natgillin/translations-raw huggingface dataset:
Protocol assistance will remain a priority area for these incentives. 
Pomoč pri protokolu bo ostalo prednostno področje, kar zadeva te spodbude.
Generic, hybrid products, etc. 
Generična, hibridna zdravila itd.
The volume of translations is expected to increase to 40,950 pages - 95% more than in 2006. 
Pričakuje se, da se bo obseg prevodov povečal na 40.950 strani - 95 % več kot v letu 2006.
302 Translation 
302 Prevajanje
This database is in the first stages of the design process. 
Ta zbirka podatkov je v prvih fazah načrtovalskega procesa.
Except for specification, work on extending the system to mutual recognition and decentralised procedures has been postponed to 2008-2009. 
Z izjemo specifikacije je bilo delo na področju širitve sistema medsebojnega priznavanja in decentraliziranih postopkov odloženo v obdobje 2008-2009.
2.11 Coordination group 
2.11 Usklajevalna skupina
System or process 2007 milestones 
Sistem ali proces Mejniki za leto 2007
The number of applications and related workload has increased over the last years. 
Število vlog in povezana delovna obremenitev sta se v zadnjih letih povečala.
The SME office has been set up within the agency to address the particular needs of smaller companies. 
Urad za mala in srednje velika podjetja je bil ustanovljen v okviru Agencije, da bi obravnaval posebne potrebe manjših družb.
The Agency will work to ensure timely and smooth transitions from the former Committees. 
Agencija si bo prizadevala zagotoviti pravočasne in gladke prehode iz prejšnjih odborov.
With this in view, a number of guidance documents will be developed. 
V ta namen bodo pripravljeni številni usmeritveni dokumenti.
Following discussion with stakeholders and interested parties, work will start on establishing a ‘Strategic plan for new technologies'. 
Po razpravi z interesnimi skupinami in zainteresiranimi stranmi se bodo začela dela za oblikovanje „Strateškega načrta za nove tehnologije“.
2.10 Scientific committees, working parties and scientific advisory groups 
2.10 Znanstveni odbori, delovne skupine in znanstvene svetovalne skupine
Some outcomes of these initiatives will contribute to the ongoing discussion on planning of activities at the level of the European medicines network. 
Nekateri rezultati teh pobud bodo prispevali k trenutni razpravi o načrtovanju dejavnosti na ravni Evropske mreže zdravil.
The Agency plans to test 40 products in 2007. 
Agencija načrtuje, da bo v letu 2007 preizkusila 40 proizvodov.
The increase also takes into account activities postponed from 2006, as well as participation of representatives of candidate countries in meetings, training courses and conferences. 
Povečanje upošteva tudi dejavnosti, preložene iz leta 2006, ter sodelovanje predstavnikov držav kandidatk na sestankih, tečajih usposabljanja in konferencah.
This document provides a summary of the Agency's work programme 2007. 
Ta dokument je povzetek delovnega programa Agencije za leto 2007.
This new method has been used for the numbers as of 2006. 
Ta nova metoda je bila uporabljena za podatke od leta 2006 naprej.
Scientific opinions for non-EU markets 
Znanstvena mnenja za trge zunaj EU
5 Support activities 
5 Podporne dejavnosti
Mutual recognition agreements (MRAs) with Australia, New Zealand, Switzerland, Canada and Japan are currently operational, but with slightly different provisions as to scope and applicability. 
Trenutno veljajo sporazumi o medsebojnem priznavanju (MRA) z Avstralijo, Novo Zelandijo, Švico, Kanado in Japonsko, vendar pa se njihove določbe nekoliko razlikujejo glede obsega in uporabe.
As part of the implementation of the European pharmaceutical policy and legislation, the Agency was given responsibility to implement the EU telematics strategy. 
V okviru izvajanja evropske farmacevtske politike in zakonodaje je bila Agencija zadolžena za izvajanje telematske strategije EU.
305 Community programmes 
305 Programi Skupnosti
AD 16 AD 15 AD 14 AD 13 AD 12 AD 11 AD 10 AD 9 AD 8 AD 7 AD 6 AD 5 Total Function Group AD AST 11 AST 10 AST 9 AST 8 AST 7 AST 6 AST 5 AST 4 AST 3 AST 2 AST 1 Total Function Group AST Total Staff 
AD 16 AD 15 AD 14 AD 13 AD 12 AD 11 AD 10 AD 9 AD 8 AD 7 AD 6 AD 5 Funkcionalna skupina AD skupaj AST 11 AST 10 AST 9 AST 8 AST 7 AST 6 AST 5 AST 4 AST 3 AST 2 AST 1 Funkcionalna skupina AST skupaj Osebje skupaj
The majority of EU telematics systems will be in use at the beginning of 2007. 
Večina telematskih sistemov EU se bo začela uporabljati na začetku leta 2007.
Availability or lack thereof will have a direct impact on the productivity of the HMPC in 2007 and beyond. 
Njihova razpoložljivost ali pomanjkanje bo neposredno vplivalo na storilnost HMPC v letu 2007 in po njem.
Implementation of advanced network-management and performance services. 
Uresničitev naprednega mrežnega upravljanja in izvajalskih storitev.
I wish to point out that this new area of responsibility will affect the existing core activities of the Agencyfor example scientific advice, an area in which the Agency expects to receive 30% more requests than in 2006. 
Rad bi poudaril, da bo to novo področje odgovornosti vplivalo na obstoječe glavne dejavnosti Agencije - na primer znanstveno svetovanje, kjer Agencija pričakuje, da bo prejela 30 % več zahtevkov kot v letu 2006.
1.7 International cooperation 
1.7 Mednarodno sodelovanje
Please note that figures for 2007 given in charts are estimates only. 
Opozarjamo, da so številke za leto 2007, navedene v grafikonih, le ocene.
Provision of additional EudraNet back-up systems. 
Zagotovitev dodatnih podpornih sistemov za EudraNet.
The Agency will ensure optimal coordination between concerned parties to minimise ‘unnecessary' referrals. 
Agencija bo zagotovila optimalno koordinacijo med zadevnimi strankami, da bi čim bolj znižala število „nepotrebnih“ napotitev.
EU Telematics Controlled Terms (2nd Proof of Concept concluded) 
EU Telematics Controlled Terms (zaključeno drugo preverjanje zasnove)
This programme will allow the two countries to prepare themselves for participation in the activities of the EMEA and to develop the confidence of the existing Members States in the systems in place in the two candidate countries. 
Program bo tema dvema državama omogočil, da se pripravita na sodelovanje pri dejavnostih EMEA in povečata zaupanje obstoječih držav članic v sisteme, ki veljajo v teh dveh državah kandidatkah.
− Provide opinions on medicinal products intended for non-EU markets; 
− dajanje mnenj o zdravilih, ki niso namenjena trgom EU;
In 2007, the Agency will seek to consolidate these activities, based on a review of the experience gained from the first year of operation of the CMD(h) and CMD(v). 
V letu 2007 si bo Agencija prizadevala utrditi te dejavnosti na podlagi pregleda izkušenj, pridobljenih v prvem letu delovanja CMD(h) in CMD(v).
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. 
Tesno bomo sodelovali z državami članicami in njihovimi strokovnjaki, da bi tako zagotovili najvišjo kakovost naših informacij v vseh jezikih.
A second key task will relate to the development of risk-management plans at the time when scientific advice is sought. 
Druga ključna naloga bo povezana z razvojem načrtov za obvladovanje tveganj, kadar bo zaprošeno za znanstveno svetovanje.
Bringing inspections agencies into service over EudraNet where these are not part of the national competent authority. 
Vključitev inšpekcijskih agencij v delovanje prek EudraNeta, kadar niso del nacionalnega pristojnega organa.
We look forward to fruitful cooperation with scientific experts from these countries to bring effective and safe medicines to all European citizens. 
Veselimo se plodnega sodelovanja z znanstvenimi strokovnjaki iz teh držav, saj bomo tako lahko vsem evropskim državljanom zagotovili učinkovita in varna zdravila.
1.8 Integrated management at the Agency 
1.8 Integrirano upravljanje Agencije
The aim of the Agency's activities will be to build contacts and relationships between Croatia and Turkey and the EMEA. 
Dejavnosti Agencije bodo namenjene ustvarjanju stikov in odnosov med Hrvaško in Turčijo ter EMEA.
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. 
Po razpisnem postopku v letu 2006 se pričakuje, da bo sistem preko leta nameščen v agencijah po celotnem Evropskem gospodarskem prostoru, ki ga zahtevajo.
The Agency will remain focused on the objectives of the Lisbon agenda. 
Agencija bo ostala usmerjena k ciljem lizbonske strategije.
The list of these European experts is available for examination on request at the EMEA offices. 
Seznam teh evropskih strokovnjakov je na zahtevo na voljo v uradih EMEA.
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. 
Leto 2007 bo trinajsto leto delovanja Evropske agencije za zdravila (EMEA) ter njenega prispevanja k spodbujanju in varovanju zdravja ljudi in živali.
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. 
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.
The EMEA supports the objectives of the Lisbon agenda. 
EMEA podpira cilje programa lizbonske strategije.
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). 
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).
The Agency estimates an increase in the number of reimbursed meetings by 30% and the number of reimbursed delegates by 25% in 2007. 
Agencija ocenjuje, da se bo v letu 2007 število sestankov s povrnjenimi stroški povečalo za 30 %, število delegatov s povrnjenimi stroški pa za 25 %.
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. 
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.
3.3 Sampling and testing 
3.3 Vzorčenje in preizkušanje
In addition, there is a set of horizontal services that are necessary to support the implementation of the systems mentioned. 
Temu je treba dodati še sklop horizontalnih storitev, potrebnih za podporo izvajanju navedenih sistemov.
The large number of applications received in 2006 will have a significant impact on the workload in 2007 since procedures run over several months. 
Veliko število vlog, prejetih v letu 2006, bo močno vplivalo na delovno obremenitev v letu 2007, saj postopki trajajo več mesecev.
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.
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 
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.
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. 
To delo bo opravljeno v okviru evropske strategije o obvladovanju tveganj (ERMS) ter bo vključevalo razvoj dodatnih dejavnosti in uresničevanje dogovorjenih pobud.
Promoting the safety of medicines has been an important area for the Agency over many years, and will remain a priority in 2007. 
Spodbujanje varnosti zdravil je bilo dolga leta pomembno področje delovanja Agencije in bo tudi v letu 2007 ostalo prednostna naloga.
In some areas, growth during 2006 was substantial, with an increased workload expected again in 2007. 
Na nekaterih področjih je bila rast v letu 2006 precejšnja in v letu 2007 se ponovno pričakuje povečana delovna obremenitev.
A wide range of documents are published by the EMEA, including press releases, general information documents, annual reports and work programmes. 
EMEA objavlja širok razpon dokumentov, vključno s sporočili za javnost, splošnimi informativnimi dokumenti, letnimi poročili in delovnimi programi.
Cooperation will continue with the partner EU agencies and the European Directorate for the Quality of Medicines. 
Nadaljevalo se bo sodelovanje s partnerskimi agencijami EU in Evropskim direktoratom za kakovost zdravil.
To this end, the Agency has established a working group with healthcare professionals, which will prepare a framework for interaction with healthcare professionals' organisations. 
V ta namen je Agencija ustanovila delovno skupino z zdravstvenimi strokovnjaki, ki bo pripravila okvir za medsebojno povezanost z organizacijami zdravstvenih strokovnjakov.
The Agency welcomes the national competent authorities of the two new Member States, Bulgaria and Romania, as valued partners in the European medicines network. 
Agencija izraža dobrodošlico pristojnim nacionalnim organom dveh novih držav članic, Bolgarije in Romunije, kot cenjenim partnerjem v Evropski mreži zdravil.
Annex 3 Revenue and expenditure overview 2005-2007 
Priloga 3 Pregled prihodkov in odhodkov za obdobje 2005-2007
We will also strive to improve our communications more generally, covering both our scientific and non-scientific activities. 
Prizadevali si bomo tudi splošno izboljšati svoje komunikacije, vključno z znanstvenimi in neznanstvenimi dejavnostmi.
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. 
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.
1.5 European public health activities 
1.5 Evropske dejavnosti na področju javnega zdravja
The EMEA will also begin the gradual establishment of a European network for paediatric research. 
EMEA bo začela tudi postopno vzpostavljati evropsko mrežo za pediatrične raziskave.
17 Entertainment and representation expenses 18 Staff insurances 
17 Stroški dodatkov za razvedrilo in reprezentanco 18 Zavarovanje osebja
The Agency will also develop measures to assist companies with authorisation of products for minor markets. 
Agencija bo razvila tudi ukrepe za pomoč podjetjem pri pridobivanju dovoljenj za proizvode, namenjene majhnim trgom.
Integrated quality management - Internal audit 
Celovito obvladovanje kakovosti - interna revizija
European public assessment report (EPAR). 
Evropsko javno poročilo o oceni zdravila (EPAR).
The latter will help to maintain and improve the quality of translations of non-product information documents. 
Te slednje bodo pomagale vzdrževati in izboljševati kakovost prevodov dokumentov z informacijami, ki se ne nanašajo na proizvod.
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. 
Zaradi nove zakonodaje je Agencija lahko uvedla številne postopke, ki zagotavljajo hitrejšo dostopnost najbolj potrebnih zdravil in visoko kakovost rezultatov opravljenega dela.
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. 
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.
1.3 Support for innovation and access to medicines 
1.3 Podpora inovacijam in dostopnost zdravil
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 
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
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). 
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).
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. 
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.
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. 
Zdravila sirote so namenjena diagnosticiranju, preprečevanju ali zdravljenju smrtno nevarnih ali kronično izčrpavajočih bolezni, ki prizadenejo majhno število bolnikov v Evropski skupnosti.
Over 4 000 experts are used by the EMEA in its scientific evaluation work. 
EMEA pri svojem znanstvenem ocenjevalnem delu uporablja več kot 4000 strokovnjakov.
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. 
Pričakuje se, da bo število napotitev zaradi varnostnih pomislekov, kjer obstaja interes Skupnosti, ostalo nizko, saj se za leto 2007 napoveduje le ena.
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. 
Agencija bo oblikovala, načrtovala in izvedla obnovitvene projekte v novih prostorih, da bodo popolnoma opremljeni za potrebe odposlancev in osebja Agencije.
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). 
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).
The table below provides an overview of the development of the systems in 2007. 
Spodnja tabela vsebuje pregled razvoja sistemov v letu 2007.
This will be done through various initiatives, which will also include development and maintenance of a scientific memory database. 
To bo izvedla prek različnih pobud, ki bodo zajemale tudi razvoj in vzdrževanje zbirke podatkov znanstvenega pomnilnika.
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. 
Agencija bo sodelovala v programu, namenjenem več upravičencem, katerega cilj je podpirati sodelovanje Hrvaške in Turčije pri delu določenih agencij Skupnosti.
The external evaluations will continue into late 2007. 
Zunanja ocenjevanja se bodo nadaljevala daleč v leto 2007.
Any comments on the content of this draft SME User Guide should also be forwarded to the SME office. 
Kakršne koli pripombe o vsebini tega osnutka Vodnika za uporabnike iz malih in srednje velikih podjetij pošljite Uradu za mala in srednje velika podjetja.
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. 
Razlog za to povečanje je predvsem dejstvo, da je začela veljati nova zakonodaja, ki spreminja področje postopkov in uvaja nove postopke.
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. 
Pri ravni dostopa se bo upoštevala zahteva po zagotovitvi varstva osebnih podatkov in poslovni zaupnosti nekaterih podatkov, shranjenih v EudraVigilance.
This system is intended to act as a central repository for controlled terms for the European medicines network. 
Namen tega sistema je delovati kot osrednje skladišče za nadzorovane izraze za evropsko mrežo zdravil.
Work will continue on implementing the vision outlined in the long-term strategies prepared by the EMEA and the national competent authorities. 
Še naprej se bo izvajala vizija, začrtana v dolgoročnih strategijah, ki so jo pripravili EMEA in pristojni nacionalni organi.
2.3 Initial evaluation 
2.3 Začetna ocena
The first version of this database will be delivered early in 2007. 
Prva različica te zbirke podatkov bo na voljo na začetku leta 2007.
Expertise needed in the working parties will be addressed together with the Heads of Medicines Agencies. 
Potrebno strokovno znanje in izkušnje delovnih skupin bodo obravnavani skupaj z vodji agencij za zdravila.
5.3 Meetings and conferences at the EMEA 
5.3 Sestanki in konference v EMEA
The Agency issues certificates of medicinal products to support the work of health authorities outside the European Union, in particular in developing countries. 
Agencija izdaja potrdila za zdravila, da bi podprla delo zdravstvenih organov zunaj Evropske unije, zlasti v državah v razvoju.
− Strengthen cooperation on pharmacovigilance, EU telematics, scientific advice, support to SMEs and communication; 
− krepitev sodelovanja na področju farmakovigilance, telematike EU, znanstvenega svetovanja, podpore malim in srednje velikim podjetjem ter obveščanja;
E-procurement tools, systems and procedures will be introduced and developed in 2007. 
V letu 2007 bodo uvedeni in razviti sistemi, orodja, in postopki za e-naročila.
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. 
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.
The strategy aims to increase efficiency and enhance transparency, and to support and facilitate the operation of procedures established by legislation. 
Strategija je namenjena povečanju učinkovitosti in preglednosti ter podpori in spodbujanju izvajanja postopkov, ki jih določa zakonodaja.
A fifth scientific committee, the Paediatric Committee, will be established in the second quarter of 2007. 
V drugi četrtini leta 2007 bo ustanovljen peti znanstveni odbor - Odbor za pediatrijo.
The Agency will receive entirely new responsibilities in the field of paediatric medicines. 
Agencija bo prevzela popolnoma nove odgovornosti na področju zdravil za pediatrično uporabo.
Innovation and research are the primary driving forces for new medicines, and, consequently, motors for improved public and animal health. 
Inovacije in raziskave so glavna gonilna sila za nova zdravila ter posledično tudi gibalo za boljše zdravje ljudi in živali.