natgillin/translations-raw huggingface dataset:
case definitions concerning each communicable disease and related special health issue subject to epidemiological surveillance, in order to ensure the comparability and compatibility at Union level of the collected data;
opredelitve primerov za vsako nalezljivo bolezen in z njo povezan posebni zdravstveni problem, ki se epidemiološko spremlja, da se na ravni Unije zagotovita primerljivost in združljivost zbranih podatkov;
procedures for the operation of the epidemiological surveillance network as developed in application of Articles 5, 10 and 11 of Regulation (EC) No 851/2004.
postopke za delovanje mreže epidemiološkega spremljanja, ki so bili oblikovani ob uporabi členov 5, 10 in 11 Uredbe (ES) št. 851/2004.
On duly justified imperative grounds of urgency related to the severity or novelty of a serious cross-border threat to health or to the rapidity of its spread between the Member States, the Commission may adopt the measures referred to in points (a) and (b) through immediately applicable implementing acts in accordance with the procedure referred to in Article 18(3).
V izredno nujnih ustrezno utemeljenih primerih, kadar je resna čezmejna nevarnost za zdravje nova ali huda ali se med državami članicami hitro širi, lahko sprejme Komisija v skladu s postopkom iz člena 18(3) ukrepe iz točk (a) in (b) z izvedbenimi akti, ki se začnejo uporabljati takoj.
Ad hoc monitoring
Začasno spremljanje
Following an alert notified pursuant to Article 9 concerning a threat to health as referred to in point (iii) of point (a) of Article 2(1) and in points (b), (c) or (d) of Article 2(1), the Member States shall, in liaison with the Commission and on the basis of the available information from their monitoring systems, inform each other through the EWRS and, if the urgency of the situation so requires, through the HSC about developments with regard to the threat concerned at national level.
Po objavi opozorila na podlagi člena 9 o nevarnosti za zdravje iz točke (iii) točke (a) člena 2(1) in iz točk (b), (c) ali (d) člena 2(1) se države članice na podlagi razpoložljivih informacij iz svojih sistemov spremljanja ob sodelovanju s Komisijo prek Sistema zgodnjega obveščanja in odzivanja, in če je to potrebno zaradi nujnosti, prek OZV, medsebojno obveščajo o novostih v zvezi z zadevno nevarnostjo na nacionalni ravni.
The information transmitted pursuant to paragraph 1, shall include in particular any change in geographical distribution, spread and severity of the threat concerned and of the means of detection, if available.
Med informacijami, posredovanimi v skladu z odstavkom 1, so predvsem vse spremembe geografske porazdelitve, širjenje in resnost zadevne nevarnosti in načini zaznavanja, če so na voljo.
The Commission shall, by means of implementing acts, adopt, where necessary, the case definitions to be used for ad hoc monitoring, in order to ensure the comparability and compatibility at Union level of the collected data.
Komisija z izvedbenimi akti po potrebi sprejme opredelitve primerov, ki se uporabljajo za začasno spremljanje, ter tako zagotovi, da so zbrani podatki primerljivi in združljivi na ravni Unije.
On duly justified imperative grounds of urgency related to the severity of a serious cross-border threat to health or to the rapidity of its spread between the Member States, the Commission may adopt or update the case definitions referred to in the first subparagraph through immediately applicable implementing acts in accordance with the procedure referred to in Article 18(3).
V izredno nujnih ustrezno utemeljenih primerih, kadar je resna čezmejna nevarnost za zdravje huda ali se med državami članicami hitro širi, lahko Komisija v skladu s postopkom iz člena 18(3), z izvedbenimi akti, ki se začnejo uporabljati takoj, sprejme ali prilagodi opredelitve primerov iz prvega pododstavka.
EARLY WARNING AND RESPONSE
ZGODNJE OBVEŠČANJE IN ODZIVANJE
Establishment of an early warning and response system
Vzpostavitev Sistema zgodnjega obveščanja in odzivanja
A rapid alert system for notifying at Union level alerts in relation to serious cross-border threats to health, an ‘Early Warning and Response System’ (EWRS), is hereby established.
Vzpostavi se „Sistem zgodnjega obveščanja in odzivanja“, ki je sistem hitrega opozarjanja za objavljanje opozoril na ravni Unije o resnih čezmejnih nevarnostih za zdravje.
The EWRS shall enable the Commission and the competent authorities responsible at national level to be in permanent communication for the purposes of alerting, assessing public health risks and determining the measures that may be required to protect public health.
S tem sistemom je zagotovljena stalna komunikacija med Komisijo in pristojnimi organi, odgovornimi na nacionalni ravni, za namene opozarjanja, ocenjevanja tveganj za javno zdravje in določanja ukrepov, ki bi bili lahko potrebni za varovanje javnega zdravja.
The Commission shall, by means of implementing acts, adopt procedures concerning the information exchange in order to ensure the proper functioning of the EWRS and the uniform implementation of Articles 8 and 9 and to avoid overlap of activities or conflicting actions with existing structures and mechanisms for monitoring, early warning and combating serious cross-border threats to health.
Komisija z izvedbenimi akti sprejme postopke za izmenjavo informacij, s čimer zagotovi pravilno delovanje Sistema zgodnjega obveščanja in odzivanja ter enotno izvajanje členov 8 in 9 ter prepreči, da bi dejavnosti podvajale obstoječe strukture in mehanizme za spremljanje resnih čezmejnih nevarnosti za zdravje, zgodnje obveščanje o njih in boj proti njim ali da bi bili ukrepi v nasprotju s temi strukturami in mehanizmi.
Alert notification
Objava opozorila
National competent authorities or the Commission shall notify an alert in the EWRS where the emergence or development of a serious cross-border threat to health fulfils the following criteria:
Pristojni nacionalni organi ali Komisija objavijo opozorilo v Sistemu zgodnjega obveščanja in odzivanja, če pojav ali razvoj resne čezmejne nevarnosti za zdravje izpolnjuje naslednja merila:
it is unusual or unexpected for the given place and time, or it causes or may cause significant morbidity or mortality in humans, or it grows rapidly or may grow rapidly in scale, or it exceeds or may exceed national response capacity; and
je neobičajen ali nepričakovan za zadevni kraj in čas, če povzroča ali bi lahko povzročil precejšnjo obolevnost ali umrljivost ljudi ali če se hitro širi ali bi se lahko hitro razširil ali če preseže ali bi lahko presegel nacionalno zmogljivost odzivanja, in
it affects or may affect more than one Member State; and
vpliva ali bi lahko vplival na več kot eno državo članico in
it requires or may require a coordinated response at Union level.
je zanj potrebno ali bi lahko bilo potrebno usklajeno odzivanje na ravni Unije.
Where the national competent authorities notify the WHO of events that may constitute public health emergencies of international concern in accordance with Article 6 of the IHR, they shall at the latest simultaneously notify an alert in the EWRS, provided that the threat concerned falls within those referred to in Article 2(1) of this Decision.
Kadar pristojni organi na nacionalni ravni obvestijo SZO o dogodkih, ki bi lahko pomenili izredne razmere mednarodnih razsežnosti na področju javnega zdravja v skladu s členom 6 Mednarodnega zdravstvenega pravilnika (2005), najpozneje sočasno z obvestitvijo te organizacije objavijo opozorilo tudi v Sistemu zgodnjega obveščanja in odzivanja, če gre pri zadevni nevarnosti za katero od nevarnosti iz člena 2(1) tega sklepa.
When notifying an alert, the national competent authorities and the Commission shall promptly communicate through the EWRS any available relevant information in their possession that may be useful for coordinating the response such as:
Ko pristojni organi na nacionalni ravni in Komisija objavijo opozorilo, prek Sistema zgodnjega obveščanja in odzivanja nemudoma sporočijo vse razpoložljive ustrezne informacije, ki so jim na voljo in bi lahko bile koristne za usklajevanje odzivanja, denimo:
the type and origin of the agent;
vrsto in izvor povzročitelja;
the date and place of the incident or outbreak;
datum in kraj dogodka ali izbruha;
means of transmission or dissemination;
načine prenašanja ali širjenja;
toxicological data;
toksikološke podatke;
detection and confirmation methods;
metode zaznavanja in potrjevanja;
public health risks;
tveganja za javno zdravje;
public health measures implemented or intended to be taken at national level;
javno-zdravstvene ukrepe, ki so bili izvedeni ali so predvideni na nacionalni ravni;
measures other than public health measures;
druge ukrepe, ki niso javno-zdravstveni ukrepi;
personal data necessary for the purpose of contact tracing in accordance with Article 16;
osebne podatke, potrebne za namene sledenja stikov v skladu s členom 16;
any other information relevant to the serious cross-border threat to health in question.
vse druge informacije, ki se nanašajo na zadevno resno čezmejno nevarnost za zdravje.
The Commission shall make available to the national competent authorities through the EWRS any information that may be useful for coordinating the response referred to in Article 11, including information related to serious cross-border threats to health and public health measures related to serious cross-border threats to health transmitted through rapid alert and information systems established under other provisions of Union law or the Euratom Treaty.
Komisija pristojnim nacionalnim organom prek Sistema zgodnjega obveščanja in odzivanja zagotovi vse informacije, ki so lahko koristne za usklajevanje odzivanja iz člena 11, vključno z informacijami, povezanimi z resnimi čezmejnimi nevarnostmi za zdravje, in informacijami o javno-zdravstvenih ukrepih, povezanih z resnimi čezmejnimi nevarnostmi za zdravje, ki se pošiljajo prek sistemov hitrega opozarjanja in obveščanja, vzpostavljenih v skladu z drugimi določbami prava Unije ali Pogodbe Euratom.
Public health risk assessment
Ocena tveganja za javno zdravje
Where an alert is notified pursuant to Article 9, the Commission shall, where necessary for the coordination of the response at Union level and upon request of the HSC referred to in Article 17 or on its own initiative, make promptly available to the national competent authorities and to the HSC, through the EWRS, a risk assessment of the potential severity of the threat to public health, including possible public health measures.
Kadar je v skladu s členom 9 objavljeno opozorilo, Komisija, kadar je to potrebno zaradi usklajevanja odzivanja na ravni Unije in na zahtevo OZV iz člena 17 ali na lastno pobudo pristojnim nacionalnim organom in OZV prek Sistema zgodnjega obveščanja in odzivanja nemudoma zagotovi oceno tveganja o tem, kako resna bi bila lahko nevarnost za javno zdravje, vključno z možnimi javno-zdravstvenimi ukrepi.
That risk assessment shall be carried out by:
To oceno tveganja opravi:
the ECDC in accordance with Article 7(1) of Regulation (EC) No 851/2004 in the case of a threat referred to in points (i) and (ii) of point (a) of Article 2(1) or point (d) of Article 2(1); and/or
ECDC v skladu s členom 7(1) Uredbe (ES) št. 851/2004 v primeru nevarnosti iz točk (i) in (ii) točke (a) člena 2(1) ali točke (d) člena 2(1) in/ali
the European Food Safety Authority (EFSA) in accordance with Article 23 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety [16] in the case of a threat referred to in Article 2 of this Decision where the threat falls under the mandate of the EFSA; and/or
Evropske agencije za varnost hrane v skladu s členom 23 Uredbe (ES) št. 178/2002 Evropskega parlamenta in Sveta z dne 28. januarja 2002 o določitvi splošnih načel in zahtevah živilske zakonodaje, ustanovitvi Evropske agencije za varnost hrane in postopkih, ki zadevajo varnost hrane [16], v primeru nevarnosti iz člena 2 tega sklepa, kadar ta nevarnost spada med naloge Evropske agencije za varnost hrane, in/ali
other relevant Union agencies.
drugih ustreznih agencij Unije.
Where the risk assessment needed is totally or partially outside the mandates of the agencies referred to in paragraph 1, and it is considered necessary for the coordination of the response at Union level, the Commission shall, upon request of the HSC or its own initiative, provide an ad hoc risk assessment.
Če je potrebna ocena tveganja v celoti ali delno zunaj nalog agencij iz odstavka 1 in se šteje, da je nujna za usklajevanje odzivanja na ravni Unije, Komisija na zahtevo OZV ali na lastno pobudo zagotovi ad hoc oceno tveganja.
The Commission shall make the risk assessment available to the national competent authorities promptly through the EWRS.
Komisija zagotovi, da je ocena tveganja nemudoma na voljo pristojnim nacionalnim organom prek Sistema zgodnjega obveščanja in odzivanja.
Where the risk assessment is to be made public, the national competent authorities shall receive it prior to its publication.
Kadar se ocena tveganja javno objavi, jo pred objavo prejmejo pristojni nacionalni organi.
The risk assessment shall take into account, if available, relevant information provided by other entities, in particular by the WHO in the case of a public health emergency of international concern.
V primeru izrednih razmer mednarodnih razsežnosti na področju javnega zdravja se v oceni tveganja upoštevajo ustrezne informacije drugih subjektov, če so na voljo, zlasti SZO.
The Commission shall ensure that information that may be relevant for the risk assessment is made available to the national competent authorities through the EWRS and to the HSC.
Komisija zagotovi, da so informacije, ki so morda pomembne za oceno tveganja, na voljo pristojnim nacionalnim organom prek Sistema zgodnjega obveščanja in odzivanja ter OZV.
Following an alert pursuant to Article 9, on a request from the Commission or a Member State and on the basis of the available information, including the information referred to in Article 9 and the risk assessments referred to in Article 10, Member States shall consult each other within the HSC and in liaison with the Commission with a view to coordinating:
Države članice se po opozorilu na podlagi člena 9 na zahtevo Komisije ali države članice in na podlagi razpoložljivih informacij, tudi informacij iz člena 9 in ocene tveganja iz člena 10, ob sodelovanju Komisije medsebojno posvetujejo v okviru OZV, da bi uskladile:
national responses to the serious cross-border threat to health, including where a public health emergency of international concern is declared in accordance with the IHR and falls within Article 2 of this Decision;
nacionalno odzivanje na resno čezmejno nevarnost za zdravje, tudi takrat, ko so v skladu z Mednarodnim zdravstvenim pravilnikom (2005) razglašene izredne razmere mednarodnih razsežnosti na področju javnega zdravja, ki so zajete v členu 2 tega sklepa;
risk and crisis communication, to be adapted to Member State needs and circumstances, aimed at providing consistent and coordinated information in the Union to the public and to healthcare professionals.
obveščanje o tveganjih in kriznih razmerah, ki mora biti prilagojeno potrebam držav članic in razmeram v njih ter naj bi javnosti in zdravstvenim delavcem v Uniji zagotovilo skladne in usklajene informacije.
Where a Member State intends to adopt public health measures to combat a serious cross-border threat to health, it shall, before adopting those measures, inform and consult the other Member States and the Commission on the nature, purpose and scope of the measures, unless the need to protect public health is so urgent that the immediate adoption of the measures is necessary.
Kadar namerava država članica sprejeti javno-zdravstvene ukrepe za boj proti resni čezmejni nevarnosti za zdravje, pred sprejetjem teh ukrepov obvesti druge države članice in Komisijo ter se z njimi posvetuje o vrsti, namenu in obsegu ukrepov, razen če je varovanje javnega zdravja tako nujno, da je treba ukrepe sprejeti takoj.
Where a Member State has to adopt, as a matter of urgency, public health measures in response to the appearance or resurgence of a serious cross-border threat to health, it shall, immediately upon adoption, inform the other Member States and the Commission on the nature, purpose and scope of those measures.
Kadar mora država članica nujno sprejeti javno-zdravstvene ukrepe zaradi pojava ali ponovitve resne čezmejne nevarnosti za zdravje, takoj po sprejetju ukrepov obvesti druge države članice in Komisijo o vrsti, namenu in obsegu teh ukrepov.
In the event of a serious cross-border threat to health overwhelming the national response capacities, an affected Member State may also request assistance from other Member States through the Community Civil Protection Mechanism established by Decision 2007/779/EC, Euratom.
V primeru resne čezmejne nevarnosti za zdravje, ki presega nacionalne zmogljivosti odzivanja, lahko prizadeta država članica tudi zaprosi za pomoč druge države članice prek mehanizma Skupnosti na področju civilne zaščite, vzpostavljenega z Odločbo 2007/779/ES, Euratom.
The Commission shall, by means of implementing acts, adopt the procedures necessary for the uniform implementation of the information exchange, consultation and coordination provided for in paragraphs 1 to 3.
Komisija z izvedbenimi akti sprejme postopke, potrebne za enotno izvajanje izmenjave informacij, posvetovanja in usklajevanja, določenih v odstavkih 1 do 3.
EMERGENCY SITUATIONS
IZREDNE RAZMERE
Recognition of emergency situations
Razglasitev izrednih razmer
The Commission may recognise a situation of public health emergency in relation to:
Komisija lahko kot izredne razmere na področju javnega zdravja razglasi:
epidemics of human influenza considered to have pandemic potential, where the Director-General of the WHO has been informed and has not yet adopted a decision declaring a situation of pandemic influenza in accordance with the applicable rules of the WHO; or
epidemijo človeške gripe, za katero se ocenjuje, da bi se lahko razvila v pandemijo, pri čemer je Komisija obvestila generalnega direktorja SZO, ki pa še ni sprejel odločitve o razglasitvi pandemije človeške gripe v skladu z veljavnimi pravili SZO, ali
cases other than that referred to in point (a) where the Director-General of the WHO has been informed and has not yet adopted a decision declaring a public health emergency of international concern in accordance with the IHR, and where:
primere, ki niso zajeti v točki (a), pri čemer je Komisija obvestila generalnega direktorja SZO, ki pa še ni sprejel odločitve o razglasitvi izrednih razmer mednarodnih razsežnosti na področju javnega zdravja v skladu z Mednarodnim zdravstvenim pravilnikom (2005), ter če
the serious cross-border threat to health in question endangers public health at the Union level;
zadevna resna čezmejna nevarnost za zdravje ogroža javno zdravje na ravni Unije;
medical needs are unmet in relation to that threat, which means that no satisfactory method of diagnosis, prevention or treatment is authorised in the Union or, despite the existence of such a method, the authorisation of a medicinal product would nonetheless be of major therapeutic advantage to those affected.
zdravstvene potrebe za to nevarnost niso pokrite, kar pomeni, da v Uniji ni odobrena nobena zadovoljiva metoda za diagnosticiranje, preventivo ali zdravljenje te nevarnosti oziroma, četudi taka metoda obstaja, bi odobritev zdravila lahko kljub temu imela znatne terapevtske koristi za obolele osebe.
The Commission shall adopt the measure referred to in paragraph 1 by means of implementing acts.
Komisija sprejme ukrep iz člena 1 z izvedbenimi akti.
On duly justified imperative grounds of urgency related to the severity of a serious cross-border threat to health or to the rapidity of its spread among Member States, the Commission may recognise situations of public health emergency pursuant to paragraph 1 through immediately applicable implementing acts in accordance with the procedure referred to in Article 18(3).
V izredno nujnih ustrezno utemeljenih primerih, kadar je resna čezmejna nevarnost za zdravje huda ali se med državami članicami hitro širi, lahko Komisija uradno razglasi izredne razmere na področju javnega zdravja na podlagi odstavka 1 z izvedbenimi akti, ki se začnejo uporabljati takoj v skladu s postopkom iz člena 18(3).
The Commission shall inform the Director-General of the WHO of the adoption of the measures referred to in paragraph 1.
Komisija obvesti generalnega direktorja SZO o sprejetju ukrepov iz odstavka 1.
Legal effects of recognition
Pravni učinki razglasitve
The recognition of an emergency situation pursuant to Article 12(1) shall have the sole legal effect of enabling point 2 of Article 2 of Regulation (EC) No 507/2006 to apply or, where the recognition specifically concerns epidemics of human influenza considered as having a pandemic potential, of enabling Article 21 of Regulation (EC) No 1234/2008 to apply.
Edini pravni učinek razglasitve izrednih razmer v skladu s členom 12(1) je, da se omogoči uporaba točke 2 člena 2 Uredbe (ES) št. 507/2006 ali, če razglasitev posebej zadeva epidemijo človeške gripe, za katero se šteje, da bi se lahko razvila v pandemijo, uporaba člena 21 Uredbe (ES) št. 1234/2008.
Termination of the recognition
Preklic razglasitve
The Commission shall, by means of implementing acts, terminate the recognition referred to in Article 12(1) as soon as one of the applicable conditions laid down therein is no longer met.
Komisija z izvedbenimi akti prekliče razglasitev iz člena 12(1), takoj ko vsaj eden od veljavnih pogojev iz navedenega člena ni več izpolnjen.
Termination of the recognition, as referred to in the first paragraph, shall not affect the validity of marketing authorisations granted on the basis of Regulation (EC) No 507/2006 to medicinal products referred to in point 2 of Article 2 thereof or granted in accordance with the procedure referred to in Article 21 of Regulation (EC) No 1234/2008.
Preklic razglasitve iz prvega odstavka ne vpliva na veljavnost dovoljenj za promet, podeljenih na podlagi Uredbe (ES) št. 507/2006 za zdravila iz točke 2 člena 2 navedene uredbe ali podeljenih v skladu s postopkom iz člena 21 Uredbe (ES) št. 1234/2008.
Each Member State shall designate, by 7 March 2014:
Vsaka država članica do 7. marca 2014 imenuje:
the competent authorities responsible within the Member State for epidemiological surveillance as referred to in Article 6;
pristojne organe, ki so v državi članici odgovorni za epidemiološko spremljanje iz člena 6;
the competent authority or authorities responsible at national level for notifying alerts and determining the measures required to protect public health, for the purposes of Articles 8, 9 and 10;
pristojni organ ali organe, ki so na nacionalni ravni odgovorni za objavljanje opozoril in določanje ukrepov, potrebnih za varovanje javnega zdravja, za namene členov 8, 9 in 10;
one representative and an alternate in the HSC referred to in Article 17.
enega predstavnika in njegovega namestnika v OZV iz člena 17;
Member States shall notify the Commission and other Member States of the designations referred to in paragraph 1 and of any change thereof.
Države članice obvestijo Komisijo in druge države članice o imenovanjih iz odstavka 1 in vseh spremembah teh imenovanj.
In the event of such change, the Commission shall distribute immediately to the HSC an updated list of such designations.
V primeru takšnih sprememb Komisija OZV nemudoma pošlje posodobljeni seznam takšnih imenovanj.
The Commission shall make publicly available the updated list of the authorities designated in accordance with points (a) and (c) of paragraph 1, as well as the updated list of the authorities to which the representatives in the HSC belong.
Komisija objavi posodobljeni seznam imenovanj organov, imenovanih v skladu s točkama (a) in (c) odstavka 1, ter posodobljeni seznam organov, iz katerih prihajajo predstavniki v OZV.