natgillin/translations-raw huggingface dataset:
The Agency's policy on fee reductions for orphan medicines was amended in 2006 to take into account the increasing number of fee-reduction requests being received. 
Politika Agencije o znižanjih pristojbin za zdravila sirote je bila spremenjena leta 2006, da bi se upoštevalo naraščajoče število prejetih zahtevkov za znižanje pristojbine.
The EMEA has worked hard in 2006 to prepare the ground for ensuring the smooth implementation of this new piece of legislation. 
EMEA se je v letu 2006 trudila pripraviti podlago za zagotovitev gladkega izvajanja tega novega dela zakonodaje.
And 2006 was indeed a year with plenty to report on. 
Leto 2006 je bilo dejansko leto, v katerem se je zgodilo veliko takega, o čemer je mogoče poročati.
As in previous years, there were more positive opinions on orphan designation for cancer treatments than in any other therapeutic area. 
Kot v prejšnjih letih je bilo sprejetih več pozitivnih mnenj o določitvi zdravil sirot za zdravljenje raka kot na katerem koli drugem terapevtskem področju.
Eight applications were withdrawn by applicants before an opinion could be adopted. 
Osem vlog so vlagatelji umaknili, preden je bilo sprejeto mnenje.
These focused on improving the safety of medicines, increasing the availability of new medicines, and enhancing scientific competence within the network. 
Ukrepi so bili osredotočeni na izboljšanje varnosti zdravil, povečanje razpoložljivosti novih zdravil in krepitev znanstvenih pristojnosti znotraj mreže.
This included a review of results from: risk-management, internal and external audits; self-assessments related to internal control standards; self-assessments as part of the Benchmarking of European Medicines Agencies (BEMA); the environmental analysis 2006; and the 2006 staffmotivation survey. 
To je vključevalo pregled rezultatov iz: obvladovanja tveganja, notranjih in zunanjih revizij, samoocen, povezanih s standardi notranjega nadzora, samoocen kot delov primerjalnih analiz evropskih agencij za zdravila (Benchmarking of European Medicines Agencies - BEMA), okoljske analize za leto 2006 in raziskave o motivaciji zaposlenih iz leta 2006.
Developing an action plan for better harmonisation and work-sharing between authorities in the European Surveillance Strategy (ESS) for veterinary medicines. 
razvoj akcijskega načrta za boljšo usklajenost in delitev dela med organi oblasti v evropski strategiji nadzorovanja (European Surveillance Strategy - ESS) za veterinarska zdravila;
This overview is intended to support the Commission with the preparation of its report to the European Parliament and to the Council concerning the application of the relevant legislative provisions relating to traditional herbal medicinal products. 
Ta pregled je namenjen zagotavljanju podpore Komisiji pri pripravi njenega poročila Evropskemu parlamentu in Svetu glede uporabe ustreznih zakonskih določb, povezanih s tradicionalnimi zdravili rastlinskega izvora.
PIM (Product Information Management - a process that supports the electronic exchange of product information between applicants and the EMEA, as well as the review of this information). 
PIM (upravljanje informacij o izdelkih - proces, ki podpira elektronsko izmenjavo informacij o izdelkih med vlagatelji in EMEA ter ponovno preučevanje teh informacij).
A total of €6.7 million was granted to fund fee reductions for orphan medicines in 2006, primarily from the EU special contribution. 
V letu 2006 je bilo dodeljenih skupaj 6,7 milijona EUR za financiranje znižanj pristojbin za zdravila sirote, predvsem iz posebnega prispevka EU.
They provides for the extension of marketing authorisations granted by one Member State to one or more other Member States identified by the applicant. 
Postopka predvidevata razširitev dovoljenj za promet z zdravilom, ki jih izda ena država članica, na eno ali več drugih držav članic, ki jih določi vlagatelj.
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.
Finally, the EMEA was an important contributor for the development of strategic research agendas for both human and veterinary medicinal products within the 7th Framework Programme, the EU's chief instrument for funding scientific research and technological development over the period 2007 to 
Nazadnje, EMEA je pomembno prispevala k razvoju strateških razvojnih agend za zdravila za uporabo v humani in veterinarski medicini v okviru Sedmega okvirnega programa, glavnega instrumenta EU za financiranje znanstvenih raziskav in tehnološkega razvoja v obdobju od 2007 do 2013.
A further improvement was also registered in the average clock-stop time required by applicant companies. 
Nadaljnji napredek je bil viden tudi pri povprečnih zaustavitvah časa, ki so jih zahtevali vlagatelji.
Work continued on improving the operation of the sampling-and-testing programme. 
Nadaljevalo se je delo za izboljšanje delovanja programa vzorčenja in preizkušanja.
Project status at the end of 2006 
Status projektov na koncu leta 2006
The Agency reviewed 80% of the RMPs submitted as part of new applications. 
Agencija je preučila 80 % načrtov za obvladovanje tveganja, ki so bili predloženi kot del novih vlog.
New indications broaden scope of existing medicines 
Nove terapevtske indikacije razširjajo obseg obstoječih zdravil
The presence of representatives from patients', doctors' and veterinarians' organisations, who joined the Board in September 2005, has added a new dimension to how the Board operates, and their experience and expertise has made an invaluable contribution to the Board's functioning. 
Prisotnost predstavnikov organizacij bolnikov, zdravnikov in veterinarjev, ki so se upravnemu odboru pridružili septembra 2005, je dodala novo razsežnost delu upravnega odbora, njihove izkušnje in strokovno znanje pa so dragoceno pripomogle k delovanju tega odbora.
Warnings and contra-indications were added for the classes of medicinal products (class labelling) below: 
Dodana so bila opozorila in kontraindikacije za spodaj navedene razrede zdravil (označevanje razreda):
EudraNet (secure communication between stakeholders in the European Medicines Regulatory Network). 
EudraNet (varno komuniciranje med zainteresiranimi stranmi v evropski regulativni mreži za zdravila).
This was due to the frequent update of the Annexes to the Community marketing authorisations of parallel-distributed products and to other changes proposed by parallel distributors (e.g. addition of countries of origin). 
To je bila posledica pogostega posodabljanja prilog k dovoljenjem Skupnosti za promet z izdelki, ki se vzporedno distribuirajo, in drugih sprememb, ki jih predlagajo vzporedni distributerji (npr. dodatek držav izvora).
Almost forty organisations representing patients and consumers answered the Agency's call in 2006 for expressions of interest in becoming involved in EMEA activities, of which 16 met the EMEA eligibility criteria and were placed on a public list on the Agency's website, which will be updated regularly. 
Skoraj štirideset organizacij, ki predstavljajo bolnike in potrošnike, je odgovorilo na poziv Agencije iz leta 2006 za izraz interesa za sodelovanje v dejavnostih EMEA, od katerih jih je 16 izpolnjevalo merila ustreznosti EMEA in so tako bile vpisane na javni seznam na spletni strani Agencije, ki se bo redno posodabljal.
1.3 Information and communication 
1.3 Zagotavljanje informacij in obveščanje
In order to review the experience gained with risk-management plans to date, and to introduce further improvements, a Review and Learning Project was set up, involving the EMEA, CHMP, PhVWP and CMD(h). 
Za preučitev izkušenj, ki so bile do sedaj pridobljene iz načrtov za obvladovanja tveganja, in za uvedbo dodatnih izboljšav je bil oblikovan revizijski in učni projekt, v katerem sodelujejo EMEA, CHMP, PhVWP in CMD(h).
This was the first full year of operation of the new pharmaceutical legislation introduced in the European Union in November 2005, under which the EMEA assumed new responsibilities and saw the scope of its tasks greatly extended. 
V tem letu se je prvič celo leto izvajala nova farmacevtska zakonodaja, uvedena v Evropski uniji novembra 2005, v skladu s katero je EMEA prevzela nove odgovornosti, močno pa se je povečal tudi obseg njenih nalog.
Questionand-answer documents are now systematically published to give relevant information at the time of withdrawal or refusal of applications. 
Dokumenti z vprašanji in odgovori se zdaj sistematično objavljajo tako, da so ustrezne informacije zagotovljene ob umiku ali zavrnitvi vlog.
New dossiers concerning generics and novel aspects of pharmaceutical development 
Novi dosjeji v zvezi z generičnimi in novimi vidiki farmacevtskega razvoja
We also contributed towards stimulating research and development of new medicines through our involvement in the Innovative Medicines Initiative and the European Technology Platform for Global Animal Health, but in particular through the dedicated support provided to small and medium-sized companies by our SME Office, which, in its first year of operation, generated even greater interest than had been expected. 
K spodbujanju raziskav in razvoja novih zdravil smo prispevali tudi z vključenostjo v pobudo za inovativna zdravila in evropske tehnološke platforme za globalno zdravje živali, še zlasti pa s specializirano podporo, ki jo malim in srednje velikim podjetjem zagotavlja naš Urad za mala in srednje velika podjetja, ki je v prvem letu svojega delovanja zbudil celo večji interes, kot je bilo pričakovano.
The CVMP completed the assessment and issued opinions in 4 referral procedures, 3 of which started in 2006 and 1 in 2005. 
CVMP je zaključil ocenjevanje in izdal mnenja v štirih postopkih napotitve, od katerih so se tri začeli leta 2006, eden pa leta 2005.
At the conclusion of the scientific evaluation, undertaken in 210 days within the Agency, the opinion of the scientific committee is transmitted to the European Commission to be transformed into a single market authorisation valid throughout the whole European Union. 
Na koncu znanstvenega vrednotenja, ki ga Agencija opravi v 210 dneh, se mnenje znanstvenega odbora sporoči Evropski komisiji in ta izda enotno dovoljenje za promet z zdravilom, veljavno po vsej Evropski uniji.
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 zajema 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.
In February 2006, the Agency began publishing summaries of European public assessment reports (EPARs) that are specially written to be understandable by patients and members of the general public. 
Februarja 2006 je Agencija začela izdajati povzetke evropskih javnih poročil o oceni zdravila (EPAR), ki so posebej napisana tako, da jih lahko razumejo bolniki in člani širše javnosti.
The increasing importance of the Agency's role in the provision of high-quality information to patients and healthcare professionals led to a number of initiatives in the area of information and communication in 2006, as briefly outlined below. 
Vse večji pomen Agencije pri zagotavljanju visokokakovostnih informacij bolnikom in zdravstvenim delavcem je privedel do številnih pobud na področju zagotavljanja informacij in obveščanja v letu 2006, ki so na kratko opisane v nadaljevanju.
Developing efficient and transparent procedures to allow rapid access by users to safe and effective innovative medicines and to generic and non-prescription medicines through a single European marketing authorisation. 
razvojem učinkovitih in preglednih postopkov, ki uporabnikom omogočajo hiter dostop do varnih in učinkovitih inovativnih zdravil ter do generičnih zdravil in zdravil brez recepta z enotnim evropskim dovoljenjem za promet;
The approval of biosimilar products places Europe at the forefront of medicines regulation in this area and represents an important contribution to public health in the EU. 
Odobritev biološko podobnih izdelkov uvršča Evropo v ospredje na področju regulacije zdravil in je pomemben prispevek k javnemu zdravju v EU.
The majority of new indications related to medicinal products approved for the treatment of various forms of cancer. 
Večina novih terapevtskih indikacij se je nanašala na zdravila, odobrena za zdravljenje različnih oblik raka.
More than half of orphan-designated medicines are for treatment of children 
Več kot polovica zdravil, določenih za zdravila sirote, je namenjena zdravljenju otrok
Further progress with EudraVigilance 
Nadaljnji napredek pri EudraVigilance
The EMEA and national competent authorities of the EU Member States carried out a number of actions aimed at strengthening the European medicines network - one of the Executive Director's priorities for 2006. 
EMEA in nacionalni pristojni organi držav članic EU so izvedli vrsto ukrepov, namenjenih krepitvi Evropske mreže zdravil, ki je bila ena izmed prednostnih nalog izvršnega direktorja v letu 2006.
of Commission Regulation (EC) No 1084/2003 
Uredbe Komisije (ES) št. 1084/2003
1.1 Improving the safety of medicines 
1.1 Izboljšanje varnosti zdravil
The centralised procedure is compulsory for all medicinal products for human and animal use derived from biotechnology processes. 
Centralizirani postopek je obvezen za vsa zdravila za uporabo v humani in veterinarski medicini, pridobljena z biotehnološkimi postopki.
The EMEA and national competent authorities made further progress with the European RiskManagement Strategy for human medicines, particularly in the areas highlighted below. 
EMEA in nacionalni pristojni organi so dosegli nadaljnji napredek pri evropski strategiji obvladovanja tveganja za zdravila za uporabo v humani medicini, zlasti na področjih, ki so navedena v nadaljevanju.
Revenue and expenditure in 2006 
Prihodki in odhodki v letu 2006
The main change to the policy concerned a re-focusing of incentives on support for protocol assistance and other pre-authorisation assistance. 
Glavna sprememba politike se je nanašala na preusmeritev glavne pozornosti pobud na podporo pomoči pri protokolu in druge pomoči pred izdajo dovoljenja.
* The 36-day EMEA post-opinion phase in 2006 accounts for the Agency's processing time as well as the time required by applicants and Member States to carry out their post-opinion translation checks. 
* 36-dnevna faza po sprejetju mnenja EMEA v letu 2006 predstavlja čas obdelave Agencije in čas, ki ga vlagatelji in države članice potrebujejo za izvedbo preverjanj prevoda po sprejetju mnenja.
These led to authorisations under exceptional circumstances and are subject to specific obligations and follow-up measures, including enhanced pharmacovigilance measures, to ensure the safe use of these products. 
Te so pripeljale do izdaje dovoljenj v izjemnih okoliščinah, cepivi pa sta predmet posebnih obveznosti in dodatnih ukrepov, vključno z okrepljenimi ukrepi farmakovigilance za zagotovitev varne uporabe teh izdelkov;
By the end of the year, 161 sponsors of clinical trials being conducted in the European Economic Area were reporting suspected unexpected serious adverse reactions to the EudraVigilance Clinical Trial Module (EVCTM). 
Do konca leta 2006 je 161 sponzorjev, ki so izvajali klinična preizkušanja znotraj evropskega gospodarskega prostora (EGP), poročalo o sumih na resne nepričakovane neželene učinke v modul kliničnih preizkušanj EudraVigilance (EudraVigilance Clinical Trial Module - EVCTM).
Four additional members were appointed to the Scientific Advice Working Party (SAWP), and its meetings were extended to three days, allowing more meetings to be held with applicant companies for discussions. 
v delovno skupino za znanstveno svetovanje (Scientific Advice Working Party - SAWP) so bili imenovani štirje dodatni člani, sestanki te delovne skupine pa so bili podaljšani na tri dni, kar omogoča več razprav z družbami vlagateljicami;
This prompt action, together with accelerated decision-making procedures by the European Commission, enabled authorised vaccines of high quality to be made available for use across the EU at a time of increased risk of avian-influenza occurrence in the autumn of 2006. 
Tovrstno pospešeno ukrepanje je skupaj s pospešenim postopkom odločanja Evropske komisije omogočilo, da so bila med povečanim tveganjem za pojav aviarne influence jeseni leta 2006 na voljo odobrena visokokakovostna cepiva v EU.
Much effort was placed on competence-development in 2006. 
V letu 2006 je bilo veliko prizadevanj posvečenih razvoju pristojnosti.
To date, a total of 53,642 ICSRs, corresponding to 26,997 individual cases, have been transmitted to EVCTM. 
Do sedaj je bilo v modul EVCTM posredovanih skupaj 53.642 ICSR-jev, kar ustreza 26.997 posameznim primerom.
For the third consecutive year, more than one hundred applications were received for the designation of orphan medicinal products: a total of 104 applications were submitted. 
Že tretje leto zapored je bilo prejetih več kot sto vlog za določitev zdravila kot zdravila sirote: skupaj so bile predložene 104 vloge.
The European Commission Directorate-General for Enterprise and the EMEA published a joint Priority Action Plan in July 2006 for implementation of the regulation, and a dedicated task-force was set up within the Agency to manage this plan. 
Generalni direktorat za podjetništvo Evropske komisije in EMEA sta julija 2006 objavila skupni prednostni akcijski načrt za izvajanje uredbe, za upravljanje tega načrta pa je bila v okviru Agencije oblikovana specializirana projektna skupina.
The Agency organised a number of conferences, workshops and training sessions for assessors and inspectors, designed to share competencies and strengthen cooperation among the network of European experts. 
Agencija je organizirala več konferenc, delavnic in usposabljanj za ocenjevalce in inšpektorje, ki so bili namenjeni izmenjavi znanja in krepitev sodelovanja znotraj mreže evropskih strokovnjakov.
Management and internal-control systems are part of EMEA governance and are consolidated in an integrated management system at the Agency. 
Sistem upravljanja in sistem notranje kontrole sta sestavna dela upravljanja EMEA ter sta povezana v integriran sistem upravljanja v EMEA.
Increasing availability of medicines for rare diseases 
Povečanje razpoložljivosti zdravil za redke bolezni
MANAGING THE AGENCY 
UPRAVLJANJE AGENCIJE
European Risk-Management Strategy (ERMS) for medicines for human use 
Evropska strategija obvladovanja tveganja (European Risk-Management StrategyERMS) za zdravila za uporabo v humani medicini
Six new contra-indications were also adopted, for medicinal products used in fields such as depression, diabetes and infectious diseases. 
Sprejetih je bilo tudi šest novih kontraindikacij za zdravila, ki se uporabljajo na področjih, kot so depresija, sladkorna bolezen in nalezljive bolezni.
The launch of the database is a first step towards providing public access to comprehensive and up-to-date information about all authorised medicines in the European Union. 
Uporaba zbirke podatkov je prvi korak k zagotavljanju javnega dostopa do celovitih in najnovejših informacij o vseh zdravilih, ki imajo dovoljenje za promet v Evropski uniji.
In particular, major progress was made on adapting the data requirements for products for minor uses and minor species. 
Pomemben napredek je bil dosežen pri prilagajanju podatkovnih zahtev za proizvode za manjšo uporabo in manj pomembne vrste.
As part of its implementation of EU pharmaceutical legislation, the EMEA launched a first version of EudraPharm - a new medicines-information database for the EU - on 6 December 2006. 
EMEA je v okviru izvajanja farmacevtske zakonodaje EU 6. decembra 2006 začela uporabljati prvo različico EudraPharm, nove zbirke podatkov informacij o zdravilih za EU.
1.2 Improving access to medicines and stimulating R&D Implementing the new framework for scientific advice 
1.2 Izboljšanje dostopa do zdravil in spodbujanje raziskav in razvoja Uvedba novega okvira za znanstveno svetovanje
Europe first to approve biosimilars 
Evropa prva odobrila biološko podobne izdelke
6.1 Management Board 
6.1 Upravni odbor
Reinforcing the scientific expertise of the Pharmacovigilance Working Party (PhVWP) of the Committee for Medicinal Products for Human Use (CHMP) by co-opting 8 specialised experts. 
Krepitev znanstvenega strokovnega znanja in izkušenj delovne skupine za farmakovigilanco (Pharmacovigilance Working Party - PhVWP) Odbora za zdravila za uporabo v humani medicini (CHMP) z vključitvijo osmih specializiranih članov.
The scientific committees were able to speed up the average assessment time for several key procedures, including initial evaluations, orphan designations and scientific advice, thus helping to accelerate the development and availability of new medicines. 
znanstveni odbori so pospešili povprečni čas vrednotenja za več ključnih postopkov, vključno z začetnim vrednotenjem, določanjem zdravil sirot in znanstvenim svetovanjem, in tako pripomogli k pospeševanju razvoja in razpoložljivosti novih zdravil.
Thereafter, subject to budgetary capacity, it is hoped to extend the system to the decentralised and mutual-recognition procedures. 
Če bodo na voljo proračunska sredstva, se bo sistem predvidoma razširil tudi na decentraliziran postopek in postopek medsebojnega priznavanja;
First Article 78 procedure 
Prvi postopek na podlagi člena 78
The availability of an adequate pharmacovigilance-signals-detection system is important to the Agency's efforts for monitoring the safety of medicines. 
Razpoložljivost ustreznega sistema za odkrivanje signalov farmakovigilance je pomembna za prizadevanja Agencije za spremljanje varnosti zdravil.
Efforts to improve public access to information about medicines 
Prizadevanja za izboljšanje dostopa javnosti do informacij o zdravilih
The number of procedures for arbitrations, referrals and Article 5(3) opinions started in 2006 was 79% greater than in 2005. 
Število postopkov za arbitražo, napotitev in mnenj po členu 5(3), ki so se začeli leta 2006, je bilo za 79 % višje kot leta 2005.
No opinions were adopted on products evaluated through compassionateuse or accelerated-assessment procedures. 
Sprejeto ni bilo nobeno mnenje o proizvodih, vrednotenih s postopki za sočutno uporabo zdravil ali postopki za pospešeno ocenjevanje.
In addition to initial notifications, the Agency received 2,201 notifications of a change, representing a 120% increase compared to 2005 (1,018). 
Poleg začetnih obvestil je Agencija prejela 2.201 obvestilo o spremembi, kar pomeni 120-odstotno povečanje v primerjavi z letom 2005 (1.018).
Mobilising and coordinating scientific resources from throughout the EU to provide high-quality evaluation of medicinal products, to advise on research and development programmes, to perform inspections for ensuring fundamental GxP1 provisions are consistently achieved, and to provide useful and clear information to users and healthcare professionals. 
zbiranjem in usklajevanjem znanstvenih virov iz vse EU zaradi zagotovitve visoke kakovosti vrednotenja zdravil, svetovanje o raziskovalnih in razvojnih programih, izvajanje inšpekcijskih pregledov za zagotavljanje doslednega izvajanja temeljnih določb GXP1 ter zagotovitev uporabnih in jasnih informacij uporabnikom in zdravstvenim delavcem.
Controlling the safety of medicines for humans and animals, in particular through a pharmacovigilance network and the establishment of safe limits for residues in food-producing animals. 
nadziranjem varnosti zdravil za ljudi in živali, predvsem z mrežo farmakovigilance in določitvijo varnih mejnih vrednosti ostankov v živalih, namenjenih proizvodnji hrane;
Applications withdrawn prior to opinion Negative opinions 
Vloge, umaknjene pred sprejetjem mnenja Negativna mnenja