natgillin/translations-raw huggingface dataset:
COMMENTS ON INTERNAL CONTROLS 12. In 2014, the Agency carried out an administrative procedure against its Information, Communication and Technology (ICT) manager. 
KOMMENTARER OM INTERNKONTROLLER 12. r 2014 genomfrde myndigheten ett administrativt frfarande mot den person som ansvarade fr information, kommunikation och teknik (IKT).
However, the effectiveness of the measures taken has yet to be evaluated by the Agency. OTHER COMMENTS 13. 
Myndigheten har dock nnu inte utvrderat hur ndamlsenliga tgrderna var. VRIGA KOMMENTARER 13.
One of the Agency’s tasks is to distribute appropriate pharmacovigilance information to Member States and to the general public. 
En av myndighetens uppgifter r att sprida lmplig information om skerhetsvervakning av lkemedel till medlemsstaterna och allmnheten.
However, the Agency is largely dependent on controls and inspections carried out by Member States’ authorities. 
Myndigheten r dock till stor del beroende av de kontroller och inspektioner som genomfrs av medlemsstaternas myndigheter.
These determine the completeness and accuracy of information disseminated to the public. 14. 
Dessa avgr hur fullstndig och exakt den information som sprids till allmnheten r.
In 2014 the Agency concluded a 15 million euro framework contract (covering the years 2014 to 2017) for high-level management consultancy services. 
14. r 2014 ingick myndigheten ett ramkontrakt p 15 miljoner euro (fr ren 2014Đ2017) fr konsulttjnster till den hgsta ledningen.
The objectives and activities to be carried out were not sufficiently specific to justify the procurement decision or the volume of the contract. 
De ml som ska uppns och de verksamheter som ska genomfras var inte tillrckligt specifika fr att motivera upphandlingsbeslutet eller kontraktets volym.
There is no evidence that the Management Board had been consulted on the procurement decision, which would have been appropriate given the nature and value of the contract, even though the Financial Regulation does not require it. 
Det finns inga bevis fr att styrelsen konsulterades om upphandlingsbeslutet, vilket hade varit lmpligt med tanke p kontraktets karaktr och vrde, ven om det inte krvs enligt budgetfrordningen.
An overview of the corrective actions taken in response to the Court's comments from previous years is provided in Annex I. This Report was adopted by Chamber IV, headed by Mr Milan Martin CVIKL, Member of the Court of Auditors, in Luxembourg at its meeting of 8 September 2015. 
En versikt ver de korrigerande tgrder som har vidtagits som en reaktion p revisionsrttens kommentarer frn tidigare r finns i bilaga I. Denna rapport antogs av revisionsrttens avdelning IV, med ledamoten Milan Martin CVIKL som ordfrande, vid dess sammantrde i Luxemburg den 8 september 2015.
For the Court of Auditors Vítor Manuel da SILVA CALDEIRA President 6 ADB057222EN04-15PP-CH059-15APCFIN-RAS-EMA_2014-OR.doc 8.9.2015 
Fr revisionsrtten Vtor Manuel da SILVA CALDEIRA ordfrande 6 ADB057222SV04-15PP-CH059-15APCFIN-RAS-EMA_2014-TR.docx 8.9.2015
Year 2012 1 Status of corrective action (Completed / Ongoing / Outstanding / N/A) Completed 1 Annex I Follow-up of previous years’ comments Court ́s comment In addition to the education allowances provided for in the Staff Regulations1, the Agency pays education contributions directly to schools for staff whose children attend primary or secondary school without having contracts with schools in place. 
Uppfljning av tidigare rs kommentarer 1 Bilaga I Genomfrande av korrigerande tgrder (Har genomfrts/Pgr/Har inte genomfrts/e.t.) Revisionsrttens kommentar Utver det utbildningstillgg som anges i tjnstefreskrifterna1 betalar myndigheten utbildningsbidrag direkt till skolorna fr personal vars barn gr i en primr-eller sekundrskola utan att det finns kontrakt med skolorna.
Such expenditure is not covered by the Staff Regulations and irregular. Article 3 of Annex VII provides for twice the basic allowance of 252,81 euro = 505,62 euro. 
Dessa utgifter omfattas inte av tjnstefreskrifterna och r oriktiga. r 2012 Har genomfrts 1 I artikel 3 i bilaga VII anges att bidraget ska vara dubbelt s stort som grundtillgget p 252,81 euro = 505,62 euro.
ADB057222EN04-15PP-CH059-15APCFIN-RAS-EMA_2014-OR.doc 8.9.2015 Annex II 1 Areas of Union competence deriving from the Treaty (Article 168 of the Treaty on the Functioning of the European Union) Competences of the Agency (Regulation (EC) No 726/2004 of the European Parliament and of the Council) European Medicines Agency (London) Competences and activities Collection of information Governance A high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities. 
ADB057222SV04-15PP-CH059-15APCFIN-RAS-EMA_2014-TR.docx 8.9.2015 Bilaga II 1 Unionens behrighetsomrde enligt frdraget (artikel 168 i EUF-frdraget) Myndighetens behrighet (Europaparlamentets och rdets frordning (EG) nr 726/2004) Europeiska lkemedelsmyndigheten (London) Behrighet och verksamhet Informationsinsamling Organisation En hg hlsoskyddsniv fr mnniskor ska skerstllas vid utformning och genomfrande av all unionspolitik och alla unionstgrder.
Union action, which shall complement national policies, shall be directed towards improving public health, preventing physical and mental illness and diseases, and obviating sources of danger to physical and mental health. 
Unionens 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 den fysiska och mentala hlsan.
Such action shall cover the fight against the major health scourges, by promoting research into their causes, their transmission and their prevention, as well as health information and education, and monitoring, early warning of and combating serious cross-border threats to health. 
Sdana insatser ska innefatta kamp mot de stora folksjukdomarna genom att frmja forskning om deras orsaker, hur de verfrs och hur de kan frebyggas samt hlsoupplysning och hlsoundervisning, liksom vervakning av, tidig varning fr och bekmpning av allvarliga grnsverskridande hot mot mnniskors hlsa.
Objectives – To coordinate the scientific resources that the Member States’ authorities make available to the Agency for the authorisation and supervision of medicinal products for human and veterinary use; – to provide the Member States and the institutions of the European Union with scientific advice on medicinal products for human or veterinary use. 
Ml Đ Samordna de vetenskapliga resurser som stlls till myndighetens frfogande av medlemsstaternas myndigheter fr prvning av och tillsyn ver humanlkemedel och veterinrmedicinska lkemedel. Đ Ge medlemsstaterna och Europeiska unionens institutioner vetenskaplig rdgivning om humanlkemedel och veterinrmedicinska lkemedel.
The Committee for Medicinal Products for Human Use (CHMP) is responsible for preparing the Agency's opinions on all questions concerning medicines for human use. 
Kommittn fr humanlkemedel (CHMP) har ansvaret fr att utarbeta myndighetens yttranden i alla frgor som rr humanlkemedel.
The CHMP consists of one member and one alternate from each Member State, one member and an alternate nominated by Iceland and by Norway and up to five co-opted members. 
Kommittn bestr av en ledamot och en suppleant frn varje medlemsstat, en ledamot och en suppleant som utses av Island och Norge samt upp till fem adjungerade ledamter.
The CVMP consists of one member and one alternate from each Member State, one member and an alternate nominated by Iceland and by Norway and up to five co-opted members. 
Kommittn bestr av en ledamot och en suppleant frn varje medlemsstat, en ledamot och en suppleant som utses av Island och Norge samt upp till fem adjungerade ledamter.
The Committee on Orphan Medicinal Products (COMP) is responsible for reviewing applications from people or companies seeking orphan medicinal product designation. 
2 Kommittn fr srlkemedel (COMP) har ansvaret fr att kontrollera anskningar frn personer eller fretag om att f ett lkemedel klassificerat som srlkemedel.
The COMP consists of one member from each Member State, three members nominated by the European Commission representing patients’ organisations, three members nominated by the European Commission on the Agency’s recommendation, one member nominated by Iceland, one by Liechtenstein and one by Norway, and one European Commission representative. 
Kommittn bestr av en ledamot frn varje medlemsstat, tre ledamter som utses av Europeiska kommissionen fr att fretrda patientfreningar, tre ledamter som utses av Europeiska kommissionen p rekommendation av myndigheten, en ledamot som utses av Island, en som utses av Liechtenstein och en som utses av Norge samt en fretrdare fr Europeiska kommissionen.
The Committee on Herbal Medicinal Products (HMPC) is responsible for preparing the Agency’s opinions on herbal medicines. 
Kommittn fr vxtbaserade lkemedel (HMPC) har ansvaret fr att utarbeta myndighetens yttranden om vxtbaserade lkemedel.
The HMPC consists of one member and one alternate from each Member State and from Iceland and Norway, and up to five co-opted members. 
Kommittn bestr av en ledamot och en suppleant frn varje medlemsstat och frn Island och Norge samt upp till fem adjungerade ledamter.
The Paediatric Committee (PDCO) is responsible for assessing the content of applications for paediatric investigation plans, waivers, deferrals and compliance checks, and adopting opinions on them. 
Pediatriska kommittn (PDCO) ansvarar fr bedmningen av innehllet i anskningarna om pediatriska prvningsprogram, kontroller av undantag, uppskov och efterlevnad och antar yttranden ver dem.
The PDCO consists of five members of the CHMP and their five alternates, one member and one alternate from each Member State which is not represented by the five above, and six members and alternates appointed by the European Commission representing healthcare professionals and patients’ associations. 
Kommittn bestr av fem ledamter frn kommittn fr humanlkemedel och deras fem suppleanter, en ledamot och en suppleant frn varje medlemsstat som inte fretrds av de fem ovan och sex ledamter och suppleanter som utses av Europeiska kommissionen och fretrder sjukvrdpersonal och patientfreningar.
The Committee for Advanced Therapy (CAT) is responsible for assessing the quality, safety and efficacy of advanced therapy medicinal products (ATMPs) and following scientific developments in the field. 
Kommittn fr avancerad terapi (CAT) har ansvaret fr att bedma kvalitet, skerhet och effektivitet nr det gller lkemedel fr avancerad terapi och fr att flja den vetenskapliga utvecklingen p omrdet.
The CAT consists of five members of the CHMP and their five alternates, one member and one alternate from each Member State which is not represented by the five above, and four members and four alternates appointed by the European Commission representing patients’ associations and clinicians. 
Kommittn bestr av fem ledamter frn kommittn fr humanlkemedel och deras fem suppleanter, en ledamot och en suppleant frn varje medlemsstat som inte fretrds av de fem ovan och fyra ledamter och fyra suppleanter som utses av Europeiska kommissionen och fretrder patientfreningar och kliniska lkare.
The Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for assessing and monitoring safety issues for human medicines. 
Kommittn fr skerhetsvervakning och riskbedmning av lkemedel (PRAC) har ansvaret fr att bedma och vervaka skerhetsaspekter nr det gller humanlkemedel.
The PRAC consists of one member and one alternate from each Member State, one member and an alternate nominated by Iceland and by Norway, six independent scientific experts nominated by the European Commission and two members and two alternates nominated by the European Commission to represent healthcare professionals and patients’ organisations. 
Kommittn bestr av en ledamot och en suppleant frn varje medlemsstat, en ledamot och en suppleant frn Island och Norge, sex oberoende vetenskapliga experter som utses av Europeiska kommissionen och tv ledamter och tv suppleanter som utses av Europeiska kommissionen och fretrder sjukvrdspersonal och patientorganisationer.
The Management Board consists of one member and one alternate from each Member State, two representatives of the Commission, two representatives of the European Parliament and 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 frn varje medlemsstat, tv fretrdare fr kommissionen, tv fretrdare fr Europaparlamentet och 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 rapporten.
The Executive Director is appointed by the Management Board on a proposal from the Commission. 
Den verkstllande direktren utses av styrelsen p frslag av kommissionen.
ADB057222EN04-15PP-CH059-15APCFIN-RAS-EMA_2014-OR.doc 8.9.2015 
ADB057222SV04-15PP-CH059-15APCFIN-RAS-EMA_2014-TR.docx 8.9.2015
3 Resources made available to the Agency in 2014 (2013) Products and services in 2014 (2013) External audit European Court of Auditors. 
3 Medel till myndighetens frfogande 2014 (2013) Produkter och tjnster 2014 (2013) Myndighet som beviljar ansvarsfrihet Europaparlamentet p rdets rekommendation.
Final Budget 282,47 (251,56) million euro1; Union contribution: 8,2 % (13,0 %)2 Staff as at 31 December 2014 599 (611) posts in the establishment plan, of which occupied: 580 (583) 210 (144) other staff (contract staff, seconded national experts, employment agency staff) Total staff: 790 (727) undertaking the following tasks: operational: 621 (590), administrative: 169 (137) Medicinal Products for Human Use – Applications for marketing authorisations: 100 (80) – Favourable opinions: 82 (80) – Average evaluation time: 179 (200) days – Opinions after authorisation: 5 958 (5 447) – Pharmacovigilance (CAP EEA and non-EEA ADR reports): 691 897 (679 413) reports – Periodic safety update reports (PSUR): 4713 (525) – Scientific advice finalised: 532 (474) – Mutual Recognition Procedures and Decentralised Procedures4: started 7 231 (6 293); ended 6 412 (6 242) – Applications for paediatric procedures at the PDCO: 485 (480)5 Medicinal Products for Veterinary Use – Applications for marketing authorisations: 12 (23) – Applications for variations: 340 (315) – Applications for line extensions: 6 (5) Inspections Inspections: 506 (480) Herbal Medicinal Products Herbal monographs: 11 (9) List of herbal substances, preparations and combinations thereof: 1 (0) Orphan Medicinal Products – Designation applications: 329 (201) – Favourable Orphan designation opinions: 196 (136) SMEs – Requests for SME status 499 (401) ADB057222EN04-15PP-CH059-15APCFIN-RAS-EMA_2014-OR.doc 8.9.2015 
Slutlig budget 282,47 (251,56) miljoner euro1, bidrag frn unionen: 8,2 % (13,0 %)2 Personalstyrka den 31 december 2014 599 (611) tjnster enligt tjnstefrteckningen, varav tillsatta: 580 (583), 210 (144) vriga anstllda (kontraktsanstllda, utstationerade nationella experter och inhyrd personal). Personalstyrka totalt: 790 (727) varav anstllda med uppgifter inom verksamheten: 621 (590), administrativa uppgifter: 169 (137). Humanlkemedel Đ Anskningar om godknnande fr frsljning: 100 (80).
– Applications for fee reduction or deferrals 333 (336) 1 Thisisthefinalbudget,nottheactualtotalofthebudgetaryoutturnaccount. 
Detta r den slutliga budgeten och inte det faktiska totalbeloppet i sammanstllningen av 2 3 4 5 Klla: Bilagan har tillhandahllits av myndigheten.
2 ThisisthepercentageofthebudgetedEUcontribution(excludingspecialcontributionfor orphan fee reductions and excluding the use of surplus n-2) in relation to the final budget. 
Detta r procentandelen av det budgeterade EU-bidraget (exklusive det srskilda bidraget till snkta avgifter fr srlkemedel och exklusive budgetmyndighetens anvndning av verskottet frn budgetret n-2) nr det gller den slutliga budgeten.
3 ThefigurestakeintoaccountthePSURsfinalisedasofendof2014. 
Uppgifterna tar hnsyn till pediatriska kommittns rkenskaper som avslutades i slutet av 2014.
4 IncludesinitialMRP/DCP,typeIA,IB,IIandworksharingvariations. 
Inbegriper ursprunglig MRP/DCP, typ IA, IB, II och arbetsfrdelningsvarianter.
5 Datafor2014(andfor2013)arereportednowforallPDCOprocedures,includingfirstPIP applications, modifications of agreed PIP, waiver applications, and compliance check applications. 
Uppgifterna fr 2014 (och fr 2013) rapporteras nu fr alla frfaranden i pediatriska kommittn, dribland de frsta PIP-anskningarna, ndringar av verenskomna PIP, anskningar om undantag och anskningar om efterlevnadskontroller.
4 ADB057222EN04-15PP-CH059-15APCFIN-RAS-EMA_2014-OR.doc 8.9.2015 
4 ADB057222SV04-15PP-CH059-15APCFIN-RAS-EMA_2014-TR.docx 8.9.2015
European Medicines Agency THE AGENCY’S REPLY 11. 
European Medicines Agency MYNDIGHETENS SVAR 11.
The further planned automation of the latter was delayed because of the Agency’s reorganisation in 2014. 
Den planerade fortsatta automatiseringen av avgiftshanteringen frsenades p grund av myndighetens omorganisation under 2014.
To ensure compliance with the Agency’s fee regulation concerning due dates, this automation is now planned to be implemented by the end of 2015. 
Fr att skerstlla att kraven i myndighetens avgiftsfrordning avseende tidsfrister uppfylls har nu automatiseringen inplanerats fr genomfrande i slutet av 2015.
Whilst weaknesses in management control were detected, no considerable financial risks were reported in the administrative enquiry report to the Executive Director. 
Brister i frvaltningskontrollen uppdagades, men i den administrativa utredningsrapporten till verkstllande direktren rapporterades det inte om ngra betydande finansiella risker.
EMA coordinates the EU pharmacovigilance network system and manages key information systems to support data exchange in pharmacovigilance, in particular EudraVigilance and the Article 57 database of medicinal products. 
EMA samordnar EU:s ntverk fr skerhetsvervakning av lkemedel och hanterar de centrala informationssystem som mjliggr datautbytet i samband med denna skerhetsvervakning, i synnerhet EudraVigilance-databasen och lkemedelsdatabasen som avses i artikel 57.
An inter-service consultation was conducted prior to the launch of the procurement procedure for a framework contract leading to an estimate of 15 000 person days over four years. The consultation sought to identify for the departments from the perspective of the time certain objectives, estimated profiles, and person days, as well as the assumed nature of services and approximate timing. Given the advance nature of the required estimates the Agency cannot share the Court’s comments. 
Ett avdelningsvergripande samrd hlls infr upphandlingsfrfarandet gllande ett ramkontrakt berknat att ta 15 000 mandagar i ansprk i fyra rs tid. Med samrdet skte vi kartlgga de resurser som kommer att krvas av respektive avdelning med utgngspunkt i specifika ml, berknade profiler och mandagar, samt faststlla en ungefrlig tidsplan och identifiera vilken typ av tjnster det kan frvntas bli frga om.
EN 1.12.2016 Official Journal of the European Union C 449/123 REPORT on the annual accounts of the European Medicines Agency for the financial year 2015, together with the AgencyŐs reply (2016/C 449/22) INTRODUCTION 1. 
SV 1.12.2016 Europeiska unionens officiella tidning C 449/123 RAPPORT om rsredovisningen fr Europeiska lkemedelsmyndigheten fr budgetret 2015 med myndighetens svar (2016/C 449/22) INLEDNING 1.
The European Medicines Agency (hereinafter Ôthe AgencyŐ, aka ÔEMAŐ), which is located in London, was established by Council Regulation (EEC) No 2309/93, which was replaced by Regulation (EC) No 726/2004 of the European Parliament and of the Council (1). 
Europeiska lkemedelsmyndigheten (nedan kallad myndigheten) ligger i London och inrttades genom rdets frordning (EEG) nr 2309/93, som har ersatts av Europaparlamentets och rdets frordning (EG) nr 726/2004(1).
The Agency operates through a network and coordinates the scientific resources made available by the national authorities in order to ensure the evaluation and supervision of medicinal products for human or veterinary use. 
Myndigheten arbetar i ett ntverk och samordnar de vetenskapliga resurser som stlls till dess frfogande av nationella myndigheter fr att skerstlla utvrderingen av och tillsynen ver humanlkemedel och veterinrmedicinska lkemedel.
Table Key figures for the Agency 2015 Budget (million EUR) 304 Total staff as at 31 December (1) 775 (1) Staff includes officials, temporary and contract staff and seconded national experts. 
Nyckeltal fr myndigheten Budget (miljoner euro) Personalstyrka totalt den 31 december (1) Tabell 2014 272 752 2015 304 775 (1) Personalen bestr av tjnstemn, tillflligt anstllda och kontraktsanstllda samt utstationerade nationella experter.
2014 272 752 STATEMENT OF ASSURANCE 4. 
REVISIONSF RKLARING 4.
The management is responsible for the preparation and fair presentation of the annual accounts of the Agency and the legality and regularity of the underlying transactions (5): (1) OJ L 214, 24.8.1993, p. 
Ledningen har ansvaret fr att upprtta en rsredovisning fr myndigheten som ger en rttvisande bild och fr att de underliggande transaktionerna r lagliga och korrekta (5): (1) EGT L 214, 24.8.1993, s.
In accordance with the latter Regulation, the AgencyŐs original name, the European Agency for the Evaluation of Medicinal Products, was changed to the European Medicines Agency. 
I enlighet med den senare frordningen har myndighetens ursprungliga namn ndrats (gller ej svenska).
(2) More information on the AgencyŐs competences and activities is available on its website: www.ema.europa.eu (3) These include the balance sheet and the statement of financial performance, the cash flow table, the statement of changes in net assets and a summary of the significant accounting policies and other explanatory notes. 
(2) Ytterligare information om myndighetens behrighet och verksamhet finns p myndighetens webbplats: www.ema.europa.eu (3) Hr ingr balans-och resultatrkningen, kassafldesanalysen, sammanstllningen av frndringar i nettotillgngarna och en sammanfattning av de viktigaste redovisningsprinciperna och andra frklarande noter.
C 449/124 Official Journal of the European Union 1.12.2016 EN (a) The managementŐs responsibilities in respect of the AgencyŐs annual accounts include designing, implementing and maintaining an internal control system relevant to the preparation and fair presentation of financial statements that are free from material misstatement, whether due to fraud or error; selecting and applying appropriate accounting policies on the basis of the accounting rules adopted by the CommissionŐs accounting officer (6); making accounting estimates that are reasonable in the circumstances. 
C 449/124 Europeiska unionens officiella tidning 1.12.2016 SV a) I ledningens ansvar fr myndighetens rsredovisning ingr att utforma, infra och upprtthlla de system fr internkontroll som krvs fr upprttandet av rkenskaper som ger en rttvisande bild och som inte innehller vsentliga felaktigheter, vare sig dessa beror p oegentligheter eller fel, vlja och tillmpa ndamlsenliga redovisningsprinciper utifrn de redovisningsregler som antagits av kommissionens rkenskapsfrare (6) och gra uppskattningar i redovisningen som r rimliga med hnsyn till omstndigheterna.