natgillin/translations-raw huggingface dataset:
The Management Board asked the European Commission to provide the aforementioned study before it can respond about the Agency's ability to take on the new responsibility. 
Upravni odbor je Evropsko komisijo pozval, naj mu zagotovi zgoraj navedeno študijo, da se bo lahko odzval na trditev o sposobnosti agencije za prevzem nove pristojnosti.
Adverse drug reaction reports contain a large number of fields which need to be reviewed to protect the identity of a person when granting access to the report. 
Poročila o neželenih učinkih zdravil vključujejo številna podatkovna polja, ki jih je treba pregledati za varstvo identitete osebe pri dodelitvi dostopa do poročila.
Analysis and assessment of the Executive Director's annual activity report 2009 
Analiza in ocena letnega poročila o dejavnostih izvršnega direktorja za leto 2009
In addition to information that used to be provided previously, the report now elaborates on how EudraVigilance contributes to the conduct of pharmacovigilance in the EU. 
V poročilu, ki vključuje informacije, ki so se zagotavljale že prej, se zdaj proučuje prispevek sistema EudraVigilance k izvajanju farmakovigilance v EU.
The European Commission will contact the candidates and those applicants who were late to send their applications to explain the procedure. 
Evropska komisija bo navezala stik s kandidati in tistimi vlagatelji, ki so se prijavili prepozno, ter jim pojasnila postopek.
• Discharge from the European Parliament on the EMA final accounts for the financial year 2008. 
• Razrešnica Evropskega parlamenta o končnih računovodskih izkazih agencije EMA za proračunsko leto 2008.
The Board discussed the possibility of publishing, in future, information on Member States' compliance with the legal timeframe of 15 days for transmission of individual case safety reports (ICSRs) to the Agency. 
Upravni odbor je razpravljal o možnosti prihodnjega objavljanja informacij o skladnosti držav članic s pravnim časovnim okvirom za posredovanje varnostnih poročil o posameznih primerih (ICSR) agenciji, ki je 15 dni.
The Vice-Chair continued to chair the meeting during the election process of the Management Board Chair. 
Podpredsednica je predsedovala seji tudi med postopkom izvolitve predsednika upravnega odbora.
Update on future accommodation of the Agency 
Posodobljene informacije o prihodnjih prostorih agencije
In accordance with Management Board Rules of procedure there are 35 voting members in the Management Board, 28 members were present at the time of the election and 4 proxies were received: from the Czech Republic to Denmark, DG Enterprise to DG Sanco, Greece to Italy and Sweden to Slovenia. 
V skladu s poslovnikom upravnega odbora ima glasovalno pravico 35 članov upravnega odbora, od tega jih je bilo ob izvolitvi navzočih 28, prejeta pa so bila štiri pooblastila za zastopanje, in sicer pooblastila Češke republike Danski, GD za podjetništvo in industrijo GD za zdravje in potrošnike, Grčije Italiji in Švedske Sloveniji.
Therefore for all the aforementioned reasons, Prof. Nisticò does not endorse the nomination of the new nominee from Poland as CHMP member". 
Prof. Nisticò zato ne podpira imenovanja novega kandidata s Poljske za člana odbora CHMP.“
The report will be reviewed by the European Commission in preparation of the Commission's report to the Council on the implementation of the Fee Regulation by November 2010. 
Evropska komisija bo do novembra 2010 proučila poročilo v okviru priprave poročila Komisije Svetu o izvajanju uredbe o pristojbinah.
CHMP and CVMP meetings are already broadcast internally and now the technical facilities are available to broadcast to national competent authorities. 
Sestanki odborov CHMP in CVMP (Odbor za zdravila za uporabo v veterinarski medicini) se že predvajajo interno, zdaj pa so na voljo tudi tehnične zmogljivosti za predvajanje nacionalnim pristojnim organom.
Nominations to CVMP and CHMP under consultation 
Imenovanja v odbora CHMP in CVMP, o katerih potekajo posvetovanja
In response to this observation, the Polish representative to the Board emphasised that: “The decision to nominate a candidate to the CHMP is a sovereign decision of a Member State and Poland based its decision on the candidate's scientific background and professional experience.” 
Poljski predstavnik v upravnem odboru je v odgovoru na to pripombo poudaril: „Odločitev o imenovanju kandidata v odbor CHMP je suverena odločitev države članice, Poljska pa jo je sprejela na podlagi kandidatovega strokovnega znanja in delovnih izkušenj.“
Referrals to CVMP of veterinary medicinal products: a report from the Agency 
Napotitve zdravil za uporabo v veterinarski medicini Odboru za zdravila za uporabo v veterinarski medicini (CVMP): poročilo agencije
Management Board meeting dates 2011 
Datumi sej upravnega odbora v letu 2011
The Management Board noted the outcomes of the evaluation of the Agency which was conducted in 2009 at the request of the European Commission. 
Upravni odbor se je seznanil z izidi ocene agencije, ki je bila na zahtevo Evropske komisije opravljena leta 2009.
Preparation for a written procedure on adoption of the Agency's final accounts for the year ending 31 December 2009 
Priprava na pisni postopek za sprejetje končnih računovodskih izkazov agencije za leto, ki se je končalo 31. decembra 2009
The actions encompass EMA processes having an impact on clinical trials carried out at different stages of the lifecycle of medicinal products and the relationship with regulators in all parts of the world, with a view to achieving a robust framework for the oversight and conduct of clinical trials. 
Ukrepi zajemajo postopke agencije EMA, ki vplivajo na klinična preskušanja, ki se izvajajo v različnih fazah življenjskega ciklusa zdravil, in odnose z regulativnimi organi v vseh delih sveta za oblikovanje trdnega okvira za nadzor in izvajanje kliničnih preskušanj.
10bis Appointment of Accounting Officer ad interim 
10a Imenovanje začasnega računovodje
London, 10 June 2010 
V Londonu, 10. junija 2010
Procedure for the appointment of the Executive Director 
Postopek imenovanja izvršnega direktorja
The Management Board re-elected Pat O'Mahony as its Chair for a new three-year term, by unanimous vote. 
Upravni odbor je Pata O'Mahonyja znova soglasno izvolil za predsednika za nov triletni mandat.
Outcome of the evaluation of the Agency 
Izid ocene agencije
The Board was informed that the CVMP established a Task Force on referrals which will review strategic options for the harmonisation of products, develop a methodology for prioritisation of issues for referral and will develop proposals in relation to future legislation concerning veterinary medicinal products on issues related to referrals. 
Upravni odbor je bil obveščen, da je odbor CVMP ustanovil projektno skupino o napotitvah, ki bo pregledala strateške možnosti za usklajevanje zdravil, razvila metodologijo za prednostno razvrščanje vprašanj za napotitev in oblikovala predloge v zvezi s prihodnjo zakonodajo o zdravilih za uporabo v veterinarski medicini v zvezi z vprašanji, ki se nanašajo na napotitve.
Due to the disruption of travel following the volcanic eruption in Iceland, the Agency's Committee for Medicinal Products for Human Use worked extensively using teleconferencing tools. 
Zaradi oteženih potovanj po izbruhu vulkana na Islandiji je bilo veliko dela v Odboru za zdravila za uporabo v humani medicini (CHMP) agencije EMA opravljenega s telekonferenčnimi orodji.
During the discussion, the Management Board considered both nominations in their wider context of the workings of the Committees and reflected favourably on both of the nominees' background and professional experience, with the exception of the European Parliament representative, Prof. Giuseppe Nisticò, who asked that his specific remarks be included in the minutes: “The previous Polish CHMP member's curriculum, who was considered in the CHMP as the reference member for assessment of drug treatment in respiratory diseases, is much more specific and appropriate in terms of regulatory and clinical competence, as opposed to that of the newly proposed member. 
Med razpravo je obravnaval obe imenovanji v širšem okviru delovanja odborov ter pozitivno ocenil poklicne in delovne izkušnje kandidatov, le predstavnik Evropskega parlamenta, prof. Giuseppe Nisticò, je zahteval, naj se v zapisnik vključijo njegove posebne pripombe: „Življenjepis prejšnjega poljskega člana odbora CHMP, ki je v odboru CHMP veljal za referenčnega člana za ocenjevanje zdravil za zdravljenje bolezni dihal, je precej podrobnejši in ustreznejši v smislu regulativne in klinične usposobljenosti v primerjavi z življenjepisom novega predlaganega člana.
During its discussion, the Board reflected on the issue that a significant amount of work done by the national competent authorities is not compensated in the current fee system. 
Upravni odbor je med razpravo o sistemu opozoril, da v sedanjem sistemu pristojbin veliko dela, ki ga opravijo nacionalni pristojni organi, ni plačanega.
• Agenda point 10_Advertisement of the vacancy notice for the recruitment of the Executive Director for the EMA. 
• Točka 10 dnevnega reda - Naznanilo obvestila o prostem delovnem mestu za zaposlitev izvršnega direktorja agencije EMA.
In the context of the two appeals, the European Ombudsman concluded that the Agency has to grant access to adverse drug reaction reports and clinical trial data. 
Varuh človekovih pravic je v zvezi z dvema pritožbama ugotovil, da mora agencija dodeliti dostop do poročil o neželenih učinkih zdravil in podatkov o kliničnih preskušanjih.
Observers 
Opazovalci
• [EMEA/221701/2010] Update report on the Agency's implementation of the EU telematics strategy. 
• [EMEA/221701/2010] Dopolnjeno poročilo o telematski strategiji EU, ki jo izvaja agencija.
The members noted the update report from the European Commission on a range of topics, including the following: 
Člani odbora so se seznanili s posodobljenim poročilom Evropske komisije v zvezi z več temami, vključno s/z:
The Executive Director announced the appointment of Jean-Claude Brival as head of the newly created Product Data Management Sector in Veterinary Medicines and Product Data Management Unit and Alexis Nolte as head of the Sector for Quality of Medicines. 
Izvršni direktor je napovedal imenovanje Jeana-Clauda Brivala za vodjo novega oddelka za upravljanje podatkov o proizvodih v enoti za zdravila za uporabo v veterinarski medicini in upravljanje podatkov o proizvodih, ter Alexisa Nolteja za vodjo oddelka za kakovost zdravil.
The Board thanked the topic coordinators - Jytte Lyngvig, Pat O'Mahony and Kristin Raudsepp - for preparing a comprehensive draft analysis and assessment of the report. 
Upravni odbor se je tematskim koordinatorjem - Jytte Lyngvig, Patu O'Mahonyju in Kristin Raudseppzahvalil za pripravo celovitega osnutka analize in ocene poročila.
HMA supported the constitution of a permanent group of medical devices competent authorities. 
Vodje agencij za zdravila so podprli oblikovanje stalne skupine pristojnih organov za medicinske pripomočke.
Legislation on access to documents requires making documents held by the Agency public, while the requirements to safeguard commercially confidential information and personal data restrict access. 
Čeprav zakonodaja o dostopu do dokumentov določa, da so dokumenti, ki jih hrani agencija, javni, pa dostop omejujejo zahteve za varstvo komercialno zaupnih informacij in osebnih podatkov.
The Board stressed that it is of utmost importance to guarantee the involvement of best scientific expertise to ensure assessments of the highest quality. 
Poudaril je, da je za zagotavljanje visokokakovostnih ocen bistveno zagotoviti vključenost najboljših znanstvenih strokovnjakov.
While the number of referrals for arbitrations arising from consideration of applications by CMDv eased, the referrals taking up increasingly resources of the Committee and the Agency secretariat relate particularly to harmonisation and ‘Community interest' referrals which set precedents and practice that will be followed in subsequent, similar cases. 
Medtem ko se je število napotitev za arbitražo, ki izhajajo iz obravnave vlog, ki jo izvaja Koordinacijska skupina za postopek medsebojnega priznavanja in decentralizirani postopek (veterina) (CMDv), nekoliko zmanjšalo, pa zahtevajo čedalje več virov Odbora in sekretariata agencije napotitve, ki se nanašajo zlasti na usklajevalne napotitve in napotitve v zvezi z „interesom Skupnosti“, ki določajo precedense in prakso, ki se bodo upoštevali v poznejših podobnih primerih.
The Board made a general scrutiny reservation about the report. 
Upravni odbor je v zvezi s poročilom podal splošni proučitveni pridržek.
Memorandum of understanding between the EMA and the NCAs on the monitoring of the scientific level and independence of evaluations 
Memorandum o soglasju, sklenjen med agencijo EMA in nacionalnimi pristojnimi organi o spremljanju znanstvene ravni in neodvisnosti vrednotenja
The Board thanked the topic coordinators -Jean Marimbert and Lisette Tiddens - for their contribution to this work. 
Upravni odbor se je zahvalil tematskima koordinatorjema Jeanu Marimbertu in Lisette Tiddens za njun prispevek k temu delu.
A further update will be provided in October. 
Nove posodobljene informacije bodo predložene oktobra.
Chairs of management boards of EU agencies 
Predsedniki upravnih odborov agencij EU
Fourteen agencies participated and elected Pat O'Mahony as the chair of the group. 
Udeležili so se ga predstavniki 14 agencij, ki so Pata O'Mahonyja izvolili za predsednika skupine.
Following the discussion at the March 2010 meeting about the allocation of responsibility within the EU on a vigilance system for substances of human origin, the Executive Director wrote a letter to the European Commission that was followed by a discussion between DG Sanco and EMA staff. 
Izvršni direktor je po razpravi o podelitvi pristojnosti za sistem stalnega nadzora za snovi človeškega izvora v EU, ki je potekala na seji marca 2010, Evropski komisiji poslal dopis, temu pa je sledila razprava med GD za zdravje in potrošnike ter osebjem agencije EMA.
The report will now be presented to the HMA in July and published on the Agency's website. 
Poročilo bo julija predstavljeno vodjem agencij za zdravila (HMA) in objavljeno na spletni strani agencije.
The updated document will be presented at the HMA meeting in July and submitted to the Management Board for adoption by written procedure. 
Posodobljeni dokument bo predstavljen na julijskem sestanku vodij agencij za zdravila (HMA) in predložen upravnemu odboru v sprejetje s pisnim postopkom.
• Improving linkage between HMA and medical devices competent authorities. 
• izboljšanjem povezav med vodjami agencij za zdravila in pristojnimi organi za medicinske pripomočke.
Einar Magnússon (Iceland) Brigitte Batliner (Liechtenstein) Gro Ramsten Wesenberg (Norway) 
Einar Magnússon (Islandija) Brigitte Batliner (Lihtenštajn) Gro Ramsten Wesenberg (Norveška)
A detailed report on lessons learned will be provided for the October meeting. 
Podrobno poročilo o spoznanjih bo predloženo na oktobrski seji.
[EMA/MB/210895/2010] The agenda was adopted with amendments to agenda item 14. 
[EMA/MB/210895/2010] Dnevni red je bil sprejet s spremembami točke 14. 2.
The Board stressed that it is essential for the national competent authorities to recover the costs fully. 
Poudaril je, da je za te bistveno, da v celoti izterjajo stroške.
Members suggested that a questionnaire be prepared to gather and share information on what practices are put in place in NCAs with regards to the handing of conflicts of interest. 
Člani so predlagali oblikovanje vprašalnika za zbiranje in izmenjavo informacij o praksah nacionalnih pristojnih organov za obravnavo primerov navzkrižja interesov.
The group met with a Commission representative to discuss the findings of the evaluation of the EU agencies carried out by the European Commission in 
Skupina se je sestala s predstavnikom Komisije in z njim razpravljala o ugotovitvah ocenjevanja agencij EU, ki ga je Evropska komisija izvedla leta 2009.
In the meantime, the Agency will present its proposals for the policy on access to documents, which will also address the release of clinical trials data following completion of procedures, at the July meeting of the Heads of Medicines Agencies. 
Agencija bo medtem na julijskem sestanku vodij agencij za zdravila predstavila predloge za politiko o dostopu do dokumentov, v kateri bo obravnavano tudi objavljanje podatkov iz kliničnih preskušanj po dokončanju postopkov.
[EMA/MB/289198/2010] Pending the receipt of the opinion of the Court of Auditors on provisional accounts, a written procedure will be launched shortly to adopt the Management Board opinion on the Agency's annual accounts for the year ended 31 December 2009. 
[EMA/MB/289198/2010] V pričakovanju mnenja Računskega sodišča o začasnih računovodskih izkazih se bo kmalu začel pisni postopek za sprejetje mnenja upravnega odbora o končnih računovodskih izkazih agencije za leto, ki se je končalo 31. decembra 2009.
A high-level update on the outcomes of the workshop will be provided to the Management Board in October. 
Upravnemu odboru bodo oktobra predložene posodobljene informacije na visoki ravni o izidih delavnice.
Report from the European Commission 
Poročilo Evropske komisije
Draft reflection paper on ethical and GCP aspects of clinical trials of medicinal products for human use conducted in third countries and submitted in marketing authorisation applications to the EMA 
Osnutek študije o etičnem vidiku in vidiku dobre klinične prakse glede kliničnih preskušanj zdravil za uporabo v humani medicini, ki se izvajajo v tretjih državah in so agenciji EMA predložena kot del vloge za pridobitev dovoljenja za promet
• [EMEA/MB/298753/2010] Summary of transfers of appropriations in the budget 2010. 
• [EMEA/MB/298753/2010] Povzetek prerazporeditve sredstev v proračunu za leto 2010.
The HMA aims to complete the paper by the end of this year. 
Vodje agencij za zdravila ga nameravajo dokončati do konca tega leta;
• [EMA/MB/281850/2010] Outcome of written procedures during the period from 26 February 2010 to 2 June 2010. 
• [EMA/MB/281850/2010] Rezultat pisnih postopkov v obdobju od 26. februarja 2010 do
[EMA/MB/302460/2010] The Management Board had adopted revised contractual arrangements which contain a number of key performance indicators. 
[EMA/MB/302460/2010] Upravni odbor je sprejel spremenjene pogodbene ureditve, ki vključujejo več ključnih kazalnikov uspešnosti.
[EMA/MB/298741/2010] The Management Board discussed two ongoing consultation procedures: one for the CVMP and one for the CHMP. 
[EMA/MB/298741/2010] Upravni odbor je razpravljal o dveh trenutnih postopkih posvetovanja in sicer enem za odbor CVMP in enem za odbor CHMP.
[EMA/MB/297535/2010; EMA/MB/168222/2010] The Management Board adopted the analysis and assessment of the annual activity report 2009. 
[EMA/MB/297535/2010; EMA/MB/168222/2010] Upravni odbor je potrdil analizo in oceno letnega poročila o dejavnostih za leto 2009.
[EMA/MB/311466/2010] The Management Board discussed the memorandum of understanding (MoU) which clarifies the responsibilities between the EMA and national competent authorities for monitoring of the scientific level and independence of evaluations. 
[EMA/MB/311466/2010] Upravni odbor je razpravljal o memorandumu o soglasju, v katerem so pojasnjene obveznosti agencije EMA in nacionalnih pristojnih organov za spremljanje znanstvene ravni in neodvisnosti vrednotenja.
Documents for information 
Dokumenti v vednost
Minutes of the 67th meeting of the Management Board 
Zapisnik 67. seje upravnega odbora
[EMA/MB/338709/2010; EMA/712397/2009] The Management Board noted the draft reflection paper, which elaborates on four areas of action from the strategy paper 'Acceptance of clinical trials conducted in third countries for evaluation in Marketing Authorisation Applications'. 
[EMA/MB/338709/2010; EMA/712397/2009] Upravni odbor se je seznanil z osnutkom študije, v kateri so podrobneje obravnavana štiri področja ukrepov iz strateškega dokumenta „Sprejemanje kliničnih preskušanj, izvedenih v tretjih državah, za ocenjevanje v vlogah za pridobitev dovoljenja za promet“.
Representatives of patients' organisations 
Predstavniki organizacij bolnikov
Election of the Management Board Chair 
Izvolitev predsednika upravnega odbora
[EMA/MB/354158/2010] The Management Board endorsed the appointment of an ad interim accounting officer until the return to office of the accounting officer. 
[EMA/MB/354158/2010] Upravni odbor je potrdil imenovanje začasnega računovodje, dokler se ne bo računovodja vrnil na delo.
[EMA/MB/276960/2010; EMA/319831/2010] The Management Board noted the Agency's report to the European Commission providing the Agency's views on the experience with the Fee Regulation. 
[EMA/MB/276960/2010; EMA/319831/2010] Upravni odbor se je seznanil s poročilom agencije Evropski komisiji, v katerem so navedena njena stališča glede izkušenj z uredbo o pristojbinah.
[EMA/MB/13787/2009] The Management Board noted the update report on the implementation of EudraVigilance for veterinary products. 
[EMA/MB/13787/2009] Upravni odbor se je seznanil s posodobljenim poročilom o izvajanju sistema EudraVigilance za proizvode za uporabo v veterinarski medicini.
Report from the Heads of Medicines Agencies 
Poročilo vodij agencij za zdravila
[EMA/MB/345587/2010] The Management Board discussed the new format of the EudraVigilance report. 
[EMA/MB/345587/2010] Upravni odbor je razpravljal o novi obliki poročila o sistemu EudraVigilance.
Chair: Pat O'Mahony 
Predsednik: Pat O'Mahony
The members noted the update report from the Heads of Medicines Agencies (HMA) on a number of topics, including: 
Člani upravnega odbora so se seznanili s posodobljenim poročilom vodij agencij za zdravila o več temah, vključno s/z:
[EMA/MB/298674/2010] The Management Board adopted its meeting dates for 2011 and noted tentative meeting dates for 2012. 
[EMA/MB/298674/2010] Upravni odbor je potrdil datume sej za leto 2011 in se seznanil z okvirnimi datumi sej za leto 2012.
[EMA/MB/311343/2010; EMA/255244/2010; EMA/MB/353273/2010] The Management Board discussed and agreed in principle on a way forward for introducing changes to the way the Agency handles potential conflicts of interests of experts involved in the evaluation of medicines. 
[EMA/MB/311343/2010; EMA/255244/2010; EMA/MB/353273/2010] Upravni odbor je razpravljal o prihodnjih ukrepih za uvedbo sprememb načina, kako agencija obravnava mogoča navzkrižja interesov strokovnjakov, ki sodelujejo pri vrednotenju zdravil, in se načelno strinjal s prihodnjimi ukrepi.
[EMA/MB/282448/2010] The Management Board heard the report on arbitration and referral activities of the CVMP. 
[EMA/MB/282448/2010] Upravni odbor se je seznanil s poročilom o dejavnostih arbitraže in napotitev odbora CVMP.
[EMA/MB/372194/2010, EMA/MB/400828/2010] The Management Board noted the decision of the European Commission to re-open the vacancy announcement following advice of the European Commission legal service with regard to a wider publication of the vacancy. 
[EMA/MB/372194/2010, EMA/MB/400828/2010] Upravni odbor se je seznanil s sklepom Evropske komisije, da v skladu z nasvetom pravne službe Evropske komisije, da je treba poskrbeti za širšo objavo prostega delovnega mesta, znova objavi obvestilo o prostem delovnem mestu.
• The progress on the HMA strategy paper. 
• napredkom pri strateškem dokumentu vodij agencij za zdravila.
The Board constituted a group of topic coordinators to work together with the Agency's staff: Chair, Vice-chair, Kent Woods, Giuseppe Nisticò, Guido Rasi. 
V njej bodo predsednik, podpredsednica, Kent Woods, Giuseppe Nisticò in Guido Rasi.
Otherwise, the national competent authorities may have significant difficulties contributing to activities which are important for public health. 
Treba je vzpostaviti povezavo med obsegom dela in razpoložljivimi viri za opravljanje potrebnega dela, drugače bodo nacionalni pristojni organi le težko prispevali k dejavnostim, ki so pomembne za javno zdravje.
Representative of veterinarians' organisations 
Predstavniki veterinarskih organizacij
Veterinary medicinal products 
Zdravila za uporabo v veterinarski medicini