natgillin/translations-raw huggingface dataset:
The majority of recalls (14) were classified as ‘Class 3' recalls, which are not associated with serious public health hazards. 
Večina umikov (14) je bila razvrščena kot umiki "3. razreda", ki niso povezani z resnimi nevarnostmi za zdravje ljudi.
Strengthened procedures for detection of pharmacovigilance signals 
Okrepljeni postopki za odkrivanje signalov farmakovigilance
Management and internal-control systems are part of EMEA corporate governance and are consolidated in an integrated management system at the EMEA. 
Sistem upravljanja in sistem notranje kontrole sta sestavna dela podjetniškega upravljanja EMEA ter sta povezana v integriran sistem upravljanja v EMEA.
The strategy aims to contribute to better protection and promotion of public and animal health, to improve the regulatory environment for medicinal products, and to stimulate innovation, research and development in the EU. 
Cilj strategije je prispevati k boljši zaščiti in spodbujanju zdravja ljudi in živali, izboljšati regulativno okolje za zdravila in spodbujati inovacije, raziskave in razvoj v EU.
Fee reductions for scientific advice, inspections and (for veterinary medicines) establishment of maximum residue limits 
znižanja pristojbin za znanstveno svetovanje, inšpekcijske preglede in (za veterinarska zdravila) opredelitev mejnih vrednosti ostankov;
The first production version of the product information management (PIM) review system for regulatory authorities and the first production version of the PIM light-authoring tool for applicants were ready, enabling formal delivery very early in 2006. 
Pripravljeni sta bili prva proizvodna različica presoje sistema upravljanja informacij o izdelkih (product information management - PIM) za regulativne organe in prva proizvodna različica orodja Light-Authoring PIM za vlagatelje, kar je omogočilo uradno dostavo že zelo zgodaj v letu 2006.
The Committee for Orphan Medicinal Products (COMP) adopted 88 positive opinions on designation of orphan medicines in 2005 - the highest number since the entry into force of EU legislation on orphan medicines (Regulation (EC) No 141/2000) in 2000. 
Odbor za zdravila sirote (COMP) je v letu 2005 sprejel 88 pozitivnih mnenj o določitvi zdravila kot zdravila sirote - to je najvišje število pozitivnih mnenj, sprejetih od začetka veljavnosti EU zakonodaje v zvezi z zdravili sirotami (Uredba (ES) št. 141/2000) leta 2000.
This European approach uses a ‘core dossier' that allows the completion of the evaluation and approval of an application based on a mock-up vaccine (with an influenza virus strain similar to the pandemic strain) before the outbreak of a pandemic. 
Ta evropski pristop uporablja "temeljno dokumentacijo", ki omogoča vrednotenje in odobritev vloge na podlagi modela cepiva (s sevom virusa influence, ki je podoben pandemičnemu sevu) pred izbruhom pandemije.
One application was withdrawn prior to opinion. 
Ena vloga je bila umaknjena pred sprejetjem mnenja.
Taking into account the greater scientific role of the Agency, stemming from the revised EU pharmaceutical legislation and the Road Map, the Agency started the implementation of training profiles for all EMEA staff. 
Ob upoštevanju večje znanstvene vloge Agencije, ki izhaja iz revidirane farmacevtske zakonodaje EU in usmeritvenega načrta, je Agencija začela izvajati profile usposabljanja za vse osebje EMEA.
The Agency is involved in the steering group of the platform, and there are therefore good opportunities to influence and improve the development and availability of veterinary medicines. 
Agencija sodeluje v usmerjevalni skupini platforme, zato ima veliko možnosti za vplivanje in krepitev razvoja in razpoložljivosti veterinarskih zdravil.
Pharmacovigilance in the veterinary sector was a top priority for the EMEA in 2005. 
Farmakovigilanca v veterinarskem sektorju je bila najpomembnejša prednostna naloga EMEA v letu 2005.
The Agency made continuous improvements to its processes and interfaces with partners in the European network and ensures the logistics of the benchmarking of medicines agencies of 28 EU/EEA countries. 
Agencija je izvedla številne izboljšave svojih procesov in vmesnikov s partnerji v evropski mreži ter zagotavljala logistiko za primerjalne analize agencij za zdravila za 28 držav članic EU/EGP.
In the beginning of 2005, the Agency published its long-term strategy, the ‘European Medicines Agency Road Map to 2010: Preparing the Ground for the Future'. 
EMEA je na začetku leta 2005 objavila svojo dolgoročno strategijo z naslovom "Usmeritveni načrt Evropske agencije za zdravila do leta 2010: Priprava podlage za prihodnost".
In addition, the Committee gave 3 opinions for the extrapolation of existing MRLs to further species, in line with its policy on availability of veterinary medicines. 
Poleg tega je Odbor predložil 3 mnenja za ekstrapolacijo obstoječih najvišjih mejnih vrednosti ostankov na dodatne vrste v skladu s svojo politiko o razpoložljivosti veterinarskih zdravil.
In the event of a pandemic, the actual influenza strain is submitted as a variation to the core dossier. 
V primeru pandemije se dejanski sev influence predloži kot sprememba temeljne dokumentacije.
The new groups are set up under the revised EU pharmaceutical legislation to examine any question relating to the marketing of a medicinal product for human or veterinary use in two or more Member States, in accordance with the mutual recognition procedure (MRP) or the new decentralised procedure (DCP). 
Novi skupini sta bili ustanovljeni v skladu z revidirano farmacevtsko zakonodajo EU za preučevanje vprašanj, povezanih s trženjem zdravil za humano in veterinarsko uporabo v dveh ali več državah članicah, v skladu s postopkom medsebojnega priznavanja ali novim decentraliziranim postopkom.
A total of 880 suspected signals, concerning 87 products, were detected and investigated. 
Odkrilo in preučilo se je skupaj 880 sumov signalov, ki so zadevali 87 izdelkov.
The revised EU pharmaceutical legislation gives the Agency a greater mandate to provide scientific advice, and gives the Executive Director direct responsibility for establishing efficient structures for its provision - particularly with regard to advice for the development of new therapies. 
Revidirana farmacevtska zakonodaja EU Agenciji daje več pooblastil za zagotavljanje znanstvenega svetovanja in izvršnemu direktorju nalaga odgovornost za vzpostavitev učinkovitih struktur za njegovo zagotavljanje - zlasti glede svetovanja za razvoj novih zdravljenj.
Following a period of external consultation with stakeholders, the Agency finalised and published a procedure for the development of pharmaceutical guidelines and related documents, proposing a consistent and transparent approach to their development, consultation and publication. 
Po končanem obdobju javnih posvetovanj z zainteresiranimi stranmi je Agencija dokončna oblikovala in objavila postopek za razvoj farmacevtskih smernic in povezanih dokumentov ter predlagala skladen in pregleden pristop k njihovemu razvoju, zadevnem posvetovanju in objavi.
A class-labelling procedure was also conducted in relation to the use of epoetins in cancer patients, and another one in relation to dental, periodontal and psychiatric disorders possibly associated with the use of peginterferon alfa. 
Eden izmed postopkov označevanja razreda je bil izveden tudi v zvezi z uporabo epoetinov pri bolnikih z rakom in drugi pa v zvezi z dentalnimi, parodontalnimi in psihiatričnimi motnjami, ki so verjetno povezane z uporabo peginterferona alfa.
The investigations revealed some regulatory and scientific discrepancies, which were mainly addressed through amendment of the testing documentation by the marketing authorisation holders concerned. 
Preiskave so odkrile nekatere regulativne in znanstvene neskladnosti, ki so bile pretežno razrešene s spremembo dokumentov preizkušanja s strani zadevnih imetnikov dovoljenj za promet z zdravilom.
Contributions were made to the Innovative Medicines Initiative (IMI), the development of the European Technology Platform on Global Animal Health (ETPGAH), and the establishment of priorities for rare diseases. 
Agencija je prispevala k pobudi za inovativna zdravila, k razvoju evropske tehnološke platforme za globalno zdravje živali (European Technology Platform on global Animal Health - ETPGAH) in določitvi prednostnih nalog za redke bolezni.
An important aspect of information and communication is the provision of safety-related information to patients and healthcare professionals. 
Pomemben vidik obveščanja in komuniciranja je zagotavljanje informacij o varnosti bolnikom in zdravstvenim strokovnjakom.
Safety reviews 
Presoje varnosti
In November 2005, the MRFG was replaced by the ‘Coordination Group for Mutual Recognition and Decentralised Procedures-Human', or ‘CMD(h)' and the VMRFG was replaced by the ‘Coordination Group for Mutual Recognition and Decentralised Procedures-Veterinary', or ‘CMD(v)'. 
Novembra 2005 je bila MRFG nadomeščena z "Usklajevalno skupino za postopek medsebojnega priznavanja in decentralizirani postopek - humana medicina" ali "CMD(h)", VMRFG pa je bila nadomeščena z "Usklajevalno skupino za postopek medsebojnega priznavanja in decentralizirani postopek - veterinarska medicina" ali "CMD(v)".
the successful launch of the Agency's SME Office, which provides specific assistance to the smaller companies that are so often at the cutting edge of medicinal technologies development; 
uspešen začetek Urada za MSP Agencije, ki nudi posebno pomoč manjšim podjetjem, ki so pogosto tista, ki se ukvarjajo z razvojem vrhunske medicinske tehnologije;
By the end of the year, the majority of the Member States' authorities were submitting their adverse drug reaction reports electronically to the Agency. 
Do konca leta je večina organov držav članic Agenciji po elektronski poti pošiljala poročila o neželenih učinkih zdravil.
Broader advice e.g. on non-product related issues will now be offered, and, in parallel, workshops and think-tank meetings will create opportunities for increased awareness and dialogue with specific experts. 
Na voljo bo širše svetovanje, npr. o vprašanjih, ki niso povezana z izdelki, medtem ko bodo delavnice in ustvarjalni sestanki hkrati zagotavljali možnosti za večjo ozaveščenost in dialog s posebnimi strokovnjaki.
As anticipated, 2005 was quite an extraordinary year for the European Medicines Agency. 
Leto 2005 je bilo po vseh pričakovanjih izredno leto za Evropsko agencijo za zdravila.
During 2005, the Agency provided guidance in preparation for the entry into force of the revised legislation. 
V letu 2005 je Agencija med pripravami na začetek veljavnosti revidirane zakonodaje zagotavljala vse potrebne smernice.
Suspension of a centrally authorised hexavalent vaccine due to concerns over the level of longterm protection offered by one of its components 
začasno izključitvijo heksavalentnega cepiva, za katerega je bilo izdano dovoljenje po centraliziranem postopku, zaradi pomislekov o ravni dolgoročne zaščite, ki jo zagotavlja ena od njegovih sestavin;
Twenty-one applications received related to the more complex type-II variations. 
Enaindvajset prejetih vlog se je nanašalo na kompleksnejše spremembe tipa II.
Similar biological medicinal products: An overarching guideline on similar biological medicines was finalised in November 2005. 
Podobna biološka zdravila: novembra 2005 so bile dokončno oblikovane skupne smernice o podobnih bioloških zdravilih.
Several class-labelling procedures were performed for HIV products. 
Za zdravila za zdravljenje HIV je bilo izpeljanih več postopkov označevanja razreda.
6 ENCOURAGING RESEARCH AND DEVELOPMENT OF MEDICINES 
6 SPODBUJANJE RAZISKAV IN RAZVOJA ZDRAVIL
When appropriate, further follow-up was undertaken to inform the Rapporteur and to assess the need for the collection of additional data from the marketing authorisation holders or the amendment of the product information via a type-II variation. 
Če je bilo primerno, so bili sproženi nadaljnji ukrepi za obveščanje poročevalca in oceno potrebe po zbiranju dodatnih podatkov od imetnikov dovoljenj za promet z zdravilom ali spremembi informacij o izdelku prek spremembe tipa II.
As part of the consultation process, a major public conference was organised in December 2005, with the participation of industry, regulators, academia, healthcare professionals and patients. 
Kot del postopka posvetovanja je bila decembra 2005 organizirana pomembna javna konferenca, na kateri so sodelovali panožna podjetja, zakonodajalci, akademska javnost, zdravstveni strokovnjaki in bolniki.
the European Commission, as well as interested parties, who provided valuable feedback during the public consultation on guidelines and procedures. 
in zainteresiranih strani, ki so med javnimi posvetovanji o smernicah in postopkih zagotovili dragocene povratne informacije.
As the EU institutions progressed their discussions in 2005 on new EU legislation on medicines for children, over half of the designation opinions in 2005 were for conditions that affect children. 
Medtem ko so institucije EU v letu 2005 nadaljevale razprave o novi zakonodaji EU za zdravila za otroke, se je več kot polovica mnenj o določitvi zdravila kot zdravila sirote v letu 2005 nanašala na bolezni, ki prizadenejo otroke.
Conclusion of the safety review of COX-2 inhibitors 
zaključkom presoje varnosti zaviralcev COX-2;
In 2005, the EMEA received and validated 3 new applications for maximum residue limits (MRLs). 
V letu 2005 je EMEA prejela in potrdila 3 nove vloge za najvišje mejne vrednosti ostankov (maximum residue limits - MRL).
A similar sub-group was created of CMD(v) representatives, an observer of the Commission and the EMEA to draw up such a list for veterinary medicinal products. 
Podobna podskupina je bila sestavljena iz predstavnikov CMD(v), opazovalca iz Komisije in EMEA za pripravo takšnega seznama za veterinarska zdravila.
In order to allow the development of these activities within a broader and more structured environment, the Management Board adopted, in December 2005, a ‘Framework of Interaction' between the EMEA and patients' and consumers' organisations. 
Da se omogoči razvoj teh dejavnosti v širšem in bolj strukturiranem okolju, je upravni odbor decembra 2005 sprejel "okvir za sodelovanje" med EMEA ter organizacijami bolnikov in potrošnikov.
The reform of EU pharmaceutical legislation, implementation of the EMEA's Road Map to 2010 and dealing with pharmacovigilance issues required alertness, steadfastness and commitment to the important task of promoting public health. 
Reforma farmacevtske zakonodaje EU, izvajanje usmeritvenega načrta Agencije do leta 2010 in obravnavanje vprašanj farmakovigilance so zahtevali pozornost, odločnost in zavezanost pomembni nalogi spodbujanja javnega zdravja.
In addition, the EMEA set up an initiative reminding all marketing authorisation holders of their obligation to submit existing data not yet submitted to the competent authorities, in particular data relating to paediatric use of authorised medicines. 
Poleg tega je EMEA vzpostavila pobudo, ki vse imetnike dovoljenj za promet z zdravilom opozarja na njihovo obveznost, da pristojnim organom predložijo obstoječe podatke, ki jih še niso predložili, zlasti podatke o pediatrični uporabi zdravil, za katera je že bilo izdano dovoljenje.
A new initiative in 2005 was the publication of summaries of certain post-authorisation opinions, namely opinions on extension of indications and on the addition of new contra-indications or warnings. 
Nova pobuda v letu 2005 je bila objava povzetkov določenih mnenj po izdaji dovoljenja, in sicer mnenj o razširitvi terapevtskih indikacij in dodanih kontraindikacijah ali opozorilih.
Once adopted products containing the listed substances can be used by veterinarians for the treatment of horses under the conditions of the ‘cascade principle' providing a minimum 6-month withdrawal period is applied. 
Po sprejetju lahko veterinarji uporabljajo izdelke, ki vsebujejo snovi s seznama za zdravljenje konjev pod pogoji "kaskadnega načela", če se uporablja minimalna šestmesečna karenca.
Medicines for paediatric use 
Zdravila za pediatrično uporabo
Two scientific advice requests received in 2005 were eligible for free advice under the pilot scheme for free scientific advice for veterinary medicines for minor uses and minor species (MUMS). 
Dva zahtevka za znanstveno svetovanje, prejeta v letu 2005, sta bila upravičena do brezplačnega svetovanja v okviru pilotnega programa za brezplačno znanstveno svetovanje za veterinarska zdravila za manjšo uporabo in manj pomembne živalske vrste (MUMS).
Compassionate use: A guideline was drafted in preparation for the submission of any request by Member States for CHMP opinions. 
Sočutna uporaba: oblikovan je bil osnutek smernic v pripravah na predložitev zahtevkov držav članic za mnenja CHMP.
The European Surveillance Strategy (ESS), which focuses on improved cooperation between all EU competent authorities and the EMEA in the field of pharmacovigilance for veterinary medicinal products, was revived, with the EMEA Secretariat now as a partner. 
Ponovno je oživela evropska strategija nadzorovanja (European Surveillance Strategy - ESS), ki namenja glavno pozornost izboljšanemu sodelovanju med vsemi pristojnimi organi in EMEA na področju farmakovigilance za veterinarska zdravila, pri čemer sekretariat EMEA sedaj sodeluje kot partner.
Implementation of additional tools provided by the revised EU pharmaceutical legislation for monitoring the safety of medicines 
izvajanjem dodatnih orodij, ki jih zagotavlja revidirana farmacevtska zakonodaja EU za spremljanje varnosti zdravil;
The CVMP launched a public consultation for a number of guidelines proposing the adaptation of data requirements for the testing of veterinary medicines for minor uses and minor species regarding quality, safety, including maximum residue limits (MRLs), and efficacy, while ensuring public health. 
CVMP je organiziral javno posvetovanje za številne smernice in predlagal prilagoditev podatkovnih zahtev za preizkušanje veterinarskih zdravil za manjšo uporabo in manj pomembne vrste v zvezi s kakovostjo, varnostjo, vključno z najvišjimi mejnimi vrednostmi ostankov (MRL), in učinkovitostjo ter hkratnim zagotavljanjem javnega zdravja.
Following on from the developments in human medicines, the Committee reviewed the safety of COX-2 inhibitors and NSAIDs used in animals, looking in particular at potential exposure of consumers. 
Na podlagi razvoja dogodkov v humani medicini je Odbor preučil varnost zaviralcev COX-2 in nesteroidnih protivnetnih zdravil (NSAID-ov), ki se uporabljajo pri živalih, pri čemer je posebno pozornost namenil zlasti morebitni izpostavljenosti potrošnikov.
Self-medication medicines: Amendments were proposed in 2005 to existing Commission guidance on the supply of non-prescription medicines, in particular relating to use of the centralised procedure for self-medication medicines. 
Zdravila za samozdravljenje: v letu 2005 so bile predlagane spremembe trenutno veljavnih smernic Skupnosti o preskrbi z zdravili brez recepta, zlasti v zvezi z uporabo centraliziranega postopka za zdravila za samozdravljenje.
Addressing antimicrobial resistance by progressing a new strategy on risk management and risk assessment for antimicrobials in veterinary medicinal products 
obravnavanjem protimikrobne odpornosti z razvijanjem nove strategije obvladovanja tveganja in ocene tveganja za protimikrobne snovi v veterinarskih zdravilih;
The Agency also made significant contributions to wider European public-health activities, most notably with regard to pandemic-influenza preparedness, and the preparation of new legislation on medicines for children and advanced therapies. 
Agencija je pomembno prispevala tudi k širšim dejavnostim v zvezi z javnim zdravjem v Evropi, in sicer predvsem glede pripravljenosti na pandemijo gripe ter v zvezi z novo zakonodajo o zdravilih za otroke in zdravilih za napredno zdravljenje.
EMEA budget: revenue 
Proračun EMEA: prihodki
These include the publication of a summary of the European public assessment report (EPAR) in a manner that is easily understandable to the public, the publication of withdrawals of marketing-authorisation applications prior to an opinion, and the publication of refusals of marketing authorisations. 
Te vključujejo objavo povzetka evropskega javnega poročila o oceni zdravila (European public assessment report - EPAR) na način, ki je javnosti hitro razumljiv, objavo umikov vlog za izdajo dovoljenj za promet z zdravilom pred izdajo mnenja in objavo zavrnitev dovoljenj za promet z zdravilom.
Public health impact of opinions in 2005 Of the medicinal products intended for the European market for which a positive opinion was adopted: 2 are for use in cancer therapy, including the treatment of lung cancer - one of the highest causes of cancer-related deaths in the EU 7 are anti-infectives, of which 2 are for the treatment of HIV and AIDS 4 are for the treatment of metabolic disorders, of which 1 offers a new route of administration for diabetes patients by allowing insulin to be delivered via the lungs 5 are for the treatment of diseases of the central nervous system and sensory organs 6 are for the diagnosis or treatment of cardiovascular or pulmonary diseases. 
Vpliv mnenj na javno zdravje v letu 2005 Med zdravili, namenjenimi evropskemu trgu, za katere je bilo sprejeto pozitivno mnenje: se 2 uporabljata za zdravljenje raka, vključno za zdravljenje pljučnega raka - enega od najpogostejših vzrokov smrti zaradi raka v EU; je 7 antiinfekcijskih zdravil, od katerih se 2 uporabljata za zdravljenje HIV in AIDS; se 4 uporabljajo za zdravljenje motenj presnove, od katerih 1 ponuja nov način dajanja zdravila bolnikom s sladkorno boleznijo, saj omogoča vnos insulina skozi pljuča; je 5 zdravil za zdravljenje bolezni centralnega živčnega sistema in čutil; je 6 zdravil za diagnosticiranje ali zdravljenje kardiovaskularnih ali pljučnih bolezni.
On the basis of this, the Committee for Medicinal Products for Veterinary Use (CVMP) gave more guidance on advisable treatment in the case of accidental human injection. 
Na podlagi tega je Odbor za zdravila za uporabo v veterinarski medicini (CVMP) zagotovil več smernic o priporočljivem zdravljenju v primeru nenamernega vnosa v človeka.
Summary of the annual report of the European Medicines Agency 
Povzetek letnega poročila Evropske agencije za zdravila za leto 2005
This covers a large number of projects, which are essentially designed to increase efficiency of the European medicines network, to provide better information to patients and users of medicinal products, and to contribute to the safe and effective use of these products. 
Ta pokriva veliko število projektov, oblikovanih predvsem za povečanje učinkovitosti Evropske mreže zdravil, zagotavljanje boljših informacij bolnikom in uporabnikom zdravil ter prispevanje k varni in učinkoviti uporabi teh izdelkov.
Public health impact of post-authorisation activities 
Vpliv dejavnosti po izdaji dovoljenja na javno zdravje
These tools enable the analysis of safety data of medicines against complex criteria to highlight potential trends for further investigation in the context of the assurance of product safety. 
Ta orodja omogočajo analizo podatkov o varnosti zdravil glede na kompleksna merila za poudarek možnih trendov za nadaljnje preiskave v okviru zagotovitve varnosti izdelka.
The CVMP, in consultation with the Federation of Veterinarians in Europe, prepared a proposal for a list of essential substances for the treatment of horses following the request from the European Commission. 
CVMP je v posvetovanju s Federacijo veterinarjev Evrope na zahtevo Evropske komisije pripravil predlog za seznam bistvenih snovi za zdravljenje konjev.
A number of ‘Dear Doctor Letters' were agreed by the CHMP, in addition to public statements. 
CHMP je poleg izjav za javnost odobril tudi številna pisma "Spoštovani zdravnik".
Work on the completion of phase 2a of EudraCT, the European Clinical Trails registration database, was delayed due to unforeseen difficulties with the final steps of the upgrade to version 
Prišlo je do zamud pri zaključku faze 2a EudraCT, sistema zbirke podatkov o registraciji evropskih kliničnih preizkušanj, zaradi nepredvidenih težav pri zadnjih korakih nadgradnje različice 3.0.0.