natgillin/translations-raw huggingface dataset:
I am confident that the next ten-year period will also prove to be a successful one for European cooperation.
Prepričan sem, da bo tudi naslednje desetletno obdobje uspešno za evropsko sodelovanje.
Probability of approval (%)
Verjetnost odobritve (%)
These new members had not yet been appointed by the end of the year.
Ti novi člani pa ob koncu leta še niso bili imenovani.
These and other documents are available:
Ti in drugi dokumenti so na voljo:
It is forwarded to the European Parliament, Council, Commission and Member States.
Poslano je Evropskemu parlamentu, Svetu, Komisiji in državam članicam.
• Security: security policies were proposed for adoption
• varnost: varnostne politike so bile predlagane za sprejetje
This allows more efficient coordination of the network
To omogoča učinkovitejše usklajevanje mreže.
Transitional period ended.
Prehodno obdobje je končano.
The strategy is to concentrate on a small number of projects with high European added value.
Strategija je usmerjena na majhno število projektov z visoko stopnjo evropske dodane vrednosti.
With the enlargement of the European Union in 2004, the number of official EU languages increased from 11 to 20.
Z razširitvijo Evropske unije v letu 2004 se je število uradnih jezikov EU povečalo z 11 na 20.
In my capacity as Chairman of the Management Board, I have noticed that Member States have a strong will to implement these goals.
Kot predsednik upravnega odbora sem opazil trdno odločenost pri državah članicah, da te cilje izvedejo.
Two meetings with representatives from Member States were organised to identify existing systems.
Organizirana sta bila dva sestanka s predstavniki iz držav članic za opredelitev obstoječih sistemov.
The EMEA provides special support to small and medium-sized enterprises (SMEs).
EMEA zagotavlja posebno podporo malim in srednje velikim podjetjem (MSP).
This helps to enhance the financial stability of the Agency.
To pomaga okrepiti finančno stabilnost Agencije.
These groups continue to bring additional expertise into the European regulatory system.
Te skupine še naprej vnašajo dodatno strokovno znanje v evropski regulativni sistem.
New responsibilities under the revised legislation
Nove odgovornosti v skladu z revidirano zakonodajo
In 2004, the Agency had a record 25 551 visitors.
V letu 2004 je Agencija zabeležila 25.551 obiskovalcev.
Similar rules were adopted by all EU agencies to bring them in line with other EU institutions.
Vse agencije EU so sprejele podobne predpise, da bi jih uskladile z drugimi institucijami EU.
Second and third-level support
Podpora na drugi in tretji ravni
This is still under investigation to see if it is an isolated incident.
Ta primer se še vedno preučuje, da bi se ugotovilo, ali je osamljen.
The opinion of the scientific committee is transmitted to the European Commission.
Mnenje znanstvenega odbora se sporoči Evropski komisiji.
Further details on both procedures can be found in section 2.6.
Dodatne podrobnosti o obeh postopkih so predstavljene v oddelku 2.6.
No guidelines released or adopted.
Ni bilo predstavljenih ali sprejetih smernic.
The positive effects of such initiatives should become visible from 2005 onwards.
Pozitivni učinki takih pobud bi se morali začeti kazati od leta 2005 dalje.
I would also like to thank members of the Management Board for all the support given to me at the start of my Chairmanship in spring 2004.
Želel bi se zahvaliti tudi članom upravnega odbora za vso podporo, ki so jo izkazali ob začetku mojega predsedstva spomladi leta 2004.
• Adopted 2005 work programme and budget totalling 110 160 000, together with an establishment plan requesting 379 temporary-agent posts for 2005
• sprejetje delovnega programa in proračuna za leto 2005 v skupni višini 110.160.000 EUR skupaj z ustanovitvenim načrtom, ki zahteva 379 začasnih delovnih mest za leto 2005
The group also adopted and revised a number of documents on the management of procedures.
Skupina je sprejela in revidirala tudi vrsto dokumentov o upravljanju postopkov.
No decision on formal extension of the transitional period has been taken
Ni bila sprejeta odločitev o uradnem podaljšanju prehodnega obdobja.
Competing risk analysis P-value = 0.02
Konkurenčna analiza tveganja P-vrednost = 0.02
The certificate of compliance is valid throughout the European Community.
Potrdilo o skladnosti velja v vsej Evropski skupnosti.
The network within which the EMEA operates increased from 27 to 42 national competent authorities.
Mreža, v kateri deluje EMEA, se je povečala s 27 na 42 pristojnih nacionalnih organov.
The EMEA plays a role in both procedures:
EMEA sodeluje v obeh postopkih:
Reception - visitors to the agency
Sprejem - obiskovalci v Agenciji
Many of the recommendations are now in the process of being implemented.
Mnogo priporočil je zdaj v procesu izvajanja.
For the first time, the discharge for the implementation of the 2002 budget was given to the Executive Director by the European Parliament.
Prvič je razrešnico za izvajanje proračuna za leto 2002 izvršnemu direktorju dal Evropski parlament.
In brief, 2004 was a year of change, a year of hard work, but also a year of significant achievement.
Skratka, leto 2004 je bilo leto sprememb in težkega dela, pa tudi leto pomembnih dosežkov.
However, these were due to difficulties with method transfer, rather than actual problems with the products.
Vendar so bili ti rezultati posledica težav pri prenosu metode in ne dejanskih težav z izdelkom.
• Infrastructure: the initial environments were put in place
• infrastruktura: uvedena so bila začetna okolja
Work is still ongoing on the implementation of this action plan, although, overall, good progress has been made.
Čeprav dela v zvezi z izvajanjem tega akcijskega načrta še vedno potekajo, je bil na splošno dosežen dober napredek.
The annual report for inspection activities is given in Chapter 4.
Letno poročilo dejavnosti inšpekcijskih pregledov je predstavljeno v poglavju 4.
Recruitment of new staff continued particularly from the new Member States.
Nadaljevalo se je zaposlovanje novega osebja, zlasti iz novih držav članic.
1 This figure refers to all reports received either on paper or electronically by the Agency.
1 Številka se nanaša na vsa poročila, ki jih je Agencija prejela bodisi na papirju ali elektronsko.
• All new Member States connected by 1 April 2004
• vse nove države članice so se priključile do 1. aprila 2004
The revised legislative package has significant impact on the Agency.
Revidirani zakonodajni okvir odločilno vpliva na Agencijo.
24 May 2004 - Extraordinary meeting
24. maj 2004 - izredno zasedanje
1.2 Implementation of the review of the European system
1.2 Izvedba revizije evropskega sistema
The new Financial Regulation allows the Agency to build up a reserve from positive balance out-turns.
Nova finančna uredba Agenciji omogoča, da ustvari rezervo iz pozitivnih bilančnih rezultatov.
The pilot phase will last one year, after which the experience and value of the programme will be reassessed.
Pilotna faza bo trajala eno leto, nato pa se bodo ponovno ocenile pridobljene izkušnje in vrednost programa.
The Executive Director answered questions of the Committee members during the annual hearing in November 2004.
Izvršni direktor je odgovarjal na vprašanja članov odbora med letno obravnavo novembra 2004.
In addition, the Board takes numerous decisions on Agency policies.
Sprejema tudi številne odločitve o politikah Agencije.
The Committee elected five new members, who joined in September 2004.
Odbor je izvolil pet novih članov in pridružili so se mu septembra 2004.
It introduces new responsibilities and a new administrative structure for the Agency.
Uvaja nove odgovornosti in novo upravno strukturo Agencije.
The database now totals approximately 5 000 records.
Zbirka podatkov zdaj skupaj vsebuje približno 5000 vpisov.
For 10 of these defect reports a recall was necessary; the remainder were classified as minor.
Pri desetih od teh poročil o pomanjkljivostih je bil potreben umik; ostala so bila razvrščena kot manj pomembna.
The European Commission adopts its decision with the assistance of a standing committee composed of representatives of the Member States.
Evropska komisija sprejme odločitev s pomočjo stalnega odbora, ki ga sestavljajo predstavniki držav članic.
Implementation of the EU telematics strategy, administration and other support activities are described in Chapters 5 and 6.
Izvajanje telematske strategije EU, upravljanje in druge podporne dejavnosti so opisane v poglavjih 5 in 6.
The new Rules of Procedure were discussed and adopted in July 2004.
Nov poslovnik je bil obravnavan in sprejet julija 2004.
2.10 Parallel distribution
2.10 Vzporedna distribucija
In addition, the composition of the new Scientific Advice Working Party (SAWP) was expanded from 18 to 21 members.
Poleg tega se je povečala sestava nove Delovne skupine za znanstveno svetovanje (SAWP) z 18 na 21 članov.
Participation in the development of the third phase of an automated meetings management system (MMS) to manage the meeting process as a whole was effective.
Sodelovanje v razvoju tretje faze avtomatiziranega sistema vodenja sestankov (meeting management system, MMS) za vodenje celotnega procesa sestanka je bilo učinkovito.
This represents an overall 41 % increase in the level of reporting.
To pomeni povprečno 41-odstotno povišanje ravni poročanja.
1.8 Organisational changes to the Agency
1.8 Organizacijske spremembe v Agenciji
Following the approval of this long-term strategy in December 2004, the Agency s operations now and over the next few years will centre on its implementation.
Potem ko je bila ta dolgoročna strategija decembra 2004 odobrena, bodo dejavnosti Agencije zdaj in v naslednjih nekaj letih usmerjene na njeno izvajanje.
• This is a new requirement, on which specification work was initiated
• to je nova zahteva, za katero so se začele priprave v zvezi s specifikacijo
A provisional Audit Advisory Committee was established in September 2004 with a number of external and internal members.
Septembra 2004 je bil ustanovljen začasni Posvetovalni odbor za revizije s številnimi zunanjimi in notranjimi člani.
Discussions were ongoing to bring about further development and improvements in the services provided.
Potekale so razprave za nadaljnji razvoj in izboljšave storitev, ki se zagotavljajo.
The remaining 10 reports are in the process of finalisation and expected by the end of April 2005.
Ostalih 10 poročil je v zaključnem postopku, končana pa naj bi bila do konca aprila 2005.
EU special contribution
Poseben prispevek EU
Observers from the European Commission and from accession countries also participate in the monthly meetings.
Na mesečnih zasedanjih sodelujejo tudi opazovalci iz Evropske komisije in držav pristopnic.
Consumers expect that residues be avoided as far as possible, and, where not possible, that they be safe.
Potrošniki pričakujejo, da se ostankom zdravil čim bolj izognemo, kadar pa to ni mogoče, da so ti varni.
It is also important to strengthen pharmacoepidemiological research in individual Member States and at EU level.
Pomembno je tudi, da se okrepijo farmakoepidemiološke raziskave v posameznih državah članicah in EU.
1.3 A long-term strategy for the EMEA
1.3 Dolgoročna strategija za EMEA
The Agency also received 6 referrals under Articles 29 and 30.
Agencija je prejela tudi 6 predložitev v skladu s členoma 29 in 30.
These changes should increase the process efficiency and lead to shorter timelines.
Te spremembe naj bi povečale učinkovitost postopka in skrajšale njegovo trajanje.
My deepest personal thanks go to all of the Agency s staff and to all those in the European network who contributed to this, the 10th successful year of operation of the EMEA.
Osebno bi se želel najiskreneje zahvaliti vsemu osebju Agencije ter vsem v evropski mreži, ki so prispevali k temu desetemu uspešnemu letu delovanja EMEA.
6 Support activities
6 Podporne dejavnosti
Following this, the European Commission asked the CHMP to carry out a further review at Community level.
Evropska komisija je nato prosila CHMP, da opravi dodatni pregled na ravni Skupnosti.
The EU enlargement in May 2004, with the accession of 10 new Member States, had a significant impact on the EU, its institutions and agencies.
Širitev EU maja 2004 s pristopom 10 novih držav članic je pomembno vplivala na EU, njene institucije in agencije.
This legislation is particularly relevant for biotechnology-derived products, which means that there is likely to be an increasing number of such applications in the coming years.
Ta zakonodaja je zlasti pomembna za biotehnološka zdravila, kar pomeni, da bo število takih vlog v naslednjih letih verjetno naraščalo.
The task of this group is to establish, together with the Member States, a cost-based reimbursement system for rapporteurship.
Naloga te skupine je skupaj z državami članicami za poročevalce določiti sistem povračila na podlagi stroškov.
VMRFG members met with interested parties from the animal health industry 5 times during 2004, in February, April, June, September and December.
Člani VMRFG so se v letu 2004 petkrat sestali z zainteresiranimi stranmi s področja zdravja živali, in sicer v februarju, aprilu, juniju, septembru in decembru.
In addition, a management audit based on ISO 9004:2000 was conducted.
Poleg tega je bila opravljena revizija upravljanja na podlagi ISO 9004:2000.
The Czech Republic was the first of the new Member States to transmit data to EudraVigilance.
Češka je bila prva nova država članica, ki je posredovala podatke v EudraVigilance.
The Agency also contributes to, and participates in, a number of multilateral forums, and has close relations with a number of non-EU competent authorities.
Agencija prispeva k številnim večstranskim forumom in v njih sodeluje ter ima tesne odnose s številnimi pristojnimi organi, ki niso iz EU.
One-day individual implementation meetings were organised with each national competent authority to achieve better and more robust planning.
Z vsakim pristojnim nacionalnim organom so bili organizirani enodnevni individualni sestanki za izvajanje, da bi se doseglo boljše in močnejše načrtovanje.
At the time of writing of this report, testing was completed and results reported for 31 products.
V času pisanja tega poročila je bilo preizkušanje opravljeno in rezultati objavljeni za 31 proizvodov.
My particular thanks go to the Executive Director of the Agency and his staff for their support and cooperation on the work of the Management Board.
Zlasti se zahvaljujem izvršnemu direktorju Agencije in njegovemu osebju za podporo in sodelovanje pri delu upravnega odbora.
Corporate helpdesk To provide help and support between the hours of 08h30 and 18h00, five days a week
Pomoč podjetjem Zagotoviti pomoč in podporo od 8.30 do 18.00, pet dni v tednu
In 2005, new Community legislation will introduce a requirement for risk management plans in relation to certain medicines with important (established or potential) risks.
V letu 2005 bo nova zakonodaja Skupnosti uvedla zahtevo po načrtih za obvladovanje tveganja v zvezi z nekaterimi zdravili s pomembnim (ugotovljenim ali možnim) tveganjem.
The provision of interpretation was reviewed and tailored to real needs, and thus interpretation days were reduced by 68 % compared to the previous year.
Zagotavljanje tolmačenja je bilo revidirano in prilagojeno resničnim potrebam, zato so se dnevi tolmačenja zmanjšali za 68 % v primerjavi s prejšnjim letom.
Based on the findings of the audit, an action plan was developed to implement the opportunities for improvement identified.
Na podlagi ugotovitev revizije je bil razvit akcijski načrt za izvedbo ugotovljenih možnosti za izboljšanje.
For product defect and other quality-related matters:
Za pomanjkljivosti izdelkov in druge zadeve v zvezi z njihovo kakovostjo:
Budget for 2005 as adopted by the Management Board on 16.12.2004.
Proračun za leto 2005, kot ga je sprejel upravni odbor 16. 12. 2004.
Ten Member States acted as reference Member State in these procedures, compared with 9 in 2003.
V teh postopkih je deset držav članic delovalo kot referenčna država članica v primerjavi z letom 2003, ko jih je bilo devet.
On the international stage, there were two significant developments.
Na mednarodnem področju sta bila pomembnejša dva dogodka.
The unexpected withdrawal of certain medicinal products last year demonstrates in a concrete way how vulnerable EU pharmacovigilance efforts still are.
Lanski nepričakovani umik določenih zdravil dejansko kaže, kako občutljiva so še vedno prizadevanja farmakovigilance EU.
New internal control standards were adopted in December 2004.
Novi standardi notranje kontrole so bili sprejeti decembra 2004.
The decentralised procedure (or mutual recognition procedure) applies to the majority of conventional medicinal products and is based upon the principle of mutual recognition of national authorisations.
Decentralizirani postopek (ali postopek medsebojnega priznavanja) se uporablja za večino konvencionalnih zdravil in temelji na načelu medsebojnega priznavanja nacionalnih dovoljenj za promet.
• HIV/AIDS (3 new combinations of products)
• HIV/AIDS (3 nove kombinacije izdelkov)
Type-II variations *The numbers include multiple procedures as stated at 31 December 2004.
Spremembe tipa II *Številke zajemajo večnamenske postopke po podatkih z dne 31. decembra 2004.
The overall objectives were revised and published and a new testing scheme was agreed in principle.
Pregledani in objavljeni so bili splošni cilji in načeloma je bil dogovorjen nov sistem preizkušanja.
Two major safety reviews
Dve pomembni presoji varnosti
The summarised comparative budget statements for 2003 to 2005 are as follows: (Amounts expressed in euro)
Povzetek primerjalnih proračunskih poročil za obdobje 2003 do 2005: (Zneski, izraženi v EUR)
Draft guidance documents were developed, including external guidance that will become publicly available in 2005.
Razviti so bili osnutki smernic vključno z zunanjimi smernicami, ki bodo na voljo javnosti v letu 2005.
Work is ongoing with respect to harmonised rapid alert procedures and annual reporting provisions.
Potekajo dela v zvezi z usklajenimi postopki hitrega opozarjanja in določbami o letnem poročanju.
The effective coordination, management and resourcing of these projects led to their successful delivery.
Rezultat učinkovitega usklajevanja, vodenja in načrtovanja virov teh projektov je bila njihova uspešna izvedba.
In previous years, discharge was given by the Agency s Management Board.
Prejšnja leta je razrešnico dal upravni odbor Agencije.
Due to an increase in the workload and the implementation of a new publishing process, EPARs were published within three to four weeks after the Commission decisions.
Zaradi povečane delovne obremenitve in uvedbe novega postopka objavljanja so se EPARji objavljali tri do štiri tedne po sprejetju odločitve Komisije.
Number of variation applications in excess of 1 000 for the first time
Prvič več kot 1000 vlog za spremembo
The remaining provisions will come into force 18 months later, on 20 November 2005.
Druge določbe bodo začele veljati 18 mesecev pozneje, in sicer 20. novembra 2005.
It has an advisory function for integrated quality management at the Agency.
Ima svetovalno vlogo pri integriranem upravljanju kakovosti v Agenciji.
The policy aims to assist the effective planning, operation and control of processes within the Agency, and to continually improve its interaction with partners in the European network.
Namen politike je podpreti učinkovito načrtovanje, delovanje in kontrolo postopkov znotraj Agencije ter nenehno izboljševati njeno sodelovanje s partnerji v evropski mreži.
They are intended to guarantee a consistent level of internal control of all business activities throughout the Agency, whether their financial impact is direct or indirect.
Njihov namen je zagotoviti doslednost pri notranji kontroli vseh poslovnih dejavnosti v Agenciji, ne glede na to, ali je njihov finančni učinek neposreden ali posreden.
The Board now has one representative per Member State (and no longer two), two representatives of the European Parliament, two representatives of the European Commission and, for the first time, two representatives of patients organisations and one representative each of doctors and veterinarians organisations.
Odbor ima zdaj enega predstavnika za vsako državo članico (in ne več dva), dva predstavnika Evropskega parlamenta, dva predstavnika Evropske komisije in - prvič - dva predstavnika organizacij bolnikov ter po enega predstavnika organizacij zdravnikov in organizacij veterinarjev.
The Legal Affairs Sector brings together the legal resources of the Agency into one specialised group in response to the increasing demand for legal services.
Sektor za pravne zadeve združuje pravne vire Agencije v eno specializirano skupino zaradi vse večje potrebe po pravnih storitvah.
The new products that received a positive opinion in 2004 will benefit patients in the following areas:
Novi izdelki, za katere so bila v letu 2004 izdana pozitivna mnenja, bodo bolnikom prinesli koristi na naslednjih področjih:
Cooperation between the EMEA and the World Health Organization (WHO) was strengthened during 2004.
Sodelovanje med EMEA in Svetovno zdravstveno organizacijo (WHO) se je v letu 2004 okrepilo.
Training profiles were proposed for a range of job profiles at all levels within the Agency.
Predlagani so bili profili usposabljanja za vrsto poklicev na vseh ravneh Agencije.
Pharmacovigilance involves a process of continuous monitoring of medicinal products on the market.
Farmakovigilanca pomeni proces stalnega spremljanja zdravil na trgu.
In line with the Agency s continuous drive for excellence, the availability of training was increased, with the aim of achieving up to 5 days of training per staff member per year.
V skladu z nenehnimi prizadevanji Agencije za odličnost se je povečala razpoložljivost usposabljanja, cilj pa je doseči do 5 dni usposabljanja na člana osebja na leto.
In addition, an extraordinary meeting was held in December in order to discuss safety concerns relating to SSRIs and SNRIs (see section 2.5).
Poleg tega je imel v decembru plenarno zasedanje, na katerem je razpravljal o varnostnih vprašanjih glede SSRI in SNRI (glej oddelek 2.5).
This was one of the key components helping the Sector achieve availability targets of 99.5 %
To je bil eden od ključnih elementov, ki je sektorju pomagal doseči cilj 99,5-odstotne razpoložljivosti.
Geographical distribution at EMEA - 31 December 2004
Geografska porazdelitev v EMEA - 31. december 2004
The Agency continually reviews its transparency policy with a view to increasing access to information and improving understanding of how it operates.
Agencija nenehno revidira svojo politiko preglednosti, da bi povečala dostop do informacij in izboljšala razumevanje svojega delovanja.
The EMEA Code of Conduct was revised in 2004 in order to clarify the meaning of some sections.
Kodeks ravnanja EMEA je bil revidiran leta 2004, da bi razjasnili pomen nekaterih poglavij.
This should result in increased regulatory and scientific consistency of the outcome of scientific evaluations from 2005 onwards.
Posledica tega bi morala biti povečana regulativna in znanstvena skladnost rezultatov znanstvenih vrednotenj od leta 2005 dalje.
The EMEA actively contributed to the public consultation on proposals to replace the existing Regulation on the establishment of maximum residue limits.
EMEA je aktivno sodelovala v javnem posvetovanju o predlogih za zamenjavo obstoječe Uredbe o določitvi mejnih vrednosti ostankov.
There were very few deviations from planned results, one notable exception being the slow implementation of EudraVigilance by Member States.
Bilo je zelo malo odstopanj od načrtovanih rezultatov, večja izjema je bila le počasno izvajanje projekta EudraVigilance v državah članicah.
The standards define the management rules all services must follow in their management of resources.
Standardi določajo pravila upravljanja, ki jih morajo upoštevati vse službe pri upravljanju z viri.
This number is lower than in previous years, possibly reflecting a better understanding among sponsors of the procedure and criteria for orphan designation.
Ta številka je nižja kot v prejšnjih letih, kar morda odseva boljše razumevanje sponzorjev glede postopka in meril za določitev zdravil sirot.