natgillin/translations-raw huggingface dataset:
The Court notes that the AgencyŐs new financial regulation, as finally adopted after receipt of the CommissionŐs opinion, takes account of the observations which the Court made in its previous report (5). 
Revisionsrtten noterar att det i myndighetens nya budgetfrordning, ssom den slutligt antogs efter yttrande av kommissionen, har tagits hnsyn till de iakttagelser revisionsrtten lmnade i sin frra rapport (5).
Similarly, the system for managing the AgencyŐs fixed assets has been considerably improved (6). 
Likas har myndighetens system fr frvaltning av anlggningstillgngar frbttrats vsenligt (6).
This Report was adopted by the Court of Auditors in Luxembourg at its meeting of 5 October 2005. 
Denna rapport har antagits av revisionsrtten vid dess sammantrde i Luxemburg den 5 oktober 2005.
For the Court of Auditors Hubert WEBER President (1) OJ L 214, 24.8.1993, p. 
Fr revisionsrtten Huber WEBER Ordfrande (1) EGT L 214, 24.8.1993, s.
(3) These accounts were drawn up on 29 September 2005 and received by the Court on 29 September 2005. 
(3) Rkenskaperna upprttades den 29 september 2005 och togs emot av revisionsrtten den 29 september 2005.
(4) Article 53(3). 
(4) Artikel 53.3.
(5) See paragraph 7 of the Report for the financial year 2003 (OJ C 324, 30.12.2004, p. 
(5) Se punkt 7 i rapporten om budgetret 2003 (EUT C 324, 30.12.2004, s.
(6) See paragraph 10 of the Report for the financial year 2003. 
(6) Se punkt 10 i rapporten om budgetret 2003.
C 332/10 EN Official Journal of the European Union 28.12.2005 Areas of Community competence deriving from the Treaty Competences of the Agency Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 Governance The Committee for Propri-Resources made available to the Agency (2003 figures) Products and services ties make available to the Community action, which Agency for the authorisa-Favourable opinions: 34 (39) Average evaluation time: 187 days (190 days) Opinions after authorisation: 926 (941) Pharmacovigilance: 64 186 reports (45 538 reports) Periodic reliability reports: 253 (276) Monitoring measures: 948 (1 025) Scientific opinions: 77 (65) Procedures for mutual recognition: 7 081 (4 080) Veterinary medicinal products New applications: 8 (10) Applications in respect of variants: 40 (64) Inspection: 93 (76) Objectives Tasks 1. 
C 332/10 SV Europeiska unionens officiella tidning 28.12.2005 Gemenskapens behrighetsomrde enligt frdraget Myndighetens behrighet enligt Europaparlamentets och rdets frordning (EG) nr 726/2004 av den 31 mars 2004 Organisation Medel till byrns frfogande Produkter och tjnster Uppgift 1. frande av all gemenskapspo-Ń Samordna de vetenskap-Ń Samordna den vetenskapliga Kommittn fr farmaceutiska specialiteter bestr av tv ledamter per medlemsstat och utarbetar yttranden i alla frgor som rr utvrdering av humanlkemedel.
99,1 million euro lion euro) including the Community contribution (excluding subsidy for orphan medicines): 24,7 % (22,9 %) Applications for marketing authorisations: 51 (39) shall complement national tion and supervision of policies, shall be directed medicinal products for Ń towards improving public human and veterinary health, preventing human ill-use; ness and diseases and obviating sources of danger to Ń to provide the Member human health. (...) 
Slutlig budget Humanlkemedel En hg hlsoskyddsniv fr mnniskor skall skerstllas vid utformning och genom-Ml litik och alla gemenskapst-liga resurser som stlls till vrderingen av lkemedel som grder. dess frfogande av med-omfattas av gemenskapens lemsstaterna fr prvning frfaranden fr godknnande 99,1 miljoner euro (84,2 miljoner euro) varav bidrag frn gemenskapen (exklusive bidrag fr srlkemedel): 24,7 % (22,9 %). Anskningar om godknnande fr frsljning: 51 (39) av och tillsyn ver human-fr frsljning.
States and the institutions to coordinate the supervision of medicinal products which 2. have been authorised within the Community; (pharma-covigilance); The Committee for Veterinary Medicinal Products, consisting of two members from each Member State, advises on any question relating to the evaluation of veterinary medicinal products. Staff numbers at 31 December 2004: (Article 152 of the Treaty) with scientific advice on medicinal products for to advise on the maximum limits for residues of veterinary medicinal products which may be accepted in 3. foodstuffs of animal origin; Posts occupied: 290 (256) Source: Information supplied by the Agency. of the European Union Ń 314 (287) posts provided for in the establishment plan human or veterinary use. 
Personalstyrka den 31 december 2004 Positivt yttrande: 34 (39) Genomsnittlig tidstgng fr vrdering: skall komplettera den natio-medicinska lkemedel. nella politiken, skall inriktas Ń Samordna kontrollen av lke-187 dagar (190 dagar) Yttrande efter godknnande: 926 (941) p att frbttra folkhlsan, medel som har godknts av frebygga ohlsa och sjukdo-Ń Ge medlemsstaterna och gemenskapen (skerhetsver-314 (287) tjnster enligt tjnstefrteckningen mar hos mnniskor och gemenskapens institutio-vakning). undanrja faror fr mnnis-ner vetenskaplig rdgiv-kors hlsa. (...) ning om humanlkemedel Ń Yttra sig om maximalt tilltna Klla: Uppgifter frn myndigheten och veterinrmedicinska restmngder av veterinrme-lkemedel. varav tillsatta: 290 (256) + 50 (48) andra tjnster (extraan-Skerhetsvervakning: 64 186 rapporter (Artikel 152 i frdraget) dicinska lkemedel i livsmedel 3. med animaliskt ursprung.
The Management Board, consisting of two representatives of each Member State, two representatives of the Commission and two representatives appointed by the European Parliament. 
Styrelsen bestr av tv fretrdare fr varje medlemsstat, tv fretrdare fr kommissionen och tv fretrdare som utses av Europaparlamentet.
The Board adopts the work programme and the annual report. 
Antar arbetsprogrammet och den rliga verksamhetsrapporten.
Ń to coordinate verification of compliance with the principles of good manufacturing practice, good laboratory practice and good clinical practice; + 50 (48) other posts (auxiliary contracts, seconded national experts, local staff, employment agency staff) Ń to record the status of 4. marketing authorisations granted for medicinal products. 
(45 538 rapporter) Ń Samordna kontrollen av verensstmmelse med principerna fr god tillverkningssed, god laboratoriesed och god klinisk sed. stllda, nationella experter, lokalt anstllda, korttidsanstllda) terkommande rapporter om skerhet: 253 (276) Ń Fra register ver lkemedel 4. som godknts fr frsljning.
The Executive Director is appointed by the Management Board on a proposal from the Commission. Total staff: 340 (304) Assigned to the following duties: operational: 271 (242) administrative: 69 (62) Table 1 European Medicines Agency (London) 5. 
Direktren utses av styrelsen efter frslag frn kommissionen. uppgifter inom verksamheten: 271 (242) Frfaranden fr msesidigt godknnande: 7 081 (4 080) Tabell 1 Europeiska lkemedelsmyndigheten (London) 5.
External audit: European Court of Auditors 6. Discharge is given by the Parliament on a recommendation from the Council. 
Extern granskning Revisionsrtten. administrativa uppgifter: 69 (62) Veterinrlkemedel 6.
(84,2 mil-(2003 figures) 28.12.2005 EN Official Journal of the European Union C 332/11 Origin of revenue Revenue entered in the final budget for the financial year Revenue collected Allocation of expenditure outstand- Community subsidies (1) 29 073 29 022 Title I Staff 36 064 34 151 33 509 642 1 913 534 424 110 36 598 34 685 33 933 642 2 023 Own revenue 67 000 67 350 Title II Administration 23 994 23 878 12 943 10 935 116 7 265 6 749 516 31 259 31 143 19 692 10 935 632 Other revenue 3 016 3 013 Title III Operating activities 39 031 38 686 27 512 11 174 345 8 316 7 878 438 47 347 47 002 35 390 11 174 783 Total 99089 99385 Total 99089 96715 73964 22751 2374 16115 15051 1064 115204 112830 89015 22751 3438 Revenue Expenditure (1) Including subsidies received from the European Economic Area. 
28.12.2005 SV Europeiska unionens officiella tidning C 332/11 Inkomsternas ursprung Inkomster i den slutliga budgeten fr budgetret Faktiska inkomster Anslag i den slutliga budgeten budge-tagan- betalda verfr- ende betalda fr-anslag tagan-betalda ver-frfallna Bidrag frn gemenskapen (1) 29 073 29 022 Avdelning I Personal 36 064 23 994 34 151 23 878 33 509 12 943 642 1 913 10 935 116 534 424 110 36 598 34 685 33 933 642 2 023 Egna inkomster vriga inkomster 67 000 67 350 Avdelning II Administration 7 265 6 749 516 31 259 31 143 19 692 10 935 632 Totalt 99 089 99 385 Totalt 99089 96715 73964 22751 2374 16115 15051 1064 115204 112830 89015 22751 3438 Inkomster Utgifter 3 016 3 013 Avdelning III Drift 39031 38686 27512 11174 345 8316 7 878 438 47 347 47 002 35 390 11 174 783 (1) Inklusive bidrag frn Europeiska ekonomiska samarbetsomrdet.
Source: The AgencyŐs data Ń 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.
Table 2 European Medicines Agency Ń Implementation of the budget for the financial year 2004 Appropriations in the final budget Appropriations carried over from the previous financial year Appropriations available (2004 budget and financial year 2003) entered com-paid carried can-ing paid can-appro- commit-paid carried cancelled mitted over celled commit- ments celled priations ted over (1 000 euro) C 332/12 EN Official Journal of the European Union Table 3 28.12.2005 (1 000 euro) 2003 (1) 58 657 19 786 2 814 1 208 1 703 1 788 85 956 29 663 10 835 32 838 2 364 0 75 700 10 256 676 10 932 European Medicines Agency Ń Revenue and expenditure account for the financial years 2004 and 2003 Revenue Fees relating to marketing authorisations Commission subsidy including contributions received from the EEA Community subsidy for orphan medicines Contributions for Community programmes Administrative revenue Sundry revenue Expenditure Staff expenditure Administrative expenditure Operating expenditure Depreciation Other expenses Total (a) Total (b) Operating result (c = a Đ b) Financial result (e) Economic outturn (f = c + e) 2004 68 412 20 529 4 026 0 1 973 1 473 96 413 34 333 11 224 38 573 3 650 280 88 060 8 353 1 160 9 513 (1) The data for the financial year 2003 have been reprocessed to make them comparable to those of 2004. 
C 332/12 Inkomster Avgifter fr godknnande fr frsljning p marknaden Bidrag frn kommissionen, inklusive bidrag frn EES Bidrag frn gemenskapen fr srlkemedel Bidrag fr gemenskapsprogram Inkomster frn administrativ verksamhet vriga inkomster Utgifter Personalutgifter Administrativa utgifter Driftsutgifter Avskrivningar vriga kostnader SV Europeiska unionens officiella tidning Tabell 3 Europeiska lkemedelsmyndigheten Đ Resultatrkning fr budgetren 2004 och 2003 28.12.2005 (1 000 euro) 2003 (1) 58 657 19 786 2 814 1 208 1 703 1 788 85 956 29 663 10 835 32 838 2 364 0 75 700 10 256 676 10 932 Totalt (a) Totalt (b) Resultat av verksamheten (c = a Đ b) Finansiellt resultat (e) Ekonomiskt resultat (f = c + e) 2004 68 412 20 529 4 026 0 1 973 1 473 96 413 34 333 11 224 38 573 3 650 280 88 060 8 353 1 160 9 513 (1) Uppgifterna fr budgetret 2003 har omarbetats fr att kunna jmfras med uppgifterna fr 2004.
28.12.2005 EN Official Journal of the European Union C 332/13 Assets 2004 5 109 2 480 1 375 3 151 7 006 1 888 148 1 795 2 061 5 892 35 010 53 017 2003 3 401 1 635 1 011 2 548 5 194 1 105 107 1 034 64 2 310 28 286 39 191 Liabilities (1 000 euro) 2004 2003 Amounts owed by Community institutions and bodies Current liabilities Other accounts payable Advances from customers Sundry accounts receivable Sundry receivables and advances Available assets Subtotal Total Subtotal Total Table 4 European Medicines Agency Ń Balance sheet at 31 December 2004 and 31 December 2003 Intangible assets Fixed assets Own capital Plant, machinery and tools Furniture and vehicle fleet Computer equipment Current assets VAT paid and to be recovered Economic outturn Current liabilities Subtotal Subtotal Amounts owed in social security charges Amounts owed to Community institutions and bodies Outturn carried over from previous financial years 13 767 9 513 23 280 320 4 910 13 151 106 11 250 29 737 53 017 6 872 10 932 17 804 0 479 11 936 127 8 845 21 387 39 191 Source: The AgencyŐs data Ń This table summarises the data provided by the Agency in its annual accounts. 
28.12.2005 SV Europeiska unionens officiella tidning C 332/13 Tabell 4 Europeiska lkemedelsmyndigheten Đ Balansrkning per den 31 december 2004 och den 31 december 2003 Tillgngar Immateriella anlggningstillgngar 2004 5 109 2 480 1 375 3 151 7 006 1 888 148 1 795 2 061 5 892 35 010 53 017 2003 3 401 1 635 1 011 2 548 5 194 1 105 107 1 034 64 2 310 28 286 39 191 Skulder och eget kapital (1 000 euro) 2004 2003 13 767 6 872 9 513 10 932 23 280 17 804 320 0 4 910 479 13 151 11 936 106 127 11 250 8 845 29 737 21 387 53 017 39 191 Materiella anlggningstillgngar Installationer, maskiner och verktyg Inventarier och fordon Datautrustning Omsttningstillgngar Momsfordran Fordringar p gemenskapsorgan och gemenskapsinstitutioner Ekonomiskt resultat Kortfristiga skulder Skulder avseende sociala avgifter Skulder till gemenskapsorgan och gemenskapsinstitutioner Lpande skulder vriga skulder Frskott frn kunder Delsumma Eget kapital Resultat som frts ver frn fregende budgetr Diverse gldenrer Diverse fordringar och frskott Likvida medel Delsumma Delsumma Totalt Delsumma Totalt Klla: Uppgifter frn myndigheten.
C 332/14 EN Official Journal of the European Union 28.12.2005 THE AGENCYŐS REPLIES 7. 
C 332/14 SV Europeiska unionens officiella tidning 28.12.2005 MYNDIGHETENS SVAR 7.
The Audit Advisory Committee is a consultative body and has no operational role in the internal organisation of the Agency. 
Granskningskommittn r ett rdgivande organ och har ingen operativ roll i myndighetens interna organisation.
On 4 February 2005 the Management Board of the agency adopted the Terms of Reference of the Audit Advisory Committee which include the mission statement of this committee as well as the rules of proceedings. 
Den 4 februari 2005 antog styrelsen den rdgivande granskningskom-mittns mandat, som innefattar uppdragsbeskrivningen fr kommittn samt dess arbetsordning.
The Agency has had to implement a wide-ranging reform of the Financial Regulation and Accounting procedures over the last few years. 
Myndigheten har under de senaste ren varit tvungen att i omfattande grad modernisera budgetfrordningen och redovis-ningsfrfarandena.
It was considered prudent not to seek a change in the main bank at the same time due to the integration of our systems with this bankŐs electronic payment system. 
Det har inte ansetts lmpligt att samtidigt byta huvudbank eftersom vra system samordnats med denna banks elektroniska betalningssystem.
Now that the Agency is in the final stage of implementing the new Financial Regulation, a call for tender will be launched in the last quarter of this year. 
Nu nr myndigheten befinner sig i slutskedet av den nya budgetfrordningens genomfrande kommer en anbudsinfordran att utfrdas i r under det sista kvartalet.
However it should be noted that substantial reductions in bank transfer costs have been achieved through direct negotiations with the bank and automation of payments. 
Det br dock noteras att kraftiga minskningar av kostnaderna fr bankverfringar har stadkommits genom direkta frhandlingar med banken och automatisering av betalningarna.
Also placements of funds are subject to individual bids from up to three banks based on the market rates on a particular day. 
Likas r placeringar av medel freml fr enskilda anbud frn upp till tre banker i enlighet med marknadskurserna en viss dag.
The Agency notes with satisfaction that these points, mentioned in the CourtŐs report on the 2003 accounts, have been resolved. 
Myndigheten noterar med tillfredsstllelse att dessa punkter som nmnts i revisionsrttens rapport om rkenskaperna fr 2003 har tgrdats.
C 312/12 EN Official Journal of the European Union 19.12.2006 REPORT on the annual accounts of the European Medicines Agency for the financial year 2005 together with the AgencyŐs replies (2006/C 312/03) CONTENTS INTRODUCTION ........................................................... 
C 312/12 SV Europeiska unionens officiella tidning 19.12.2006 RAPPORT om rsredovisningen fr Europeiska lkemedelsmyndigheten fr budgetret 2005 samt myndighetens svar (2006/C 312/03) INNEHLLSF RTECKNING INLEDNING ...............................................................
OBSERVATIONS............................................................ 
3Đ6 13 IAKTTAGELSER ............................................................
7-11 13 Tables1to4 .......................................................................... 
7Đ11 13 Tabeller1Đ4...........................................................................
15 TheAgencyŐsreplies................................................................... 
15 Myndighetenssvar ....................................................................
17 Paragraph Page 1-2 13 3-6 13 
17 Punkt Sida 1Đ2 13
19.12.2006 EN Official Journal of the European Union C 312/13 INTRODUCTION 1. 
19.12.2006 SV Europeiska unionens officiella tidning C 312/13 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 ÓmyndighetenÓ) 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).
Table 1 summarises the AgencyŐs competences and activities. 
I tabell 1 ges en sammanfattning av myndighetens behrighet och verksamhet.
Key information from the financial statements drawn up by the Agency for the financial year 2005 is presented in Tables 2, 3 and 4. 
De viktigaste uppgifterna i myndighetens rsredovisning fr budgetret 2005 presenteras i tabellerna 2, 3 och 4.
This Statement is addressed to the European Parliament and the Council in accordance with Article 185(2) of Council Regulation (EC, Euratom) No 1605/2002 (2); it was drawn up following an examination of the AgencyŐs accounts, as required by Article 248 of the Treaty establishing the European Community. 
Denna revisionsfrklaring riktas till Europaparlamentet och rdet i enlighet med artikel 185.2 i rdets frordning (EG, Euratom) nr 1605/2002 (2). Den har utarbetats efter en granskning av myndighetens rkenskaper i enlighet med bestmmelserna i artikel 248 i frdraget om upprttandet av Europeiska gemenskapen.
The AgencyŐs accounts for the financial year ended 31 December 2005 (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 2005 (3) har upprttats av myndighetens direktr i enlighet med artikel 68 i frordning (EG) nr 726/2004 och verlmnats till revisionsrtten som skall avge en frklaring om deras tillfrlitlighet och om de underliggande transaktionernas laglighet och korrekthet.
18 and OJ L 136, 30.4.2004, p. 
18 och EUT L 136, 30.4.2004, s.
(3) These accounts were drawn up on 27 June 2006 and received by the Court on 27 July 2006. 
(3) Rkenskaperna upprttades den 27 juni 2006 och togs emot av revi-6.
Reliability of the accounts The AgencyŐs accounts for the financial year ended 31 December 2005 are, in all material respects, reliable. 
Rkenskapernas tillfrlitlighet Myndighetens rkenskaper fr det budgetr som slutade den 31 december 2005 r i allt vsentligt tillfrlitliga.
As regards the implementation of the budget, the utilisation rates for commitment appropriations (94 %) and payment appropriations (82 %) were on the whole high. 
Nr det gller budgetgenomfrandet var utnyttjandegraden fr tagandebemyndiganden (94 %) och betalningsbemyndiganden (82 %) generellt sett hg.
For administrative expenditure (Title II), however, the utilisation rate for commitment appropriations was less than 90 %, and more than 40 % of the commitments made were carried over to the following financial year. 
Nr det gller administrativa kostnader (avdelning II) var dock utnyttjandegraden fr tagandebemyndiganden mindre n 90 %, och ver 40 % av de taganden som ingtts har verfrts till nstkommande budgetr.
The access rights to the computer system did not always correspond to the delegations in force. In 2005, a member of staff, who had had no delegation since 2004, still had the corresponding access rights to the computer system. 
Tilltrdesrttigheterna till datasystemet motsvarar inte alltid den gllande ansvarsdelegeringen. r 2005 hade en tjnsteman som inte hade haft ngot delegerat ansvar sedan 2004 fortfarande tilltrdesrttigheter till datasystemet.
From the end of 2004, the Agency has managed funds (4) collected from other Agencies and bodies to finance a common support service to develop their financial management information systems. 
Frn slutet av 2004 frvaltade myndigheten medel (4) frn andra byrer och organ fr att finansiera en gemensam stdtjnst i syfte att utveckla informationssystemen fr finansfrvaltning.
Up to 2005, these funds were not presented in the AgencyŐs annual accounts, as was the case with other Agencies which managed the funds in earlier years following a rotational system. 
Fram till 2005 tog myndigheten inte upp dessa medel i sin rsredovisning, vilket de andra organen gjorde nr de enligt ett rota-tionssystem frvaltade medlen under tidigare r.
There were (4) Approximately 400 000 euro. 
(4) Omkring 400 000 euro.
C 312/14 EN Official Journal of the European Union 19.12.2006 no formal decisions concerning the appointment of evaluation committees. 
C 312/14 SV Europeiska unionens officiella tidning 19.12.2006 om att ledamterna i kommitterna skall vara hierarkiskt oberoende av varandra fljdes inte.
The Court again notes that the contracts concluded with the banks have been in force for over six years even though the detailed rules for the implementation of the AgencyŐs financial regulation lay down that there should be a new call for tenders at least once every five years. 
Revisionsrtten gr terigen iakttagelsen att kontrakten med banker gller sedan mer n fem r tillbaka trots att det i genomfrandebestmmelserna till myndighetens budgetfrordning sgs att en ny upphandling skall gras minst vart femte r.
19.12.2006 EN Official Journal of the European Union C 312/15 Areas of Community competence deriving from the Treaty Competences of the Agency Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 Governance 1. The Committee for Medicinal Products Resources made available to the Agency in 2005 (2004) Products and Services in 2005 (2004) A high level of human health protection shall be ensured in the definition and implementation of all Community policies and activities. 
19.12.2006 SV Europeiska unionens officiella tidning C 312/15 Gemenskapens behrighetsomrde enligt frdraget Myndighetens behrighet enligt Europaparlamentets och rdets frordning (EG) nr 726/2004 av den 31 mars 2004 Organisation Medel till byrns frfogande 2005 (2004) Produkter och tjnster 2005 (2004) Humanlkemedel En hg hlsoskyddsniv fr mnniskor skall skerstllas vid utformning och genomfrande av all gemenskapspolitik och alla gemenskapstgrder Ml Uppgift 1.