natgillin/translations-raw huggingface dataset:
offer a high level of expertise and have the capacity to produce good practice guidelines and to implement outcome measures and quality control;
nudijo visoko raven strokovnega znanja in imajo zmogljivosti za oblikovanje smernic za dobro prakso ter izvajanje merjenja izidov in nadzorovanja kakovosti;
make a contribution to research;
prispevajo k raziskavam;
organise teaching and training activities; and
organizirajo izobraževalne dejavnosti in usposabljanja; in
collaborate closely with other centres of expertise and networks at national and international level;
tesno sodelujejo z drugimi strokovnimi centri in mrežami na nacionalni in mednarodni ravni;
develop and publish criteria for establishing and evaluating European reference networks;
oblikuje in objavi merila za ustanavljanje in ocenjevanje evropskih referenčnih mrež;
facilitate the exchange of information and expertise in relation to the establishment of European reference networks and their evaluation.
olajša izmenjavo informacij in strokovnega znanja v zvezi z vzpostavitvijo mrež in njihovo oceno.
The Commission shall adopt the measures referred to in paragraph 4(a) by means of delegated acts in accordance with Article 17 and subject to the conditions of Articles 18 and 19.
Komisija sprejme ukrepe iz točke (a) odstavka 4 z delegiranimi akti v skladu s členom 17 in pod pogoji iz členov 18 in 19.
The measures referred to in points (b) and (c) of paragraph 4 shall be adopted in accordance with the regulatory procedure referred to in Article 16(2).
Ukrepi iz točk (b) in (c) odstavka 4 se sprejmejo v skladu z regulativnim postopkom iz člena 16(2).
Measures adopted pursuant to this Article shall not harmonise any laws or regulations of the Member States and shall fully respect the responsibilities of the Member States for the organisation and delivery of health services and medical care.
Z ukrepi, sprejetimi v skladu s tem členom, se ne usklajujejo zakoni ali predpisi držav članic in se v celoti spoštujejo odgovornosti držav članic pri organizaciji in opravljanju zdravstvenih storitev in zdravstvene oskrbe.
The Commission shall support Member States in cooperating in the development of diagnosis and treatment capacity in particular by aiming to:
Komisija podpira države članice, ki sodelujejo pri razvoju zmogljivosti za diagnosticiranje in zdravljenje, zlasti s ciljem:
make health professionals aware of the tools available to them at Union level to assist them in the correct diagnosis of rare diseases, in particular the Orphanet database, and the European reference networks;
obvestiti zdravstvene delavce o orodjih, ki so jim na voljo na ravni Unije za pomoč pri pravilnem diagnosticiranju redkih bolezni, zlasti o zbirki podatkov Orphanet in evropskih referenčnih mrežah;
make patients, health professionals and those bodies responsible for the funding of healthcare aware of the possibilities offered by Regulation (EC) No 883/2004 for referral of patients with rare diseases to other Member States even for diagnosis and treatments which are not available in the Member State of affiliation.
obvestiti paciente, zdravstvene delavce in tiste organe, ki so odgovorni za financiranje zdravstvenega varstva o možnostih, ki jih nudi Uredba (ES) št. 883/2004 za pošiljanje pacientov z redkimi boleznimi v druge države članice, tudi za diagnosticiranja in zdravljenja, ki niso na voljo v državi članici zdravstvenega zavarovanja.
The Union shall support and facilitate cooperation and the exchange of information among Member States working within a voluntary network connecting national authorities responsible for eHealth designated by the Member States.
Unija podpira in olajšuje sodelovanje in izmenjavo informacij med državami članicami v okviru prostovoljne mreže, ki povezuje nacionalne organe, pristojne za e-zdravje, ki jih imenujejo države članice.
The objectives of the eHealth network shall be to:
Cilji mreže e-zdravje so:
work towards delivering sustainable economic and social benefits of European eHealth systems and services and interoperable applications, with a view to achieving a high level of trust and security, enhancing continuity of care and ensuring access to safe and high-quality healthcare;
doseči trajnostne gospodarske in družbene koristi evropskih sistemov in storitev ter interoperabilnih aplikacij e-zdravje, z namenom, da se doseže visoka raven zaupanja in varnosti, izboljša stalnost oskrbe ter zagotovi dostop do varnega in visokokakovostnega zdravstvenega varstva;
draw up guidelines on:
pripraviti smernice za:
a non-exhaustive list of data that are to be included in patients’ summaries and that can be shared between health professionals to enable continuity of care and patient safety across borders; and
neizčrpen seznam podatkov, ki se vključijo v povzetke o pacientih in ki se lahko izmenjujejo med zdravstvenimi delavci, da bi tako zagotovili neprekinjenost oskrbe in varnost pacientov preko meja; ter
effective methods for enabling the use of medical information for public health and research;
učinkovite metode, s katerimi se omogoči uporaba zdravstvenih informacij za javno zdravje in raziskave;
support Member States in developing common identification and authentication measures to facilitate transferability of data in cross-border healthcare.
podpira države članice pri oblikovanju skupnih ukrepov za identifikacijo in ugotavljanje avtentičnosti, na podlagi katerih se olajša prenosljivost podatkov v čezmejnem zdravstvenem varstvu.
The objectives referred to in points (b) and (c) shall be pursued in due observance of the principles of data protection as set out, in particular, in Directives 95/46/EC and 2002/58/EC.
Pri zasledovanju ciljev iz točk (b) in (c) je treba ustrezno upoštevati načela varstva podatkov, kakor so določena zlasti v direktivah 95/46/ES in 2002/58/ES.
The Commission shall, in accordance with the regulatory procedure referred to in Article 16(2), adopt the necessary measures for the establishment, management and transparent functioning of this network.
Komisija v skladu z regulativnim postopkom iz člena 16(2) sprejme potrebne ukrepe za vzpostavitev, upravljanje in pregledno delovanje te mreže.
Cooperation on health technology assessment
Sodelovanje pri ocenjevanju zdravstvene tehnologije
The Union shall support and facilitate cooperation and the exchange of scientific information among Member States within a voluntary network connecting national authorities or bodies responsible for health technology assessment designated by the Member States.
Unija podpira in olajšuje sodelovanje in izmenjavo znanstvenih informacij med državami članicami v okviru prostovoljne mreže, ki povezuje nacionalne organe ali telesa, pristojne za ocenjevanje zdravstvene tehnologije, ki jih imenujejo države članice.
The Member States shall communicate their names and contact details to the Commission.
Države članice njihova imena in kontaktne podatke posredujejo Komisiji.
The members of such a health technology assessment network shall participate in, and contribute to, the network’s activities in accordance with the legislation of the Member State where they are established.
Člani takšne mreže za ocenjevanje zdravstvene tehnologije sodelujejo pri dejavnostih mreže ter prispevajo k njim v skladu z zakonodajo države članice, v kateri imajo svoj sedež.
That network shall be based on the principle of good governance including transparency, objectivity, independence of expertise, fairness of procedure and appropriate stakeholder consultations.
Ta mreža temelji na načelih dobrega upravljanja, vključno s preglednostjo, objektivnostjo, strokovno neodvisnostjo, poštenimi postopki in ustreznim posvetovanjem z zainteresiranimi stranmi.
The objectives of the health technology assessment network shall be to:
Cilji mreže za ocenjevanje zdravstvene tehnologije so:
support cooperation between national authorities or bodies;
podpora sodelovanju med nacionalnimi organi ali telesi;
support Member States in the provision of objective, reliable, timely, transparent, comparable and transferable information on the relative efficacy as well as on the short- and long-term effectiveness, when applicable, of health technologies and to enable an effective exchange of this information between the national authorities or bodies;
podpora državam članicam pri zagotavljanju objektivnih, zanesljivih, pravočasnih, preglednih, primerljivih in prenosljivih informacij o sorazmerni učinkovitosti in, ko je to potrebno, o kratko- in dolgoročni učinkovitosti zdravstvenih tehnologij ter omogočanje učinkovite izmenjave teh informacij med nacionalnimi organi ali telesi;
support the analysis of the nature and type of information that can be exchanged;
podpirati preučevanje narave in vrste informacij, ki se lahko izmenjujejo;
avoid duplication of assessments.
preprečevati podvajanje ocenjevanja.
In order to fulfil the objectives set out in paragraph 2, the network on health technology assessment may receive Union aid.
Za izpolnitev ciljev iz odstavka 2 lahko mreža za ocenjevanje zdravstvene tehnologije prejme pomoč Unije.
Aid may be granted in order to:
Pomoč se lahko dodeli za namene:
contribute to the financing of administrative and technical support;
prispevanja k financiranju upravne in tehnične pomoči;
support collaboration between Member States in developing and sharing methodologies for health technology assessment including relative effectiveness assessment;
podpore sodelovanju med državami članicami pri razvoju in izmenjavi metod ocenjevanja zdravstvene tehnologije, vključno z ocenjevanjem relativne učinkovitosti;
contribute to the financing of the provision of transferable scientific information for use in national reporting and case studies commissioned by the network;
prispevanja k financiranju zagotavljanja prenosljivih znanstvenih informacij za uporabo v okviru nacionalnega poročanja in študij primerov, ki jih naroči mreža;
facilitate cooperation between the network and other relevant institutions and bodies of the Union;
olajšanja sodelovanja med mrežo ter drugimi ustreznimi institucijami in organi Unije;
facilitate the consultation of stakeholders on the work of the network.
olajšanja posvetovanja zainteresiranih strani o delu mreže.
Arrangements for granting the aid, the conditions to which it may be subject and the amount of the aid, shall be adopted in accordance with the regulatory procedure referred to in Article 16(2).
Ureditev dodeljevanja pomoči, morebitni pogoji ter višina pomoči se določijo v skladu z regulativnim postopkom iz člena 16(2).
Only those authorities and bodies in the network designated as beneficiaries by the participating Member States shall be eligible for Union aid.
Do pomoči Unije so upravičeni samo organi in telesa, udeleženi v mreži, ki so jih za upravičence določile sodelujoče države članice.
The appropriations required for measures provided for in this Article shall be decided each year as part of the budgetary procedure.
Sredstva, potrebna za ukrepe iz tega člena, se določijo vsako leto v okviru proračunskega postopka.
Measures adopted pursuant to this Article shall not interfere with Member States’ competences in deciding on the implementation of health technology assessment conclusions and shall not harmonise any laws or regulations of the Member States and shall fully respect the responsibilities of the Member States for the organisation and delivery of health services and medical care.
Ukrepi, sprejeti v skladu s tem členom, ne vplivajo na pristojnosti držav članic za odločitve o izvajanju ugotovitev ocenjevanja zdravstvene tehnologije, z njimi se tudi ne usklajujejo zakoni ali predpisi držav članic in se v celoti upoštevajo pristojnosti držav članic pri organizaciji in izvajanju zdravstvenih storitev in zdravstvene oskrbe.
The Commission shall be assisted by a Committee, consisting of representatives of the Member States and chaired by the Commission representative.
Komisiji pomaga odbor, ki ga sestavljajo predstavniki držav članic in ki mu predseduje predstavnik Komisije.
The delegation of powers shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 18.
Prenos pooblastila se samodejno podaljša za enako obdobje, razen če Evropski parlament ali Svet pooblastilo prekliče v skladu s členom 18.
The powers to adopt delegated acts are conferred on the Commission subject to the conditions laid down in Articles 18 and 19.
Pooblastilo za sprejemanje delegiranih aktov je preneseno na Komisijo pod pogoji, določenimi v členih 18 in 19.
The delegation of power referred to in Articles 11(5) and 12(5) may be revoked at any time by the European Parliament or by the Council.
Pooblastilo iz členov 11(5) in 12(5) lahko kadar koli prekliče Evropski parlament ali Svet.
The institution which has commenced an internal procedure for deciding whether to revoke the delegation of power shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated powers which could be subject to revocation and possible reasons for a revocation.
Institucija, ki je začela notranji postopek za odločitev o morebitnem preklicu pooblastila, si prizadeva o tem obvestiti drugo institucijo in Komisijo v razumnem roku pred sprejetjem končne odločitve ter pri tem navede pooblastila, ki bi se lahko preklicala, in možne razloge za preklic.
The European Parliament or the Council may object to the delegated act within a period of 2 months from the date of notification.
1. Evropski parlament ali Svet lahko nasprotuje delegiranemu aktu v dveh mesecih od datuma uradnega obvestila.
If the European Parliament or the Council objects to a delegated act within the period referred to in paragraph 1, it shall not enter into force.
Če Evropski parlament ali Svet nasprotuje delegiranemu aktu v roku iz odstavka 1, akt ne začne veljati.
The Commission shall by 25 October 2015 and subsequently every 3 years thereafter, draw up a report on the operation of this Directive and submit it to the European Parliament and to the Council.
Komisija do 25. oktobra 2015, nato pa vsaka tri leta, pripravi poročilo o izvajanju te direktive ter ga predloži Evropskemu parlamentu in Svetu.
The report shall in particular include information on patient flows, financial dimensions of patient mobility, the implementation of Article 7(9) and Article 8, and on the functioning of the European reference networks and national contact points.
Poročilo vsebuje zlasti informacije o pretokih pacientov, finančnih vidikih mobilnosti pacientov, izvajanju člena 7(9) in člena 8 in delovanju evropskih referenčnih mrež in nacionalnih kontaktnih točk.
To this end, the Commission shall conduct an assessment of the systems and practices put in place in the Member States, in the light of the requirements of this Directive and the other Union legislation relating to patient mobility.
V ta namen Komisija oceni sisteme in prakso, uveljavljene v državah članicah, z vidika zahtev te direktive in druge zakonodaje Unije o mobilnosti pacientov.
The Member States shall provide the Commission with assistance and all available information for carrying out the assessment and preparing the reports.
Države članice zagotavljajo Komisiji podporo in vse razpoložljive informacije za ocenjevanje in pripravo poročil.
Member States and the Commission shall have recourse to the Administrative Commission established pursuant to Article 71 of Regulation (EC) No 883/2004, in order to address the financial consequences of the application of this Directive on the Member States which have opted for reimbursement on the basis of fixed amounts, in cases covered by Articles 20(4) and 27(5) of that Regulation.
Države članice in Komisija lahko v primerih iz členov 20(4) in 27(5) Uredbe (ES) št. 883/2004, kar zadeva obvladovanje finančnih posledic uporabe te direktive za države članice, ki so izbrale povračila na podlagi pavšalnih zneskov, za pomoč zaprosijo Upravno komisijo, ustanovljeno v skladu s členom 71 navedene uredbe.
The Commission shall monitor and regularly report on the effect of Article 3(c)(i) and Article 8 of this Directive.
Komisija spremlja učinke člena 3(c)(i) in člena 8 te direktive in o njih redno poroča.
OJ C 175, 28.7.2009, p. 116.
UL C 175, 28.7.2009, str. 116.
OJ C 120, 28.5.2009, p. 65.
UL C 120, 28.5.2009, str. 65.
Position of the European Parliament of 23 April 2009 (OJ C 184 E, 8.7.2010, p. 368), position of the Council at first reading of 13 September 2010 (OJ C 275 E, 12.10.2010, p. 1), position of the European Parliament of 19 January 2011 (not yet published in the Official Journal) and decision of the Council of 28 February 2011.
Stališče Evropskega parlamenta z dne 23. aprila 2009 (UL C 184 E, 8.7.2010, str. 368), stališče Sveta v prvi obravnavi z dne 13. septembra 2010 (UL C 275 E, 12.10.2010, str. 1), stališče Evropskega parlamenta z dne 19. januarja 2011 (še ni objavljeno v Uradnem listu) in odločitev Sveta z dne 28. februarja 2011.
OJ L 344, 29.12.2010, p. 1.
UL L 344, 29.12.2010, str. 1.
OJ C 151, 3.7.2009, p. 7.
UL C 151, 3.7.2009. str. 7.
OJ C 128, 6.6.2009, p. 20.
UL C 128, 6.6.2009, str. 20.
OJ L 40, 11.2.1989, p. 8.
UL L 40, 11.2.1989, str. 8.
OJ L 210, 31.7.2006, p. 19.
UL L 210, 31.7.2006, str. 19.
The powers to adopt delegated acts referred to in Articles 11(5) and 12(5) shall be conferred on the Commission for a period of 5 years from 24 April 2011.
Pooblastilo za sprejemanje delegiranih aktov iz členov 11(5) in 12(5) se prenese na Komisijo za obdobje petih let od 24. aprila 2011.
The Commission shall make a report in respect of the delegated powers not later than 6 months before the end of the five-year period.
Komisija pripravi poročilo o pooblastilu najpozneje šest mesecev pred koncem petletnega obdobja.
A first report shall be presented by 25 October 2013.
Prvo poročilo se predloži do 25. oktobra 2013.
On the basis of these reports, the Commission shall, where appropriate, make proposals to alleviate any disproportionalities.
Komisija na podlagi teh poročil po potrebi sestavi predloge za ublažitev kakršnih koli nesorazmerij.
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 25 October 2013.
Države članice uveljavijo zakone in druge predpise, potrebne za uskladitev s to direktivo, najpozneje do 25. oktobra 2013.
With regard to requests for prior authorisation made by an insured person with a view to receiving cross-border healthcare, the Member State of affiliation shall ascertain whether the conditions laid down in Regulation (EC) No 883/2004 have been met. Where those conditions are met, the prior authorisation shall be granted pursuant to that Regulation unless the patient requests otherwise.
Glede zahtevka za predhodno odobritev, ki ga zavarovana oseba vloži z namenom, da bi bila deležna čezmejnega zdravstvenega varstva v drugi državi članici, država članica zdravstvenega zavarovanja preveri, ali so izpolnjeni pogoji iz Uredbe (ES) št. 883/2004, in v tem primeru odobri predhodno odobritev v skladu z navedeno uredbo, razen če pacient ne zahteva drugače.
Commission Directive 2011/25/EU
Direktiva Komisije 2011/25/EU
amending Council Directive 91/414/EEC to include bupirimate as active substance and amending Commission Decision 2008/934/EC
o spremembi Direktive Sveta 91/414/EGS zaradi vključitve bupirimata kot aktivne snovi in o spremembi Odločbe 2008/934/ES
That list included bupirimate.
Navedeni seznam je vključeval bupirimat.
Consequently, Commission Decision 2008/934/EC of 5 December 2008 concerning the non-inclusion of certain active substances in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing these substances [4] was adopted on the non-inclusion of bupirimate.
Zato je bila v zvezi z nevključitvijo bupirimata sprejeta Odločba Komisije 2008/934/ES z dne 5. decembra 2008 o nevključitvi nekaterih aktivnih snovi v Prilogo I k Direktivi Sveta 91/414/EGS in o preklicu registracije fitofarmacevtskih sredstev, ki vsebujejo navedene snovi [4].
It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 26 November 2009.
Navedeno poročilo je 26. novembra 2009 predložila Evropski agenciji za varnost hrane (v nadaljnjem besedilu: Agencija) in Komisiji.
In accordance with Article 20(1) of Regulation (EC) No 33/2008 and at the request of the Commission, the Authority presented its conclusion on bupirimate to the Commission on 20 September 2010 [6].
V skladu s členom 20(1) Uredbe (ES) št. 33/2008 in na zahtevo Komisije je Agencija 20. septembra 2010 Komisiji predstavila svoje sklepe o bupirimatu [6].
The draft assessment report, the additional report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 28 January 2011 in the format of the Commission review report for bupirimate.
Osnutek poročila o oceni, dodatno poročilo in sklep Agencije so države članice in Komisija pregledale v okviru Stalnega odbora za prehranjevalno verigo in zdravje živali ter končno različico pripravile 28. januarja 2011 v obliki poročila Komisije o pregledu glede bupirimata.
It has appeared from the various examinations made that plant protection products containing bupirimate may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which have been examined and detailed in the Commission review report.
Različne preiskave so pokazale, da se za fitofarmacevtska sredstva, ki vsebujejo bupirimat, lahko pričakuje, da na splošno izpolnjujejo zahteve iz člena 5(1)(a) in (b) Direktive 91/414/EGS, zlasti v zvezi z uporabami, ki so bile preučene in podrobno navedene v poročilu Komisije o pregledu.
It is therefore appropriate to include bupirimate in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive.
Zato je primerno vključiti bupirimat v Prilogo I, da se v vseh državah članicah v skladu z določbami navedene direktive lahko registrirajo fitofarmacevtska sredstva, ki vsebujejo to aktivno snov.
Therefore, it is appropriate to require that the applicant submit further information to confirm the soil degradation, the kinetic parameters, the adsorption and the desorption parameter for the major soil metabolite de-ethyl-bupirimate (DE-B).
Zato je primerno zahtevati, da vlagatelj predloži dodatne informacije in potrdi degradacijo tal, parametre kinetike, parametre adsorpcije in desorpcije za glavni metabolit De-etil-bupirimat (DE-B) v tleh.
Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing authorisations of plant protection products containing bupirimate to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC.
Brez poseganja v obveznosti iz Direktive 91/414/EGS, ki izhajajo iz vključitve aktivne snovi v Prilogo I, je državam članicam treba omogočiti, da v šestih mesecih po vključitvi snovi pregledajo obstoječe registracije fitofarmacevtskih sredstev, ki vsebujejo bupirimat, da zagotovijo izpolnjevanje zahtev iz Direktive 91/414/EGS, zlasti iz člena 13 in ustreznih pogojev iz Priloge I. Države članice v skladu z določbami Direktive 91/414/EGS obstoječe registracije po potrebi spremenijo, nadomestijo ali prekličejo.
The line concerning bupirimate in the Annex to Decision 2008/934/EC is deleted.
V Prilogi k Odločbi 2008/934/ES se črta vrstica, ki zadeva bupirimat.