natgillin/translations-raw huggingface dataset:
The Chair informed the Board that he had examined declarations of interests of members together with the Vice-chair and the secretariat, and concluded that there were no conflicts of interest that could interfere with the topics of the meeting. 
Predsednik je upravni odbor obvestil, da je pregledal izjave o interesih članov, podpredsednika in sekretariata, in ugotovil, da ni navzkrižij interesov, ki bi posegala v teme seje.
The Executive Director briefed the Board about a range of topics discussed at the meeting, among which were the communication strategy of the Agency and the implementation of the pharmacovigilance legislation. 
Izvršni direktor je upravnemu odboru poročal o različnih temah, o katerih se je razpravljajo na srečanju, med drugim o komunikacijski strategiji agencije in izvajanju zakonodaje o farmakovigilanci.
The Management Board welcomed the Agency's efforts in this domain and recognised the contribution of staff in establishing fruitful and exemplary cooperation with its stakeholders. 
Upravni odbor je pozdravil prizadevanja agencije na tem področju in izrekel priznanje za prispevek osebja pri vzpostavitvi uspešnega in vzornega sodelovanja z zainteresiranimi stranmi agencije.
This was the last Management Board meeting for Hans-Georg Wagner, Head of Information and Communications Technology (ICT) Unit, who was shortly to retire after serving with the Agency since May 2002. 
To je bila zadnja seja upravnega odbora za Hansa-Georga Wagnerja, vodjo enote za informacijsko in komunikacijsko tehnologijo, ki se bo kmalu upokojil, delo pri agenciji pa je nastopil maja 2002.
Members welcomed Guido Rasi, the Executive Director of the Agency, for whom this was the first Management Board meeting in this capacity. 
Člani so pozdravili Guida Rasija, izvršnega direktorja agencije, ki se je seje upravnega odbora prvič udeležil v tej funkciji.
• The implementation of the pharmacovigilance legislation (seven implementing measures are being prepared; public consultation finished in November 2011; the most relevant measure, which is relevant for national authorities, sets out minimum requirements for the pharmacovigilance system applied at NCA level). 
• izvajanje zakonodaje o farmakovigilanci (pripravlja se sedem izvedbenih ukrepov; javno posvetovanje se je končalo novembra 2011; najpomembnejši ukrep, ki je pomemben za nacionalne organe, določa minimalne zahteve za sistem farmakovigilance, ki se uporabljajo na ravni nacionalnih pristojnih organov);
8 Germany 9 Greece by proxy 10 Ireland 11 Italy 
8 Nemčija 9 Grčija po pooblaščencu 10 Irska
The European Commission also pointed out that the ICT budget should be revisited and that there is scope for reducing meetings and missions. 
Evropska komisija je poleg tega poudarila, da je treba ponovno obravnavati proračun za IKT ter da bi bilo mogoče zmanjšati število sej in službenih potovanj.
In particular, the Board decided to defer the election process for the Vice-chair of the Board and the Chair of the Management Board Telematics Committee (MBTC) until after the civil society nominations have been made, which is anticipated in June 2012. 
Upravni odbor se je zlasti odločil, da postopek izvolitve podpredsednika upravnega odbora in predsednika odbora upravnega odbora za telematiko (Management Board Telematics Committee, MBTC) preloži, dokler ne bodo opravljena imenovanja predstavnikov civilne družbe, kar bo predvidoma junija 2012.
Rannveig Gunnarsdóttir (Iceland) Brigitte Batliner (Liechtenstein) Gro Wesenberg (Norway) 
Rannveig Gunnarsdóttir (Islandija) Brigitte Batliner (Lihtenštajn) Gro Wesenberg (Norveška)
The Board noted the letter from Paola Testori, Director-General of the DG for Health and Consumers, on the subject. 
Upravni odbor se je seznanil z dopisom Paole Testori, generalne direktorice Generalnega direktorata za zdravje in potrošnike, o tej temi.
Management Board Telematics Committee (MBTC) 
Odbor upravnega odbora za telematiko (MBTC)
The planned fee revenue is increased by 7.5% over the 2011 budget to €173 million, in line with the increased number of applications and workload. 
Načrtovani prihodki iz provizij so se v primerjavi s proračunom za leto 2011 povečali za 7,5 % in zdaj znašajo 173 milijonov EUR, kar je odraža večje število vlog in povečano delovno obremenitev.
Mary Baker Apologies from Mike O'Donovan 
Mary Baker Opravičilo Mika O'Donovana
The Management Board adopted the establishment plan for 2012 of 590 posts, which increases the number of temporary agent (TA) posts by 23 for the implementation of the pharmacovigilance legislation. 
Upravni odbor je sprejel kadrovski načrt za leto 2012, ki zajema 590 delovnih mest in povečuje število delovnih mest začasnih uslužbencev, potrebnih za izvajanje zakonodaje o farmakovigilanci, za 23.
Held in London on 15 December 2011 
V Londonu, 15. decembra 2011
Andreas had been in charge of the Agency as acting Executive Director since January 2011 and has demonstrated his leadership, personal judgement and dedication by leading the organisation in a complex environment throughout 2011. 
Kot vršilec dolžnosti izvršnega direktorja je vodil agencijo od januarja 2011 in dokazal svoje vodstvene veščine, sposobnost osebne presoje in predanost vodenju organizacije v kompleksnem okolju vse leto 2011.
The Board was informed that the Agency had sent letters to respective Member States' Permanent Representations in Brussels inviting nominations to the Committee with the deadline of 15 January 
Upravni odbor je bil obveščen, da je agencija poslala dopise ustreznim stalnim predstavništvom držav članic v Bruslju, v katerih jih je pozvala k predložitvi imenovanj v odbor najpozneje do 15. januarja 2012.
The framework focuses on the following areas of interaction: accessing the best-possible expertise, contributing to a more efficient and targeted communication to healthcare professionals, and enhancing HCP organisations' understanding of the role of the Agency and of the network. 
Okvir namenja glavno pozornost naslednjim področjem sodelovanja: dostopu do najboljšega mogočega strokovnega znanja in izkušenj, prispevanju k učinkovitejši in bolj ciljno usmerjeni komunikaciji z zdravstvenimi delavci ter izboljšanju razumevanja organizacij zdravstvenih delavcev o vlogi agencije in mreže.
In their discussion, members stressed that the role of the Board and the types of decisions taken are significantly different from those of the scientific committees. 
Na razpravi so poudarili, da se vloga upravnega odbora in vrste sprejetih odločitev bistveno razlikujejo od vloge in vrst odločitev znanstvenih odborov.
These factors are beyond the reach of regulators. 
Na te dejavnike zakonodajalci ne morejo vplivati.
Members also stressed that with regard to Management Board members, the majority are also covered by similar conflicts of interests policies of their national authorities. 
Člani so poleg tega poudarili, da se v zvezi z večino članov upravnega odbora prav tako uporabljajo podobne politike o navzkrižju interesov njihovih nacionalnih organov.
d.) ICT budgets and projects for 2012 
d) Proračuni in projekti IKT za leto 2012
EMA conflicts of interests policies a.) Second update on the implementation of the conflicts of interests policy for experts 
Politike agencije EMA o navzkrižjih interesov a) Druge novice o izvajanju politike o navzkrižju interesov za strokovnjake
The meeting also noted that both the network of HCPs and that of patients' and consumers' organisations will work together on topics of common interest. 
Udeleženci seje so se poleg tega seznanili, da bosta mreža zdravstvenih delavcev ter mreža organizacij bolnikov in potrošnikov sodelovali pri temah skupnega interesa.
Draft reflection paper on ethical and GCP aspects of clinical trials 
Osnutek študije o etičnem vidiku in vidiku dobre klinične prakse glede kliničnih preskušanj
Taking into account that the current memberships on the Board of Lisette Tiddens and Mike O'Donovan expire on 4 March 2012, as do their mandates as Chair and a member of the MBTC respectively, and pending new appointments of the civil society representatives to the Board, the meeting decided to appoint Kent Woods as interim Chair of the MBTC effective 5 March 2012. 
Ob upoštevanju dejstva, da bo sedanje članstvo Lisette Tiddens in Mika O'Donovana v odboru poteklo 4. marca 2012, pri čemer se bosta iztekla tudi njuna mandata predsednice oziroma člana odbora MBTC, so se udeleženci seje odločili, da do novega imenovanja predstavnikov civilne družbe v odbor imenujejo Kenta Woodsa za začasnega predsednika odbora MBTC, in sicer s 5. marcem 2012.
IAS strategic audit plan for 2012-2014 
Strateški revizijski načrt službe za notranjo revizijo (IAS) za obdobje 2012-2014
• [EMA/MB/902317/2011] Summary of transfers of appropriations in the budget 2011. 
• [EMA/MB/902317/2011] Povzetek prenosov dodeljenih sredstev v proračun za leto 2011.
• EU database for veterinary medicines (in light of the revision of the veterinary legislation, the HMA reflected on a global strategic direction with regard to its IT infrastructure, particularly in the area of medicinal products databases). 
• zbirka podatkov EU o zdravilih za uporabo v veterinarski medicini (zaradi spremembe veterinarske zakonodaje so vodje agencij za zdravila obravnavali globalno strateško usmeritev v zvezi z infrastrukturo IT, zlasti na področju zbirk podatkov o zdravilih);
• The implementation of the falsified medicines legislation (the Commission has launched public consultation on the following two implementing measures: the unique identifier and the assessment of the GMP status for active substances from non-EU countries). 
• izvajanje zakonodaje o ponarejenih zdravilih (Komisija je začela javno posvetovanje o naslednjih dveh izvedbenih ukrepih: posebnem identifikatorju in oceni statusa glede dobre proizvodne prakse za zdravilne učinkovine iz držav, ki niso članice EU);
Members raised concern that the legislation does not provide for alternate members of the civil society representatives on the Management Board. 
Člani so izrazili zaskrbljenost, da zakonodaja ne omogoča, da bi upravni odbor imel namestnike predstavnikov civilne družbe.
The Chair of the HMA management group provided an update on a number of items, including the following: 
Predsednik upravne skupine vodij agencij za zdravila je predstavil posodobljene informacije o več temah, vključno z naslednjim:
• [EMA/876327/2011] EMA preparations for the impact of the Olympic Games 2012. 
• [EMA/876327/2011] Priprave agencije EMA na vpliv olimpijskih iger leta 2012.
2011 EudraVigilance-Human mid-year report 
Vmesno poročilo o stanju sistema EudraVigilance za zdravila za uporabo v humani medicini za leto 2011
The Management Board thanked the topic coordinators Aginus Kalis, Marcus Müllner, Pat O'Mahony and Kent Woods for their contribution in preparing the topics on the work programme and the budget for the discussion. 
Upravni odbor se je zahvalil tematskim koordinatorjem Aginusu Kalisu, Marcusu Müllnerju, Patu O'Mahonyju in Kentu Woodsu za njihovo vlogo pri pripravi tem v zvezi z delovnim programom in proračunom za razpravo.
The Board took the opportunity to thank the topic coordinators (Xavier De Cuyper, Walter Schwerdtfeger and Lisette Tiddens) for preparing this topic for the discussion, and will look forward to a further discussion at the next meeting. 
Upravni odbor se je tematskim koordinatorjem (Xavier De Cuyper, Walter Schwerdtfeger in Lisette Tiddens) ob tej priložnosti zahvalil za pripravo te teme za razpravo in povedal, da se veseli nadaljnje razprave na naslednji seji.
11bis Preparation for written procedures: Non-automatic carry-over 2011-2012 
Priprava na pisne postopke: nesamodejni prenos v obdobje 2011-2012
The Board also decided to invite the current civil society representativesMary Baker, Mike O'Donovan and Lisette Tiddens - to participate at the next meeting as observers, to enable them to provide valuable input to the work of the Board. 
Poleg tega se je odločil, da sedanje predstavnike civilne družbe - Mary Baker, Mika O'Donovana in Lisette Tiddens - povabi k sodelovanju na naslednji seji v vlogi opazovalcev, da lahko s svojimi dragocenimi izkušnjami prispevajo k delu upravnega odbora.
Mike O'Donovan gives his vote by proxy to Mary G Baker. 
Mike O'Donovan za glasovanje pooblašča Mary G Baker.
The adopted framework focuses on the interaction in the area of human medicines. 
Sprejet okvir namenja glavno pozornost sodelovanju na področju zdravil za uporabo v humani medicini.
Amendments to Management Board implementing rules on the Agency's fees 
Spremembe izvedbenih pravil upravnega odbora o pristojbinah agencije
5 Denmark 
5 Danska
In addition, members were asked to declare any specific interests that could be considered to be prejudicial to their independence with respect to the items on the agenda. 
Člani odbora so bili poleg tega pozvani, naj se izrečejo o kakršnih koli posebnih interesih v zvezi s katero koli točko dnevnega reda, ki bi lahko vplivali na njihovo neodvisnost.
• [EMA/907269/2011] EU telematics projects report; [EMA/907270/2011] EU telematics operations report; [EMA/907383/2011] Minutes from the Management Board Telematics Committee meeting held on 22 September 2011. 
• [EMA/907269/2011] Poročilo o telematskih projektih EU; [EMA/907270/2011] Poročilo o telematskih operacijah EU; [EMA/907383/2011] Zapisnik seje odbora upravnega odbora za telematiko, ki je potekala 22. septembra 2011.
• Progress on identifying commercially confidential information (a revised guidance document will be presented at the next HMA meeting in February 2012). 
• napredek pri opredelitvi poslovno zaupnih informacij (na naslednji seji vodij agencij za zdravila februarja 2012 bodo predstavljene spremenjene smernice);
b.) Second update on the implementation of the conflicts of interests policy for staff 
b) Druge novice o izvajanju politike o navzkrižju interesov za osebje
• Adoption of 73rd Management Board meeting minutes finalised on 25 November 2011. 
• Sprejetje zapisnika 73. seje upravnega odbora je bilo končano 25. novembra 2011.
[EMA/MB/902165/2011] The mid-year report showed positive trends in the area of signal detection and management. 
[EMA/MB/902165/2011] V vmesnem poročilu so bili ugotovljeni pozitivni trendi na področju odkrivanja in obvladovanja znakov.
George Antoniou (Cyprus) gives his vote by proxy to Patricia Vella Bonanno (Malta). 
George Antoniou (Ciper) za glasovanje pooblašča Patricio Vella Bonanno (Malta).
Reflection paper on medicinal product supply shortages caused by manufacturing/GMP compliance problems 
Študija o nezadostni oskrbi z zdravili, ki jo povzročijo proizvodne težave/težave v zvezi z zagotavljanjem skladnostji z dobro proizvodno prakso
[EMA/MB/826035/2011] The agenda was adopted. 
[EMA/MB/826035/2011] Dnevni red je bil sprejet.
The amendments concern the following areas: inspections, plasma master files, certificates for medicinal products, type II variations to MUMS marketing authorisations for non-food-producing species, and core dossiers for medicinal products to be used in a human pandemic situation. 
certifikate za zdravila, spremembe tipa II dovoljenj za promet z zdravili MUMS (manjša uporaba in manj pomembne živalske vrste) za vrste živali, ki niso živali za proizvodnjo živil, in temeljne dokumentacije za zdravila, ki se uporabljajo v razmerah pandemije med ljudmi.
This reflection paper focuses only on supply shortages in the area of human medicines. 
Ta študija je osredotočena le na nezadostno oskrbo na področju zdravil za uporabo v humani medicini.
3 Belgium 
3 Belgija
The Board wished to return to this topic at a future meeting. 
Upravni odbor je izrazil željo, da se o tej temi razpravlja na eni od prihodnjih sej.
c.) The revised Management Board conflicts of interests policy 
c) Spremenjena politika upravnega odbora o navzkrižjih interesov
a.) The work programme 2012 
a) Delovni program za leto 2012
Claude Hemmer (Luxembourg) gives his vote by proxy to Aginus Kalis (Netherlands). 
Claude Hemmer (Luksemburg) za glasovanje pooblašča Aginusa Kalisa (Nizozemska).
6 Estonia 
6 Estonija
Changes in management 
Spremembe v vodstvu agencije
[EMA/MB/924270/2011; EMA/914836/2011] This item (for information) was deferred to the next meeting. 
[EMA/MB/924270/2011; EMA/914836/2011] Ta točka (v vednost) je bila preložena na naslednjo sejo.
List of participants at the 74th meeting of the Management Board, held in London on 15 December 2011 
Seznam udeležencev 74. seje upravnega odbora v Londonu 15. decembra 2011
Ioannis Toutas (Greece) gives his vote by proxy to Pat O'Mahony (Ireland). 
Ioannis Toutas (Grčija) za glasovanje pooblašča Pata O'Mahonyja (Irska).
Revised Management Board rules of procedure 
Spremenjen poslovnik upravnega odbora
13 Lithuania 14 Malta 
12 Latvija 13 Litva
7 Finland 
7 Finska
European Commission Paola Testori Coggi Apologies from Pedro Ortum Silvan 
Paola Testori Coggi Opravičilo Pedra Ortuma Silvana
With regard to the financing of the implementation of the pharmacovigilance legislation, the European Commission intends to present a 'bridging budget' for the year 2013. 
Evropska komisija namerava v zvezi s financiranjem izvajanja zakonodaje o farmakovigilanci predstaviti „premostitveni proračun“ za leto 2013.
The meeting was cautious about the implementation of public hearings at an early stage. 
Udeleženci seje so poudarili potrebo po previdnosti glede izvajanja javnih obravnav v zgodnji fazi.
Veterinarian organisations 
Veterinarske organizacije
Planning 2012 
Načrtovanje za leto 2012
• [EMA/MB/868582/2011] Outcome of written procedures during the period 15 September 2011 to 
• [EMA/MB/868582/2011] Rezultat pisnih postopkov v obdobju od 15. septembra 2011 do 30. novembra 2011.
Vote on the adoption of agenda item 7c - MB conflicts of interests policy 
Glasovanje o sprejetju točke 7c dnevnega reda - Politika upravnega odbora o navzkrižjih interesov
[EMA/MB/643417/2011] The Management Board noted the revised staff policy plan, in line with the reduced staffing and budget compared to the 2012 preliminary draft budget. 
[EMA/MB/643417/2011] Upravni odbor se je seznanil s spremenjenim načrtom kadrovske politike v skladu z manjšim številom zaposlenih in manjšim proračunom v primerjavi s predhodnim predlogom proračuna za leto 2012.
Communication, transparency, future veterinary legislation, interactions with health technology assessment (HTA) bodies, process reengineering to increase efficiency of operations, and assuring functioning of the Agency during the busy Olympic period in London will be other areas of focus for 
Druge teme, ki jim bo v letu 2012 posvečeno veliko pozornosti, so komuniciranje, preglednost, prihodnja veterinarska zakonodaja, sodelovanje z organi za ocenjevanje zdravstvene tehnologije, preoblikovanje postopkov za povečanje učinkovitosti operacij in zagotavljanje delovanja agencije v pestrem obdobju olimpijskih iger v Londonu.
[EMA/MB/899250/2011; EMA/INS/GMP/774201/2011] The Board discussed the issue of supply shortages, considering it to be of importance to public health. 
[EMA/MB/899250/2011; EMA/INS/GMP/774201/2011] Upravni odbor je razpravljal o vprašanju nezadostne oskrbe in menil, da je to vprašanje pomembno za javno zdravje.
Czech Republic Bulgaria 
Češka republika Bolgarija
[EMA/MB/880875/2011] The Management Board endorsed the adaptation of the fixed hourly cost to €41 for the year 2012 (the cost had been €40 since 2009). 
[EMA/MB/880875/2011] Upravni odbor je potrdil prilagoditev fiksne urne postavke na 41 EUR za leto 2012 (od leta 2009 je ta postavka znašala 40 EUR).
Chair: Sir Kent Woods 
Predsednik: Kent Woods
[EMA/MB/811207/2011] The Management Board endorsed the report on the Agency's procurement procedure and the proposed improvement action plan. 
[EMA/MB/811207/2011] Upravni odbor je potrdil poročilo o postopku javnih naročil agencije in predlagani akcijski načrt za izboljšave.
Minutes of the 74th meeting of the Management Board 
Zapisnik 74. seje upravnega odbora
[EMA/MB/554514/2011] The Management Board adopted the work programme 2012. 
[EMA/MB/554514/2011] Upravni odbor je sprejel delovni program za leto 2012.
The Board also discussed the fact that management of supply shortages is equally complicated and involves various parties, such as the Agency, national competent authorities (NCAs), healthcare professionals, health ministries, companies and other bodies, all of which should work in a way that is efficient and responsive. 
Upravni odbor je razpravljal tudi o dejstvu, da je obvladovanje nezadostne oskrbe enako zapleteno in vključuje različne vpletene strani, kot so agencija, nacionalni pristojni organi, zdravstveni delavci,
c.) Draft budget and establishment plan 2012 
c) Predlog proračuna in kadrovski načrt za leto 2012
[EMA/MB/915206/2011; Ares(2011)992230 - 20/09/2011] The Management Board endorsed the IAS strategic audit plan for 2012-2014. 
[EMA/MB/915206/2011; Ares(2011)992230 - 20/09/2011] Upravni odbor je potrdil strateški revizijski načrt službe IAS za obdobje 2012-2014.
[EMA/MB/834867/2011] The Management Board welcomed the proposed revisions to the Management Board policy on conflicts of interests. 
[EMA/MB/834867/2011] Upravni odbor je pozdravil predlagane spremembe politike upravnega odbora o navzkrižjih interesov.
[EMA/MB/856505/2011] The Management Board noted the information on the ICT budget and the projects planned for 2012. 
[EMA/MB/856505/2011] Upravni odbor se je seznanil z informacijami o proračunu in projektih IKT, načrtovanimi za leto 2012.
[EMA/MB/828587/2011] The Management Board noted the final minutes, adopted by written procedure on 23 November 2011. 
[EMA/MB/828587/2011] Upravni odbor se je seznanil s končnim zapisnikom, ki je bil sprejet s pisnim postopkom 23. novembra 2011.
[EMA/MB/115339/2004/Rev.3] The Management Board adopted changes to the Management Board rules of procedure. 
[EMA/MB/115339/2004/Rev.3] Upravni odbor je sprejel spremembe poslovnika upravnega odbora.
b.) MBTC chairmanship arrangements 
b) Ureditev predsedovanja odboru MBTC
Pedro Ortun Silvan by proxy 
Pedro Ortun Silvan po pooblaščencu
Pedro Ortun Silvan (DG Enter) gives his vote by proxy to Paola Testori-Coggi (DG Sanco). 
Pedro Ortun Silvan (GD za podjetništvo in industrijo) za glasovanje pooblašča Paolo Testori-Coggi (GD za zdravje in varstvo potrošnikov).
• No 11/2011 - the appointment of Frederic Klein as CVMP alternate, proposed by Belgium, finalised on 19 October 2011. 
• Št. 11/2011 - imenovanje Frederica Kleina za namestnika v odboru CVMP na predlog Belgije, ki je bilo končano 19. oktobra 2011.
[EMA/MB/882002/2011] The Management Board noted that a written procedure for non-automatic carry-forward will be launched for adoption no later than 15 February 2012. 
[EMA/MB/882002/2011] Upravni odbor je bil seznanjen, da se bo najpozneje 15. februarja 2012 začel izvajati pisni postopek za sprejetje nesamodejnega prenosa.
A reflection paper on veterinary product supply shortages should be discussed. 
Treba bi bilo torej razpravljati tudi o študiji o nezadostni oskrbi z zdravili za uporabo v veterinarski medicini.
[EMA/MB/901680/2011; EMA/901869/2011] The Management Board endorsed the implementing activities for 2012. 
[EMA/MB/901680/2011; EMA/901869/2011] Upravni odbor je potrdil izvedbene dejavnosti za leto 2012.
[EMA/MB/239263/2011] The Management Board adopted amendments to the fee implementing rules. 
[EMA/MB/239263/2011] Upravni odbor je sprejel spremembe izvedbenih pravil o pristojbinah.
• No 12/2011 - the appointment of Alia Michaelidou-Patsia as CVMP alternate, proposed by Cyprus, finalised on 28 November 2011. 
• Št. 12/2011 - imenovanje Alie Michaelidou-Patsia za namestnico v odboru CVMP na predlog Cipra, ki je bilo končano 28. novembra 2011.
Proxies announced by the Chair 
Pooblastila za zastopanje, ki jih je napovedal predsednik
e.) Staff policy plan 2012 
e) Načrt kadrovske politike za leto 2012
• No 10/2011 - the appointment of Eva Persson as CVMP alternate, proposed by Sweden, finalised on 19 October 2011. 
• Št. 10/2011 - imenovanje Eve Persson za namestnico v odboru CVMP na predlog Švedske, ki je bilo končano 19. oktobra 2011.
The Chair announced the proxies held by members present. 
Predsednik je povedal, kateri prisotni člani imajo pooblastila za zastopanje.
Abstained 
Vzdržani