natgillin/translations-raw huggingface dataset:
The Agency devoted considerable effort in 2008 to setting up its sixth scientific committee - the Committee for Advanced Therapies (CAT) - and putting in place all relevant procedures and personnel ahead of the Committee's inaugural meeting in January 2009. 
Agencija je v letu 2008 posvetila veliko naporov ustanovitvi šestega znanstvenega odbora, Odbora za napredno zdravljenje, in vzpostavitvi vseh zadevnih postopkov ter osebja pred inavguralno sejo Odbora januarja 2009.
Closer to home, the Agency continued to work with its EU institutional partners and the national regulatory authorities of the Member States to stimulate innovation in the pharmaceutical sector, strengthen the safety-monitoring of medicines, exchange expertise on a wide range of issues, and forge close relations to build the best possible regulatory system for Europe. 
V domačem okolju pa je Agencija še naprej sodelovala s svojimi institucionalnimi partnerji in nacionalnimi regulativnimi organi držav članic pri spodbujanju inovacij v farmacevtskem sektorju, krepitvi nadzora varnosti zdravil, izmenjavi strokovnega znanja s širokega področja ter oblikovanju tesnih povezav za izgradnjo najboljšega možnega regulativnega sistema za Evropo.
Reporting in EudraVigilance Veterinary 
Poročanje v sistemu EudraVigilance Veterinary
an ongoing programme of activities designed to help the regulatory authorities of Croatia, Turkey and the former Yugoslav Republic of Macedonia prepare for integration into the European medicines network upon the eventual accession of these countries to the EU; 
stalni program dejavnosti za pomoč regulativnim organom na Hrvaškem, v Turčiji in Makedoniji pri pripravi za integracijo v Evropsko mrežo zdravil ob morebitni pridružitvi teh držav v EU;
This section provides an overview of the main activities of the European Medicines Agency in 2008, listed according to priority areas the Agency set itself in its work programme for the year. 
V tem razdelku je pregled glavnih dejavnosti Evropske agencije za zdravila v letu 2008, te pa so razvrščene po prednostnih področjih, ki si jih je Agencija zastavila v delovnem programu za to leto.
The COMP's opinion is forwarded to the European Commission, which takes the final decision on orphan designation. 
Mnenje Odbora za zdravila sirote se pošlje Evropski komisiji, ki sprejme končno odločitev o določitvi zdravila sirote.
The majority of positive CHMP opinions adopted in 2008 related to cancer medicines, followed by antiinfectives and medicines for the treatment of neurological and central-nervous-system conditions. 
Večina pozitivnih mnenj CHMP, ki so bila sprejeta v letu 2008, se je nanašala na zdravila za raka, sledijo zdravila proti okužbam in zdravila za zdravljenje bolezni živčevja in centralnega živčnega sistema.
It assesses the quality, safety and efficacy of the medicine concerned, and adopts a positive opinion if it is satisfied that the data submitted demonstrate that the medicine's benefits outweigh any risks associated with its use. 
Odbor ovrednoti kakovost, varnost in učinkovitost zadevnih zdravil ter sprejme pozitivno mnenje, če predloženi podatki dokazujejo, da so koristi zdravila večje od tveganja, ki je povezano z njegovo uporabo.
The total number of people employed by the Agency at the end of 2008, including regular staff plus contract agents, visiting experts, interims and trainees, was 624, or some 14% more than the 547 employed in 2007. 
Skupno število zaposlenih v Agenciji konec leta 2008, vključno z rednim osebjem, pogodbeniki, gostujočimi strokovnjaki, začasno zaposlenimi in pripravniki, je bilo 624, kar je približno za 14 % več kot v letu 2007, ko je bilo zaposlenih 547 oseb.
An equivalent system, called EudraVigilance Veterinary, exists to receive reports of adverse reactions occurring through the use of authorised veterinary medicines. 
Enakovreden sistem, imenovan EudraVigilance Veterinary, obstaja za prejemanje poročil o neželenih učinkih, ki se pojavljajo pri uporabi odobrenih veterinarskih zdravil.
Three of these applications concerned generic versions of previously authorised medicines. 
Tri od teh vlog so zadevale generične različice že odobrenih zdravil.
published a revised and updated version of its SME User Guide on the Agency's website; 
na spletišču Agencije objavil popravljeno in posodobljeno različico Uporabniškega priročnika za mala in srednje velika podjetja;
A further 308 reports related to adverse reactions occurring in humans following exposure to veterinary medicines. 
Dodatnih 308 poročil se je nanašalo na neželene učinke pri ljudeh po izpostavitvi veterinarskim zdravilom.
As pharmaceutical development and clinical trials of medicines move increasingly beyond the traditional spheres of Europe and North America, regulators are becoming more keenly aware of the need for international cooperation on ensuring that safe and ethical practices are being used for the development and testing of medicinal products in all parts of the world. 
Frmacevtski razvoj in klinična preskušanja zdravil pa vse pogosteje potekajo izven tradicionalnega okolja Evrope in Severne Amerike, zato se regulativni organi vse bolj zavedajo potrebe po mednarodnem sodelovanju, s katerim bi zagotovili uporabo varnih in etičnih praks pri razvoju in preskušanju zdravil po celem svetu.
These mock-ups are not themselves intended for production, but can be used to greatly speed up the authorisation procedure for ‘real' vaccines once the strain of the virus causing the pandemic has been identified. 
Modelni cepivi nista namenjeni izdelavi, temveč lahko bistveno pospešita postopek odobritve „pravih“ cepiv po identifikaciji pandemičnega seva.
conducted 5 compliance-checks as part of the validation process for marketing-authorisation applications; 
opravil 5 preverjanj skladnosti kot del validacijskega postopka vlog za odobritev dovoljenja za promet z zdravilom;
A dedicated SME Office within the Agency provides support to SMEs on these and related issues, to help them maximise the benefits available to them, and thus contributes towards stimulating innovation of new medicines and improving their availability to patients. 
Specializirani urad za mala in srednje velika podjetja v Agenciji tem zagotavlja podporo pri takšnih in sorodnih vprašanjih, pomaga kar najbolj izkoristiti koristne razpoložljive možnosti, in s tem prispeva k spodbujanju inovacij novih zdravil in izboljšanju njihove dostopnosti bolnikom.
Activities carried out in 2008 to provide greater transparency of documents and data controlled by the Agency included: 
Dejavnosti za zagotovitev večje preglednosti dokumentov in podatkov, ki jih obvladuje Agencija, so bile v letu 2008:
A total of 1,943 reports of adverse reactions in animals were recorded in EudraVigilance Veterinary in 2008, of which 1,712 related to reactions in companion animals (971 in dogs and 704 in cats) and 231 in food-producing animals (cows, pigs, etc.). 
V sistemu EudraVigilance za veterino je bilo v letu 2008 ugotovljenih skupno 1 934 poročil o neželenih učinkih pri živalih, od katerih se je 1 712 poročil nanašalo na reakcije pri hišnih živalih (971 pri psih in 704 pri mačkah) ter 231 pri živalih, namenjenih proizvodnji hrane (kravah, prašičih itn.).
It can be used with other anticancer medicines after the cancer has been removed by surgery. 
Lahko se uporablja z drugimi zdravili proti raku po odstranitvi rakavega tkiva s kirurškim posegom.
These reports compile all known safety data relating to the use of the medicine concerned, including information that becomes available through additional trials conducted after the medicine has been authorised. 
Ta poročila vsebujejo vse znane varnostne podatke v zvezi z uporabo zadevnega zdravila, vključno s podatki, ki postanejo dostopni v dodatnih preskušanjih po odobritvi zdravila.
The Paediatric Committee adopts decisions on certain classes of medicines for which no PIP needs to be established, such as medicines intended to treat conditions that do not affect children or adolescents (e.g. Parkinson's disease). 
Odbor za pediatrijo sprejme odločitve o določenih skupinah zdravil, za katere niso potrebni načrti pediatričnih raziskav, kot so zdravila za zdravljenje bolezni, ki se ne pojavljajo pri otrocih in mladostnikih (npr. Parkinsonova bolezen).
Its aim is to put in place measures that allow the early detection, assessment, minimisation and communication of risks associated with medicines throughout their lifecycle. 
Njen cilj je uvedba ukrepov, ki omogočajo zgodnje odkrivanje, vrednotenje, čim večje zmanjšanje tveganja in prenos informacij o tveganju, povezanem z zdravili v njihovem celotnem življenjskem ciklu.
All 13 procedures resulted in a positive opinion being adopted by the Agency's Committee for Medicinal Products for Veterinary Use (CVMP). 
Vseh 13 postopkov se je končalo s pozitivnim mnenjem, ki ga je sprejel Odbor za zdravila za uporabo v veterinarski medicini (CVMP).
This will allow doctors a wider scope when prescribing these medicines to patients, which benefits patients by extending the treatment options available to them; 
To omogoča zdravnikom več možnosti pri predpisovanju teh zdravil bolnikom, kar koristi bolnikom, saj se povečajo možnosti zdravljenja, ki so jim na voljo;
The Agency engages in an intensive annual programme of activities with its regulatory and scientific partners across Europe, and with their counterparts on other continents, to contribute towards these global efforts for better and safer medicines. 
Agencija ima intenziven letni program dejavnosti s svojimi regulativnimi in znanstvenimi partnerji v Evropi ter njej enakovrednimi organi na drugih celinah z namenom prispevati k tem globalnim naporom za boljša in varnejša zdravila.
National origins of Agency staff 
Narodnost osebja Agencije
Twenty-three applications were withdrawn by applicants before completion of the evaluation procedure. 
Vlagatelji so umaknili 23 vlog pred zaključkom postopka ocenjevanja.
31 were type-II variation procedures that resulted in positive opinions from the CHMP on the extension of indication of authorised medicines. 
je bilo 31 postopkov spremembe tipa II, ki so se končali s pozitivnim mnenjem CHMP o razširitvi indikacije odobrenega zdravila.
Reviewing periodic safety update reports for human and veterinary medicines 
Pregled periodičnih poročil o varnosti zdravil za uporabo v humani in veterinarski medicini
In recognition of this, special provisions have been made in EU legislation to offer financial incentives for such companies, including the reduction or deferment of fees payable to the Agency for regulatory procedures such as marketingauthorisation applications or, for veterinary medicines, the establishment of maximum residue limits8. 
V priznanje temu so v zakonodaji EU posebna določila za ponujanje finančnih spodbud tem podjetjem, vključno z zmanjšanjem ali odlogom pristojbin, ki se plačajo Agenciji za regulativne postopke, kot so vloge za izdajo dovoljenja za promet z zdravilom ali določitev najvišjih mejnih vrednosti ostankov za zdravila za uporabo v veterinarski medicini8.
Post-authorisation procedures finalised 
Zaključeni postopki po izdaji dovoljenja
‘Post-authorisation procedures' relate to the processing of applications received from marketingauthorisation holders (licensees) who wish to make changes to their authorised medicines, or who are obliged to do so (for example, to include new safety warnings in the prescribing information). 
„Postopki po izdaji dovoljenja za promet“ se nanašajo na obdelavo vlog, prejetih od imetnikov dovoljenj za promet z zdravili (imetnikov licence), ki želijo spremeniti odobreno zdravilo ali morajo to storiti (na primer zaradi vključitve novih varnostnih opozoril v informacije za predpisovanje zdravila).
The Agency devoted much effort during the year to preparing for the entry into force of the EU's new Advanced Therapies Regulation - a piece of legislation that will greatly strengthen regulatory procedures relating to medicines at the cutting edge of medical science. 
Agencija si je med letom posvetila močno prizadevala za pripravo uvedbe nove zakonodaje EU o zdravilih za napredno zdravljenje - delu zakonodaje za močno okrepitev regulativnih postopkov v zvezi z zdravili, ki so rezultat visoko razvite medicinske znanosti.
the first vaccine for adults against Japanese encephalitis, a disease transmitted by mosquitoes that causes inflammation of the brain and which can lead to long-term disability or death. 
Prvo cepivo za odrasle proti japonskemu encefalitisu, bolezni, ki jo prenašajo komarji in povzroča vnetje možganov, kar povzroči dolgotrajno invalidnost ali smrt.
over 100 were type-II variation procedures that resulted in new information, including safety warnings or precautions, being added to the prescribing information for authorised medicines, thereby helping to reduce the risk of misuse or unwanted side-effects associated with the use of these medicines; 
je bilo več kot 100 postopkov spremembe tipa II, ki so se končali z dodatkom novih informacij (vključno varnostnih opozoril in previdnostnih ukrepov) v informacije za predpisovanje odobrenih zdravil, kar pripomore k zmanjšanju tveganja napačne uporabe ali neželenih učinkov, ki so povezani z uporabo zadevnih zdravil;
In 2008, the HMPC: finalised 17 Community herbal monographs4 for traditional and well-established herbal medicines; 
V letu 2008 je HMPC: dokončal 17 monografij rastlin Skupnosti4 za tradicionalna in dobro uveljavljena zdravila rastlinskega izvora;
Assessing applications for orphan designation 
Vrednotenje vlog za določitev zdravila sirote
the first pre-pandemic vaccine for use in adults against the H5N1 subtype of the influenza-A virus, which may cause avian influenza in humans. 
Prvo predpandemično cepivo za uporabo pri odraslih proti virusu influence A podtipa H5N1, ki lahko povzroči ptičjo gripo pri človeku.
7 Centrally authorised medicines are ones that have been simultaneously approved in all EEA countries, through procedures operated by the European Medicines Agency, whereas non-centrally authorised medicines have been approved separately by one or more EEA countries. 
Zdravila, za katera je bilo izdano dovoljenje po centraliziranem postopku, so tista, ki so bila sočasno odobrena v vseh državah EGP v postopkih, ki jih je vodila Evropska agencija za zdravila, zdravila, za katera ni bilo izdano dovoljenje po centraliziranem postopku, pa so bila ločeno odobrena v eni ali več državah EGP.
The year 2008 was one of consolidation and steady progress for the European Medicines Agency (EMEA), rather than one of major leaps and bounds. 
Leto 2008 je bilo za Evropsko agencijo za zdravila (EMEA) leto utrjevanja in preudarnega napredka, in ne leto velikih korakov in mejnikov.
a new compound in an existing class of antiretroviral medicines that can be used to treat adults infected with HIV-1 (the virus that causes AIDS) in whom treatment with other medicines in the same class has been unsuccessful. 
Nova spojina iz obstoječe skupine protiretrovirusnih zdravil, ki se lahko uporablja za zdravljenje odraslih bolnikov, okuženih z virusom HIV-1 (virusom, ki povzroča AIDS), pri katerih je bilo zdravljenje z drugimi zdravili iz iste skupine neuspešno.
One further application was withdrawn by the applicant before completion of the evaluation procedure. 
Eno vlogo pa je vlagatelj umaknil pred zaključkom postopka ocenjevanja.
As part of its ongoing efforts to strengthen the efficiency of the network, the Agency focused in 2008 on: 
Agencija se je v svojih prizadevanjih za krepitev učinkovitosti mreže v letu 2008 osredotočila na:
CAP EEA reports CAP non-EEA reports non-CAP EEA reports non-CAP non-EEA reports 
Poročila za CAP iz EGP Poročila za CAP izven EGP Poročila za neCAP iz EGP Poročila za neCAP izven EGP
At any stage in their development of a medicine, a company can request scientific advice on how best to conduct the various trials and studies that are necessary to demonstrate the quality, safety and efficacy of their product, and thus improve their chances of obtaining a marketing authorisation for it. 
Podjetje lahko na vsaki stopnji razvoja zdravila prosi za znanstveno svetovanje o najboljšem načinu izvedbe različnih preskušanj in študij, ki so potrebne za dokaz kakovosti, varnosti in učinkovitosti zdravila, ter s tem poveča možnosti odobritve dovoljenja za promet z zdravilom.
Evaluating medicines for human use Record number of positive opinions adopted for new human medicines 
Vrednotenje zdravil za uporabo v humani medicini Rekordno število sprejetih pozitivnih mnenj za nova zdravila za uporabo v humani medicini
made 1 positive recommendation on extending the use of a medicine authorised for use in adults to use in children, based on clinical-trial data generated in accordance with an agreed PIP. 
izdal 1 pozitivno priporočilo o razširitvi uporabe zdravila, ki je odobreno za uporabo pri odraslih, na uporabo pri otrocih zaradi rezultatov kliničnih preskušanj, ki so bili pridobljeni skladno z dogovorjenim načrtom pediatričnih raziskav.
The establishment of the CAT was stipulated in the EU's Advanced Therapies Regulation9 - a new and important piece of legislation that introduces special procedures for the evaluation and authorisation of ‘advanced therapy medicinal products' - medicines derived from gene therapy, somatic cell therapy or tissue engineering - which offer groundbreaking treatment options for patients. 
Ustanovitev Odbora za napredno zdravljenje določa Uredba EU o naprednem zdravljenju9, nov in pomemben del zakonodaje, ki uvaja posebne postopke za oceno in odobritev „zdravil za napredno zdravljenje“ - zdravil, pridobljenih z gensko terapijo, terapijo s somatskimi celicami ali tkivnim inženirstvom -, ki bolnikom omogočajo najnovejše možnosti zdravljenja.
Four were line-extension applications. 
Štiri vloge so bile za razširitev indikacij.
Healthcare professionals, patients and other consumers of medicines are key stakeholders in the work of the Agency because, besides being the primary end-users of the medicines and information about medicines for which the Agency is responsible, they have specific knowledge and expertise to offer the Agency in return. 
Zdravstveni delavci, bolniki in drugi potrošniki zdravil so ključne interesne skupine v delu Agencije, ker so primarni končni uporabniki zdravil in informacij o zdravilih, za katere je odgovorna Agencija.
more positive opinions on orphan designation were given in respect of cancer medicines than any other type of medicines; 
bilo za zdravila proti raku izdanih več pozitivnih mnenj kot za vsa ostala zdravila;
Initial-evaluation applications relate to new medicines that have not previously been authorised in any form in the European Union. 
Vloge za začetno oceno se nanašajo na nova zdravila, ki prej v nobeni obliki niso bila odobrena v Evropski uniji.
As a result, 66 new medicines - including ones for the prevention or treatment of serious and debilitating conditions such as bone cancer in children, immune-system diseases, HIV and rheumatoid arthritis - will become available to European citizens. 
Zaradi tega bo Evropejcem na voljo 66 novih zdravil - vključno z zdravili za preprečevanje ali zdravljenje resnih in izčrpavajočih bolezni, kot so kostni rak pri otrocih, bolezni imunskega sistema, okužbe z virusom HIV in revmatoidni artritis.
Companies intending to submit a marketing-authorisation application for a medicine they are developing for use in children or adolescents must first submit a paediatric investigation plan (PIP), setting out the studies they will conduct to demonstrate the quality, safety and efficacy of their medicine when used in these populations. 
Družbe, ki nameravajo predložiti vlogo za odobritev dovoljenja za promet za zdravilo, ki ga razvijajo za uporabo pri otrocih ali mladostnikih, morajo najprej predložiti načrt pediatričnih raziskav, v katerem predstavijo študije, ki jih bodo izvedli za dokaz kakovosti, varnosti in učinkovitosti svojih zdravil pri uporabi v omenjenih populacijah.
preparing and releasing for consultation a policy on appropriate levels of access by regulatory authorities, healthcare professionals, patients, pharmaceutical industry and the general public to information contained in EudraVigilance - the EU's database of adverse reactions to medicines; 
priprava politike o primernih ravneh dostopa regulativnih organov, zdravstvenih strokovnjakov, bolnikov, farmacevtske industrije in splošne javnosti do informacij v sistemu EudraVigilance, zbirke podatkov EU o neželenih učinkih zdravil, in posvetovanje o njej;
1 procedure resulted in the first-ever positive opinion from the CHMP on changing the classification of an authorised medicine from ‘prescription only' to ‘non-prescription'. 
je bil 1 postopek, ki se je prvič končal s pozitivnim mnenjem CHMP za spremembo razvrstitve odobrenega zdravila iz „samo na recept“ v „brez recepta“.
received 271 applications for PIPs; 
prejel 271 vlog za načrt pediatričnih raziskav;
Type-II (quality) variations 
Spremembe tipa II (kakovost)
adopted 48 opinions on applications for product-specific waivers; 
sprejel 48 mnenj o vlogah za opustitev, specifičnih za zdravilo;
In 2008, the total number of post-authorisation procedures finalised was 2,157, or some 13% higher than in the previous year. 
V letu 2008 je bilo skupno število postopkov po izdaji dovoljenja za promet z zdravilom 2 157 ali približno 13 % več kot prejšnje leto.
Evaluating medicines for veterinary use Thirteen positive opinions adopted for new veterinary medicines 
Vrednotenje zdravil za uporabo v veterinarski medicini Trinajst pozitivnih mnenj za nova zdravila za uporabo v veterinarski medicini
One draft entry was released for public consultation. 
v javno razpravo dal en osnutek vnosa.
To be eligible for these incentives, the company must first submit an application to the Agency, which, through its Committee for Orphan Medicinal Products (COMP), assesses whether or not the medicine should be designated as an orphan medicine. 
Pogoji za omenjene spodbude so, da mora družba najprej predložiti vlogo Agenciji, ki prek Odbora za zdravila sirote oceni, ali se lahko zdravilo določi kot zdravilo sirota.
Holders of marketing authorisations for medicines that are already approved for use in adults can apply for a paediatric-use marketing authorisation (PUMA) if they wish their medicine to be approved for use in children or adolescents. 
Imetniki dovoljenj za promet za zdravila, ki so že odobrena za uporabo pri odraslih, lahko zaprosijo za odobritev dovoljenja za promet z zdravili za uporabo v pediatriji, če želijo da je njihovo zdravilo odobreno za uporabo pri otrocih in mladostnikih.
Monitoring the safety of medicines Reporting in EudraVigilance 
Spremljanje varnosti zdravil Poročanje v sistemu EudraVigilance
designed to provide convenient access to the main regulatory and procedural guidance documents relevant to the operation of the centralised authorisation procedure; creation of a ‘Medicines for the elderly' section of the Agency's public website 13, dedicated to providing information on the work the Agency is conducting with its partners to develop harmonised standards for the development, testing, approval and use of medicines for the elderly. 
, ki omogoča prikladen dostop do glavnih dokumentov z regulativnimi in postopkovnimi smernicami, ki zadevajo potek postopka pridobitve dovoljenja za promet po centraliziranem postopku; pripravo razdelka „Zdravila za starostnike“ na spletni strani Agencije13, ki je namenjen zagotavljanju podatkov o delu Agencije s partnerji pri razvijanju usklajenih standardov za razvoj, preskušanje, odobritev in uporabo zdravil za starostnike.
These reports cover all adverse reactions (unwanted side-effects) that have been observed, whether within the European Economic Area (EEA)6 or elsewhere in the world, and concern both centrally authorised7 and non-centrally authorised medicines (shown as ‘CAP' and ‘non-CAP', respectively, in the chart below). 
Ta poročila obsegajo vse neželene učinke (stranske učinke), ki so bili opaženi v Evropskem gospodarskem prostoru (EGP)6 ali drugje po svetu, in zadevajo tako zdravila, za katera je bilo izdano dovoljenje po centraliziranem postopku7 (v preglednicah prikazana kot „CAP“), ter zdravila, za katera ni bilo izdano dovoljenje po centraliziranem postopku (v preglednicah prikazana kot „neCAP“).