natgillin/translations-raw huggingface dataset:
– ob upoštevanju poročila Odbora za industrijo, raziskave in energetiko in mnenj Odbora za proračun, Odbora za proračunski nadzor, Odbora za okolje, javno zdravje in varnost hrane ter Odbora za pravne zadeve (A6‑0000/2007),
– having regard to the report of the Committee on Industry, Research and Energy and the opinions of the Committee on Budgets and the Committee on the Environment, Public Health and Food Safety ( A6‑0479/2007 ),
(10) Cilj skupne tehnološke pobude za "inovativna zdravila" bi moral okrepiti sodelovanje med vsemi zainteresiranimi stranmi, kot so industrija, organi oblasti (vključno z zakonodajalci), organizacije bolnikov, akademski krogi in klinični centri.
(10) The objective of the Joint Technology Initiative on "Innovative Medicines” should be to foster collaboration between all stakeholders such as industry, public authorities (including regulators), organisations of patients, academia and clinical centres.
V skupni tehnološki pobudi za "inovativna zdravila" bi bilo treba opredeliti skupno dogovorjeni raziskovalni program (v nadaljnjem besedilu "raziskovalni program"), ki bi dosledno upošteval priporočila strateškega raziskovalnega programa, ki ga je pripravila Evropska tehnološka platforma za "inovativna zdravila".
The Joint Technology Initiative on "Innovative Medicines” should define a commonly agreed research agenda (hereinafter referred to as "Research Agenda"), closely following the recommendations of the Strategic Research Agenda developed by the European Technology Platform on "Innovative Medicines".
(10) Cilj skupne tehnološke pobude za "inovativna zdravila" bi moral okrepiti sodelovanje med vsemi zainteresiranimi stranmi, kot so industrija , vključno z malimi in srednjimi podjetji (MSP) , organi oblasti (vključno z zakonodajalci), organizacije bolnikov, mala in srednja podjetja, akademski krogi in klinični centri.
(10) The objective of the Joint Technology Initiative on "Innovative Medicines” should be to foster collaboration between all stakeholders such as industry , including small and medium-sized enterprises (SMEs) , public authorities (including regulators), organisations of patients, academia and clinical centres.
Tudi mala in srednja podjetja morajo sodelovati v skupnem podjetju za pobudo za inovativna zdravila.
SMEs should also be stakeholders in the IMI.
(11) Skupna tehnološka pobuda za "inovativna zdravila" bi morala predlagati usklajen pristop za odpravo ugotovljenih ozkih grl raziskav v postopku razvoja zdravil in podporo "predkonkurenčnih farmacevtskih raziskav in razvoja", da se pospeši razvoj varnih in učinkovitejših zdravil za bolnike.
(11) The Joint Technology Initiative on "Innovative Medicines” should propose a coordinated approach to overcome identified research bottlenecks in the drug development process, and to support 'pre-competitive pharmaceutical research and development', in order to accelerate the development of safe and more effective medicines for patients.
V tem okviru je treba "predkonkurenčne farmacevtske raziskave in razvoj" razumeti kot raziskave orodij in metodologij, ki se uporabljajo v postopku razvoja zdravil.
In the present context 'pre-competitive pharmaceutical research and development' should be understood as research on the tools and methodologies used in the drug development process.
V tem okviru je treba "predkonkurenčne farmacevtske raziskave in razvoj" razumeti kot raziskave orodij in metodologij, ki se uporabljajo v postopku razvoja zdravil na splošno in ne za razvoj posameznega zdravila.
In the present context 'pre-competitive pharmaceutical research and development' should be understood as research into the tools and methodologies used in the drug development process generally, rather that in the process of developing any particular drug .
Intelektualna lastnina, ki izhaja iz projekta skupne tehnološke pobude za "inovativna zdravila", mora biti na voljo tretjim stranem pod poštenimi in razumnimi pogoji.
Intellectual property arising under a Joint Technology Initiative on "Innovative Medicines" project should be licensed to third parties on fair and reasonable terms.
Cilj skupnega podjetja za pobudo za inovativna zdravila je opredelitev "ozkih grl" in ne sme biti izkoriščeno kot finančni vir za izdelavo enega samega posebnega zdravila.
The IMI is intended to identify 'research bottlenecks', and should not be used as a means of funding the development of particular drugs.
(13a) Za dosego ciljev posebnega programa "Sodelovanje" mora skupno podjetje za pobudo za inovativna zdravila upoštevati dinamiko sodelovanja malih in srednjih podjetij, zahvaljujoč se med drugim izboljšanju upravnih postopkov, pri boljšem upoštevanju njihovih potreb in izvajanju podpornih dejavnosti.
(13a) In pursuit of the objectives of the Specific Programme Cooperation, the IMI Joint Undertaking should make provision for boosting SME participation, inter alia by improving administrative procedures, taking their requirements more fully into account and deploying support measures.
Mala in srednja podjetja nimajo vedno na voljo vse logistike, potrebne za določene naloge.
SMEs do not always have all the logistical resources required for certain tasks.
Pobuda za inovativna zdravila ne sme predstavljati prevelikega administrativnega bremena za ta podjetja, ki morajo pogosto oddajati podizvajalcem nekatere naloge, ki jih zaradi majhnosti ne morejo izvesti.
The IMI should not impose excessively onerous administrative formalities on small and medium-sized firms, which are often obliged to contract out certain activities which they lack the structural capacity to carry out themselves.
(13b) Za dosego ciljev odločbe Sveta 2006/974/ES z dne 19. decembra 2006 o posebnem programu Zmogljivosti za izvajanje sedmega okvirnega programa Evropske skupnosti za raziskave, tehnološki razvoj in predstavitvene dejavnosti (2007–2013), mora skupno podjetje za pobudo za inovativna zdravila pokazati pripravljenost za naložbe v raziskave v korist malih in srednjih podjetij s krepitvijo njihovih sposobnosti za inovacije in njihovih zmožnosti za izkoriščanje rezultatov raziskav.
(13b) In pursuit of the objectives of Council Decision 2006/974/EC of 19 December 2006 on the Specific Programme: Capacities implementing the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (2007 to 2013) 1 , the IMI Joint Undertaking should be attuned to investment in research for the benefit of SMEs and to enhancing their capacity for innovation and their ability to exploit the results of research.
1 UL L 400, 30.12.09, str.
1 OJ L 400, 30.12.2009, p.
(14) Skupno podjetje bi bilo treba ustanoviti za začetno obdobje, ki se bo končalo 31. decembra 2017, da se zagotovi ustrezno upravljanje raziskovalnih dejavnosti, ki so bile uvedene med izvajanjem Sedmega okvirnega programa (2007–2013) in v tem času še niso bile končane.
(14) The IMI Joint Undertaking should be set up for an initial period ending on 31 December 2017 to ensure the appropriate management of research activities initiated but not concluded during the Seventh Framework Programme (2007-2013).
(14) Skupno podjetje bi bilo treba ustanoviti za začetno obdobje, ki se bo končalo 31. decembra 2013.
(14) The IMI Joint Undertaking should be set up for an initial period ending on 31 December 2013.
Tako bi se zagotovilo ustrezno upravljanje raziskovalnih dejavnosti, ki so bile uvedene med izvajanjem Sedmega okvirnega programa (2007–2013) in v tem času še niso bile končane, dela v teku pa bi se lahko nadaljevala do 31. decembra 2017.
To ensure the appropriate management of research activities initiated but not concluded during the Seventh Framework Programme (2007-2013) , work in progress should continue until 31 December 2017, if necessary .
Trajanje skupnega podjetja mora biti usklajeno s sedmim okvirnim programom za raziskave in razvoj, ker se delno iz njega tudi financira.
The duration of the IMI Joint Undertaking must be modelled on that of the Seventh Framework Programme, because it is partly funded by it.
Vseeno pa se to obdobje lahko podaljša zaradi dokončanja del, ki še potekajo.
An additional period may nonetheless be granted in order to complete work in progress.
(16) Skupno podjetje bi moralo biti telo, ki ga ustanovijo Skupnosti, razrešnico za izvajanje njegovega proračuna pa bi moral dati Evropski parlament na priporočilo Sveta , vendar ob upoštevanju posebnosti, ki so posledica narave skupnih tehnoloških pobud kot javno-zasebnih partnerstev in zlasti prispevka zasebnega sektorja k proračunu.
(16) The IMI Joint Undertaking should be a body set up by the Communities and discharge for the implementation of its budget should be given by the European Parliament, on the recommendation of the Council, taking however into account the specificities resulting from the nature of JTIs as public-private partnerships and in particular from the private sector contribution to the budget.
(16) Skupno podjetje bi moralo biti organ, ki ga ustanovijo Skupnosti, razrešnico za izvrševanje njegovega proračuna pa bi moral dati Evropski parlament ob upoštevanju priporočila Sveta .
(16) The IMI Joint Undertaking should be a body set up by the Communities and discharge for the implementation of its budget should be given by the European Parliament, taking into account a recommendation from the Council.
Po analogiji s sklepi trialoga z dne 7. marca 2007 o skupnem podjetju ITER bi moral biti Evropski parlament v celoti in brezpogojno odgovoren za razrešnico za izvajanje proračuna skupnega podjetja za pobudo za inovativna zdravila.
By analogy with the conclusions of the trilogue of 7 March 2007 on the Joint Undertaking for ITER, the European Parliament should be given full and unconditional responsibility for the discharge of the implementation of the budget of the IMI JU.
(17) Ustanovni članici skupnega podjetja bi morali biti Evropska skupnost in Zveza EFPIA.
(17) Founding members of the IMI Joint Undertaking should be the European Community and EFPIA.
(17) Ustanovni članici skupnega podjetja sta Evropska skupnost in Zveza EFPIA.
(17) The founding members of the IMI Joint Undertaking are the European Community and EFPIA.
(26) Farmacevtske družbe, ki temeljijo na raziskavah in so polnopravne članice Zveze EFPIA, niso upravičene do prejema podpore s strani skupnega podjetja.
(26) The research based pharmaceutical companies that are full members of EFPIA activities shall not be eligible to receive support from the IMI Joint Undertaking.
(26) Farmacevtske družbe, ki temeljijo na raziskavah in so polnopravne članice Zveze EFPIA, niso upravičene do prejema posredne ali neposredne podpore s strani skupnega podjetja.
(26) The research based pharmaceutical companies that are full members of EFPIA activities shall not be eligible to receive direct or indirect support from the IMI Joint Undertaking.
Treba je pojasniti vrsto finančne podpore, da ne bi prišlo do nejasnosti.
To avoid confusion, the nature of the support precluded should be clarified.
(27) Skupno podjetje bi moralo imeti svoj finančni pravilnik, o katerem se je treba prej posvetovati s Komisijo, temeljil bi na načelih iz okvirne finančne uredbe in upošteval bi njegove posebne operativne potrebe, ki bodo izhajale zlasti iz potrebe po združevanju sredstev Skupnosti in zasebnih sredstev za učinkovito in pravočasno podporo raziskovalnih in razvojnih dejavnosti.
(27) The IMI Joint Undertaking should have, subject to prior consultation with the Commission, a distinct Financial Regulation based on the principles of the framework financial regulation which takes into account its specific operating needs arising, in particular, from the need to combine Community and private funding to support research and development activities in an efficient and timely manner.
(27) Finančna pravila, ki veljajo za Skupno podjetje, ne bi smela odstopati od Uredbe Komisije (ES, Euratom) št. 2343/2002 z dne 23. decembra 2002 o okvirni finančni uredbi za organe iz člena 185 Uredbe Sveta (ES, Euratom) št. 1605/2002 z dne 25. junija 2002 o finančni uredbi, ki se uporablja za splošni proračun Evropskih skupnosti 1 , razen če je to nujno zaradi njegovih posebnih operativnih potreb, zlasti zaradi potrebe po združevanju sredstev Skupnosti in zasebnih sredstev za učinkovito in pravočasno podporo raziskovalnih in razvojnih dejavnosti.
(27) The financial rules applicable to the IMI Joint Undertaking should not depart from Commission Regulation (EC, Euratom) No 2343/2002 of 23 December 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities 1 , unless their specific operating needs so require , in particular the need to combine Community and private funding to support research and development activities in an efficient and timely manner.
Za sprejetje vseh pravil, ki odstopajo od uredbe Komisije (ES, Euratom) št. 2343/2002, je potrebno predhodno soglasje Komisije.
The prior consent of the Commission is required for the adoption of any rules which depart from Regulation (EC, Euratom) No 2343/2002.
O takšnih odstopanjih je treba obvestiti proračunski organ.
The budgetary authority should be informed of such derogations.
Popravek v UL L 2, 7.1.2003, str.
Corrigendum in OJ L 2, 7.1.2003, p.
Skupno podjetje mora dokazati, da brez teh odstopanj ne more jamčiti za svoje ustrezno delovanje v okvirih uredbe o njegovi ustanovitvi.
The Joint Undertaking has to prove beyond any doubt that such a derogation is the only way to guarantee its proper functioning within the limits of its founding regulation.
(28) Potreba , da se zagotovijo stabilni pogoji zaposlovanja in enaka obravnava osebja ter da se privabi najboljše specializirano znanstveno in tehnično osebje, zahteva uporabo kadrovskih predpisov za uradnike Evropskih skupnosti in pogojev za zaposlitev drugih uslužbencev Evropskih skupnosti ("kadrovski predpisi") za vse osebje, ki ga najame skupno podjetje .
(28) The need to ensure stable employment conditions and equal treatment of staff, and in order to attract specialised scientific and technical staff of the highest calibre, requires the application of the Staff Regulations of Officials of the European Communities and the Conditions of Employment of Other Servants of the European Communities, ("the Staff Regulation") to all staff recruited by the IMI Joint Undertaking.
(28) Zahteva , da se zagotovijo stabilni pogoji zaposlovanja, enaka obravnava osebja ter potreba po najboljšem specializiranem znanstvenem in tehničnem osebju , zahteva določeno fleksibilnost pri zaposlovanju osebja skupnega podjetja .
(28) The requirement to ensure stable employment conditions and equal treatment of staff, and the need for specialised scientific and technical staff of the highest calibre, call for a degree of flexibility in the recruitment of staff for the IMI Joint Undertaking.
Partnerstvo mora biti uravnoteženo in vsak ustanovni član mora imeti možnost zaposlovati osebje.
The partnership should be balanced and each of the Founding Members should be in a position to recruit staff.
Treba je omogočiti prilagodljiv in neobremenjen pristop.
Preference should be given to a flexible, light-touch approach.
Partnerstvo mora biti uravnoteženo in vsak ustanovni član (Komisija/EFPIA) mora imeti možnost zaposlovati osebje.
The partnership should be balanced, and each founding member (Commission/EFPIA) should be in a position to recruit staff.
(33) Skupno podjetje bi moralo imeti sedež v Bruslju v Belgiji.
(33) The IMI Joint Undertaking should be established in Brussels, Belgium.
Skupno podjetje in Belgija bi morali skleniti gostiteljski sporazum glede namestitve pisarn, privilegijev in imunitet ter druge podpore, ki jo bo Belgija priznala skupnemu podjetju.
A host agreement should be concluded between the IMI Joint Undertaking and Belgium concerning office accommodation, privileges and immunities and other support to be provided by Belgium to the IMI Joint Undertaking.
Skupno podjetje in Belgija skleneta gostiteljski sporazum o pomoči glede namestitve pisarn, privilegijev in imunitet ter druge podpore, ki jo bo zagotovila Belgija skupnemu podjetju.
A host agreement should be concluded between the IMI Joint Undertaking and Belgium concerning the assistance with regard to office accommodation, privileges and immunities and other support to be provided by Belgium to the IMI Joint Undertaking.
Treba bi bilo jasno določiti, da se od vsake države, ki gosti agencijo, pričakuje, da bo zagotovila finančno in vso drugo pomoč, potrebno za olajšanje vzpostavitve in poslovanja organa Skupnosti.
It should be clearly stipulated that the host country of any agency or similar Community body is expected to provide financial and all other assistance necessary to facilitate the setting-up and running of the Community body.
Za izvajanje skupne tehnološke pobude za inovativna zdravila se ustanovi skupno podjetje za obdobje do 31. decembra 2017 (v nadaljnjem besedilu „skupno podjetje“).
For the implementation of the Joint Technology Initiative on Innovative Medicines, a Joint Undertaking is hereby set up for a period ending on 31 December 2017 (hereinafter referred to as "IMI Joint Undertaking").
To obdobje lahko Svet podaljša .
This period may be extended by the Council. .
Za izvajanje skupne tehnološke pobude za inovativna zdravila se ustanovi skupno podjetje za obdobje do 31. decembra 2013 (v nadaljnjem besedilu „skupno podjetje“).
For the implementation of the Joint Technology Initiative on Innovative Medicines, a Joint Undertaking is hereby set up for a period ending on 31 December 2013 (hereinafter referred to as "IMI Joint Undertaking").
Dela v teku pa bi se vendarle lahko nadaljevala do 31. decembra 2017.
Work in progress may nonetheless continue until 31 December 2017.
Skupno podjetje je organ po členu 185 finančne uredbe in točki 47 medinstitucionalnega sporazuma z dne 17. maja 2006.
The IMI Joint Undertaking is a body as referred to in Article 185 of the Financial Regulation and Point 47 of the IIA of 17 May 2006.
Po analogiji s sklepi trialoga z dne 7. marca 2007 o skupnem podjetju ITER je treba tudi skupno podjetje za pobudo za inovativna zdravila obravnavati kot agencijo Skupnosti za namene uporabe točke 47 medinstitucionalnega sporazuma.
By analogy with the conclusions of the trilogue of 7 March 2007 on the Joint Undertaking for ITER, the IMI JU is also to be considered as a Community agency for the purpose of the application of point 47 of the IIA.
To mora biti razvidno iz pravne podlage, ki je navedena v uredbi.
This has to be reflected in the legal bases referred to in the Regulation.
b) podpirati izvajanje prednostnih nalog na področju raziskav, kot so določene v raziskovalnem programu skupne tehnološke pobude za "inovativna zdravila", v nadaljnjem besedilu "raziskovalne dejavnosti", predvsem z dodeljevanjem nepovratnih sredstev na podlagi pozivov za zbiranje predlogov;
(b) support the implementation of the research priorities as set out by the Research Agenda of the Joint Technology Initiative on "Innovative Medicines" (hereinafter referred to as "Research Activities"), notably by awarding grants following competitive calls for proposals;
b) podpirati izvajanje prednostnih nalog na področju raziskav, kot so določene v raziskovalnem programu skupne tehnološke pobude za "inovativna zdravila", v nadaljnjem besedilu "raziskovalne dejavnosti", predvsem z dodeljevanjem nepovratnih sredstev na podlagi pozivov za zbiranje predlogov za raziskave izključno v državah članicah in v državah, pridruženih k sedmemu okvirnemu programu;
(b) support the implementation of the research priorities as set out by the Research Agenda of the Joint Technology Initiative on "Innovative Medicines" (hereinafter referred to as "Research Activities"), notably by awarding grants following competitive calls for proposals relating to research to be carried out exclusively in the Member States and the countries associated with the Seventh Framework Programme ;
Skupno podjetje za pobudo za inovativna zdravila želi podpirati zlasti raziskave v Evropi.
The IMI is primarily intended to support research in Europe.
Tekoče stroške skupnega podjetja krijejo njegove članice.
The running costs of the IMI Joint Undertaking shall be financed by its Members.
K tekočim stroškom prispevata Skupnost in Zveza EFPIA v enakovrednih delih.
The Community and EFPIA shall contribute in equal part to such running costs.
Tekoči stroški ne smejo preseči 4% celotnega proračuna.
The running costs shall not exceed 4% of the total budget.
V letnem poročilu ni govora samo o doseženem napredku, ampak tudi o morebitnih težavah.
The annual report not only covers progress made but also any problems.
Člen 7, točka (a)
Article 7, point (a)
(a) mikro, mala in srednje velika podjetja v smislu Priporočila Komisije 2003/361/ES;
(a) micro, small and medium-sized enterprises within the meaning of Commission Recommendation 2003/361/EC;
(a) mikro, mala in srednja podjetja v smislu priporočila Komisije 2003/361/ES v skladu s posebnimi cilji, ki jim jih je postavil sedmi okvirni program ;
(a) micro, small and medium-sized enterprises within the meaning of Commission Recommendation 2003/361/EC , in accordance with the specific objectives set for them in the Seventh Framework Programme ;
Člen 7, točka (g)
Article 7, point (g)
(g) kvalificirane nepridobitne organizacije bolnikov.
(g) qualified non-profit patients organisations.
(g) zakonito ustanovljene nepridobitne organizacije bolnikov.
(g) legally established non-profit patients' organisations.
Finančni pravilnik skupnega podjetja temelji na načelih iz okvirne finančne uredbe.
The IMI Joint Undertaking's Financial Regulation shall be based on the principles of the Framework Financial Regulation.
Lahko odstopa od okvirne finančne uredbe, če to zahtevajo posebne operativne potrebe skupnega podjetja in po predhodnem posvetovanju s Komisijo .
It may depart from the Framework Financial Regulation where the specific operating needs of the IMI Joint Undertaking so require and subject to prior consultation with the Commission.
Finančna pravila, ki se uporabljajo za skupno podjetje, ne smejo odstopati od Uredbe (ES, Euratom) št. 2343/2002, razen če je to potrebno zaradi njegovih posebnih operativnih potreb, s tem pa se mora predhodno strinjati Komisija.
The financial rules applicable to the IMI Joint Undertaking may not depart from Regulation (EC, Euratom) No 2343/2002, unless its specific operating needs so require and subject to the prior consent of the Commission.
O vsakem takem odstopanju se obvesti proračunski organ.
The budgetary authority shall be informed of any such derogation.
Skupno podjetje imenuje zunanjega revizorja, ki preverja poštenost in pravilnost zaključnih računov skupnega podjetja.
The IMI Joint Undertaking may appoint an external auditor in order to verify the fairness and accuracy of the annual accounts drawn up by the IMI Joint Undertaking.
Možnost imeti zakonitega revizorja je dobra alternativa za zagotavljanje ustreznega spremljanja zaključnih računov in ugotavljanje morebitnih stvarnih prispevkov članov.
The possibility of calling on an auditor is a good alternative way of ensuring satisfactory scrutiny of the annual accounts and the potential evaluation of contributions in kind by the members.
Zunanji revizor je odgovoren za zagotavljanje ustreznega spremljanja zaključnih računov in ocenjevanje prispevkov članov in udeležencev v raziskovalnih projektih.
The external auditor shall be responsible for ensuring satisfactory scrutiny of the annual accounts and the evaluation of the contributions made by the members and by the participants in the research projects.
Priloga, Člen 7 B (novo)
Annex, Article 7 B (new)
Udeleženci projekta dajo skupnemu podjetju v presojo letna znanstvena in finančna poročila o projektih, ki so jih podprli.
Annual scientific and financial reports on the projects supported shall be submitted to the IMI Joint Undertaking by the participants.
V poročilih so natančno navedene raziskovalne dejavnosti, ki se izvajajo, ter stroški takšnih dejavnosti.
Such reports shall give details of the research activities carried out and the costs of such activities.