natgillin/translations-raw huggingface dataset:
the patient will, according to a clinical evaluation, be exposed with reasonable certainty to a patient-safety risk that cannot be regarded as acceptable, taking into account the potential benefit for the patient of the sought cross-border healthcare;
če bo pacient skladno s klinično oceno z zadostno gotovostjo izpostavljen tveganju za varnost pacienta, ki se ne more razumeti kot sprejemljivo, pri čemer se upoštevajo morebitne prednosti, ki bi jih za pacienta imelo čezmejno zdravstveno varstvo;
the general public will be exposed with reasonable certainty to a substantial safety hazard as a result of the cross-border healthcare in question;
če bo širša javnost zaradi zadevnega čezmejnega zdravstvenega varstva z zadostno gotovostjo izpostavljena varnostnemu tveganju;
this healthcare is to be provided by a healthcare provider that raises serious and specific concerns relating to the respect of standards and guidelines on quality of care and patient safety, including provisions on supervision, whether these standards and guidelines are laid down by laws and regulations or through accreditation systems established by the Member State of treatment;
če mora biti zadevno zdravstveno varstvo zagotovljeno s strani izvajalca zdravstvenega varstva, glede katerega obstajajo resni in konkretni pomisleki v zvezi s spoštovanjem standardov in smernic glede kakovosti oskrbe in varnosti pacienta, vključno z določbami o nadzoru, ne glede na to, ali te standarde in smernice določajo zakoni in predpisi ali akreditacijski sistemi, ki jih je določila država članica zdravljenja;
this healthcare can be provided on its territory within a time limit which is medically justifiable, taking into account the current state of health and the probable course of the illness of each patient concerned.
če se to zdravstveno varstvo lahko – ob upoštevanju trenutnega zdravstvenega stanja posameznega zadevnega pacienta in verjetnega razvoja bolezni – v roku, ki je utemeljen z medicinskega vidika, opravi na njenem ozemlju.
The Member State of affiliation shall make publicly available which healthcare is subject to prior authorisation for the purposes of this Directive, as well as all relevant information on the system of prior authorisation.
Država članica zdravstvenega zavarovanja javno objavi, za katero zdravstveno varstvo je potrebna predhodna odobritev za namene te direktive ter vse pomembne informacije o sistemu predhodne odobritve.
Administrative procedures regarding cross-border healthcare
Upravni postopki v zvezi s čezmejnim zdravstvenim varstvom
The Member State of affiliation shall ensure that administrative procedures regarding the use of cross-border healthcare and reimbursement of costs of healthcare incurred in another Member State are based on objective, non-discriminatory criteria which are necessary and proportionate to the objective to be achieved.
Država članica zdravstvenega zavarovanja zagotovi, da upravni postopki v zvezi s čezmejnim zdravstvenim varstvom in povračilom stroškov zdravstvenega varstva, nastalih v drugi državi članici, temeljijo na objektivnih, nediskriminatornih merilih, ki so nujna in sorazmerna za dosego ciljev.
Any administrative procedure of the kind referred to in paragraph 1 shall be easily accessible and information relating to such a procedure shall be made publicly available at the appropriate level.
Kakršen koli upravni postopek vrste, ki je navedena v odstavku 1, je dostopen na enostaven način, informacije v zvezi s takim postopkom pa so objavljene na ustrezni ravni.
Such a procedure shall be capable of ensuring that requests are dealt with objectively and impartially.
Tak postopek mora biti zmožen zagotavljati, da so zahtevki obravnavani objektivno in nepristransko.
Member States shall set out reasonable periods of time within which requests for cross-border healthcare must be dealt with and make them public in advance.
Države članice določijo razumne roke, v katerih je treba obravnavati zahtevke za čezmejno zdravstveno varstvo, in jih vnaprej objavijo.
When considering a request for cross-border healthcare, Member States shall take into account:
Države članice pri obravnavi zahtevkov za čezmejno zdravstveno varstvo upoštevajo:
the specific medical condition;
specifično zdravstveno stanje,
the urgency and individual circumstances.
nujnost in posamezne okoliščine.
Member States shall ensure that individual decisions regarding the use of cross-border healthcare and reimbursement of costs of healthcare incurred in another Member State are properly reasoned and subject, on a case-by-case basis, to review and are capable of being challenged in judicial proceedings, which include provision for interim measures.
Države članice zagotovijo, da je za posamezno odločitev v zvezi s čezmejnim zdravstvenim varstvom in povračilom stroškov zdravstvenega varstva, nastalih v drugi državi članici, potrebno ustrezno utemeljiti in v posameznih primerih opraviti pregled ter da jih je mogoče spodbijati v okviru sodnega postopka, ki omogoča izdajo začasnih ukrepov.
This Directive is without prejudice to Member States’ right to offer patients a voluntary system of prior notification whereby, in return for such notification, the patient receives a written confirmation of the amount to be reimbursed on the basis of an estimate.
Ta direktiva ne vpliva na pravico držav članic, da pacientom ponudijo prostovoljni sistem predhodnega obveščanja, na podlagi katerega pacient v zameno za predhodno obvestilo prejme pisno potrdilo o znesku povračila stroškov na podlagi ocene.
This estimate shall take into account the patient’s clinical case, specifying the medical procedures likely to apply.
Ta ocena upošteva zdravstveno stanje pacienta in opredeli medicinske postopke, ki bodo verjetno uporabljeni.
Member States may choose to apply the mechanisms of financial compensation between the competent institutions as provided for by Regulation (EC) No 883/2004.
Države članice se lahko odločijo za uporabo mehanizmov finančne odškodnine med pristojnimi nosilci, kot določa Uredba (ES) št. 883/2004.
Where a Member State of affiliation does not apply such mechanisms, it shall ensure that patients receive reimbursement without undue delay.
Kadar država članica zdravstvenega zavarovanja ne uporablja takšnih mehanizmov, država članica zagotovi, da se stroški pacientom povrnejo brez nepotrebnega odlašanja.
COOPERATION IN HEALTHCARE
SODELOVANJE NA PODROČJU ZDRAVSTVENEGA VARSTVA
Mutual assistance and cooperation
Vzajemna pomoč in sodelovanje
Member States shall render such mutual assistance as is necessary for the implementation of this Directive, including cooperation on standards and guidelines on quality and safety and the exchange of information, especially between their national contact points in accordance with Article 6, including on provisions on supervision and mutual assistance to clarify the content of invoices.
Države članice zagotovijo tako vzajemno pomoč, kot je potrebna za izvajanje te direktive, vključno s sodelovanjem pri standardih in smernicah glede kakovosti in varnosti ter izmenjavo informacij, zlasti med njihovimi nacionalnimi kontaktnimi točkami v skladu s členom 6, vključno z določbami o nadzoru, in z vzajemno pomočjo za pojasnitev podatkov na računih.
Member States shall facilitate cooperation in cross-border healthcare provision at regional and local level as well as through ICT and other forms of cross-border cooperation.
Države članice olajšujejo sodelovanje pri zagotavljanju čezmejnega zdravstvenega varstva na regionalni in lokalni ravni ter prek IKT in z drugimi oblikami čezmejnega sodelovanja.
The Commission shall encourage Member States, particularly neighbouring countries, to conclude agreements among themselves.
Komisija spodbuja države članice, zlasti sosednje države, da med seboj sklenejo sporazume.
The Commission shall also encourage the Member States to cooperate in cross-border healthcare provision in border regions.
Države članice spodbuja tudi k sodelovanju pri zagotavljanju čezmejnega zdravstvenega varstva na obmejnih območjih.
Member States of treatment shall ensure that information on the right to practise of health professionals listed in national or local registers established on their territory is, upon request, made available to the authorities of other Member States, for the purpose of cross-border healthcare, in accordance with Chapters II and III and with national measures implementing Union provisions on the protection of personal data, in particular Directives 95/46/EC and 2002/58/EC, and the principle of presumption of innocence.
Države članice zdravljenja zagotovijo, da so informacije o dovoljenju za opravljanje dejavnosti zdravstvenih delavcev, navedene v nacionalnih ali lokalnih registrih na njihovem ozemlju, na zahtevo na voljo organom drugih držav članic zaradi čezmejnega zdravstvenega varstva v skladu s poglavjema II in III in nacionalnimi ukrepi, s katerimi se izvajajo določbe Unije o varstvu osebnih podatkov, zlasti direktivi 95/46/ES in 2002/58/ES, ter z načelom o domnevi nedolžnosti.
The exchange of information shall take place via the Internal Market Information system established pursuant to Commission Decision 2008/49/EC of 12 December 2007 concerning the implementation of the Internal Market Information System (IMI) as regards the protection of personal data [36].
Izmenjava informacij poteka prek informacijskega sistema za notranji trg, vzpostavljenega v skladu z Odločbo Komisije 2008/49/ES z dne 12. decembra 2007 o izvajanju informacijskega sistema za notranji trg (IMI) v zvezi z varstvom osebnih podatkov [36].
Recognition of prescriptions issued in another Member State
Priznavanje receptov, izdanih v drugi državi članici
If a medicinal product is authorised to be marketed on their territory, in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004, Member States shall ensure that prescriptions issued for such a product in another Member State for a named patient can be dispensed on their territory in compliance with their national legislation in force, and that any restrictions on recognition of individual prescriptions are prohibited unless such restrictions are:
Če je zdravilo odobreno za trženje na ozemljih držav članic v skladu z Direktivo 2001/83/ES ali Uredbo (ES) št. 726/2004, države članice zagotovijo, da se recepti za to zdravilo, izdani v drugi državi članici za imenovanega pacienta, lahko uporabljajo na njihovem ozemlju v skladu z njihovo veljavno nacionalno zakonodajo in da so omejitve priznavanja posameznih receptov prepovedane, razen če so te omejitve:
limited to what is necessary and proportionate to safeguard human health, and non-discriminatory; or
omejene na tisto, kar je nujno in sorazmerno za varovanje zdravja ljudi, in so nediskriminatorne; ali
based on legitimate and justified doubts about the authenticity, content or comprehensibility of an individual prescription.
utemeljene z legitimnimi in utemeljenimi dvomi o verodostojnosti, vsebini ali razumljivosti posameznega recepta.
The recognition of such prescriptions shall not affect national rules governing prescribing and dispensing, if those rules are compatible with Union law, including generic or other substitution.
Priznavanje takšnih receptov ne vpliva na nacionalna pravila o predpisovanju in izdajanju zdravil, vključno z generičnimi ali drugimi oblikami nadomeščanja.
The recognition of prescriptions shall not affect the rules on reimbursement of medicinal products.
Priznavanje receptov ne vpliva na pravila o povračilu stroškov zdravil.
Reimbursement of costs of medicinal products is covered by Chapter III of this Directive.
Povračilo stroškov zdravil je urejeno v poglavju III te direktive.
In particular, the recognition of prescriptions shall not affect a pharmacist’s right, by virtue of national rules, to refuse, for ethical reasons, to dispense a product that was prescribed in another Member State, where the pharmacist would have the right to refuse to dispense, had the prescription been issued in the Member State of affiliation.
Priznavanje receptov zlasti ne vpliva na pravico farmacevta, da na podlagi nacionalnih pravil iz etičnih razlogov zavrne izdajo zdravila, za katerega je bil recept predpisan v drugi državi članici, če bi farmacevt imel pravico zavrniti izdajo zdravila, za katerega bi recept bil predpisan v državi članici zdravstvenega zavarovanja.
The Member State of affiliation shall take all necessary measures, in addition to the recognition of the prescription, in order to ensure continuity of treatment in cases where a prescription is issued in the Member State of treatment for medicinal products or medical devices available in the Member State of affiliation and where dispensing is sought in the Member State of affiliation.
Država članica zdravstvenega zavarovanja sprejme vse potrebne ukrepe, poleg priznanja predpisanega recepta, da bi zagotovila neprekinjeno zdravljenje v primerih, v katerih je recept predpisan v državi članici zdravljenja za zdravila ali medicinske pripomočke, ki so na voljo v državi članici zdravstvenega zavarovanja, in kadar se izdaja zdravil ali medicinskih pripomočkov zahteva v državi članici zdravstvenega zavarovanja.
This paragraph shall also apply to medical devices that are legally placed on the market in the respective Member State.
Ta odstavek se uporablja tudi za medicinske pripomočke, ki so zakonito dani na trg v zadevni državi članici.
In order to facilitate implementation of paragraph 1, the Commission shall adopt:
Komisija za lažje izvajanje odstavka 1 sprejme:
measures enabling a health professional to verify the authenticity of the prescription and whether the prescription was issued in another Member State by a member of a regulated health profession who is legally entitled to do so through developing a non-exhaustive list of elements to be included in the prescriptions and which must be clearly identifiable in all prescription formats, including elements to facilitate, if needed, contact between the prescribing party and the dispensing party in order to contribute to a complete understanding of the treatment, in due respect of data protection;
ukrepe, ki zdravstvenemu delavcu omogočajo, da preveri, ali je recept verodostojen in ali ga je v drugi državi članici predpisal imetnik reguliranega zdravstvenega poklica, ki je za to upravičen, s tem, da bo oblikovala neizčrpen seznam podatkov, ki jih morajo vsebovati recepti in ki morajo biti jasno razpoznavni v vseh oblikah receptov, vključno z elementi, ki po potrebi zagotovijo povezavo med osebo, ki je recept predpisala, in osebo, ki ga je izdala, da se prispeva k zagotavljanju celovitega razumevanja zdravljenja, ob upoštevanju varstva podatkov;
guidelines supporting the Member States in developing the interoperability of ePrescriptions;
smernice za podporo državam članicam pri razvoju interoperabilnosti e-receptov;
measures to facilitate the correct identification of medicinal products or medical devices prescribed in one Member State and dispensed in another, including measures to address patient safety concerns in relation to their substitution in cross border healthcare where the legislation of the dispensing Member State permits such substitution.
ukrepe za pravilno identifikacijo zdravil ali medicinskih pripomočkov, predpisanih v eni in dani pacientu v drugi državi članici, vključno z ukrepi za reševanje pomislekov o varnosti pacienta v zvezi z nadomestitvijo zdravil ali medicinskih pripomočkov pri čezmejnem zdravstvenem varstvu, če je takšna nadomestitev dopustna v skladu z zakonodajo države članice izdaje.
The Commission shall consider, inter alia, using the International Non-proprietary Name and the dosage of medicinal products;
Komisija med drugim preuči uporabo mednarodnega nelastniškega imena in odmerjanje zdravil;
measures to facilitate the comprehensibility of the information to patients concerning the prescription and the instructions included on the use of the product, including an indication of active substance and dosage.
ukrepe za olajšanje razumevanja informacij za paciente v zvezi z receptom in navodili za uporabo izdelka, vključno z navedbo zdravilne učinkovine in doziranja.
Measures referred in point (a) shall be adopted by the Commission no later than 25 December 2012 and measures in points (c) and (d) shall be adopted by the Commission no later than 25 October 2012.
Komisija sprejme ukrepe iz točke (a) najpozneje do 25. decembra 2012, ukrepe iz točke (c) in (d) pa Komisija sprejme najpozneje do 25. oktobra 2012.
The measures and guidelines referred to in points (a) to (d) of paragraph 2 shall be adopted in accordance with the regulatory procedure referred to in Article 16(2).
Ukrepi in smernice iz točk (a) do (d) odstavka 2 se sprejmejo v skladu z regulativnim postopkom iz člena 16(2).
In adopting measures or guidelines under paragraph 2, the Commission shall have regard to the proportionality of any costs of compliance with, as well as the likely benefits of, the measures or guidelines.
Pri sprejemanju ukrepov ali smernic v skladu z odstavkom 2 Komisija upošteva sorazmernost stroškov usklajevanja z ukrepi ali smernicami in njihove morebitne koristi.
For the purpose of paragraph 1, the Commission shall also adopt, by means of delegated acts in accordance with Article 17 and subject to the conditions of Articles 18 and 19 and no later than 25 October 2012 measures to exclude specific categories of medicinal products or medical devices from the recognition of prescriptions provided for under this Article, where necessary in order to safeguard public health.
Za namene odstavka 1 Komisija z delegiranimi akti v skladu s členom 17 in pod pogoji iz členov 18 in 19 ter najpozneje do 25. oktobra 2012 sprejme tudi ukrepe za izključitev posebnih kategorij zdravil ali medicinskih pripomočkov iz obsega priznavanja receptov, določenega v tem členu, kadar je to potrebno zaradi varovanja javnega zdravja.
Paragraph 1 shall not apply to medicinal products subject to special medical prescription provided for in Article 71(2) of Directive 2001/83/EC.
Odstavek 1 se ne uporablja za zdravila, za katere so potrebni posebni recepti, kot je določeno v členu 71(2) Direktive 2001/83/ES.
European reference networks
Evropske referenčne mreže
The Commission shall support Member States in the development of European reference networks between healthcare providers and centres of expertise in the Member States, in particular in the area of rare diseases.
Komisija podpira države članice pri razvoju evropskih referenčnih mrež med izvajalci zdravstvenega varstva in strokovnimi centri v državah članicah, zlasti na področju redkih bolezni.
The networks shall be based on voluntary participation by its members, which shall participate and contribute to the networks’ activities in accordance with the legislation of the Member State where the members are established and shall at all times be open to new healthcare providers which might wish to join them, provided that such healthcare providers fulfil all the required conditions and criteria referred to in paragraph 4.
Mreže temeljijo na prostovoljnem sodelovanju svojih članov, ki v skladu z zakonodajo države članice, v kateri imajo člani svoj sedež, sodelujejo pri dejavnostih mrež ter prispevajo k njim, ter so vedno odprte za nove izvajalce zdravstvenega varstva, ki se jim želijo pridružiti, pod pogojem, da takšni izvajalci storitev zdravstvenega varstva izpolnjujejo vse zahtevane pogoje in merila iz odstavka 4.
European reference networks shall have at least three of the following objectives:
2. Evropske referenčne mreže imajo vsaj tri od naslednjih ciljev:
to help realise the potential of European cooperation regarding highly specialised healthcare for patients and for healthcare systems by exploiting innovations in medical science and health technologies;
pomagati pri uresničevanju potenciala evropskega sodelovanja na področju visoko-specializiranega zdravstvenega varstva za paciente in sisteme zdravstvenega varstva z uporabo inovacij na področju medicine in zdravstvene tehnologije;
to contribute to the pooling of knowledge regarding sickness prevention;
prispevati k zbiranju znanja glede preprečevanja bolezni;
to facilitate improvements in diagnosis and the delivery of high-quality, accessible and cost-effective healthcare for all patients with a medical condition requiring a particular concentration of expertise in medical domains where expertise is rare;
omogočati izboljševanje diagnosticiranja in izvajanje visokokakovostnega, dostopnega in stroškovno učinkovitega zdravstvenega varstva za vse paciente, katerih zdravstveno stanje zahteva posebno združevanje strokovnega znanja na medicinskih področjih, kjer primanjkuje strokovnega znanja;
to maximise the cost-effective use of resources by concentrating them where appropriate;
zagotoviti najbolj stroškovno učinkovito uporabo virov prek primernega združevanja virov;
to reinforce research, epidemiological surveillance like registries and provide training for health professionals;
spodbujati raziskave in epidemiološko spremljanje, na primer pri registrih, ter zagotoviti usposabljanje za zdravstvene delavce;
to facilitate mobility of expertise, virtually or physically, and to develop, share and spread information, knowledge and best practice and to foster developments of the diagnosis and treatment of rare diseases, within and outside the networks;
olajšati virtualno ali fizično razširjanje strokovnega znanja ter v okviru mrež in zunaj njih razvijati, izmenjavati in širiti informacije, znanje in najboljše prakse, ter spodbujati razvoj diagnosticiranja in zdravljenja redkih bolezni;
to encourage the development of quality and safety benchmarks and to help develop and spread best practice within and outside the network;
spodbujati razvoj meril kakovosti in varnosti ter pomagati pri razvoju in širjenju najboljše prakse znotraj in zunaj mreže;
to help Member States with an insufficient number of patients with a particular medical condition or lacking technology or expertise to provide highly specialised services of high quality.
pomagati državam članicam z nezadostnim številom pacientov s posebnim zdravstvenim stanjem ali pomanjkanjem tehnologije ali strokovnega znanja za zagotavljanje kakovostnih visoko specializiranih storitev.
Member States are encouraged to facilitate the development of the European reference networks:
Države članice se spodbuja, da olajšajo razvoj evropskih referenčnih mrež tako, da:
by connecting appropriate healthcare providers and centres of expertise throughout their national territory and ensuring the dissemination of information towards appropriate healthcare providers and centres of expertise throughout their national territory;
na svojem ozemlju povežejo ustrezne izvajalce zdravstvenega varstva in strokovne centre ter zagotovijo širjenje informacij med ustreznimi izvajalci zdravstvenega varstva in strokovnimi centri na svojem ozemlju;
by fostering the participation of healthcare providers and centres of expertise in the European reference networks.
spodbujajo sodelovanje izvajalcev zdravstvenega varstva in strokovnih centrov v evropskih referenčnih mrežah.
For the purposes of paragraph 1, the Commission shall:
Za namene odstavka 1 Komisija:
adopt a list of specific criteria and conditions that the European reference networks must fulfil and the conditions and criteria required from healthcare providers wishing to join the European reference network.
sprejme seznam posebnih meril in pogojev, ki jih morajo izpolnjevati evropske referenčne mreže, ter pogoje in merila, ki jih morajo izpolnjevati izvajalci zdravstvenega varstva, ki se želijo pridružiti evropski referenčni mreži.
These criteria and conditions shall ensure, inter alia, that European reference networks:
Ta merila in pogoji med drugim zagotovijo, da evropske referenčne mreže:
have knowledge and expertise to diagnose, follow-up and manage patients with evidence of good outcomes, as far as applicable;
imajo znanje in strokovne izkušnje, da lahko, kolikor je to izvedljivo, z dokazi o dobrih rezultatih postavljajo diagnozo, spremljajo in obravnavajo paciente;
follow a multi-disciplinary approach;
izvajajo večdisciplinarni pristop;