natgillin/translations-raw huggingface dataset:
This Decision lays down rules on epidemiological surveillance, monitoring, early warning of, and combating serious cross-border threats to health, including preparedness and response planning related to those activities, in order to coordinate and complement national policies.
Za usklajevanje in dopolnjevanje nacionalnih politik določa ta sklep pravila za epidemiološko spremljanje, spremljanje resnih čezmejnih nevarnosti za zdravje, zgodnje obveščanje o njih in boj proti njim, vključno z načrtovanjem pripravljenosti in odzivanja v zvezi z navedenimi dejavnostmi.
This Decision aims to support cooperation and coordination between the Member States in order to improve the prevention and control of the spread of severe human diseases across the borders of the Member States, and to combat other serious cross-border threats to health in order to contribute to a high level of public health protection in the Union.
Namen tega sklepa je podpreti sodelovanje in usklajevanje med državami članicami ter s tem izboljšati preprečevanje in obvladovanje širjenja hujših bolezni ljudi čez meje držav članic ter boj proti drugim resnim čezmejnim nevarnostim za zdravje in na ta način pripomoči k visoki ravni varovanja javnega zdravja v Uniji.
This Decision also clarifies the methods of cooperation and coordination between the various actors at Union level.
V tem sklepu so pojasnjene tudi metode sodelovanja in usklajevanja med različnimi akterji na ravni Unije.
This Decision shall apply to public health measures in relation to the following categories of serious cross-border threats to health:
Ta sklep se uporablja za javno-zdravstvene ukrepe, povezane z naslednjimi kategorijami resnih čezmejnih nevarnosti za zdravje:
threats of biological origin, consisting of:
nevarnosti biološkega izvora, ki zajemajo:
communicable diseases;
nalezljive bolezni;
antimicrobial resistance and healthcare-associated infections related to communicable diseases (hereinafter ‘related special health issues’);
protimikrobno odpornost in bolnišnične okužbe, povezane z nalezljivimi boleznimi (v nadaljnjem besedilu: povezani posebni zdravstveni problemi);
biotoxins or other harmful biological agents not related to communicable diseases;
biotoksine ali druga škodljiva biološka sredstva, ki niso povezana z nalezljivimi boleznimi;
threats of chemical origin;
nevarnosti kemičnega izvora;
threats of environmental origin;
nevarnosti okoljskega izvora;
threats of unknown origin;
nevarnosti neznanega izvora;
events which may constitute public health emergencies of international concern under the IHR, provided that they fall under one of the categories of threats set out in points (a) to (d).
dogodki, ki lahko pomenijo izredne razmere mednarodnih razsežnosti na področju javnega zdravja v skladu z Mednarodnim zdravstvenim pravilnikom (2005), če spadajo v eno od kategorij nevarnosti iz točk od (a) do (d).
This Decision shall also apply to the epidemiological surveillance of communicable diseases and of related special health issues.
Ta sklep se uporablja tudi za epidemiološko spremljanje nalezljivih bolezni ter povezanih posebnih zdravstvenih problemov.
The provisions of this Decision are without prejudice to provisions of other Union acts governing specific aspects of monitoring, early warning of, the coordination of preparedness and response planning for, and the coordination of, combating serious cross- border threats to health, including measures setting quality and safety standards for specific goods and measures concerning specific economic activities.
Določbe tega sklepa ne posegajo v določbe drugih aktov Unije, ki urejajo posebne vidike spremljanja, zgodnjega obveščanja, usklajevanja načrtovanja pripravljenosti in odzivanja za boj proti resnim čezmejnim nevarnostim za zdravje in njegovo usklajevanje, vključno z ukrepi za določitev standardov kakovosti in varnosti za posebno blago ter ukrepi za posebne gospodarske dejavnosti.
In exceptional emergency situations, a Member State or the Commission may request response coordination within the HSC, as referred to in Article 11, for serious cross-border threats to health other than those covered in Article 2(1), if it is considered that public health measures taken previously have proven insufficient to ensure a high level of protection of human health.
V izjemnih primerih izrednih razmer lahko država članica ali Komisija za čezmejne nevarnosti za zdravje, razen tistih iz člena 2(1), zahteva uskladitev odzivanja v okviru OZV, kakor je določeno v členu 11, če se šteje, da sprejeti javno-zdravstveni ukrepi ne zagotavljajo dovolj visoke ravni varovanja zdravja ljudi.
The Commission shall, in liaison with the Member States, ensure coordination and information exchange between the mechanisms and structures established under this Decision and similar mechanisms and structures established at Union level or under the Euratom Treaty whose activities are relevant for preparedness and response planning, monitoring, early warning of, and combating serious cross-border threats to health.
Komisija v sodelovanju z državami članicami zagotovi usklajevanje in izmenjavo informacij med mehanizmi in strukturami, vzpostavljenimi s tem sklepom, ter podobnimi mehanizmi in strukturami, vzpostavljenimi na ravni Unije ali s Pogodbo Euratom, katerih dejavnosti so pomembne za načrtovanje pripravljenosti in odzivanja, spremljanje resnih čezmejnih nevarnosti za zdravje, zgodnje obveščanje o njih ter boj proti njim.
Member States shall retain the right to maintain or introduce additional arrangements, procedures and measures for their national systems in the fields covered by this Decision, including arrangements provided for in existing or future bilateral or multilateral agreements or conventions, on condition that such additional arrangements, procedures and measures do not impair the application of this Decision.
Države članice obdržijo pravico, da v svojih nacionalnih sistemih na področjih, ki jih zajema ta sklep, ohranijo ali uvedejo dodatne ureditve, postopke in ukrepe, vključno z ureditvami, predvidenimi v obstoječih ali prihodnjih dvo- ali večstranskih sporazumih ali konvencijah, pod pogojem, da take dodatne ureditve, postopki in ukrepi ne ovirajo uporabe tega sklepa.
‘case definition’ means a set of commonly agreed diagnostic criteria that have to be fulfilled in order to accurately identify cases of a targeted serious cross-border threat to health in a given population, while excluding the detection of unrelated threats;
„opredelitev primera“ pomeni sklop skupno dogovorjenih diagnostičnih meril, ki morajo biti izpolnjena za natančno prepoznavanje primerov zadevne čezmejne nevarnosti za zdravje v določeni populaciji in obenem izključujejo zaznavanje nepovezanih groženj;
‘communicable disease’ means an infectious disease caused by a contagious agent which is transmitted from person to person by direct contact with an infected individual or by indirect means such as exposure to a vector, animal, fomite, product or environment, or exchange of fluid, which is contaminated with the contagious agent;
„nalezljiva bolezen“ pomeni infekcijsko bolezen, ki jo povzroči nalezljivi povzročitelj, ki se prenaša s človeka na človeka neposredno s stikom z okuženo osebo ali posredno, na primer z izpostavljenostjo prenašalcu bolezni, živali, okuženemu predmetu, izdelku ali okolici ali z izmenjavo tekočin, ki so okužene z nalezljivim povzročiteljem;
‘contact tracing’ means measures implemented in order to trace persons who have been exposed to a source of a serious cross-border threat to health, and who are in danger of developing or have developed a disease;
„sledenje stikov“ pomeni ukrepe, izvedene zaradi sledenja osebam, ki so bile izpostavljene viru resne čezmejne nevarnosti za zdravje in za katere obstaja nevarnost, da bodo ali so že zbolele;
‘epidemiological surveillance’ means the systematic collection, recording, analysis, interpretation and dissemination of data and analysis on communicable diseases and related special health issues;
„epidemiološko spremljanje“ pomeni sistematično zbiranje, evidentiranje, analiziranje, razlaganje in razširjanje podatkov o nalezljivih boleznih in povezanih posebnih zdravstvenih problemih ter njihove analize;
‘monitoring’ means the continuous observation, detection or review of changes in a condition, in a situation, or in activities, including a continuous function that uses systematic collection of data and analysis on specified indicators relating to serious cross-border threats to health;
„spremljanje“ pomeni nenehno opazovanje, zaznavanje ali preučevanje sprememb stanja, situacije ali dejavnosti, vključno s stalno funkcijo, pri kateri se uporabljata sistematično zbiranje podatkov in analiza določenih kazalnikov, povezanih z resnimi čezmejnimi nevarnostmi za zdravje;
‘public health measure’ means a decision or an action which is aimed at preventing, monitoring or controlling the spread of diseases or contamination, combating severe risks to public health or mitigating their impact on public health;
„javno-zdravstveni ukrep“ pomeni odločitev ali dejavnost, katere namen je preprečevanje, spremljanje ali obvladovanje širjenja bolezni ali kontaminacije oziroma boj proti resnim tveganjem za javno zdravje ali ublažitev njihovega vpliva na javno zdravje;
‘serious cross-border threat to health’ means a life-threatening or otherwise serious hazard to health of biological, chemical, environmental or unknown origin which spreads or entails a significant risk of spreading across the national borders of Member States, and which may necessitate coordination at Union level in order to ensure a high level of human health protection.
„resna čezmejna nevarnost za zdravje“ pomeni smrtno ali drugače resno nevarnost za zdravje biološkega, kemičnega, okoljskega ali neznanega izvora, ki se širi ali pri kateri obstaja resno tveganje za širjenje prek državnih meja držav članic in zaradi katere bi morda bilo potrebno usklajevanje na ravni Unije, da bi se zagotovila visoka stopnja varovanja zdravja ljudi.
Member States and the Commission shall consult each other within the HSC referred to in Article 17 with a view to coordinating their efforts to develop, strengthen and maintain their capacities for the monitoring, early warning and assessment of, and response to, serious cross-border threats to health.
Države članice in Komisija se v okviru OZV iz člena 17 medsebojno posvetujejo, da bi uskladile svoja prizadevanja za razvoj, krepitev in ohranjanje zmogljivosti za spremljanje resnih čezmejnih nevarnosti za zdravje, zgodnje obveščanje o njih, njihovo ocenjevanje in odzivanje nanje.
That consultation shall be aimed at:
Namen tega posvetovanja je:
sharing best practice and experience in preparedness and response planning;
izmenjava najboljših praks in izkušenj pri načrtovanju pripravljenosti in odzivanja;
promoting the interoperability of national preparedness planning;
spodbujanje interoperabilnosti nacionalnega načrtovanja pripravljenosti;
addressing the intersectoral dimension of preparedness and response planning at Union level; and
obravnava medsektorske razsežnosti načrtovanja pripravljenosti in odzivanja na ravni Unije in
supporting the implementation of core capacity requirements for surveillance and response as referred to in Articles 5 and 13 of the IHR.
podpora uresničevanju zahtev glede osnovnih zmogljivosti za spremljanje in odzivanje, kot so navedene v členih 5 in 13 Mednarodnega zdravstvenega pravilnika (2005).
For the purpose of paragraph 1, Member States shall by 7 November 2014 and every three years thereafter provide the Commission with an update on the latest situation with regard to their preparedness and response planning at national level.
Za namen odstavka 1 države članice do 7. novembra 2014 in nato vsaka tri leta Komisijo seznanijo o najnovejših razmerah, kar zadeva njihovo načrtovanje pripravljenosti in odzivanja na nacionalni ravni.
That information shall cover the following:
Te informacije vsebujejo naslednje elemente:
identification of, and update on the status of the implementation of, the core capacity standards for preparedness and response planning as determined at national level for the health sector, as provided to the WHO in accordance with IHR;
opredelitev in najnovejše podatke o statusu izvajanja standardov osnovnih zmogljivosti za načrtovanje pripravljenosti in odzivanja, kot so za zdravstveni sektor določeni na nacionalni ravni, kot sta predložena tudi SZO v skladu z Mednarodnim zdravstvenim pravilnikom (2005);
description of the measures or arrangements aimed at ensuring interoperability between the health sector and other sectors including the veterinary sector, that are identified as being critical in the case of an emergency, in particular:
opis ukrepov ali ureditev za zagotovitev interoperabilnosti med zdravstvenim sektorjem in drugimi sektorji, vključno z veterinarskim sektorjem, ki so opredeljeni kot ključni v izrednih razmerah, zlasti:
coordination structures in place for cross-sectoral incidents;
strukture usklajevanja, vzpostavljene za dogodke, ki zajemajo več sektorjev;
emergency operational centres (crisis centres);
izredni operativni centri (krizni centri);
description of the business continuity plans, measures or arrangements aimed at ensuring the continuous delivery of critical services and products.
opis načrtov neprekinjenega delovanja ukrepov ali ureditev za neprekinjeno zagotavljanje ključnih storitev in proizvodov.
The obligation to provide the information referred to in points (b) and (c) shall only apply if such measures or arrangements are in place or are provided for as part of national preparedness and response planning.
Obveznost zagotavljanja informacij iz točk (b) in (c) se uporablja le, če takšni ukrepi ali ureditve že obstajajo ali so predvidene kot del nacionalnega načrtovanja pripravljenosti in odzivanja.
For the purpose of paragraph 1, when substantially revising national preparedness planning, Member States shall inform the Commission in a timely manner of the main aspects of the revision of their preparedness planning at national level that are relevant to the objectives referred to in paragraph 1 and to the specific issues referred to in paragraph 2.
Za namen odstavka 1 države članice pri konkretni reviziji načrtovanja nacionalne pripravljenosti pravočasno obvestijo Komisijo o glavnih vidikih revizije načrtovanja pripravljenosti na nacionalni ravni, ki so pomembni za cilje iz odstavka 1 in za posebna vprašanja iz odstavka 2.
When receiving classified information transmitted pursuant to paragraphs 2 and 3 of this Article, the Commission and the HSC shall apply the rules set out in the Annex to Commission Decision 2001/844/EC, ECSC, Euratom of 29 November 2001 amending its internal Rules of Procedure [12].Each Member State shall ensure that its national security regulations apply to all natural persons resident on its territory and all legal persons established on its territory that handle the information referred to in paragraphs 2 and 3 of this Article.
Za prejem tajnih informacij, poslanih v skladu z odstavkoma 2 in 3 tega člena, Komisija in OZV uporabljata pravila iz Priloge k Sklepu Komisije 2001/844/ES, ESPJ, Euratom z dne 29. novembra 2001 o spremembah njenega Poslovnika [12].Vsaka država članica zagotovi, da njeni nacionalni varnostni predpisi veljajo za vse fizične osebe s prebivališčem na njenem ozemlju in vse pravne osebe s sedežem na njenem ozemlju, ki ravnajo z informacijami iz odstavkov 2 in 3 tega člena.
Those national security regulations shall offer a degree of protection of classified information at least equivalent to that provided by the rules on security as set out in the Annex to Commission Decision 2001/844/EC, ECSC, Euratom and by Council Decision 2011/292/EU of 31 March 2011 on the security rules for protecting EU classified information [13].
Ti nacionalni varnostni predpisi zagotavljajo vsaj takšno raven varovanja tajnih podatkov, kot jo zagotavljata pravilnik o varnosti iz Priloge k Sklepu Komisije 2001/844/ES, ESPJ, Euratom in Sklep Sveta 2011/292/EU z dne 31. marca 2011 o varnostnih predpisih za varovanje tajnih podatkov EU [13].
The Commission shall make the information received in accordance with paragraphs 2 and 3 available to the members of the HSC.
Komisija da informacije, ki jih prejme v skladu z odstavkoma 2 in 3, na voljo članom OZV.
On the basis of that information, and for the purpose of paragraph 1, the Commission shall, in a timely manner, initiate discussion in the HSC, including, where appropriate, on the basis of synthesis or thematic progress reports.
Komisija na podlagi teh informacij in za namen odstavka 1 pravočasno začne razpravo v OZV, za katero so, če je ustrezno, podlaga tudi zbirna ali tematska poročila o napredku.
The Commission shall, by means of implementing acts, adopt templates to be used by the Member States when providing the information referred to in paragraphs 2 and 3 in order to ensure its relevance to the objectives identified in paragraph 1 and its comparability.
Komisija z izvedbenimi akti sprejme obrazce, ki jih države članice uporabijo pri pošiljanju informacij iz odstavkov 2 in 3, ter tako zagotovi, da te informacije ustrezajo ciljem iz odstavka 1 ter da so primerljive.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 18(2).
Ti izvedbeni akti se sprejmejo v skladu s postopkom pregleda iz člena 18(2).
The institutions of the Union and any Member States which so desire may engage in a joint procurement procedure conducted pursuant to the third subparagraph of Article 104(1) of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union [14] and pursuant to Article 133 of Commission Delegated Regulation (EU) No 1268/2012 of 29 October 2012 on the rules of application of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council on the financial rules applicable to the general budget of the Union [15], with a view to the advance purchase of medical countermeasures for serious cross-border threats to health.
Institucije Unije in države članice, ki tako želijo, lahko sodelujejo v postopku skupnega javnega naročila, izvedenem v skladu s tretjim pododstavkom člena 104(1) Uredbe (EU, Euratom) št. 966/2012 Evropskega parlamenta in Sveta z dne 25. oktobra 2012 o finančnih pravilih, ki se uporabljajo za splošni proračun Unije [14] ter v skladu s členom 133 Delegirane uredbe Komisije (EU) št. 1268/2012 z dne 29. oktobra 2012 o pravilih uporabe Uredbe (EU, Euratom) št. 966/2012 Evropskega parlamenta in Sveta o finančnih pravilih, ki se uporabljajo za splošni proračun Unije [15], da bi tako pospešile nakup zdravstvenih protiukrepov za resne čezmejne nevarnosti za zdravje.
The joint procurement procedure referred to in paragraph 1 shall comply with the following conditions:
Postopek skupnega javnega naročila iz odstavka 1 izpolnjuje naslednje pogoje:
participation in the joint procurement procedure is open to all Member States until the launch of the procedure;
do začetka postopka se lahko postopku skupnega javnega naročila pridružijo vse države članice;
the rights and obligations of Member States not participating in the joint procurement are respected, in particular those relating to the protection and improvement of human health;
spoštujejo se pravice in obveznosti držav članic, ki ne sodelujejo pri skupnem javnem naročilu, predvsem tiste, povezane z varovanjem in izboljšanjem zdravja ljudi;
the joint procurement does not affect the internal market, does not constitute discrimination or a restriction of trade or does not cause distortion of competition;
skupno javno naročilo ne vpliva na notranji trg, ni diskriminatorno in ne omejuje trgovine ali izkrivlja konkurence;
the joint procurement does not have any direct financial impact on the budget of Member States not participating in the joint procurement.
skupno javno naročilo finančno ne vpliva neposredno na proračun držav članic, ki ne sodelujejo pri skupnem javnem naročilu.
The joint procurement procedure referred to in paragraph 1 shall be preceded by a Joint Procurement Agreement between the Parties determining the practical arrangements governing that procedure, and the decision-making process with regard to the choice of the procedure, the assessment of the tenders and the award of the contract.
Pred postopkom skupnega javnega naročila iz odstavka 1 stranke sklenejo dogovor o skupnem javnem naročilu, v katerem določijo praktično ureditev tega postopka ter postopek odločanja za izbiro postopka, oceno ponudb in oddajo javnega naročila.
EPIDEMIOLOGICAL SURVEILLANCE AND AD HOC MONITORING
EPIDEMIOLOŠKO SPREMLJANJE IN ZAČASNO SPREMLJANJE
A network for the epidemiological surveillance of the communicable diseases and of the related special health issues referred to in points (i) and (ii) of point (a) of Article 2(1), is hereby established.
Vzpostavi se mreža za epidemiološko spremljanje nalezljivih bolezni ter z njimi povezanih posebnih zdravstvenih problemov iz točk (i) in (ii) točke (a) člena 2(1).
The network shall be operated and coordinated by the ECDC.
Mrežo upravlja in usklajuje ECDC.
The epidemiological surveillance network shall bring into permanent communication the Commission, the ECDC, and the competent authorities responsible at national level for epidemiological surveillance.
Mreža epidemiološkega spremljanja zagotovi stalno komunikacijo med Komisijo, ECDC ter pristojnimi organi, ki so na nacionalni ravni odgovorni za epidemiološko spremljanje.
The national competent authorities referred to in paragraph 2 shall communicate the following information to the participating authorities of the epidemiological surveillance network:
Pristojni nacionalni organi iz odstavka 2 sporočijo organom, ki sodelujejo v mreži epidemiološkega spremljanja, naslednje informacije:
comparable and compatible data and information in relation to the epidemiological surveillance of communicable diseases and related special health issues referred to in points (i) and (ii) of point (a) of Article 2(1);
primerljive in združljive podatke ter informacije o epidemiološkem spremljanju nalezljivih bolezni ter z njimi povezanih posebnih zdravstvenih problemov iz točk (i) in (ii) točke (a) člena 2(1);
relevant information concerning the progression of epidemic situations;
ustrezne informacije o napredovanju epidemičnih razmer;
relevant information concerning unusual epidemic phenomena or new communicable diseases of unknown origin, including those in third countries.
ustrezne informacije glede nenavadnih epidemičnih pojavov ali novih nalezljivih boleznih neznanega izvora, tudi tistih, ki se pojavijo v tretjih državah.
When reporting information on epidemiological surveillance, the national competent authorities shall, where available, use the case definitions adopted in accordance with paragraph 5 for each communicable disease and related special health issue referred to in paragraph 1.
Pristojni nacionalni organi pri sporočanju informacij o epidemiološkem spremljanju uporabljajo razpoložljive opredelitve primerov, sprejete v skladu z odstavkom 5, za vsako nalezljivo bolezen in z njo povezano posebno zdravstveno vprašanje iz odstavka 1.
The Commission shall, by means of implementing acts, establish and update:
Komisija z izvedbenimi akti pripravi in posodablja:
the list of communicable diseases and related special health issues established according to the criteria set out in the Annex and referred to in points (i) and (ii) of point (a) of Article 2(1), in order to ensure coverage of communicable diseases and related special health issues by the epidemiological surveillance network;
seznam nalezljivih bolezni in z njimi povezanih posebnih zdravstvenih problemov iz točk (i) in (ii) točke (a) člena 2(1), ki je sestavljen v skladu z merili iz Priloge, da se zagotovi spremljanje nalezljivih bolezni in z njimi povezanih posebnih zdravstvenih problemov v okviru mreže za epidemiološko spremljanje;