natgillin/translations-raw huggingface dataset:
Direktiva 2005/36/ES o priznavanju poklicnih kvalifikacij določa, da svoboda izvajanja začasnih ali priložnostnih storitev v drugi državi članici, vključno s storitvami zdravstvenih delavcev, v skladu s posebnimi določbami zakonodaje Skupnosti ne sme biti omejena iz nobenega razloga, povezanega s poklicnimi kvalifikacijami.
Directive 2005/36/EC on the recognition of professional qualifications stipulates that free provision of services of a temporary or occasional nature, including services provided by health professionals, in another Member State should not, subject to specific provisions of Community law, be restricted for any reason relating to professional qualifications.
Ta direktiva ne sme posegati v navedene določbe Direktive 2005/36/ES.
This Directive should be without prejudice to those provisions of Directive 2005/36/EC.
(37) Da se zagotovi varna, visokokakovostna in učinkovita čezmejna oskrba, morajo sodelovati izvajalci, kupci in regulativni organi iz različnih držav članic na nacionalni, regionalni ali lokalni ravni.
(37) Cooperation is required between providers, purchasers and regulators of different Member States at national, regional or local level in order to ensure safe, high quality and efficient care across borders.
To zlasti velja za sodelovanje na obmejnih območjih, na katerih je izvajanje zdravstvenega varstva morda najučinkovitejši način organiziranja zdravstvenega varstva za lokalne prebivalce, vendar doseganje trajnostnega čezmejnega izvajanja zdravstvenega varstva zahteva sodelovanje med zdravstvenimi sistemi različnih držav članic.
This is particularly the case for cooperation in border regions, where cross-border provision of healthcare may be the most efficient way of organising healthcare for the local populations, but where achieving such cross-border provision on a sustained basis requires cooperation between the health systems of different Member States.
Odveč je omenjati notranji trg čezmejnega zdravstvenega varstva, saj ta direktiva zadeva vse vrste oskrbe.
As this Directive concerns all forms of care, it is illusory to mention an internal market for cross-border healthcare.
Ta del se prenese v novo uvodno izjavo 37a, da se natančneje opredeli.
The part is moved to a new Recital 37 a, where it is to be formulated more precisely.
(39) Kadar so medicinski izdelki odobreni znotraj pacientove države članice v skladu z Direktivo 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini ter so predpisani v drugi državi članici za posameznega, po imenu navedenega pacienta, mora biti za takšne zdravniške recepte načeloma možno, da so priznani in da uporabljajo v pacientovi državi članici.
(39) Where medicinal products are authorised within the patient's Member State in accordance with Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use and have been prescribed in another Member State for an individual named patient, it should be in principle possible for such prescriptions to be medically recognised and used in the patient's own Member State.
Odstranitev regulativnih in upravnih ovir za priznavanje zdravniških receptov ne posega v potrebo po ustreznem soglasju pacientovega lečečega zdravnika ali farmacevta v vsakem posameznem primeru, če je to upravičeno z zaščito zdravja ljudi in je nujno in sorazmerno za dosego navedenega cilja.
The removal of regulatory and administrative barriers to such recognition is without prejudice to the need for appropriate agreement of the patients' 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.
Takšno priznavanje zdravniških receptov prav tako ne sme posegati v odločitev države članice pacientovega zdravstvenega zavarovanja v zvezi z vključitvijo takšnih medicinskih izdelkov v storitve, ki jih krije sistem socialne varnosti, v katerega je vključen pacient.
Such medical recognition should also be without prejudice to the decision of the Member State of affiliation regarding the inclusion of such medicinal products within the benefits covered by the social security system of affiliation.
Izvajanje načela priznavanja bo olajšalo sprejetje ukrepov, potrebnih za zaščito varnosti pacienta ter odpravo napačne uporabe ali zamenjave medicinskih izdelkov.
The implementation of the principle of recognition will be facilitated by the adoption of measures necessary for safeguarding the safety of a patient, and avoiding the misuse or confusion of medicinal products.
(39) Kadar so medicinski izdelki odobreni znotraj pacientove države članice v skladu z Direktivo 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini , vključno s prihodnjo o zakonodajo o ponarejenih zdravilih (direktiva XXXX/XX/ES) in farmakovigilanci (direktiva XXXX/XX/ES), ter so predpisani v drugi državi članici za posameznega, po imenu navedenega pacienta, mora biti za takšne zdravniške recepte načeloma možno, da so priznani in da se uporabljajo v lekarnah v pacientovi državi članici.
(39) Where medicinal products are authorised within the patient's Member State in accordance with Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, including the future legislation on falsified medicinal products (Directive XXXX/XX/EC) and pharmacovigilance (Directive ZZZZ/ZZ/EC), and have been prescribed in another Member State for an individual named patient, it should be in principle possible for such prescriptions to be recognised medically or in pharmacies and used in the patient's own Member State.
Odprava regulativnih in upravnih ovir za priznavanje zdravniških receptov ne posega v potrebo po ustreznem soglasju pacientovega lečečega zdravnika ali farmacevta v vsakem posameznem primeru, če je to upravičeno z zaščito zdravja ljudi in je nujno in sorazmerno za dosego navedenega cilja.
The removal of regulatory and administrative barriers to such recognition is without prejudice to the need for appropriate agreement of the patients' 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.
Takšno priznavanje zdravniških receptov prav tako ne sme posegati v odločitev države članice pacientovega zdravstvenega zavarovanja v zvezi z vključitvijo takšnih medicinskih izdelkov v storitve, ki jih krije sistem socialne varnosti, v katerega je vključen pacient , in brez poseganja v veljavnost nacionalnih pravil glede cen in plačevanja .
Such medical recognition should also be without prejudice to the decision of the Member State of affiliation regarding the inclusion of such medicinal products within the benefits covered by the social security system of affiliation and without prejudice to the validity of national pricing and payment rules .
(41a) Medobratovalnost e-zdravstvenih storitev se mora izvajati ob spoštovanju nacionalnih predpisov o zagotavljanju zdravstvenih storitev, ki so bili sprejeti za zaščito pacientov, vključno z zakonodajo o internetnih lekarnah, zlasti pa z nacionalnimi prepovedmi poštnega pošiljanja medicinskih izdelkov, ki se izdajajo na recept, v skladu s sodno prakso Sodišča Evropskih skupnosti in Direktivo 97/7/ES o varstvu potrošnikov glede sklepanja pogodb pri prodaji na daljavo 1 .
(41a) The interoperability of e-health solutions should be achieved whilst respecting national regulations on the provision of health 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 in accordance with the case-law of the European Court of Justice and Directive 97/7/EC of the European Parliament and of the Council of 20 May 2007 on the protection of consumers in respect of distance contracts 1 .
V skladu s sodno prakso Sodišča Evropskih skupnosti (sodba z dne 11. decembra 2003 v zadevi C-322/01, Deutscher Apothekerverband) in členom 14 direktive o prodaji na daljavo (97/7/ES) je treba poudariti, da ta direktiva ne posega v možnost uvedbe prepovedi na pošiljanje medicinskih izdelkov, ki se izdajajo na recept, po pošti, saj to pomeni nevarnost za javno zdravje.
In line with the case-law of the European Court of Justice (judgment of 11 December 2003, C-322/01, Deutscher Apothekerverband) and Article 14 of the Distance Selling Directive (97/7/EC), it should be made clear that this directive does not affect the permissibility of bans on mail order of prescription-only medicinal products on the grounds of dangers to public health.
(43) Stalni napredek medicine in zdravstvene tehnologije prinaša priložnosti in izzive za zdravstvene sisteme držav članic.
(43) The constant progress of medical science and health technologies presents both opportunities and challenges to the health systems of the Member States.
Sodelovanje pri ocenjevanju nove zdravstvene tehnologije lahko države članice podpira prek ekonomij obsega in z izogibanjem podvajanja prizadevanj, poleg tega pa lahko zagotovi boljšo podlago podatkov za najboljšo možno uporabo nove tehnologije, da se zagotovi varno, visoko kakovostno in učinkovito zdravstveno varstvo.
Cooperation in the evaluation of new health technologies can support Member States through economies of scale and avoiding duplication of effort, and provide a better basis of evidence for optimal use of new technologies to ensure safe, high-quality and efficient healthcare.
To bo prav tako prispevalo k notranjemu trgu z največjim možnim pospeševanjem in širjenjem obsega inovacij na področju medicine in zdravstvene tehnologije.
This will also contribute to the internal market by maximising the speed and scale of diffusion of innovations in medical science and health technologies.
Takšno sodelovanje zahteva trajnostne strukture, ki vključujejo vse pomembne organe vseh držav članic, za nadgrajevanje obstoječih pilotnih projektov.
Such cooperation requires sustained structures involving all the relevant authorities of all the Member States, building on existing pilot projects.
Kljub temu se zaradi ocenjevanja zdravstvene tehnologije in možne omejitve dostopa do novih tehnologij, ki bi bila lahko posledica nekaterih odločitev upravnih organov, postavljajo nekatera bistvena družbena vprašanja, ki bi jih bilo treba reševati s sodelovanjem številnih akterjev ter z vzpostavitvijo modela trajnega upravljanja.
However, the assessment of health technologies and the possible restriction of access to new technologies by certain decisions by administrative bodies raise a number of fundamental social issues which require contributions from a wide range of stakeholders and the establishment of a viable governance model.
Zato morajo pri tem sodelovati pristojni organi vseh držav članic, pa tudi vsi zadevni akterji, vključno z zdravstvenimi delavci, predstavniki pacientov in industrijo.
Accordingly any cooperation should involve not only the competent authorities of all the Member States but also all the stakeholders concerned, including health professionals and representatives of patients and industry.
Poleg tega mora to sodelovanje temeljiti na trajnostnih načelih dobrega upravljanja, kot so preglednost, odprtost, objektivnost in nepristranskost v postopkih.
Moreover, this cooperation should be based on viable principles of good governance such as transparency, openness, objectivity and the impartiality of procedures.
Izmenjava informacij med organi za ocenjevanje zdravstvene tehnologije določa in zahteva, da se pri ocenjevanju, ki ga opravljajo države članice, uporabljajo načela dobre prakse (na primer dobro upravljanje, preglednost in sodelovanje zadevnih akterjev).
Exchanges of information between health technology assessment bodies presuppose and require the application of good practice principles (for example good governance, transparency and participation by stakeholders) in the assessments performed by Member States.
Zato mora ocenjevanje zdravstvene tehnologije izpolnjevati merila odprtosti in objektivnosti ter temeljiti na dialogu in vključenosti zadevnih akterjev, med drugim tudi pacientov in industrije.
Health technology assessments must therefore meet criteria regarding openness and objectivity and be based on dialogue and the involvement of stakeholders, including patients and representatives of industry.
(45) Komisiji je zlasti treba podeliti pooblastila, da sprejme naslednje ukrepe, in sicer seznam zdravljenj, razen tistih, ki zahtevajo prenočitev pacienta, za katere velja enak režim kot za bolnišnično oskrbo; spremljevalne ukrepe za izključitev posebnih kategorij medicinskih izdelkov ali snovi iz obsega priznavanja zdravniških receptov, izdanih v drugi državi članici, ki ga določa ta direktiva; seznam posebnih meril in pogojev, ki jih morajo izpolnjevati evropske referenčne mreže, postopek za vzpostavitev evropskih referenčnih mrež.
(45) In particular, power should be conferred on the Commission to adopt the following measures: a list of treatments, other than those requiring overnight accommodation, to be subject to the same regime as hospital care; accompanying measures to exclude specific categories of medicinal products or substances from the recognition of prescriptions issued in another Member State provided for in this Directive; a list of specific criteria and conditions that European reference networks must fulfil; the procedure for establishing European reference networks.
Navedeni ukrepi so splošnejše narave in so namenjeni spremembi nebistvenih elementov te direktive ali nadomestitvi te direktive z dodajanjem novih nebistvenih elementov, zato jih je treba sprejeti v skladu z regulativnim postopkom s pregledom, določenim v členu 5a Sklepa 1999/468/ES.
Since those measures are of general scope and are designed to amend non-essential elements of this Directive, or to supplement this Directive by the addition of new non-essential elements, they should be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
Ta predlog spremembe je prilagoditev na predlogane spremembe členov 8 in 15 iste avtorice.
This amendment corresponds to the amendment by the same author to Article 8 and Article 15.
(46a) Država članica pacientovega zdravstvenega zavarovanja in država članica zdravljenja morata ob predhodnem dvostranskem sodelovanju in v posvetovanju s pacientom zagotoviti, da bosta po odobrenem zdravljenju na voljo ustrezna nadaljnja oskrba in pomoč v kateri koli od obeh držav članic in da bodo pacienti imeli dostop do jasnih informacij o možnostih in stroških nadaljnje oskrbe.
(46a) The Member State of affiliation and the Member State of treatment should by prior bilateral cooperation and in consultation with the patient ensure that appropriate aftercare and support is made available in either Member State following the authorised medical treatment and that clear information is available to patients about aftercare options and costs.
V ta namen morajo države članice sprejeti ukrepe, da zagotovijo:
To do this, Member States should adopt measures to ensure that:
(a) prenos potrebnih zdravstvenih in socialnovarstvenih podatkov ob upoštevanju zaupnosti do pacienta; and
(a) the necessary medical and social care data is transferred with due regard to patient confidentiality; and
(b) možnost, da se delavci v zdravstvu in socialnem varstvu v obeh državah med seboj posvetujejo in pacientu zagotovijo najkakovostnejše zdravljenje in nadaljnjo oskrbo (vključno s socialno podporo).
(b) medical and social care professionals in both countries are able to consult each other to ensure the highest quality treatment and aftercare (including social support) for the patient.
Tak učinek direktive bi pomenil pozitiven prispevek k sistemom zdravstvenega varstva v državah članicah, vendar je treba njene rezultate pozorno spremljati.
When the Directive has this as an outcome it would have a positive contribution to the healthcare systems in the Member States, but careful monitoring is needed to check the results of the Directive.
Ta direktiva določa splošen okvir za zagotavljanje varnega, visoko kakovostnega in učinkovitega čezmejnega zdravstvenega varstva .
This Directive establishes a general framework for the provision of safe, high quality and efficient cross-border healthcare.
Ta direktiva določa pravila za dostop do varnega in visokokakovostnega zdravstvenega varstva v drugi državi članici in vzpostavlja mehanizme sodelovanja na področju zdravstvenega varstva med državami članicami ter povsem upošteva nacionalne pristojnosti pri organiziranju in izvajanju zdravstvenega varstva .
This Directive lays down rules for access to safe and high-quality healthcare in another Member State and establishes cooperation mechanisms on healthcare between Member States, whilst full y respect ing national competencies in the organisation and deliver y of healthcare.
Države članice pri uporabi te direktive upoštevajo načeli visokokakovostne oskrbe in enakosti.
In the application of this Directive, Member States shall take into account the principles of good quality care and equity.
Ta direktiva se uporablja za izvajanje zdravstvenega varstva, ne glede na to, kako je organizirano, zagotovljeno in financirano oz. ali je javno ali zasebno.
This Directive shall apply to provision of healthcare regardless of how it is organised, delivered and financed or whether it is public or private.
Ta direktiva se uporablja za izvajanje čezmejnega zdravstvenega varstva, ne glede na to, kako je organizirano, zagotovljeno in financirano oziroma ali je javno ali zasebno.
This Directive shall apply to provision of cross-border healthcare regardless of how it is organised, delivered and financed or whether it is public or private.
Uporablja se brez poseganja veljavni okvir sodelovanja med sistemi socialne varnosti, kot je določen v Uredbi (EGS) št. 1408/71 in Uredbi št. 883/2004, ki jo je nasledila.
It shall be without prejudice to the existing framework on the coordination of social security systems as laid down in Regulation (EEC) No 1408/71 and its successor Regulation (EC) No 883/2004 .
Ta direktiva se ne uporablja za zdravstvene storitve, ki so pretežno usmerjene v dolgoročno zdravljenje, zlasti storitve, ki se izvajajo skozi daljše časovno obdobje in katerih namen je podpora ljudem, ki potrebujejo pomoč pri opravljanju vsakodnevnih rutinskih opravil.
This Directive shall not apply to health services whose main focus is in the field of long-term care, including services provided over an extended period of time whose purpose is to support people in need of assistance in carrying out routine, everyday tasks.
Ta direktiva se tudi ne uporablja za presaditve organov.
This Directive shall also not apply to organ transplantation.
Člen 3 – odstavek 1 – točki - a a in - a b (novo)
Article 3 - paragraph 1 - points - a a and - a b (new)
(-aa) Direktivo 2005/36/ES o priznavanju poklicnih kvalifikacij;
(-aa) Directive 2005/36/EC on the recognition of professional qualifications;
(-ab) 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;
(-ab) 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;
Člen 3 – odstavek 1 – točka (g a) (novo)
Article 3 - paragraph 1 - point g a (new)
(ga ) Direktivo 2002/98/ES Evropskega parlamenta in Sveta z dne 27. januarja 2003 o določitvi standardov kakovosti in varnosti za zbiranje, preskušanje, predelavo, shranjevanje in razdeljevanje človeške krvi in komponent krvi ter o spremembi Direktive 2001/83/ES;
(ga ) Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC;
Člen 3 – odstavek 1 – točka g b (novo)
Article 3 - paragraph 1 - point g b (new)
(gb) Direktivo 2004/23/ES Evropskega parlamenta in Sveta z dne 31. marca 2004 o določitvi standardov kakovosti in varnosti, darovanja, pridobivanja, testiranja, predelave, konzerviranja, shranjevanja in razdeljevanja človeških tkiv in celic;
(gb) Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells;
Člen 3 – odstavek 1 – točka g c (novo)
Article 3 - paragraph 1 - point g c (new)
(gc) Direktivo 92/49/EGS o uskladitvi zakonov in drugih predpisov o neposrednem zavarovanju razen življenjskega zavarovanja, kar zadeva Komisiji podeljena izvedbena pooblastila;
(gc) Directive 92/49/EEC on the coordination of laws, regulations and administrative provisions relating to direct insurance other than life assurance, as regards the implementing powers conferred on the Commission;
V okoliščinah, v katerih je treba odobriti zahtevek za odobritev ustreznega zdravljenja v drugi državi članici v skladu s členom 22 Uredbe (EGS) št. 1408/71, se uporabljajo določbe navedene uredbe, določbe iz členov 6, 7, 8 in 9 te direktive pa se ne uporabljajo.
When the circumstances under which an authorisation to go to another Member State in order to receive appropriate treatment under Article 22 of Regulation (EC) No 1408/71 must be granted are met, the provisions of that Regulation shall apply and the provisions of Articles 6, 7, 8 and 9 of this Directive shall not apply.
V nasprotnem primeru, kadar zavarovana oseba išče zdravstveno varstvo v drugi državi članici v drugačnih okoliščinah, se uporabljajo členi 6, 7, 8 in 9 te direktive, člen 22 Uredbe Sveta (EGS) št. 1408/71 pa se ne uporablja.
Conversely, when an insured person seeks healthcare in another Member State in other circumstances, Articles 6, 7, 8 and 9 of this Directive apply and Article 22 of Council Regulation (EC) No 1408/71 shall not apply.
Kadar pa so izpolnjeni pogoji za odobritev zahtevka iz člena 22(2) Uredbe (EGS) št. 1408/71, se zahtevek odobri in storitve izvedejo v skladu z navedeno uredbo.
However, whenever the conditions for granting an authorisation set out in Article 22(2) of Regulation (EC) No 1408/71 are fulfilled, the authorisation shall be accorded and the benefits provided in accordance with that Regulation .
V nasprotnem primeru, kadar zavarovana oseba išče zdravstveno varstvo v drugi državi članici v drugačnih okoliščinah, tudi kadar so izpolnjeni pogoji za odobritev zahtevka iz Uredbe (EGS) št. 1408/71 in Uredbe (ES) št. 883/2004 od dneva začetka njene uporabe, zahtevek pa ni odobren, se uporabljajo členi 6, 7, 8 in 9 te direktive, člen 22 Uredbe Sveta (ES) št. 1408/71 pa se ne uporablja.
Conversely, when an insured person seeks healthcare in another Member State in other circumstances, including when the conditions for granting an authorisation under Regulation (EEC) No 1408/71 and, from its date of application, Regulation (EC) No 883/2004 are fulfilled but the authorisation is not granted, Articles 6, 7, 8 and 9 of this Directive shall apply and Article 22 of Council Regulation (EC) No 1408/71 shall not apply.
Če so določbe te direktive v nasprotju z določbo drugega akta Skupnosti, ki ureja posebne vidike zdravstvenega varstva, veljajo določbe drugega akta Skupnosti in se uporabljajo za zadevne posebne situacije.
If the provisions of this Directive conflict with a provision of another Community act governing specific aspects of healthcare, the provision of the other Community act shall prevail and shall apply to those specific situations concerned.
Ti akti vključujejo:
These include:
(a) Direktivo 2005/36/ES o priznavanju poklicnih kvalifikacij;
(a) Directive 2005/36/EC on the recognition of professional qualifications;