natgillin/translations-raw huggingface dataset:
The EU telematics programme is delivering improved communication and better access to data.
Telematski program EU zagotavlja izboljšano sporočanje in boljši dostop do podatkov.
The EMEA plans to review its key processes in order to rationalise their functioning.
EMEA načrtuje pregled svojih ključnih procesov, da bi racionalizirala njihovo delovanje.
In the increasingly global pharmaceuticals sector, the Agency's contribution to international scientific forums on harmonisation of the regulatory environment is significant.
V vse bolj globaliziranem farmacevtskem sektorju je prispevek Agencije k mednarodnim znanstvenim forumom o usklajevanju regulativnega okolja bistven.
11 Staff in active employment 13 Mission expenses
11 Aktivno zaposleno osebje 13 Stroški nalog
The corresponding suite for veterinary medicines will be rolled out in September 2006.
Ustrezen nabor za veterinarska zdravila bo objavljen septembra 2006.
A pilot exercise for web meetings will run during the first half of 2006 to examine the potential benefits of this approach.
Pilotna izvedba spletnih sestankov se bo začela v prvi polovici leta 2006, da bi preučili morebitne prednosti tega pristopa.
Information on nationally authorised products may be included for those Member States who have provided their product data and signed a memorandum of understanding on data exchange and maintenance.
Informacije o nacionalno odobrenih izdelkih se lahko vključijo za tiste države članice, ki so zagotovile podatke o svojih izdelkih in podpisale memorandum o soglasju glede izmenjave podatkov in vzdrževanja.
The Agency's involvement in this cycle will continue in 2006.
Sodelovanje Agencije v tem ciklusu se bo nadaljevalo tudi v letu 2006.
The Agency therefore needs to revisit its policy on access to documents and related copyright issues.
Agencija mora tako pregledati svojo politiko dostopa do dokumentacije in s tem povezanih vprašanj avtorskih pravic.
In the coming year, the Agency will continue to build on the priorities set out in its long-term strategy, and will focus on the following areas:
V prihajajočem letu bo Agencija še naprej gradila na prednostnih nalogah, določenih v njeni dolgoročni strategiji, in se osredotočila na naslednja področja:
The Agency will continue to work with its international partners to create a more comprehensible regulatory environment and to improve access to medicines.
Agencija bo še naprej sodelovala s svojimi mednarodnimi partnerji za oblikovanje razumljivejšega regulativnega okolja in izboljšanje dostopa do zdravil.
Strengthening the European medicines network.
krepitev Evropske mreže zdravil.
Emphasis will be placed on full implementation of the new Community legislation and on the monitoring of this implementation.
Posebna pozornost se bo posvetila polnemu izvajanju nove zakonodaje Skupnosti in njegovemu spremljanju.
As a result of measures implemented in 2005, the Agency now provides a wider range of information to the public about the medicinal products it evaluates.
Agencija zaradi izvedenih ukrepov leta 2005 sedaj javnosti zagotavlja več vrst informacij o zdravilih, ki jih vrednoti.
Consolidating and fully operating the procedures introduced by the Agency in 2005, following the entry into force of the new EU pharmaceutical legislation.
utrditev in polna uporaba postopkov, ki jih je Agencija uvedla leta 2005, ko je začela veljati nova farmacevtska zakonodaja EU.
Contribute to the EU programme to reduce animal testing and develop other modern approaches for safety assessment of substances.
prispevek k programu EU za zmanjšanje poskusov na živalih in razvoj drugih modernih pristopov za oceno varnosti snovi.
In the field of transparency, the Agency will build on the achievements of previous years, and will concentrate its efforts in three areas:
Na področju preglednosti bo Agencija gradila na dosežkih preteklih let in bo svoja prizadevanja usmerila na tri področja:
Patients and healthcare professionals need access to useful, targeted and easily understandable information about medicines.
Bolniki in zdravstveni strokovnjaki potrebujejo dostop do uporabnih, ciljno naravnanih in enostavno razumljivih informacij o zdravilih.
At the international level, the Agency will continue to coordinate the EU's participation in the International Conferences on Harmonisation (ICH and VICH), with an increased contribution expected from the Agency and its scientific committees in 2006.
Na mednarodni ravni bo Agencija še naprej usklajevala sodelovanje EU na Mednarodnih konferencah o usklajevanju (ICH in VICH), kjer se pričakuje večji prispevek Agencije in njenih znanstvenih odborov leta 2006.
The number of meetings is forecast to increase by 5% and the number of reimbursed delegates by 33%.
Napovedano je, da se bo število sestankov povečalo za 5 %, število delegatov, ki jim je treba povrniti stroške, pa za 33 %.
This is a challenging legislative initiative, requiring new expertise on medicines and diseases not encountered in Europe.
To je zahtevna zakonodajna pobuda, za katero je treba imeti dodatno strokovno znanje o zdravilih in boleznih, ki jih v Evropi ni.
The second goal is to effectively manage arbitrations and referrals.
Drugi cilj je učinkovito upravljanje arbitraže in predložitev.
Number of videoconferences and reimbursed meetings
Število videokonferenc in sestankov s povrnjenim stroški
The Agency is working to provide information that contributes towards more effective and safer use of medicines, for the benefit of its stakeholders.
Agencija si prizadeva zagotoviti informacije, ki prispevajo k učinkovitejši in varnejši uporabi zdravil v korist njenih zainteresiranih strani.
(until 30 April 2006) Category & Grade
(do 30. aprila 2006) Skupina in stopnja
The database will contribute towards improved consistency of scientific assessments;
Zbirka podatkov bo pomagala okrepiti skladnost znanstvenih ocen;
The EMEA will closely monitor the effectiveness and adequacy of all new tools, procedures and processes, and will fine-tune their operation to deliver the best results.
EMEA bo skrbno spremljala učinkovitost in ustreznost vseh novih orodij, postopkov in procesov in uskladila njihovo delovanje za zagotovitev najboljših rezultatov.
Evaluating risk-management plans (RMPs).
ocenjevanje načrtov za obvladovanje tveganja.
The Agency's orphan-medicines policy is designed to support innovation and research, including that conducted by small and medium-sized enterprises.
Politika Agencije na področju zdravil sirot je usmerjena v podporo inovacijam in raziskavam, tudi tistim, ki jih izvajajo mala in srednje velika podjetja.
In addition, the partners of the network will consider new ways to optimise the activities they perform, and will strengthen their efforts to provide high-quality information to patients and healthcare professionals throughout the EU.
Poleg tega bodo partnerji mreže preučili nove načine za optimizacijo dejavnosti, ki jih izvajajo, in okrepili prizadevanja za zagotavljanje visoko kakovostnih informacij bolnikom in zdravstvenim strokovnjakom po vsej EU.
This will also result in a higher demand on the Member States' national competent authorities to provide the necessary competences in these scientific areas.
To bo od nacionalnih pristojnih organov v državah članicah tudi zahtevalo, da zagotovijo več ustreznih pristojnosti na teh znanstvenih področjih.
Building/equipment
Objekti/oprema
The constant monitoring of the safety of medicines after authorisation (‘pharmacovigilance') is an important part of the work of the national competent authorities and EMEA.
Stalno spremljanje varnosti zdravil po izdaji dovoljenja za promet ("farmakovigilanca") je pomemben element dela pristojnih nacionalnih organov in EMEA.
14 Socio-medical infrastructure 15 Exchange of civil servants and experts 16/17 Social welfare, entertainment and representation expenses
14 Socio-medicinska infrastruktura 15 Izmenjava državnih uradnikov in strokovnjakov 16/17 Stroški socialnega varstva, dodatkov za razvedrilo in reprezantance
(as from 1 May 2006) Category & Grade
(od 1. maja 2006) Skupina in stopnja
The Agency will also work with the US Department of Agriculture to exchange relevant information on veterinary medicines.
Agencija bo sodelovala tudi z Ministrstvom za kmetijstvo v ZDA in si izmenjavala ustrezne informacije o veterinarskih zdravilih.
Similar activities will start under the PHARE multi-beneficiary programme on participation of Croatia and Turkey in certain Community Agencies, in order to support preparation of these countries for accession.
Podobne dejavnosti se bodo začele izvajati v okviru večnamenskega programa PHARE pri sodelovanju Hrvaške in Turčije v nekaterih agencijah Skupnosti, da bi tako podprli pripravo teh držav na vstop v EU.
The Agency will seek feedback on the level of satisfaction with the new procedure for veterinary medicines.
Agencija bo poskušala dobiti povratne informacije o ravni zadovoljstva z novim postopkom za veterinarska zdravila.
The quality-assurance system will be strengthened by implementing recommendations resulting from the audit of the Committee for Medicinal Products for Veterinary Use (CVMP) conducted in October 2005.
sistem zagotavljanja kakovosti bo okrepljen z izvedbo priporočil, ki izhajajo iz presoje Odbora za zdravila za uporabo v veterinarski medicini (CVMP), opravljene oktobra 2005.
The volume of applications to the Agency, and of associated tasks, will increase substantially in 2006.
Količina vlog, predloženih Agenciji, in s tem povezanih nalog se bo v letu 2006 bistveno povečala.
Regular contacts will be maintained with other decentralised agencies of the EU, in particular the European Food Safety Authority, the European Monitoring Centre for Drugs and Drug Addiction, and the European Centre for Disease Prevention and Control.
Ohranili se bodo tudi redni stiki z drugimi decentraliziranimi agencijami EU, zlasti z Evropsko agencijo za varno hrano, Evropskim centrom za spremljanje drog in odvisnosti in Evropskim centrom za preprečevanje in nadzor bolezni.
The related processes undergo continuous evaluation and improvement, with the close cooperation of the national competent authorities.
S tem povezani postopki se v tesnem sodelovanju s pristojnimi nacionalnimi organi stalno ocenjujejo in izboljšujejo.
In 2006, the Agency will remain focused on the development and implementation of measures to promote the availability of medicines.
Leta 2006 se bo Agencija še naprej posvečala razvoju in izvajanju ukrepov za spodbujanje dostopnosti zdravil.
A coordinated approach to continuous quality improvement across the European medicines network of more than 40 members is essential if we are to have strong quality-assurance systems in place.
Koordiniran pristop za dodatno izboljšanje kakovosti po vsej Evropski mreži zdravil, ki ima več kot 40 članov, je bistven za vzpostavitev močnega sistema zagotavljanja kakovosti.
A wide range of documents are published by the EMEA, including press releases, general information documents, annual reports and work programmes.
EMEA objavlja dolgo vrsto dokumentov, vključno s sporočili za javnost, splošnimi informativnimi dokumenti, letnimi poročili in delovnimi programi.
After celebrating the 10th anniversary of the EMEA, and following a challenging year of implementing the new EU pharmaceutical legislation, the Agency enters a new phase of its development.
Po praznovanju desete obletnice Evropske agencije za zdravila (EMEA) in po izzivov polnem letu izvajanja nove farmacevtske zakonodaje EU Agencija stopa v novo fazo svojega razvoja.
Continued provision of scientific advice on issues relating to the quality, safety and efficacy of medicines during different stages of their development;
nadaljnje zagotavljanje znanstvenega svetovanja o vprašanjih, ki se nanašajo na kakovost, varnost in učinkovitost zdravil na različnih stopnjah njihovega razvoja;
Number of visits to the Agency
Število obiskov na Agenciji
The number of certificate requests is expected to increase by 16%, due to the increased number of approved marketing authorisations.
Pričakuje se, da se bo število zahtevkov za potrdila povečalo za 16 %, in sicer zaradi povečanega števila odobrenih dovoljenj za promet.
The Agency will continue to improve on its communication to the public and encourage a reporting culture through its collaborative efforts with interested parties and the Member States.
Agencija bo še naprej izboljševala komunikacijo z javnostjo ter prek prizadevanja za sodelovanje z zainteresiranimi stranmi in državami članicami negovala kulturo poročanja.
Highlights in 2006 for initial evaluation of medicines for human use are expected in four main areas:
V letu 2006 se najpomembnejše dogajanje pri začetnem ocenjevanju zdravil za uporabo v humani medicini pričakuje na štirih poglavitnih področjih:
National competent authorities are expected to complete the remaining internal evaluation work and follow-up with new Member States in the context of the EC-Canada mutual-recognition agreement.
Od nacionalnih pristojnih organov se pričakuje, da bodo dokončali preostali del notranjega ocenjevanja in spremljali nove države članice glede sporazuma o vzajemnem priznavanju med EU in Kanado.
This year, the Agency will work to implement new risk-management tools stemming from the legislation and, among other initiatives, will develop an intensive drug-monitoring system.
Letos si bo Agencija prizadevala za uvedbo novih orodij za obvladovanje tveganja, ki izhajajo iz zakonodaje, in bo med drugimi pobudami razvila intenziven sistem za spremljanje drog.
As the programme advances, the benefits, including those listed below, become more apparent
Z napredovanjem programa postajajo očitnejše tudi njegove prednosti, vključno z navedenimi spodaj:
The number of parallel-distribution notifications is forecast to increase by a further 14% in 2006, reaching 750.
Napoveduje se, da bo v letu 2006 obvestil o vzporedni distribuciji še za 14 % več, tako da bodo dosegla število 750.
Chapter 5 Support activities
Poglavje 5 Podporne dejavnosti
In 2006, development work on a number of EU telematics projects and sub-projects needs to be continued.
V letu 2006 je treba nadaljevati vrsto telematskih projektov in podprojektov EU.
Through this office, SMEs will be able to obtain fee reductions, exemptions or deferred payments for certain administrative and scientific services of the Agency, as well as assistance with translating product-information documents.
S pomočjo tega urada bodo mala in srednje velika podjetja lahko dosegla znižanje pristojbin, izjeme ali preložitev plačil za nekatere upravne in znanstvene storitve Agencije ter dobila pomoč pri prevajanju dokumentov o informacijah o izdelku.
The first will include introduction of further improvements to referral procedures dealing with the safety of medicines, so as to shorten the time between initiation of the referral procedure and adoption of the Committee's opinion.
Prvi bo zajemal uvedbo dodatnih izboljšav v postopke predložitve, ki zadevajo varnost zdravil, tako da se bo skrajšal čas med začetkom postopka predložitve in sprejetjem mnenja odbora.
The project format will include participation in selected meetings and training courses, and organisation of specific conferences.
Projekt bo zajemal sodelovanje na izbranih sestankih in tečajih usposabljanja ter organizacijo posebnih konferenc.
Assuring the quality of assessments, including strengthened regulatory and scientific consistency.
zagotavljanje kakovosti ocenjevanja, vključno z večjo regulativno in znanstveno usklajenostjo.
Improving the safety of medicines to provide for better-protected patients;
izboljšanje varnosti zdravil za večjo zaščito bolnikov;
EU reports Non-EU reports
Poročila iz držav članic EU Poročila iz držav nečlanic EU
Chapter 4 EU telematics strategy
Poglavje 4 Telematska strategija EU
Scientific advice to enterprises
Znanstveno svetovanje podjetjem
However, despite the mandatory nature of the notification procedure, compliance is still considered to be an issue, and the forecast will be closely monitored.
Čeprav je postopek obveščanja obvezen, še vedno ostaja nerešeno vprašanje skladnosti, in napovedi se bodo pozorno spremljale.
Special EU contribution for IT telematics strategy Special EU contribution for orphan medicinal products Contribution from EEA
Posebni prispevek EU za IT in telematsko strategijo Posebni prispevek EU za zdravila sirote Prispevek iz EGP
EU institutions, agencies and European and international partners Managing the Agency
Institucije, agencije ter evropski in mednarodni partnerji EU Upravljanje Agencije
Development and implementation of the EMEA transparency and communication strategy, as well as active contribution to the development and implementation of a transparency and communication strategy for the European medicines network;
razvoj in izvajanje strategije EMEA o preglednosti in obveščanju ter dejavni prispevek k razvoju in izvajanju strategije o preglednosti in obveščanju za Evropsko mrežo zdravil;
In addition, a number of recommendations stemming from the Agency's work with patients' and consumers' organisations will be implemented, contacts with patients and healthcare professionals will be strengthened through development of specific frameworks, and a new working group with healthcare professionals will be established.
Poleg tega bodo izvedena številna priporočila, ki izhajajo iz sodelovanja Agencije z organizacijami bolnikov in potrošnikov, okrepljeni bodo stiki z bolniki in zdravstvenimi strokovnjaki prek razvoja posebnih okvirov, ustanovljena pa bo tudi nova delovna skupina z zdravstvenimi strokovnjaki.
Reviewing the efficiency of the Agency's operations is particularly important at this time, as it faces challenges resulting from the increased complexity and volume of its activities, from its wider scope of responsibilities, from the heightened expectations of its stakeholders, from challenges posed by the advent of new and more complex technologies, and from the continuing globalisation of the pharmaceutical sector.
Pregled učinkovitosti delovanja Agencije je v tem trenutku še posebej pomemben, saj se Agencija spopada z izzivi, ki izhajajo iz vedno večje zahtevnosti in količine njenih dejavnosti, iz vedno večjega obsega odgovornosti, iz povečanih pričakovanj zainteresiranih strani, iz izzivov, ki jih predstavlja prihod novih in bolj zapletenih tehnologij, in nadaljnje globalizacije farmacevtskega sektorja.
The year 2006 is the first year of full operation of the revised pharmaceutical legislation.
Leto 2006 je prvo leto, ko se je spremenjena farmacevtska zakonodaja začela polno izvajati.
The Agency plans to undertake a major refurbishment project to increase meeting facilities for the Agency's scientific committees and working groups, following entry into force of the new legislation.
Agencija namerava uvesti večji projekt obnove, tako da bi pridobila prostore za sestanke znanstvenih odborov in delovnih skupin Agencije po začetku veljavnosti nove zakonodaje.
The Agency is committed to full implementation of the EMEA integrated quality-management system and internal control standards.
Agencija je zavezana, da bo v celoti izvajala integriran sistem EMEA za vodenje kakovosti in standarde notranje kontrole.
EU institutions, agencies and European and international partners
Institucije, agencije ter evropski in mednarodni partnerji EU
Where necessary, action will be taken to further refine procedures as a result of experience gained and the growing number of applications.
Po potrebi se bodo sprejeli ukrepi za dodatno dodelavo postopkov na podlagi pridobljenih izkušenj in vse večjega števila vlog.
Integrated quality management and audit
Integrirano upravljanje kakovosti in pregledo vanje
The improved procedures will allow smoother operation of the process, and will be fully integrated into the Agency's working practices in 2006.
Izboljšani postopki bodo prispevali k temu, da bodo postopki potekali bolj gladko, in v delovne postopke Agencije bodo popolnoma vključeni v letu 2006.
The Agency will make every effort to enhance cooperation between European partners on all activities relating to medicines, particularly those which contribute to the safety of patients in Europe and to the availability of new, effective and safe medicines.
Agencija si bo z vsemi sredstvi prizadevala okrepiti sodelovanje med evropskimi partnerji pri vseh dejavnostih, povezanih z zdravili, zlasti tistih, ki prispevajo k varnosti bolnikov v Evropi in dostopnosti novih, učinkovitih in varnih zdravil.
The EMEA will contribute to international harmonisation discussions on quality systems and implementation of quality risk-management and pharmaceutical development.
EMEA bo prispevala k mednarodnim razpravam o harmonizaciji sistemov kakovosti ter izvedbi kakovostnega obvladovanja tveganja in razvoju farmacije.
It is projected that the number of applications for scientific advice and protocol assistance (for designated orphan medicinal products) received in 2006 will be twice as high as in 2004; in particular, the ratio of scientific-advice requests relating to products for new therapies and technologies is expected to rise.
Predvideva se, da bo število vlog za znanstveno svetovanje in pomoč pri protokolu (za določena zdravila sirote), ki bodo prispele v letu 2004, za dvakrat presegalo število iz leta 2004; pričakuje se zlasti povečanje deleža zahtevkov za znanstveno svetovanje za izdelke, povezane z novimi terapijami in tehnologijami.
In 2006, the Agency will be in a position to consolidate the integrated management measures implemented over the years.
Leta 2006 bo lahko Agencija povezala ukrepe integriranega upravljanja, ki so se izvajali v preteklih letih.
The Agency expects that all national competent authorities will be reporting electronically to the EudraVigilance system by the end of 2006, which is reflected in the forecast increase of electronic reports in the chart below.
Agencija od vseh nacionalnih pristojnih organov pričakuje, da bodo do konca leta 2006 začeli pošiljati elektronska poročila v sistem EudraVigilance, kar je razvidno iz napovedi o povečanju števila poročil v elektronski obliki v spodnjem grafikonu.
Provision of support and incentives to SMEs developing medicinal products;
zagotavljanje podpore in spodbud malim in srednje velikim podjetjem, ki razvijajo zdravila;
The main priorities for 2006 are: continued development and modification of systems to implement the new legislation; reliable operation of the EU telematics systems and related services; and continued analysis and development of the EU telematics IT projects.
Glavne prednostne naloge za leto 2006 so: nadaljevanje razvoja in spreminjanja sistemov za izvedbo nove zakonodaje; zanesljivo delovanje telematskih sistemov EU in povezanih storitev ter stalna analiza in razvoj projektov IT na področju telematike EU.
In order to support innovation and research that leads to improved availability of medicines - and to promote access to them - the Agency will conduct a range of activities and implement a variety of tools, as follows:
Za podporo inovacijam in raziskavam, ki vodijo k večji dostopnosti zdravil - in za spodbujene dostopa do njih - bo Agencija opravila vrsto dejavnosti in uporabila vrsto orodij, kot je opisano spodaj:
Once completed, the database will be a further source of authoritative information about medicines for patients, healthcare professionals and regulators.
Ko bo ta zbirka podatkov dokončana, bo dodatni vir verodostojnih informacij o zdravilih za bolnike, zdravstvene strokovnjake in zakonodajalce.
The Agency will also continue its work with the World Health Organization, Codex Alimentarius and OIE.
Agencija bo tudi nadaljevala sodelovanje s Svetovno zdravstveno organizacijo, Codexom Alimentariusom in Mednarodnim uradom za živalske kužne bolezni (OIE).
In the area of veterinary medicines:
Na področju veterinarskih zdravil:
This comes in response to heightened public awareness and a subsequent demand for the re-use of information.
Tako se bo odzvala na večjo javno ozaveščenost in posledične zahteve po vnovični uporabi informacij.