natgillin/translations-raw huggingface dataset:
Indicate type of serious infringement detected, in reference to the number (left column) in Annex XXX to Implementing Regulation (EU) No 404/2011. In addition, the serious infringements referred to in Article 90(1)(a), (b) and (c) of the Control Regulation shall be respectively identified by the numbers ‘13’, ‘14’ and ‘15’.
Navedite vrsto ugotovljene hude kršitve glede na število (levi stolpec) v Prilogi XXX Izvedbene uredbe (EU) št. 404/2011; poleg tega se hude kršitve iz člena 90(1)(a), (b) in (c) uredbe o nadzoru označijo s številkami 13, 14 oziroma 15.
Confiscation SC
Zaplemba
of 26 June 2013
z dne 26. junija 2013
providing the rules for the establishment, management and transparent functioning of the Network of national authorities or bodies responsible for health technology assessment
o pravilih za vzpostavitev, upravljanje in pregledno delovanje mreže nacionalnih organov ali teles, pristojnih za ocenjevanje zdravstvene tehnologije
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 Article 15(4) thereof,
ob upoštevanju Direktive 2011/24/ES Evropskega parlamenta in Sveta z dne 9. marca 2011 o uveljavljanju pravic pacientov pri čezmejnem zdravstvenem varstvu [1] in zlasti člena 15(4) Direktive,
Article 15 of Directive 2011/24/EU assigned the Union to support and facilitate cooperation and the exchange of information among Member States working within a voluntary network connecting national authorities responsible for health technology assessment (‘HTA’) designated by Member States (hereinafter ‘the HTA Network’).
Člen 15 Direktive 2011/24/EU nalaga Uniji, da podpira in olajšuje sodelovanje in izmenjavo informacij med državami članicami v okviru prostovoljne mreže, ki povezuje nacionalne organe, pristojne za ocenjevanje zdravstvene tehnologije (health technology assessment – HTA), ki jih imenujejo države članice (v nadaljnjem besedilu: mreža HTA).
In accordance with Article 15(4) of Directive 2011/24/EU the Commission has an obligation to adopt the necessary rules for the establishment, management and transparent functioning of the HTA Network.
V skladu s členom 15(4) Direktive 2011/24/EU mora Komisija sprejeti potrebna pravila za vzpostavitev, upravljanje in pregledno delovanje mreže HTA.
Participation in the HTA Network being voluntary, Member States should be able to join at any time.
Ker je sodelovanje v mreži HTA prostovoljno, se države članice lahko kadar koli pridružijo.
For organisational purposes, Member States wishing to participate should inform the Commission of this intention in advance.
Zaradi organizacijskih potreb morajo države članice, ki nameravajo sodelovati, o svoji nameri vnaprej obvestiti Komisijo.
Personal data should be processed in accordance with Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data [2], Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) [3] and Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data [4], as appropriate.
Obdelava osebnih podatkov mora potekati v skladu z Direktivo Evropskega parlamenta in Sveta 95/46/ES z dne 24. oktobra 1995 o varstvu posameznikov pri obdelavi osebnih podatkov in o prostem pretoku takih podatkov [2], Direktivo 2002/58/ES Evropskega parlamenta in Sveta z dne 12. julija 2002 o obdelavi osebnih podatkov in varstvu zasebnosti na področju elektronskih komunikacij (Direktiva o zasebnosti in elektronskih komunikacijah) [3] in Uredbo (ES) št. 45/2001 Evropskega parlamenta in Sveta z dne 18. decembra 2000 o varstvu posameznikov pri obdelavi osebnih podatkov v institucijah in organih Skupnosti in o prostem pretoku takih podatkov [4], če je to primerno.
The Union has co-financed actions in the field of HTA through the Public Health Programme established by Decision No 1786/2002/EC of the European Parliament and of the Council [5] and the Health Programme established by Decision No 1350/2007/EC of the European Parliament and of the Council [6], thereby supporting scientific and technical cooperation between national and regional organisations responsible for HTA with the acronym EUnetHTA [7].
Unija je sofinancirala ukrepe na področju ocenjevanja zdravstvene tehnologije prek programa javnega zdravja, uvedenega s Sklepom št. 1786/2002/ES Evropskega parlamenta in Sveta [5], in zdravstvenega programa, uvedenega s Sklepom št. 1350/2007/ES Evropskega parlamenta in Sveta [6], s čimer podpira znanstveno in tehnično sodelovanje med nacionalnimi in regionalnimi organizacijami, pristojnimi za ocenjevanje zdravstvene tehnologije, s kratico EUnetHTA [7].
It has also financed methodological work in the field of HTA through the 7th Research Framework Programme, established by Decision No 1982/2006/EC of the European Parliament and of the Council [8] and the Competitiveness and Innovation Programme established by Decision No 1639/2006/EC of the European Parliament and of the Council [9].
Financirala je tudi metodološko delo na področju ocenjevanja zdravstvene tehnologije v okviru Sedmega okvirnega programa za raziskave, vzpostavljenega s Sklepom št. 1982/2006/ES Evropskega parlamenta in Sveta [8], in programa za konkurenčnost in inovativnost, vzpostavljenega s Sklepom št. 1639/2006/ES Evropskega parlamenta in Sveta [9].
The measures provided for in this Decision are in accordance with the opinion of the Committee set up by Article 16 of Directive 2011/24/EU,
Ukrepi iz tega sklepa so v skladu z mnenjem odbora, ustanovljenega s členom 16 Direktive 2011/24/EU –
This Decision sets out the necessary rules for the establishment, management and transparent functioning of the Network of national authorities or bodies responsible for health technology assessment, as provided for by Article 15(1) of Directive 2011/24/EU.
Ta sklep določa potrebna pravila za vzpostavitev, upravljanje in pregledno delovanje mreže nacionalnih organov ali teles, pristojnih za ocenjevanje zdravstvene tehnologije, v skladu s členom 15(1) Direktive 2011/24/EU.
In pursuing those objectives assigned to it by Article 15(2) of Directive 2011/24/EU, the HTA Network shall build on the experience gained in previous actions in the field of HTA supported by the Union and ensure relevant synergies with ongoing actions.
Pri uresničevanju navedenih ciljev, ki so ji dodeljeni s členom 15(2) Direktive 2011/24/EU, mreža HTA gradi na izkušnjah iz prejšnjih ukrepov na področju ocenjevanja zdravstvene tehnologije, ki jih podpira Unija, in skrbi za ustrezne sinergije s sedanjimi ukrepi.
Membership — Designation
Članstvo – imenovanje
Members of the HTA Network shall be national authorities or bodies responsible for HTA designated by the participating Member States.
Člani mreže HTA so nacionalni organi ali telesa, pristojni za ocenjevanje zdravstvene tehnologije, ki jih imenujejo sodelujoče države članice.
Member States wishing to participate in the HTA Network shall notify in writing to the Commission this intention as well as the national authority or body responsible for HTA designated in accordance with Article 15(1) of Directive 2011/24/EU.
Države članice, ki želijo sodelovati pri mreži HTA, o svoji nameri pisno obvestijo Komisijo in nacionalni organ oziroma telo, ki je pristojno za ocenjevanje zdravstvene tehnologije in ki so ga imenovale v skladu s členom 15(1) Direktive 2011/24/EU.
Member States may designate a second national authority or body as an alternate Member.
Države članice lahko za nadomestnega člana imenujejo še en nacionalni organ ali telo.
If deemed necessary by the Member State, it may also designate an expert to accompany the Member.
Če država članica meni, da je potrebno, lahko imenuje tudi strokovnjaka, ki spremlja člana.
The names of Member States’ designated authorities or bodies may be published on the Commission web pages.
Imena imenovanih organov ali teles držav članic so lahko objavljena na spletnih straneh Komisije.
Personal data shall be collected, processed and published in accordance with Directives 95/46/EC and 2002/58/EC and Regulation (EC) No 45/2001, as appropriate.
Osebni podatki se zbirajo, obdelujejo in objavljajo v skladu z direktivama 95/46/ES in 2002/58/ES ter Uredbo (ES) št. 45/2001, če je to primerno.
The HTA Network shall adopt by a simple majority of its Members its rules of procedure, on the proposal submitted by the Commission.
Mreža HTA z navadno večino svojih članov sprejme poslovnik na predlog Komisije.
The rules of procedure shall facilitate appropriate stakeholder consultation and liaison with Union bodies, researchers and international organisations on the work of the Network.
V poslovniku se omogočijo ustrezna posvetovanja z deležniki ter sodelovanje z organi Unije, raziskovalci in mednarodnimi organizacijami glede dela mreže.
The HTA Network shall adopt a strategic multiannual work programme and an evaluation instrument on the implementation of such programme.
Mreža HTA sprejme strateški večletni delovni program in instrument za oceno njegovega izvajanja.
The HTA Network shall be supported by a scientific and technical cooperation and may initiate or participate in activities involving all or some of its Members, if such involvement contributes to the objectives of the HTA Network.
Mreža HTA deluje ob podpori znanstvenega in tehničnega sodelovanja ter lahko začenja dejavnosti ali sodeluje pri dejavnostih, ki vključujejo vse ali nekatere njene člane, če takšno sodelovanje prispeva k ciljem mreže HTA.
The HTA Network may set up working groups to examine specific questions on the basis of terms of reference defined by the HTA Network.
Mreža HTA lahko ustanovi delovne skupine za preučitev posebnih vprašanj pod referenčnimi pogoji, ki jih določi mreža HTA.
Such working groups shall be disbanded as soon as their mandate is fulfilled.
Take delovne skupine se razpustijo takoj, ko izpolnijo svoj mandat.
Members of the HTA Network and their representatives, as well as invited experts and observers, shall comply with the obligations of professional secrecy laid down by Article 339 of the Treaty and its implementing rules, as well as with the Commission’s rules on security regarding the protection of EU classified information, laid down in the Annex to Commission Decision 2001/844/EC, ECSC, Euratom of 29 November 2001 amending its internal Rules of Procedure [10].
Člani mreže HTA in njihovi predstavniki ter povabljeni strokovnjaki in opazovalci spoštujejo obveznosti o varovanju poslovnih skrivnosti iz člena 339 Pogodbe in njenih izvedbenih pravilih ter iz Pravilnika Komisije o varnosti v zvezi z zaščito tajnih podatkov EU iz Priloge k Sklepu Komisije 2001/844/ES, ESPJ, Euratom z dne 29. novembra 2001 o spremembah njenega poslovnika [10].
Should they fail to respect these obligations, the Chair of the HTA Network may take all appropriate measures.
Če teh obveznosti ne spoštujejo, lahko predsedujoči mreže HTA sprejme vse ustrezne ukrepe.
The HTA Network shall be chaired by the Commission representative.
Mreži HTA predseduje predstavnik Komisije.
The chair person shall not vote.
Predsednik ne glasuje.
Commission officials with an interest in the proceedings may attend meetings of the HTA Network and its working groups.
Sestankov mreže HTA in njenih delovnih skupin se lahko udeležujejo zainteresirani uradniki Komisije.
Upon request of the Commission, the European Medicines Agency may participate in meetings of the HTA Network and its working groups.
Na zahtevo Komisije lahko na sestankih mreže HTA in njenih delovnih skupin sodeluje Evropska agencija za zdravila.
The HTA Network may invite European and international organisations to attend meetings as observers.
Mreža HTA lahko povabi evropske in mednarodne organizacije, naj se udeležijo sestankov kot opazovalci.
Secretariat of the HTA Network
Sekretariat mreže HTA
The Secretariat of the HTA Network shall be provided by the Commission, who will draw up the minutes.
Sekretariat mreže HTA zagotovi Komisija, ki pripravi zapisnik.
The Commission shall publish on its website relevant information on the activities carried out by the HTA Network.
Komisija na svojem spletišču objavlja ustrezne informacije o dejavnostih, ki jih izvaja mreža HTA.
Participants in the meetings of the HTA Network shall not be remunerated by the Commission for their services.
Komisija udeležencem sestankov mreže HTA ne plača za njihovo delo.
Travel and subsistence expenses incurred by participants in the activities of the HTA Network shall be reimbursed by the Commission in accordance with the provisions in force within the Commission.
Komisija sodelujočim povrne potne stroške in stroške bivanja v zvezi z dejavnostmi mreže HTA v skladu z veljavnimi predpisi Komisije.
Those expenses shall be reimbursed within the limits of the available appropriations allocated under the annual procedure for the allocation of resources.
Navedeni stroški se povrnejo v mejah razpoložljivih odobrenih sredstev v okviru letnega postopka dodelitve sredstev.
Done at Brussels, 26 June 2013.
V Bruslju, 26. junija 2013
www.eunethta.eu; Commission Implementing Decision C2011/7195 on the awarding of grants for proposals for 2011 under the second Health Programme (2008-13).
www.eunethta.eu; Izvedbeni sklep Komisije C2011/7195 o dodelitvi nepovratnih sredstev za predloge za leto 2011 v skladu z drugim programom zdravja (2008–2013).
on the position to be taken on behalf of the European Union with regard to the adoption of the Rules of Procedure of the EPA Committee, the Customs Cooperation Committee and the Joint Development Committee provided for by the Interim Agreement establishing a framework for an Economic Partnership Agreement between the Eastern and Southern Africa States, on the one part, and the European Community and its Member States, on the other part
o stališču, ki se zavzame v imenu Evropske unije glede sprejetja poslovnikov Odbora SGP, Odbora za carinsko sodelovanje in Skupnega odbora za razvoj iz Začasnega sporazuma o določitvi okvira za sporazum o gospodarskem partnerstvu med državami Vzhodne in Južne Afrike na eni strani ter Evropsko skupnostjo in njenimi državami članicami na drugi strani
Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 207 and 209 in conjunction with Article 218(9) thereof,
ob upoštevanju Pogodbe o delovanju Evropske unije in zlasti členov 207 in 209 v povezavi s členom 218(9) Pogodbe,
Having regard to Council Decision 2012/196/EC of 13 July 2009 on the signing and provisional application of the Interim Agreement establishing a framework for an Economic Partnership Agreement between the Eastern and Southern Africa States, on the one part, and the European Community and its Member States, on the other part [1],
ob upoštevanju Sklepa Sveta 2012/196/ES z dne 13. julija 2009 o podpisu in začasni uporabi Začasnega sporazuma o določitvi okvira za sporazum o gospodarskem partnerstvu med državami Vzhodne in Južne Afrike na eni strani ter Evropsko skupnostjo in njenimi državami članicami na drugi strani [1],
The Interim Agreement establishing a framework for an Economic Partnership Agreement between the Eastern and Southern Africa States, on the one part, and the European Community and its Member States, on the other part [2] (hereinafter referred to as ‘the Agreement’) was signed on 29 August 2009 and is provisionally applied since 14 May 2012.
Začasni sporazum o določitvi okvira za sporazum o gospodarskem partnerstvu med državami Vzhodne in Južne Afrike na eni strani ter Evropsko skupnostjo in njenimi državami članicami na drugi strani [2] (v nadaljnjem besedilu: Sporazum) je bil podpisan 29. avgusta 2009 in se začasno uporablja od 14. maja 2012.
Article 64 of the Agreement establishes an EPA Committee, which is responsible for the administration of the Agreement and for the fulfilment of any of the tasks mentioned therein.
Člen 64 Sporazuma ustanavlja Odbor SGP, ki je pristojen za upravljanje Sporazuma in izpolnjevanje nalog iz Sporazuma.
Article 64 of the Agreement provides that the EPA Committee adopts its rules of procedure.
V skladu s členom 64 Sporazuma Odbor SGP sprejme svoj poslovnik.
The EPA Committee is assisted in the performance of its duties by the Customs Cooperation Committee, which is established in accordance with Article 41 of Protocol 1 to the Agreement, and the Joint Development Committee, which is established in accordance with Article 52 of the Agreement.
Odboru SGP pri opravljanju nalog pomagata Odbor za carinsko sodelovanje, ustanovljen v skladu s členom 41 Protokola 1 k Sporazumu, in Skupni odbor za razvoj, ustanovljen v skladu s členom 52 Sporazuma.
It is appropriate to establish the position to be adopted on behalf of the Union with regard to the adoption of the Rules of Procedure of the EPA Committee, the Customs Cooperation Committee and the Joint Development Committee,
Primerno je določiti stališče, ki se sprejme v imenu Unije glede sprejetja poslovnikov Odbora SGP in Odbora za carinsko sodelovanje in Skupnega odbora za razvoj –
The position to be adopted on behalf of the Unionwith regard to the adoption of a decision of the EPA Committee provided for by the Interim Agreement establishing a framework for an Economic Partnership Agreement between the Eastern and Southern Africa States, on the one part, and the European Community and its Member States, on the other part, on its Rules of Procedure, on the Rules of Procedure of the Customs Cooperation Committee and on the Rules of Procedure of the Joint Development Committee shall be based on the draft Decision of the EPA Committee attached to this Decision.
Stališče, ki se sprejme v imenu Unije glede sprejetja sklepa Odbora SGP, ustanovljenega na podlagi Začasnega sporazuma o določitvi okvira za sporazum o gospodarskem partnerstvu med državami Vzhodne in Južne Afrike na eni strani ter Evropsko skupnostjo in njenimi državami članicami na drugi strani, o svojem poslovniku ter Poslovniku Odbora za carinsko sodelovanje in Poslovniku Skupnega odbora za razvoj temelji na osnutku sklepa Odbora SGP, ki je priložen temu sklepu.
Minor changes to the draft Decision of the EPA Committee may be agreed to without further decision of the Council.
O manjših spremembah osnutka sklepa Odbora SGP se lahko dogovori brez nadaljnjih sklepov Sveta.
DECISION No …/2013 OF THE EPA COMMITTEE
SKLEP št. …/2013 ODBORA SGP
set up by the Interim Agreement establishing a framework for an Economic Partnership Agreement between the Eastern and Southern Africa States, on the one part, and the European Community and its Member States, on the other part concerning the adoption of the Rules of Procedure of the EPA Committee, the Customs Cooperation Committee and the Joint Development Committee
ustanovljenega z Začasnim sporazumom o določitvi okvira za sporazum o gospodarskem partnerstvu med državami Vzhodne in Južne Afrike na eni strani ter Evropsko skupnostjo in njenimi državami članicami na drugi strani, o sprejetju poslovnikov Odbora SGP, Odbora za carinsko sodelovanje in Skupnega odbora za razvoj
Having regard to the Interim Agreement establishing a framework for an Economic Partnership Agreement between the Eastern and Southern Africa States, on the one part, and the European Community and its Member States, on the other part (hereinafter referred to as ‘the Agreement’), signed in Grand Baie on 29 August 2009 and provisionally applied since 14 May 2012, and in particular Article 64 thereof,
ob upoštevanju Začasnega sporazuma o določitvi okvira za sporazum o gospodarskem partnerstvu med državami Vzhodne in Južne Afrike na eni strani ter Evropsko skupnostjo in njenimi državami članicami na drugi strani (v nadaljnjem besedilu: Sporazum), ki je bil podpisan v Grand Baie 29. avgusta 2009 in se začasno uporablja od 14. maja 2012 in zlasti člena 64 Sporazuma,
The Agreement provides that the EPA Committee adopts its rules of procedure.
V skladu s Sporazumom Odbor SGP sprejme svoj poslovnik.
The EPA Committee is to be assisted in the performance of its duties by the Customs Cooperation Committee, which is established in accordance with Article 41 of the Protocol 1 of the Agreement, and the Joint Development Committee, which is established in accordance with Article 52 of the Agreement,
Odboru SGP pri opravljanju nalog pomagata Odbor za carinsko sodelovanje, ustanovljen v skladu s členom 41 Protokola 1 k Sporazumu, in Skupni odbor za razvoj, ustanovljen v skladu s členom 52 Sporazuma –
The Rules of Procedure of the following committees are hereby established as set out in the Annexes:
Sprejmejo se poslovniki za naslednje odbore, kot so navedeni v prilogah:
Annex I – the EPA Committee;
Priloga I: Odbor SGP;
Annex II – the Customs Cooperation Committee;
Priloga II: Odbor za carinsko sodelovanje;
Annex III – the Joint Development Committee.
Priloga III: Skupni odbor za razvoj.
Those Rules of Procedure are without prejudice to any special rules provided for in the Agreement or which may be decided by the EPA Committee.
Navedeni poslovniki ne posegajo v posebna pravila iz Sporazuma ali pravila, ki jih določi Odbor SGP.
This Decision shall enter into force on ….
Ta sklep začne veljati …
Done at (place), on (date)
V (kraj), dne (datum).
on the conclusion on behalf of the European Union of the Protocol on the implementation of the 1991 Alpine Convention in the field of transport (Transport protocol)
o sklenitvi Protokola o izvajanju Alpske konvencije iz leta 1991 na področju prometa (Protokol promet) v imenu Evropske Unije
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 91 in conjunction with Article 218(6)(a)(v), and the first paragraph of Article 218(8) thereof,
ob upoštevanju Pogodbe o delovanju Evropske unije in zlasti člena 91 v povezavi s členom 218(6)(a)(v) in prvim odstavkom člena 218(8) Pogodbe,
The Convention on the protection of the Alps (Alpine Convention) was concluded on behalf of the European Community by the Council by Decision 96/191/EC [2].
Svet je v imenu Evropske skupnosti sklenil Konvencijo o varstvu Alp (v nadaljnjem besedilu: Alpska konvencija)s Sklepom 96/191/ES [2].
The Council decided on the signature, on behalf of the Community, of the Protocol on the implementation of the 1991 Alpine Convention in the field of transport (Transport protocol) by Decision 2007/799/EC [3].
Sklep je odločil o podpisu, v imenu Skupnosti, Protokola o izvajanju Alpske konvencije iz leta 1991 na področju prometa (Protokol promet) s Sklepom 2007/799/ES [3].
The Transport protocol is an important step in the implementation of the Alpine Convention and the Union is committed to the achievement of the objectives of that Convention.
Protokol promet pomeni pomemben korak pri izvajanju Alpske konvencije, pri čemer je Evropska Unija zavezana k doseganju ciljev navedene konvencije.
The economic, social and ecological cross-border problems of the Alps remain a major challenge to be addressed in this highly sensitive area.
Gospodarski, družbeni in ekološki čezmejni problemi Alp ostajajo glavni izziv, ki ga je treba reševati na tem izredno občutljivem območju.
The Transport protocol provides a framework, based on the precautionary principle, the preventive principle and the polluter-pays principle, for ensuring sustainable mobility and protection of the environment, in relation to all modes of transport in the Alpine region in the light of Article 2 of the Alpine Convention.
Protokol promet ob upoštevanju 2. člena Alpske konvencije določa okvir, ki temelji na previdnostnem načelu, načelu preprečevanja in načelu onesnaževalec plača, s čimer naj bi se v alpski regiji zagotovila trajnostna mobilnost in varstvo okolja v zvezi z vsemi vrstami prevoza.