natgillin/translations-raw huggingface dataset:
This becomes an emerging risk for the financing of the Agency in the light of the likely negative financial impact of the revised variations regulation, uncertainty of the impact of a new payment system to Member States and the current economic climate.
To je nastajajoče tveganje za financiranje Agencije zaradi po vsej verjetnosti negativnega finančnega učinka revidirane uredbe o spremembah, negotovosti glede učinka novega plačilnega sistema za države članice in sedanjih gospodarskih razmer.
A proposal taking into account the Board's views will be submitted in December 2009.
Predlog, v katerem bodo upoštevana stališča upravnega odbora, bo predložen decembra 2009.
The group intends to work in three stages: draft the statements in consultation with the agencies under some 35 topics; consider the experience under those topics; make proposals for the future.
Skupina namerava delovati v treh fazah: v posvetovanju z agencijami pripraviti izjave v zvezi s približno 35 temami, obravnavati izkušnje v zvezi z zadevnimi temami in pripraviti predloge za prihodnost.
The proposed rules transpose the rules that are applied in the European Commission for secondment of their staff to organisations outside the EU.
Predlagana pravila prenašajo pravila, ki se uporabljajo pri Evropski komisiji za dodelitev njenega osebja organizacijam zunaj EU.
Resource requirements of the CVMP
Zahteve v zvezi z viri odbora CVMP
The Board noted the progress made in the previous year, major developments in the management and control systems and conclusions of audits.
Upravni odbor se je seznanil z napredkom, doseženim v lanskem letu, pomembnimi spremembami upravljavskega in kontrolnega sistema ter sklepi revizij.
Specifically, the scientific committee reviewed scientific information and recommended extending the shelf life of Tamiflu from 5 to 7 years; it also provided an opinion on the use of antiviral medicine Tamiflu in children under one year and in pregnant and breastfeeding women.
Natančneje, znanstveni odbor je proučil znanstvene informacije in priporočil podaljšanje roka uporabnosti zdravila Tamiflu s 5 na 7 let; poleg tega je predložil mnenje o uporabi protivirusnega zdravila Tamiflu pri otrocih, mlajših od enega leta, nosečnicah in doječih ženskah.
The FDA colleague will join the EMEA in June.
Član urada FDA se bo agenciji EMEA pridružil junija.
As discussed above, in addition there is a proposal at the Commission to cancel the earmarked revenue from the 2008 surplus.
Kot je bilo navedeno že zgoraj, Komisija predlaga tudi ukinitev namenskega prihodka iz presežka v letu 2008.
Mr Johannes Löwer's invitation as an observer is extended to all future meetings of the Management Board.
Povabilo Johannesu Löwerju kot opazovalcu velja za vse prihodnje seje upravnega odbora.
The members invited the Agency to elaborate more on the mandate and role of the coordinating group of the proposed network, the composition of this group and expected competencies of members.
Člani so Agencijo pozvali, naj natančno opredeli pristojnosti in vlogo usklajevalne skupine predlagane mreže, sestavo te skupine in pričakovane kompetence članov.
Developing the European Medical Information network
Razvoj evropske mreže zdravstvenih informacij
Participants at the sixty-third meeting of the Management Board London, 11 June 2009
Udeleženci triinšestdesete seje upravnega odbora London, 11. junija 2009
The Management Board welcomed the results of the Agency's operations in 2008 and the strong contribution of the EMEA to EU-wide efforts in support of making high-quality, safe and effective medicines available for use in human and animal populations.
Upravni odbor je pozdravil rezultate dejavnosti Agencije v letu 2008 in velik prispevek agencije EMEA k prizadevanjem EU v podporo omogočanju razpoložljivosti visokokakovostnih, varnih in učinkovitih zdravil za uporabo v humani in veterinarski medicini.
A consequence analysis, including resource needs, will follow this proposal.
Temu predlogu bo sledila analiza posledic, vključno s potrebami po virih.
Currently, the Agency is in dialogue with manufacturers of vaccines and with European and international regulators to discuss scientific and regulatory issues in order to facilitate the availability of vaccines for use in an influenza pandemic situation.
Agencija je vzpostavila dialog s proizvajalci cepiv ter evropskimi in mednarodnimi regulatorji za razpravo o znanstvenih in regulativnih vprašanjih, kar bo olajšalo razpoložljivost cepiv za uporabo v pandemijah gripe.
The Management Board was informed that the court of first instance dismissed a company's application in relation to suspension of the Agency's decision and the adoption of interim measures.
Upravni odbor je bil obveščen, da je sodišče prve stopnje zavrnilo pritožbo nekega podjetja v zvezi z začasno razveljavitvijo odločbe Agencije in sprejetjem začasnih ukrepov.
The proposals aim to create visual identity for the Agency, to further promote its recognition and reputation.
Cilj predlogov je oblikovati vizualno podobo Agencije, ki bo dodatno krepila njeno prepoznavnost in ugled.
The members noted the update report from the European Commission on a range of topics, including: work on novel influenza and the Council's conclusions regarding strategy for vaccine development; pharmaceutical package and good progress with pharmacovigilance and anticounterfeiting proposals, as well as Member States' concerns over the proposal for drug information provisions.
Člani so se seznanili s posodobljenim poročilom Evropske komisije o različnih temah, vključno z: delom v zvezi z novo gripo in sklepi Sveta o strategiji za razvoj cepiva, farmacevtskim svežnjem in dobrim napredkom v zvezi s predlogi o farmakovigilanci in boju proti ponarejanju zdravil, ter pomisleki držav članic o predlogu določb glede informacij o zdravilih.
The Executive Director announced the appointment of Edit Weidlich as head of the Agency's internal audit and Fergus Sweeney as head of the Agency's inspections sector.
Izvršni direktor je napovedal imenovanje Edit Weidlich za vodjo službe za notranjo revizijo Agencije in Fergusa Sweeneya za vodjo inšpekcijskega sektorja Agencije.
In addition, the members enquired whether it would be useful to determine the level of conflicts of interest of new nominees during the nomination procedure, raising potential issues with the nominating authority.
Poleg tega je člane zanimalo, ali bi bilo koristno opredeliti stopnjo navzkrižij interesov novih kandidatov med postopkom imenovanja, kar je problematika, ki bi jo mogoče lahko obravnaval organ za imenovanja.
The Management Board is involved in 4 stages of the process: the provision of the opinion on the vacancy notice, nomination of an observer to a pre-selection committee at the European Commission, nomination of a director from a shortlist proposed by the European Commission, and appointment of the director after the nominee's presentation at a committee of the European Parliament (in the case of the EMEA - the concerned committee is the Committee on Environment, Public Health and Food Safety).
Upravni odbor je vključen v štiri faze tega postopka: predložitev mnenja o objavi prostega delovnega mesta, imenovanje opazovalca v predizbirno komisijo pri Evropski komisiji, imenovanje direktorja iz ožjega seznama kandidatov, ki ga predlaga Evropska komisija, in imenovanje direktorja po predstavitvi, ki jo kandidat opravi v ustreznem odboru Evropskega parlamenta (v primeru agencije EMEA je to Odbor za okolje, javno zdravje in varnost hrane).
The rules follow those of the European Commission with derogation regarding the calculation of the duration of the mission for departure and arrival times from London stations and airports.
Ta pravila temeljijo na pravilih Evropske komisije, od katerih se razlikujejo glede izračuna trajanja misije za čas odhoda in prihoda iz londonskih postaj in letališč.
The Management Board considered that it is feasible to increase the level of allowable conflicts of interests, but this needs to be matched with increased transparency to assure the public that opinions and decisions will continue to be reached with utmost independence.
Upravni odbor je menil, da je mogoče povečati stopnjo dopustnih navzkrižij interesov, vendar bo treba hkrati povečati preglednost in javnosti tako zagotoviti, da se mnenja in odločitve še naprej sprejemajo popolnoma neodvisno.
The comments received at the meeting will be incorporated and the policy will be published for public consultation.
Pripombe, prejete na seji, se bodo upoštevale, objavljena pa bo tudi politika za namene javnega posvetovanja.
The Management Board noted the developments in the budgetary procedure for 2010.
Upravni odbor se je seznanil s spremembami proračunskega postopka za leto 2010.
The proposals, including scheduling of referrals in line with the ability of the Committee to manage them, will be submitted to the Management Board and the Heads of Medicines Agencies.
Predlogi, vključno s časovnim razporejanjem napotitev v skladu s sposobnostjo Odbora, da jih upravlja, se bodo nato predložili upravnemu odboru in vodjem agencij za zdravila.
The Management Board heard an update on the Agency's work in the field of novel swine influenza (so called A/H1N1).
Upravni odbor se je seznanil z delom Agencije na področju nove prašičje gripe (tako imenovane gripe A/H1N1).
The Board discussed that it is important to understand that EU agencies differ in their roles, the sectors they operate in and the stakeholders they are accountable for.
Upravni odbor je poudaril, da je treba upoštevati, da se agencije EU razlikujejo glede na svojo vlogo, sektorje, v katerih delujejo, in zainteresirane strani, za katere so pristojne.
The Management Board will also be informed of the 35 statements once all the findings have been consolidated.
Upravni odbor bo po združitvi vseh ugotovitev obveščen tudi o 35 izjavah.
The Chair invited the members to submit their expression of interests to participate as observers in the preselection committee.
Predsedujoči je člane pozval, naj predložijo prijavo interesa za sodelovanje v vlogi opazovalca v predizbirni komisiji.
Experts with a higher level of conflicts of interests than permitted under the present policy could be allowed to provide their recommendations, but they would not participate in the decision making.
Strokovnjakom z višjo stopnjo navzkrižij interesov, kot jo dovoljuje sedanja politika, bi se lahko dovolila predložitev priporočil, vendar ti strokovnjaki ne bi smeli sodelovati pri odločanju.
The European Commission guidelines state that directors of EU agencies are appointed at the AD14 grade.
V smernicah Evropske komisije je določeno, da so direktorji agencij EU imenovani na ravni razreda AD14.
The members suggested sending the public vacancy notice through the Heads of Medicines Agencies to the national authorities for publishing on national websites.
Člani so predlagali, naj se javna objava prostega delovnega mesta prek vodij agencij za zdravila pošlje nacionalnim organom za objavo na nacionalnih spletnih straneh.
The proposal will then be submitted to the Heads of Medicines Agencies for discussion.
Predlog se bo nato predložil vodjem agencij za zdravila v razpravo.
In preparation for the bird flu pandemic, the Agency has developed a novel approach using a mock-up virus for assessment of pandemic vaccines.
Agencija je med pripravami na pandemijo ptičje gripe razvila nov pristop z uporabo modelnega virusa za ocenjevanje pandemičnih cepiv.
In addition to the centralised regulatory approval, there may be for some A/H1N1 vaccines the option to obtain approval via national authorisation routes.
Poleg centralizirane odobritve cepiv po centraliziranem postopku je mogoče nekatera cepiva za gripo A/H1N1 odobriti tudi z nacionalnimi postopki za izdajo dovoljenja.
Report from the Heads of Medicines Agencies The members noted the written report.
Poročilo vodij agencij za zdravila Člani so se seznanili s pisnim poročilom.
Draft agenda for 11 June 2009 meeting [EMEA/MB/45799/2009] The agenda was adopted.
Osnutek dnevnega reda za sestanek 11. junija 2009 [EMEA/MB/45799/2009] Dnevni red je bil sprejet.
*As part of the cooperation between the Management Board and the Heads of Medicines Agencies, Mr Johannes Löwer, the chair of the HMA management group, participated in the Board meeting as an observer.
* Kot del sodelovanja med upravnim odborom in vodji agencij za zdravila se je seje upravnega odbora kot opazovalec udeležil Johannes Löwer, predsednik uprave skupine HMA.
European Medicines Network, as having different practices would have a negative impact on the network, and robust policies need to be implemented alongside the transparency policy.
Zato je treba poiskati načine za zagotavljanje doslednega pristopa v Evropski mreži zdravil, saj bi različne prakse negativno vplivale na mrežo, poleg politike preglednosti pa je treba izvajati tudi trdne politike.
The Board expressed concern about the European Commission's intention to cancel the arrangements which allowed treating positive balance of the Agency's outturn account as ‘earmarked revenue' for the Agency for subsequent years.
Upravni odbor je izrazil zaskrbljenost glede namere Evropske komisije, da bo ukinila ureditev, v skladu s katero je pozitivno stanje v izkazu poslovnega izida Agencije mogoče obravnavati kot „namenski prihodek“ Agencije za prihodnja leta.
The Agency works with vaccine manufacturers to identify the required data to allow for the modification of the marketing authorisation which would replace the current mock-up virus with one of the A/H1N1-derived pandemic-like strains as recommended by the WHO.
Agencija sodeluje s proizvajalci cepiv pri opredeljevanju potrebnih podatkov, ki bodo omogočili spremembo dovoljenja za promet z zdravilom, s čimer bi se sedanji modelni virus v skladu s priporočili SZO nadomestil z enim od sevov, ki je podoben pandemičnemu in je bil razvit iz virusa gripe A/H1N1.
The Agency has done significant work on antiviral medicines to date.
Agencija je opravila že veliko dela v zvezi s protivirusnimi zdravili.
Draft EMEA transparency policy
Osnutek politike preglednosti agencije EMEA
The group will continue its work presenting the proposals at a Heads of Medicines Agencies meeting.
Skupina bo nadaljevala svoje delo in predloge predstavila na sestanku vodij agencij za zdravila.
The new corporate identity will be rolled out in December 2009, together with the new public website of the Agency.
Nova celostna podoba bo skupaj z novo javno spletno stranjo Agencije predstavljena decembra 2009.
Update on EMEA work in relation to novel influenza
Posodobljene informacije o delu agencije EMEA v zvezi z novo gripo
The Management Board discussed that the grade should reflect the size and complexity of an agency.
Upravni odbor je razpravljal o tem, da bi moral biti razred odvisen od velikosti in kompleksnosti agencije.
The Board considered that the recruitment grade for a future director of the Agency should be increased.
Upravni odbor je menil, da je treba zvišati razred zaposlitve prihodnjega direktorja Agencije.
The Board expressed a concern that once vaccines are developed the regulators will be under significant pressure from various parties to authorise the products.
Upravni odbor je izrazil zaskrbljenost, da bodo regulatorji po končanem razvoju cepiv izpostavljeni velikim pritiskom različnih strani, ki si bodo prizadevale za pridobitev dovoljenja za promet z zdravilom.
The proposal will be further reflected upon at the October meeting.
O tem predlogu se bo nadalje razpravljalo na oktobrski seji.
Necessary mitigating actions need to be implemented and their conflicts of interests should be made public.
Treba je izvajati potrebne ukrepe za ublažitev posledic in javno objaviti navzkrižja interesov strokovnjakov.
The Board will approach the European Commission with a request to review the recruitment grade for the EMEA's director.
Upravni odbor se bo obrnil na Evropsko komisijo z zahtevo po proučitvi razreda zaposlitve za direktorja agencije EMEA.
The Executive Director undertook to update the Management Board on the progress of the inter-institutional discussions.
Izvršni direktor se je zavezal k sprotnemu obveščanju upravnega odbora o napredku medinstitucionalnih razprav.
This process should be seen as a possibility to recognise EU agencies in the governance landscape of the EU.
Zavedati se je treba, da ta proces lahko prispeva k priznanju vloge agencij EU na področju vodenja v EU.
The Board was briefed about the ongoing inter-institutional debate on the creation and role of EU agencies.
Upravni odbor se je seznanil s tekočo medinstitucionalno razpravo o oblikovanju in vlogi agencij EU.
The notice will be sent to all Board members for comments.
Obvestilo bo poslano vsem članom upravnega odbora, ki nato podajo pripombe.
Changes to the Mission rules [EMEA/MB/694348/2008] The Management Board adopted the rules on missions.
Spremembe pravil o misijah [EMEA/MB/694348/2008] Upravni odbor je sprejel pravila o misijah.
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 so bili pozvani, naj navedejo kakršne koli posebne interese v zvezi s katero koli točko dnevnega reda, ki bi lahko vplivali na njihovo neodvisnost.
The Management Board stressed that it is essential to come to an agreement at the EU and intentional levels on the requirements for pandemic vaccines.
Upravni odbor poudarja, da je treba v zvezi z zahtevami glede pandemičnih cepiv doseči sporazum na ravni EU in mednarodni ravni.
The Management Board discussed the guidelines for appointment of executive directors of EU agencies.
Upravni odbor je razpravljal o smernicah za imenovanje izvršnih direktorjev agencij EU.
[EMEA/MB/300234/2009] The topic coordinators presented three proposals to improve the consultation procedure: the revision of the CV template to obtain more information on scientific qualifications of nominees; a pre-selection panel listing its advantages and disadvantages; and amendments to the request for nomination letter.
[EMEA/MB/300234/2009] Tematski koordinatorji so predstavili tri predloge za izboljšanje posvetovalnega postopka: spremembo modela življenjepisa za pridobitev več informacij o znanstvenih kvalifikacijah kandidatov, predizbirni seznam, na katerem se navedejo njihove prednosti in slabosti, in spremembe zahtevka za pismo o imenovanju.
The EMEA will approach the Commission's Directorate-General for Budget expressing these concerns.
Agencija EMEA bo svoje pomisleke posredovala Generalnemu direktoratu za proračun pri Komisiji.
Irene Sacristan - Sannchez
Irene Sacristan - Sanchez
[EMEA/MB/301036/2009] The members heard EMEA concerns that due to high number of referrals, the ability of the Committee for Medicinal Products for Veterinary Use (CVMP) to handle these procedures is reaching capacity.
[EMEA/MB/301036/2009] Člani so se seznanili z zaskrbljenostjo agencije EMEA, da bo Odbor za zdravila za uporabo v veterinarski medicini (CVMP) zaradi velikega števila napotitev kmalu dosegel zgornjo mejo svojih zmogljivosti za izvajanje teh postopkov.
Recommendations from the Management Board group on the consultation of nominations to the committees
Priporočilo upravnega odbora v zvezi s posvetovanji o imenovanjih v odbore
[EMEA/MB/170391/2009/Rev.2] The Management Board adopted the revisions to Articles 3(2) and 4 of the Fee implementing rules.
[EMEA/MB/170391/2009/Rev.2] Upravni odbor je sprejel spremembe členov 3(2) in 4 izvedbenih pravil o pristojbinah.
[EMEA/MB/284297/2009/Rev.1] The Management Board discussed the first proposal on simplification of contractual arrangements in December 2006.
[EMEA/MB/284297/2009/Rev.1] Upravni odbor je o prvem predlogu poenostavitve pogodbenih ureditev razpravljal decembra 2006.
The decision is at the discretion of the European Commission.
Evropska komisija bo odločitev sprejela po lastni presoji.
Minutes of the sixty-third meeting of the Management Board
Zapisnik triinšestdesete seje upravnega odbora
The Management Board noted the update report on progress of the preparations for exchange of staff between the EMEA and the US FDA.
Izmenjava osebja med agencijo EMEA in uradom FDA Upravni odbor se je seznanil s posodobljenim poročilom o napredku priprav za izmenjavo osebja med agencijo EMEA in ameriškim Uradom za živila in zdravila (FDA).
[EMEA/MB/306935/2009] The Management Board discussed the proposal to establish a European medical information network.
[EMEA/MB/306935/2009] Upravni odbor je razpravljal o predlogu oblikovanja evropske mreže zdravstvenih informacij.
The Board thanked the topic coordinators (Mindaugas Būta, Jytte Lyngvig Marcus Müllner, Pat O'Mahony and Kristin Raudsepp) for detailed review of the report and the proposed analysis and assessment.
Upravni odbor se je tematskim koordinatorjem (Mindaugas Būta, Jytte Lyngvig Marcus Müllner, Pat O'Mahony in Kristin Raudsepp) zahvalil za podroben pregled poročila in predlagano analizo ter oceno.
Rules on attachment of staff
Dodelitev osebja
European Commission communication on EU agencies
Sporočilo Evropske komisije o agencijah EU
[EMEA/MB/279887/2009] Following the consultation process, the Management Board considered and endorsed the proposals for the new corporate identity of the EMEA, including the new logo and acronym of the Agency.
[EMEA/MB/279887/2009] Upravni odbor je po posvetovalnem postopku obravnaval in potrdil predloge za novo celostno podobo agencije EMEA, vključno z novim logotipom in kratico Agencije.
Minutes from the 62nd meeting, held on 4-5 March 2009 [EMEA/MB/45799/2009] The Management Board noted the adoption of the minutes by written procedure.
Zapisnik dvainšestdesete seje, ki je potekala 4. in 5. marca 2009 [EMEA/MB/45799/2009] Upravni odbor se je seznanil s sprejetjem zapisnika s pisnim postopkom.
[EMEA/MB/246063/2009; EMEA/MB/251948/2009] The members noted the information on upcoming written procedures.
[EMEA/MB/246063/2009; EMEA/MB/251948/2009] Člani so se seznanili z informacijami o prihodnjih pisnih postopkih.
EMEA highlights from the Executive Director
Poudarki izvršnega direktorja agencije EMEA
[EMEA/MB/138548/2009; EMEA/MB/305863/2009; EMEA/MB/356427/2009] The Board heard a presentation on the experience with the policy on the handling of conflicts of interests at the EMEA committees and working parties.
[EMEA/MB/138548/2009; EMEA/MB/305863/2009; EMEA/MB/356427/2009] Upravnemu odboru so bile predstavljene izkušnje v zvezi s politiko o obravnavanju navzkrižij interesov v odborih in delovnih skupinah agencije EMEA.
[EMEA/MB/186559/2009; EMEA/MB/319028/2009] The Management Board adopted the analysis and assessment of the Executive Director's annual activity report 2008.
[EMEA/MB/186559/2009; EMEA/MB/319028/2009] Upravni odbor je sprejel analizo in oceno letnega poročila o dejavnostih za leto 2008, ki ga je predstavil izvršni direktor.
The topic coordinators (Jean Marimbert and Marcus Müllner) were thanked for their contributions.
Tematskima koordinatorjema (Jean Marimbert in Marcus Müllner) je bila izražena zahvala za njun prispevek.
EMEA policy and procedure on the handling of conflicts of interests of EMEA scientific committees' members and experts
Politika in postopek agencije EMEA za obravnavanje navzkrižij interesov članov in strokovnjakov znanstvenih odborov agencije EMEA poročilo o izkušnjah za obdobje 2006-2008 študija o smernicah za prihodnost pregled politike agencije EMEA za obravnavanje navzkrižij interesov znanstvenih odborov agencije EMEA
The Board thanked the EMEA and Management Board topic coordinators (Jean Marimbert and Lisette Tiddens-Engwirda) for their contributions.
Upravni odbor se je agenciji EMEA in tematskima koordinatorjema (Jean Marimbert in Lisette Tiddens-Engwirda) zahvalil za njihove prispevke.
[EMEA/MB/295158/2009] The Board discussed the EMEA rules on attachment of staff.
[EMEA/MB/295158/2009] Upravni odbor je razpravljal o pravilih agencije EMEA o dodelitvi osebja.
The Management Board thanked the Board topic coordinators (Aginus Kalis, Jean Marimbert, Marcus Müllner, Gro Wesenberg) for their contribution.
Upravni odbor se je zahvalil tematskim koordinatorjem (Aginus Kalis, Jean Marimbert, Marcus Müllner, Gro Wesenberg) za njihov prispevek.