natgillin/translations-raw huggingface dataset:
Objectives: Tasks: Final budget for 2005: 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. (...) 
Kommittn fr humanlkemedel bestr av en ledamot och en suppleant per medlemsstat och utarbetar yttranden i alla frgor som rr utvrdering av humanlkemedel Slutlig budget 2005 Gemenskapens insatser, som skall komplettera den nationella politiken, skall 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. (...)
The Committee for Medicinal Products for Veterinary Use, consisting of one member and one alternate from each Member State, advises on any question relating to the evaluation of veterinary medicinal products. Community contribution (excluding subsidy for orphan medicines): 22,7 % (24,7 %) Ń Favourable opinions: 24 (34) (Article 152 of the Treaty) Posts occupied: 337,5 (290) Ń Pharmacovigilance: 91 565 reports (64 186 reports) Source: Information supplied by the Agency. 
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 Bidrag frn gemenskapen (frutom bidrag fr srlkemedel): 22,7 % (24,7 %) Ń Positiva yttranden: 24 (34) (Artikel 152 i frdraget) Ń Yttra sig om hgsta tilltna restmngder av veterinrmedicinska lkemedel i livsmedel med animaliskt ursprung varav tillsatta: 337,5 (290) + 34 (50) andra tjnster Ń Skerhetsvervakning: 91 565 rapporter (64 186 rapporter) Klla: Uppgifter frn myndigheten.
3. The Committee for Orphan Medicinal Products, consisting of one member and one alternate from each Member State, advises on any question relating to the evaluation of orphan medicinal products. 379 (314) posts provided for in the establishment plan Ń Opinions after authorisation: 1 148 (926) Ń to coordinate the supervision of medicinal products which have been authorised within the Community; (pharma-covigilance), Staff numbers at 31 December 2005: Ń Average evaluation time: 203 days (187 days) Ń to advise on the maximum limits for residues of veterinary medicinal products which may be accepted in foodstuffs of animal origin, 4. 
Ń Samordna de vetenskapliga resurser som stlls till dess frfogande av medlemsstaterna fr godknnande av och tillsyn ver humanlkemedel Ń Samordna den vetenskapliga utvrderingen av lkemedel som omfattas av gemenskapens frfaranden fr godknnande fr frsljning 111,8 miljoner euro (99,4 miljoner euro) Ń Anskningar om godknnande fr frsljning: 43 (51) och veterinrmedicinska lkemedel Ń Samordna kontrollen av lkemedel som har godknts av gemenskapen (skerhetsvervakning) Personalstyrka den 31 december 2005 Ń Genomsnittlig tidstgng fr utvrdering: 203 dagar (187 dagar) Ń Ge medlemsstaterna och Europeiska unionens institutioner vetenskaplig rdgivning om humanlkemedel och veterinrmedicinska lkemedel 3.
The Committee on Herbal Medicinal Products, consisting of one member and one alternate from each Member State, advises on any question relating to the evaluation of herbal medicinal products. + 34 (50) other posts (auxiliary contracts, seconded national experts, local staff, employment agency staff) Ń Periodic reliability reports: 279 (253) Ń to coordinate verification of compliance with the principles of good manufacturing practice, good laboratory practice and good clinical practice, 5. 
Kommittn fr srlkemedel bestr av en ledamot och en suppleant per medlemsstat och utarbetar yttranden i alla frgor som rr utvrdering av srlkemedel 379 (314) tjnster enligt tjnstefrteckningen Ń Yttranden efter godknnande: 1 148 (926) Ń Samordna kontrollen av efterlevnad av principerna fr god tillverkningssed, god laboratoriesed och god klinisk sed 5.
The Management Board consisting 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 patients organisations, one representative from doctors organisations and one representative from veterinarians 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: Operational: 302,5 (271) Administrative: 69 (69) Ń Procedures for mutual recognition: 8 451 (7 081) Ń to record the status of marketing authorisations granted for medicinal products. 
Styrelsen antar arbetsprogrammet och den rliga verksamhetsrapporten Personalstyrka totalt: 371,5 (340) Ń Vetenskapliga yttranden: 135 (77) Ń Fra register ver lkemedel som godknts fr frsljning 302,5 (271) 8 451 (7 081) Tabell 1 Europeiska lkemedelsmyndigheten (London) 4.
The Executive Director is appointed by the Management Board on a proposal from the Commission. variants: 70 (40) Ń Inspections: 114 (93) Orphan Medicinal Products Ń Applications: 118 (108) 7. 
Verkstllande direktren utses av styrelsen efter frslag frn kommissionen Ń Inspektioner: 114 (93) Srlkemedel Ń Anskningar: 118 (108) Ń Positiva yttranden: 88 (75) 7.
External audit: European Court of Auditors and European CommissionŐs Internal Audit Service. 8. 
Extern revision Europeiska revisionsrtten och kommissionens tjnst fr internrevision 8.
C 312/16 EN Official Journal of the European Union 19.12.2006 Source of revenue Allocation of expenditure Community subsidies (1) 31 180 77 455 33 734 71 895 Title I Staff 41356 39307 38608 700 2048 642 536 106 41998 39949 39 144 700 2 154 Own revenue Other revenue Title II Administration 27105 24047 15974 10041 1090 10935 10590 345 38040 34982 26564 10041 1435 Operating revenue Assets Community subsidies Revenue 28 957 24 556 71 857 96 413 Fixed assets Receivables Cash accounts 17 437 5 490 29 934 52 861 12 115 5 892 35 010 53 017 Operating expenditure Total Staff Administration Operating activities 40 057 22 459 41 999 34 333 15 154 38 573 88 060 Liabilities Other income (d) Other charges (e) 1 160 0 9 513 Total 111835 109396 Total 111835 105354 88489 18833 4513 22751 21649 1102 134586 128105 110138 18833 5615 Revenue Expenditure Revenue entered in the final budget for the financial year Revenue collected Final budget appropriations Appropriations carried over from the previous financial year Appropriations for the financial year plus appropriations carried over from the previous financial year 3 200 3 767 Title III Operating activities (1) Including subsidies received from the European Economic Area. 
C 312/16 SV Europeiska unionens officiella tidning 19.12.2006 Inkomsternas ursprung Inkomster i den slutliga budgeten fr budgetret Faktiska inkomster Anslag i den slutliga budgeten Anslag som frts ver frn det fregende budgetret Anslag fr budgetret och fr det fregende budgetret Bidrag frn gemenskapen (1) 31 180 77 455 33 734 71 895 Avdelning I Personal 41356 39307 38608 700 2048 642 536 106 41998 39949 39144 700 2154 Egna inkomster Avdelning II Administration vriga inkomster 3 200 3 767 Avdelning III Drift Driftsintkter Tillgngar Totalt 111 835 109 396 Totalt 111835 105354 88489 18833 4513 22751 21649 1102 134586 128105 110138 18833 5615 Bidrag frn gemenskapen Intkter 28 957 24 556 71 857 96 413 Anlggningstillgngar Omsttningstillgngar Likvida medel 17 437 5 490 29 934 52 861 12 115 5 892 35 010 53 017 Driftskostnader Totalt Personal Administration Drift 40 057 22 459 41 999 34 333 15 154 38 573 88 060 Skulder och eget kapital vriga intkter (d) vriga kostnader (e) 1 160 0 Inkomster Utgifter (1) Inklusive bidrag frn Europeiska ekonomiska samarbetsomrdet.
Table 3 Table 4 Revenue and expenditure account for the financial years 2005 and 2004 Balance sheet at 31 December 2005 and 2004 104 515 2 121 2 257 0 Economicresult(f=c+dĐe) 4378 Results accumulated from previous financial years Economic result for the year Current liabilities 23 280 4 378 25 203 52 861 13 767 9 513 29 737 53 017 Total (b) Operating result (c = a Đ b) 8 353 Total Source: Agency data Ń These tables summarise the data supplied by the Agency in its annual accounts. 
Tabell 3 Tabell 4 Resultatrkning fr budgetren 2005 och 2004 Balansrkning per den 31 december 2005 och 2004 Totalt (b) Driftsresultat (c = a Đ b) 104 515 2 121 2 257 0 Ackumulerat verskott/underskott Ekonomiskt resultat fr budgetret Kortfristiga skulder 23 280 4 378 25 203 52 861 13 767 9 513 29 737 53 017 Ekonomiskt resultat (f = c + d Đ e) 4 378 9 513 Klla: Uppgifter frn myndigheten.
Total (a) 106 636 2005 2004 2005 2004 77 679 EUROPEAN MEDICINES AGENCY (1 000 euro) (1 000 euro) Table 2 Implementation of the budget for the financial year 2005 entered commit-paid carried can-available paid can-available committed over celled celled ted paid carried over cancelled 43 374 42 000 33 907 8 092 1 375 11 174 10 523 651 54 548 53 174 44 430 8 092 2 026 (1 000 euro) 
Utgiftsfrdelning budgeten tagan-betalda ver-frfallna dispo-betalda frfallna dispo-tagan- betalda ver-frfallna den frda nibla nibla den frda Totalt (a) 106 636 2005 2004 2005 2004 77 679 EUROPEISKA LKEMEDELSMYNDIGHETEN (1 000 euro) (1 000 euro) 8 353 Totalt Tabell 2 Budgetgenomfrande fr budgetret 2005 27105 24047 15974 10041 1090 10935 10590 345 38040 34982 26564 10041 1435 43 374 42 000 33 907 8 092 1 375 11 174 10 523 651 54 548 53 174 44 430 8 092 2 026 (1 000 euro)
19.12.2006 EN Official Journal of the European Union C 312/17 THE AGENCYŐS REPLIES 7. 
19.12.2006 SV Europeiska unionens officiella tidning C 312/17 MYNDIGHETENS SVAR 7.
The high carry-over 2004-2005 on Title 2 is mainly due to the Telematics expenditure programme, which accounts for 80 % of the carry-overs. The Telematics carry-overs were high because this programme comprises a number of large and complex multi-annual projects covering the whole EU that stretched from 2004 through into 2005. 
De stora verfringarna 2004Đ2005 fr avdelning 2 beror i huvudsak p telematikprogrammet som str fr 80 % av verfringarna. verfringarna fr telematikprogrammet var stora eftersom detta program bestr av ett antal stora och komplexa flerriga projekt som omfattar hela EU och som pgick under hela 2004 och fortsatte in i 2005.
Security access has been rectified and all delegated authorising officers were instructed that they must take care to sign the right transaction (in SI2) based on the delegation decision and that they must act with due diligence in this regard. 
Skerhetsbehrigheter har rttats till och samtliga utanordnare med delegerat ansvar har ftt instruktioner om att de mste vara noga med att godknna rtt transaktion (i SI2) med delegeringsbeslutet som grund och att de skall visa stor omsorg nr de gr detta.
The CSS expenditure for 2006 will be included in the EMEA budget with the first Amending Budget and the costs will be charged to the members. 
Utgifterna under 2006 fr det gemensamma supportcentrumet kommer att tas med i EMEA:s budget vid den frsta nd-ringsbudgeten, och kostnaderna kommer att debiteras medlemmarna.
Disclosure of the CSS activities in 2005 has been made in note 4 of the EMEA 2005 Accounts. 
Verksamheten fr det gemensamma supportcentrumet under 2005 beskrevs i anmrkning 4 i EMEA:s rsredovisning 2005.
The composition of evaluation committees, often made up of more than three persons, is based on the principle that bids should be evaluated by persons both independent and with appropriate expertise. 
Sammansttningen av utvrderingskommitter, som ofta bestr av fler n tre personer, grundar sig p principen att anbud skall utvrderas av personer som bde r oberoende och har lmplig sakkunskap.
In any case, a minimum of three persons participate to the meetings and the minutes for each meeting are distributed for discussion and approval. 
Minst tre personer deltar alltid i mtena, och protokoll frn varje mte distribueras fr diskussion och godknnande.
In the future, the Agency will request that minutes include a justification in case of absence of a member. 
I framtiden kommer myndigheten att begra att protokollet innehller en motivering om ngon ledamot varit frnvarande.
In 2006, the Agency has launched a tender for banking services. 
Under 2006 har myndigheten inlett en upphandling av banktjnster.
The delay mentioned by the Court is due to the fact that over the last years, the financial system of the Agency has been overhauled and it would have been too disruptive to implement a change of bank. 
Frseningen som revisionsrtten nmner beror p det faktum att lkemedelmyndighetens finansiella system har genomgtt en versyn under de senaste ren, och det skulle ha varit alltfr strande att genomfra ett byte av bank.
C 309/34 EN Official Journal of the European Union 19.12.2007 REPORT on the annual accounts of the European Medicines Agency for the financial year 2006 together with the AgencyŐs replies (2007/C 309/07) CONTENTS INTRODUCTION ........................................................... 
C 309/34 SV Europeiska unionens officiella tidning 19.12.2007 RAPPORT om rsredovisningen fr Europeiska lkemedelsmyndigheten fr budgetret 2006 samt myndighetens svar (2007/C 309/07) INNEHLLSF RTECKNING INLEDNING ...............................................................
OBSERVATIONS............................................................ 
3Đ6 35 IAKTTAGELSER ............................................................
7-8 35 Tables1to4 .......................................................................... 
7Đ8 35 Tabell1Đ4 ............................................................................
37 TheAgencyŐsreplies................................................................... 
37 Myndighetenssvar ....................................................................
39 Paragraph Page 1-2 35 3-6 35 
39 Punkt Sida 1Đ2 35
19.12.2007 EN Official Journal of the European Union C 309/35 INTRODUCTION 1. 
19.12.2007 SV Europeiska unionens officiella tidning C 309/35 INLEDNING 1.
The European Medicines Agency (hereinafter Ôthe AgencyŐ) 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).
Key data summarised from the financial statements drawn up by the Agency for the financial year 2006 is presented inTables 2, 3 and 4 for information purposes. 
De viktigaste uppgifterna i myndighetens rsredovisning fr budgetret 2006 terges 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 upprttades efter en granskning av myndighetens rkenskaper i enlighet med artikel 248 i frdraget om upprttandet av Europeiska gemenskapen.
The AgencyŐs accounts for the financial year ended 31 December 2006 (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 2006 (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 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 21 June 2007 and received by the Court on 17 July 2007. 
(3) Rkenskaperna upprttades den 21 juni 2007 och mottogs av revisionsrtten den 17 juli 2007.
Reliability of the accounts The AgencyŐs accounts for the financial year ended 31 December 2006 are, in all material respects, reliable. 
Rkenskapernas tillfrlitlighet Myndighetens rkenskaper fr det budgetr som slutade den 31 december 2006 r i allt vsentligt tillfrlitliga.
As regards the implementation of the budget for administrative expenditure (Title II), the utilisation rate for commitment appropriations was less than 60 %. More than 40 % of the commitments, in particular in the area of Information Technology, were carried over to the financial year 2007. 
Nr det gller genomfrandet av budgeten fr administrativa utgifter (avdelning II) var utnyttjandegraden fr tagandebemyndiganden lgre n 60 %. ver 40 % av tagandena, i synnerhet fr informationsteknik, frdes ver till budgetret 2007.
Article 12(4) of the Fee Regulation (4) states ÔAny review of the fees shall be based on an evaluation of the AgencyŐs costs and on the basis of the related costs of the services provided for by the Member States. 
I artikel 12.4 i frordningen om avgifter (4) anges att Óvarje versyn av avgifterna skall grundas p en utvrdering av myndighetens kostnader och de tillhrande kostnaderna fr de tjnster som tillhandahlls av medlemsstaterna.
Those costs shall be calculated in accordance with generally accepted international costing methods, which shall be adopted in accordance with Article 11(2).Ő Up to now, (4) As amended by Council Regulation (EC) No 1905/2005 amending Council Regulation (EC) No 297/95 (OJ L 304, 23.11.2005, p. 1). 
Kostnaderna skall berknas enligt internationellt vedertagna metoder fr bestmning av kostnader, vilka skall antas i enlighet med artikel 11.2.Ó Hittills har myndighetens kunder fakturerats ett belopp som delas i tv (4) Ssom ndrad genom rdets frordning (EG) nr 1905/2005 om ndring av rdets frordning (EG) nr 297/95 (EUT L 304, 23.11.2005, s. 1).
C 309/36 EN Official Journal of the European Union 19.12.2007 the AgencyŐs customers are billed an amount which is divided into two parts: one part covers the AgencyŐs costs and the other is repaid to the Member StatesŐ rapporteurs to cover their own. 
C 309/36 SV Europeiska unionens officiella tidning 19.12.2007 delar: en del som tcker myndighetens kostnader och en annan del som betalas till medlemsstaternas rapportrer fr att tcka deras kostnader.
As the Member StatesŐ rapporteurs did never provide full evidence or documentation of their real costs, this situation was in breach of the Fee Regulation. 
Eftersom medlemsstaternas rapportrer aldrig lmnade fullstndiga bevis eller dokumentation p sina verkliga kostnader stred detta mot frordningen om avgifter.
The Agency has not been in a position to make a comprehensive analysis of the costs incurred by Member StatesŐ rapporteurs in order to obtain an objective and documented basis on which to adapt its payments to them and, consequently, the fees charged to its customers. 
Myndigheten har inte haft mjlighet att utfrligt analysera de kostnader medlemsstaternas rapportrer haft i syfte att f en objektiv och dokumenterad bas som utgngspunkt fr sina betalningar till rapportrerna, och ocks fr de avgifter som debiteras myndighetens kunder.
19.12.2007 EN Official Journal of the European Union C 309/37 Areas of Community competence deriving from the Treaty Competences of the Agency as defined in Regulation (EC) No 726/2004 and Regulation (EC) No 141/2000 Governance 1. The Committee for Medicinal Products Resources made available to the Agency in 2006 (2005) Products and Services in 2006 A high level of human health protection shall be ensured in the definition and implementation of all Community policies and activities. 
19.12.2007 SV Europeiska unionens officiella tidning C 309/37 Gemenskapens behrighetsomrde enligt frdraget Myndighetens behrighet enligt frordning (EG) nr 726/2004 och frordning (EG) nr 141/2000 Organisation Medel till byrns frfogande under 2006 (2005) Produkter och tjnster 2006 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.
Objectives Tasks Final budget for 2006: 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. (...) 
Ml Uppgifter Kommittn fr humanlkemedel bestr av Gemenskapens insatser, som skall komplettera den nationella politiken, skall 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. (...)
The Committee for Medicinal Products for Veterinary Use, consisting of one member and one alternate from each Member State, advises on any question relating to the evaluation of veterinary medicinal products. Ń Favourable opinions: 51 Staff numbers at 31 Decem-(24) (Article 152 of the Treaty) Union with scientific covigilance); Posts occupied: 395 (337,5) + 77 (34) other staff (auxiliary Ń Pharmacovigilance: 94 081 reports (91 565 reports) Source: Information supplied by the Agency. 
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. utom bidrag fr srlkemedel): 21,63 % (22,7 %) Ń Positiva yttranden: 51 (24) Ń Genomsnittlig tidstgng (Artikel 152 i frdraget) Yttra sig om maximalt tilltna restmngder av veterinrmedicinska lkemedel i livsmedel med animaliskt ursprung. Tillsatta tjnster: 395 (337,5) + 77 (34) andra tjnster (extra-Ń Skerhetsvervakning av lkemedel: 94 081 rapporter (91 565 rapporter) Klla: Uppgifter frn myndigheten.
138,7 (111,8) million euro Community contribution Ń Applications for marketing authorisations: 79 (43) human and veterinary Ń To coordinate the super-ber 2006: Ń Average evaluation time: 171 days (203 days) use; vision of medicinal prod-Ń To provide the Member ucts which have been States and the institu-authorised within the tions of the European Community (pharma-3. 
Ń Anskningar om godknnande fr frsljning: 79 ver humanlkemedel och veterinrmedicinska Ń lkemedel. Samordna kontrollen av lkemedel som har godknts av gemenskapen (skerhetsvervakning). Personalstyrka den 31 december 2006: fr vrdering: 171 dagar (203 dagar) Ń Ge medlemsstaterna och gemenskapens institutioner vetenskaplig rdgivning om human-Ń lkemedel och veterinrmedicinska lkemedel.
The Committee for Orphan Medicinal Products, consisting of one member and one alternate from each Member State, advises on any question relating to the evaluation of orphan medicinal products. 
Kommittn fr srlkemedel bestr av en ledamot och en suppleant per medlemsstat och utarbetar yttranden i alla frgor som rr utvrdering av srlkemedel.
424 (379) posts provided for in the establishment plan Ń Opinions after authorisation: 1 380 (1 148) advice on medicinal Ń To advise on the maxi-products for human or mum limits for residues veterinary use. of veterinary medicinal 4. 
424 (379) tjnster enligt tjnstefrteckningen Ń Yttrande efter godknnande: 1 380 (1 148) Ń Samordna kontrollen av verensstmmelse med principerna fr god tillverkningssed, god laboratoriesed och god klinisk sed. 5.