natgillin/translations-raw huggingface dataset:
The budget is in line with the work programme and totals €222.5 million (6.5% increase over the 2011 budget), which includes a general EU contribution of €23 million, the 2010 surplus of €9.9 million and the €6 million orphan medicinal products fund.
Proračun je v skladu z delovnim programom in znaša 222,5 milijona EUR (6,5-odstotno povečanje v primerjavi s proračunom za leto 2011), kar vključuje splošni prispevek EU v višini 23 milijonov EUR, presežek iz leta 2010 v višini 9,9 milijona EUR in 6 milijonov EUR iz sklada za zdravila sirote.
The extended information sharing is important to enable effective and reliable cooperation for handling various situations and to contribute to an effective use of international inspection resources.
Razširjena souporaba informacij je pomembna, da se omogoči učinkovito in zanesljivo sodelovanje za obvladovanje različnih razmer in za prispevanje k učinkoviti uporabi mednarodnih inšpekcijskih zmogljivosti.
The Agency and the network will need to consider ways of reducing the burden of fixed costs through the review and introduction of new technologies that have a cost-saving effect.
Agencija in mreža bosta morali proučiti načine za zniževanje fiksnih stroškov s pregledom in uvedbo novih tehnologij, ki znižujejo stroške.
15 Romania 16 Slovakia 17 Slovenia 18 Sweden 19 United Kingdom 20 Mary Baker 21 Mike O'Donovan by proxy
15 Romunija 16 Slovaška 17 Slovenija 18 Švedska 19 Združeno kraljestvo 20 Mary Baker 21 Mike O'Donovan po pooblaščencu 22 Lisette Tiddens
The report follows the request of the European Parliament during the discharge procedure in 2011 to review the Agency's procurement practices.
Poročilo je bilo pripravljeno na zahtevo Evropskega parlamenta med postopkom podelitve razrešnice leta 2011 za pregled praks javnega naročanja agencije.
The main focus of the work programme is the implementation of the new pharmacovigilance legislation and the legislation on falsified medicines.
Glavna pozornost v delovnem programu je namenjena izvajanju nove zakonodaje o farmakovigilanci in zakonodaje o ponarejenih zdravilih.
The Agency had taken action to remedy shortcomings identified earlier in the process.
Agencija je sprejela ukrepe za odpravo pomanjkljivosti, ki so bile ugotovljene v zgodnejši fazi postopka.
In this area, it was suggested to extend the period during which restrictions apply from two years to five years following the expiry of the conflict.
Na tem področju je bilo predlagano, naj se po izteku navzkrižja interesov podaljša obdobje veljavnosti omejitev z dveh na pet let.
A number of interim arrangements will be made pending the completion of the process.
Do dokončanja postopka bo sprejetih več začasnih ureditev.
Some of the factors contributing to supply shortages are trade issues, concentration and economics of manufacturing, and the drive for cost savings in healthcare systems.
Nekateri dejavniki, ki prispevajo k nezadostni oskrbi, so trgovinska vprašanja, koncentracija in ekonomika proizvodnje ter usmerjenost k zniževanju stroškov v sistemih zdravstvenega varstva.
The Board discussed the importance of sharing the contents of the European clinical trials database with the countries with which the Agency cooperates in the area of clinical trials.
Razpravljal je o pomenu souporabe vsebine podatkovne zbirke o evropskih kliničnih preskušanjih z državami, s katerimi agencija sodeluje na področju kliničnih preskušanj.
The report also showed an increase in requests for data from EudraVigilance, a significant increase of Member States working with the EudraVigilance Data Analysis System, and improved compliance with the legal timeframes for the transmission of individual case safety reports.
V poročilu je bilo ugotovljeno tudi povečanje števila zahtevkov za podatke iz sistema EudraVigilance, precejšnje povečanje števila držav, ki uporabljajo sistem EudraVigilance za analizo podatkov, in boljša skladnost z zakonskimi roki za predložitev varnostnih poročil o posameznih primerih.
This is then followed by a signal management procedure.
Temu sledi postopek obvladovanja znakov.
• Letter from the European Commission, Paola Testori Coggi, regarding EU level support in the field of tissues and cells.
• Dopis Evropske komisije, Paole Testori Coggi, o podpori na ravni EU na področju tkiv in celic.
The process to prepare detailed plans and fitting-out requirements is ongoing and should finish in February 2012.
Postopek priprave podrobnih načrtov in zahtev za opremo prostorov poteka in se bo predvidoma končal februarja 2012.
The Commission pointed out that the focus should be on what can be done within the current legislative framework in view of the resource implications.
Komisija je poudarila, da je treba glavno pozornost nameniti vprašanju, kaj je mogoče doseči v sedanjem zakonodajnem okviru glede na finančne posledice.
Andreas Pott had been appointed as Deputy Executive Director of the Agency effective 1 December 2011.
Andreas Pott je bil s 1. decembrom 2011 imenovan za namestnika izvršnega direktorja agencije.
The proposed action plan focuses on the following areas: centralised multi-annual procurement planning, use of negotiated procedures in exceptional circumstances, and the Advisory Committee on Procurement and Contracts.
V predlaganem akcijskem načrtu je glavna pozornost namenjena naslednjim področjem: centraliziranemu večletnemu načrtovanju javnih naročil, uporabi postopkov s pogajanji v izjemnih okoliščinah ter svetovalnemu odboru za javna naročila in pogodbe.
The meeting also considered whether additional provisions should be included in respect of attendance at meetings and conferences sponsored by the pharmaceutical industry.
Udeleženci seje so tudi obravnavali, ali bi bilo treba vključiti dodatne določbe v zvezi z udeležbo na sejah in konferencah, ki jih je podpira farmacevtska industrija.
This requires the Management Board to have a specific policy that differs in a number of aspects from that of the scientific committees.
Upravni odbor mora zato imeti posebno politiko, ki se v več vidikih razlikuje od politike znanstvenih odborov.
The Management Board thanked Hans-Georg for his leadership, skill and contribution to achieving the Agency's objectives over this period, and wished him all the best for his future plans.
Upravni odbor se je Hansu-Georgu zahvalil za vodenje, znanje in prispevek k izpolnjevanju ciljev agencije v tem obdobju in mu zaželel vse najboljše pri njegovih prihodnjih načrtih.
The Management Board expressed its condolences to the family and its deepest regret following the death of its valued member Henk Vaarkamp who represented veterinary organisations on the Board for almost 3 years.
Upravni odbor je izrazil sožalje družini in globoko obžalovanje zaradi smrti svojega cenjenega člana Henka Vaarkampa, ki je bil skoraj tri leta predstavnik veterinarskih organizacij v upravnem odboru.
• The proposal on information to patients (the provisions related to the pharmacovigilance legislation are now dissociated from the proposal on information to patients; progress on the latter proposal remains slow).
• predlog o obveščanju bolnikov (določbe v zvezi z zakonodajo o farmakovigilanci so zdaj ločene od predloga o obveščanju bolnikov; napredek v zvezi z zadnjim predlogom je še vedno počasen);
• Substances of human origin (the Commission will establish an information system on the substances; the Agency and ECDC will have an advisory role within their areas of competence).
• snovi človeškega izvora (Komisija bo vzpostavila informacijski sistem o teh snoveh; agencija in center ECDC bosta imela svetovalno vlogo v okviru svojih pristojnosti).
Effort will also be made to enhance the coordination of the scientific committees in light of the increasing complexity of interaction following the establishment of the seventh committee, which will deal with pharmacovigilance topics.
Prizadevajo si tudi za okrepitev usklajevanja dela znanstvenih odborov ob upoštevanju vse večje zapletenosti sodelovanja po ustanovitvi sedmega odbora, ki se bo ukvarjal s temami v zvezi s farmakovigilanco.
In addition to his responsibilities as Deputy Executive Director, Andreas will continue in his position as Head of Administration Unit.
Poleg odgovornosti namestnika izvršnega direktorja bo še naprej opravljal funkcijo vodje enote za administrativne zadeve.
With regard to this particular concern, the meeting was reminded that the issue was discussed when preparing the experts' policy.
V zvezi s tem posebnim pomislekom so bili udeleženci seje opozorjeni, da se je o tem vprašanju razpravljalo pri pripravi politike za strokovnjake.
Interaction between the Agency and healthcare professionals a.) Framework for interaction between the Agency and healthcare professionals, and b.) Criteria to be fulfilled by healthcare professionals' organisations involved in Agency activities
Sodelovanje agencije in zdravstvenih delavcev a) Okvir za sodelovanje agencije in zdravstvenih delavcev b) Merila, ki jih morajo izpolnjevati organizacije zdravstvenih delavcev, ki so vključene v dejavnosti agencije
Vote on the adoption of agenda item 7bis - Personnel matter
Glasovanje o sprejetju točke 7a dnevnega reda - Kadrovska zadeva
The Board therefore asked to consider expanding this approach to veterinary medicines.
Upravni odbor je zato pozval k razmisleku o razširitvi tega pristopa na zdravila za uporabo v veterinarski medicini.
The Management Board discussed at length the implementation of the provision on public hearings in the context of the revised urgent Union procedure.
Upravni odbor je obširno razpravljal o izvajanju določbe o javnih obravnavah v okviru spremenjenega nujnega postopka Unije.
The Board discussed the proposal to introduce restrictions in certain cases where potential conflicts of interests can be perceived.
Upravni odbor je razpravljal o predlogu za uvedbo omejitev v nekaterih primerih, v katerih je mogoče zaznati morebitna navzkrižja interesov.
The decision was taken following a long period of discussions between the Commission, the European
Ta odločitev je bila sprejeta po dolgotrajnih razpravah med Komisijo, Evropsko agencijo za zdravila in
A new member of the Committee is introduced to represent the business activities of the Agency.
Predstavljen je bil nov član odbora za zastopanje poslovnih interesov agencije.
This improved response time reflects stronger collaboration between the Agency secretariat and the CHMP and its Pharmacovigilance Working Party, especially in terms of increased awareness of the current signal management process.
Ta izboljšani odzivni čas je plod tesnejšega sodelovanja med sekretariatom agencije in odborom CHMP (Odborom za zdravila za uporabo v humani medicini) ter njegovo delovno skupino za farmakovigilanco, zlasti v smislu večje ozaveščenosti o sedanjem postopku obvladovanja znakov.
• The cross-border directive (progress has been achieved in setting up a voluntary cooperation structure with Member States in the area of health technology assessment; a network of Member States in the e-health area was established; a new proposal on cross-border health threats was adopted).
• direktiva o čezmejnem zdravstvenem varstvu (dosežen je bil napredek z vzpostavitvijo strukture za prostovoljno sodelovanje z državami članicami na področju ocenjevanja zdravstvene tehnologije; oblikovana je bila mreža držav članic na področju e-zdravja; sprejet je bil nov predlog o čezmejnih nevarnostih za zdravje);
Nomination to the new Pharmacovigilance Risk Assessment Committee (PRAC)
Imenovanja v novi Odbor za ocenjevanje tveganja na področju farmakovigilance (Pharmacovigilance Risk Assessment Committee, PRAC)
The mandates of the current civil society members of the Board expire on 4 March 2012.
Mandati sedanjih članov upravnega odbora, ki so predstavniki civilne družbe, se iztečejo 4. marca 2012.
The meeting also stressed that a mechanism to effectively address unethical behaviour should be put in place and would be an important instrument to ensure compliance with the requirements.
Udeleženci seje so polega tega poudarili, da je treba vzpostaviti mehanizem za učinkovito obravnavo neetičnega vedenja, ki bi bil pomemben instrument za zagotavljanje skladnosti z zahtevami.
The European Parliament granted the discharge for the implementation of the Agency's 2009 budget on 25 October 2011.
Evropski parlament je 25. oktobra 2011 podelil razrešnico za izvrševanje proračuna agencije za leto 2009.
The European Commission reminded the Board of the fact that the EU contribution to the Agency's budget is a balancing contribution.
Evropska komisija je upravni odbor opozorila na dejstvo, da je prispevek EU v proračun agencije izravnalni prispevek.
The meeting discussed that the Agency has to continue to review the scope of its activities and, when relevant, to reallocate resources from activities that are not strictly required by legislation.
Udeleženci seje so razpravljali, da mora agencija še naprej pregledovati obseg svojih dejavnosti in po potrebi prerazporediti sredstva iz dejavnosti, ki jih zakonodaja ne zahteva izrecno.
The Board agreed to discuss a first draft proposal on public hearings at the next meeting.
Upravni odbor se je strinjal, da bo o prvem osnutku predloga o javnih obravnavah razpravljal na naslednji seji.
List of written procedures during the period from 15 September 2011 to 30 November 2011
Seznam pisnih postopkov v obdobju od 15. septembra 2011 do 30. novembra 2011
With regard to communication, the Board was informed that the Agency plans to reassess and further improve its communication activities with a view to providing the Agency's stakeholders with information about how the Agency and EU institutions contribute to public health.
V zvezi s komuniciranjem je bil upravni odbor obveščen, da agencija namerava ponovno oceniti in dodatno izboljšati svoje komunikacijske dejavnosti, da bo zainteresiranim stranem agencije zagotavljala informacije, kako agencija in institucije EU prispevajo k javnemu zdravju.
Draft agenda for 15 December 2011 meeting
Osnutek dnevnega reda za sejo dne 15. decembra 2011
The meeting was also informed that the Agency is preparing further guidance to experts about its policies on conflicts of interests.
Udeleženci seje so bili tudi obveščeni, da agencija pripravlja dodatne smernice za strokovnjake o svojih politikah o navzkrižjih interesov.
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);