FrancophonIA/ELRC3.0 huggingface dataset:
English: We will work closely with Member States and their experts to ensure that the information we provide is of the highest quality in all languages.
Slovenian: Tesno bomo sodelovali z državami članicami in njihovimi strokovnjaki, da bi tako zagotovili najvišjo kakovost naših informacij v vseh jezikih.
English: A second key task will relate to the development of risk-management plans at the time when scientific advice is sought.
Slovenian: Druga ključna naloga bo povezana z razvojem načrtov za obvladovanje tveganj, kadar bo zaprošeno za znanstveno svetovanje.
English: Bringing inspections agencies into service over EudraNet where these are not part of the national competent authority.
Slovenian: Vključitev inšpekcijskih agencij v delovanje prek EudraNeta, kadar niso del nacionalnega pristojnega organa.
English: We look forward to fruitful cooperation with scientific experts from these countries to bring effective and safe medicines to all European citizens.
Slovenian: Veselimo se plodnega sodelovanja z znanstvenimi strokovnjaki iz teh držav, saj bomo tako lahko vsem evropskim državljanom zagotovili učinkovita in varna zdravila.
English: 1.8 Integrated management at the Agency
Slovenian: 1.8 Integrirano upravljanje Agencije
English: The aim of the Agency's activities will be to build contacts and relationships between Croatia and Turkey and the EMEA.
Slovenian: Dejavnosti Agencije bodo namenjene ustvarjanju stikov in odnosov med Hrvaško in Turčijo ter EMEA.
English: Following the tender procedure in 2006, it is anticipated that over the year, the system will be installed in agencies across the European Economic Area that require it.
Slovenian: Po razpisnem postopku v letu 2006 se pričakuje, da bo sistem preko leta nameščen v agencijah po celotnem Evropskem gospodarskem prostoru, ki ga zahtevajo.
English: The Agency will remain focused on the objectives of the Lisbon agenda.
Slovenian: Agencija bo ostala usmerjena k ciljem lizbonske strategije.
English: The list of these European experts is available for examination on request at the EMEA offices.
Slovenian: Seznam teh evropskih strokovnjakov je na zahtevo na voljo v uradih EMEA.
English: The year 2007 will be the thirteenth year of operation of the EMEA and of its contribution towards the promotion and protection of public and animal health.
Slovenian: Leto 2007 bo trinajsto leto delovanja Evropske agencije za zdravila (EMEA) ter njenega prispevanja k spodbujanju in varovanju zdravja ljudi in živali.
English: Although there has been a major increase in electronic reporting of ICSRs over the last two years, the EMEA will continue its initiatives to speed up the implementation of such reporting.
Slovenian: Čeprav se je v zadnjih dveh letih močno povečalo elektronsko sporočanje varnostnih poročil o posameznih primerih (ICSR), bo EMEA nadaljevala svoje pobude za pospešitev izvajanja takega poročanja.
English: The EMEA supports the objectives of the Lisbon agenda.
Slovenian: EMEA podpira cilje programa lizbonske strategije.
English: The Agency expects a significant increase in the number of arbitration and referral procedures in particular in the number of Article 29 arbitrations (relating to difference in opinions at the Member State level).
Slovenian: Agencija pričakuje precejšnje povečanje števila postopkov arbitraže in napotitve, zlasti pri številu arbitraž po členu 29 (glede na razliko v mnenjih na ravni držav članic).
English: The Agency estimates an increase in the number of reimbursed meetings by 30% and the number of reimbursed delegates by 25% in 2007.
Slovenian: Agencija ocenjuje, da se bo v letu 2007 število sestankov s povrnjenimi stroški povečalo za 30 %, število delegatov s povrnjenimi stroški pa za 25 %.
English: The Agency considers the availability of the same, high-quality information about medicines in all official EU languages to be essential for their optimal use in all Member States.
Slovenian: Agencija meni, da je razpoložljivost enakih visokokakovostnih informacij o zdravilih v vseh uradnih jezikih EU izredno pomembno za njihovo optimalno uporabo v vseh državah članicah.
English: 3.3 Sampling and testing
Slovenian: 3.3 Vzorčenje in preizkušanje
English: In addition, there is a set of horizontal services that are necessary to support the implementation of the systems mentioned.
Slovenian: Temu je treba dodati še sklop horizontalnih storitev, potrebnih za podporo izvajanju navedenih sistemov.
English: The large number of applications received in 2006 will have a significant impact on the workload in 2007 since procedures run over several months.
Slovenian: Veliko število vlog, prejetih v letu 2006, bo močno vplivalo na delovno obremenitev v letu 2007, saj postopki trajajo več mesecev.
English: 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.
Slovenian: Stalno spremljanje varnosti zdravil po izdaji dovoljenja za promet („farmakovigilanca“) je pomemben element dela pristojnih nacionalnih organov in EMEA.
English: The Agency's full work programme 2007, which was adopted by the Management Board on 19 December 2006, can be found on the Agency's website: www.emea.europa.eu
Slovenian: Celoten delovni program Agencije za leto 2007, ki ga je upravni odbor sprejel 19. decembra 2006, je na voljo na spletni strani Agencije www.emea.europa.eu.
English: The work will be carried out in the context of the European Risk Management Strategy (ERMS), and will include the development of additional activities and the implementation of agreed initiatives.
Slovenian: To delo bo opravljeno v okviru evropske strategije o obvladovanju tveganj (ERMS) ter bo vključevalo razvoj dodatnih dejavnosti in uresničevanje dogovorjenih pobud.
English: Promoting the safety of medicines has been an important area for the Agency over many years, and will remain a priority in 2007.
Slovenian: Spodbujanje varnosti zdravil je bilo dolga leta pomembno področje delovanja Agencije in bo tudi v letu 2007 ostalo prednostna naloga.
English: In some areas, growth during 2006 was substantial, with an increased workload expected again in 2007.
Slovenian: Na nekaterih področjih je bila rast v letu 2006 precejšnja in v letu 2007 se ponovno pričakuje povečana delovna obremenitev.
English: A wide range of documents are published by the EMEA, including press releases, general information documents, annual reports and work programmes.
Slovenian: EMEA objavlja širok razpon dokumentov, vključno s sporočili za javnost, splošnimi informativnimi dokumenti, letnimi poročili in delovnimi programi.
English: Cooperation will continue with the partner EU agencies and the European Directorate for the Quality of Medicines.
Slovenian: Nadaljevalo se bo sodelovanje s partnerskimi agencijami EU in Evropskim direktoratom za kakovost zdravil.
English: To this end, the Agency has established a working group with healthcare professionals, which will prepare a framework for interaction with healthcare professionals' organisations.
Slovenian: V ta namen je Agencija ustanovila delovno skupino z zdravstvenimi strokovnjaki, ki bo pripravila okvir za medsebojno povezanost z organizacijami zdravstvenih strokovnjakov.
English: The Agency welcomes the national competent authorities of the two new Member States, Bulgaria and Romania, as valued partners in the European medicines network.
Slovenian: Agencija izraža dobrodošlico pristojnim nacionalnim organom dveh novih držav članic, Bolgarije in Romunije, kot cenjenim partnerjem v Evropski mreži zdravil.
English: Annex 3 Revenue and expenditure overview 2005-2007
Slovenian: Priloga 3 Pregled prihodkov in odhodkov za obdobje 2005-2007
English: We will also strive to improve our communications more generally, covering both our scientific and non-scientific activities.
Slovenian: Prizadevali si bomo tudi splošno izboljšati svoje komunikacije, vključno z znanstvenimi in neznanstvenimi dejavnostmi.
English: As in previous years, the Agency will carry out a number of self-assessment activities, internal audits and stakeholder surveys, and will introduce a system for 360-degree evaluation of management.
Slovenian: Agencija bo tako kot prejšnja leta izvajala številne dejavnosti samoocenjevanja, notranjih revizij in pregledov s strani interesnih skupin ter uvedla sistem za presojo upravljanja po načelu 360 stopinj.
English: 1.5 European public health activities
Slovenian: 1.5 Evropske dejavnosti na področju javnega zdravja
English: The EMEA will also begin the gradual establishment of a European network for paediatric research.
Slovenian: EMEA bo začela tudi postopno vzpostavljati evropsko mrežo za pediatrične raziskave.
English: 17 Entertainment and representation expenses 18 Staff insurances
Slovenian: 17 Stroški dodatkov za razvedrilo in reprezentanco 18 Zavarovanje osebja
English: The Agency will also develop measures to assist companies with authorisation of products for minor markets.
Slovenian: Agencija bo razvila tudi ukrepe za pomoč podjetjem pri pridobivanju dovoljenj za proizvode, namenjene majhnim trgom.
English: Integrated quality management - Internal audit
Slovenian: Celovito obvladovanje kakovosti - interna revizija
English: European public assessment report (EPAR).
Slovenian: Evropsko javno poročilo o oceni zdravila (EPAR).
English: The latter will help to maintain and improve the quality of translations of non-product information documents.
Slovenian: Te slednje bodo pomagale vzdrževati in izboljševati kakovost prevodov dokumentov z informacijami, ki se ne nanašajo na proizvod.
English: Thanks to the new legislation, the Agency was able to introduce a number of procedures which provide faster availability of most-needed medicines and assure high quality of the results of the work performed.
Slovenian: Zaradi nove zakonodaje je Agencija lahko uvedla številne postopke, ki zagotavljajo hitrejšo dostopnost najbolj potrebnih zdravil in visoko kakovost rezultatov opravljenega dela.
English: It also deals with other emerging therapies and new technologies that are not within the scope of the upcoming regulation on advanced therapies and which will strongly influence the Agency's work in this field.
Slovenian: Ukvarja se tudi z drugimi novimi terapijami in tehnologijami, ki ne spadajo v področje predvidene uredbe o naprednih terapijah in ki bodo močno vplivale na delo Agencije na tem področju.
English: 1.3 Support for innovation and access to medicines
Slovenian: 1.3 Podpora inovacijam in dostopnost zdravil
English: 21 Expenditure on data processing 22 Movable property and asset costs 23 Other administrative expenditure 24 Postage and communications 25 Expenditure on formal and other meetings
Slovenian: 21 Odhodki za obdelavo podatkov 22 Premično premoženje in s tem povezani stroški 23 Drugi upravni odhodki 24 Poštnine in obveščanje 25 Izdatki za uradna in druga srečanja
English: In addition, following the entry into force of the legislation on access to documents, the Agency expects there to be 100 such requests, compared to 50 requests in 2006 (a single request may encompass hundreds of documents).
Slovenian: Poleg tega Agencija pričakuje, da bo po začetku veljavnosti zakonodaje o dostopu do dokumentov tovrstnih zahtevkov 100, medtem ko jih je bilo v letu 2006 le 50 (en sam zahtevek lahko obsega stotine dokumentov).
English: Fostering this spirit of cooperation and seeking practical solutions to present and future challenges brought by developments in our field will be my final, but nonetheless important, priority for 2007.
Slovenian: Spodbujati sodelovanje in iskanje praktičnih rešitev za sedanje in prihodnje izzive, ki jih prinaša razvoj na našem področju, bo moja zadnja, vendar kljub temu pomembna prednostna naloga v letu 2007.
English: Orphan medicinal products are intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions affecting a small number of patients in the European Community.
Slovenian: Zdravila sirote so namenjena diagnosticiranju, preprečevanju ali zdravljenju smrtno nevarnih ali kronično izčrpavajočih bolezni, ki prizadenejo majhno število bolnikov v Evropski skupnosti.
English: Over 4 000 experts are used by the EMEA in its scientific evaluation work.
Slovenian: EMEA pri svojem znanstvenem ocenjevalnem delu uporablja več kot 4000 strokovnjakov.
English: The number of referrals triggered by safety concerns where there is a Community interest is expected to remain low, with only 1 predicted for 2007.
Slovenian: Pričakuje se, da bo število napotitev zaradi varnostnih pomislekov, kjer obstaja interes Skupnosti, ostalo nizko, saj se za leto 2007 napoveduje le ena.
English: The Agency will design, plan and carry out refurbishment projects in the new space to make it fully equipped for the needs of the Agency's delegates and staff.
Slovenian: Agencija bo oblikovala, načrtovala in izvedla obnovitvene projekte v novih prostorih, da bodo popolnoma opremljeni za potrebe odposlancev in osebja Agencije.
English: The Agency forecasts the number of serious adverse reaction reports will rise to well over 400, with 64 PSURs4 being submitted (54 were submitted in 2006).
Slovenian: Agencija predvideva, da bo število poročil o resnih neželenih učinkih precej preseglo številko 400, saj je bilo predloženih 64 PSUR4 (v letu 2006 jih je bilo predloženih 54).
English: The table below provides an overview of the development of the systems in 2007.
Slovenian: Spodnja tabela vsebuje pregled razvoja sistemov v letu 2007.
English: This will be done through various initiatives, which will also include development and maintenance of a scientific memory database.
Slovenian: To bo izvedla prek različnih pobud, ki bodo zajemale tudi razvoj in vzdrževanje zbirke podatkov znanstvenega pomnilnika.
English: The Agency will participate in the multi-beneficiary programme dedicated to supporting the participation of Croatia and Turkey in the work of certain Community agencies.
Slovenian: Agencija bo sodelovala v programu, namenjenem več upravičencem, katerega cilj je podpirati sodelovanje Hrvaške in Turčije pri delu določenih agencij Skupnosti.
English: The external evaluations will continue into late 2007.
Slovenian: Zunanja ocenjevanja se bodo nadaljevala daleč v leto 2007.
English: Any comments on the content of this draft SME User Guide should also be forwarded to the SME office.
Slovenian: Kakršne koli pripombe o vsebini tega osnutka Vodnika za uporabnike iz malih in srednje velikih podjetij pošljite Uradu za mala in srednje velika podjetja.
English: This increase is due, to a large extent, to the entry into force of the new legislation modifying the scope of procedures and introducing new procedures.
Slovenian: Razlog za to povečanje je predvsem dejstvo, da je začela veljati nova zakonodaja, ki spreminja področje postopkov in uvaja nove postopke.
English: The level of access will take into account the requirement to guarantee personal data protection as well as the commercial confidentiality of some of the data stored in EudraVigilance.
Slovenian: Pri ravni dostopa se bo upoštevala zahteva po zagotovitvi varstva osebnih podatkov in poslovni zaupnosti nekaterih podatkov, shranjenih v EudraVigilance.
English: This system is intended to act as a central repository for controlled terms for the European medicines network.
Slovenian: Namen tega sistema je delovati kot osrednje skladišče za nadzorovane izraze za evropsko mrežo zdravil.
English: Work will continue on implementing the vision outlined in the long-term strategies prepared by the EMEA and the national competent authorities.
Slovenian: Še naprej se bo izvajala vizija, začrtana v dolgoročnih strategijah, ki so jo pripravili EMEA in pristojni nacionalni organi.
English: 2.3 Initial evaluation
Slovenian: 2.3 Začetna ocena
English: The first version of this database will be delivered early in 2007.
Slovenian: Prva različica te zbirke podatkov bo na voljo na začetku leta 2007.
English: Expertise needed in the working parties will be addressed together with the Heads of Medicines Agencies.
Slovenian: Potrebno strokovno znanje in izkušnje delovnih skupin bodo obravnavani skupaj z vodji agencij za zdravila.
English: 5.3 Meetings and conferences at the EMEA
Slovenian: 5.3 Sestanki in konference v EMEA
English: The Agency issues certificates of medicinal products to support the work of health authorities outside the European Union, in particular in developing countries.
Slovenian: Agencija izdaja potrdila za zdravila, da bi podprla delo zdravstvenih organov zunaj Evropske unije, zlasti v državah v razvoju.
English: − Strengthen cooperation on pharmacovigilance, EU telematics, scientific advice, support to SMEs and communication;
Slovenian: − krepitev sodelovanja na področju farmakovigilance, telematike EU, znanstvenega svetovanja, podpore malim in srednje velikim podjetjem ter obveščanja;
English: E-procurement tools, systems and procedures will be introduced and developed in 2007.
Slovenian: V letu 2007 bodo uvedeni in razviti sistemi, orodja, in postopki za e-naročila.
English: The EMEA, together with the European Commission, plans to continue preliminary discussions with the Japanese medicines agency (MHWL/PMDA) in order to explore the possibility of setting up confidentiality arrangements similar to those concluded with the FDA.
Slovenian: EMEA namerava skupaj z Evropsko komisijo nadaljevati predhodne pogovore z japonsko agencijo za zdravila (MHWL/PMDA) zato, da bi preučili možnost oblikovanja dogovorov o zaupnosti, ki so podobni dogovorom, sklenjenim s FDA.
English: The strategy aims to increase efficiency and enhance transparency, and to support and facilitate the operation of procedures established by legislation.
Slovenian: Strategija je namenjena povečanju učinkovitosti in preglednosti ter podpori in spodbujanju izvajanja postopkov, ki jih določa zakonodaja.
English: A fifth scientific committee, the Paediatric Committee, will be established in the second quarter of 2007.
Slovenian: V drugi četrtini leta 2007 bo ustanovljen peti znanstveni odbor - Odbor za pediatrijo.
English: The Agency will receive entirely new responsibilities in the field of paediatric medicines.
Slovenian: Agencija bo prevzela popolnoma nove odgovornosti na področju zdravil za pediatrično uporabo.
English: Innovation and research are the primary driving forces for new medicines, and, consequently, motors for improved public and animal health.
Slovenian: Inovacije in raziskave so glavna gonilna sila za nova zdravila ter posledično tudi gibalo za boljše zdravje ljudi in živali.
English: The detection, evaluation and tracking of potential safety issues will be reinforced through the availability of the EudraVigilance Data Warehouse and Analysis System.
Slovenian: Odkrivanje, ocenjevanje in spremljanje morebitnih varnostnih vprašanj bodo okrepljena z razpoložljivostjo sistema za shranjevanje in analizo podatkov EudraVigilance.
English: The number of submissions for scientific advice for veterinary medicines will increase to 16 for 2007.
Slovenian: Število vlog za znanstveno svetovanje glede zdravil za uporabo v veterinarski medicini se bo v letu 2007 povečalo na 16.
English: The Agency will complete the development of the communication and transparency strategy and begin its implementation during 2007.
Slovenian: Agencija bo dokončala razvoj strategije o obveščanju in preglednosti ter jo v letu 2007 začela izvajati.
English: Firstly, the Agency will further improve the EudraVigilance database and individual case safety reporting.
Slovenian: Prvič, Agencija bo še naprej izboljševala zbirko podatkov EudraVigilance in varnostno poročanje o posameznih primerih.
English: GMP (including PMF) GCP (including pharmacovigilance) GLP
Slovenian: GMP (vključno s PMF) GCP (vključno s farmakovigilanco) GLP
English: The Agency's task-force on innovation will continue its work, and the EMEA/CHMP think-tank on innovation will finalise its report in the beginning of the year.
Slovenian: Delovna skupina Agencije za inovacije bo nadaljevala svoje delo, ustvarjalna enota EMEA/CHMP za inovacije pa bo na začetku leta dokončala svoje poročilo.
English: The number of type-I and II variations will change in line with the growing number of centrally authorised products.
Slovenian: Število sprememb tipa I in II se bo spremenilo v skladu z vse večjim številom zdravil, odobrenih po centraliziranem postopku.
English: Safety of veterinary medicines in the post-authorisation phase and the need to implement and further improve a risk-management approach to this important issue will continue to be a high priority for the Agency in 2007.
Slovenian: Varnost zdravil za uporabo v veterinarski medicini po izdaji dovoljenja ter potreba po uresničevanju in nadaljnjem izboljševanju pristopa obvladovanja tveganj v tej pomembni zadevi bosta ostali pomembni prednostni nalogi za Agencijo v letu 2007.
English: The factors influencing the growing number of meetings to be held at the Agency in 2007 include: the increasing responsibilities of the Agency (paediatric legislation); a growing interest in the centralised procedure (leading to more meetings with applicants); activities in the field of innovation; and intensified cooperation in the network (including training activities).
Slovenian: Dejavniki, ki vplivajo na rastoče število sestankov, organiziranih na Agenciji v letu 2007, vključujejo: vedno večje odgovornosti Agencije (pediatrična zakonodaja); rastoče zanimanje za centralizirani postopek (kar vodi k vedno večjemu številu sestankov z vlagatelji); dejavnosti na področju inovacij in intenzivnejše sodelovanje v mreži (vključno z dejavnostmi usposabljanja).
English: − Operate and increase the effectiveness of marketing authorisation procedures for facilitating availability of medicines, while maintaining the highest quality standards.
Slovenian: − izvajanje in povečanje učinkovitosti postopkov izdajanja dovoljenj za promet za omogočanje dostopnosti zdravil ob ohranjanju najvišjih standardov kakovosti.
English: The number of meetings and increasing number of staff due to the growing responsibilities of the Agency made it necessary for the Agency to acquire additional office space in 2006.
Slovenian: Precejšnje število sestankov in rastoče število zaposlenih zaradi vedno večjih odgovornosti Agencije, je EMEA prisililo v pridobitev dodatnega pisarniškega prostora v letu 2006.
English: Parallel-distribution notifications transferred from 2005 to 2006 Parallel-distribution notifications
Slovenian: Obvestila o vzporedni distribuciji, prenesena iz leta 2005 v leto Obvestila o vzporedni distribuciji
English: Work will continue on improving the cost-effectiveness of arrangements for working parties, including a review of their mandates, the distribution of work, and the support provided by the secretariat.
Slovenian: Nadaljevalo se bo delo na področju izboljševanja stroškovne učinkovitosti ureditev za delovne skupine, vključno s pregledom njihovih pooblastil, razdeljevanjem dela in podporo, ki jo nudi sekretariat.
English: During 2007, it is anticipated that the high-level design will be completed, that the system will be prototyped, and that work on the first production version will be initiated.
Slovenian: Pričakuje se, da bo med letom 2007 končan načrt na visoki ravni, da bo sistem dobil svoj prototip in da se bo začelo delo na prvi proizvodni različici.
English: The MMS financial module will speed up the process of reimbursing delegates and provide clearer information to delegates and national competent authorities.
Slovenian: Finančni modul MMS bo pospešil postopek povračila stroškov odposlancem ter zagotovil jasnejše informacije odposlancem in pristojnim nacionalnim organom.
English: The Agency will rationalise the certification process in 2007.
Slovenian: Agencija bo v letu 2007 racionalizirala nekatere postopke certificiranja.
English: − Further implement the EMEA transparency measures and increase the openness of the Agency's activities to underpin its corporate governance;
Slovenian: − nadaljnje izvajanje ukrepov EMEA za preglednost in večja odprtost dejavnosti Agencije, da se poudari podjetniško upravljanje;
English: The Agency's highlights for this year will include completion of the two-year process-improvement exercise.
Slovenian: V tem letu se bo Agencija posvetila dokončanju dveletnega izboljševanja postopkov.