FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: Sodelovanje v razvoju tretje faze avtomatiziranega sistema vodenja sestankov (meeting management system, MMS) za vodenje celotnega procesa sestanka je bilo učinkovito.
English: This represents an overall 41 % increase in the level of reporting.
Slovenian: To pomeni povprečno 41-odstotno povišanje ravni poročanja.
English: 1.8 Organisational changes to the Agency
Slovenian: 1.8 Organizacijske spremembe v Agenciji
English: 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.
Slovenian: Potem ko je bila ta dolgoročna strategija decembra 2004 odobrena, bodo dejavnosti Agencije zdaj in v naslednjih nekaj letih usmerjene na njeno izvajanje.
English: • This is a new requirement, on which specification work was initiated
Slovenian: • to je nova zahteva, za katero so se začele priprave v zvezi s specifikacijo
English: A provisional Audit Advisory Committee was established in September 2004 with a number of external and internal members.
Slovenian: Septembra 2004 je bil ustanovljen začasni Posvetovalni odbor za revizije s številnimi zunanjimi in notranjimi člani.
English: Discussions were ongoing to bring about further development and improvements in the services provided.
Slovenian: Potekale so razprave za nadaljnji razvoj in izboljšave storitev, ki se zagotavljajo.
English: The remaining 10 reports are in the process of finalisation and expected by the end of April 2005.
Slovenian: Ostalih 10 poročil je v zaključnem postopku, končana pa naj bi bila do konca aprila 2005.
English: EU special contribution
Slovenian: Poseben prispevek EU
English: Observers from the European Commission and from accession countries also participate in the monthly meetings.
Slovenian: Na mesečnih zasedanjih sodelujejo tudi opazovalci iz Evropske komisije in držav pristopnic.
English: Consumers expect that residues be avoided as far as possible, and, where not possible, that they be safe.
Slovenian: Potrošniki pričakujejo, da se ostankom zdravil čim bolj izognemo, kadar pa to ni mogoče, da so ti varni.
English: It is also important to strengthen pharmacoepidemiological research in individual Member States and at EU level.
Slovenian: Pomembno je tudi, da se okrepijo farmakoepidemiološke raziskave v posameznih državah članicah in EU.
English: 1.3 A long-term strategy for the EMEA
Slovenian: 1.3 Dolgoročna strategija za EMEA
English: The Agency also received 6 referrals under Articles 29 and 30.
Slovenian: Agencija je prejela tudi 6 predložitev v skladu s členoma 29 in 30.
English: These changes should increase the process efficiency and lead to shorter timelines.
Slovenian: Te spremembe naj bi povečale učinkovitost postopka in skrajšale njegovo trajanje.
English: 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.
Slovenian: Osebno bi se želel najiskreneje zahvaliti vsemu osebju Agencije ter vsem v evropski mreži, ki so prispevali k temu desetemu uspešnemu letu delovanja EMEA.
English: 6 Support activities
Slovenian: 6 Podporne dejavnosti
English: Following this, the European Commission asked the CHMP to carry out a further review at Community level.
Slovenian: Evropska komisija je nato prosila CHMP, da opravi dodatni pregled na ravni Skupnosti.
English: 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.
Slovenian: Širitev EU maja 2004 s pristopom 10 novih držav članic je pomembno vplivala na EU, njene institucije in agencije.
English: 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.
Slovenian: Ta zakonodaja je zlasti pomembna za biotehnološka zdravila, kar pomeni, da bo število takih vlog v naslednjih letih verjetno naraščalo.
English: The task of this group is to establish, together with the Member States, a cost-based reimbursement system for rapporteurship.
Slovenian: Naloga te skupine je skupaj z državami članicami za poročevalce določiti sistem povračila na podlagi stroškov.
English: VMRFG members met with interested parties from the animal health industry 5 times during 2004, in February, April, June, September and December.
Slovenian: 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.
English: In addition, a management audit based on ISO 9004:2000 was conducted.
Slovenian: Poleg tega je bila opravljena revizija upravljanja na podlagi ISO 9004:2000.
English: The Czech Republic was the first of the new Member States to transmit data to EudraVigilance.
Slovenian: Češka je bila prva nova država članica, ki je posredovala podatke v EudraVigilance.
English: 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.
Slovenian: Agencija prispeva k številnim večstranskim forumom in v njih sodeluje ter ima tesne odnose s številnimi pristojnimi organi, ki niso iz EU.
English: One-day individual implementation meetings were organised with each national competent authority to achieve better and more robust planning.
Slovenian: Z vsakim pristojnim nacionalnim organom so bili organizirani enodnevni individualni sestanki za izvajanje, da bi se doseglo boljše in močnejše načrtovanje.
English: At the time of writing of this report, testing was completed and results reported for 31 products.
Slovenian: V času pisanja tega poročila je bilo preizkušanje opravljeno in rezultati objavljeni za 31 proizvodov.
English: 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.
Slovenian: Zlasti se zahvaljujem izvršnemu direktorju Agencije in njegovemu osebju za podporo in sodelovanje pri delu upravnega odbora.
English: Corporate helpdesk To provide help and support between the hours of 08h30 and 18h00, five days a week
Slovenian: Pomoč podjetjem Zagotoviti pomoč in podporo od 8.30 do 18.00, pet dni v tednu
English: In 2005, new Community legislation will introduce a requirement for risk management plans in relation to certain medicines with important (established or potential) risks.
Slovenian: 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.
English: The provision of interpretation was reviewed and tailored to real needs, and thus interpretation days were reduced by 68 % compared to the previous year.
Slovenian: Zagotavljanje tolmačenja je bilo revidirano in prilagojeno resničnim potrebam, zato so se dnevi tolmačenja zmanjšali za 68 % v primerjavi s prejšnjim letom.
English: Based on the findings of the audit, an action plan was developed to implement the opportunities for improvement identified.
Slovenian: Na podlagi ugotovitev revizije je bil razvit akcijski načrt za izvedbo ugotovljenih možnosti za izboljšanje.
English: For product defect and other quality-related matters:
Slovenian: Za pomanjkljivosti izdelkov in druge zadeve v zvezi z njihovo kakovostjo:
English: Budget for 2005 as adopted by the Management Board on 16.12.2004.
Slovenian: Proračun za leto 2005, kot ga je sprejel upravni odbor 16. 12. 2004.
English: Ten Member States acted as reference Member State in these procedures, compared with 9 in 2003.
Slovenian: V teh postopkih je deset držav članic delovalo kot referenčna država članica v primerjavi z letom 2003, ko jih je bilo devet.
English: On the international stage, there were two significant developments.
Slovenian: Na mednarodnem področju sta bila pomembnejša dva dogodka.
English: The unexpected withdrawal of certain medicinal products last year demonstrates in a concrete way how vulnerable EU pharmacovigilance efforts still are.
Slovenian: Lanski nepričakovani umik določenih zdravil dejansko kaže, kako občutljiva so še vedno prizadevanja farmakovigilance EU.
English: New internal control standards were adopted in December 2004.
Slovenian: Novi standardi notranje kontrole so bili sprejeti decembra 2004.
English: 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.
Slovenian: Decentralizirani postopek (ali postopek medsebojnega priznavanja) se uporablja za večino konvencionalnih zdravil in temelji na načelu medsebojnega priznavanja nacionalnih dovoljenj za promet.
English: • HIV/AIDS (3 new combinations of products)
Slovenian: • HIV/AIDS (3 nove kombinacije izdelkov)
English: Type-II variations *The numbers include multiple procedures as stated at 31 December 2004.
Slovenian: Spremembe tipa II *Številke zajemajo večnamenske postopke po podatkih z dne 31. decembra 2004.
English: The overall objectives were revised and published and a new testing scheme was agreed in principle.
Slovenian: Pregledani in objavljeni so bili splošni cilji in načeloma je bil dogovorjen nov sistem preizkušanja.
English: Two major safety reviews
Slovenian: Dve pomembni presoji varnosti
English: The summarised comparative budget statements for 2003 to 2005 are as follows: (Amounts expressed in euro)
Slovenian: Povzetek primerjalnih proračunskih poročil za obdobje 2003 do 2005: (Zneski, izraženi v EUR)
English: Draft guidance documents were developed, including external guidance that will become publicly available in 2005.
Slovenian: Razviti so bili osnutki smernic vključno z zunanjimi smernicami, ki bodo na voljo javnosti v letu 2005.
English: Work is ongoing with respect to harmonised rapid alert procedures and annual reporting provisions.
Slovenian: Potekajo dela v zvezi z usklajenimi postopki hitrega opozarjanja in določbami o letnem poročanju.
English: The effective coordination, management and resourcing of these projects led to their successful delivery.
Slovenian: Rezultat učinkovitega usklajevanja, vodenja in načrtovanja virov teh projektov je bila njihova uspešna izvedba.
English: In previous years, discharge was given by the Agency s Management Board.
Slovenian: Prejšnja leta je razrešnico dal upravni odbor Agencije.
English: 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.
Slovenian: Zaradi povečane delovne obremenitve in uvedbe novega postopka objavljanja so se EPARji objavljali tri do štiri tedne po sprejetju odločitve Komisije.
English: Number of variation applications in excess of 1 000 for the first time
Slovenian: Prvič več kot 1000 vlog za spremembo
English: The remaining provisions will come into force 18 months later, on 20 November 2005.
Slovenian: Druge določbe bodo začele veljati 18 mesecev pozneje, in sicer 20. novembra 2005.
English: It has an advisory function for integrated quality management at the Agency.
Slovenian: Ima svetovalno vlogo pri integriranem upravljanju kakovosti v Agenciji.
English: 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.
Slovenian: Namen politike je podpreti učinkovito načrtovanje, delovanje in kontrolo postopkov znotraj Agencije ter nenehno izboljševati njeno sodelovanje s partnerji v evropski mreži.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Sektor za pravne zadeve združuje pravne vire Agencije v eno specializirano skupino zaradi vse večje potrebe po pravnih storitvah.
English: The new products that received a positive opinion in 2004 will benefit patients in the following areas:
Slovenian: Novi izdelki, za katere so bila v letu 2004 izdana pozitivna mnenja, bodo bolnikom prinesli koristi na naslednjih področjih:
English: Cooperation between the EMEA and the World Health Organization (WHO) was strengthened during 2004.
Slovenian: Sodelovanje med EMEA in Svetovno zdravstveno organizacijo (WHO) se je v letu 2004 okrepilo.
English: Training profiles were proposed for a range of job profiles at all levels within the Agency.
Slovenian: Predlagani so bili profili usposabljanja za vrsto poklicev na vseh ravneh Agencije.
English: Pharmacovigilance involves a process of continuous monitoring of medicinal products on the market.
Slovenian: Farmakovigilanca pomeni proces stalnega spremljanja zdravil na trgu.
English: 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.
Slovenian: 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.
English: In addition, an extraordinary meeting was held in December in order to discuss safety concerns relating to SSRIs and SNRIs (see section 2.5).
Slovenian: Poleg tega je imel v decembru plenarno zasedanje, na katerem je razpravljal o varnostnih vprašanjih glede SSRI in SNRI (glej oddelek 2.5).
English: This was one of the key components helping the Sector achieve availability targets of 99.5 %
Slovenian: To je bil eden od ključnih elementov, ki je sektorju pomagal doseči cilj 99,5-odstotne razpoložljivosti.
English: Geographical distribution at EMEA - 31 December 2004
Slovenian: Geografska porazdelitev v EMEA - 31. december 2004
English: The Agency continually reviews its transparency policy with a view to increasing access to information and improving understanding of how it operates.
Slovenian: Agencija nenehno revidira svojo politiko preglednosti, da bi povečala dostop do informacij in izboljšala razumevanje svojega delovanja.
English: The EMEA Code of Conduct was revised in 2004 in order to clarify the meaning of some sections.
Slovenian: Kodeks ravnanja EMEA je bil revidiran leta 2004, da bi razjasnili pomen nekaterih poglavij.
English: This should result in increased regulatory and scientific consistency of the outcome of scientific evaluations from 2005 onwards.
Slovenian: Posledica tega bi morala biti povečana regulativna in znanstvena skladnost rezultatov znanstvenih vrednotenj od leta 2005 dalje.
English: The EMEA actively contributed to the public consultation on proposals to replace the existing Regulation on the establishment of maximum residue limits.
Slovenian: EMEA je aktivno sodelovala v javnem posvetovanju o predlogih za zamenjavo obstoječe Uredbe o določitvi mejnih vrednosti ostankov.
English: There were very few deviations from planned results, one notable exception being the slow implementation of EudraVigilance by Member States.
Slovenian: Bilo je zelo malo odstopanj od načrtovanih rezultatov, večja izjema je bila le počasno izvajanje projekta EudraVigilance v državah članicah.
English: The standards define the management rules all services must follow in their management of resources.
Slovenian: Standardi določajo pravila upravljanja, ki jih morajo upoštevati vse službe pri upravljanju z viri.
English: This number is lower than in previous years, possibly reflecting a better understanding among sponsors of the procedure and criteria for orphan designation.
Slovenian: Ta številka je nižja kot v prejšnjih letih, kar morda odseva boljše razumevanje sponzorjev glede postopka in meril za določitev zdravil sirot.
English: Typically, this is done to benefit from price differentials.
Slovenian: Praviloma se to izvaja zato, da se lahko izkoristijo ugodnosti zaradi razlik v ceni.
English: Orphan medicinal products are intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions that affect not more than five in 10 000 people in the European Union.
Slovenian: Zdravila sirote so namenjena za ugotavljanje, preprečevanje ali zdravljenje življenjsko nevarnih ali kronično izčrpavajočih zdravstvenih stanj, ki v Evropski skupnosti ne prizadenejo več kot pet od 10.000 ljudi.
English: Title IV of the new Regulation entered into force on 20 May 2004.
Slovenian: Naslov IV nove uredbe je začel veljati 20. maja 2004.
English: The EMEA ensures efficient support for the meetings it organises, providing facilities and services, and constantly improves the resources available.
Slovenian: EMEA zagotavlja učinkovito podporo srečanjem, ki jih organizira, zagotavlja zmogljivosti in storitve ter stalno izboljšuje razpoložljive vire.
English: The time taken by companies to answer questions relating to deficiencies in their applications (referred to as clock stop ) increased.
Slovenian: Podaljšal se je čas, ki ga potrebujejo podjetja, da odgovorijo na vprašanja v zvezi s pomanjkljivostmi v njihovih vlogah (tako imenovana "zaustavitev časa").
English: Special attention was paid to improving communication between the stakeholders and to increasing transparency and understanding.
Slovenian: Posebna pozornost je bila posvečena izboljšanju komuniciranja med interesnimi skupinami ter povečanju preglednosti in razumevanja.
English: A total of 87 requests were received and 77 were finalised.
Slovenian: Prejetih je bilo skupaj 87 zahtevkov, 77 pa jih je bilo dokončno obdelanih.
English: The new legislative framework consists of:
Slovenian: Nov zakonodajni okvir zajema:
English: New regulatory framework
Slovenian: Nov regulativni okvir
English: This represents a 40 % increase in activity when compared to 2003, and indicates that companies developing medicines for rare diseases have a high level of interest in receiving support and advice during the research and development phase.
Slovenian: To je 40-odstotno povečanje dejavnosti v primerjavi z letom 2003 in kaže, da je pri podjetjih, ki razvijajo zdravila za redke bolezni, prisoten velik interes za prejemanje podpore in svetovanja med fazo raziskav in razvoja.
English: The accounts sector maintains the accounts, makes payments and collects revenue in accordance with the procedures laid down in the Financial Regulation.
Slovenian: Računovodski sektor vodi račune, opravlja plačila in zbira prihodke v skladu s postopki iz finančne uredbe.
English: A total of 5 925 delegate visits were reimbursed, leading to a 47 % increase in expenditure in 2004.
Slovenian: Stroški so bili povrnjeni za skupaj 5925 obiskov delegatov, zaradi česar so se odhodki v letu 2004 povečali za 47 %.
English: The existing procedures were updated to take account of the consequences of the EU enlargement and the revision of the pharmaceutical legislation.
Slovenian: Obstoječi postopki so bili posodobljeni tako, da upoštevajo posledice širitve EU in revizijo farmacevtske zakonodaje.
English: To achieve 99.5 % availability for all IT services supporting the corporate activities of the EMEA
Slovenian: Doseči 99,5-odstotno razpoložljivost vseh storitev IT za podporo podjetniških dejavnosti EMEA
English: Cooperation with EFSA
Slovenian: Sodelovanje z EFSA
English: Of the medicinal products having received a positive opinion, some were more notable in terms of therapeutic progress:
Slovenian: Pri zdravilih, za katera so bila izdana pozitivna mnenja, so bila nekatera še posebej pomembna z vidika napredka v zdravljenju:
English: The majority (>90 %) of results received show that the products were of high quality and complied with their authorised specifications.
Slovenian: Večina (> 90 %) pridobljenih rezultatov kaže, da so izdelki visoke kakovosti in skladni s specifikacijami, ki so odobrene zanje.
English: Two informal meetings were held in 2004, in Dublin and Scheveningen.
Slovenian: V letu 2002 sta bila opravljena dva neformalna sestanka v Dublinu in Scheveningenu.
English: The work for final MRLs for these two substances is well underway and is likely to be completed in 2005.
Slovenian: Dela za končno določitev MRL-jev za ti dve učinkovini potekajo in bodo verjetno dokončana v letu 2005.
English: Elements of the new legislation which came into force in 2004 include:
Slovenian: Elementi nove zakonodaje, ki so začeli veljati v letu 2004, zajemajo:
English: There were also regular bilateral meetings between the EMEA and the secretaries of various interested parties.
Slovenian: Potekali so redni dvostranski sestanki med EMEA in sekretariati različnih zainteresiranih strani.
English: 1.7 Corporate governance - Integrated management system
Slovenian: 1.7 Podjetniško upravljanje - integrirani sistem upravljanja
English: Surpluses in one budget year are returned to the Commission, where they are earmarked to compensate for shortfalls in fee income in following budget years.
Slovenian: Presežki iz enega proračunskega leta se vrnejo Komisiji, kjer se namensko rezervirajo za izravnavo primanjkljajev v prihodkih iz pristojbin v naslednjih proračunskih letih.
English: In 2004, the VMRFG provided answers to a wide range of questions from both Member States and Industry on a number of different regulatory issues.
Slovenian: V letu 2004 je VMRFG pripravil odgovore na številna vprašanja, ki so jih predstavile države članice in industrija glede vrste različnih regulativnih vprašanj.
English: This is the highest number of positive opinions adopted in any year since orphan medicinal product legislation was implemented in 2000.
Slovenian: To je najvišje število pozitivnih mnenj, sprejetih v katerem koli letu, odkar je bila leta 2000 uvedena zakonodaja v zvezi z zdravili sirotami.
English: I am pleased to report that the integration of the 10 new Member States into the European regulatory network was successful beyond all expectations thanks to excellent preparatory work conducted in the years leading up to the EU enlargement.
Slovenian: Z veseljem ugotavljam, da je uspeh vključitve 10 novih držav članic v evropsko regulativno mrežo presegel vsa pričakovanja, za kar se lahko zahvalimo odličnim pripravam, opravljenim v letih pred širitvijo EU.
English: # Denotes an orphan medicinal product designated under Regulation (EC) No 121/2000.
Slovenian: # Označuje zdravilo siroto, določeno v skladu z Uredbo (ES) št. 121/2000.
English: • Revised the rules on public access to EMEA documents 16 December 2004
Slovenian: • revizija predpisov o javnem dostopu do dokumentov EMEA 16. december 2004
English: By the end of 2004, almost 10 % of the total of 335 EMEA staff members were nationals of one of the 10 new Member States.
Slovenian: Do konca leta 2004 je bilo skoraj 10 % od skupaj 335 članov osebja EMEA iz ene od 10 novih držav članic.
English: In 2004, 2 referrals were received; no arbitration was submitted.
Slovenian: V letu 2004 sta bili prejeti dve predložitvi, predložena pa ni bila nobena arbitraža.
English: The new legislation introduced a simplified registration procedure for traditional herbal medicinal products.
Slovenian: Nova zakonodaja je uvedla poenostavljen postopek registracije za tradicionalna zeliščna zdravila.