natgillin/translations-raw huggingface dataset:
By the end of 2006, the Agency employed a total of 497 staff. 
Konec leta 2006 je Agencija zaposlovala skupaj 497 članov osebja.
Both procedures are based upon the principle of recognition of national authorisations. 
Oba postopka temeljita na načelu medsebojnega priznavanja nacionalnih dovoljenj za promet.
Before I come to the end, I would like to commemorate our dear friend and Management Board colleague, Professor Gianmartino Benzi, who passed away in November 2006. 
Preden zaključim, želim počastiti spomin na našega dragega prijatelja in kolega iz upravnega odbora, profesorja Gianmartina Benzija, ki je umrl novembra 2006.
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 09 E-mail: mail@emea.europa.eu http://www.emea.europa.eu 
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.: (44-20) 74 18 84 00 Faks: (44-20) 74 18 84 09 E-pošta: mail@emea.europa.eu http://www.emea.europa.eu
2006 was also the first full year in which the Management Board operated in its full composition. 
Leto 2006 je bilo tudi prvo leto, v katerem je upravni odbor deloval v popolni sestavi.
The Board has been closely following the Agency's achievements in 2006. 
Odbor je tesno spremljal dosežke Agencije v letu 2006.
Average assessment time quicker than in 2005 
Povprečni čas ocenjevanja krajši kot v letu 2005
The network is in place, connecting regulatory authorities in the European Economic Area, including the two new EU Member States, Bulgaria and Romania. 
Mreža je vzpostavljena in povezuje regulativne organe v evropskem gospodarskem prostoru, vključno z dvema novima državama članicama EU, Bolgarijo in Romunijo;
First year of the EMEA SME Office: supporting innovation among Europe's SMEs 
Prvo leto Urada za mala in srednje velika podjetja EMEA: podpiranje inovativnosti med evropskimi malimi in srednje velikimi podjetji
Similar biological products 
Biološko podobni izdelki
The decisions and actions arising from the management review are incorporated in planning directives, annual work programme and budget. 
Sklepi in ukrepi, ki izhajajo iz pregleda upravljanja, so vključeni v načrtovalne direktive, letni program dela in proračun.
I am also grateful the European Commission and the European Parliament for their continuous support to the EMEA and its mission for public and animal health over the past year. 
Zahvaljujem se tudi Evropski komisiji in Evropskemu parlamentu za njuno stalno podporo EMEA in njenemu poslanstvu za zdravje ljudi in živali v zadnjih letih.
A meeting with stakeholders held early in the year confirmed the successful removal of the legalisation step previously performed by the European Commission's UK representation. 
Srečanje z zainteresiranimi stranmi, organizirano na začetku leta, je potrdilo uspešno odstranitev zakonodajnega koraka, ki ga je predhodno opravljalo predstavništvo Evropske komisije v Združenem kraljestvu.
The decentralised procedure and the mutual recognition procedure apply to the majority of conventional medicinal products. 
Decentralizirani postopek in postopek medsebojnega priznavanja se uporabljata za večino konvencionalnih zdravil.
The Agency is responsible for implementing the EU telematics strategy agreed by the European Commission, Member States and the EMEA. 
Agencija je odgovorna za izvajanje telematske strategije EU, o kateri so se dogovorile Evropska komisija, države članice in EMEA.
Italy 10% Ireland 
Latvija 0% Italija 10% Irska
All inspections were completed within the legal timeframes and to the standards required by the Agency's quality-management system. 
Vsi inšpekcijski pregledi so bili zaključeni v zakonskih rokih in v skladu s standardi, ki jih zahteva sistem upravljanja kakovosti Agencije.
Coordinators and their assessors/experts are now systematically involved in the planning/presubmission phase of all scientific-advice procedures. 
koordinatorji in njihovi ocenjevalci/strokovnjaki se sedaj sistematično vključujejo v fazo načrtovanja/fazo pred oddajo vlog vseh postopkov znanstvenega svetovanja.
The number of withdrawn applications (20) was the lowest in the past 6 years. 
Število umaknjenih vlog (20) je bilo najnižje v zadnjih šestih letih.
The Committee for Orphan Medicinal Products (COMP) adopted 81 positive opinions. 
Odbor za zdravila sirote (COMP) je sprejel 81 pozitivnih mnenj.
The Agency subsequently accepted a place in the coordination group set up to convert those parts of the agenda dealing with regulatory issues into an action plan. 
Agencija je naknadno sprejela mesto v usklajevalni skupini, ustanovljeni za preoblikovanje tistih delov agende, ki zadevajo regulativna vprašanja, v akcijski načrt.
In addition, a project has also been running to prepare such summaries for products approved prior to 2006. 
Poleg tega poteka projekt za pripravo takih povzetkov za proizvode, ki so bili odobreni pred letom 2006.
The successes we were able to achieve were due to the smooth operation of the European network as a whole, and in particular to the outstanding work of our scientific committees, working parties and secretariat personnel. 
Uspehi, ki smo jih dosegli, so rezultat nemotenega delovanja evropske mreže kot celote in zlasti izjemnega dela naših znanstvenih odborov, delovnih skupin in osebja sekretariata.
In July 2006, the Agency implemented a new framework for the provision of scientific advice. 
Julija 2006 je Agencija uvedla nov okvir za zagotavljanje znanstvenega svetovanja.
2.6 Arbitration, Community referrals and ‘opinions on any scientific matter' Substantial increase in arbitration and referral activity in 2006 
2.6 Arbitraža, napotitve Skupnosti in „mnenja o katerikoli znanstveni zadevi“ Bistveno povečanje obsega dejavnosti arbitraže in napotitev leta 2006
At the end of 2006, new European legislation aimed at promoting the development of medicines for children was adopted. 
Konec leta 2006 je bila sprejeta nova evropska zakonodaja, usmerjena k spodbujanju razvoja zdravil za otroke.
The members have therefore started to look at new ways to improve the Board's involvement in the work of the Agency and its strategic decisiontaking. 
Člani so zato začeli iskati nove načine za izboljšanje vključenosti odbora v delo Agencije in njeno strateško odločanje.
This document provides a summary of the EMEA annual report for 2006. 
Ta dokument je povzetek letnega poročila EMEA za leto 2006.
Pharmacovigilance in the veterinary sector in the EU is undergoing changes triggered by the new legislation. 
Farmakovigilanca v veterinarskem sektorju v EU doživlja spremembe, ki jih je sprožila nova zakonodaja.
Contributing to the European Technology Platform for Global Animal Health 
Prispevek k Evropski tehnološki platformi za globalno zdravje živali
Monitoring the new legal tools relating to risk-management, in particular risk-management plans. 
Spremljanje novih zakonskih orodij, povezanih z obvladovanjem tveganja, zlasti načrtov za obvladovanje tveganja.
The scheme is part of the Agency's strategy to improve the availability of such medicines. 
Program je del strategije Agencije za izboljšanje razpoložljivosti takih zdravil.
Of the 681 such opinions adopted, 60% related to safety and efficacy, and 40% related to quality changes. 
Izmed sprejetih 681 tovrstnih mnenj se jih je 60 % nanašalo na varnost in učinkovitost, 40 % pa na spremembe kakovosti.
The changes brought about by the revised pharmaceutical legislation had a fundamental impact on the structure and organisation of the Management Board. 
Spremembe, ki jih je povzročila revidirana farmacevtska zakonodaja, so bistveno vplivale na sestavo in organizacijo upravnega odbora.
The electronic exchange of pharmacovigilance information within the EU is improving, as are active surveillance, harmonisation and risk-management. 
Elektronska izmenjava informacij farmakovigilance v EU se izboljšuje podobno kot aktiven nadzor, usklajevanje in obvladovanje tveganja.
The scientific advice procedure has been improved and is used increasingly by sponsors of medicinal products. 
Postopek znanstvenega svetovanja je bil izboljšan, vse bolj pa ga uporabljajo tudi sponzorji zdravil.
The Board encourages the Agency to continue its good work and to remain alert in view of the threat levels. 
Odbor spodbuja Agencijo, naj nadaljuje z dobrim delom in ostane v pripravljenosti zaradi stopnje nevarnosti.
2.4 Post-authorisation activities Number of variation applications up by almost one third 
2.4 Dejavnosti po izdaji dovoljenja Število vlog za spremembe naraslo skoraj za tretjino
In addition, about 45 people worked at the Agency on a contractual basis, mainly on IT projects. 
Poleg tega je okoli 45 ljudi delalo v Agenciji na podlagi pogodbe, predvsem pri projektih IT.
In 2006, information on 14 withdrawals and 7 refusals was published. 
V letu 2006 so bile objavljene informacije o štirinajstih umikih in sedmih zavrnitvah.
This is a considerable increase - more than twice the number received in 2005 - and would appear to result from efforts to promote awareness of expedited reporting. 
To je bistveno povečanje, več kot dvakratno število prejetih vlog leta 2005, za katero se zdi, da je posledica prizadevanj za spodbujanje ozaveščenosti o pospešenem poročanju.
Keen interest expressed by patients' and consumers' organisations 
Velik interes organizacij bolnikov in potrošnikov
Generics, hybrid products, etc. 
Generična zdravila, hibridna zdravila itd.
Further work is being done to better define minor uses and limited markets, in order to facilitate use of the guidelines and to allow for a harmonised implementation across the EU. 
Opravlja se dodatno delo za boljšo opredelitev manjših uporab in omejenih trgov, da bi tako poenostavili uporabo smernic in zagotovili usklajeno izvajanje po vsej EU.
The scientific-advice procedure was streamlined to allow finalisation within 40 days (up to a maximum of 70 days), whereas the previous procedure could take up to 100 days. 
postopek znanstvenega svetovanja je bil racionaliziran tako, da omogoča zaključek v 40 dneh (do največ 70 dni), medtem ko je prejšnji postopek lahko trajal do 100 dni;
Speeding up electronic reporting by all involved parties and discussing ways to improve the quality of the data submitted. 
Pospeševanje elektronskega poročanja vseh vključenih strank in obravnavanje načinov za izboljšanje kakovosti predloženih podatkov.
4.2 Sampling and testing 
4.2 Vzorčenje in preizkušanje
The EMEA continued its work on improving the availability of medicines. 
EMEA je nadaljevala z delom za izboljšanje razpoložljivosti zdravil.
The Agency has continued its contribution to the promotion of research and development in Europe. 
Agencija še naprej spodbuja raziskave in razvoj v Evropi.
There was a substantial increase (of €150,000) in the training budget, the range of professional-training opportunities was extended, and, for each staff member, a ‘training profile' was developed to serve as a competence-development guideline for the coming years. 
Proračun za usposabljanje se je bistveno povečal (za 150.000 EUR), obseg možnosti za strokovno usposabljanje je bil razširjen in za vsakega člana osebja je bil razvit „profil usposabljanja“, ki bo služil kot smernica razvoja pristojnosti v prihodnjih letih.
The results presented in the annual report 2006 document that the Agency's preparatory work to implement the new legal provisions has fully paid off: the Agency has demonstrated that it adapted successfully to the new regulatory framework and was able to run new and existing procedures successfully and efficiently. 
Rezultati, predstavljeni v letnem poročilu za leto 2006 dokazujejo, da je bilo pripravljalno delo Agencije za izvajanje novih zakonskih določb nadvse plodno: Agencija je dokazala, da se je uspešno prilagodila novemu regulativnemu okviru, prav tako je uspešno in učinkovito izvajala nove in obstoječe postopke.
of Directive 2001/83/EC 
Direktive 2001/83/ES
His spirit, his enthusiasm and his contributions to the work of the European Medicines Agency are greatly missed. 
Močno pogrešamo njegov duh, entuziazem in prispevek k delu Evropske agencije za zdravila.
By saying this I would also like to take this opportunity to thank all the Board members for their contributions to the work of the Board. 
Ob tej priložnosti bi se rad zahvalil tudi članom upravnega odbora za njihove prispevke k delu odbora.
The number of such procedures finalised in 2006 was also greater, with a total of 32 opinions being adopted. 
Število takih postopkov, ki so bili zaključeni leta 2006, je bilo prav tako višje, sprejetih pa je bilo skupaj 32 mnenj.
As always, I am grateful to the national competent authorities for the scientific resources they have made available to the EMEA. 
Tudi tokrat se zahvaljujem nacionalnim pristojnim organom za znanstvene vire, ki so jih dali na razpolago EMEA.
This required no fee or formal application, provided the scientific criteria allowing such extrapolations were met. 
Za to niso bile potrebne nobene pristojbine ali formalne vloge, če so bila izpolnjena znanstvena merila, ki omogočajo take ekstrapolacije.
The full EMEA annual report for 2006 was adopted by the Management Board on 8 March 2007, and is available on the EMEA website: 
Celotno letno poročilo EMEA za leto 2006 je upravni odbor sprejel 8. marca 2007 in je na voljo na spletni strani EMEA:
Procedures for reporting into EudraVigilance Veterinary were considerably enhanced during the year. 
Postopki za poročanje v EudraVigilance za veterinarstvo so se med letom bistveno okrepili.
I am convinced that the efforts made will help to secure and build up public confidence in the Agency's actions in relation to medicinal products. 
Prepričan sem, da bodo ta prizadevanja pomagala ohraniti in okrepiti zaupanje javnosti v ukrepe Agencije v zvezi z zdravili.
Where the original national authorisation cannot be recognised, the points in dispute are submitted to the EMEA for arbitration. 
Kadar se izvorno nacionalno dovoljenje za promet z zdravilom ne more priznati, se sporne točke predložijo EMEA v arbitražo.
Although these generic medicines are not innovative, they are considered to represent an important contribution to public health in the EU. 
Čeprav ta generična zdravila niso inovativna, se jih obravnava kot zdravila, ki bistveno prispevajo k javnemu zdravju v EU.
The Committee reconfirmed its previous conclusion that no action was required regarding concerns of possible cardiovascular effects and skin reactions for this class of medicines. 
Odbor je ponovno potrdil svoj predhodni sklep, da ni potrebno nobeno ukrepanje glede pomislekov o možnih kardiovaskularnih učinkih in kožnih reakcijah za ta razred zdravil.
There is a balanced geographical representation of EU Member State nationalities among the EMEA staff, with emphasis being made in recent years on recruiting from the new EU accession countries. 
V osebju EMEA so uravnoteženo geografsko zastopana državljanstva držav članic EU, v zadnjih letih pa je poudarek na zaposlovanju osebja iz novih držav pristopnic EU.
1.5 Better medicines for children 
1.5 Boljša zdravila za otroke
This was the first procedure conducted under the new pharmacovigilance provision of Article 78 of Directive 2001/82/EC, as amended. 
To je bil prvi postopek, izveden v skladu z novo določbo farmakovigilance iz člena 78 Direktive 2001/82/ES, kakor je bila spremenjena.
The EMEA contributed towards the preparation of the new Paediatric Regulation2, which was published in December 2006. 
EMEA je prispevala k pripravi nove pediatrične uredbe2, ki je bila objavljena decembra 2006.
Further progress was made in other areas too, notably our transparency, information and communication initiatives, preparations for the accession to the EU of Bulgaria and Romania, arrangements for the participation of Croatia and Turkey in EMEA activities, and international cooperation with our scientific and regulatory partners at the European and global levels. 
Napredek je bil dosežen tudi na drugih področjih, predvsem pri naših pobudah za preglednost, zagotavljanje informacij in obveščanje, pripravah za pristop Bolgarije in Romunije k EU, ureditvi za sodelovanje Hrvaške in Turčije v dejavnostih EMEA in mednarodnem sodelovanju z našimi znanstvenimi in regulativnimi partnerji na evropski in svetovni ravni.
Facilitating innovation and stimulating research, hence contributing to the competitiveness of EU-based pharmaceutical industry. 
pospeševanjem inovacij in spodbujanjem raziskav, s čimer prispeva h konkurenčnosti farmacevtske industrije EU;
The average time required to finalise procedures for provision of scientific advice in 2006 was 55 days. 
Povprečen čas, potreben za zaključek postopkov za zagotavljanje znanstvenega svetovanja, je leta 2006 znašal 55 dni.
Other revenue SME contribution Telematics strategy Orphan drug contribution Total fee revenue Basic EU contribution 
Drugi prihodki Prispevek MSP Telematska strategija Prispevek zdravil sirot Skupni prihodki iz pristojbin Osnovni prispevek EU
As part of this, an ad hoc working group was created to re-define the Management Board's role and responsibilities. 
V okviru tega je bila oblikovana priložnostna delovna skupina za ponovno opredelitev vloge in odgovornosti upravnega odbora.
Contra-indications, class labelling and warnings 
Kontraindikacije, označevanje razreda in opozorila
To prepare a strategy for establishing a pan-European paediatric-research network, the EMEA met with existing networks in the EU. 
Za pripravo strategije za vzpostavitev vseevropske mreže za pediatrične raziskave se je EMEA sestala z obstoječimi mrežami v EU.
1.7 Tackling antimicrobial resistance 
1.7 Obravnavanje protimikrobne odpornosti
However, 2 products were found not to comply with their authorised specifications. 
Ugotovljeno je bila, da dva izdelka nista bila skladna s svojimi specifikacijami.
All initial evaluations were carried out within the 210-day regulatory time limit. 
Vsa začetna vrednotenja so bila opravljena v 210-dnevnem regulativnem roku.
In one case, this resulted in the recall of a batch of the product. 
V enem primeru je to povzročilo umik serije izdelka.
The EMEA Management Board met four times in 2006, under chairman Hannes Wahlroos, from Finland, and vice-chairman Jytte Lyngvig, from Denmark. 
Upravni odbor EMEA je leta 2006 zasedal štirikrat, predsedoval mu je Hannes Wahlroos iz Finske, podpredsednica pa je bila Jytte Lyngvig iz Danske.
The good progress observed in 2005 with EudraVigilance continued in 2006. 
Dober napredek, opažen leta 2005 pri izvajanju EudraVigilance, se je leta 2006 nadaljeval.
of Regulation (EC) No 726/2004 
Uredbe (ES) št. 726/2004
An analysis of all defects reported during 2005 was completed and published. 
Zaključena in objavljena je bila analiza vseh pomanjkljivosti, prijavljenih leta 2005.
1.4 European medicines network Sharing expertise and competence-development in the network 
1.4 Evropska mreža zdravil Izmenjava strokovnega znanja in izkušenj ter razvoj pristojnosti znotraj mreže
Efforts to improve transparency of regulatory activity 
Prizadevanja za izboljšanje preglednosti regulativne dejavnosti
In addition, the Agency made a successful start with the SME Office, which provides assistance to small and medium-sized enterprises involved in the development of medicines in Europe. 
Poleg tega je pri Agenciji uspešno začel delovati Urad za mala in srednje velika podjetja, ki zagotavlja pomoč malim in srednje velikim podjetjem, ki se ukvarjajo z razvojem zdravil v Evropi.
The Agency also attended meetings with the European Commission Directorate-General for Research to prepare the funding of research on off-patent medicines. 
Agencija se je udeležila tudi srečanj z Generalnim direktoratom za raziskave Evropske komisije za pripravo financiranja raziskav o zdravilih brez patenta.
The CHMP concluded that these medicinal products continue to offer effective protection against hepatitis B, but recommended some changes to the prescribing information. 
CHMP je sklenil, da ta zdravila še naprej zagotavljajo učinkovito zaščito pred hepatitisom B, vendar je priporočil nekaj sprememb glede informacij pri predpisovanju;
The concept of risk-management plans (RMPs) was fully implemented in 2006 as part of the new legislative provisions of Regulation (EC) No 726/2004. 
Koncept načrtov za obvladovanje tveganja je bil kot del novih zakonskih določb Uredbe (ES) št. 726/2004 leta 2006 izveden v celoti.
The Agency managed to further reduce the average processing time for designation procedures to 57 days - the shortest average time since the start of the procedure, in the year 2000. 
Agenciji je uspelo dodatno skrajšati povprečen čas obdelave postopkov določanja na 57 dni, kar je najkrajši povprečni čas od začetka postopka v letu 2000.
Product defects and deviations 
Pomanjkljivosti in odstopanja pri proizvodih
There were 25 applications relating to the more complex type-II variations. 
Petindvajset vlog se je nanašalo na kompleksnejše spremembe tipa II.
EMEA/88802/2007/EN/FINAL 
EMEA/230199/2007/SL/KONČ.
EU contribution and fee revenue (€ million), 1995-2006 
Prispevek EU in prihodki iz pristojbin (milijon EUR), 1995-2006
These recommendations are to be included in the risk-management plans of all pandemic-influenza vaccines. 
Ta priporočila bodo vključena v načrte za obvladovanje tveganja vseh cepiv proti pandemiji influence.
The Audit Advisory Committee, whose external members were selected by tender, is reinforcing the integrated management and internal-audit system. 
Svetovalni odbor za proračun, katerega zunanji člani so bili izbrani na razpisu, krepi integriran sistem upravljanja in notranje revizije.
Work is required to implement extended search, technical structuring of the content, incorporation of data from national competent authorities, and a multilingual approach. 
Potrebno je delo za izvajanje razširjenega iskanja, tehničnega strukturiranja vsebine, vključevanja podatkov od nacionalnih pristojnih organov in večjezičnega pristopa;
At the end of 2006, EudraVigilance contained a total of 677,976 individual-case-safety reports (ICSRs), corresponding to 409,138 individual cases. 
Na koncu letu 2006 je EudraVigilance vsebovala skupaj 677.976 varnostnih poročil o posameznih primerih (individual case safety reports - ICSR), kar ustreza 409.138 posameznim primerom.
The new framework helps to manage an increasing workload and the new legal requirements in relation to medicines for human use. 
Novi okvir pomaga obvladovati vse večjo delovno obremenitev in izvajati nove zakonske zahteve v zvezi z zdravili za uporabo v humani medicini.
Despite the operational challenges and increased workload this entailed, the Agency was able to achieve all the main objectives it had set itself for the year, and once more delivered good performance results across the entire spectrum of its activities. 
Čeprav je to prineslo operativne izzive in večjo delovno obremenitev, je Agencija dosegla vse glavne cilje, ki si jih je zastavila za zadevno leto, in ponovno dosegla dobre rezultate na vseh področjih svojega delovanja.
The Agency is part of the Steering Council of the European Technology Platform for Global Animal Health and assisted in finalising its Strategic Research Agenda aimed at promoting access to the market for innovative products for animal health, including those for limited markets. 
Agencija je del usmerjevalnega odbora Evropske tehnološke platforme za globalno zdravje živali in je pomagala pri dokončanju njegove agende strateškega raziskovanja, katere cilj je spodbujanje dostopa na trg za inovativne proizvode za zdravje živali, vključno s proizvodi za omejene trge.
Thanks to the newly streamlined procedure, the SAWP was able to complete these scientific-advice procedures more quickly than in previous years. 
Delovna skupina za znanstveno svetovanje (SAWP) je zaradi nedavno racionaliziranega postopka zaključila zadevne postopke znanstvenega svetovanja hitreje kot v prejšnjih letih.
Most of those not reviewed related to active substances whose safety profile was well known. 
Večina načrtov, ki niso bili preučeni, se je nanašala na zdravilne učinkovine, katerih varnostni profil je bil dobro znan.