVO OBVLADOVANJE
DISEASE AWARENESS, PREPAREDNESS AND CONTROL
NASLOV I
TITLE I
OZAVEŠČANJE O BOLEZNIH IN PRIPRAVLJENOST NANJE
DISEASE AWARENESS AND PREPAREDNESS
Načrti ukrepov in simulacijske vaje
Contingency plans and simulation exercises
Člen 43
Article 43
Načrti ukrepov
Contingency plans
Države članice po ustreznem posvetovanju s strokovnjaki in ustreznimi deležniki pripravijo in posodabljajo načrte ukrepov in po potrebi podrobna navodila, v katerih določijo ukrepe, ki se sprejmejo v zadevni državi članici v primeru pojava bolezni s seznama iz točke (a) člena 9(1) oziroma porajajočih se bolezni, da bi tako zagotovila visoko stopnjo ozaveščenosti o boleznih in pripravljenosti nanje ter sposobnosti hitrega odzivanja.
The Member States shall, after appropriate consultation of experts and relevant stakeholders, draw up, and keep up to date, contingency plans and, where necessary, detailed instruction manuals laying down the measures to be taken in the Member State concerned in the event of the occurrence of a listed disease referred to in point (a) of Article 9(1) or, as the case may be, of an emerging disease, in order to ensure a high level of disease awareness and preparedness and the ability to launch a rapid response.
Ti načrti ukrepov in, kadar je to ustrezno, podrobna navodila zajemajo vsaj naslednje zadeve:
Those contingency plans and, where applicable, detailed instruction manuals shall cover at least the following matters:
določitev hierarhije dajanja navodil v pristojnem organu ter z drugimi javnimi organi, da se zagotovi hitro in učinkovito odločanje na ravni države članice ter na regionalni in lokalni ravni;
the establishment of a chain of command within the competent authority and with other public authorities, to ensure a rapid and effective decision–making process at Member State, regional and local level;
okvir za sodelovanje med pristojnim organom ter drugimi sodelujočimi javnimi organi in ustreznimi deležniki, da se zagotovi povezano in usklajeno sprejemanje ukrepov;
the framework for cooperation between the competent authority and the other public authorities and relevant stakeholders involved, to ensure that actions are taken in a coherent and coordinated manner;
dostop do:
access to:
objektov;
facilities;
laboratorijev;
laboratories;
opreme;
equipment;
osebja;
personnel;
sredstev za nujne primere;
emergency funds;
vsega drugega ustreznega materiala in virov, potrebnih za hitro in učinkovito izkoreninjenje bolezni s seznama iz točke (a) člena 9(1) ali porajajočih se bolezni;
all other appropriate materials and resources necessary for the rapid and efficient eradication of the listed diseases referred to in point (a) of Article 9(1) or of emerging diseases;
razpoložljivost naslednjih centrov in skupin, ki imajo potrebno strokovno znanje za pomoč pristojnemu organu:
the availability of the following centres and groups with the necessary expertise to assist the competent authority:
operativnega osrednjega centra za obvladovanje bolezni;
a functional central disease control centre;
regionalnih in lokalnih centrov za obvladovanje bolezni, kot je ustrezno glede na upravne in geografske razmere v zadevni državi članici;
regional and local disease control centres, as appropriate for the administrative and geographical situation of the Member State concerned;
operativnih strokovnih skupin;
operational expert groups;
izvajanje ukrepov za obvladovanje bolezni iz poglavja 1 naslova II za bolezni s seznama iz točke (a) člena 9(1) in za porajajoče se bolezni;
implementation of the disease control measures provided for in Chapter 1 of Title II for the listed diseases referred to in point (a) of Article 9(1) and for emerging diseases;
določbe o cepljenju v nujnih primerih, kadar je to ustrezno;
provisions on emergency vaccination, where appropriate;
načela za geografsko razmejitev območij z omejitvami, ki jih je določil pristojni organ v skladu s členom 64(1);
principles for the geographical demarcation of the restricted zones established by the competent authority in accordance with Article 64(1);
usklajevanje s sosednjimi državami članicami ter sosednjimi tretjimi državami in ozemlji, kadar je to ustrezno.
coordination with neighbouring Member States and neighbouring third countries and territories, where appropriate.
Člen 44
Article 44
Izvedbena pooblastila za načrte ukrepov
Implementing powers for contingency plans
Komisija z izvedbenimi akti določi potrebne ukrepe glede izvajanja načrtov ukrepov iz člena 43(1) v državah članicah.
The Commission shall, by means of implementing acts, lay down necessary measures concerning the implementation in the Member States of the contingency plans provided for in Article 43(1).
Člen 45
Article 45
Simulacijske vaje
Simulation exercises
Pristojni organ zagotovi, da se simulacijske vaje v zvezi z načrti ukrepov iz člena 43(1) izvajajo redno ali v ustreznih časovnih presledkih za:
The competent authority shall ensure that simulation exercises concerning the contingency plans provided for in Article 43(1) are carried out regularly or at appropriate intervals:
zagotovitev visoke stopnje ozaveščenosti o bolezni in pripravljenosti nanjo ter sposobnosti hitrega odzivanja v zadevni državi članici;
to ensure a high level of disease awareness and preparedness and the ability to launch a rapid response in the Member State concerned;
preverjanje delovanja navedenih načrtov ukrepov.
to verify the functionality of those contingency plans.
Kadar je to izvedljivo in ustrezno, se simulacijske vaje izvajajo v tesnem sodelovanju s pristojnimi organi sosednjih držav članic ter sosednjih tretjih držav in ozemelj.
Where feasible and appropriate, simulation exercises shall be carried out in close collaboration with the competent authorities of neighbouring Member States and neighbouring third countries and territories.
Države članice dajo Komisiji in drugim državam članicam na njihovo zahtevo na voljo poročilo o glavnih rezultatih izvedenih simulacijskih vaj.
Member States shall make available to the Commission and to the other Member States, on request, a report on the main results of the simulation exercises carried out.
Kadar je to ustrezno in potrebno, Komisija z izvedbenimi akti določi pravila o praktičnem izvajanju simulacijskih vaj v državah članicah glede:
When appropriate and necessary, the Commission shall, by means of implementing acts, lay down rules concerning the practical implementation of simulation exercises in the Member States, relating to:
pogostosti simulacijskih vaj;
the frequencies of simulation exercises;
simulacijskih vaj, ki zajemajo več kot eno bolezen s seznama iz točke (a) člena 9(1).
simulation exercises covering more than one listed disease referred to in point (a) of Article 9(1).
Uporaba veterinarskih zdravil za preprečevanje in obvladovanje bolezni
The use of veterinary medicinal products for disease prevention and control
Člen 46
Article 46
Države članice lahko sprejmejo ukrepe glede uporabe veterinarskih zdravil za bolezni s seznama, da zagotovijo kar najučinkovitejše preprečevanje ali obvladovanje teh bolezni, pod pogojem, da so taki ukrepi ustrezni ali potrebni.
The Member States may take measures concerning the use of veterinary medicinal products for listed diseases, to ensure the most efficient prevention or control of those diseases, provided that such measures are appropriate or necessary.
Ti ukrepi lahko zajemajo:
Those measures may cover the following:
prepovedi in omejitve uporabe veterinarskih zdravil;
prohibitions and restrictions on the use of veterinary medicinal products;
obvezno uporabo veterinarskih zdravil.
the compulsory use of veterinary medicinal products.
Države članice pri določanju, ali in kako se morajo veterinarska zdravila uporabljati kot ukrepi za preprečevanje in obvladovanje določene bolezni s seznama, upoštevajo naslednja merila:
Member States shall take the following criteria into consideration when determining whether or not to use, and how to use, veterinary medicinal products as prevention and control measures for a specific listed disease:
porazdelitev bolezni s seznama v:
the distribution of the listed disease in:
zadevni državi članici;
the Member State concerned;
Uniji;
the Union;
sosednjih tretjih državah in na ozemljih, kadar je to ustrezno;
where relevant, neighbouring third countries and territories;
tretjih državah in na ozemljih, iz katerih se živali in proizvodi vnašajo v Unijo;
third countries and territories from which animals and products are brought into the Union;
razpoložljivost in učinkovitost zadevnih veterinarskih zdravil ter z njimi povezana tveganja;
the availability and effectiveness of the veterinary medicinal products in question, and the risks attaching to them;
razpoložljivost diagnostičnih testov za ugotavljanje okužb pri živalih, zdravljenih z zadevnimi veterinarskimi zdravili;
the availability of diagnostic tests for detecting infections in animals treated with the veterinary medicinal products concerned;
posledice uporabe zadevnih veterinarskih zdravil za gospodarstvo, družbo, dobrobit živali in okolje v primerjavi z drugimi razpoložljivimi strategijami preprečevanja in obvladovanja bolezni.
the economic, social, animal welfare and environmental impact of the use of the veterinary medicinal products concerned compared to other available disease prevention and control strategies.
Države članice sprejmejo ustrezne preventivne ukrepe v zvezi z uporabo veterinarskih zdravil v znanstvenih študijah ali za namene razvoja in testiranja teh zdravil pod nadzorovanimi pogoji za varovanje zdravja živali in javnega zdravja.
Member States shall take appropriate preventive measures concerning the use of veterinary medicinal products for scientific studies or for the purposes of developing and testing them under controlled conditions to protect animal and public health.
Člen 47
Article 47
Prenos pooblastil glede uporabe veterinarskih zdravil
Delegation of powers for the use of veterinary medicinal products
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 264 v zvezi z vsem, kar bi utegnilo predstavljati ustrezne in potrebne ukrepe, določene v členu 46, glede:
The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning what might constitute appropriate and necessary measures as set out in Article 46, in relation to:
posebnih pogojev za uporabo veterinarskih zdravil za določeno bolezen s seznama;
specific conditions for the use of veterinary medicinal products for a specific listed disease;
ukrepov za zmanjšanje tveganja, da se prepreči širjenje bolezni s seznama prek živali, ki so bile zdravljene z veterinarskimi zdravili, ali proizvodov iz takšnih živali;
risk-mitigation measures to prevent the spread of listed diseases through animals treated with the veterinary medicinal products or products from such animals;
spremljanja določenih bolezni s seznama po uporabi cepiv in drugih veterinarskih zdravil.
surveillance for specific listed diseases following the use of vaccines and other veterinary medicinal products.
Komisija pri določitvi pravil iz odstavka 1 tega člena upošteva merila, določena v členu 46(2).
The Commission shall take into account the criteria set out in Article 46(2) when laying down the rules provided for in paragraph 1 of this Article.
Kadar se pojavijo tveganja, se za pravila, sprejeta na podlagi odstavka 1 tega člena, v izredno nujnih primerih uporablja postopek iz člena 265.
Where, in the case of emerging risks, imperative grounds of urgency so require, the procedure provided for in Article 265 shall apply to rules adopted pursuant to paragraph 1 of this Article.
Banke antigenov, cepiv in diagnostičnih reagentov
Antigen, vaccine and diagnostic reagent banks
Člen 48
Article 48
Vzpostavitev bank antigenov, cepiv in diagnostičnih reagentov Unije
The establishment of Union antigen, vaccine and diagnostic reagent banks
Za bolezni s seznama iz točke (a) člena 9(1), za katere cepljenje ni prepovedano z delegiranim aktom, sprejetim v skladu s členom 47, Komisija lahko vzpostavi banke antigenov, cepiv in diagnostičnih reagentov Unije za shranjevanje in menjavo zalog enega ali več od naslednjih bioloških proizvodov ter je odgovorna za upravljanje teh bank:
For listed diseases referred to in point (a) of Article 9(1) in respect of which vaccination is not prohibited by a delegated act adopted pursuant to Article 47, the Commission may establish and be responsible for managing Union antigen, vaccine and diagnostic reagent banks for the storage and replacement of stocks of one or more of the following biological products:
antigenov;
antigens;
cepiv;
vaccines;
zalog izhodiščnih sevov cepnih virusov;
vaccine master seed–stocks;
diagnostičnih reagentov.
diagnostic reagents.
Komisija zagotovi, da banke antigenov, cepiv in diagnostičnih reagentov Unije iz odstavka 1: