natgillin/translations-raw huggingface dataset:
This would enable the Management Board to take decisions on establishment plans in the knowledge of the views of the European Commission (taking into account that the Commission opinion is transmitted to the budgetary authority).
To bi upravnemu odboru omogočilo sprejemanje sklepov o načrtih delovnih mest na podlagi znanih stališč Evropske komisije (upoštevajoč, da se mnenje Komisije posreduje proračunskemu organu).
Following the publication of relevant guidance, the work to extend the EudraCT database in line with the requirements of the legislation on paediatric medicinal products will continue.
Po objavi ustreznih smernic se bo delo pri razširitvi podatkovne zbirke EudraCT v skladu z zahtevami zakonodaje o pediatričnih zdravilih nadaljevalo.
The Agency has also implemented the legislation on advanced therapy medicinal products (ATMPs) and established the Committee for Advanced Therapies.
Agencija je tudi izvajala zakonodajo o zdravilih za napredno zdravljenje (ATMP) in ustanovila Odbor za napredno zdravljenje.
The annual report will now be submitted to the members for a three-week consultation period, after which time a written procedure for the adoption will be launched.
Letno poročilo bo zdaj predloženo članom v tritedensko obdobje posvetovanja, po katerem bo sprožen pisni postopek za sprejetje.
The year 2008 saw a further growth in the volume of core activities.
Leto 2008 je zaznamovala nadaljnja rast obsega ključnih dejavnosti.
Incentives for products for minor uses and minor species or for limited markets
Spodbude za zdravila, namenjena manjši uporabi in manj pomembnim vrstam ali omejenim trgom
The work programme and budget focus on the development of corporate information-technology systems, which aim to increase the efficiency with which procedures are monitored and tracked.
Delovni program in proračun se osredotočata na razvoj poslovnih informacijskih sistemov, namenjenih izboljšanju učinkovitosti spremljanja in sledenja postopkov.
Preparation for written procedures: changes to the rules for the implementation of Regulation (EC) No 297/95 on fees payable to the EMEA and other measures
Priprava za pisne postopke: spremembe izvedbenih pravil Uredbe (ES) št. 297/95 o pristojbinah, ki se plačujejo agenciji EMEA in drugih ukrepov
The request to develop similar interactions with representatives of healthcare professionals will be forwarded to the Healthcare Professionals Working Group, and will be discussed during the preparation of the framework for interaction with health care professional organisations.
Zahteva za razvoj podobnih odnosov s predstavniki zdravstvenih delavcev bo posredovana delovni skupini za zdravstvene delavce, o njej pa se bo razpravljalo med pripravo okvira za sodelovanje z organizacijami zdravstvenih delavcev.
The Management Board reiterated the need to find alternative ways of working, including greater use of communication technologies and, possibly, revision of the architecture of the system.
Upravni odbor je znova poudaril, da je treba najti druge načine dela, vključno z večjo uporabo komunikacijskih tehnologij in morda pregledom arhitekture sistema.
In case the Agency's budget is not sufficient to meet the demand, the Agency may introduce additional criteria to make sure that those products of highest benefit, in terms of animal health, continue to receive support.
Če proračun Agencije ne bo izpolnil povpraševanja, bo Agencija morda vpeljala dodatna merila za zagotovitev, da bodo zdravila z največjim učinkom v smislu zdravja živali še naprej prejemala podporo.
Proposal for involvement and participation of patients'/consumers' representatives in the meetings of the CHMP Pharmacovigilance Working Party
Predlog za vključitev in sodelovanje predstavnikov bolnikov/potrošnikov na sestankih delovne skupine odbora CHMP za farmakovigilanco.
EMEA annual report 2008
Letno poročilo agencije EMEA za leto 2008
The experience from this pilot will help to develop a general strategy to further involve patients and consumers at different levels of the Agency's work, as well as will help the Agency to acquire experience that will be useful in the context of the future pharmacovigilance legislation.
Izkušnje iz tega projekta bodo pomagale pri razvijanju splošne strategije nadaljnjega vključevanja bolnikov in potrošnikov na različne ravni dela Agencije, prav tako pa bodo pomagale Agenciji pridobiti izkušnje, ki bodo koristne v smislu prihodnje zakonodaje s področja farmakovigilance.
Governance of EU agencies The point was deferred to the next meeting.
Upravljanje agencij EU Točka je bila preložena na naslednjo sejo.
The wording in the rules of procedure will be clarified together with the European Commission, and the document will be submitted for adoption by written procedure.
Besedilo poslovnika bo prečiščeno ob sodelovanju Evropske komisije, dokument pa bo predložen za sprejetje s pisnim postopkom.
As part of the EU-FDA confidentiality arrangements, and of increased collaboration and cooperation between the EMEA and the US Food and Drug Administration (FDA), the two authorities have agreed to exchange staff on a defined-term basis.
Kot del sporazumov o zaupnosti med EU in uradom FDA ter povečanega obsega sodelovanja med agencijo EMEA in ameriškim Uradom za živila in zdravila (FDA) sta se organa dogovorila o izmenjavi osebja za določen čas.
Although the minutes are adopted by written procedure, they will continue to appear on the agenda to allow members to raise matters arising from a previous meeting.
Čeprav se zapisnik sprejema s pisnim postopkom, se bo še vedno uvrščal na dnevni red, da bodo člani lahko razpravljali o zadevah s prejšnje seje.
The Management Board was informed that the Court of Auditors will possibly visit the Agency later this year to review the progress of the revision of the remuneration system for the work of (co)rapporteurs.
Upravni odbor je bil obveščen, da bo Računsko sodišče pozneje letos verjetno obiskalo Agencijo, da bi pregledalo napredek pri reviziji sistema plačevanja nadomestil (so)poročevalcem.
The number of applications increased in the areas of scientific advice, initial evaluation, post-authorisation, paediatrics and other activities.
Povečalo se je število vlog na področju znanstvenega svetovanja, začetnega vrednotenja, dejavnosti po izdaji dovoljenja, pediatrije in drugih dejavnosti.
The task force was set up in response to the Management Board's legal role in the appointment process, with a view to further improving the consultation process.
Projektna skupina je bila ustanovljena kot odgovor na pravni položaj upravnega odbora v postopku imenovanja, da bi še izboljšala posvetovalni postopek.
Mandate for the Management Board task force on scientific qualification of committee members
Mandat projektne skupine upravnega odbora o znanstveni usposobljenosti članov odbora
In addition to adoption of the necessary procedures and changes to the fee-implementing rules, the Agency is currently preparing other measures that are necessary to put in place the proposed incentives, such as amendments to guidance, a communication strategy with stakeholders, and an official launch of the scheme, foreseen for later in 2009.
Agencija poleg sprejetja potrebnih postopkov in sprememb izvedbenih pravil o pristojbinah zdaj pripravlja druge ukrepe, ki so potrebni za izvajanje predlaganih spodbud, kot so spremembe smernic, strategija za komunikacijo z zainteresiranimi stranmi in uradni začetek programa spodbud, ki je predviden za nadaljevanje leta 2009.
Participants at the sixty-second meeting of the Management Board London, 4-5 March 2009 Chair: Pat O'Mahony
Udeleženci dvainšestdesete seje upravnega odbora London, 4. in 5. marca 2009 Predsednik Pat O'Mahony
The Board supported the amendments proposed by delegations to Articles 2(2) (Responsibilities of chair and vice-chair) and 5(4) (CAT (co)rapporteur and assessment team).
Odbor je podprl spremembe člena 2(2) (Odgovornosti predsednika in podpredsednika) in člena 5(4) (CAT (so)poročevalec in skupina za vrednotenje), ki so jih predlagale delegacije.
The meeting also noted the discussions to date, and encouraged the task force to take the time necessary to review the various options and liaise with the chairs and members of the scientific committees.
Na sestanku se je upravni odbor seznanil tudi s preteklimi razpravami in spodbudil projektno skupino, naj si vzame potreben čas, da pregleda različne možnosti ter stopi v stik s predsedniki in člani znanstvenih odborov.
It will be a year marked by further increases in the volume and complexity of activities.
Zaznamovala ga bo nadaljnja rast obsega in kompleksnosti dejavnosti.
The two-day meeting opened on Wednesday, 4 March 2009, with presentations and discussions on: future global challenges and directions for regulators; challenges linked to the globalisation of clinical trials; risk-based prioritisation of resources.
Dvodnevni sestanek se je začel v sredo, 4. marca 2009, s predstavitvami in razpravami o prihodnjih globalnih izzivih in usmeritvah za regulatorje; izzivih v zvezi z globalizacijo kliničnih preskušanj; prednostnem razvrščanju virov, ki temelji na tveganju.
The members welcomed the performance of the Agency and the achievement of substantial milestones in 2008.
Člani so pozdravili uspešno delovanje Agencije in pomembne mejnike, ki jih je dosegla v letu 2008.
Significant work was carried out in the fields of safety-monitoring of medicines (EudraVigilance, ENCePP projects), communication and transparency, support to innovation, and international activities.
Pomembno delo je bilo opravljeno na področjih spremljanja varnosti zdravil (EudraVigilance, projekti ENCePP), komunikacije in preglednosti, podpiranja inovativnosti in mednarodnih dejavnosti.
The Board agreed to the common understanding that the fee reductions or waivers will be borne by both the Agency and the national competent authorities that take up the (co)rapporteurships.
Odbor je sprejel skupni dogovor, da bodo stroške znižanja pristojbin oziroma oprostitve plačila nosili Agencija in pristojni nacionalni organi, ki pripravljajo (so)poročanje.
In February 2009, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a positive opinion recommending a marketing authorisation under exceptional circumstances for BTVPUR Alsap 8, intended for the active immunisation of sheep and cattle, to prevent viraemia and to reduce clinical signs caused by the bluetongue virus serotype 8.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je februarja 2009 sprejel pozitivno mnenje, v katerem priporoča izdajo dovoljenja za promet z zdravilom v izjemnih okoliščinah za cepivo BTVPUR Alsap 8, ki je namenjeno aktivnemu cepljenju ovac in goveda za preprečevanje viremije in zmanjšanje kliničnih znakov, ki jih povzroča virus bolezni modrikastega jezika serotip 8.
The Board asked to revise the proposed wording of Article 8(7) to make it clear that the CHMP issues an opinion which is transmitted to the European Commission for adoption of a decision.
Odbor je zaprosil za spremembo predlaganega besedila člena 8(7), da bi bilo jasno, da odbor CHMP izda mnenje, ki se posreduje Evropski komisiji, ta pa nato sprejme sklep.
The European Commission representative requested the Board in the future, to allow that the draft establishment plan be submitted to the Directorate-General for Industry and Enterprise, the Directorate-General for Personnel and Administration and the Directorate-General for Budget ahead of the March Management Board meetings in order to allow the Commission to produce its consolidated opinion on the draft plan.
Predstavnik Evropske komisije je Odboru naložil, naj v prihodnje osnutek načrta delovnih mest predloži Generalnemu direktoratu za podjetništvo in industrijo, Generalnemu direktoratu za kadrovske zadeve in administracijo ter Generalnemu direktoratu za proračun pred sejami upravnega odbora v marcu, da bi Komisija lahko pripravila konsolidirano mnenje o osnutku načrta.
However, the funding of information-technology and telematics projects has a structural issue that will be further affected by future legislation in the field of pharmaceuticals (pharmacovigilance, counterfeit medicines and, possibly, information to patients).
Vendar pa se pri financiranju projektov informatizacije in telematike pojavlja strukturna težava, ki jo bo še povečala prihodnja zakonodaja s področja farmacevtskih izdelkov (farmakovigilanca, ponarejena zdravila in mogoče obveščanje bolnikov).
The Management Board was given a presentation about the Agency's transparency-policy project and associated action plan.
Upravnemu odboru sta bila predstavljena projekt Agencije za politiko preglednosti in s tem povezani akcijski načrt.
Following the completion of the discussion on the interaction between the CHMP and the CAT, the Management Board will consider whether any further revision of the rules of procedure are necessary.
Po koncu razprave o vzajemnem delovanju odborov CHMP in CAT bo upravni odbor preučil potrebo po nadaljnjih spremembah poslovnika.
The Management Board noted the upcoming written procedures regarding changes to the feeimplementing rules.
Upravni odbor se je seznanil s prihodnjimi pisnimi postopki v zvezi s spremembami izvedbenih pravil za pristojbine.
The Management Board noted the Executive Director's presentation on the ongoing work to review the Agency's organisational structure.
Upravni odbor se je seznanil s predstavitvijo izvršnega direktorja o tekočem delu za pregled organizacijske strukture Agencije.
The Board wished to be informed of the outcome of this discussion and the rationale for the future agreement between the CAT and CHMP on this issue.
Odbor želi biti obveščen o rezultatu te razprave in utemeljitvi prihodnjega sporazuma o tem vprašanju, ki naj bi ga sklenila odbora CAT in CHMP.
The latter is a new sector with responsibilities for centralising product-information management at the Agency and for improving the interoperability of databases.
To je popolnoma nov sektor, ki je odgovoren za centralizacijo upravljanja podatkov o zdravilih pri Agenciji in izboljšanje povezljivosti podatkovnih zbirk.
The written procedures will include fees for veterinary medicinal products indicated for minor uses and minor species/limited markets, and fees for medicinal products to be used in a health pandemic that affects humans.
Pisni postopki bodo zajemali pristojbine za zdravila za uporabo v veterinarski medicini, namenjena manjši uporabi in manj pomembnim vrstam/omejenim trgom, in pristojbine za zdravila, namenjena uporabi v primeru zdravstvene pandemije, ki prizadene ljudi.
Preliminary draft budget 2010
Predhodni osnutek proračuna za leto 2010
[EMEA/261645/2008] The Management Board endorsed the proposal for a pilot project that aims for greater involvement of patients and consumers in the work of the Agency.
[EMEA/261645/2008] Upravni odbor je potrdil predlog pilotnega projekta, namenjenega večji vključenosti bolnikov in potrošnikov v delo Agencije.
The former was delayed due to some performance issues and stability problems.
Pri izvajanju te zbirke so se pojavile zamude zaradi težav z delovanjem in stabilnostjo.
The Management Board was notified of the first legal case regarding a paediatric investigation planrelated application.
Upravni odbor je bil obveščen o prvem sodnem postopku v zvezi z izvajanjem načrta pediatričnih raziskav.
By the end of the process, the Agency expects to have adopted a formal corporate identity, harmonised the presentation of its communications materials and rationalised its use of document templates.
Nadeja se, da bo ob koncu tega procesa sprejela uradno celostno podobo, uskladila predstavitev svojih komunikacijskih materialov in racionalizirala uporabo predlog dokumentov.
Proxy votes from the representatives of France and Luxembourg were given to Belgium, Malta gave its vote by proxy to Cyprus and the United Kingdom gave its vote by proxy to Denmark.
Predstavnika Francije in Luksemburga sta za glasovanje pooblastila Belgijo, Malta je pooblastila Ciper, Združeno kraljestvo pa Dansko.
Updated quality policy of the European Medicines Agency [EMEA/MB/355781/2007/Rev.1] The Management Board adopted the updated quality policy, which, among other changes, incorporates references to the revised internal-control standards, and clarifies the separation of audit and integrated-quality-management advice functions.
Posodobljena politika kakovosti Evropske agencije za zdravila [EMEA/MB/355781/2007/Rev.1] Upravni odbor je sprejel posodobljeno politiko kakovosti, med katere spremembami je sklicevanje na revidirane standarde notranjega nadzora, v njej pa je pojasnjena tudi ločitev funkcij revizije in svetovanja za enotno upravljanje kakovosti.
The proposed budget is subject to a number of risk factors, including: the difficult global economic climate; the entry into force of the revised variations legislation, which may result in a loss of revenue for the Agency and therefore create the need for an increased Community contribution; revision of the remuneration system for rapporteurships; and risks associated with significant fluctuation of exchange rates.
Predlagani proračun je izpostavljen številnim dejavnikom tveganja, vključno s: težkimi globalnimi gospodarskimi razmerami, začetkom veljavnosti spremenjene zakonodaje s področja sprememb pogojev dovoljenj za promet z zdravili, kar lahko privede do izgube prihodkov Agencije in posledično potrebe po večjem prispevku Skupnosti; pregleda sistema plačevanja nadomestil za poročevalce in tveganj v zvezi z bistvenimi nihanji menjalnih tečajev.
Draft agenda for 4-5 March 2009 meeting [EMEA/MB/663707/2008] The agenda was adopted.
Osnutek dnevnega reda za sestanka 4. in 5. marca 2009 [EMEA/MB/663707/2008] Dnevni red je bil sprejet.
The Management Board noted the report from the Heads of Medicines Agencies (HMA), which included: information on the election of Johannes Löwer as the new chair of the HMA management group, replacing Jytte Lyngvig; discussions regarding the EudraPharm database; resources of the network; work on antimicrobial resistance.
Upravni odbor se je seznanil s poročilom vodij agencij za zdravila (HMA), ki je zajemalo: informacijo o izvolitvi Johannesa Löwera za novega predsednika upravne skupine HMA, ki je zamenjal Jytte Lyngvig, razprave v zvezi s podatkovno zbirko EudraPharm, mrežne vire in delo na področju protimikrobne odpornosti.
The first switch from prescription-only to non-prescription status of a centrally authorised product took place in 2008.
Prvi premik na področju statusa zdravil, ki so pridobila dovoljenje za promet po centraliziranem postopku, od zdravil, ki se izdajajo le na recept, k zdravilom, ki se izdajajo brez recepta, je bil narejen leta 2008.
Points for information
Točke v informativne namene
Start of the term of office of the Management Board members nominated by the Council [EMEA/MB/87076/2009] The Management Board adopted the decision whereby the term of office of the four members of the Management Board listed in Article 1 of Council Decision No 2009/75/EC commenced on 5 March 2009.
Začetek mandata članov upravnega odbora, ki jih je imenoval Svet [EMEA/MB/87076/2009] Upravni odbor je sprejel sklep, da se je mandat štirih članov upravnega odbora, navedenih v členu 1 Sklepa Sveta št. 2009/75/ES, začel 5. marca 2009.
The members noted the update report from the European Commission on a range of topics, including: the guideline setting out what clinical-trial information should be made available to the public; the pharmaceutical package (legislative proposals on pharmacovigilance, tackling counterfeiting of medicines, and information to patients); the evaluation of the EMEA; a recent meeting with Member State representatives on health-technology assessment; the draft Directive on the application of patients' rights with regard to cross-border healthcare; the Commission communication and proposal on patient safety in Europe; and the launch of a public consultation on the future of Europe's workforce for health.
Člani so se seznanili s posodobljenim poročilom Evropske komisije o različnih temah, vključno s: smernicami, ki določajo, kateri podatki o kliničnih preskušanjih bi morali biti na voljo javnosti, farmacevtskem svežnju (zakonodajni predlogi o farmakovigilanci, boju proti ponarejanju zdravil in obveščanju bolnikov), vrednotenju agencije EMEA, nedavnem sestanku s predstavniki držav članic o vrednotenju zdravstvene tehnologije, osnutku direktive o izvajanju pravic bolnikov v zvezi s čezmejnim zdravstvenim varstvom, sporočilom in predlogom Komisije o varnosti bolnikov v Evropi ter začetkom javnega posvetovanja o prihodnosti evropskih delavcev v zdravstvu.
Some of the deviations of note related to the implementation of the Product Information Management (PIM) and the EU database of clinical trials (EudraCT) projects.
Pri tem je treba upoštevati nekatera odstopanja v zvezi z izvajanjem upravljanja podatkov o zdravilih (PIM) in podatkovne zbirke EU o projektih kliničnih preskušanj (EudraCT).
Rules of procedure of the scientific committees:
Poslovniki znanstvenih odborov:
Transparency policy
Preglednost
Election of the Management Board Vice-chair [EMEA/MB/81623/2009] The Management Board elected Mrs Lisette Tiddens-Engwirda as Vicechair with the following votes: Sole round - 34 votes Lisette Tiddens-Engwirda
Volitve podpredsednika upravnega odbora [EMEA/MB/81623/2009] Upravni odbor je za podpredsednico izvolil Lisette Tiddens-Engwirda z naslednjim številom glasov: Prvi krog - 34 glasov Lisette Tiddens-Engwirda
[EMEA/MB/58755/2009] The Management Board also considered the potential financial and budgetary impact of the fee incentives proposed under MUMS/limited markets.
[EMEA/MB/58755/2009] Upravni odbor je obravnaval tudi morebitne finančne in proračunske posledice spodbud za pristojbine, predlaganih v okviru MUMS/omejenih trgov.
Preliminary draft work programme 2010
Predhodni osnutek delovnega programa za leto 2010
[EMEA/MB/632200/2008; EMEA/MB/502942/2008; EMEA/MB/94586/2009; EMEA/MB/579221/ 2008] The Management Board adopted the preliminary draft work programme, budget and staff-policy plan for 2010.
[EMEA/MB/632200/2008; EMEA/MB/502942/2008; EMEA/MB/94586/2009; EMEA/MB/579221/ 2008] Upravni odbor je sprejel predhodne osnutke delovnega programa, proračuna in načrta kadrovske politike za leto 2010.
The Board nominated Aginus Kalis, Marcus Müllner, Lisette Tiddens and Gro Ramsten Wesenberg as topic coordinators for this project.
Odbor je za tematske koordinatorje tega projekta imenoval Aginusa Kalisa, Marcusa Müllnerja, Lisette Tiddens in Gro Ramsten Wesenberg.
The main objectives of the intended new organisation include: integration of the human pre- and postauthorisation (line extensions and variations) procedures; more focus on safety-monitoring of medicines through separation of pharmacovigilance and of risk-management activities from postauthorisation work; creation of a new sector for data management.
Glavni cilji predvidene nove organizacijske ureditve vključujejo: integracijo postopkov pred izdajo dovoljenja za promet (razširitev indikacij in spremembe) z zdravilom za uporabo v humani medicini in po izdaji takega dovoljenja, večji poudarek na spremljanju varnosti zdravil z ločitvijo farmakovigilance in dejavnosti upravljanja tveganj od dejavnosti po izdaji dovoljenja za promet ter oblikovanje novega sektorja za upravljanje podatkov.
[EMEA/MB/673201/2008] The Management Board adopted the proposed mandate of the task force, with a deletion of Point 4, relating to future legislative changes.
[EMEA/MB/673201/2008] Upravni odbor je sprejel predlagani mandat projektne skupine ob črtanju točke 4, ki se nanaša na prihodnje spremembe zakonodaje.
Revised organisational structure of the EMEA
Spremembe organizacijske strukture agencije EMEA
In 2008, the Agency launched a project to review its corporate identity.
Agencija je leta 2008 začela projekt posodobitve svoje celostne podobe.