natgillin/translations-raw huggingface dataset:
Information should be provided by national contact points to patients in any of the official languages of the Member State in which the contact points are situated.
Nacionalne kontaktne točke bi morale pacientom informacije zagotoviti v katerem koli uradnem jeziku države članice, v kateri se kontaktne točke nahajajo.
Information may be provided in any other language.
Informacije se lahko zagotovijo tudi v katerem koli drugem jeziku.
The Member States should decide on the form and number of their national contact points.
Države članice bi morale določiti obliko in število njihovih nacionalnih kontaktnih točk.
Such national contact points may also be incorporated in, or build on, activities of existing information centres provided that it is clearly indicated that they are also national contact points for cross-border healthcare.
Nacionalne kontaktne točke se lahko vključijo v dejavnosti obstoječih informacijskih središč ali jih nadgradijo, pod pogojem, da je jasno navedeno, da so to tudi nacionalne kontaktne točke za čezmejno zdravstveno varstvo.
National contact points should be established in an efficient and transparent way and they should be able to consult with patient organisations, healthcare insurers and healthcare providers.
Nacionalne kontaktne točke bi morale biti vzpostavljene na učinkovit in pregleden način ter bi jim moralo biti omogočeno, da se posvetujejo z organizacijami pacientov, nosilci zdravstvenega zavarovanja in izvajalci zdravstvenega varstva.
The national contact points should have appropriate facilities to provide information on the main aspects of cross-border healthcare.
Nacionalne kontaktne točke bi morale imeti ustrezne prostore za zagotavljanje informacij o glavnih vidikih čezmejnega zdravstvenega varstva.
The Commission should work together with the Member States in order to facilitate cooperation regarding national contact points for cross-border healthcare, including making relevant information available at Union level.
Komisija bi morala skupaj z državami članicami olajšati sodelovanje v zvezi z nacionalnimi kontaktnimi točkami za čezmejno zdravstveno varstvo, vključno z omogočanjem dostopa do pomembnih informacij na ravni Unije.
The existence of national contact points should not preclude Member States from establishing other linked contact points at regional or local level, reflecting the specific organisation of their healthcare system.
Obstoj nacionalnih kontaktnih točk državam članicam ne bi smel onemogočiti, da vzpostavijo druge povezane kontaktne točke na regionalni ali lokalni ravni, ki odražajo specifično organizacijo njihovega sistema zdravstvenega varstva.
Member States should facilitate cooperation between healthcare providers, purchasers and regulators of different Member States at national, regional or local level in order to ensure safe, high-quality and efficient cross-border healthcare.
Države članice bi morale olajšati sodelovanje med izvajalci zdravstvenega varstva, kupci in regulativnimi organi iz različnih držav članic na nacionalni, regionalni ali lokalni ravni, da se zagotovi varno, visokokakovostno in učinkovito čezmejno zdravstveno varstvo.
This could be of particular importance in border regions, where cross-border provision of services may be the most efficient way of organising health services for the local population, but where achieving such cross-border provision on a sustained basis requires cooperation between the health systems of different Member States.
To bi bilo lahko še posebej pomembno na obmejnih območjih, kjer je čezmejno izvajanje storitev morda najučinkovitejši način organiziranja zdravstvenih storitev za lokalne prebivalce, vendar doseganje trajnostnega čezmejnega izvajanja storitev zahteva sodelovanje med zdravstvenimi sistemi različnih držav članic.
Such cooperation may concern joint planning, mutual recognition or adaptation of procedures or standards, interoperability of respective national information and communication technology (hereinafter ‘ICT’) systems, practical mechanisms to ensure continuity of care or practical facilitating of cross-border provision of healthcare by health professionals on a temporary or occasional basis.
Takšno sodelovanje lahko zajema skupno načrtovanje, vzajemno priznavanje ali prilagajanje postopkov ali standardov, interoperabilnost posameznih nacionalnih sistemov informacijske in komunikacijske tehnologije (v nadaljnjem besedilu: IKT), praktične mehanizme za zagotavljanje stalnosti oskrbe ali praktično olajševanje čezmejnega izvajanja zdravstvenega varstva s strani zdravstvenih delavcev na začasni ali priložnostni osnovi.
Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications [10] stipulates that free provision of services of a temporary or occasional nature, including services provided by health professionals, in another Member State is not, subject to specific provisions of Union law, to be restricted for any reason relating to professional qualifications.
Direktiva 2005/36/ES Evropskega parlamenta in Sveta z dne 7. septembra 2005 o priznavanju poklicnih kvalifikacij [10] določa, da svoboda izvajanja storitev na začasni ali občasni osnovi, vključno s storitvami zdravstvenih delavcev, v drugi državi članici v skladu s posebnimi določbami prava Unije ni omejena iz nobenega razloga, povezanega s poklicnimi kvalifikacijami.
This Directive should be without prejudice to Directive 2005/36/EC.
Ta direktiva ne bi smela posegati v Direktivo 2005/36/ES.
The Commission should encourage cooperation between Member States in the areas set out in Chapter IV of this Directive and may, in accordance with Article 168(2) TFEU, take, in close contact with the Member States, any useful initiative to facilitate and promote such cooperation.
Komisija bi morala spodbujati sodelovanje med državami članicami na področjih, določenih v poglavju IV te direktive, v skladu s členom 168(2) PDEU pa lahko v tesnem sodelovanju z državami članicami sprejme kakršno koli koristno pobudo za olajševanje in spodbujanje takšnega sodelovanja.
In that context, the Commission should encourage cooperation in cross-border healthcare provision at regional and local level, particularly by identifying major obstacles to collaboration between healthcare providers in border regions, and by making recommendations and disseminating information and best practices on how to overcome such obstacles.
V tem okviru bi morala Komisija spodbujati sodelovanje pri izvajanju čezmejnega zdravstvenega varstva na regionalni in lokalni ravni, zlasti z ugotavljanjem glavnih ovir za sodelovanje med izvajalci zdravstvenega varstva v obmejnih regijah, ter s pripravo priporočil in s širjenjem informacij in dobrih praks o tem, kako je mogoče odpraviti takšne ovire.
The Member State of affiliation may need to receive confirmation that the cross-border healthcare will be, or has been, delivered by a legally practising health professional.
Država članica zdravstvenega zavarovanja mora morda prejeti potrdilo, da bo ali je storitve čezmejnega zdravstvenega varstva že opravil zdravstveni delavec, ki storitve opravlja v skladu z zakonom.
It is therefore appropriate to ensure that information on the right to practise contained in the national or local registers of health professionals, if established in the Member State of treatment, are, upon request, made available to the authorities of the Member State of affiliation.
Zato je primerno, da se zagotovi, da so informacije o dovoljenju za opravljanje zdravstvenih storitev, ki so navedene v nacionalnih ali lokalnih registrih zdravstvenih delavcev, če ti storitve opravljajo v državi članici zdravljenja, na zahtevo na voljo organom držav članic zdravstvenega zavarovanja.
Where medicinal products are authorised within a Member State and have been prescribed in that Member State by a member of a regulated health profession within the meaning of Directive 2005/36/EC for an individual named patient, it should, in principle, be possible for such prescriptions to be medically recognised and for the medicinal products to be dispensed in another Member State in which the medicinal products are authorised.
Kadar so zdravila odobrena v eni državi članici in jih v tej državi članici predpiše imetnik reguliranega zdravstvenega poklica v smislu Direktive 2005/36/ES za posameznega, po imenu navedenega pacienta, bi moralo biti načeloma možno, da se takšni recepti priznajo z medicinskega vidika in zdravila na te recepte izdajo v drugi državi članici, kjer so ta zdravila odobrena.
The removal of regulatory and administrative barriers to such recognition should be without prejudice to the need for appropriate agreement of the patient’s treating physician or pharmacist in every individual case, if this is warranted by protection of human health and is necessary and proportionate to that objective.
Odstranitev regulativnih in upravnih ovir za takšno priznavanje receptov ne bi smelo posegati v potrebo po ustreznem soglasju pacientovega lečečega zdravnika ali farmacevta v vsakem posameznem primeru, če je to upravičeno z zaščito zdravja ljudi ter je nujno in sorazmerno za dosego navedenega cilja.
The recognition of prescriptions from other Member States should not affect any professional or ethical duty that would require pharmacists to refuse to dispense the prescription.
Priznavanje receptov iz drugih držav članic ne bi smelo vplivati na poklicno ali etično dolžnost, ki bi farmacevtu narekovala, da zavrne izdajo izdelka na recept.
Such medical recognition should also be without prejudice to the decision of the Member State of affiliation regarding the inclusion of such medicinal products among the benefits covered by the social security system of affiliation.
Takšno priznavanje receptov prav tako ne bi smelo posegati v odločitev države članice zdravstvenega zavarovanja v zvezi z vključitvijo takšnih zdravil med storitve, ki se krijejo iz sistema socialne varnosti, v katerega je pacient vključen.
It should further be noted that the reimbursement of medicinal products is not affected by the rules on mutual recognition of prescriptions, but covered by the general rules on reimbursement of cross-border healthcare in Chapter III of this Directive.
Poleg tega bi bilo treba opozoriti, da se za povračilo stroškov zdravil ne uporabljajo pravila vzajemnega priznavanja receptov, temveč splošna pravila o povračilu stroškov čezmejnega zdravstvenega varstva iz poglavja III te direktive.
The implementation of the principle of recognition should be facilitated by the adoption of measures necessary for safeguarding the safety of a patient, and avoiding the misuse or confusion of medicinal products.
Izvajanje načela priznavanja bi moralo olajšati sprejetje ukrepov, potrebnih za zaščito varnosti pacienta ter preprečevanje napačne uporabe ali zamenjave zdravil.
These measures should include the adoption of a non-exhaustive list of elements to be included in prescriptions.
Ti ukrepi vključujejo sprejetje neizčrpnega seznama elementov, ki jih mora vsebovati recept.
Nothing should prevent Member States from having further elements in their prescriptions, as long as this does not prevent prescriptions from other Member States that contain the common list of elements from being recognised.
Državam članicam nič ne bi smelo preprečiti, da v svoje recepte vključijo dodatne elemente, pod pogojem, da to ne preprečuje priznavanja receptov iz drugih držav članic, ki vsebujejo skupen seznam elementov.
The recognition of prescriptions should also apply for medical devices that are legally placed on the market in the Member State where the device will be dispensed.
Priznavanje receptov bi se moralo uporabljati tudi za medicinske pripomočke, ki so zakonito dani na trg v državi članici, v kateri bo pripomoček izdan.
The Commission should support the continued development of European reference networks between healthcare providers and centres of expertise in the Member States.
Komisija bi morala podpirati stalen razvoj evropskih referenčnih mrež izvajalcev zdravstvenega varstva in strokovnih centrov v državah članicah.
European reference networks can improve the access to diagnosis and the provision of high-quality healthcare to all patients who have conditions requiring a particular concentration of resources or expertise, and could also be focal points for medical training and research, information dissemination and evaluation, especially for rare diseases.
Evropske referenčne mreže lahko izboljšajo dostop do diagnoze in izvajanje visokokakovostnega zdravstvenega varstva za vse paciente, katerih zdravstveno stanje zahteva posebno koncentracijo virov ali strokovnega znanja, in bi lahko bile tudi osrednje točke za medicinsko usposabljanje in raziskave, širjenje informacij in ocenjevanje zlasti za redke bolezni.
This Directive should therefore give incentives to Member States to reinforce the continued development of European reference networks.
Ta direktiva bi zato morala spodbujati države članice h krepitvi stalnega razvoja evropskih referenčnih mrež.
European reference networks are based on the voluntary participation of their members, but the Commission should develop criteria and conditions that the networks should be required to fulfil in order to receive support from the Commission.
Slednje temeljijo na prostovoljnem sodelovanju njihovih članov, vendar bi morala Komisija oblikovati merila in pogoje, ki bi jih morale biti mreže dolžne izpolniti za prejem podpore od Komisije.
Rare diseases are those that meet a prevalence threshold of not more than five affected persons per 10000, in line with Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products [11], and they are all serious, chronic and often life threatening.
Redke bolezni so tiste, ki dosegajo prag razširjenosti do največ pet obolelih oseb na 10000 oseb, v skladu z Uredbo (ES) št. 141/2000 Evropskega parlamenta in Sveta z dne 16. decembra 1999 o zdravilih sirotah [11], vse pa so resne, kronične ter pogosto življenjsko nevarne.
Some patients affected by rare diseases face difficulties in their quest for a diagnosis and treatment to improve their quality of life and to increase their life expectancy, difficulties which were also recognised by the Council Recommendation of 8 June 2009 on an action in the field of rare diseases [12].
Nekateri pacienti, oboleli za redko boleznijo, se soočajo s težavami pri diagnosticiranju in zdravljenju, da bi izboljšali kakovost svojega življenja in podaljšali pričakovano življenjsko dobo; te težave je Svet priznal v Priporočilu z dne 8. junija 2009 o ukrepanju na področju redkih bolezni [12].
Technological developments in cross-border provision of healthcare through the use of ICTs may result in the exercise of supervisory responsibilities by Member States being unclear, and can thus hinder the free movement of healthcare and give rise to possible additional risks to health protection.
Zaradi tehnološkega napredka čezmejnega zagotavljanja zdravstvenega varstva prek uporabe IKT je lahko uveljavljanje nadzornih pristojnosti držav članic nejasno in zato lahko ovira prosti pretok zdravstvenega varstva ter vodi do možnega dodatnega tveganja za varovanje zdravja.
Widely different and incompatible formats and standards are used for provision of healthcare using ICTs throughout the Union, creating both obstacles to this mode of cross-border healthcare provision and possible risks to health protection.
V Uniji se za zagotavljanje zdravstvenega varstva s pomočjo IKT uporabljajo zelo različne in nezdružljive oblike in standardi, ki ovirajo to obliko zagotavljanja čezmejnega zdravstvenega varstva in vodijo do možnih tveganj za varovanje zdravja.
It is therefore necessary for Member States to aim at interoperability of ICT systems.
Zato si morajo države članice prizadevati za interoperabilnost sistemov IKT.
The deployment of health ICT systems, however, is entirely a national competence.
Vendar je uvedba sistemov IKT v zdravstvu v celoti v pristojnosti držav članic.
This Directive therefore should recognise the importance of the work on interoperability and respect the division of competences by providing for the Commission and Member States to work together on developing measures which are not legally binding but provide additional tools that are available to Member States to facilitate greater interoperability of ICT systems in the healthcare field and to support patient access to eHealth applications, whenever Member States decide to introduce them.
Ta direktiva bi zato morala priznati pomembnost prizadevanj za interoperabilnost in upoštevati delitev pristojnosti, tako da se Komisiji in državam članicam omogoči skupno oblikovanje ukrepov, ki niso pravno zavezujoči, vendar pa predstavljajo dodatna orodja, ki jih lahko države članice uporabijo za spodbujanje večje interoperabilnosti sistemov IKT na področju zdravstvenega varstva ter za podporo dostopa pacientov do aplikacij e-zdravja, kadar se države članice odločijo, da jih bodo uvedle.
The interoperability of eHealth solutions should be achieved whilst respecting national regulations on the provision of healthcare services adopted in order to protect the patient, including legislation on Internet pharmacies, in particular national bans on mail order of prescription-only medicinal products to the extent that they are compatible with the case-law of the Court of Justice and Directive 97/7/EC of the European Parliament and of the Council of 20 May 1997 on the protection of consumers in respect of distance contracts [13] and Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market [14].
Interoperabilnost rešitev e-zdravja bi bilo treba doseči ob spoštovanju nacionalnih predpisov o zagotavljanju storitev zdravstvenega varstva, ki so bili sprejeti za zaščito pacientov, vključno z zakonodajo o internetnih lekarnah, še posebej pa z nacionalnimi prepovedmi naročanja zdravil, ki se izdajajo samo na recept, po pošti, v kolikor so v skladu s sodno prakso Sodišča in Direktivo 97/7/ES Evropskega parlamenta in Sveta z dne 20. maja 1997 o varstvu potrošnikov glede sklepanja pogodb pri prodaji na daljavo [13] ter Direktivo 2000/31/ES Evropskega parlamenta in Sveta z dne 8. junija 2000 o nekaterih pravnih vidikih storitev informacijske družbe, zlasti elektronskega poslovanja na notranjem trgu [14].
The constant progress of medical science and health technologies presents both opportunities and challenges to the health systems of the Member States.
Stalni napredek medicine in zdravstvene tehnologije prinaša priložnosti in tudi izzive za zdravstvene sisteme držav članic.
Cooperation in the evaluation of new health technologies can support Member States through economies of scale and avoid duplication of effort, and provide a better evidence base for optimal use of new technologies to ensure safe, high-quality and efficient healthcare.
Sodelovanje pri ocenjevanju novih zdravstvenih tehnologij je lahko državam članicam v pomoč prek ekonomij obsega in v izogib podvajanja prizadevanj, ter lahko zagotovi boljšo dokazno podlago za najboljšo možno uporabo novih tehnologij, da se zagotovi varno, visokokakovostno in učinkovito zdravstveno varstvo.
Such cooperation requires sustained structures involving all the relevant authorities of the Member States, building on existing pilot projects and consultation of a wide range of stakeholders.
Za takšno sodelovanje so potrebne trajnostne strukture, ki vključujejo vse pomembne organe držav članic in gradijo na obstoječih pilotnih projektih ter na posvetovanju s številnimi zainteresiranimi stranmi.
This Directive should therefore provide a basis for continued Union support for such cooperation.
Zato bi morala ta direktiva zagotoviti podlago za stalno podporo Unije takšnemu sodelovanju.
According to Article 291 TFEU, rules and general principles concerning mechanisms for the control by Member States of the Commission’s exercise of implementing powers are to be laid down in advance by a regulation adopted in accordance with the ordinary legislative procedure.
V skladu s členom 291 PDEU se pravila in splošna načela, na podlagi katerih države članice nadzirajo izvajanje izvedbenih pooblastil Komisije, določijo vnaprej, in sicer z uredbo, sprejeto po rednem zakonodajnem postopku.
Pending the adoption of that new Regulation, Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [15] continues to apply, with the exception of the regulatory procedure with scrutiny, which is not applicable.
Do sprejetja te nove uredbe se še naprej uporablja Sklep Sveta 1999/468/ES z dne 28. junija 1999 o določitvi postopkov za uresničevanje Komisiji podeljenih izvedbenih pooblastil [15], razen regulativnega postopka s pregledom, ki se ne uporablja.
The Commission should be empowered to adopt delegated acts in accordance with Article 290 TFEU in respect of measures that would exclude specific categories of medicinal products or medical devices from the recognition of prescriptions, as provided for in this Directive.
Komisijo bi bilo treba pooblastiti, da v skladu s členom 290 PDEU sprejme delegirane akte v zvezi z ukrepi, ki bi izključili posebne kategorije zdravil ali medicinskih pripomočkov iz obsega priznavanja receptov, kot je določeno v tej direktivi.
In order to identify the reference networks which should benefit from support by the Commission, the Commission should also be empowered to adopt delegated acts in respect of the criteria and conditions that European reference networks have to fulfil.
Da bi opredelili referenčne mreže, ki bi morale imeti koristi od podpore Komisije, bi bilo treba Komisijo tudi pooblastiti, da sprejme delegirane akte v zvezi z merili in pogoji, ki jih morajo izpolnjevati evropske referenčne mreže.
It is of particular importance that, when empowered to adopt delegated acts in accordance with Article 290 TFEU, the Commission carry out appropriate consultations during its preparatory work, including at expert level.
Zlasti je pomembno, da Komisija, kadar je pooblaščena za sprejemanje delegiranih aktov v skladu s členom 290 PDEU, pri svojem pripravljalnem delu opravi ustrezna posvetovanja, vključno na ravni strokovnjakov.
In accordance with point 34 of the Interinstitutional Agreement on better law-making [16], Member States are encouraged to draw up, for themselves and in the interests of the Union, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public.
V skladu s točko 34 Medinstitucionalnega sporazuma o boljši pripravi zakonodaje [16] se države članice poziva, da za lastne potrebe in v interesu Unije pripravijo tabele, ki naj kar najbolj nazorno prikazujejo korelacijo med to direktivo in ukrepi za prenos, ter da te tabele objavijo.
The European Data Protection Supervisor has also delivered his opinion on the proposal for this Directive [17].
O predlogu te direktive je svoje mnenje podal tudi Evropski nadzornik za varstvo podatkov [17].
Since the objective of this Directive, namely providing rules for facilitating the access to safe and high quality cross-border healthcare in the Union, cannot be sufficiently achieved by the Member States and can therefore, by reason of its scale and effects, 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 cilja te direktive, in sicer zagotavljanja pravil za lažji dostop do varnega in visokokakovostnega čezmejnega zdravstvenega varstva v Uniji, države članice ne morejo zadovoljivo doseči in ker se ta cilj zaradi obsega in učinkov lažje 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 Directive does not go beyond what is necessary in order to achieve that objective,
V skladu z načelom sorazmernosti iz navedenega člena ta direktiva ne presega tistega, kar je potrebno za doseganje navedenega cilja –