natgillin/translations-raw huggingface dataset:
With regard to pandemic vaccines, in the context of limited production capacities at global level, such a procedure would be undertaken with the aim of enabling more equitable access to vaccines for the Member States involved, to help them to better meet the vaccination needs of their citizens, in line with vaccination policies in the Member States.
V primeru omejenih proizvodnih zmogljivostih cepiv proti pandemiji na svetovni ravni bi se ta postopek uporabil, da bi se državam članicam, ki jih je pandemija prizadela, omogočil pravičnejši dostop do cepiv in se jim olajšalo pokritje potreb po cepljenju njihovih državljanov v skladu z njihovimi nacionalnimi politikami cepljenja.
Unlike communicable diseases, the surveillance of which at Union level is carried out on a permanent basis by the ECDC, other serious cross-border threats to health do not currently necessitate a systematic monitoring.
Za razliko od nalezljivih bolezni, ki jih na ravni Unije redno spremlja ECDC, drugih resnih čezmejnih nevarnosti za zdravje trenutno ni treba sistematično spremljati.
A risk-based approach, whereby monitoring is carried out by Member States’ monitoring systems and available information is exchanged through the EWRS, is therefore more appropriate to those threats.
Zato je za te druge nevarnosti primernejši pristop na podlagi tveganja, pri katerem spremljanje izvajajo države članice prek svojih sistemov spremljanja, razpoložljive informacije pa se izmenjujejo prek Sistema zgodnjega obveščanja in odzivanja.
The Commission will strengthen cooperation and activities with the ECDC, the Member States, the European Medicines Agency and the WHO to improve the methods and processes through which information related to the coverage of vaccine-preventable diseases is provided.
Komisija bo okrepila sodelovanje in dejavnosti z ECDC, državami članicami, Evropsko agencijo za zdravila in SZO, da bi izboljšali metode in postopke zagotavljanja informacij o spremljanju bolezni, ki jih je mogoče preprečiti s cepljenjem.
A system enabling the notification at Union level of alerts related to serious cross-border threats to health should be put in place in order to ensure that competent public health authorities in Member States and the Commission are duly informed in a timely manner.
Vzpostaviti bi bilo treba sistem, ki bo na ravni Unije omogočal opozarjanje o resnih čezmejnih nevarnostih za zdravje, za zagotovitev, da so pristojni organi za javno zdravje v državah članicah in Komisija ustrezno in pravočasno obveščeni.
The EWRS should, therefore, be extended to all the serious cross-border threats to health covered by the present Decision.
Zato bi bilo treba Sistem zgodnjega obveščanja in odzivanja razširiti na vse resne čezmejne nevarnosti za zdravje, ki jih ureja ta sklep.
The operation of the EWRS should remain within the remit of the ECDC.
Delovanje Sistema zgodnjega obveščanja in odzivanja bi moralo ostati pod okriljem ECDC.
The notification of an alert should be required only where the scale and severity of the threat concerned are or could become so significant that they affect or could affect more than one Member State and require or could require a coordinated response at the Union level.
Opozorilo bi moralo biti potrebno le, kadar sta obseg in resnost zadevne nevarnosti že oziroma bi lahko postala tolikšna, da prizadeneta oziroma bi lahko prizadela več kot eno državo članico ter je potrebno oziroma bi lahko bilo potrebno usklajeno odzivanje na ravni Unije.
To avoid duplication, the Commission should ensure that alert notifications under the EWRS and other rapid alert systems at Union level are linked to each other to the extent possible so that the competent authorities of the Member States can avoid as much as possible notifying the same alert through different systems at Union level.
Da se prepreči podvajanje, bi morala Komisija zagotoviti, da so opozorila v Sistemu zgodnjega obveščanja in odzivanja ter drugih sistemih hitrega obveščanja na ravni Unije med seboj čim bolj povezana, da bi se pristojni organi držav članic lahko v čim večji meri izognili pošiljanju istega obvestila prek različnih sistemov na ravni Unije.
In order to ensure that the assessment of risks to public health at the Union level from serious cross-border threats to health is consistent as well as comprehensive from a public health perspective, the available scientific expertise should be mobilised in a coordinated manner, through appropriate channels or structures depending on the type of threat concerned.
Da se z vidika javnega zdravja zagotovi skladna in celovita ocena tveganja za javno zdravje na ravni Unije zaradi resnih čezmejnih nevarnosti za zdravje, bi bilo treba usklajeno uporabljati razpoložljivo znanstveno znanje, in sicer prek ustreznih poti ali struktur, odvisno od vrste zadevne nevarnosti.
That assessment of risks to public health should be developed by means of a fully transparent process and should be based on principles of excellence, independence, impartiality and transparency.
To oceno tveganja za javno zdravje bi bilo treba razviti po povsem preglednem postopku in bi morala temeljiti na načelih odličnosti, neodvisnosti, nepristranskosti in preglednosti.
That assessment should be provided by the agencies of the Union in accordance with their missions or by the Commission if the risk assessment required is totally or partially outside the mandates of the agencies of the Union.
Opraviti bi jo morale agencije Unije v skladu s svojimi nalogami ali Komisija, kadar je ocena tveganja v celoti ali delno zunaj mandata agencij Unije.
Taking account of the applicable rules in each case, scientific experts should make declarations of interest and of commitments.
Znanstveniki bi morali ob upoštevanju pravil, ki se uporabljajo za vsak primer, dati izjave o interesu in o zavezah.
Such declarations should include any activity, position, circumstances or other facts potentially involving direct or indirect interest in order to make it possible to identify interests which could be considered prejudicial to those experts’ independence.
Te izjave bi morale vključevati vsakršno dejavnost, položaj, okoliščine ali druga dejstva, morebiti povezana z neposrednim ali posrednim interesom, da bi se lahko opredelili tisti interesi, za katere bi se lahko štelo, da posegajo v neodvisnost teh znanstvenikov.
Effectively responding to serious cross-border threats to health at national level could require consultation among Member States, in conjunction with the Commission, with a view to coordinating national responses and could necessitate exchange of information.
Za učinkovito odzivanje na resne čezmejne nevarnosti za zdravje na nacionalni ravni bi lahko bilo potrebno posvetovanje med državami članicami in v sodelovanju s Komisijo, da bi se uskladilo odzivanje na nacionalni ravni, lahko pa bi bila potrebna tudi izmenjava informacij.
Pursuant to Decision No 2119/98/EC, the Member States already consult each other in liaison with the Commission with a view to coordinating their efforts and their response at Union level with regard to communicable diseases.
V skladu z Odločbo št. 2119/98/ES se države članice med seboj in v sodelovanju s Komisijo že posvetujejo, da bi na ravni Unije uskladile prizadevanja in odzivanje glede nalezljivih bolezni.
A similar mechanism should apply to all serious cross-border threats to health regardless of their origin.
Podoben mehanizem bi se moral uporabljati za vse resne čezmejne nevarnosti za zdravje ne glede na njihov izvor.
It should also be recalled that, independently of this Decision, a Member State may, in the case of a major emergency, request assistance under Council Decision 2007/779/EC, Euratom of 8 November 2007 establishing a Community Civil Protection Mechanism [5].
Prav tako bi bilo treba opozoriti, da lahko država članica v primeru izrednih razmer večjega obsega neodvisno od tega sklepa zahteva pomoč na podlagi Odločbe Sveta 2007/779/ES, Euratom z dne 8. novembra 2007 o vzpostaviti mehanizma Skupnosti na področju civilne zaščite [5].
The obligations of Member States to provide information under this Decision do not affect the application of point (a) of Article 346(1) TFEU pursuant to which no Member State is obliged to supply information the disclosure of which it considers contrary to the essential interests of its security.
Obveznosti držav članic, da v skladu s tem sklepom zagotovijo informacije, ne vplivajo na uporabo točke (a) člena 346(1) PDEU, v skladu s katerim nobena država ni dolžna dajati informacij, za katere meni, da bi bilo njihovo razkritje v nasprotju z bistvenimi interesi njene varnosti.
The Member States have a responsibility to manage public health crises at national level.
Države članice so na nacionalni ravni odgovorne za upravljanje kriz na področju javnega zdravja.
However, measures taken by individual Member States could damage the interests of other Member States if they are inconsistent with one another or based on diverging risk assessments.
Vendar bi ukrepi, ki jih sprejme posamezna država članica, lahko škodovali interesom drugih držav članic, če med seboj ne bi bili usklajeni ali če bi temeljili na razlikujočih se ocenah tveganja.
The aim to coordinate the response at Union level should, therefore, seek to ensure, inter alia, that measures taken at national level are proportionate and limited to public health risks related to serious cross-border threats to health, and do not conflict with obligations and rights laid down in the TFEU such as those related to the restriction on travel and trade.
Zato bi morali z usklajevanjem odzivanja na ravni Unije med drugim zagotoviti, da so ukrepi, sprejeti na nacionalni ravni, sorazmerni in omejeni na tveganja za javno zdravje, povezana z resnimi čezmejnimi nevarnostmi za zdravje, ter da ti ukrepi niso v nasprotju z obveznostmi in pravicami iz PDEU, kot so tiste, povezane z omejevanjem potovanja in trgovine.
Inconsistent or confusing communication with the public and stakeholders such as healthcare professionals can have a negative impact on the effectiveness of the response from a public health perspective as well as on economic operators.
Neskladna ali nejasna komunikacija z javnostjo in zainteresiranimi stranmi, kot so zdravstveni delavci, lahko z vidika javnega zdravja negativno vpliva na učinkovitost odzivanja in nosilce gospodarske dejavnosti.
The coordination of the response within the HSC, assisted by relevant subgroups, should, therefore, encompass rapid information exchange concerning communication messages and strategies and addressing communication challenges with a view to coordinating risk and crisis communication, based on robust and independent evaluation of public health risks, to be adapted to national needs and circumstances.
Usklajevanje odzivanja v OZV, ki mu pomagajo ustrezne podskupine, bi zato moralo vključevati hitro izmenjavo informacij, kar zadeva obveščanje in strategije ter obravnavo izzivov v zvezi z obveščanjem, da bi se na podlagi zanesljive in neodvisne ocene tveganj za javno zdravje uskladilo obveščanje o tveganjih in kriznih razmerah, ki bo prilagojeno nacionalnim potrebam in okoliščinam.
Such exchanges of information are intended to facilitate monitoring of the clarity and coherence of messages to the public and to healthcare professionals.
Takšne izmenjave informacij so namenjene olajšanju spremljanja jasnosti in skladnosti sporočil javnosti in zdravstvenim delavcem.
The applicability of certain specific provisions of Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council [6] and of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products [7] depends on the recognition at Union level, in the framework of Decision No 2119/98/EC, of an emergency situation or of a pandemic situation with respect to human influenza.
Uporabljivost nekaterih posebnih določb Uredbe Komisije (ES) št. 507/2006 z dne 29. marca 2006 o pogojnem dovoljenju za promet zdravil za humano uporabo, ki sodijo na področje uporabe Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta [6], in Uredbe Komisije (ES) št. 1234/2008 z dne 24. novembra 2008 o pregledu sprememb pogojev dovoljenj za promet z zdravili za uporabo v humani medicini in zdravili za uporabo v veterinarski medicini [7] je odvisna od tega, ali se na ravni Unije v okviru Odločbe št. 2119/98/ES za virus človeške gripe razglasijo izredne razmere ali pandemične razmere.
Those provisions allow for the accelerated marketing of certain medicinal products in the case of urgent need, by means, respectively, of a conditional marketing authorisation and of the temporary option of granting a variation to the terms of a marketing authorisation for a human influenza vaccine even where certain non-clinical or clinical data are missing.
Te določbe dovoljujejo pospešeno trženje nekaterih zdravil v nujnih primerih, in sicer s pogojnim dovoljenjem za promet z zdravilom oziroma na podlagi začasne možnosti odobritve spremembe pogojev, ki veljajo za dovoljenje za promet s cepivom proti človeški gripi, tudi če nekateri neklinični ali klinični podatki manjkajo.
However, in spite of the utility of such provisions in the event of a crisis, to date no specific procedure exists for issuing such recognitions at Union level.
Kljub temu, da se takšne določbe uporabljajo v kriznih razmerah, pa posebni postopek za tovrstno razglasitev na ravni Unije še ne obstaja.
It is therefore appropriate to provide for such a procedure as part of laying down the standards of quality and safety for medicinal products.
Zato je primerno, da se takšen postopek zagotovi kot del standardov kakovosti in varnosti zdravil.
Before recognising a situation of public health emergency at Union level, the Commission should liaise with the WHO in order to share the Commission’s analysis of the situation of the outbreak and to inform the WHO of its intention to issue such a decision.
Preden se na ravni Unije razglasijo izredne razmere na področju javnega zdravja, bi se Komisija morala povezati s SZO in z njo izmenjati svojo analizo izbruha in jo obvestiti, da namerava izdati tak sklep.
Where such a decision is adopted, the Commission should also inform the WHO thereof.
Kadar sprejme tak sklep, bi morala o tem obvestiti tudi SZO.
The occurrence of an event that is linked to serious cross-border threats to health and is likely to have Europe-wide consequences could require the Member States concerned to take particular control or contact-tracing measures in a coordinated manner to identify those persons already contaminated and those persons exposed to risk.
Zaradi dogodka, ki je povezan z resnimi čezmejnimi nevarnostmi za zdravje in bo verjetno imel posledice za vso Evropo, bi zadevne države članice morda morale usklajeno sprejeti posebne ukrepe za nadzor ali sledenje stikov, da bi našle že okužene osebe in osebe, izpostavljene tveganju.
Such cooperation could require the exchange of personal data through the system, including sensitive information related to health and information about confirmed or suspected human cases of disease, between those Member States directly involved in the contact-tracing measures.
Za namene tega sodelovanja bi morda bila med državami članicami, v katerih se neposredno izvajajo ukrepi za sledenje stikov, potrebna izmenjava osebnih podatkov prek sistema, vključno z občutljivimi informacijami o zdravju in informacijami o potrjenih primerih okužbe ali primerih suma okužbe ljudi.
Cooperation with third countries and international organisations in the field of public health should be fostered and it is particularly important to ensure the exchange of information with the WHO on the measures taken pursuant to this Decision.
Spodbujati bi bilo treba sodelovanje s tretjimi državami in mednarodnimi organizacijami na področju javnega zdravja, zlasti pa je pomembno zagotoviti izmenjavo informacij s SZO o ukrepih, sprejetih na podlagi tega sklepa.
In particular, it could be in the interests of the Union to conclude international cooperation agreements with third countries or international organisations, including the WHO, to foster the exchange of relevant information from monitoring and alerting systems on serious cross-border threats to health.
V interesu Unije bi lahko bila predvsem sklenitev mednarodnih sporazumov o sodelovanju s tretjimi državami ali mednarodnimi organizacijami, vključno s SZO, da bi se spodbudila izmenjava ustreznih informacij iz sistemov spremljanja in obveščanja o resnih čezmejnih nevarnostih za zdravje.
Within the limits of the Union’s competences, such agreements could include, where appropriate, the participation of such third countries or international organisations in the relevant epidemiological surveillance monitoring network and the EWRS, exchange of good practice in the areas of preparedness and response planning, public health risk-assessment and collaboration on response coordination.
V okviru pristojnosti Unije bi takšni sporazumi po potrebi lahko vključevali sodelovanje teh tretjih držav ali mednarodnih organizacij v zadevni mreži epidemiološkega spremljanja ter Sistemu zgodnjega obveščanja in odzivanja, izmenjavo dobrih praks na področjih načrtovanja pripravljenosti in odzivanja, oceno tveganja za javno zdravje in sodelovanje pri usklajevanju odzivanja.
The processing of personal data for the purpose of implementing this Decision should comply with Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data [8] and Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data [9].
Obdelava osebnih podatkov za namene izvajanja tega sklepa bi morala biti skladna z Direktivo 95/46/ES Evropskega parlamenta in Sveta z dne 24. oktobra 1995 o varstvu posameznikov pri obdelavi osebnih podatkov in o prostem pretoku takih podatkov [8] ter Uredbo (ES) št. 45/2001 Evropskega parlamenta in Sveta z dne 18. decembra 2000 o varstvu posameznikov pri obdelavi osebnih podatkov v institucijah in organih Skupnosti in o prostem pretoku takih podatkov [9].
In particular, the operation of the EWRS should provide for specific safeguards for the safe and lawful exchange of personal data for the purpose of contact tracing measures implemented by Member States at national level.
Zlasti bi moral Sistem zgodnjega obveščanja in odzivanja delovati tako, da bi zagotovil posebne zaščitne ukrepe za varno in zakonito izmenjavo osebnih podatkov za ukrepe sledenja stikov, ki jih izvajajo države članice na nacionalni ravni.
Since the objectives of this Decision, cannot be sufficiently achieved by the Member States alone due to the cross-border dimension of serious threats to health and can, therefore, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union.
Ker ciljev tega sklepa države članice zaradi čezmejne razsežnosti resnih nevarnosti za zdravje ne morejo zadovoljivo doseči same in ker se te cilje laže doseže na ravni Unije, lahko Unija sprejme ukrepe v skladu z načelom subsidiarnosti iz člena 5 Pogodbe o Evropski uniji.
In accordance with the principle of proportionality, as set out in that Article, this Decision does not go beyond what is necessary in order to achieve those objectives.
V skladu z načelom sorazmernosti iz navedenega člena ta sklep ne presega tistega, kar je potrebno za doseganje navedenih ciljev.
As responsibility for public health is not an exclusively national matter in certain Member States, but is substantially decentralised, national authorities should, where appropriate, involve the relevant competent authorities in the implementation of this Decision.
Ker odgovornost za javno zdravje v nekaterih državah članicah ni urejena izključno na nacionalni ravni, temveč je občutno decentralizirana, bi morali nacionalni organi, kjer je to ustrezno, k izvajanju tega sklepa pritegniti ustrezne pristojne organe.
In order to ensure uniform conditions for the implementation of this Decision, implementing powers should be conferred on the Commission to adopt implementing acts in relation to: templates to be used when providing the information on preparedness and response planning; the establishment and update of a list of communicable diseases and related special health issues subject to the network of epidemiological surveillance and the procedures for the operation of such a network; the adoption of case definitions for those communicable diseases and special health issues covered by the epidemiological surveillance network and, where necessary, for other serious cross-border threats to health subject to ad hoc monitoring; the procedures for the operation of the EWRS; the procedures for the information exchange on and the coordination of the responses of the Member States; the recognition of situations of public health emergency at Union level and the termination of such a recognition.
Za zagotovitev enotnih pogojev izvajanja tega sklepa bi bilo treba na Komisijo prenesti izvedbena pooblastila za sprejemanje izvedbenih aktov v zvezi s/z: obrazci za pošiljanje informacij o načrtovanju pripravljenosti in odzivanja; vzpostavitvijo in posodobitvijo seznama nalezljivih bolezni in s tem povezanih posebnih zdravstvenih problemov, ki so vključeni v mrežo epidemiološkega spremljanja in za katere se uporabljajo postopki za delovanje takšne mreže; sprejetjem opredelitev primerov navedenih nalezljivih bolezni in posebnih zdravstvenih problemov, zajetih v mreži epidemiološkega spremljanja, in po potrebi drugih resnih čezmejnih nevarnosti za zdravje, ki se jih začasno spremlja; postopki za delovanje Sistema zgodnjega obveščanja in odzivanja; postopki za izmenjavo informacij o odzivanju držav članic in usklajevanje tega odzivanja; razglasitvijo izrednih razmer na področju javnega zdravja na ravni Unije in preklicem takšne razglasitve.
As the implementing acts provided for by this Decision concern the protection of human health, the Commission may not adopt a draft implementing act where the Committee on serious cross-border threats to health delivers no opinion, in accordance with point (a) of the second subparagraph of Article 5(4) of Regulation (EU) No 182/2011.
Ker se izvedbeni akti, ki jih predvideva ta sklep, nanašajo na varovanje zdravja ljudi, Komisija v skladu s točko (a) drugega pododstavka člena 5(4) Uredbe (EU) št. 182/2011 ne sme sprejeti osnutka izvedbenega akta, kadar Odbor za resne čezmejne nevarnosti za zdravje ne sprejme mnenja.
The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to the severity or novelty of a serious cross-border threat to health or to the rapidity of its spread between the Member States imperative grounds of urgency so require.
Komisija bi morala sprejeti izvedbene akte, ki se začnejo uporabljati takoj, kadar je to potrebno iz izredno nujnih razlogov v ustrezno utemeljenih primerih, kadar je resna čezmejna nevarnost za zdravje tako huda ali nova ali se med državami članicami hitro širi.
The European Data Protection Supervisor has been consulted in accordance with Article 28(2) of Regulation (EC) No 45/2001 and has adopted an opinion [11].
V skladu s členom 28(2) Uredbe (ES) št. 45/2001 je bilo opravljeno posvetovanje z Evropskim nadzornikom za varstvo podatkov, ki je sprejel mnenje [11].
Accordingly, Decision No 2119/98/EC should be repealed and replaced by this Decision,
Zato bi bilo treba Odločbo št. 2119/98/ES razveljaviti in nadomestiti s tem sklepom –