natgillin/translations-raw huggingface dataset:
Evropske tehnološke platforme so včasih dosegle tako ambiciozen obseg in področje delovanja, da bodo zahtevale mobilizacijo visokih javnih in zasebnih naložb ter znatnih raziskovalnih virov za izvajanje pomembnih elementov svojih strateških raziskovalnih programov.
In a small number of cases, ETPs have reached such an ambitious scale and scope that they will require the mobilisation of considerable public and private investments as well as substantial research resources to implement important elements of their Strategic Research Agendas.
Skupne tehnološke pobude se predlagajo kot sredstvo za izpolnitev potreb teh nekaj evropskih tehnoloških platform.
JTIs are proposed as means of meeting the needs of this small number of ETPs.
V posebnem programu „Sodelovanje“
In the Cooperation Specific Programme
UL L 400, 30.12.2006, str.
OJ L 400, 30.12.2006, p.
66-241. je opredeljenih šest področij, na katerih bi bile lahko skupne tehnološke pobude še posebej pomembne: vodik in gorivne celice, aeronavtika in zračni promet, inovativna zdravila, vgrajeni računalniški sistemi, nanoelektronika in GMES (globalno nadzorovanje okolja in varnosti).
66-241. six areas are identified where a JTI could have particular relevance: hydrogen and fuel cells, aeronautics and air transport, innovative medicines, embedded computing systems, nanoelectronics and GMES (global monitoring for environment and security).
V tem okviru je skupno podjetje za pobudo za inovativna zdravila (skupno podjetje) pravna oseba, ki bo odgovorna za izvajanje skupne tehnološke pobude za inovativna zdravila.
Against this background, the Innovative Medicines Initiative Joint Undertaking (IMI JU) is the legal entity that will be responsible for implementation of the Joint Technology Initiative on Innovative Medicines (IMI JTI).
Ta predlog se nanaša na ustanovitev skupnega podjetja v skladu s členom 171 Pogodbe.
The present proposal relates to the setting-up of the IMI JU under Article 171 of the Treaty.
Skupno podjetje bi bilo treba obravnavati kot organ Skupnosti in ga ustanoviti za obdobje do 31. decembra 2017.
The IMI JU should be considered as a Community body and be established for a period ending on 31 December 2017.
Sedež bo imelo v Bruslju v Belgiji.
It will have its seat in Brussels, Belgium.
Ustanovili ga bosta Evropska skupnost, ki jo zastopa Evropska komisija, in Evropska zveza farmacevtske industrije in farmacevtskih združenj, EFPIA.
It will be founded by the European Community, represented by the EC, and the European Federation of Pharmaceutical Industries and Associations, EFPIA.
Dejavnosti skupnega podjetja bosta skupno financirali njegovi ustanoviteljici.
The activities of the IMI JU will be jointly funded by its founders.
Evropska skupnost in zveza EFPIA bosta enakovredno prispevali za stroške poslovanja skupnega podjetja.
The European Community and EFPIA will contribute in equal parts to the running costs of the IMI JU.
Raziskovalne dejavnosti se bodo skupno financirale s prispevki družb članic zveze EFPIA v obliki virov (osebje, oprema, potrošni material itd.) in enakovrednim prispevkom Evropske skupnosti.
The research activities will be jointly funded through contributions by the EFPIA member companies with resources (personnel, equipment, consumables, etc.), and a matching contribution from the European Community.
Celoten proračun skupnega podjetja bo znašal dve milijardi EUR.
The IMI JU will have a total budget of EUR 2 billion.
Skupnost bo iz sedmega okvirnega programa prispevala eno milijardo EUR.
The EC will contribute with EUR 1 billion from FP7.
Preostalo milijardo EUR bodo prispevale zveza EFPIA in farmacevtske družbe, ki temeljijo na raziskavah in so polnopravne članice zveze EFPIA.
The remaining EUR 1 billion will be contributed by EFPIA and the research-based pharmaceutical companies that are full members of EFPIA.
Za prispevek EU bosta uvedeni dve novi proračunski vrstici:
Two new budget lines will be created for the EU contribution:
08.02 01 10 „Odhodki poslovanja za raziskovalne dejavnosti skupnega podjetja za pobudo za inovativna zdravila“
08.02 01 10 "Operational expenditures for research activities of the IMI Joint Undertaking"
08.02 01 20 „Podporni odhodki za stroške poslovanja skupnega podjetja za pobudo za inovativna zdravila“
08.02 01 20 "Support expenditures for running costs of the IMI Joint Undertaking"
z naslednjim profilom odhodkov:
with the following expenditure profile:
Leto 2008
Year 2008
2013 in kasneje
2013 and later
Odhodki 08.02 01 10 „Odhodki poslovanja za raziskovalne dejavnosti skupnega podjetja za pobudo za inovativna zdravila“
Expenditure 08.02 01 10 "Operational expenditures for research activities of the IMI Joint Undertaking"
Odhodki 08.02 01 20 „Podporni odhodki za tekoče stroške skupnega podjetja za pobudo za inovativna zdravila“
Expenditure 08.02 01 20 "Support expenditures for running costs of the IMI Joint Undertaking"
Predlogi sprememb pripravljavke mnenja temeljijo predvsem na dveh pomislekih:
The draftswoman's amendments are mainly based on two concerns:
1) Skupno podjetje je ustanovljeno za začetno obdobje do 31. decembra 2017 (ki se lahko celo podaljša na kasnejši čas), medtem ko večletni finančni okvir zajema le obdobje do leta 2013.
1) The JU is established for an initial period ending on 31 December 2017 (which may even be extended to a later date), whereas the MFF only covers the period up to 2013.
Vse zahteve za finančna sredstva Skupnosti za skupno podjetje po letu 2013 je treba zato na novo oceniti v okviru pogajanj za nov finančni okvir.
Therefore, any request for Community funding for the IMI JU after 2013 has to be newly evaluated in the context of the negotiations for a new financial framework.
Kar zadeva tekoče obdobje, je predlog, čeprav spada pod oddelek 1a, ki ima na voljo čedalje manj sredstev, skladen z večletnim finančnim okvirom iz preprostega razloga, ker je potreben prispevek EU vzet iz sedmega okvirnega programa in je kot tak že vključen v finančno načrtovanje Komisije.
As for the current period, the proposal - although falling under Heading 1a with its dwindling margins - is compatible with the MFF, for the simple reason, that the EU contribution required is taken from the FP7 and has as such already been included in the Commission's financial programming.
Pripravljavka mnenja bi vseeno rada opozorila, da finančne obveznosti za čas po trenutnem večletnem finančnem okviru niso mogoče (predlog spremembe 1).
Nevertheless, your draftswoman would like to point out that no financial commitments can be made for the time after the current MFF (Amendment 1).
2) Po analogiji s pogajanji o skupnem podjetju ITER v začetku leta 2007, ki so privedla do dogovora o sklepih na trialogu 7. marca 2007, je treba skupno podjetje obravnavati kot agencijo v smislu člena 185 finančne uredbe in je zato za njegovo financiranje potrebno soglasje proračunskega organa (predlogi sprememb 2, 3, 7 in 11).
2) By analogy with the negotiations on the ITER Joint Undertaking at the beginning of 2007 which led to the Conclusions agreed at the Trilogue of 7 March 2007, the IMI JU has to be considered as an agency within the meaning of Article 185 of the Financial Regulation and is therefore subject to an agreement by the budgetary authority on its financing (Amendments 2, 3, 7 and 11).
Obenem velja, da mora biti skupno podjetje ob osnovni predpostavki, da ga je treba za proračunske namene obravnavati kot agencijo, v skladu s splošnim načinom obravnave agencij, ki se je v preteklih letih izoblikoval v Odboru za proračun.
At the same time, if the basic assumption is that the IMI JU is to be treated as an agency for budgetary purposes, it has to be consistent with the general approach on agencies that the Committee on Budgets has developed over the past years.
Pripravljavka mnenja zato predlaga vrsto predlogov sprememb, ki zagotavljajo takšen usklajen pristop (predlogi sprememb 4–6, 8–10 in 12–26).
Your draftswoman therefore presents a series of amendments which guarantee such a consistent approach (Amendments 4-6, 8-10 and 12-26).
ob upoštevanju Uredbe Sveta (ES, Euratom) št. 1605/2002 z dne 25. junija 2002 o finančni uredbi, ki se uporablja za splošni proračun Evropskih skupnosti 1 (finančna uredba), in zlasti člena 185 te uredbe,
Having regard to 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 (Financial Regulation), and in particular Article 185 thereof,
ob upoštevanju Medinstitucionalnega sporazuma z dne 17. maja 2006 med Evropskim parlamentom, Svetom in Komisijo o proračunski disciplini in dobrem finančnem poslovodenju 2 ter zlasti točke 47 tega sporazuma,
Having regard to the Interinstitutional Agreement of 17 May 2006 between the European Parliament, the Council and the Commission on budgetary discipline and sound financial management 2 (IIA) , and in particular Point 47 thereof,
Po analogiji s sklepi trialoga z dne 7. marca 2007 o skupnem podjetju ITER je treba za namene uporabe točke 47 medinstitucionalnega sporazuma tudi skupno podjetje za pobudo za inovativna zdravila obravnavati kot agencijo Skupnosti.
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.
(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 telo, ki ga ustanovijo Skupnosti, razrešnico za izvajanje njegovega proračuna pa bi moral ob upoštevanju priporočila Sveta dati Evropski parlament.
(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.
(27) Finančna pravila, ki se uporabljajo za skupno podjetje za pobudo za inovativna zdravila, 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 finančne uredbe 1 , razen če se to posebej zahteva za njegove operativne potrebe, zlasti 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 the Financial Regulation 1 , unless specifically required for its operating needs , 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 treba zahtevati predhodno soglasje Komisije.
The prior consent of the Commission should be required for the adoption of any rules which derogate from Regulation (EC, Euratom) No 2343/2002.
O takšnih odstopanjih se obvesti proračunski organ.
The budgetary authority should be informed of such derogations.
Odstopanj od uredbe št. 2343/2002 bi moralo biti čim manj.
Derogations from Regulation No 2343/2002 should be kept to an absolute minimum.
Skupno podjetje mora dokazati, da brez teh odstopanj ne more jamčiti za svoje ustrezno delovanje v okvirih sklepa o njeni 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.
Skupno podjetje in Belgija bi morali skleniti gostiteljski sporazum o pomoči države gostiteljice glede namestitve pisarn, privilegijev in imunitet ter druge podpore, ki jo bo Belgija zagotovila skupnemu podjetju.
A host agreement should be concluded between the IMI Joint Undertaking and Belgium concerning the host country's assistance with regard to office accommodation, privileges and immunities and other support to be provided by Belgium to the IMI Joint Undertaking.
Treba je jasno določiti, da se od države gostiteljice katere koli agencije ali podobnega organa Skupnosti 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.
To obdobje lahko Svet podaljša.
This period may be extended by the Council .
To obdobje se lahko podaljša z revizijo te uredbe .
This period may be extended by a revision of this Regulation .
Skupno podjetje za pobudo za inovativna zdravila je organ, ustanovljen v skladu s členom 185 finančne uredbe in točko 47 medinstitucionalnega sporazuma z dne 17. maja 2006.
The IMI Joint Undertaking is a body set up in accordance with Article 185 of the Financial Regulation and Point 47 of the IIA of 17 May 2006.
Za podaljšanje obstoja skupnega podjetja je treba slediti ustreznemu zakonodajnemu postopku.
For any extension of the Joint Undertaking's lifetime, the respective legislative procedure has to be followed.
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 za pobudo za inovativna zdravila, ne smejo odstopati od Uredbe ES, Euratom) št. 2343/2002, razen če je to posebej potrebno za njegove operativne potrebe in po predhodnem soglasju Komisije.
The financial rules applicable to the IMI Joint Undertaking may not depart from Regulation (EC, Euratom) No 2343/2002, unless specifically required for its operating needs and subject to prior consent of the Commission.
O takšnih odstopanjih se obvesti proračunski organ.
The budgetary authority shall be informed of such derogations.
Razrešnico za izvajanje proračuna skupnega podjetja da Evropski parlament na priporočilo Sveta v skladu s postopkom iz Finančnega pravilnika skupnega podjetja .
Discharge for the implementation of the budget of the IMI Joint Undertaking shall be given by the European Parliament, upon recommendation of the Council , in accordance with a procedure provided for by the Financial Regulation of the IMI Joint Undertaking.
Skupno podjetje in Belgija skleneta gostiteljski sporazum o pomoči države gostiteljice glede namestitve pisarn, privilegijev in imunitet ter druge podpore, ki jo bo zagotovila Belgija skupnemu podjetju.
A host agreement shall be concluded between the IMI Joint Undertaking and Belgium concerning the host country's assistance with regard to office accommodation, privileges and immunities and other support to be provided by Belgium to the IMI Joint Undertaking.
Skupno podjetje se ustanovi za začetno obdobje od objave tega statuta v Uradnem listu Evropske unije do 31. decembra 2017.
The IMI Joint Undertaking shall be established as from the publication of these Statutes in the Official Journal of the European Union for an initial period ending on 31 December 2017.
Je organ, ustanovljen v skladu s členom 185 finančne uredbe in točko 47 medinstitucionalnega sporazuma z dne 17. maja 2006.
It is a body set up in accordance with Article 185 of the Financial Regulation and Point 47 of the IIA of 17 May 2006.
Priloga, člen 4
Annex, Article 4
Priloga, člen 5, odstavek 2, točka (c), alinee od 9 do 13
Annex, Article 5, paragraph 2, point (c), indents 9 to 13
– odobri seznam izbranih predlogov za projekte;
- approve the list of selected project proposals;
– imenuje izvršnega direktorja, določi smernice in navodila zanj, spremlja njegovo učinkovitost in ga po potrebi zamenja;
- appoint the Executive Director, provide guidance and direction to the Executive Director, monitor the Executive Director's performance and, if necessary, replace the Executive Director;
Glej predloge sprememb 5, 8 in 12.
See Amendments 5, 8 and 12.
Priloga, člen 6, naslov in odstavek 1
Annex, Article 6, title and paragraph 1
Glej predloga sprememb 12 in 13.
See Amendments 12 and 13.
Priloga, člen 6, odstavek 2, uvodni del, alinee od (a) do (d) in alinea (e), uvodni del
Annex, Article 6, paragraph 2, introductory part, points (a) to (d) and point (e), introductory part
(b) izvršni direktor, ki mu pomaga njegov sekretariat, je odgovoren za operativne vidike skupnega podjetja;
(b) The Executive Director, assisted by his secretariat, shall be responsible for the operational aspects of the IMI Joint Undertaking;
(c) izvršni direktor, ki mu pomaga njegov sekretariat, je odgovoren za komunikacijske dejavnosti v zvezi s skupnim podjetjem;
(c) The Executive Director, assisted by his secretariat, shall be responsible for the communication activities related to the IMI Joint Undertaking;
(d) izvršni direktor, ki mu pomaga njegov sekretariat, ustrezno upravlja javna in zasebna sredstva;
(d) The Executive Director, assisted by his secretariat, shall manage appropriately the public and private funds;
(e) izvršni direktor, ki mu pomaga njegov sekretariat, zlasti:
(e) The Executive Director, assisted by his secretariat, shall in particular:
Glej predloge sprememb 12, 13 in 14.
See Amendments 12, 13 and 14.
Priloga, člen 6, odstavek 7, točka (g)
Annex, Article 6, paragraph 7, point (g)
(g) vodi in nadzoruje osebje skupnega podjetja,
(g) direct and supervise the staff of the IMI Joint Undertaking;
Glej predloge sprememb 12, 13, 14 in 15.
See Amendments 12, 13, 14 and 15.
Glej predloge sprememb 12, 13, 14, 15 in 16.
See Amendments 12, 13, 14, 15 and 16.
Priloga, člen 7, odstavek 6, točka (c)
Annex, Article 7, paragraph 6, point (c)
Glej predloge sprememb 12, 13, 14, 15, 16 in 17.
See Amendments 12, 13, 14, 15, 16 and 17.
Priloga, člen 11, naslov in odstavek 1
Annex, Article 11, title and paragraph 1
Finančna ureditev
Financial Regulation
Glede finančnega pravilnika skupnega podjetja se dogovori upravni odbor , ki ga tudi sprejme.
The IMI Joint Undertaking’s financial regulation shall be agreed and adopted by the Board.
Finančna pravila skupnega podjetja po posvetovanju s Komisijo sprejme upravni odbor .
The IMI Joint Undertaking’s financial rules shall be adopted by the Board after having consulted the Commission.
Glej predloge sprememb 5, 8, 12 in 13.
See Amendments 5, 8, 12 and 13.
Priloga, člen 11, odstavek 2
Annex, Article 11, paragraph 2
Glej predloge sprememb 5, 8, 12, 13 in 20.
See Amendments 5, 8, 12, 13 and 20.
Priloga, člen 11, odstavek 3
Annex, Article 11, paragraph 3
Finančni pravilnik skupnega podjetja temelji na načelih Okvirne finančne uredbe .
The IMI Joint Undertaking's Financial Regulation shall be based on the principles of the Framework Financial Regulation.
Od Okvirne finančne uredbe lahko odstopa, če to zahtevajo posebne potrebe delovanja skupnega podjetja in če se je o tem posvetovalo 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 skupnega podjetja ne smejo odstopati od Uredbe (ES, Euratom) št. 2343/2002, razen če je to potrebno za njegove posebne operativne potrebe .
The IMI Joint Undertaking's financial rules may not depart from Regulation (EC, Euratom) No 2343/2002, unless necessary for its specific operating needs .
Za sprejetje vseh pravil, ki odstopajo od Uredbe Komisije (ES, Euratom) št. 2343/2002, se zahteva predhodno soglasje Komisije.
The prior consent of the Commission shall be required for the adoption of any rules which derogate from Regulation (EC, Euratom) No 2343/2002.
Glej predloge sprememb 5, 8, 12, 13, 20 in 21.
See Amendments 5, 8, 12, 13, 20 and 21.
Priloga, člen 12, odstavek 5
Annex, Article 12, paragraph 5
Zaključni račun in bilanco stanja je treba v vednost poslati obema vejama proračunskega organa.
Accounts and balance sheets need to be sent to the two arms of the budgetary authority for information.
Priloga, člen 14, odstavek 1
Annex, Article 14, paragraph 1
Kadrovski viri se določijo v načrtu delovnih mest, ki se navede v letnem proračunu in ki ga Komisija skupaj s predhodnim predlogom proračuna Evropske unije posreduje Evropskemu parlamentu in Svetu.
The staff resources shall be determined in the establishment plan to be set out in the annual budget and to be forwarded by the Commission to the European Parliament and the Council together with the preliminary draft budget of the European Union.
Priloga, člen 21, odstavek 2
Annex, Article 21, paragraph 2
O vseh pomembnih spremembah statuta skupnega podjetja se je treba posvetovati s Parlamentom.
The European Parliament needs to be consulted on any important changes to the JU's statutes.
Priloga, člen 23a (novo)
Annex, Article 23 a (new)
Sporazum o gostovanju
Host Agreement
Skupno podjetje in država gostiteljica skleneta sporazum o gostovanju.
A host agreement shall be concluded between the IMI Joint Undertaking and the host state.
Zaradi doslednosti je treba v statut vključiti tudi običajno klavzulo o gostiteljskem sporazumu.
For the sake of consistency, the traditional host agreement clause should also be included in the statutes.
Ustanovitev skupnega podjetja za pobudo za inovativna zdravila
Establishment of the Innovative Medicines Initiative Joint Undertaking
Pobuda za inovativna zdravila je ena od šestih tako imenovanih skupnih tehnoloških pobud, ki jih uvaja posebni program sedmega okvirnega programa z naslovom Sodelovanje.
The Innovative Medicines Initiative (IMI) is one of six so called "Joint Technology Initiatives" introduced by the Specific Programme “Cooperation” of the 7 th Framework Programme.
To je nova oblika vseevropskega javno-zasebnega partnerstva med univerzami, bolnišnicami, javnimi organi, organizacijami pacientov, kliničnimi centri in farmacevtskimi podjetji z namenom, da spodbudijo biomedicinske raziskave in razvoj novih terapij.
It is a novel kind of pan-European Public Private Partnership between universities, hospitals, public authorities, patient organisations, clinical centres and pharmaceutical companies with the aim to boosting biomedical research and the development of new therapies.
Pobuda za inovativna zdravila bo ustvarjala partnerstva preko odprtih javnih razpisov v skladu z raziskovalno agendo, ki se redno posodablja.
The IMI will create partnerships through open calls for tender in accordance with a permanently updated Research Agenda.
Največ pozornosti bo namenjene predkonkurenčnemu sektorju farmacevtskih raziskav, torej orodjem za zgodnje in zanesljive napovedi o varnosti in učinkovitosti predlaganih zdravil z namenom, da se pacientom hitreje zagotovijo njihove potencialne koristi in večja zanesljivost glede uporabe terapije.
The main focus will be on the pre-competitive sector of pharmaceutical research, thus tools to make early and reliable predictions on the safety and efficiency of medicine candidates in order to deliver potential benefits faster to patients and with greater certainty about the use of therapies.
Poleg tega bo raziskovanje znotraj pobude za inovativna zdravila osredotočeno na prednostne bolezni, ki so navedene v raziskovalni agendi, kot sta na primer rak ali Alzheimerjeva bolezen, ter na spodbujanje sodelovanja med zasebnim in javnim sektorjem.
In addition, the IMI will focus research on priority diseases like cancer or Alzheimer, set out by the Research Agenda and foster the collaboration between private and public sectors.