FrancophonIA/ELRC3.0 huggingface dataset:
English: For those new applications for which the Commission delivered a decision in 2006, the average CVMP assessment time was 183 days - noticeably shorter than the average of 193 days in 2005, partly due to the accelerated assessment of avian-influenza-vaccine applications.
Slovenian: Povprečen čas, ki ga je CVMP potreboval za ocenjevanje novih vlog, za katere je Komisija sprejela mnenje leta 2006, je znašal 183 dni, kar je bistveno manj kot povprečno število 193 dni leta 2005, delno zaradi pospešenega ocenjevanja vlog za cepivo proti aviarni influenci.
English: The EMEA adopted the first positive opinion for a pandemic-influenza ‘mock-up' vaccine in December 2006.
Slovenian: EMEA je decembra 2006 sprejela prvo pozitivno mnenje za „modelno“ cepivo za pandemijo influence.
English: Pharmacovigilance activities
Slovenian: Dejavnosti farmakovigilance
English: Neurology/Central nervous system
Slovenian: Nevrologija/Centralni živčni sistem
English: Positive opinions per therapeutic area (by ATC code), 2006
Slovenian: Pozitivna mnenja po terapevtskih področjih (glede na oznako ATC) v letu
English: The same review was conducted for non-centrally authorised pimecrolimus-containing medicinal products (Elidel) under Article 31 of Directive 2001/83/EC, with the same outcome.
Slovenian: Ista presoja je bila opravljena za zdravila, ki vsebujejo pimekrolimus in za katera je bilo izdano dovoljenje po decentraliziranem postopku (Elidel) v skladu s členom 31 Direktive 2001/83/ES, pri čemer je bil rezultat isti;
English: EudraPharm (database of medicinal products authorised in the European Union to support regulatory activities and to make information on medicinal products available to the public).
Slovenian: EudraPharm (zbirka podatkov o zdravilih, za katera je bilo izdano dovoljenje v Evropski uniji za podporo regulativnih dejavnosti in zagotovitev razpoložljivosti informaciji o zdravilih javnosti).
English: 3.6 Arbitration and Community referrals
Slovenian: 3.6 Arbitraža in napotitve Skupnosti
English: The EMEA has made considerable efforts to increase its outreach to patients and healthcare professionals by providing them more and better information about medicines, most notably with the launch of the EudraPharm database, and by encouraging their participation the Agency's work.
Slovenian: EMEA si je zelo prizadevala, da bi se bolj kot do sedaj približala bolnikom in zdravstvenim delavcem ter jim zagotovila več in boljše informacije o zdravilih, zlasti z vzpostavitvijo zbirke podatkov EudraPharm ter spodbujanjem bolnikov in zdravstvenih delavcev, naj sodelujejo pri delu Agencije.
English: FOREWORD BY THE CHAIRMAN OF THE MANAGEMENT BOARD
Slovenian: PREDGOVOR PREDSEDNIKA UPRAVNEGA ODBORA
English: Building and equipmentrelated expenditure (including EU telematics)
Slovenian: Izdatki za stavbe in opremo (vključno s telematiko EU) 34 454 000 EUR
English: A total of 10 referrals were made to the CVMP in 2006 in the framework of the mutual-recognition procedure.
Slovenian: Odboru za zdravila za uporabo v veterinarski medicini (CVMP) je bilo leta 2006 predloženih skupaj deset napotitev v okviru postopka medsebojnega priznavanja.
English: Recommendations for a core pharmacovigilance plan for pandemic-influenza vaccines were developed and approved in 2006.
Slovenian: Leta 2006 so bila razvita in odobrena priporočila za temeljni načrt farmakovigilance za cepiva proti pandemiji influence.
English: These related to an antimicrobial for turkeys and gamebirds (pheasants), a live vaccine for wild rabbits, and development of a vaccine for sheep, goats and cattle.
Slovenian: Ti zahtevki so se nanašali na protimikrobno snov za purane in divje ptice (fazane), živo cepivo za divje zajce in razvoj cepiva za ovce, koze in govedo.
English: In particular, the total number of type-II variations (including extensions of indication) finalised during 2006 was 35% greater.
Slovenian: Zlasti skupno število dokončno obdelanih vlog za spremembo tipa II (vključno z razširitvijo terapevtskih indikacij) v letu 2006 je bilo za 35 % višje.
English: EU TELEMATICS STRATEGY
Slovenian: TELEMATSKA STRATEGIJA EU
English: Eight initial marketing-authorisation applications were received, 5 of which were for pharmaceuticals and 3 for immunologicals.
Slovenian: Prejetih je bilo osem začetnih vlog za izdajo dovoljenja za promet z zdravilom, izmed katerih jih je bilo pet za farmacevtske izdelke in tri za imunološka zdravila.
English: Three scientific-advice requests were deemed eligible in 2006 for free advice under the provisions of the scheme for minor uses and minor species.
Slovenian: Trije zahtevki za znanstveno svetovanje so leta 2006 izpolnjevali pogoje za brezplačno svetovanje v skladu z določbami programa za manjše uporabe in manj pomembne vrste.
English: Several extensions of indication were also granted for the diagnosis or treatment of central-nervous-system disorders, diabetes and a range of diseases.
Slovenian: Več razširitev terapevtskih indikacij je bilo odobrenih za diagnozo ali zdravljenje motenj centralnega živčnega sistema, sladkorne bolezni in vrste drugih bolezni.
English: Cancer and nervous system still the predominant therapeutic areas concerned
Slovenian: Rak in živčni sistem še vedno prevladujoči terapevtski področji
English: Referral procedures concluded in 2006
Slovenian: Postopki napotitve, zaključeni leta 2006
English: Public-health benefits of medicines recommended for approval in 2006
Slovenian: Koristi zdravil, priporočenih za odobritev v letu 2006, za javno zdravje
English: Another new group - the EMEA/CHMP Working Group with Healthcare Professionals' Organisations' - was created in December to make recommendations and proposals for developing a framework of interaction with organisations representing healthcare professionals.
Slovenian: Decembra je bila ustanovljena še ena nova skupina, delovna skupina EMEA/CHMP za sodelovanje z organizacijami zdravstvenih delavcev, ki naj bi pripravljala priporočila in predloge za razvoj okvira sodelovanja z organizacijami, ki predstavljajo zdravstvene delavce.
English: There was 1 negative opinion (which was confirmed following a re-examination) for an antimicrobial for treatment of specific skin and softtissue infections and specific acute infections of the upper respiratory tract and the urinary tract in cats and dogs.
Slovenian: Sprejeto je bilo tudi eno negativno mnenje (ki je bilo potrjeno po ponovni preučitvi) za protimikrobno snov za zdravljenje posebnih kožnih okužb in okužb mehkega tkiva ter posebnih akutnih okužb zgornjega respiratornega trakta in sečnega trakta pri mačkah in psih.
English: Preparing guidance on pharmacovigilance for vaccines.
Slovenian: Priprava smernic o farmakovigilanci za cepiva.
English: The CVMP adopted positive opinions on the authorisation of 13 new veterinary medicines for treatment of a number of conditions in chickens, cats and dogs.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je sprejel pozitivna mnenja glede izdaje dovoljenj za 13 novih veterinarskih zdravil za zdravljenje več bolezni pri piščancih, mačkah in psih;
English: Preparing guidance on paediatric pharmacovigilance.
Slovenian: Priprava smernic o pediatrični farmakovigilanci.
English: COMP opinions by therapeutic area, 2006
Slovenian: Mnenja COMP po terapevtskih področjih v letu 2006
English: The CHMP adopted positive opinions in 3 conditional-approval procedures (concerning products for treatment of cancer, epilepsy and HIV infection) and approved a further 3 products under exceptional circumstances (concerning 1 product for cancer, 1 for an enzyme-deficiency disease, and 1 pandemicinfluenza mock-up vaccine).
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je sprejel pozitivna mnenja v treh postopkih pogojne odobritve (za proizvode za zdravljenje raka, epilepsije in okužbe s HIV) in odobril nadaljnje tri proizvode v izjemnih okoliščinah (proizvod za rak, proizvod za bolezen pomanjkanja encimov in modelno cepivo proti pandemiji influence).
English: 2.3 Initial evaluation New applications in 2006
Slovenian: 2.3 Začetno vrednotenje Nove vloge v letu 2006
English: The average overall time required for approval of a marketing-authorisation application decreased significantly in 2006, with marked reductions compared to 2005 in the average times for the assessment, post-opinion and decision phases of the procedure.
Slovenian: Povprečni skupni čas, potreben za odobritev vloge za izdajo dovoljenja za promet, se je leta 2006 bistveno skrajšal, pri čemer so se v primerjavi z letom 2005 očitno skrajšali povprečni čas za fazo ocenjevanja, fazo po sprejetju mnenja in fazo odločanja.
English: A new working party - the EMEA Human Scientific Committees' Working Party with Patients' and Consumers' Organisations (PCWP) - was established to provide recommendations to the Agency and its scientific committees on all matters of interest to patients.
Slovenian: Ustanovljena je bila nova delovna skupina, delovna skupina za sodelovanje z organizacijami bolnikov in potrošnikov v okviru humanih znanstvenih odborov EMEA (Working Party Wirth Patients' and Consumers' Organisations - PCWP), ki naj bi Agenciji in njenim znanstvenim odborom svetovala v zvezi z vsemi zadevami, ki zanimajo bolnike.
English: The 5 pharmaceutical applications, 3 of which were generic applications, concerned medicinal products for dogs, while the 3 immunological applications concerned medicines for chickens principally.
Slovenian: Zadevnih pet vlog za farmacevtske izdelke, izmed katerih so bile tri vloge za generična zdravila, se je nanašalo na zdravila za pse, tri vloge za imunološka zdravila pa so se nanašala na zdravila, ki se v glavnem uporabljajo za kokoši.
English: Medical conditions affecting adults only Medical conditions affecting both children and adults Medical conditions affecting children only
Slovenian: Bolezni, ki prizadenejo samo odrasle Bolezni, ki prizadenejo otroke in odrasle Bolezni, ki prizadenejo samo otroke
English: Improving the safety of medicines for human and veterinary use was once again a focus of the Agency's efforts in 2006, with considerable success being achieved in this priority area.
Slovenian: Prizadevanja Agencije v letu 2006 so bila spet osredotočena na izboljšanje varnosti zdravil za uporabo v humani in veterinarski medicini, pri čemer je bil na tem prednostnem področju dosežen znaten napredek.
English: Efforts to improve interaction with patients
Slovenian: Prizadevanja za izboljšanje sodelovanja z bolniki
English: Faster processing of orphan designations
Slovenian: Hitrejša obdelava postopkov določanja zdravil sirot
English: EMEA revenue in 2006
Slovenian: Prihodki EMEA v letu 2006
English: By the end of 2006, a total of 31 orphan medicinal products had been granted a centralised marketing authorisation by the European Commission since the entry into force of the European orphan medicines legislation (in 2000).
Slovenian: Do konca leta 2006 je Evropska komisija od začetka veljavnosti evropske zakonodaje o zdravilih sirotah (v letu 2000) odobrila centralizirano dovoljenje za promet 31 zdravilom sirotam.
English: Of these, 14 concerned pharmaceutical products and 11 concerned immunological products.
Slovenian: Od tega je bilo 14 vlog za farmacevtske izdelke in 11 vlog za imunološka zdravila.
English: The EMEA continued to support all Member States on good-manufacturing-practice (GMP), goodclinical-practice (GCP), good-laboratory-practice (GLP) and pharmacovigilance inspection procedures.
Slovenian: EMEA je še naprej podpirala vse države članice pri postopkih inšpekcijskih pregledov dobre proizvodne prakse, dobre klinične prakse, dobre laboratorijske prakse in farmakovigilance.
English: EudraVigilance Veterinary became the main reporting tool for suspected adverse reactions used by national competent authorities in 2006.
Slovenian: EudraVigilance za veterinarstvo je v letu 2006 postalo glavno orodje nacionalnih pristojnih organov za poročanje o neželenih učinkih.
English: Use of EU special contribution for orphan medicines, 2006
Slovenian: Uporaba posebnega prispevka EU za zdravila sirote v letu
English: Oncology
Slovenian: Onkologija
English: Free scientific advice for minor uses and minor species
Slovenian: Brezplačno znanstveno svetovanje v zvezi z zdravili za manjšo uporabo in manj pomembne vrste
English: Centrally authorised tacrolimus-containing medicinal products (Protopic and Protopy), in relation to a potential risk of skin cancer and lymphoma.
Slovenian: zdravil, ki vsebujejo takrolimus in za katera je bilo izdano dovoljenje po centraliziranem postopku (Protopic in Protopy), v zvezi z možnim tveganjem za nastanek kožnega raka in limfoma.
English: Confirmation of CVMP opinion on veterinary Cox-2s and NSAIDs
Slovenian: Potrditev mnenja CVMP o veterinarskih zaviralcih COX-2 in nesteroidnih protivnetnih zdravil (NSAID)
English: A centrally authorised perflutren-containing microspheres medicinal product (Optison), further to the suspension of a manufacturing authorisation due to concerns over compliance with good manufacturing practice (GMP).
Slovenian: zdravila, ki vsebuje mikrosfere s perflutrenom in za katero je bilo izdano dovoljenje po centraliziranem postopku (Optison), po umiku dovoljenja za izdelavo zaradi pomislekov o skladnosti z dobro proizvodno prakso.
English: Following a request for consideration from a Member State, the CVMP recommended that new precautionary measures concerning user safety be added to the product literature of 21 veterinary medicinal products containing alpha2-adrenoreceptor agonists.
Slovenian: Po zahtevku za obravnavo, ki ga je predložila ena država članica, je CVMP priporočil, naj se literaturi o izdelku za 21 veterinarskih zdravil, ki vsebujejo spodbujevalce alfa2-adrenergičnih receptorjev, dodajo novi preventivni ukrepi v zvezi z varnostjo uporabnikov.
English: The Committee on Herbal Medicinal Products (HMPC) finalised Community herbal monographs in 2006 for valerian root, linseed, ispaghula husk, ispaghula seed, psyllium seed, senna pods, senna leaf, frangula bark and aloes (cape and barbados).
Slovenian: Odbor za zdravila rastlinskega izvora (HMPC) je v letu 2006 dokončno oblikoval monografije rastlin Skupnosti za baldrijanovo korenino, laneno seme, semensko lupino jajčastega trpotca, seme jajčastega trpotca, trpotčevo seme, senino luščino, senine liste, krhlikino lubje in aloje (Aloe ferox MILLER in Aloe barbadensis MILLER).
English: GXP means 'good clinical practice' (GCP), 'good manufacturing practice' (GMP) and 'good laboratory practice' (GLP) collectively.
Slovenian: GXP je skupni izraz za „dobro klinično prakso“, „dobro proizvodno prakso“ in „dobro laboratorijsko prakso“.
English: In 2006, the list of products reviewed by the Agency for detection of pharmacovigilance signals was extended to include medicinal products submitted for authorisation under the centralised procedure but not yet authorised.
Slovenian: Seznam izdelkov, ki jih je preučila Agencija za odkrivanje signalov farmakovigilance, je bil leta 2006 razširjen za vključitev zdravil, za katera je bila vložena vloga za izdajo dovoljenja za promet po centraliziranem postopku, dovoljenje pa še ni bilo izdano.
English: Support was provided primarily through the ad hoc GMP and GCP inspectors' meetings, which focused on harmonisation of procedures and interpretation of related requirements.
Slovenian: Podpora se je zagotavljala predvsem prek priložnostnih srečanj inšpektorjev za dobro proizvodno prakso in dobro klinično prakso, ki so namenjala glavno pozornost usklajevanju postopkov in razlagi povezanih zahtev.
English: There was also a shortfall in the number of applications submitted for extension or modification of MRLs, with only 3 of the forecast 7 being submitted.
Slovenian: Prav tako je bilo predloženih manj vlog za razširitev ali spremembo najvišjih mejnih vrednosti ostankov, saj so bile predložene samo tri vloge od predvidenih sedem.
English: EMEA MISSION STATEMENT
Slovenian: POSLANSTVO EMEA
English: Stimulating availability of veterinary medicines for rare uses and species
Slovenian: Spodbujanje razpoložljivosti veterinarskih zdravil za redke uporabe in vrste
English: Dermatologicals
Slovenian: Dermatologija
English: Marketing-authorisation holders started reporting electronically and implementation plans for full electronic reporting were being finalised by major veterinary pharmaceutical companies.
Slovenian: Imetniki dovoljenj za promet z zdravilom so začeli elektronsko poročati, glavne veterinarske farmacevtske družbe pa so končale izvedbene načrte za popolno elektronsko poročanje.
English: In 2006, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a total of 13 positive opinions for initial marketing-authorisation applications.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je leta 2006 sprejel skupno 13 pozitivnih mnenj za začetne vloge za izdajo dovoljenja za promet z zdravilom.
English: All variation applications were evaluated within the regulatory time limits.
Slovenian: Vse vloge za spremembo so bile ocenjene v zakonskih rokih.
English: EMEA expenditure in 2006
Slovenian: Odhodki EMEA v letu 2006
English: Number of inspections, 2004-2006
Slovenian: Število inšpekcijskih pregledov v letih 2004-2006
English: Procedures for ad hoc or emergency testing of centrally authorised products and for handling out-of-specification results were finalised and adopted.
Slovenian: Zaključeni in sprejeti so bili postopki za priložnostno preizkušanje ali izredno preizkušanje izdelkov, za katera je bilo izdano dovoljenje po centraliziranem postopku in za ravnanje z rezultati, ki so neskladni s specifikacijami.
English: Post-authorisation opinions and notifications,
Slovenian: Mnenja in obvestila po izdaji dovoljenja v letih
English: The Committee released for public consultation 2 new draft entries to the Community list, for bitter fennel fruit and sweet fennel fruit.
Slovenian: Odbor je za namene javnega posvetovanja objavil dva nova osnutka vpisov na seznam Skupnosti za grenki komarček in sladki komarček.
English: The 2006 programme for sampling and testing included 32 centrally authorised products.
Slovenian: Program vzorčenja in preizkušanja zdravil iz leta 2006 je vključeval 32 izdelkov, za katere je bilo izdano dovoljenje po centraliziranem postopku.
English: Anti-infectives once again among the most-represented therapeutic areas
Slovenian: Antimikotiki ponovno eno najbolj pogostih terapevtskih področij
English: One product for treatment of benign prostatic hypertrophy in dogs.
Slovenian: izdelek za zdravljenje benigne prostatične hipertrofije pri psih;
English: Article 6(12)
Slovenian: Člen 6(12)
English: 3.5 Safety of medicines for veterinary use
Slovenian: 3.5 Varnost zdravil za uporabo v veterinarski medicini
English: The number of certificate requests continued to climb, with 15% more being received than in
Slovenian: Število zahtevkov za izdajo potrdil je še naprej naraščalo, pri čemer je bilo prejetih 15 % več zahtevkov kot leta 2005.
English: EMEA post-opinion phase
Slovenian: Faza po mnenju EMEA
English: New applications for veterinary medicines, 2004
Slovenian: Nove vloge za veterinarska zdravila v letih 2004
English: The Agency managed record numbers of initial marketing-authorisation applications and postauthorisation variation applications, and of requests for scientific advice, parallel-distribution notifications and certificates.
Slovenian: Agencija je obravnavala rekordno število začetnih vlog za izdajo dovoljenja za promet z zdravilom, vlog za spremembo dovoljenja za promet z zdravilom po izdaji dovoljenja, zahtevkov za znanstveno svetovanje, obvestil o vzporedni distribuciji in potrdil ;
English: The overall number of applications for variations to marketing authorisations received in 2006 was lower than in 2005, despite the greater number of centrally authorised products on the market.
Slovenian: Skupno število vlog za spremembo dovoljenj za promet z zdravilom, prejetih leta 2006, je bilo manjše kot leta 2005, kljub večjemu številu izdelkov, za katera je bilo izdano dovoljenje po centraliziranem postopku, na trgu:
English: Reviewing business processes to rationalise them and make them more efficient and less timeconsuming, while improving or at least maintaining the quality of the work undertaken, was emphasised in 2006 at all levels of the EMEA's operations.
Slovenian: V letu 2006 je bil na vseh ravneh operacij EMEA poudarek dan pregledu poslovnih procesov in njihovemu preoblikovanju v učinkovitejše in manj dolgotrajne procese, ob hkratnem izboljšanju ali vsaj ohranitvi kakovosti dela, ki se opravlja.
English: INSPECTIONS
Slovenian: Inšpekcijski pregledi
English: The EMEA dealt with a number of major safety issues in 2006, involving both centrally and noncentrally authorised medicines for human use.
Slovenian: EMEA je leta 2006 obravnavala številna pomembna vprašanja o varnosti, ki so vključevala zdravila za uporabo v humani medicini, za katera je bilo izdano dovoljenje po centraliziranem in decentraliziranem postopku.
English: The HMPC also released for public consultation 5 new draft Community herbal monographs, for aniseed, anis oil, bitter fennel fruit, sweet fennel fruit and bitter-fennel-fruit oil.
Slovenian: HMPC je za namene javnega posvetovanja objavil tudi pet novih osnutkov monografij rastlin Skupnosti za janež, janeževo olje, grenki komarček, sladki komarček in eterično olje grenkega navadnega komarčka.
English: Summary of the twelfth annual report of the EMEA
Slovenian: Povzetek dvanajstega letnega poročila Evropske agencije za zdravila
English: Preparing guidance for marketing-authorisation holders and applicants on pharmacovigilance systems to put in place, and guidance for regulatory authorities on the assessment of periodic safety-update reports.
Slovenian: pripravo smernic za imetnike dovoljenj za promet z zdravilom in vlagatelje za pridobitev dovoljenja za promet z zdravilom o sistemih farmakovigilance, ki jih je treba vzpostaviti, in smernic za regulativne organe o ocenjevanju redno posodobljenih poročil o varnosti; dokončane so bile tudi preproste smernice za veterinarje o poročanju neželenih učinkov.
English: Four of the referrals related to the demonstration of efficacy and concerned pharmaceuticals.
Slovenian: Štiri napotitve so se nanašale na dokazovanje učinkovitosti farmacevtskih izdelkov.
English: Veterinary medicinal products that received a positive opinion in 2006 included: Two vaccines for chickens, against avian influenza, which were evaluated on an accelerated timetable with opinions adopted in 79 days, taking into account the epidemiological situation within the EU.
Slovenian: dve cepivi za piščance proti aviarni influenci, ki sta bili pospešeno vrednoteni in za kateri sta bili sprejeti mnenji v 79 dneh, pri čemer so se upoštevale epidemiološke razmere v EU.
English: 4.3 Certificates of a medicinal product Main developments in 2006
Slovenian: 4.3 Potrdila za zdravila Glavni dogodki v letu 2006
English: New warning for HIV products relating to the possible risk of osteonecrosis associated with their use.
Slovenian: novo opozorilo za izdelke HIV, ki se nanaša na možno tveganje za nastanek osteonekroze, povezane z njihovo uporabo;
English: By the end of 2006, 160 EPAR summaries had been published.
Slovenian: Do konca leta 2006 je bilo objavljenih 160 povzetkov evropskih javnih poročil o oceni zdravila.
English: Efforts to improve interaction with healthcare professionals
Slovenian: Prizadevanja za izboljšanje sodelovanja z zdravstvenimi delavci
English: Orphan drug fund
Slovenian: Zdravila sirote
English: Arbitration and Community referrals started
Slovenian: Začeti postopki arbitraže in napotitev Skupnosti
English: New applications (by medicinal product) New applications (by active substance)
Slovenian: Nove vloge (po zdravilnih učinkovinah)
English: Musculoskeletal and nervous system
Slovenian: Kostno-mišični in živčni sistem
English: Immunology
Slovenian: Imunologija
English: Applications for new products for use in the treatment of cancer once again represented the highest proportion by therapeutic area in 2006.
Slovenian: Glede na terapevtsko področje so leta 2006 največji delež ponovno predstavljale vloge za nove proizvode za uporabo pri zdravljenju raka.