natgillin/translations-raw huggingface dataset:
• We communicate in an open, transparent manner with all of our partners, stakeholders and colleagues. 
• Z vsemi našimi partnerji, zainteresiranimi stranmi in kolegi komuniciramo odprto in pregledno.
My role as Chair of the Management Board commenced in June 2007, following my election by the members. 
Vlogo predsednika upravnega odbora sem začel opravljati junija 2007, ko so me člani odbora izvolili na to mesto.
Throughout 2007, the EMEA worked in close cooperation with others in the European medicines network, in particular in the area of risk-management, which is so fundamental to our consumerprotection role. 
Skozi vse leto 2007 je EMEA tesno sodelovala z drugimi člani Evropske mreže zdravil, še posebej na področju upravljanja tveganj, ki je temeljnega pomena za našo vlogo pri varstvu potrošnika.
A number of the Agency's core business activities are directly aimed at facilitating innovation and research, and as such, supporting the objectives of the Lisbon agenda. 
Neposredni cilj številnih ključnih dejavnosti Agencije je olajševanje inovacij in raziskav ter tako podpiranje ciljev programa lizbonske strategije.
Altogether, 5 referrals were carried out under this procedure. 
Skupaj je bilo v skladu s tem postopkom izvedenih pet napotitev.
Thirty-one requests for classification were received. 
Prejetih je bilo 31 zahtevkov za razvrstitev.
The EMEA coordinated the post-opinion linguistic review for 76 new applications and line extensions. 
Agencija EMEA je usklajevala jezikovno pregledovanje po izdaji mnenja za 76 novih vlog in razširitev linij.
European Review System (Installation) 
Evropski sistem za presojanje (namestitev)
This reflects an increase in the number of routine inspection requests, in line with the policy on GCP inspections adopted in 2006, as well as an increasing focus on inspections in countries where there is little European experience. 
To odraža povečano število zahtevkov za rutinski inšpekcijski pregled v skladu s politiko o inšpekcijskih pregledih dobre klinične prakse, sprejeto v letu 2006, in tudi čedalje večji poudarek na inšpekcijskih pregledih v državah, v katerih je evropskih izkušenj malo.
The EMEA continued to invest in the professional development of staff. 
Agencija EMEA je še naprej vlagala v poklicno usposabljanje osebja.
In 2007, 212 companies requested SME status, and 172 requests were approved. 
V letu 2007 je 212 podjetij zaprosilo za status MSP in od tega je bilo 172 prošenj odobrenih.
This should lead to improved use of the EudraVigilance database in the overall conduct of pharmacovigilance at EU level. 
To bi moralo voditi k boljši uporabi zbirke podatkov sistema EudraVigilance pri celotnem upravljanju farmakovigilance na ravni EU.
The initial success of the EMEA's SME Office seen in 2006 was reconfirmed this year, with Europe's smaller innovative companies demonstrating a keen interest in the dedicated support on offer to them from the EMEA. 
Začetni uspehi Urada za MSP Agencije v letu 2006 so se letos znova potrdili, saj so evropska manjša inovativna podjetja pokazala veliko zanimanje za podporo, ki jim jo ponuja EMEA.
The first pilot was released in September. 
Prvi pilotni sistem je bil izdan septembra.
Applications for these 2 vaccines were evaluated on an accelerated timetable, taking into account the epidemiological situation within the EU and the contribution of the Agency to pandemic preparedness. 
Vlogi za ti dve cepivi sta bili ovrednoteni po pospešenem urniku, ker smo upoštevali epidemiološke razmere v EU in prispevek Agencije k pripravljenosti na pandemijo.
This brought the total number of companies with assigned SME status to 246 at the end of 2007. 
S tem se je število podjetij s podeljenim statusom MSP do konca leta 2007 povečalo na 246.
Daniel Brasseur, former Chair of the Committee for Medicinal Products for Human Use (CHMP) and of the former Paediatric Working Party, was elected Chair; Gérard Pons was elected Vice-chair. 
Daniel Brasseur, prejšnji predsednik Odbora za zdravila za uporabo v humani medicini (CHMP) in predhodne delovne skupine za pediatrijo, je bil izvoljen za predsednika, za podpredsednika pa je bil izvoljen Gérard Pons.
Only a few reports were submitted electronically by marketing-authorisation holders, due to the majority of large veterinary pharmaceutical companies still being in the implementation and testing phase. 
Imetniki dovoljenj za promet z zdravili so elektronsko predložili le nekaj poročil, saj je večina velikih veterinarskih farmacevtskih podjetij še vedno na stopnji uvajanja in preskušanja.
Other areas of cooperation included the development of telematics and discussion on common resource and competence planning. 
Med drugimi področji sodelovanja sta bila razvoj telematike in razprava o skupnem načrtovanju virov in kompetenc.
• recommends safe limits for residues of veterinary medicines used in food-producing animals, for the establishment of maximum residue limits by the European Commission; 
• predlaga varne mejne vrednosti ostankov veterinarskih zdravil, ki se uporabljajo pri živalih, namenjenih za proizvodnjo hrane, na podlagi katerih Evropska komisija določi najvišje mejne vrednosti ostankov;
A status report on the progress of the implementation plan for the framework of interaction with patients and consumers was presented to the Patients' and Consumers' Working Party (PCWP) during its December 2007 meeting. 
Poročilo o napredku izvedbenega načrta za okvir sodelovanja z bolniki in potrošniki je bilo predstavljeno delovni skupini bolnikov in potrošnikov (PCWP) na njenem sestanku decembra 2007.
Pharmacovigilance in the veterinary sector in the EU continues to undergo changes triggered by the revised pharmaceuticals legislation introduced in 2004. 
Področje farmakovigilance v veterinarskem sektorju v EU se še naprej spreminja, kar je povzročila spremenjena zakonodaja o farmacevtskih izdelkih, ki je začela veljati leta 2004.
Guiding principles 
Vodilna načela
The CVMP endorsed a set of proposals for measures that could be provided by the EMEA to assist companies with the submission of applications through the centralised procedure relating to limited markets, in line with the requirements of Article 79 of Regulation 726/2004. 
CVPM je potrdil skupino predlogov za ukrepe, ki bi jih agencija EMEA lahko zagotovila za pomoč podjetjem pri predložitvi vlog po centraliziranem postopku za omejene trge v skladu z zahtevami iz člena 79 Uredbe št. 726/2004.
European risk-management strategy (ERMS) for medicines for human use: further progress made 
Evropska strategija obvladovanja tveganja (ERMS) za zdravila za uporabo v humani medicini: dosežen je bil nadaljnji napredek
The first version of EudraGMP was launched in April 2007, and version 1.1 was released into production in December 2007. 
Prva različica sistema EudraGMP je bila izdana aprila 2007, ustvarjanje različice 1.1 pa se je začelo decembra 2007.
Legal role 
Pravna vloga
The number of national competent authorities and pharmaceutical companies reporting electronically to EudraVigilance (the EU database on adverse drug reactions) increased in 2007. 
Število nacionalnih pristojnih organov in farmacevtskih podjetij, ki elektronsko poročajo v sistem EudraVigilance (zbirka podatkov EU o neželenih učinkih zdravil), se je v letu 2007 povečalo.
These corresponded to 85 applications with an average of 2 to 4 indications per application. 
Te so ustrezale 85 vlogam, v katerih so bile v povprečju od dve do štiri indikacije na vlogo.
A total of 125 applications were received for the designation of orphan medicines - the fourth consecutive year in which more than one hundred such applications have been submitted. 
Za določitev zdravil sirot je bilo prejetih skupno 125 vlog; to je bilo že četrto zaporedno leto, v katerem je bilo predloženih več kot sto takih vlog.
Audioconferencing was introduced for some meetings, reducing the need for experts to travel to the EMEA. 
Pri nekaterih sestankih so bile uvedene avdiokonference, kar je zmanjšalo potrebo po tem, da strokovnjaki potujejo na sedež agencije EMEA.
Periodic safety update reports (PSURs) 
Z zadnjimi podatki dopolnjena redna poročila o varnosti (PSUR)
The full annual report for 2007 was adopted by the Management Board on 6 March 2008, and is available on the EMEA website: 
Celotno letno poročilo za leto 2007 je upravni odbor sprejel 6. marca 2008 in je na voljo na spletni strani Evropske agencije za zdravila:
The European medicines network - a partnership of more than 40 medicines regulatory authorities in the European Union (EU) - is the basis of the EMEA's success. 
Evropska mreža zdravil je partnerstvo več kot 40 regulativnih organov za zdravila v Evropski uniji (EU) in je temelj uspeha agencije EMEA.
Nine out of the 36 finalised referral procedures related to safety concerns. 
Devet od 36 končanih postopkov napotitve se je nanašalo na varnostni vidik.
EMEA/197729/2008/EN/FINAL 
EMEA/421613/2008/SL/KONČNA
Bulgarian, Romanian and (following the expiry of the derogation) Maltese were successfully included in the translations framework. 
V prevode so bile uspešno vključene bolgarščina, romunščina in (po preteku odstopanja) malteščina.
Free scientific advice for minor uses and minor species 
Brezplačno znanstveno svetovanje za manjšo uporabo in manj pomembne živalske vrste
Risk-management plans (RMPs) are submitted as part of a new application or an application involving a significant change in the marketing authorisation. 
Načrti za obvladovanje tveganja (RMP) se predložijo kot del nove vloge ali vloge, ki vključuje znatno spremembo dovoljenja za promet z zdravilom.
The Agency also organised a number of training sessions for assessors from national competent authorities. 
Agencija je tudi priredila več usposabljanj za ocenjevalce iz nacionalnih pristojnih organov.
The number of training days taken by EMEA staff was up by almost 30% on the previous year, reaching a total of 4,166 days. 
Število dni, ki jih je osebje agencije EMEA porabilo za usposabljanje, se je povečalo za skoraj 30 % v primerjavi s prejšnjim letom in je znašalo 4166 dni.
In August 2007, the HMPC provided comments on the draft communication from the Commission to the Council and the European Parliament released for consultation in May 2007 on the experience acquired as a result of the application of the provisions of Chapter 2a of Directive 2001/83/EC (introduced by Directive 2004/24/EC) on specific provisions applicable to traditional herbal medicinal products. 
V avgustu 2007 je HMPC podal pripombe k osnutku sporočila Komisije Svetu in Evropskemu parlamentu o izkušnjah, pridobljenih pri uporabi določb iz poglavja 2a Direktive 2001/83/ES (ki jo je uvedla Direktiva 2004/24/ES), objavljenega za namene posvetovanja maja 2007 o posebnih določbah, ki se uporabljajo za tradicionalna zdravila rastlinskega izvora.
In view of the possible accession of Croatia and Turkey, the Agency organised a conference in each of these countries to prepare the groundwork for their potential future integration into the European medicines network. 
Zaradi morebitne pridružitve Hrvaške in Turčije je Agencija organizirala konferenco v obeh državah, da pripravi temelje za njuno morebitno prihodnjo vključitev v Evropsko mrežo zdravil.
The EMEA started an exercise to improve the organisation of working parties, aimed at achieving more efficient meetings and a better distribution of tasks among members of the scientific committees and their working parties. 
Agencija EMEA je začela vajo za izboljšanje organiziranosti delovnih skupin, namenjeno doseganju učinkovitejših sestankov in boljše porazdelitve nalog med člani znanstvenih odborov in njihovih delovnih skupin.
The wide range of activities undertaken in the field of pharmacovigilance and maintenance have allowed a more proactive approach to safety of medicines to be taken, thus contributing to the protection of public health. 
Širok obseg izvedenih dejavnosti na področjih farmakovigilance in ohranitve je omogočil proaktivnejši pristop k varnosti zdravil in je tako prispeval k varovanju javnega zdravja.
The Agency paid a total of €53.6 million to the national competent authorities for the provision of services in the evaluation of medicines for human and veterinary use. 
Agencija je nacionalnim pristojnim organom plačala skupno 53,6 milijona EUR za zagotavljanje storitev pri vrednotenju zdravil za uporabo v humani in veterinarski medicini.
Seven out of the total number of 65 opinions adopted were negative, recommending that the marketing authorisation for these medicines be refused. 
Sedem od skupaj 65 sprejetih mnenj je bilo negativnih in je priporočalo zavrnitev dovoljenja za promet s temi zdravili.
• We make independent recommendations based on scientific evidence, using state-of-the-art knowledge and expertise in our field. 
• Izdajamo neodvisna priporočila, ki temeljijo na znanstvenih dokazih, pri čemer uporabljamo najnovejše strokovno znanje na našem področju.
I am pleased to report that the European Medicines Agency once again made a strong contribution to EU-wide efforts in support of making high-quality, safe and effective medicines available for use in human and animal populations. 
Z veseljem sporočam, da je Evropska agencija za zdravila znova močno prispevala k prizadevanjem v vsej EU za podpiranje dostopnosti visokokakovostnih, varnih in učinkovitih zdravil, dostopnih za uporabo v človeški in živalski populaciji.
Nine applications were withdrawn prior to opinion. 
Devet vlog je bilo umaknjenih pred sprejetjem mnenja.
FOREWORD BY THE CHAIR OF THE MANAGEMENT BOARD 
PREDGOVOR PREDSEDNIKA UPRAVNEGA ODBORA
The first SME workshop was held on 2 February 2007. 
Prva delavnica za MSP je bila 2. februarja 2007.
The CHMP concluded that piroxicam should no longer be used for treatment of short-term painful and inflammatory conditions. 
CHMP se je odločil, da piroksama ni več dovoljeno uporabljati za zdravljenje kratkoročnih bolečin in vnetij.
• provides scientific advice and incentives to stimulate the development and improve the availability of innovative new medicines; 
• ponuja znanstveno svetovanje in spodbude, da spodbuja razvoj in izboljša dostopnost inovativnih novih zdravil;
This latter is particularly necessary given the increasing complexity of evaluation procedures and the advent of advanced therapies and other new technologies in the medical domain. 
Slednja je glede na čedalje večjo zahtevnost postopkov vrednotenja ter pojav naprednih terapij in drugih novih tehnologij na medicinskem področju še posebno potrebna.
Summary of the thirteenth annual report of the EMEA 
Povzetek trinajstega letnega poročila agencije EMEA
Detection of pharmacovigilance signals 
Odkrivanje signalov farmakovigilance
The SME User Guide was updated in 2007 to reflect the experience gained during the course of 2006. 
Navodila za uporabnike za MSP so bila leta 2007 posodobljena, tako da posredujejo izkušnje, pridobljene leta 2006.
Specific criteria for veterinary medicines require further development. 
Natančna merila za zdravila za uporabo v veterinarski medicini je treba še naprej razvijati.
The Agency organised a highly successful conference with a wide range of stakeholders who examined the operation of the Clinical Trials Directive after three years of practical experience, and published a report on the feedback provided. 
Agencija je organizirala nadvse uspešno konferenco z veliko različnimi zainteresiranimi stranmi, ki so preučile izvajanje direktive o kliničnem preskušanju po treh letih praktičnih izkušenj, in objavila poročilo o povratnih informacijah, ki so jih podale zainteresirane strani.
The PDCO held its first meeting on 4-5 July 2007. 
PDCO je prvič zasedal 4. in 5. julija 2007.
The number of staff employed at the EMEA was 441, in addition to which there were 124 seconded national experts and contract agents. 
Agencija EMEA je zaposlovala 441 ljudi, poleg tega je pri Agenciji delalo 124 začasno dodeljenih nacionalnih strokovnjakov in pogodbenih uslužbencev.
The timelines set out in the procedures were not adhered to, due to the high number of notification requests received, a backlog from previous years and a lack of resources. 
Časovni okviri, ki so bili določeni v postopkih, so bili preseženi zaradi velikega števila zahtevkov za obvestila, zaostankov iz prejšnjih let in pomanjkanja virov.
The CVMP completed the assessment and issued opinions on 3 of the referral procedures started in 2007 and on 7 of the referral procedures started in 2006. 
CVMP je končal vrednotenje in izdal mnenja o treh postopkih napotitve, začetih v letu 2007, in sedmih postopkih napotitve, začetih v letu 2006.
• applies efficient and transparent evaluation procedures to help bring new medicines to the market by means of a single, EU-wide marketing authorisation granted by the European Commission; 
• uporablja učinkovite in pregledne postopke vrednotenja, da pripomore k uvedbi novih zdravil na trg z enotnim dovoljenjem za promet z zdravilom, ki velja za celotno EU in ga podeli Evropska komisija;
Promoting access to vaccines against major epizootic diseases of domestic livestock 
Spodbujanje dostopa do cepiv proti težkim kužnim boleznim domačih rejnih živali
The EMEA continued to support the development of medicines for rare diseases and to provide highquality scientific advice to companies developing medicines. 
Agencija EMEA je še naprej podpirala razvoj zdravil za redke bolezni in ponujala visokokakovostno znanstveno svetovanje podjetjem, ki razvijajo zdravila.
With the foundation of this new legislative framework and the EMEA's operation of it, children across Europe will begin to benefit from medicines that are developed with their specific needs and best interests at heart. 
Z ustanovitvijo tega novega pravnega okvira, ki ga upravlja EMEA, bodo otroci po vsej Evropi začeli uživati koristi zdravil, ki se z najboljšimi nameni razvijajo zanje ob upoštevanju njihovih posebnih potreb.
High performance of EudraNet was achieved both in terms of system availability and quality of management, development and operation of EudraNet applications (EudraNet II, EudraLink, ECD, Experts Database, etc.). 
Visoka učinkovitost omrežja EudraNet je bila dosežena tako v smislu dostopnosti sistema kot kakovosti upravljanja, razvoja in delovanja programov sistema EudraNet (EudraNet II, EudraLink, ECD, Experts Database itd.).
An antidote medicinal product used for treating cyanide poisoning. 
• Protistrup, ki se uporablja pri zastrupitvi s cianidom.
A medicine with a chemical structure resembling that of thalidomide. 
• Zdravilo s kemično strukturo, ki je podobna kemični strukturi talidomida.
I would like to express my gratitude to the Executive Director and all EMEA staff for their commitment and excellent contribution during the year. 
Zahvaljujem se izvršnemu direktorju in vsemu osebju agencije EMEA za njihovo predanost in izvrstno delo med letom.
With the support of the national competent authorities the Agency succeeded in establishing the Paediatric Committee (PDCO) - the Agency's fifth scientific committee - and putting in place the necessary procedures for the assessment of paediatric investigation plans (PIPs) and waiver applications. 
S podporo nacionalnih pristojnih organov je Agenciji uspelo ustanoviti Odbor za pediatrijo (PDCO) - peti znanstveni odbor Agencije - in uvesti potrebne postopke za vrednotenje načrtov pediatričnih raziskav (PIP) in vlog za opustitev.
Considerable effort was made, together with the national competent authorities for medicines in the EU Member States, to apply a proactive approach to the safety of medicines, with particular emphasis on the establishment of an intensive drug-monitoring system. 
Skupaj z nacionalnimi pristojnimi organi za zdravila v državah članicah smo vložili veliko truda, da smo uporabili proaktiven pristop k varnosti zdravil, poseben poudarek pa je bil na ustanovitvi intenzivnega sistema za spremljanje zdravil.
3.6 Arbitration and Community referrals Procedures started in 2007 
3.6 Arbitraža in napotitve Skupnosti Postopki, začeti v letu 2007
• implements measures for continuously supervising the quality, safety and efficacy of authorised medicines to ensure that their benefits outweigh their risks; 
• izvaja ukrepe za nenehen nadzor nad kakovostjo, varnostjo in učinkovitostjo zdravil, za katera so bila izdana dovoljenja, za zagotovitev, da njihova korist prevlada nad tveganji;
Forty-nine percent of orphan medicines designated in 2007 were for conditions affecting children, including 4% intended exclusively for paediatric use. 
49 % zdravil sirot, ki so bila tako določena v letu 2007, je bilo namenjenih za zdravljenje bolezni, ki prizadenejo otroke, vključno s 4 % zdravil, ki so namenjena izključno za uporabo v pediatriji.
Perhaps the most tangible and significant achievement of 2007 was the Agency's successful introduction of new procedures and creation of a new scientific committee dedicated to implementing the EU's Paediatric Regulation, which came into force on 26 January 2007. 
Najbrž najvidnejši in najpomembnejši dosežek v letu 2007 je bil, da je Agencija uspešno uvedla nove postopke in ustanovila nov znanstveni odbor, ki se ukvarja z izvajanjem Uredbe EU o zdravilih za pediatrično uporabo, ki je začela veljati 26. januarja 2007.
The Paediatric Committee - the Agency's fifth scientific committee - was launched with great enthusiasm in July of this year, and immediately began to elaborate scientific and procedural arrangements for the assessment of paediatric investigation plans and related regulatory instruments. 
Odbor za pediatrijo - peti znanstveni odbor Agencije - je bil z velikim zanosom ustanovljen julija letos ter je nemudoma začel pripravljati znanstvene in proceduralne sporazume za oceno načrtov pediatričnih študij in s tem povezanih regulativnih instrumentov.
Good manufacturing practice (GMP) inspection numbers - including inspections in the context of plasma master files (PMFs) - showed a 32% increase compared with 2006 (110). 
Število inšpekcijskih pregledov dobre proizvodne prakse (GMP) - vključno z inšpekcijskimi pregledi na podlagi glavnih dosjejev plazme (plasma master file, PMF) - kaže 32-odstotno povečanje v primerjavi z letom 2006 (110).
They form part of the overall response of the European regulatory network to the lack of availability of veterinary medicines. 
Ti predlogi so sestavni del splošnega odgovora evropske regulativne mreže na slabo dostopnost zdravil za uporabo v veterinarski medicini.
The numbers of initial parallel-distribution notifications and notifications of change exceeded the expected numbers, with 1,937 initial notifications (8% more than forecast) and 3,518 notifications of change (45% more than forecast) being received. 
Število začetnih obvestil o vzporedni distribuciji in število obvestil o spremembi sta presegli pričakovanja; prejeli smo 1937 začetnih obvestil (8 % več, kot je bilo pričakovano) in 3518 obvestil o spremembi (45 % več, kot je bilo pričakovano).
According to revised EU legislation, Member States can initiate referrals regarding herbal medicines. 
V skladu s spremenjeno zakonodajo EU lahko države članice predložijo napotitve z zvezi z zdravili rastlinskega izvora.
• We adhere to high standards of professional and personal integrity. 
• Ravnamo se po visokih standardih strokovne in osebne poštenosti.
Services provided by the SME Office included processing of requests for fee reduction or deferral, requests for administrative assistance - more than three times the initially forecasted requests were received - and translation support for product information. 
Storitve, ki jih je zagotavljal Urad za MSP, so vključevale obdelavo zahtevkov za znižanje ali odlog pristojbin, zahtevkov za upravno pomoč - prejetih je bilo trikrat toliko zahtevkov, kot je bilo predvideno na začetku - ter prevajalsko podporo za informacije o zdravilih.
The CHMP adopted 41 opinions for new indications, providing additional treatment options for patients. 
CHMP je sprejel 41 mnenj za nove terapevtske indikacije in tako zagotovil dodatne možnosti zdravljenja bolnikov.
Further improvements in relation to provision of information on medicines 
Nadaljnje izboljšave v zvezi z omogočanjem informacij o zdravilih
Extensions of indications broaden scope of existing medicines 
Razširitve terapevtskih indikacij širijo obseg obstoječih zdravil