natgillin/translations-raw huggingface dataset:
These due dates were not respected for most of the transactions audited by the Court. 
Neid thtaegu ei jrgitud enamiku kontrollikoja poolt auditeeritud tehingute puhul.
COMMENTS ON INTERNAL CONTROLS 12. 
KOMMENTAARID SISEKONTROLLIMEHHANISMIDE KOHTA 12.
In 2014, the Agency carried out an administrative procedure against its Information, Communication and Technology (ICT) manager. 
2014. aastal viis amet lbi haldusmenetluse oma IKT-juhi vastu.
Significant weaknesses in management control were reported, implying considerable operational and financial risks to the Agency. 
Halduskontrollis leiti olulisi puudusi, mis kujutavad endast ametile olulisi tegevus-ja finantsalaseid riske.
However, the effectiveness of the measures taken has yet to be evaluated by the Agency. 
Amet ei ole aga veel vetud meetmete thusust hinnanud.
One of the Agency’s tasks is to distribute appropriate pharmacovigilance information to Member States and to the general public. 
Ameti lesannete hulka kuulub asjakohase ravimiohutusteabe levitamine liikmesriikidele ja ldsusele.
This information is collected from individual national authorities and verified with the pharmaceutical companies concerned. 
Teavet kogutakse liikmesriikide ametiasutustelt ja kontrollitakse vastavalt asjaomaste ravimitootjate esitatud andmetele.
However, the Agency is largely dependent on controls and inspections carried out by Member States’ authorities. 
Amet on siiski suurel mral sltuv liikmesriikide ametiasutuste tehtavatest kontrollidest.
These determine the completeness and accuracy of information disseminated to the public. 
Nimetatud kontrollidega mratakse kindlaks ldsusele levitatava teabe tielikkus ja tpsus.
In 2014 the Agency concluded a 15 million euro framework contract (covering the years 2014 to 2017) for high-level management consultancy services. 
2014. aastal slmis amet krgetasemeliste juhtimisalaste nustamisteenuste raamlepingu suurusega 15 miljonit eurot (hlmas perioodi 2014Đ2017).
The objectives and activities to be carried out were not sufficiently specific to justify the procurement decision or the volume of the contract. 
Elluviidavad eesmrgid ja tegevused ei olnud hankeotsuse ja lepingu suuruse phjendamiseks piisavalt spetsiifilised.
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. 
Puuduvad tendid sellest, et haldusnukoguga oleks nu peetud; lepingu olemust ja suurust arvestades oleks see olnud mistlik, kuigi finantsmrusega seda ei nuta.
9 5 Agency’s fee regulation, Articles 10(1) and 11(1). 
9 5 Ameti livude mruse artikli 10 lige 1 ja artikli 11 lige 1.
ADB057222EN04-15PP-CH059-15APCFIN-RAS-EMA_2014-OR.doc 8.9.2015 
ADB057222ET04-15PP-CH059-15APCFIN-RAS-EMA_2014-TR.docx 8.9.2015
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. 
IV auditikoda, mida juhib kontrollikoja liige Milan Martin CVIKL, vttis kesoleva aruande vastu 8. septembri 2015. aasta koosolekul Luxembourgis.
For the Court of Auditors Vítor Manuel da SILVA CALDEIRA President 6 ADB057222EN04-15PP-CH059-15APCFIN-RAS-EMA_2014-OR.doc 8.9.2015 
Kontrollikoja nimel president Vtor Manuel da SILVA CALDEIRA 6 ADB057222ET04-15PP-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. 
Aasta 2012 Eelmiste aastate kommentaaride phjal vetud meetmed 1 I lisa (lpetatud / pooleli / alustamata /ei kohaldata) Lpetatud Kontrollikoja kommentaar Lisaks personalieeskirjades stestatud ppetoetustele1 maksab amet oma ttajate alg-ja keskkoolis kivate laste eest koolidele tasusid ka otse, kuigi nende tegemiseks ei ole koolidega lepinguid slmitud.
Total 2012 education contributions amounted to some 389 000 euro. 
2012. aastal moodustasid sellised maksed kokku ligikaudu 389 000 eurot.
Such expenditure is not covered by the Staff Regulations and irregular. 
Nimetatud maksed ei ole stestatud personalieeskirjades ning on seega eeskirjadevastased.
Article 3 of Annex VII provides for twice the basic allowance of 252,81 euro = 505,62 euro. 
Parandusmeetmete vtmise seis 1 VII lisa artiklis 3 stestatakse kahekordne phitoetus, st 2 x 252,81 eurot = 505,62 eurot.
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. 
II lisa 1 Aluslepingust tulenevad liidu pdevusvaldkonnad Euroopa Ravimiamet (London) Pdevus ja tegevus Teabe kogumine (Euroopa Liidu toimimise lepingu artikkel 168) Ameti pdevus (Euroopa Parlamendi ja nukogu mrus (E) nr 726/2004) Kogu liidu poliitika ja meetmete mratlemisel ja rakendamisel tagatakse inimeste tervise krgetasemeline kaitse.
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. 
Liidu meetmed, mis tiendavad liikmesriikide poliitikat, on suunatud rahvatervise parandamisele, inimeste haiguste ennetamisele ja tervist ohustavate tegurite krvaldamisele.
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. 
Sellised meetmed hlmavad vitlust olulisemate tervisehirete vastu, edendades nende phjuste, leviku ja vltimise uurimist, samuti tervishoiualast selgitus-ja kasvatustd, ning tsiste piirileste terviseohtude seiret, nende eest varajast hoiatamist ja nende vastu vitlemist.
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. 
Đ Anda liikmesriikidele ja Euroopa Liidu asutustele teaduslikku nu inim-ja veterinaarravimite kohta. lesanded Đ Koordineerida liidu mgiloa andmise menetlusele alluvate ravimite teaduslikku hindamist. Đ Koordineerida liidu kinnitatud ravimite jrelevalvet (ravimiohutuse jrelevalve).
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. 
Inimravimikomitee vastutab kigi ameti inimravimite hindamist puudutavate arvamuste koostamise eest.
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. 
Komitee koosneb hest iga liikmesriigi poolt nimetatud liikmest ja asendusliikmest, Islandi ja Norra poolt nimetatud hest liikmest ja asendusliikmest ning kuni viiest lisaliikmest.
The Committee for Medicinal Products for Veterinary Use (CVMP) is responsible for preparing the Agency's opinions on all questions concerning ADB057222EN04-15PP-CH059-15APCFIN-RAS-EMA_2014-OR.doc 8.9.2015 
Veterinaarravimite komitee vastutab kigi ameti veterinaarravimeid puudutavate arvamuste koostamise eest.
2 veterinary medicines. 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. 
Komitee koosneb hest iga liikmesriigi poolt nimetatud liikmest ja asendusliikmest, Islandi ja Norra poolt nimetatud hest liikmest ja asendusliikmest ning kuni viiest lisaliikmest.
The Committee on Orphan Medicinal Products (COMP) is responsible for reviewing applications from people or companies seeking orphan medicinal product designation. 
Harva kasutatavate ravimite komitee vastutab ksikisikute ja ettevtete poolt esitatud harva kasutatavate ravimite hindamist puudutavate taotluste lbivaatamise eest.
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. The Committee on Herbal Medicinal Products (HMPC) is responsible for preparing the Agency’s opinions on herbal medicines. 
Komitee koosneb hest iga liikmesriigi poolt nimetatud liikmest, kolmest Euroopa Komisjoni nimetatud liikmest, kes esindavad patsientide hinguid, kolmest Euroopa Komisjoni poolt ameti soovitusel nimetatud liikmest, hest Islandi poolt nimetatud liikmest, hest Juhtimine ADB057222ET04-15PP-CH059-15APCFIN-RAS-EMA_2014-TR.docx 8.9.2015
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. 
Komitee koosneb hest iga liikmesriigi ning Islandi ja Norra poolt nimetatud liikmest ja asendusliikmest ning kuni viiest lisaliikmest.
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. 
Pediaatriakomitee vastutab nende taotluste hindamise eest, mis puudutavad pediaatriliste uuringute plaane, loobumisi, edasilkkamisi ja nuetele vastavuse kontrolle, ning vtab vastu otsuseid nende kohta.
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. 
Komitee koosneb viiest inimtervishoius kasutatavate ravimite komitee liikmest ja nende viiest asendusliikmest, eelnimetatud viie hulgas esindamata liikmesriikide poolt nimetatud hest liikmest ja asendusliikmest, ning neljast komisjoni nimetatud liikmest ja asendusliikmest, kes esindavad patsientide hinguid ja arste.
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. 
Uudsete ravimeetodite komitee vastutab uudsetes ravimeetodites kasutatavate ravimite kvaliteedi, ohutuse ja efektiivsuse hindamise eest ning hoiab ennast kursis nimetatud valdkonna teaduslikus arengus toimuvaga.
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. 
Komitee koosneb viiest inimtervishoius kasutatavate ravimite komitee liikmest ja nende viiest asendusliikmest, eelnimetatud viie hulgas esindamata liikmesriikide poolt nimetatud hest liikmest ja asendusliikmest, ning neljast komisjoni nimetatud liikmest ja asendusliikmest, kes esindavad patsientide hinguid ja arste.
The Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for assessing and monitoring safety issues for human medicines. 
Ravimiohutuse riskihindamise komitee vastutab inimravimite ohutuse alaste ksimuste hindamise ja jrelevalve eest.
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. 
Komitee koosneb hest iga liikmesriigi ning Islandi ja Norra poolt nimetatud liikmest ja asendusliikmest, kuuest Euroopa Komisjoni nimetatud sltumatust teaduseksperdist ning kahest Euroopa Komisjoni poolt peale Euroopa Parlamendiga konsulteerimist nimetatud liikmest ja asendusliikmest, kes esindavad tervishoiuttajaid ja patsientide hinguid.
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. 
Haldusnukogu koosneb iga liikmesriigi poolt nimetatud liikmest ja asendusliikmest, kahest komisjoni esindajast, kahest Euroopa Parlamendi poolt nimetatud esindajast, kahest patsientide hingute esindajast, hest arstide hingute esindajast ja hest veterinaararstide hingute esindajast.
The Board adopts the work programme and the annual report. 
Nukogu vtab vastu tkava ja aasta ldaruande.
The Executive Director is appointed by the Management Board on a proposal from the Commission. 
Tegevdirektor nimetatakse ametisse haldusnukogu poolt komisjoni ettepanekul.
Internal audit European Commission Internal Audit Service (IAS) & EMA Internal Audit Capability (IAC). 
Siseaudit Euroopa Komisjoni siseauditi talitus ja ameti siseauditi ksus.
ADB057222EN04-15PP-CH059-15APCFIN-RAS-EMA_2014-OR.doc 8.9.2015 
2 ADB057222ET04-15PP-CH059-15APCFIN-RAS-EMA_2014-TR.docx 8.9.2015
2 ThisisthepercentageofthebudgetedEUcontribution(excludingspecialcontributionfor orphan fee reductions and excluding the use of surplus n-2) in relation to the final budget. 3 ThefigurestakeintoaccountthePSURsfinalisedasofendof2014. 4 IncludesinitialMRP/DCP,typeIA,IB,IIandworksharingvariations. 
ELi toetuse osakaal lplikust eelarvest (v.a harva kasutatavate ravimite livude alandamiseks antav eritoetus ja aasta n-2 tulemi kasutamine). 3 ajakohastatud ohutusaruandeid.
4 ADB057222EN04-15PP-CH059-15APCFIN-RAS-EMA_2014-OR.doc 8.9.2015 
4 ADB057222ET04-15PP-CH059-15APCFIN-RAS-EMA_2014-TR.docx 8.9.2015
European Medicines Agency THE AGENCY’S REPLY 11. 
European Medicines Agency AMETI VASTUSED 11.
During 2013-2014, the Agency has redesigned and streamlined its main operational processes including financial authorisations and fee collections. 
Aastatel 2013Đ2014 on amet mber kavandanud ja korraldanud oma peamised tegevusprotsessid, sealhulgas finantstehingute volitamise ja livude kogumise.
The further planned automation of the latter was delayed because of the Agency’s reorganisation in 2014. 
Livude kogumise kavandatud automaatssteemi kasutuselevtt hilines ameti mberkorraldamise tttu 2014. aastal.
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. 
Ameti livude mruse stestatud thtaegade jrgimiseks kavandatakse automaatssteemi kasutuselevttu nd 2015. aasta lpuks.
Whilst weaknesses in management control were detected, no considerable financial risks were reported in the administrative enquiry report to the Executive Director. 
Kuigi halduskontrollis leiti puudusi, ei teatatud haldusmenetluse aruandes tegevdirektorile olulistest finantsriskidest.
The effectiveness of the measures taken by the Agency is to be evaluated through the already planned audits in 2015 by the Internal Audit Service of the EC and the Internal Audit Capability of the Agency. 
Ameti vetud meetmete thusust hinnatakse 2015. aastal juba kavas olevates Euroopa Komisjoni siseauditi talituse ja ameti siseauditi ksuse auditites.
The regulation of medicinal products in the European Union is based on a network model. 
Euroopa Liidus toimub ravimite reguleerimine vrgustikuphise mudeli jrgi.
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 koordineerib Euroopa Liidu ravimiohutuse jrelevalve vrgustiku ssteemi ja haldab ravimiohutuse jrelevalve andmevahetuse peamisi teabessteeme, eelkige andmebaasi EudraVigilance ja artikli 57 kohast ravimite andmebaasi.
We will continue to work with our stakeholders/partners to ensure adequate protection to the EU citizen in this area. 
Jtkame tegevust sidusrhmade/partneritega, et tagada Euroopa Liidu kodanike kaitsmist selles valdkonnas.
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. 
Enne hinnanguliselt 15 000 inimpeva nelja aasta jooksul hlmava raamlepingu hankemenetluse alustamist toimus talitlustevaheline konsulteerimine.
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. 
Selle eesmrk oli leida osakondade jaoks ajalisest perspektiivist teatud eesmrgid, hinnangulised profiilid ja inimpevade arv, samuti teenuste eeldatav olemus ja ligikaudne ajastus.
Furthermore, as the Court acknowledges, the Agency was not required to consult the Management Board prior to launch of the tender. EMA reply 
Lisaks, nagu nendib ka kontrollikoda, ei nutud, et amet pidanuks enne hanke alustamist konsulteerima haldusnukoguga. EMA_ET
C 417/142 Official Journal of the European Union 6.12.2017 REPORT on the annual accounts of the European Medicines Agency for the financial year 2016, together with the AgencyŐs reply (2017/C 417/22) INTRODUCTION 1. 
ET C 417/142 Euroopa Liidu Teataja 6.12.2017 ARUANNE Euroopa Ravimiameti eelarveaasta 2016 raamatupidamise aastaaruande kohta koos ameti vastusega (2017/C 417/22) SISSEJUHATUS 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). 
Londonis asuv Euroopa Ravimiamet (edaspidi ăametŇ vi ăEMAŇ) asutati nukogu mrusega (EM) nr 2309/93, mis asendati Euroopa Parlamendi ja nukogu mrusega (E) nr 726/2004 (1).
The Agency operates through a pan-EU 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. 
Amet toimib kogu liitu hlmava vrgustiku kaudu ja koordineerib siseriiklike ametiasutuste poolt kttesaadavaks tehtud teadusressursse, et tagada inim-ja veterinaarravimite hindamine ja jrelevalve.
The table presents key figures for the Agency (2) Table Key figures for the Agency 2016 Budget (million euro) 305 Total staff as at 31 December (1) 768 (1) Staff includes officials, temporary and contract staff and seconded national experts. 
Tabelis esitatakse ameti peamised arvandmed (2). Tabel Ameti peamised arvandmed 2016 Eelarve (miljonites eurodes) 305 Ttajate arv seisuga 31. detsember (1) 768 (1) Ttajaskond hlmab ametnikke, ajutisi teenistujaid, lepingulisi ttajaid ja lhetatud riiklikke eksperte.
2015 304 775 OPINION 4. 
2015 304 775 ARVAMUS 4.
We have audited: (a) the accounts of the Agency which comprise the financial statements (3) and the reports on the implementation of the budget (4) for the financial year ended 31 December 2016; and (b) the legality and regularity of the transactions underlying those accounts; as required by Article 287 of the Treaty on the Functioning of the European Union (TFEU). 
Kontrollikoda auditeeris: a) ameti raamatupidamise aastaaruannet, mis koosneb finantsaruannetest (3) ja eelarve titmise aruannetest (4) 31. detsembril 2016. aastal lppenud eelarveaasta kohta, b) raamatupidamise aastaaruande aluseks olevate tehingute seaduslikkust ja korrektsust, nagu stestatud Euroopa Liidu toimimise lepingu artiklis 287.
(1) OJ L 214, 24.8.1993, p. 1, and OJ L 136, 30.4.2004, p. 1. 
(1) ET L 214, 24.8.1993, lk 1, ja ELT L 136, 30.4.2004, lk 1.
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. 
Vastavalt viimati mainitud mrusele muudeti ameti algne nimi, Euroopa Ravimihindamisamet, Euroopa Ravimiametiks.
(2) More information on the AgencyŐs competences and activities is available on its website: www.ema.europa.eu (3) The financial statements comprise the balance sheet, the statement of financial performance, the cash flow statement, the statement of changes in net assets and a summary of significant accounting policies and other explanatory notes. 
(2) Ameti pdevust ja tegevust tutvustav tiendav teave on leitav selle veebisaidil www.ema.europa.eu. (3) Finantsaruanded sisaldavad bilanssi, tulemiaruannet, rahavoogude aruannet, netovara muutuste aruannet, thtsamate arvestusphimtete kokkuvtet ja muud selgitavat teavet.
EN 6.12.2017 Official Journal of the European Union C 417/143 Reliability of the accounts Opinion on the reliability of the accounts 5. 
ET 6.12.2017 Euroopa Liidu Teataja C 417/143 Raamatupidamise aastaaruande usaldusvrsus Arvamus raamatupidamise aastaaruande usaldusvrsuse kohta 5.
EN C 417/144 Official Journal of the European Union 6.12.2017 12. 
ET C 417/144 Euroopa Liidu Teataja 6.12.2017 12.
For revenue, we verify the subsidy received from the Commission and assess the AgencyŐs procedures for collecting fees and other income. 
Tulude puhul kontrollib kontrollikoda komisjonilt saadud toetust ning hindab ameti tasude ja muude tulude kogumise korda.
In preparing this report and Statement of Assurance, we considered the audit work of the independent external auditor performed on the AgencyŐs accounts as stipulated in Article 208(4) of the EU Financial Regulation (1). Emphasis of matter 16. 
Kesoleva aruande ja kinnitava avalduse koostamisel vttis kontrollikoda arvesse sltumatu vlisaudiitori audititd, mis hlmas ameti raamatupidamise aastaaruande kontrollimist vastavalt ELi finantsmruse (1) artikli 208 likes 4 stestatud nuetele.
Without calling into question its opinion, the Court draws attention to the fact that the United Kingdom (UK) notified the European Council on 29 March 2017 of its decision to withdraw from the European Union. 
Ilma esitatud arvamust kahtluse alla seadmata juhib kontrollikoda thelepanu asjaolule, et 29. mrtsil 2017 teavitas hendkuningriik Euroopa lemkogu enda otsusest Euroopa Liidust vlja astumise kohta.
The provisional accounts and related notes of the Agency, which is located in London, were prepared using the limited information available at the date of signature (28 February 2017). 
Londonis paikneva ameti raamatupidamise aastaaruanne ja selle lisad koostati nimetatud aruande allkirjastamise kuupeval (28. veebruar 2017) kttesaadavate piiratud andmete alusel.
In view of upcoming decisions on the future location of the Agency, it has disclosed in its Financial Statements an estimated 448 million euro rent for the remaining rental period between 2017 and 2039 as a contingent liability, as the rental contract does not include any exit clause. 
Asutuse tulevast asukohta puudutavate otsuste tegemise ootuses kajastas amet oma finantsaruandes perioodi 2017Đ2039 hinnangulise rikulu (448 miljonit eurot) tingimusliku kohustusena, sest rileping ei sisalda lahkumisklauslit.