natgillin/translations-raw huggingface dataset:
The Management Board consists of one member and one alternate from each Member State, two representatives of the Commission, two representatives appointed by the European Parliament, two representatives from patientsŐ organisations, one representative from doctorsŐ organisations and one representative from veterinariansŐ organisations. 
Styrelsen bestr av en ledamot och en suppleant per medlemsstat, tv fretrdare fr kommissionen, tv fretrdare utnmnda av Europaparlamentet, tv fretrdare fr patientorganisationer, en fretrdare fr lkarorganisationer och en fretrdare fr veterinrorganisationer.
The Board adopts the work programme and the annual report. duties: Ń Operational: 406 (302,5) Ń Administrative: 66 (69) Ń Procedures for mutual recognition: 9 241 (8 451) Ń To record the status of marketing authorisations granted for medicinal products. 
Styrelsen antar arbetsprogrammet och den rliga verksamhetsrapporten. Personalstyrka totalt: 472 (371,5) Ń Vetenskapliga yttranden: 193 (135) Ń Fra register ver lkemedel som godknts fr frsljning. Ń med administrativa upp-Veterinrlkemedel gifter: 66 (69) Tabell 1 Europeiska lkemedelsmyndigheten (London) 1. en ledamot och en suppleant per medlemsstat och utarbetar yttranden i alla frgor som rr utvrdering av humanlkemedel.
The Executive Director is appointed by the Management Board on a proposal from the Commission. variants: 56 (40) Ń Inspections: 128 (114) Orphan Medicinal Products Ń Applications: 104 (118) Table 1 European Medicines Agency (London) 7. External audit: European Court of Auditors Ń Favourable opinions: 81 (88) 8. 
Extern granskning: Europeiska revisionsrtten. ter: 56 (40) Ń Inspektioner: 128 (114) Srlkemedel Ń Anskningar: 104 (118) Ń Positiva yttranden: 81 (88) 8. Myndighet som beviljar ansvarsfrihet: Parlamentet p rdets rekommendation.
Discharge authority: Parliament on a recommendation from the Council. (excluding subsidy for orphan medicines): 21,63 % (22,7 %) (2005) Medicinal Products for Veterinary Use Ń New applications: 5 (11) Ń Applications in respect of 
138,7 (111,8) miljoner euro Bidrag frn gemenskapen (fr-(43) varav anstllda Ń inom verksamheten: Ń Frfaranden fr msesidigt godknnande: 9 241 (8 451) 406 (302,5) (2005)
Source: Data supplied by the Agency. 
Klla: Uppgifter frn myndigheten.
This table summarises the data provided by the Agency in its annual accounts. 
I tabellen sammanfattas de uppgifter som myndigheten har lagt fram i sin rsredovisning.
Total net assets Total liabilities and net assets Table 3 Table 4 European Medicines Agency (London) Ń Economic outturn account for the financial years 2006 and 2005 European Medicines Agency (London) Ń Balance sheet at 31 December 2006 and 2005 Total (a) 101 936 26 045 37 508 85 138 14 490 29 934 61 861 Source: Data supplied by the Agency . 
Tabell 3 Tabell 4 Europeiska lkemedelsmyndigheten (London) Đ Resultatrkning fr budgetren 2006 och 2005 Europeiska lkemedelsmyndigheten (London) Đ Balansrkning per den 31 december 2006 och 2005 2006 2005 (1) 2006 2005 (1) Klla: Uppgifter frn myndigheten.
This table summarises the data provided by the Agency in its annual accounts: these accounts are drawn up on an accrual basis. 
I tabellen sammanfattas de uppgifter som myndigheten har lagt fram i sin rsredovisning.
Title III Operating activities 59 301 58 431 44 846 13 585 870 8 092 7 603 490 2006 2005 (1) 2006 2005 (1) (1 000 euro) (1 000 euro) 28 957 Table 2 European Medicines Agency (London) Ń Implementation of the budget for the financial year 2006 entered committed paid carried over cancelled entered paid cancelled Current liabilities (1) For the 2005 published accounts, the accrual accounting had not been fully implemented. 
Rkenskaperna har lagts fram enligt principerna fr periodiserad redovisning. (1 000 euro) (1 000 euro) 28 957 Tabell 2 Europeiska lkemedelsmyndigheten (London) Đ Budgetgenomfrande fr budgetret 2006 budgeten taganden betalda verfrda frfallna budgeten betalda frfallna Kortfristiga skulder Summa skulder (1) Nrdetgllerdeoffentliggjordarkenskapernafr2005hadeperiodiseradredovisningnnuinteheltgenomfrts.
Total liabilities (1 000 euro) 
(1 000 euro)
19.12.2007 EN Official Journal of the European Union C 309/39 THE AGENCYŐS REPLIES 7. 
19.12.2007 SV Europeiska unionens officiella tidning C 309/39 MYNDIGHETENS SVAR 7.
The total automatic carry over to 2007 on Title 2 amounted to 15 million euro, of which 8 million euro was for Information Technology (Chapter 21). 
Den automatiska verfringen till 2007 i titel 2 uppgick till sammanlagt 15 miljoner euro, varav 8 miljoner euro avsg utgifter fr IT (kapitel 21).
The Agency is in the process to develop and implement a multi-annual programme of EU Telematics for the regulation of medicinal products. 
Myndigheten hller p att utveckla och genomfra ett flerrigt EU-telematikprogram fr tillsynen av lkemedel.
The governance process and the nature of the projects makes it dificult to strictly observe the annuality principle, especially as many governance steps are outside the control of the EMEA. 
Styrprocessen och projektens natur gr det svrt att flja principen om ettrighet fullt ut, i synnerhet d mnga styrtgr-der ligger utanfr EMEA:s kontroll.
The Agency has together with the national competent authorities made long efforts to assess the costs incurred by the Member StatesŐ rapporteurs. 
Myndigheten har tillsammans med de nationella behriga myndigheterna lnge gjort stora anstrngningar fr att utvrdera de kostnader som medlemsstaternas rapportrer haft.
At its December 2006 meeting the Management Board of the agency Ôtook the decision in principle to revise the scale of fees systemŐ and decided to establish a costing group in order to Ô... to prepare and agree on generally accepted international costing methods referred to in Article 12 of the fee Regulation ... Representatives from all national competent authorities will be invited to participate in this work.Ő 
Vid sitt mte i december 2006 fattade lkemedelsmyndighetens styrelse ett principbeslut om att avgiftssystemet skulle ses ver, att en kostnadsgrupp skulle inrttas fr att utarbeta och enas om allmnt godknda internationella metoder fr bestmning av kostnader enligt artikel 12 i frordningen om avgifter, samt att representanter frn samtliga nationella behriga myndigheter skulle bjudas in fr att medverka i detta arbete.
5.12.2008 EN Official Journal of the European Union C 311/27 REPORT on the annual accounts of the European Medicines Agency for the financial year 2007 together with the AgencyŐs replies (2008/C 311/05) CONTENTS INTRODUCTION ........................................................... 
5.12.2008 SV Europeiska unionens officiella tidning C 311/27 RAPPORT om rsredovisningen fr Europeiska lkemedelsmyndigheten fr budgetret 2007 samt myndighetens svar (2008/C 311/05) INNEHLL INLEDNING ...............................................................
OBSERVATIONS............................................................ 
3Đ6 28 IAKTTAGELSER ............................................................
7-9 Tables1to4 .......................................................................... 
7Đ9 28 Tabell1Đ4 ............................................................................
TheAgencyŐsreplies................................................................... 
30 Myndighetenssvar ....................................................................
Paragraph Page 28 28 28 30 33 1-2 3-6 
33 Punkt Sida 1Đ2 28
C 311/28 EN Official Journal of the European Union 5.12.2008 INTRODUCTION 1. 
C 311/28 SV Europeiska unionens officiella tidning 5.12.2008 INLEDNING 1.
The European Medicines Agency (hereinafter the Agency) was created by Council Regulation (EEC) No 2309/93 of 22 July 1993, which was replaced by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 (1). 
Europeiska lkemedelsmyndigheten (nedan kallad myndigheten) inrttades genom rdets frordning (EEG) nr 2309/93 av den 22 juli 1993 som har ersatts av Europaparlamentets och rdets frordning (EG) nr 726/2004 av den 31 mars 2004 (1).
Key data summarised from the financial statements drawn up by the Agency for the financial year 2007 are presented inTables 2, 3 and 4for information purposes. 
De viktigaste uppgifterna i myndighetens rsredovisning fr budgetret 2007 terges i tabellerna 2, 3 och 4.
The AgencyŐs accounts for the financial year ended 31 December 2007 (3) were drawn up by its Executive Director, pursuant to Article 68 of Regulation (EC) No 726/2004, and sent to the Court, which is required to give a Statement of Assurance on their reliability and on the legality and regularity of the underlying transactions. 
Myndighetens rkenskaper fr det budgetr som slutade den 31 december 2007 (3) har upprttats av myndighetens verkstllande direktr i enlighet med artikel 68 i frordning (EG) nr 726/2004 och verlmnats till revisionsrtten som ska avge en frklaring om deras tillfrlitlighet och om de underliggande transaktionernas laglighet och korrekthet.
The audit was planned and performed to obtain reasonable assurance that the accounts are reliable and that the underlying transactions are legal and regular. 
Revisionen planerades och utfrdes s att revisionsrtten skulle uppn rimlig skerhet om att rkenskaperna r tillfrlitliga och de underliggande transaktionerna lagliga och korrekta.
(3) These accounts were drawn up on 15 June 2008 and received by the Court on 1 July 2008. 
(3) Rkenskaperna upprttades den 15 juni 2008 och togs emot av revisionsrtten den 1 juli 2008.
The Court has thus obtained a reasonable basis for the Statement set out below: Reliability of the accounts The AgencyŐs accounts for the financial year ended 31 December 2007 are, in all material respects, reliable. 
Revisionen har gett revisionsrtten tillrcklig grund fr revisionsfrklaringen nedan: Rkenskapernas tillfrlitlighet Myndighetens rkenskaper fr det budgetr som slutade den 31 december 2007 r i allt vsentligt tillfrlitliga.
The AgencyŐs final budget for 2007 amounted to 163,1 million euro as compared with 138,7 million euro the previous year. 
Myndighetens slutliga budget fr 2007 uppgick till 163,1 miljoner euro jmfrt med 138,7 miljoner euro ret innan.
Of the budget appropriations, 32 million euro were carried over and 4 million euro were cancelled. 
Av budgetanslagen frdes 32 miljoner euro ver och 4 miljoner euro frfll.
As in 2006, the high level of carry-overs for administrative expenditure, 18,9 million euro, was mainly due to the programme Telematics for the regulation of medical products. 
Liksom 2006 beror de omfattande verfringarna av administrativa utgifter, 18,9 miljoner euro, till strsta delen p telematikprogrammet fr tillsyn av lkemedel.
The Agency and the other parties involved in this programme must ensure better planning and monitoring of the implementation of the programme. 
Myndigheten och vriga parter som deltar i programmet mste se till att programmet planeras bttre och att vervakningen av dess genomfrande frbttras.
This situation is at odds with the annuality principle. 
Den aktuella situationen strider mot principen om ettrighet.
The Agency should consider using the differentiated appropriations system for the Telematics programme which is more suitable for the budgetary management of such programmes. 
Myndigheten br vervga att fr telematikprogrammet anvnda systemet med differentierade anslag som r lmpligare fr budgetfrvaltning av denna typ av program.
The audit of the tendering procedures showed weaknesses: insufficient justification of the chosen procedures (5) and inadequate evaluation methods for the price criteria (6). 
Revisionen av upphandlingsfrfaranden visade p brister: bristfllig motivering av valet av frfaranden (5) och olmpliga metoder fr utvrderingen av priskriteriet (6).
In the case of a joint public procurement procedure with five other Agencies, the volume of the services to be procured had not been adequately identified. 
Vid ett gemensamt offentligt upphandlingsfrfarande med fem andra byrer hade omfattningen av de tjnster som skulle upphandlas inte identifierats tillrckligt.
This resulted in difficulties in evaluating the cost of the bids as well as the need to review the volumes and values of the services to be procured. 
Detta frsvrade bedmningen av vad frslagen kostade och innebar att omfattningen och vrdet av de tjnster som skulle upphandlas behvde gs igenom igen.
The Agency should aim to improve the quality of its public procurement procedures in order to address the issues highlighted above. 
Myndigheten br frska frbttra kvaliteten p sina offentliga upphandlingsfrfaranden i syfte att tgrda de problem som belyses ovan.
(5) Two cases. 
(5) Tv fall.
(6) Three cases. 
(6) Tre fall.
5.12.2008 EN Official Journal of the European Union C 311/29 9. 
5.12.2008 SV Europeiska unionens officiella tidning C 311/29 9.
In its 2006 report (1), the Court observed that the Agency had not performed a comprehensive analysis of the costs incurred by rapporteurs. 
I rapporten fr 2006 (1) noterade revisionsrtten att myndigheten inte hade gjort ngon ingende analys av kostnaderna fr rapportrer.
The Management Board of the Agency has established a Costing Group which at the end of 2007 prepared a report on a generally accepted international costing methods and a proposal for an alternative option for remunerating the rapporteurs. 
Myndighetens styrelse har inrttat en kostnadsgrupp som i slutet av 2007 utarbetade en rapport om allmnt godknda internationella metoder fr bestmning av kostnader och ett frslag till ett alternativt stt att erstta rapportrerna.
The Court welcomes the steps the Agency has made in order to address the issue of the evaluation of the costs and calls for further progress. 
Revisionsrtten vlkomnar de steg myndigheten har vidtagit fr att frska lsa frgan om bedmningen av kostnader och pekar p behovet av ytterligare framsteg.
For the Court of Auditors Vtor Manuel da SILVA CALDEIRA President (1) OJ C 309, 19.12.2007, p. 
Fr revisionsrtten Vtor Manuel da SILVA CALDEIRA Ordfrande (1) EUT C 309, 19.12.2007, s.
C 311/30 EN Official Journal of the European Union 5.12.2008 Areas of Community competence deriving from the Treaty Competences of the Agency as defined in Regulation (EC) No 726/2004 of the European Parliament and of the Council Governance 1. 
C 311/30 SV Europeiska unionens officiella tidning 5.12.2008 Gemenskapens behrighetsomrde enligt frdraget Myndighetens behrighet enligt Europaparlamentets och rdets frordning (EG) nr 726/2004 Organisation Medel till myndighetens frfogande 2007 Produkter och tjnster 2007 En hg hlsoskyddsniv fr mnniskor ska skerstllas vid utformning och genomfrande av all gemenskapspolitik och alla gemenskapstgrder.
Objectives Tasks Final budget for 2007: Medicinal Products for Human Use Community action, which shall complement national policies, shall be directed towards improving public health, preventing human illness and diseases and obviating sources of danger to human health. (...) of medicinal products for human and veterinary use. 
Slutlig budget fr 2007: Humanlkemedel Gemenskapens insatser, som ska komplettera den nationella politiken, ska inriktas p att frbttra folkhlsan, frebygga ohlsa och sjukdomar hos mnniskor och undanrja faror fr mnniskors hlsa. (...) ver humanlkemedel och veterinrmedicinska lkemedel.
Ń 2. 
Ń 2.
The Committee for Medicinal Products for Veterinary Use, consisting of one member and one alternate from each MemberState, advises on any question relating to the evaluation of veterinary medicinal products. 
Kommittn fr veterinrmedicinska lkemedel bestr av en ledamot och en suppleant per medlemsstat och utarbetar yttranden i alla frgor som rr utvrdering av veterinrmedicinska lkemedel.
Community contribution (excluding subsidy for orphan medicines): 24,3 % (21,6 %) Ń Favourable opinions: 58 (51); Ń Average evaluation time: (Article 152 of the Treaty) Posts occupied: 422 (395) 95 (77) other staff (auxiliary agents, 150 188 reports (94 081 reports); Source: Information supplied by the Agency. 
Kommittn fr vxtbaserade lkemedel bestr av en ledamot och en suppleant per medlemsstat och utarbetar yttranden i alla frgor som rr utvrdering av vxtbaserade lkemedel. varav tillsatta: 422 (395) 95 (77) vrig personal (extraan-Ń Skerhetsvervakning av lkemedel: 150 188 rapporter (94 081 rapporter) Klla: Uppgifter frn myndigheten.
Ń To coordinate the scientific Ń resources that the Member StatesŐ authorities make available to the Agency for the authorisation and supervision To coordinate the scientific evaluation of medicinal products which are subject to Community marketing authorisation procedures. 
Ń Samordna de vetenskapliga Ń resurser som stlls till dess frfogande av medlemsstaterna fr prvning av och tillsyn Samordna den vetenskapliga vrderingen av lkemedel som omfattas av gemenskapens frfaranden fr godknnande fr frsljning.
163,1 million euro lion euro) (138,7 mil-Ń Applications for marketing authorisations: 91 (79); Ń To provide the MemberStates and the institutions of the European Union with scientific advice on medicinal products for human or veterinary use. 
163,1 miljoner euro (138,7 miljoner euro) Ń Anskningar om godknnande fr frsljning: 91 (79) Ń Ge medlemsstaterna och gemenskapens institutioner vetenskaplig rdgivning om humanlkemedel och veteri-Ń nrmedicinska lkemedel.
Ń To coordinate the supervision of medicinal products which have been authorised within the Community (pharma-covigilance). 
441 (424) tjnster i tjnstefrteckningen Ń Yttranden efter godknnande: 1 899 (1 380) Samordna kontrollen av lkemedel som har godknts av gemenskapen (skerhetsvervakning).
Staff numbers at 31 December 2007: 171 days (171 days); Ń Opinions after authorisation: To advise on the maximum limits for residues of veterinary medicinal products which may be accepted in foodstuffs of animal origin. 
Personalstyrka den 31 december 2007: vrdering: 171 dagar (171 dagar) Ń Samordna kontrollen av verensstmmelse med principerna fr god tillverkningssed, god laboratoriesed och god klinisk sed.
The Paediatric Committee, consisting of five members with their alternates of the Committee for Medicinal Products for Human Use, one member and one alternate from each Member State, six members and alternates representing healthcare professionals and patientsŐ associations, responsible for the scientific assessment and agreement of paediatric investigation plans and for the system of waivers and deferrals thereof. tion: 10 932 (9 241); Ń Applications for paediatric Ń To record the status of marketing authorisations granted for medicinal products. 
Pediatriska kommittn bestr av fem ledamter och suppleanter frn kommittn frn humanlkemedel med en ledamot och en suppleant per medlemsstat och av sex ledamter och suppleanter som fretrder vrdpersonal och patientgrupper, och ansvarar fr den vetenskapliga bedmningen och godknnandet av pediatriska prvningsprogram och fr systemet med undantag och uppskov i samband med sdana.
The Management Board consists of one member and one alternate from each MemberState, two representatives of the Commission, two representatives appointed by the European Parliament, two representatives from patientsŐ organisations, one representative from doctorsŐ organisations and one representative from veterinariansŐ organisations. 
Styrelsen bestr av en ledamot och en suppleant per medlemsstat, tv fretrdare fr kommissionen, tv fretrdare utnmnda av Europaparlamentet, tv fretrdare fr patientorganisationer, en fretrdare fr lkarorganisationer och en fretrdare fr veterinrorganisationer.
The Board adopts the work programme and the annual report. 
Styrelsen antar arbetsprogrammet och den rliga verksamhetsrapporten.
The Executive Director is appointed by the Management Board on a proposal from the Commission. 
Verkstllande direktren utses av styrelsen efter frslag frn kommissionen.
Ń Requests for SME status 212 (145); Total staff: 518 (472) Assigned to the following duties: Operational: 444 (406) Administrative: 74 (66) Ń Scientific opinions: 215 (193); Ń Procedures for mutual recogni-(Data for 2006) investigation plans: 85 (0) relating to 202 (0) indications. Medicinal Products for Veterinary Use ants: 100 (56); Ń Inspections: 185 (128). 
Ń Anskningar om stllning som litet eller medelstort fretag: 212 (145) 518 (472) Ń Vetenskapliga yttranden: 215 (193) varav anstllda Ń Frfaranden fr msesidigt godknnande: 10 932 (9 241) (uppgifter fr 2006) (uppgifter fr 2006) stllda, kontraktsanstllda, nationella experter och inhyrd personal) Ń terkommande rapporter om uppdatering av skerhet: 313 (273) inom verksamheten: 444 (406) Ń Nya anskningar: 14 (5) Ń Anskningar om varianter: Ń Anskningar om snkt avgift eller uppskov: 81
Orphan Medicinal Products Ń Applications: 125 (104); SMEs Ń Applications for fee reduction or deferrals 81. 5.12.2008 EN Official Journal of the European Union C 311/31 Source of revenue Revenue entered in the final budget for the financial year Revenue collected Allocation of expenditure Appropriations carried over from previous year(s) Own revenue Community subsidies 113 659 40 548 116 799 40 548 Title I Staff 764 Other subsidies Other revenue 6 706 2 200 5 475 2 467 Title II Administration 47 198 64 783 44 758 64 497 25 863 52 118 18 895 12 379 2 440 286 15 061 13 585 14 360 13 257 701 328 Total 163 113 165 289 Total 163 113 159 126 127 088 32 038 3 987 29 413 28 278 1 135 Revenue Expenditure Final budget appropriations Title III Operating activities NB: Any discrepancies in totals are due to the effects of rounding. 
5.12.2008 SV Europeiska unionens officiella tidning C 311/31 Inkomsternas ursprung Inkomster i den slutliga budgeten fr budgetret Faktiska inkomster Utgiftsfrdelning Anslag taganden Anslag som frts ver frn det/de fregende budgetret/budgetren Egna inkomster Bidrag frn gemenskapen 113 659 40 548 116 799 40 548 Avdelning I Personal budgeterade 51 132 49 871 betalda 49 107 verfrda 764 frfallna 1 261 budgeterade 767 betalda 661 frfallna 106 vriga bidrag vriga inkomster 6 706 2 200 5 475 2 467 Avdelning II Administration 47 198 64 783 44 758 64 497 25 863 52 118 18 895 12 379 2 440 286 15 061 13 585 14 360 13 257 701 328 Summa 163 113 165 289 Summa 163 113 159 126 127 088 32 038 3 987 29 413 28 278 1 135 Inkomster Utgifter i den slutliga budgeten Avdelning III Drift Anm.: Eventuella differenser i totalbeloppen beror p avrundningar.
Table 2 European Medicines Agency (London) Ń Implementation of the budget for the financial year 2007 entered 51 132 committed 49 871 paid 49 107 carried over cancelled 1 261 entered 767 paid 661 cancelled 106 (1 000 euro) 
Tabell 2 Europeiska lkemedelsmyndigheten (London) Đ Budgetgenomfrandet fr budgetret 2007 (1 000 euro)