natgillin/translations-raw huggingface dataset:
(e) če zadevni izvajalec zdravstvenega varstva ni pooblaščen, registriran, potrjen, akreditiran ali nima dovoljenja za zagotavljanje ali izvajanje oskrbe ali zdravljenja, za katerega je bila zaprošena odobritev, v skladu s standardi in smernicami, ki jih določajo zakoni in predpisi ali akreditacijski sistemi, ki jih je določila država članica zdravljenja.
(e) if the healthcare provider in question is not authorised, registered, licensed, certified or accredited, to provide or perform the care or treatment for which the authorisation has been sought , according to the standards and guidelines laid down by laws and regulations or through accreditation systems established by the Member State of treatment.
Primeri v kompromisnem besedilu Sveta so smotrni, vendar morajo biti omejeni samo na navedene primere.
The cases raised in the Council’s compromise are reasonable, but they must limited just to those cases.
Sistemi za vložitev zahtevka predhodne odobritve morajo biti na voljo na lokalni/regionalni ravni ter biti pacientom dostopni in pregledni.
Prior authorisation application systems must be made available at a local/regional level and must be accessible and transparent to patients.
Pravila za vložitev zahtevka in zavrnitev predhodne odobritve morajo biti javno znana in dostopna pred vložitvijo zahtevka, da se lahko zahtevki izvedejo pravično in pregledno.
The rules for application and refusal of prior authorisation must be public and available in advance of an application so that the application can be made in a fair and transparent way.
(Stališče EP– člen 8(5))
(EP position Article 8(5))
PS 79 iz prve obravnave
am 79 of first reading
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.
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, vključno s pritožbenimi postopki v primeru zavrnjene predhodne odobritve .
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 including appeal procedures in the event of a refusal to give authorisation .
(Stališče EP– člen 8(7))
(EP position Article 8(7))
PS 81 iz prve obravnave
am 81 of first reading
Pacientom, ki želijo prejeti zdravstveno varstvo v drugi državi članici, je zagotovljena pravica, da po potrebi vložijo zahtevek za predhodno odobritev v državi članici svojega zdravstvenega zavarovanja.
Patients seeking to receive healthcare provided in another Member State shall be guaranteed the right to apply for prior authorisation in the Member State of affiliation, inter alia by electronic means , where appropriate.
Pravica do vložitve zahtevka za predhodno odobritev bi morala pacientom, ki ob njegovi vložitvi niso v državi članici svojega zdravstvenega zavarovanja, omogočati, da to opravijo po elektronski poti.
The right to apply for prior authorisation should be granted electronically for patients not staying in the Member State of affiliation in the time of application.
Države članice vedno, kjer in kadar je potrebno, organizirajo prenos sredstev za ustrezne stroške čezmejnega zdravljenja neposredno med pristojnimi ustanovami.
Member States shall organise, in all cases where and when appropriate, transfer of funds of corresponding costs of cross border healthcare directly between the competent institutions.
To bi pacientom omogočilo prejemanje storitev čezmejnega zdravstvenega varstva po določbah te direktive in po možnosti z uporabo istega sistema, ki je določen z Uredbo št. 883/2004.
This would enable patients receiving cross border healthcare under the provisions of this directive to benefit, when and where possible, of the same system than the one set in the regulation 2004/883/2004.
Kjer in kadar je to dejansko izvedljivo, odvisno od nacionalnega sistema zdravstvenih napotnic (pavšal ali ne itd..), bo preprečilo, da pacientom ne bo treba plačevati vnaprej in potem čakati na povračilo.
When and where it is concretely feasible, depending on national healthcare invoice system ('forfait' or not, ...etc), this will avoid to patients to pay up front and to wait for being reimbursed.
Države članice na ne bodo imele dodatnih stroškov, saj tako ravnanje temelji na postopkih, ki so že vzpostavljeni in se uporabljajo po omenjeni uredbi.
This will not create an extra charge for MS because it will be based on the same practices that the ones already set and used in the regulation.
Če ni mogoče urediti neposrednega prenosa sredstev za kritje stroškov čezmejnega zdravstvenega varstva med zadevnimi ustanovami, in če je bila dana predhodna odobritev, država članica zdravstvenega zavarovanja pacientom zagotovi povračilo stroškov brez nepotrebnega odlašanja.
When and where not possible to organise the direct transfer of funds corresponding to the costs of cross border healthcare between the competent Institutions, and when prior authorisation has been granted, Member State of affiliation shall guarantee patients to receive reimbursement without undue delay.
Upoštevaje, da je oskrba, za katero je potrebna predhodna odobritev, navadno dražja, je ta določba bistvenega pomena, še posebej za tiste, ki imajo manj denarja.
Taking into account that care submitted to prior authorisation are in general the more expensive ones, this is a crucial provision for patients especially for ones who have less financial means.
Države članice pri določanju rokov, v katerih je treba obravnavati zahtevke za čezmejno zdravstveno varstvo, ter pri pregledu teh zahtevkov upoštevajo:
Member States shall, when setting out the time limits within which requests for cross-border healthcare must be dealt with and, when considering these requests, take into account:
(b) posamezne okoliščine,
(b) individual circumstances,
(c) pacientovo raven bolečine,
(c) the patient's degree of pain,
(d) vrsto pacientove invalidnosti in
(d) the nature of the patient's disability, and
(e) pacientovo zmožnost izvajanja njegove poklicne dejavnosti.
(e) the patient's ability to carry out a professional activity.
(Stališče EP– člen 9(4))
(EP position Article 9(4))
Predlog spremembe 87 iz prve obravnave.
1st reading - AM 87
Države članice zagotovijo, da je za vsako upravno odločitev v zvezi z uporabo zdravstvenega varstva in povračilom stroškov zdravstvenega varstva, nastalih v drugi državi članici, potreben upravni pregled in da jih je mogoče spodbijati v okviru sodnega postopka, ki vključuje zagotovitev začasnih ukrepov.
Member States shall ensure that administrative decisions regarding the use of cross-border healthcare and reimbursement of costs of healthcare incurred in another Member State are subject to administrative review and are capable of being challenged in judicial proceedings, which include provision for interim measures.
Države članice zagotovijo, da je za vsako upravno ali zdravstveno odločitev v zvezi z uporabo zdravstvenega varstva v drugi državi članici potrebno zdravstveno mnenje ali upravni pregled ( glede na posamezni primer) in da jo je mogoče spodbijati v okviru sodnega postopka, ki vključuje zagotovitev začasnih ukrepov.
Member States shall ensure that any administrative or medical decisions regarding the use of cross-border healthcare and reimbursement of costs of healthcare incurred in another Member State are subject, on a case-by-case basis, to an appeal procedure, to an additional medical opinion or an administrative review and are capable of being challenged in judicial proceedings, which include provision for interim measures.
Države članice zagotovijo toliko vzajemne pomoči, kot je potrebno za izvajanje te direktive, vključno z izmenjavo informacij o standardih in smernicah glede kakovosti in varnosti, vključno z določbami o nadzoru, in sicer za lažje izvajanje člena 7(9), ter vključno z vzajemno pomočjo za pojasnitev podatkov na računih.
Member States shall render such mutual assistance as is necessary for the implementation of this Directive, including the exchange of information about standards and guidelines on quality and safety, including provisions on supervision, in order to facilitate the implementation of Article 7(9), and including mutual assistance to clarify the content of invoices.
Države članice zagotovijo toliko vzajemne pomoči, kot je potrebno za izvajanje te direktive, vključno z izmenjavo informacij , zlasti med nacionalnimi kontaktnimi točkami v skladu s členi 4, 5 in 6 ter o standardih in smernicah glede kakovosti in varnosti, vključno z določbami o nadzoru, in sicer za lažje izvajanje člena 7(9), ter vključno z vzajemno pomočjo za pojasnitev podatkov na računih .
Member States shall render such mutual assistance as is necessary for the implementation of this Directive, including the exchange of information , especially between their national contact points in accordance with A rticles 4, 5 and 6 and about standards and guidelines on quality and safety, including provisions on supervision, in order to facilitate the implementation of Article 7(9), and including mutual assistance to clarify the content of invoices.
Države članice olajšujejo sodelovanje pri zagotavljanju čezmejnega zdravstvenega varstva na regionalni in lokalni ravni.
Member States shall facilitate cooperation in cross-border healthcare provision at regional and local level.
Države članice omogočajo sodelovanje pri izvajanju čezmejnega zdravstvenega varstva na regionalni in lokalni ravni ter prek informacijske in komunikacijske tehnologije in z drugimi oblikami čezmejnega sodelovanja .
Member States shall facilitate cooperation in cross-border healthcare provision at regional and local level as well as through information and communication technologies and other forms of cross-border cooperation.
(Stališče EP– člen 15(2))
(EP position Article 15(2))
Komisija spodbuja države članice, zlasti sosednje države, da med seboj sklepajo sporazume in oblikujejo skupne akcijske programe.
The Commission shall encourage Member States, particularly neighbouring countries, to conclude agreements among themselves and to develop joint action programmes.
Države članice tudi spodbuja k sodelovanju, da bi vzpostavile mesta, na katerih bi bil izboljšan dostop pacientov do zdravstvenega varstva, zlasti na obmejnih območjih.
The Commission shall also encourage the Member States to cooperate to create areas in which patients will have improved access to health care, particularly in cross-border areas.
Države članice zagotovijo, da so registri izvajalcev zdravstvenega varstva na voljo pristojnim organom drugih držav članic.
Member States shall guarantee that registers in which health professionals are listed are available to relevant authorities of other Member States.
(Stališče EP– člen 15(4))
(EP position Article 15(4))
PS 100 iz prve obravnave
am 100 of first reading
Člen 10 – odstavek 2c (novo)
Article 10 – paragraph 2c (new)
Države članice nemudoma in proaktivno izmenjujejo informacije o ugotovitvah disciplinskih in kazenskih postopkov proti izvajalcem zdravstvenega varstva, če vplivajo na njihovo registracijo ali pravico do opravljanja storitev .
Member States shall immediately and proactively exchange information about disciplinary and criminal findings against health professionals where they impact upon their registration or their right to provide services.
(Stališče EP– člen 15(5))
(EP position Article 15(5))
Člen 11 – odstavek 1 – pododstavek 1 – uvodni del
Article 11 – paragraph 1 – subparagraph 1 – introductory part
Če je zdravilo odobreno za trženje na ozemljih držav članic, 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:
If a medicinal product is authorised to be marketed on their territory, 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 s členom 6(1) Direktive 2001/83/ES , 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:
If a medicinal product is authorised to be marketed on their territory in accordance with Article 6(1) of Directive 2001/83/EC , 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:
Člen 11 – odstavek 1 – pododstavka 2 in 3
Article 11 – paragraph 1 – subparagraphs 2 and 3
Priznavanje receptov ne vpliva na nacionalna pravila o izdaji zdravil , če so ta pravila združljiva s pravom Unije, in ne vpliva na pravila o nadomeščanju zdravil z generičnimi ali drugih oblikah nadomeščanja.
The recognition of prescriptions shall not affect national rules governing dispensing , if those rules are compatible with Union law, and shall not affect rules governing generic or other substitution.
Priznavanje receptov ne vpliva na pravila o povračilu stroškov zdravil.
The recognition of prescriptions shall not affect the rules on reimbursement of medicinal products.
Povračilo stroškov zdravil je urejeno v poglavju III te direktive.
Reimbursement of costs of medicinal products is covered by Chapter III of this Directive.
Priznavanje receptov ne vpliva na nacionalna pravila o predpisovanju in izdajanju zdravil , vključno z nadomeščanjem zdravil z generičnimi ali drugimi oblikami nadomeščanja.
The recognition of such prescription shall not affect national rules governing prescribing and dispensing, including generic or other substitution.
Povračilo stroškov čezmejno predpisanih zdravil je urejeno v poglavju III te direktive.
Reimbursement of costs of cross-border prescriptions of medicinal products is covered by Chapter III of this Directive.
Ta odstavek se uporablja tudi za medicinske pripomočke, ki so zakonito dani na trg v zadevni državi članici.
This paragraph shall also apply to medical devices that are legally placed on the market in the respective Member State.
Priznavanje receptov ne vpliva na strokovne ali etične obveze, zaradi katerih bi moral farmacevt zavrniti izdajo izdelka, če je bil recept izdan v državi članici zdravstvenega zavarovanja.
The recognition of prescriptions shall not affect any professional or ethical duty that would require the pharmacist to refuse to dispense , had the prescription been issued in the Member State of affiliation.
(Stališče EP– člen 16(1) točke (i),(ii) in (iii))
(EP position Article 16(1) points (i),(ii) and (iii))
Predlog spremembe 101 iz prve obravnave.
1st reading - AM 101
Komisija za lažje izvajanje odstavka 1 sprejme:
In order to facilitate implementation of paragraph 1, the Commission shall adopt:
Komisija za lažje izvajanje odstavka 1 najkasneje do …* sprejme:
In order to facilitate implementation of paragraph 1, the Commission shall adopt no later than ….* :
(a) najpozneje do… ukrepe, ki zdravstvenemu delavcu omogočajo, da preveri, ali je recept verodostojen in ali ga je v drugi državi članici izdal imetnik reguliranega zdravstvenega poklica, ki je za to upravičen, s tem, da bo oblikovala neizčrpen seznam podatkov, ki jih morajo vsebovati recepti ;
(a) no later than ….* 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 ;
(a) ukrepe, ki farmacevtu ali drugemu zdravstvenemu delavcu omogočajo, da preveri, ali je zdravniški recept verodostojen in ali ga je v drugi državi članici izdal imetnik reguliranega zdravstvenega poklica, ki je za to upravičen, s tem, da bo oblikovala evropsko predlogo za čezmejne zdravniške recepte in podprla medobratovalnost receptov ;
(a) measures enabling a pharmacist or other 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 single EU cross-border prescription template and supporting interoperability of prescriptions;
(b) smernice za podporo državam članicam pri razvoju interoperabilnosti E -receptov;
(b) guidelines supporting the Member States in developing the interoperability of ePrescriptions;
(b) smernice za podporo državam članicam pri razvoju medobratovalnosti e -receptov;
(b) guidelines supporting the Member States in developing the interoperability of ePrescriptions;
(c) najpozneje do … 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.
(c) no later than ….* 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.
Komisija bo med drugim preučila uporabo mednarodnega nelastniškega imena in odmerjanje zdravil;
The Commission shall consider, inter alia , using the International Non-proprietary Name and the dosage of medicinal products;
(c) 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.
(c) 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.
(d) najpozneje do …* ukrepe za olajšanje razumevanja informacij za paciente v zvezi z receptom in navodili za uporabo zdravila ali medicinskega pripomočka;
(d) no later than …* measures to facilitate the comprehensibility of the information to patients concerning the prescription, and the instructions included therein, on the use of the medicinal products or medical devices.
(d) ukrepe za olajšanje razumevanja informacij za paciente v zvezi z receptom in navodili za uporabo zdravila ali medicinskega pripomočka , vključno z jasnostjo glede različnih poimenovanj istega zdravila ali medicinskega pripomočka ;
(d) measures to facilitate the comprehensibility of the information to patients concerning the prescription, and the instructions included therein, on the use of the medicinal products or medical devices , including clarity as to different names used for the same medicinal product or medical device ;
(Stališče EP– člen 16(2) točki (a) in (b))
(EP position Article 16(2) points (a) and (b))
PS 101 iz prve obravnave
am 101 of first reading
Člen 11 – odstavek 2 – točka d a (novo)
Article 11 – paragraph 2 – point d a (new)
(da) ukrepe, da se po potrebi zagotovi povezava med osebo, ki je izdelek predpisala, in osebo, ki ga je izdala, da se zagotovi popolna informacija o zdravljenju, ob čemer mora biti zagotovljena zaupnost pacientovih podatkov.
(d a ) measures to ensure, if needed, contact between the prescribing party and the dispensing party in order to ensure complete understanding of the treatment, whilst maintaining confidentiality of patient s' data .
(Stališče EP– člen 16(2)(d))
(EP position Article 16(2)(d))
Ukrepi in smernice iz točk (a) do (d) odstavka 2 se sprejmejo v skladu z regulativnim postopkom iz člena 15(2).
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 15(2).
Ukrepi iz točk (a) do (da) odstavka 2 se sprejmejo v skladu z regulativnim postopkom iz člena 15(2).
The measures referred to in points (a) to (da ) of paragraph 2 shall be adopted in accordance with the regulatory procedure referred to in Article 15(2).
Člen 11 – odstavek 5 – pododstavek 1 a (novo)
Article 11 – paragraph 5 – subparagraph 1 a(new)
Kadar se v državi članici zdravljenja izda recept za zdravila ali medicinske pripomočke, ki v državi članici pacientovega zdravstvenega zavarovanja običajno niso na voljo na recept, se slednja odloči, ali zdravilo izjemoma odobri ali zagotovi alternativno zdravilo, za katerega meni, da pri zdravljenju enako učinkuje.
However, where a prescription is issued in the Member State of treatment for medicinal products or medical devices which are not normally available on prescription in the Member State of affiliation, it shall be for the latter to decide whether to authorise exceptionally or to provide an alternative medicinal product deemed to have the same therapeutic effect.
(Stališče EP– člen 9(3))
(EP position Article 9(3))
Komisija podpira države članice pri razvoju evropskih referenčnih mrež med izvajalci zdravstvenega varstva in strokovnimi centri v državah članicah.
The Commission shall support Member States in the development of European reference networks between healthcare providers and centres of expertise in the Member States.
Mreže temeljijo na prostovoljnem sodelovanju njihovih članov, ki v skladu z zakonodajo države članice, v kateri imajo člani svoj sedež, sodelujejo pri dejavnostih mrež ter prispevajo k njim .
The networks shall be based on the voluntary participation of their members, which shall participate and contribute to the networks' activities in accordance with the legislation of the Member State where the members are established.
Komisija podpira države članice pri razvoju evropskih referenčnih mrež med izvajalci zdravstvenega varstva in strokovnimi centri v državah članicah , zlasti s področja redkih bolezni, ki uporabljajo izkušnje, pridobljene pri sodelovanju na področju zdravstvenega varstva v evropskih združenjih za teritorialno sodelovanje .
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, which shall draw on the health cooperation experience acquired within the European groupings of territorial cooperation (EGTCs) .
Navedene mreže so vedno odprte za nove izvajalce storitev zdravstvenega varstva, ki se jim želijo pridružiti, pod pogojem, da izpolnjujejo vse zahtevane pogoje in merila.
Those networks 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.
(Stališče EP– člen 17(1))
(EP position Article 17(1))
Predlog spremembe 102 iz prve obravnave.
1st reading - AM 102
Cilj evropskih referenčnih mrež je pomagati :
The aim of European reference networks shall be to help :