natgillin/translations-raw huggingface dataset:
The new legal basis puts the Agency in a stronger position to fulfil its public and animal health mandate. 
Nova pravna podlaga Agenciji zagotavlja boljša izhodišča za izpolnjevanje njenega mandata glede zdravja ljudi in živali.
EMEA budget: expenditure 
Proračun EMEA: odhodki
The revised pharmaceutical legislation opens the way for new types of applications to be made to the Agency. 
Revidirana farmacevtska zakonodaja odpira pot novim vrstam vlog, ki se predložijo Agenciji.
EMEA has worked on its pandemic influenza preparedness since 2003 and has put in place an innovative and proactive approach for the accelerated assessment and approval of new vaccines against a pandemic influenza. 
EMEA dela na pripravljenosti na pandemijo influence že od leta 2003, v sklopu česar je vzpostavila inovativen in proaktiven pristop za pospešeno vrednotenje in odobritev novih cepiv za pandemijo influence.
Some streamlining of the scientific advice procedure meant that, despite the increase in requests, the Agency was able to deliver more and faster scientific advice in 2005 than in previous years. 
Racionalizacija postopka znanstvenega svetovanja je omogočila, da je bila Agencija v letu 2005 kljub povečanju števila zahtevkov sposobna zagotoviti obsežnejše in hitrejše znanstveno svetovanje v primerjavi s prejšnjimi leti.
The SME Office aims to facilitate communication with SMEs through dedicated personnel within the Agency who respond to practical or procedural enquiries, monitor applications, and organise workshops and training sessions for SMEs. 
Urad za MSP si prizadeva za boljšo komunikacijo z malimi in srednje velikimi podjetji, in sicer s pomočjo predanega osebja znotraj Agencije, ki odgovarja na praktične ali postopkovne poizvedbe, spremlja vloge ter organizira delavnice in usposabljanja za mala in srednje velika podjetja.
The opinions concerned 2 medicinal products for the treatment of HIV. 
Mnenja so se nanašala na 2 zdravili za zdravljenje HIV.
Initiation of a review of mifepristone-containing medicinal products (Mifegyne) due to safety and efficacy concerns. 
začetkom presoje zdravil, ki vsebujejo mifepriston (Mifegyne), zaradi pomislekov o njihovi varnosti in učinkovitosti.
The measures already taken to expedite the assessment procedures for vaccines and conventional medicines have been welcomed and are necessary. 
Ukrepi, ki so že bili sprejeti za pospešitev postopkov vrednotenja cepiv in konvencionalnih zdravil, so bili dobro sprejeti in izkazalo se je, da so nujno potrebni.
The centralised procedure is optional for immunological veterinary medicines for animal diseases that are subject to Community prophylactic measures. 
Centralizirani postopek ni obvezen za imunološka veterinarska zdravila za živalske bolezni, za katere veljajo profilaktični ukrepi Skupnosti.
Now, with a decade of very solid progress behind it, and a good long-term plan in place to guide its forward evolution, the Agency is in better shape than ever to pursue its mission for the protection and promotion of health in Europe. 
Danes, ko ima za seboj desetletje zelo solidnega napredka in narejen dober dolgoročni načrt, ki bo usmerjal njen nadaljnji razvoj, je Agencija bolj kot kdaj koli pripravljena nadaljevati svoje poslanstvo, t.j.
The CVMP gave 3 positive opinions for the establishment of MRLs and 8 opinions for the extension of existing MRLs to other species. 
CVMP je predložil 3 pozitivna mnenja za določitev najvišjih mejnih vrednosti ostankov in 8 mnenj za razširitev obstoječih najvišjih mejnih vrednosti ostankov na druge vrste.
In addition to its activities relating to development of a pandemic influenza vaccine, the EMEA also looked at antivirals and issued guidelines in October 2005 on the use of these medicines in the event of a pandemic. 
Poleg dejavnosti v zvezi z razvojem cepiva za pandemijo influence se je EMEA ukvarjala tudi s protivirusnimi zdravili in oktobra 2005 objavila smernice za uporabo teh zdravil v primeru pandemije.
The Mutual Recognition Facilitation Group (MRFG) and the Veterinary Mutual Recognition Facilitation Group (VMRFG), which coordinated and facilitated the operations of the mutual recognition procedure for human and veterinary medicinal products respectively over the past ten years, both held their final meetings in October 2005. 
Skupina za poenostavitev medsebojnega priznavanja (Mutual Recognition Facilitation GroupMRFG) in Skupina za poenostavitev medsebojnega veterinarskega priznavanja (Veterinary Mutual Recognition Facilitation Group - VMRFG), ki sta v zadnjih desetih letih usklajevali in lajšali delovanje postopka za medsebojno priznavanje za zdravila za humano in veterinarsko uporabo, sta imeli svoji zadnji zasedanji oktobra 2005.
The membership of the Management Board finally reached its full complement during the year under review, as new representatives of patients' organisations and doctors' and veterinarians' associations appointed by the Council of Ministers joined in the work. 
Lansko leto je upravni odbor dosegel svojo popolno sestavo, saj so se pridružili novi predstavniki organizacij bolnikov in združenj zdravnikov ter veterinarjev, ki jih je imenoval Svet ministrov.
Building and equipment-related expenditure (including EU telematics) 
Izdatki za stavbe in opremo (vključno s telematiko EU) 27 105 000 EUR
Suspected adverse reactions in dogs and cats were most frequently reported. 
Najpogosteje se je poročalo o sumih na neželene učinke pri psih in mačkah.
The CVMP prepared a simple guide on veterinary pharmacovigilance, targeted primarily at veterinarians, in order to encourage reporting of adverse drug reactions. 
CVMP je pripravil preprost priročnik o veterinarski farmakovigilanci, ki je namenjen predvsem veterinarjem, za spodbujanje poročanja o neželenih učinkih zdravil.
Contra-indications and warnings: A total of 5 new contra-indications were introduced for 11 medicinal products used in the fields of HIV, immunosuppression, osteoporosis and metabolic diseases. 
Kontraindikacije in opozorila: uvedenih je bilo skupaj 5 kontraindikacij za 11 zdravil, ki se uporabljajo za zdravljenje HIV, imunosupresije, osteoporoze in bolezni presnove.
The new CHMP Working Party on Similar Biological Medicinal Products was established in 2005. 
Leta 2005 je bila ustanovljena nova delovna skupina o podobnih bioloških zdravilih CHMP.
Generic medicines: Detailed guidance was published and existing guidance updated in 2005 concerning all aspects relating to the submission to the EMEA and assessment by the CHMP of generic medicines. 
Generična zdravila: v letu 2005 so bile izdane podrobne smernice in posodobljene trenutno veljavne smernice v zvezi z vsemi vidiki, ki se nanašajo na predložitev vlog na EMEA in vrednotenje generičnih zdravil s strani CHMP.
The new pharmaceutical legislation also gives the Agency new tasks to improve product-related information. 
Nova farmacevtska zakonodaja nalaga Agenciji nove naloge za izboljšanje informacij o izdelkih.
EudraGMP: Work on the development of this system, the Community database of manufacturing authorisations and of certificates of good manufacturing practice, began. 
EudraGMP (dobra proizvodna praksa): začel se je razvoj tega sistema, zbirke podatkov Skupnosti o dovoljenjih za izdelavo in potrdilih o dobri proizvodni praksi.
While EMEA is not directly involved in this process, it does contribute to encouraging research and development in the pharmaceutical industry, ultimately improving access of patients to new and important medicines. 
Čeprav EMEA ni neposredno vključena v ta proces, pa vseeno prispeva k spodbujanju raziskav in razvoja v farmacevtski industriji ter tako v končni fazi izboljšuje dostop bolnikov do novih in pomembnih zdravil.
Altogether, more than 1,000 post-authorisation procedures were finalised in 2005, including 628 notifications for type-I variations, 505 opinions for type-II variations (50% relating to safety and efficacy, and 50% relating to quality changes) and 15 opinions for line extensions. 
V letu 2005 je bilo skupno dokončno obdelanih več kot 1000 postopkov po izdaji dovoljenja za promet z zdravilom, vključno s 628 obvestili za spremembe tipa I, 505 mnenji za spremembe tipa II (50 % v zvezi z varnostjo in učinkovitostjo in 50 % v zvezi s spremembami kakovosti) in 15 mnenji za razširitev terapevtskih indikacij.
While only few scientific advice applications for MUMS products have been received since the scheme was introduced in October 2003, industry have confirmed high interest. 
Čeprav je bilo od začetka programa v oktobru 2003 prejetih le malo zahtevkov za znanstveno svetovanje za izdelke MUMS, pa so panožna podjetja pokazala veliko zanimanje.
The EMEA continued efforts to address the shortage of essential medicines to the veterinary practitioner particularly for minor uses and minor species (MUMS), focusing in particular on the implementation of recommendations of the position paper regarding availability of products for minor uses and minor species. 
EMEA si je še naprej prizadevala obravnavati vprašanje pomanjkanja glavnih zdravil za veterinarje, zlasti za manjšo uporabo in manj pomembne vrste (MUMS), pri čemer je glavno pozornost namenjala izvajanju priporočil dokumenta o stališčih v zvezi z razpoložljivostjo izdelkov za manjšo uporabo in manj pomembne vrste.
New regulatory tools for the evaluation of medicines 
Nova regulativna orodja za vrednotenje zdravil
The EMEA Management Board adopted criteria in September 2005 for the participation of patients' or consumers' organisations in EMEA activities. 
Upravni odbor EMEA je septembra 2005 sprejel merila za sodelovanje organizacij bolnikov ali potrošnikov pri dejavnostih EMEA.
The scope of medicines for which the centralised procedure is optional has been broadened to allow for certain circumstances of expected benefit to public health, and now also includes self-medication products and generic medicines. 
Obseg zdravil, za katera centraliziran postopek ni obvezen, se je razširil z namenom zagotoviti rešitev za določene okoliščine pričakovanih koristi za zdravje ljudi, tako da sedaj vključuje tudi izdelke za samozdravljenje in generična zdravila.
New opportunities for early informal discussions in the form of briefing meetings were introduced and a pilot procedure established to facilitate the evaluation of whether emerging approaches can be considered as medicinal products and thus have access to the centralised procedure. 
Oblikovane so bile nove možnosti za zgodnje neformalne razprave v obliki informativnih sestankov, vzpostavljen pa je bil tudi pilotni postopek za poenostavitev vrednotenja, ali se lahko nastajajoče pristope obravnava kot zdravila in tako lahko imajo dostop do centraliziranega postopka.
First production versions of the EudraVigilance datawarehouse and pharmacointelligence tools were delivered for testing. 
Prve proizvodne različice podatkovnega skladišča EudraVigilance in orodij farmakointeligence so bile dostavljene za namene preizkušanja.
Availability of veterinary medicines 
Razpoložljivost veterinarskih zdravil
The EMEA received the first requests for SME status following the entry into force of the SME Regulation, and processed them. 
EMEA je po začetku veljavnosti Uredbe MSP prejela in obdelala prve zahtevke za status MSP.
facilitating innovation and stimulating research, hence contributing to the competitiveness of EU-based pharmaceutical industry, and mobilising and coordinating scientific resources from throughout the EU to provide high-quality evaluation of medicinal products, to advise on research and development programmes, to perform inspections for ensuring fundamental GxP1 provisions are consistently achieved, and to provide useful and clear information to users and healthcare professionals. 
pospeševanjem inovacij in spodbujanjem raziskav, s čimer prispeva h konkurenčnosti farmacevtske industrije EU, ter zbiranjem in usklajevanjem znanstvenih virov iz vse EU zaradi zagotovitve visoke kakovosti vrednotenja zdravil, izvajanja inšpekcijskih pregledov za zagotavljanje doslednega izvajanja temeljnih določb GXP ter zagotovitve uporabnih in jasnih informacij uporabnikom in zdravstvenemu osebju.
The Regulation also gives the EMEA important new responsibilities, in particular for the provision of better information about medicines to patients, consumers and healthcare professionals, and for strengthening the provision of scientific advice to companies. 
Uredba prav tako prinaša pomembne nove odgovornosti za EMEA, zlasti zagotavljanje boljših informacij o zdravilih bolnikom, potrošnikom in zdravstvenemu osebju, in krepitev zagotavljanja znanstvenega svetovanja podjetjem.
Good progress was made with the implementation of EudraVigilance in 2005, with 23 national competent authorities and 105 marketing authorisation holders reporting electronically to the EudraVigilance Post-Authorisation Module (EVPM). 
Pri izvajanju EudraVigilance je bil v letu 2005 dosežen dober napredek, pri čemer je 23 nacionalnih pristojnih organov in 105 imetnikov dovoljenj za promet z zdravilom elektronsko poročalo v modul EudraVigilance po izdaji dovoljenja (EudraVigilance Post-Authorisation Module - EVPM).
Risk management plans 
Načrti za obvladovanje tveganja
Designations were for products covering a wide range of therapeutic areas, but the largest number of them related to products for the treatment of cancer. 
Določitve so se nanašale na izdelke, ki so pokrivali široko vrsto terapevtskih področij, vendar je bilo največ določitev povezanih z izdelki za zdravljenje raka.
3.1.3 Initial evaluation 
3.1.3 Začetno vrednotenje
The EMEA's Mission Statement is, in the context of a continuing globalisation, to protect and promote public and animal health by developing efficient and transparent procedures to allow rapid access by users to safe and effective innovative medicines and to generic and non-prescription medicines through a single European marketing authorisation, 
Glede na nenehno globalizacijo je poslanstvo EMEA varovati in pospeševati zdravje ljudi in živali z razvojem učinkovitih in preglednih postopkov, ki uporabnikom omogočajo hiter dostop do varnih in učinkovitih inovativnih zdravil ter do generičnih zdravil in zdravil brez recepta z enotnim evropskim dovoljenjem za promet,
3.2.2 Initial evaluation 
3.2.2 Začetno vrednotenje
Initiation of a safety review for dermatological medicinal products containing tacrolimus or pimecrolimus, following concerns of potential cancer risks for patients 
začetkom presoje varnosti za dermatološka zdravila, ki vsebujejo takrolimus ali pimekrolimus, zaradi pomislekov o možnih tveganjih za nastanek raka;
This included drawing up guidelines for the new procedures, as well as contributing to the update of existing guidance documents, for both human and veterinary medicines, such as the good manufacturing practice (GMP) guide and the Notice to Applicants. 
To je vključevalo pripravo smernic za nove postopke in prispevanje k posodabljanju obstoječih usmeritvenih dokumentov za zdravila za uporabo v humani in veterinarski medicini, kot so smernice dobre proizvodne prakse in obvestila vlagateljem.
Question-and-answer documents were prepared systematically for all major safety issues involving centrally authorised products. 
Sistematično so bili pripravljeni dokumenti z vprašanji in odgovori za vsa pomembnejša vprašanja o varnosti v zvezi z izdelki, za katere je bilo izdano dovoljenje po centraliziranem postopku.
Orphan medicinal product procedures 2003 - 2005 
Postopki za zdravila sirote v obdobju 2003-2005
4 SAFETY OF MEDICINES 
4 VARNOST ZDRAVIL
Opinions in 2005 The CHMP adopted 24 positive opinions and 1 negative opinion in 2005 on products intended for the European market. 
Mnenja v letu 2005 Odbor za zdravila za uporabo v humani medicini (CHMP) je v letu 2005 sprejel 24 pozitivnih mnenj in 1 negativno mnenje v zvezi z izdelki, namenjenimi evropskemu trgu.
The number of applications for variations to marketing authorisations increased once again in 2005. 
V letu 2005 se je ponovno povečalo število vlog za spremembe dovoljenj za promet z zdravilom.
Adverse reactions in human beings following exposure to a veterinary medicinal product were reported in 49 cases during 2005, none of which resulted in fatality. 
V letu 2005 se je o neželenih učinkih pri ljudeh zaradi izpostavljenosti veterinarskim zdravilom poročalo v 49 primerih, od katerih se ni noben končal s smrtnim izidom.
While the Agency devoted great energy in 2005 to setting up these and other initiatives under its extended mandate, it also focused on improving its core scientific activities, particularly in the area of pharmacovigilance, which resulted in more efficient and effective practices for safeguarding the quality, safety and efficacy of authorised medicinal products. 
Čeprav je Agencija v letu 2005 večino svojega časa in energije posvetila tem in še nekaterim drugim pobudam, se je ukvarjala tudi z izboljševanjem svojih osrednjih znanstvenih dejavnosti, še zlasti na področju farmakovigilance, zaradi česar so postopki za ohranjanje kakovosti, varnosti in učinkovitosti odobrenih zdravil še uspešnejši in učinkovitejši.
Biotechnology medicines 
biotehnološkimi zdravili;
New applications for veterinary medicines received/forecast (Input) 
Prejete/predvidene nove vloge za veterinarska zdravila (vhodni podatek)
Working through the EMEA/CHMP Working Group with Patients' and Consumers' Organisations (the Agency's platform for interaction with patients and consumers), a set of recommendations was published in March 2005 relating to: transparency and dissemination of information; product information; pharmacovigilance; and interaction between the EMEA and patients' organisations. 
V sodelovanju EMEA/delovne skupine CHMP z organizacijami bolnikov in potrošnikov (platforma Agencije za sodelovanje z bolniki in potrošniki) je bil marca 2005 objavljen sklop priporočil, ki so se nanašala na preglednost in obveščanje, informacije o izdelkih, farmakovigilanco in sodelovanje med
Another initiative aimed in particular at encouraging the development of medicines for minor species in the important livestock sector is the extrapolation of MRLs from major to minor species. 
Še ena pobuda, ki je usmerjena zlasti na spodbujanje razvoja zdravil za manj pomembne vrste v pomembnem sektorju za živino, je ekstrapolacija najvišjih mejnih vrednoti ostankov za pomembnejše živalske vrste na manj pogoste živalske vrste.
The EMEA received 65 quality-defect reports concerning human medicinal products and 3 qualitydefect reports for veterinary medicinal products. 
EMEA je prejela 65 poročil o pomanjkljivi kakovosti pri zdravilih za uporabo v humani medicini in 3 poročila o pomanjkljivostih pri zdravilih za uporabo v veterinarski medicini.
There was a substantial increase in the number of requests for scientific advice and protocol assistance in 2005 - up 60% on the number received in 2004. 
Veliko povečanje zahtevkov za znanstveno svetovanje V letu 2005 se je število zahtevkov za znanstveno svetovanje in pomoč pri protokolu močno povečalo, in sicer za 60 % v primerjavi s številom zahtevkov, prejetih v letu 2004.
A think-tank group was established to consider innovative methods for drug development and to assess hurdles that may be encountered by pharmaceutical companies researching or developing such methods. 
Ustanovljena je bila ustvarjalna skupina za obravnavanje inovativnih načinov razvoja zdravil in oceno ovir, s katerimi se srečujejo farmacevtska podjetja, ki raziskujejo ali razvijajo takšne načine.
The EMEA coordinated and managed requests for 98 good manufacturing practice (GMP) and plasma master file inspections, 14 good clinical practice (GCP) and pharmacovigilance inspections, and 2 good laboratory practice (GLP) inspections during 2005, representing a total increase of 23% relative to 2004. 
EMEA je v letu 2005 uskladila in vodila prošnje za 98 inšpekcijskih pregledov dobre proizvodne prakse in glavnega dosjeja plazme, 14 inšpekcijskih pregledov dobre klinične prakse in farmakovigilance ter 2 inšpekcijska pregleda dobre laboratorijske prakse, kar je skupaj predstavljalo 23-odstotno relativno povečanje v primerjavi z letom 2004.
Conclusion of the safety review of the selective serotonin reuptake inhibitor (SSRI) class of antidepressants 
zaključkom presoje varnosti razreda antidepresivov SSRI (selektivni zaviralci ponovnega privzema serotonina);
3.2 Medicines for veterinary use 3.2.1 Scientific advice 
3.2 Zdravila za uporabo v veterinarski medicini 3.2.1 Znanstveno svetovanje
The Agency released the ‘EMEA pandemic influenza crisis management plan for the evaluation and maintenance of pandemic influenza vaccines and antivirals' for consultation in 2005. 
Agencija je objavila "načrt kriznega upravljanja pandemije influence za ovrednotenje in ohranitev cepiv in protivirusnih zdravil za pandemijo influence EMEA" za namene posvetovanj v letu 2005.
There were also new indications in the area of diabetes, cardiovascular, neurodegenerative and rheumatoid diseases. 
Nove terapevtske indikacije so se nanašale tudi na področje sladkorne bolezni ter kardiovaskularnih, nevrodegenerativnih in revmatoidnih bolezni.
These include risk-management plans, the collection of specific pharmacovigilance data from targeted groups of patients, and new possibilities for pharmacovigilance inspections and inspection of active substances. 
Ta vključujejo načrte za obvladovanje tveganja, zbiranje farmakovigilančnih podatkov v ciljnih skupinah bolnikov ter nove možnosti za inšpekcijske preglede farmakovigilance in inšpekcijske preglede zdravilnih učinkovin.
PIM enables the management and exchange of product information (summary of product characteristics, package leaflet and labelling) by all parties involved in the evaluation process for the centralised procedure. 
Upravljanje informacij o izdelkih omogoča upravljanje in izmenjavo informacij o izdelkih (povzetka glavnih značilnosti zdravila, navodil za uporabo in označevanja) vsem strankam, vključenim v vrednotenje za centraliziran postopek.
There was a similar increase in the number of finalised post-authorisation procedures, particularly those for type-II variations. 
Podobno se je povečalo število dokončno obdelanih postopkov po izdaji dovoljenja za promet z zdravilom, zlasti postopkov za spremembe tipa II.
As part of the revised pharmaceutical legislation, all new applications for marketing authorisation and applications for major changes to existing authorisations must be accompanied by a risk management plan. 
V skladu z revidirano farmacevtsko zakonodajo morajo biti vse nove vloge za izdajo dovoljenja za promet z zdravilom in vloge za večje spremembe obstoječih dovoljenj za promet z zdravilom opremljene z načrtom za obvladovanje tveganja.
A new Medical Information sector became fully operational in September 2005 and assumed responsibilities for interaction with patients' and healthcare professionals' organisations and for activities associated with the provision of productrelated information. 
Septembra 2005 je začel v celoti delovati novi sektor za zdravstvene informacije, ki je prevzel odgovornost za sodelovanje z organizacijami bolnikov in zdravstvenih strokovnjakov ter za dejavnosti, povezane z zagotavljanjem informacij o zdravilih.
Results requiring further investigation were found in 8 of the 39 products. 
Pri 8 od 39 izdelkov so rezultati pokazali, da so potrebne dodatne preiskave.
New indications: A total of 28 extensions of indications were introduced, a large number of which related to new treatment options for previously approved medicines in the area of cancer. 
Nove terapevtske indikacije: uvedenih je bilo skupaj 28 razširitev terapevtskih indikacij, od katerih se jih je veliko število nanašalo na nove možnosti zdravljenja s predhodno odobrenimi zdravili za zdravljenje raka.
Of these, 14 applications were for immunologicals, and concerned quality changes; 7 were for pharmaceuticals, with 4 concerning clinical changes and 3 concerning quality changes. 
Od tega je bilo 14 vlog za imunološka zdravila, ki so zadevale spremembe kakovosti; 7 vlog je bilo za farmacevtske izdelke, od tega so se 4 nanašale na klinične spremembe, 3 pa na spremembe kakovosti.