natgillin/translations-raw huggingface dataset:
Having regard to Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare [1], and in particular points (a), (c) and (d) of Article 11(2) thereof,
ob upoštevanju Direktive 2011/24/EU Evropskega parlamenta in Sveta z dne 9. marca 2011 o uveljavljanju pravic pacientov pri čezmejnem zdravstvenem varstvu [1], zlasti člena 11(2) (a), (c) in (d) Direktive,
Pursuant to Article 11(2) of Directive 2011/24/EU, the Commission has an obligation to adopt measures to facilitate the recognition of medical prescriptions issued in a Member State other than the Member State where the prescriptions are dispensed.
V skladu s členom 11(2) Direktive 2011/24/EU je Komisija obvezana sprejeti ukrepe za olajšanje priznavanja zdravniških receptov, predpisanih v eni državi članici in izdanih v drugi.
Pursuant to point (a) of Article 11(2) of Directive 2011/24/EU, the Commission is to adopt a non-exhaustive list of elements to be included in those prescriptions.
V skladu s točko (a) člena 11(2) Direktive 2011/24/EU mora Komisija sprejeti neizčrpen seznam elementov, ki jih morajo vsebovati navedeni recepti.
That list should enable the dispensing health professional to verify the authenticity of the prescription and whether it was issued by a member of a regulated health profession who is legally entitled to do so.
Navedeni seznam bi zdravstvenemu delavcu, ki izdaja zdravila, moral omogočati, da preveri, ali je recept verodostojen in ali ga je v drugi državi članici predpisal pripadnik reguliranega zdravstvenega poklica, ki je za to pravno upravičen.
The elements to be included in the prescriptions should facilitate the correct identification of medicinal products or medical devices as referred to in point (c) of Article 11 (2) of Directive 2011/24/EU.
Elementi, ki jih je treba vključiti v recepte, bi morali omogočati pravilno identifikacijo zdravil ali medicinskih pripomočkov, kot je navedeno v točki (c) člena 11(2) Direktive 2011/24/EU.
Medicinal products should therefore be indicated using the common name in order to facilitate the correct identification of products which are marketed under different brand names across the Union and of products that are not marketed in all Member States.
Navajati je treba splošna imena zdravil, da se omogoči pravilna identifikacija zdravil, ki se tržijo pod različnimi imeni blagovne znamke po vsej Uniji in tistih, ki se ne tržijo v vseh državah članicah.
That common name to be used should be either the International Non-proprietary name recommended by the World Health Organisation or, if such name does not exist, the usual common name.
Splošno ime, ki ga je treba uporabiti, mora biti mednarodno nelastniško ime, ki ga priporoča Svetovna zdravstvena organizacija ali, če tega imena ni, običajno splošno ime.
In contrast, the brand name of a medicinal product should only be used to ensure clear identification of biological medicinal products as defined in point 3.2.1.1.(b) of Annex I to 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 [2], because of the special characteristics of those products, or of other medicinal products in cases where the prescribing professional considers it medically necessary.
Nasprotno pa bi moralo ime znamke zdravila služiti le jasni opredelitvi bioloških zdravil, kot je opredeljeno v točki 3.2.1.1(b) Priloge I k Direktivi 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini [2], zaradi posebnih značilnosti navedenih proizvodov, ali drugih zdravil, kadar je to po mnenju zdravstvenega delavca, ki predpisuje zdravila, potrebno iz zdravstvenega vidika.
Medical devices do not have common names as medicinal products.
Medicinski pripomočki nimajo splošnih imen, kot to velja za zdravila.
Therefore the prescription should also include direct contact details of the prescriber which enable the dispensing professional, where necessary, to enquire about the prescribed medical device and correctly identify it.
Zato bi moral recept vključevati tudi direktne kontaktne podatke predpisovalca, da lahko zdravstveni delavec, ki izdaja recept, po potrebi poizve o predpisanem medicinskem pripomočku in ga pravilno opredeli.
The non-exhaustive list of elements to appear on the prescriptions should facilitate the comprehensibility of the information to patients concerning the prescription and the instructions included on the use of the product, as referred to in point (d) of Article 11(2) of Directive 2011/24/EU.
Neizčrpen seznam elementov, ki jih morajo vključevati recepti, bi moral omogočiti razumljivost informacij za paciente v zvezi z receptom in navodili za uporabo zdravila, kot je navedeno v točki (d) člena 11(2) Direktive 2011/24/EU.
The Commission will regularly review the situation in order to assess whether additional measures are necessary to help patients understand the instructions concerning the use of the product.
Komisija bo redno preverjala stanje, da bi ocenila, ali so potrebni dodatni ukrepi za zagotovitev razumljivih informacij za paciente v zvezi z navodili za uporabo zdravil.
To enable patients to request appropriate prescriptions, it is important that national contact points referred to in Article 6 of Directive 2011/24/EU provide patients with adequate information on the content and purpose of the non-exhaustive list of elements that should appear in those prescriptions.
Da bi pacienti lahko dobili ustrezne recepte, je pomembno, da nacionalne kontaktne točke iz člena 6 Direktive 2011/24/EU pacientom zagotovijo ustrezne informacije o vsebini in namenu neizčrpnega seznama elementov, ki bi jih morali vsebovati navedeni recepti.
As the overall impact of cross-border healthcare is limited, the non-exhaustive list of elements should apply only to prescriptions intended to be used in another Member State.
Glede na to, da je splošen vpliv čezmejnega zdravstvenega varstva omejen, bi se moral neizčrpen seznam elementov uporabljati samo za recepte, namenjene uporabi v drugi državi članici.
As the principle of mutual recognition of prescriptions derives from Article 56 of the Treaty on the Functioning of the European Union, this Directive does not preclude the Member States from applying the principle of mutual recognition to prescriptions that do not contain the elements set out in the non-exhaustive list.
Ker načelo vzajemnega priznavanja receptov izhaja iz člena 56 Pogodbe o delovanju Evropske unije, ta direktiva ne preprečuje državam članicam, da uporabljajo načelo vzajemnega priznavanja za recepte, ki ne vsebujejo elementov iz neizčrpnega seznama.
At the same time, nothing in this Directive prevents the Member States from providing that prescriptions drafted on their territory, with a view to be used in another Member State, contain additional elements that are provided for under the rules applicable on their territory, as long as these rules are compatible with Union law.
Prav tako nobena določba te direktive ne preprečuje državam članicam predpisati dodatnih elementov za recepte, ki se izdajajo na njihovem ozemlju, z namenom, da se izdajo v drugi državi članici, v okviru pravil, ki se uporabljajo na njihovem ozemlju, če so ta pravila v skladu s pravom Unije.
The measures provided for in this Directive are in accordance with the opinion of the Committee set up by Article 16(1) of Directive 2011/24/EU
Ukrepi iz te direktive so v skladu z mnenjem odbora, ustanovljenega na podlagi člena 16(1) Direktive 2011/24/EU –
This Directive lays down measures for the uniform implementation of Article 11(1) of Directive 2011/24/EU concerning the recognition of medical prescriptions issued in another Member State.
Ta direktiva določa ukrepe za enotno izvajanje člena 11(1) Direktive 2011/24/EU o priznavanju zdravniških receptov, izdanih v drugi državi članici.
This Directive shall apply to prescriptions, as defined in point (k) of Article 3 of Directive 2011/24/EU, which are issued further to a request of a patient who intends to use them in another Member State.
Ta direktiva se uporablja za recepte, kot so opredeljeni v točki (k) člena 3 Direktive 2011/24/EU, ki se predpišejo na zahtevo pacienta, ki jih namerava uporabiti v drugi državi članici.
Content of prescriptions
Vsebina receptov
Member States shall ensure that prescriptions contain at least the elements set out in the Annex.
Države članice zagotovijo, da recepti vsebujejo vsaj elemente, določene v Prilogi.
Information requirements
Zahteve o obveščanju
Member States shall ensure that the national contact points referred to in Article 6 of Directive 2011/24/EU inform patients about the elements to be included, pursuant to this Directive, in prescriptions issued in a Member State other than the Member State where they are dispensed.
Države članice zagotovijo, da nacionalne kontaktne točke iz člena 6 Direktive 2011/24/EU obvestijo paciente o elementih, ki jih morajo na podlagi te direktive vsebovati recepti, ki se predpišejo v eni državi članici in izdajo v drugi.
OJ L 88, 4.4.2011, p. 45–65
UL L 88, 4.4.2011, str. 45–65.
Non-exhaustive list of elements to be included in medical prescriptions
Neizčrpen seznam elementov, ki jih morajo vsebovati zdravniški recepti
Headings appearing in bold in this Annex are not required to feature in prescriptions
V recepte ni treba vključiti naslove, ki so v tej prilogi označeni s krepkim tiskom
Identification of the patient
Identifikacija pacienta
First name(s) (written out in full, i.e. no initials)
Ime/imena (izpisano v celoti, tj. brez kratice)
Authentication of the prescription
Avtentikacija recepta
Issue date
Datum izdaje
Identification of the prescribing health professional
Identifikacija zdravstvenega delavca, ki je predpisal zdravilo
Professional qualification
Poklicne kvalifikacije
Details for direct contact (email and telephone or fax, the latter both with international prefix)
Neposredni kontaktni podatki (elektronska pošta in telefon ali telefaks z mednarodno dohodno številko)
Work address (including the name of the relevant Member State)
Službeni naslov (vključno z imenom zadevne države članice)
Signature (written or digital, depending on the medium chosen for issuing the prescription)
Podpis (pisni ali digitalni, odvisno od medija, izbranega za izdajo recepta)
Identification of the prescribed product, where applicable
Identifikacija predpisanega zdravila, kadar je to potrebno
‘Common name’ as defined by Article 1 of 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
Splošno ime, kot je opredeljeno v členu 1 Direktive 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini
The brand name if:
Ime blagovne znamke, če:
the prescribed product is a biological medicinal product, as defined in point 3.2.1.1.(b) of Annex I (Part I) to Directive 2001/83; or
je predpisano zdravilo biološko zdravilo, kakor je opredeljeno v točki 3.2.1.1(b) Priloge I (del I) k Direktivi 2001/83/ES; ali
the prescribing health professional deems it medically necessary; in that case the prescription shall shortly state the reasons justifying the use of the brand name
če je po mnenju zdravstvenega delavca, ki je predpisal zdravilo, to potrebno iz zdravstvenega vidika; v tem primeru je treba v receptu na kratko navesti razloge, ki upravičujejo uporabo določene blagovne znamke.
Pharmaceutical formulation (tablet, solution, etc.)
Farmacevtska sestava (tableta, raztopina itd.)
Strength, as defined in Article 1 of Directive 2001/83/EC
Jakost, kakor je opredeljena v členu 1 Direktive 2001/83/ES.
Dosage regimen
Režim odmerjanja
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 25 October 2013 at the latest.
Države članice najpozneje do 25. oktobra 2013 sprejmejo zakone in druge predpise, potrebne za uskladitev s to direktivo.
Having regard to the Statute of the European System of Central Banks and of the European Central Bank and in particular Articles 3.1, 12.1, 17, 18 and 22 thereof,
ob upoštevanju Statuta Evropskega sistema centralnih bank in Evropske centralne banke ter zlasti členov 3.1, 12.1, 17, 18 in 22 Statuta,
A number of changes are made to Guideline ECB/2010/2 of 21 April 2010 on TARGET2-Securities [1].
K Smernici ECB/2010/2 z dne 21. aprila 2010 o TARGET2-Securities [1] je bilo sprejetih več sprememb.
In the interests of clarity that Guideline should be recast.
Zaradi jasnosti je treba to smernico prenoviti.
On 6 July 2006, the Governing Council of the European Central Bank (ECB) decided to explore, in cooperation with the central securities depositories (CSDs) and other market participants, the possibility of setting up a new Eurosystem service for securities settlement in central bank money, to be called TARGET2-Securities (T2S).
Svet Evropske centralne banke (ECB) je 6. julija 2006 sklenil, da se v sodelovanju s centralnimi depotnimi družbami (CDD) in drugimi udeleženci na trgu razišče možnost vzpostavitve nove službe Eurosistema za poravnavo poslov z vrednostnimi papirji v centralnobančnem denarju, ki bi se imenovala TARGET2-Securities (T2S).
As part of the Eurosystem’s tasks in accordance with Articles 17, 18 and 22 of the Statute of the ESCB, T2S is aimed at facilitating post-trading integration by offering core, neutral and borderless pan-European cash and securities settlement in central bank money so that CSDs can provide their customers with harmonised and commoditised delivery-versus-payment settlement services in an integrated technical environment with cross-border capabilities.
Kot del nalog Eurosistema v skladu s členi 17, 18 in 22 Statuta ESCB je cilj T2S olajšati integracijo potrgovalnih dejavnosti s ponudbo temeljne, nevtralne in brezmejne vseevropske poravnave denarja in vrednostnih papirjev v centralnobančnem denarju, tako da lahko CDD svojim strankam zagotovijo harmonizirane in standardizirane storitve poravnave po načelu dostava proti plačilu v integriranem tehničnem okolju s čezmejnimi zmožnostmi.
The euro area national central banks (NCBs) will provide collateral management services and settlement in central bank money in T2S.
Nacionalne centralne banke (NCB) euroobmočja bodo zagotavljale storitve upravljanja z zavarovanjem in poravnavo v centralnobančnem denarju v T2S.
On the basis of an offer made by the Deutsche Bundesbank, the Banco de España, the Banque de France and the Banca d’Italia (hereinafter the ‘4CB’), the Governing Council also decided that T2S would be developed and operated by the 4CB.
Na podlagi ponudbe centralnih bank Deutsche Bundesbank, Banco de España, Banque de France in Banca d’Italia (v nadaljnjem besedilu: 4CB) je Svet ECB sklenil tudi, da bodo T2S razvijale in upravljale 4CB.
The Governing Council adopted Decision ECB/2012/6 of 29 March 2012 on the establishment of the TARGET2-Securities Board and repealing Decision ECB/2009/6 [2].
Svet ECB je sprejel Sklep ECB/2012/6 z dne 29. marca 2012 o ustanovitvi Odbora TARGET2-Securities in razveljavitvi Sklepa ECB/2009/6 [2].
The T2S Board is a streamlined management body of the Eurosystem that will develop proposals for the Governing Council on key strategic issues and execute tasks of a purely technical nature.
Odbor T2S je poenostavljen organ upravljanja Eurosistema, ki bo za Svet ECB pripravljal predloge o ključnih strateških vprašanjih in izvrševal naloge izključno tehnične narave.
The T2S Board’s mandate contained in Annex I to Decision ECB/2012/6, represents one of the cornerstones of T2S governance.
Mandat Odbora T2S, ki ga vsebuje Priloga I k Sklepu ECB/2012/6, predstavlja enega od temeljev upravljanja T2S.
The T2S Board was simultaneously entrusted with certain implementing tasks by the Eurosystem central banks so that it can be fully operational and act on behalf of the whole Eurosystem.
Centralne banke Eurosistema so Odbor T2S hkrati pooblastile za opravljanje nekaterih izvedbenih nalog, tako da bo lahko popolnoma operativen in bo lahko nastopal v imenu celotnega Eurosistema.
This Guideline lays down in particular the basic foundations of T2S in its specification, development and operational phases.
Ta smernica določa zlasti osnovne temelje T2S v njegovih fazah priprave specifikacij, razvoja in delovanja.
It is complemented by additional legal acts and contractual arrangements under the ultimate responsibility of the Governing Council as T2S is further developed.
Ob nadaljnjem razvoju T2S jo dopolnjujejo dodatni pravni akti in pogodbeni dogovori, za katere je končno odgovoren Svet ECB.
The internal governance of T2S is based on three levels.
Notranje upravljanje T2S temelji na treh ravneh.
On the first level of governance, ultimate decision-making in relation to T2S vests in the Governing Council, which assumes overall responsibility for T2S and, under Article 8 of the Statute of the ESCB, is the decision-maker for the whole Eurosystem.
Na prvi ravni upravljanja je končno odločanje v zvezi s T2S v pristojnosti Sveta ECB, ki prevzema splošno odgovornost za T2S in je v skladu s členom 8 Statuta ESCB organ odločanja za celoten Eurosistem.
On the second level of governance, the T2S Board was established to assist the ECB decision-making bodies in ensuring the successful and timely completion of the T2S Programme.
Na drugi ravni upravljanja je bil ustanovljen Odbor T2S, da pomaga organom odločanja ECB pri zagotavljanju uspešnega in pravočasnega zaključka programa T2S.
Finally, the third level of governance is provided by the 4CB.
Končno, 4CB zagotavljajo tretjo raven upravljanja.
As T2S services are offered to CSDs, non-euro area NCBs and other central banks on the basis of contractual arrangements, it is important to structure the relationship with them throughout the development, migration and subsequent operation of T2S.
Ker se storitve T2S ponujajo CDD, NCB zunaj euroobmočja in drugim centralnim bankam na podlagi pogodbenih dogovorov, je pomembno strukturirati razmerje z njimi za ves čas razvoja, migracije in nato delovanja T2S.
A CSD Steering Group and a Non-euro Currencies Steering Group have been set up for that purpose.
V ta namen sta bili ustanovljeni Koordinacijska skupina CDD in Koordinacijska skupina za valute, ki niso euro.
T2S is not a commercial venture and is not intended to compete with CSDs or any other market participant.
T2S nima tržnega značaja in ni namenjen konkuriranju CDD ali drugim udeležencem na trgu.
An internal decision has been taken on the total investment in T2S for the Eurosystem, while the decision on the pricing of T2S services aims at full cost recovery.
O skupni investiciji v T2S za Eurosistem je bila sprejeta interna odločitev, cilj odločitve o oblikovanju cen za storitve T2S pa je polno pokrivanje stroškov.
Moreover, the Eurosystem should strictly apply the principle of non-discrimination regarding CSDs, and aim to ensure a level playing field among CSDs outsourcing their settlement platform to T2S.
Poleg tega bi moral Eurosistem dosledno spoštovati načelo nediskriminacije v zvezi s CDD in si prizadevati za zagotovitev enakih konkurenčnih pogojev za CDD, ki bodo svojo platformo za poravnavo prenesle na T2S.
T2S is a technical device that will not only be available for settlement in euro, it will also be open to non-euro area NCBs and other central banks that may wish to participate by making their currency available for central bank money settlement in T2S, as provided for in this Guideline,
T2S je tehničen mehanizem, ki ne bo na voljo zgolj za poravnavo v eurih, dostopen bo tudi NCB zunaj euroobmočja in drugim centralnim bankam, ki bi želele sodelovati tako, da bi dale svoje valute na voljo za poravnavo v centralnobančnem denarju v T2S, kakor je določeno v tej smernici –
T2S shall be based on a single technical platform integrated with central bank real-time gross settlement systems.
T2S temelji na enotni tehnični platformi, integrirani s sistemi centralnih bank za bruto poravnavo v realnem času.
It shall be a service provided by the Eurosystem to CSDs allowing for the core, neutral and borderless settlement of securities transactions on a delivery-versus-payment basis in central bank money.
Je služba, ki jo Eurosistem zagotavlja CDD in omogoča temeljno, nevtralno in brezmejno poravnavo transakcij z vrednostnimi papirji po načelu dostava proti plačilu v centralnobančnem denarju.
This Guideline lays down the rules on the internal governance of T2S.
Ta smernica določa pravila notranjega upravljanja T2S.
It also lays down the main features of T2S, defining the respective roles and responsibilities of the T2S Board and the 4CB, and the relations between them during the specification, development and operational phases.
Določa tudi glavne značilnosti T2S, pri čemer opredeljuje vloge in odgovornosti Odbora T2S in 4CB ter odnose med njimi v fazah priprave specifikacij, razvoja in delovanja.
Moreover, this Guideline provides for the basic principles of all of the following in relation to T2S: (a) the financial regime, rights and warranties; (b) how access of CSDs to T2S and contractual relations with CSDs shall be determined; (c) how currencies other than the euro become eligible for use in T2S; (d) the development of T2S.
Poleg tega ta smernica določa osnovna načela za vsa naslednja vprašanja v zvezi s T2S: (a) finančni režim, pravice in jamstva; (b) kako morajo biti določeni dostop CDD do T2S in pogodbeni odnosi z njimi; (c) kako postanejo valute, ki niso euro, primerne za uporabo v T2S; (d) razvoj T2S.
‘central securities depository’ (CSD) means an entity that: (a) enables securities to be established and settled in book entry form, and/or maintains and administers securities on behalf of others through the provision or maintenance of securities accounts; (b) operates or provides for a securities settlement system in accordance with Article 2(a) of Directive 98/26/EC of the European Parliament and of the Council of 19 May 1998 on settlement finality in payment and securities settlement systems [3] or for entities not located in the European Economic Area (EEA) in accordance with the relevant national legislation equivalent to Directive 98/26/EC and/or is regulated by a central bank; and (c) is recognised as a CSD by national regulations and/or legislation and/or is authorised or regulated as such by a competent authority;
„centralna depotna družba“ (CDD) pomeni subjekt, ki: (a) omogoča, da se vrednostni papirji oblikujejo in poravnajo v nematerializirani obliki, in/ali prek zagotavljanja ali vodenja računov vrednostnih papirjev vodi in upravlja vrednostne papirje v imenu tretjih oseb; (b) upravlja ali zagotavlja sistem poravnave vrednostnih papirjev v skladu s členom 2(a) Direktive 98/26/ES Evropskega parlamenta in Sveta z dne 19. maja 1998 o dokončnosti poravnave pri plačilih in sistemih poravnave vrednostnih papirjev [3] oziroma, v primeru subjektov, ki se ne nahajajo v Evropskem gospodarskem prostoru (EGP), v skladu z zadevno nacionalno zakonodajo, ki je enakovredna Direktivi 98/26/ES, in/ali ga regulira centralna banka; in (c) ga nacionalni predpisi in/ali zakonodaja obravnavajo kot CDD in/ali mu pristojni organ izda dovoljenje ali ga regulira kot CDD;
‘delivery-versus-payment’ means a securities settlement mechanism, which links a securities transfer and a funds transfer in such a way as to ensure that delivery occurs only if the corresponding payment occurs;
„dostava proti plačilu“ pomeni mehanizem poravnave poslov z vrednostnimi papirji, ki povezuje prenos vrednostnih papirjev in prenos denarnih sredstev na način, s katerim se zagotovi, da se dostava opravi samo, če se opravi ustrezno plačilo;
‘Eurosystem central bank’ means either a euro area NCB or the ECB, as the case may be;
„centralna banka Eurosistema“ pomeni bodisi NCB euroobmočja bodisi ECB, odvisno od primera;
‘Framework Agreement’ means the contractual framework entered into by a CSD and the Eurosystem for the development and operational phase;
„okvirni sporazum“ pomeni pogodbeni okvir, ki ga skleneta CDD in Eurosistem za fazi razvoja in delovanja;