natgillin/translations-raw huggingface dataset:
Provision of regulatory input and advice to the European Commission's DG Research on innovation and technology platforms for human and veterinary medicines, aimed at supporting innovation and facilitating the availability of medicines. 
zagotavljanje regulativnega prispevka in svetovanja Generalnemu direktoratu Evropske komisije za raziskave o inovacijah in tehnoloških platformah za zdravila za uporabo v humani medicini in veterinarska zdravila, da bi tako podpirali inovacije in spodbujali dostopnost zdravil.
Taking into account the change in the legislation regarding automatic referrals and the development of lists of medicinal products for which a harmonised summary of product characteristics (SPC) should be drawn up, an increase in arbitrations/referrals for both human and veterinary medicines is expected. 
Ob upoštevanju spremembe zakonodaje o samodejnih predložitvah in priprave seznamov zdravil, za katera je treba izdelati usklajeni Povzetek o glavnih značilnostih zdravila, se pričakuje povečanje števila arbitraž/predložitev za zdravila za uporabo v humani medicini in veterinarska zdravila.
POST-AUTHORISATION EVALUATION OF MEDICINES FOR HUMAN USE Head: Noël Wathion 
POSTEVALUATION OF MEDICINES FOR HUMAN USE Head: Noël Wathion
Existing procedures (such as the CHMP handling of safety concerns for centrally processed applications) will be revised to effectively incorporate the concept of RMPs in the evaluation process. 
Obstoječi postopki se bodo pregledali (na primer, kako CHMP obravnava varnostna vprašanja pri vlogah, obdelanih po centraliziranem postopku), tako da se bo koncept načrtov obvladovanja tveganja učinkovito vključil v postopek ocenjevanja.
Supporting innovation and research, in particular by providing support to SMEs and by discussing challenges relating to new technologies and therapies with key parties; 
podpiranje inovacij in raziskav, zlasti s podporo malim in srednje velikim podjetjem in z razpravami s ključnimi partnerji o izzivih, ki jih prinašajo nove tehnologije in terapije;
Good clinical practice (including pharmacovigilance) GMP (including PMF) 
Dobra laboratorijska praksa Dobra klinična praksa (vključno s farmakovigilanco) Dobra proizvodna praksa (vključno s PMF)
20 Investment in immovable property, renting of building and associated costs 21 Expenditure on data processing 22 Movable property and associated costs 23/25 Other administrative expenditure 24 Postage and communications 
21 Odhodki za obdelavo podatkov 22 Premično premoženje in s tem povezani stroški 23/25 Drugi dohodki za poslovanje 24 Poštnine in obveščanje
The Agency will progress its work on IP telephony, web-streaming, video-streaming and other audiovisual-meetings systems, to support the Agency's objectives in the area of meetingsmanagement. 
Agencija bo nadaljevala delo na področju telefonije IP, neprekinjenega pretoka po spletu in drugih sistemov avdiovizualnih konferenc za podporo ciljev Agencije na področju vodenja sestankov.
The Agency will continue its work to fully implement recent Community legislation on herbal medicinal products and to provide Member States and EU institutions with the best-possible scientific opinion on questions relating to herbal medicinal products. 
Agencija si bo še naprej prizadevala polno uresničiti najnovejšo zakonodajo Skupnosti o zdravilih rastlinskega izvora in zagotoviti državam članicam in ustanovam EU najboljše znanstveno svetovanje pri vprašanjih, povezanih z zdravili rastlinskega izvora.
To that effect, the EMEA will investigate translation memory, with the attendant requirement for the development of a translation-terminology database. 
Zato bo EMEA preučila pomnilnik prevodov in pri tem poskušala razviti zbirko podatkov prevajalske terminologije.
Further implementation of the orphan-medicines policy, whereby developers of designated orphan medicinal products - often derived from new technologies - enjoy reduced fees or fee waivers for a number of Agency procedures, thus stimulating the development of these products and increasing patients' access to them; 
nadaljnji razvoj politike na področju zdravil sirot, pri čemer so razvijalci določenih zdravil sirot - pogosto izpeljanih iz novih tehnologij - upravičeni do znižanih pristojbin oziroma opustitve pristojbine za številne postopke Agencije, kar spodbuja razvoj teh izdelkov in povečuje dostop bolnikov do teh zdravil;
To carry out its mission relating to protection and promotion of public health, the Agency will draw on the best-available expertise in the EU and EEA-EFTA Member States to assess medicines, to provide high-quality scientific advice, to evaluate safety profiles of medicines and to develop important guidance documents. 
Agencija bo pri uresničevanju svojega poslanstva, povezanega z zaščito in spodbujanjem javnega zdravja, črpala iz najboljšega razpoložljivega strokovnega znanja in izkušenj v EU in državah članicah EGP-EFTA ter tako ocenjevala zdravila, zagotavljala visoko kakovostno znanstveno svetovanje, vrednotila varnostne lastnosti zdravil in pripravljala pomembne usmeritvene dokumente.
CHAPTER 4 EU TELEMATICS STRATEGY CHAPTER 5 SUPPORT ACTIVITIES 
POGLAVJE 4 TELEMATSKA STRATEGIJA EU POGLAVJE 5 PODPORNE DEJAVNOSTI
The Agency will provide secretarial support to the CMDs and their working parties, whose responsibilities will include: preparation and distribution of documents; provision of lists of positions taken on similar issues; follow-up to meetings; facilitation of liaison with other scientific working groups and with interested parties; assistance on preparation of annual reports; specific activities assigned to the CMDs under their work programmes; assistance in providing regulatory and legal support to CMD activities; coordination of the 60-days procedure for discussion in case of disagreement between Member States in mutual-recognition or decentralised procedures; and preparation of the list of medicinal products for which a harmonised SPC should be drawn up. 
Agencija bo zagotavljala tajniško podporo skupinam CMD in njihovim delovnim skupinam, katerih dolžnosti bodo zajemale: pripravo in razdeljevanje dokumentov; zagotavljanje seznamov stališč do podobnih vprašanj; nadaljnja zasedanja; zagotavljanje povezav z drugimi znanstvenimi delovnimi skupinami in zainteresiranimi stranmi; pomoč pri pripravi letnih poročil; posebne dejavnosti, dodeljene skupinam CMD v skladu z njihovimi delovnimi programi; pomoč pri zagotavljanju regulativne in zakonske pomoči pri dejavnostih skupin CMD; usklajevanje 60dnevnega postopka za obravnavo v primeru nesporazumov med državami članicami pri postopkih vzajemnega sodelovanja ali decentraliziranih postopkih ter pripravo seznama zdravil, za katera je treba pripraviti usklajeni Povzetek glavnih značilnosti zdravila.
As part of the Agency's mission to provide information to interested parties, the Agency will work to improve the quality of translations. 
Agencija si bo v okviru svojega poslanstva za zagotavljanje informacij zainteresiranim stranem prizadevala izboljšati kakovost prevodov.
The Agency will also offer substantial support to small and mediumsized enterprises (SMEs) through its new SME Office, and will work with academia, learned societies and industry on issues relating to new technologies. 
Agencija bo prek svojega novega urada za mala in srednje velika podjetja zagotovila tudi pomembno podporo malim in srednje velikim podjetjem in bo sodelovala z akademskimi sveti, znanstvenimi združenji in industrijo glede vprašanj v zvezi z novimi tehnologijami.
Contributing towards stimulating the innovation and research of medicines in the EU, to allow faster access to new therapies and technologies; 
prispevek k spodbujanju inovacij in raziskav zdravil v EU, s čimer bi izboljšali dostop do novih terapij in tehnologij;
The Agency's inspection-related working parties will: harmonise inspection procedures and processes, in particular those relating to inspections of active substances and to pharmacovigilance; develop guidelines in light of the requirements of Community legislation on clinical trials and blood; and continue to work on GMP guidelines on products used as gene and cell therapies. 
Delovne skupine Agencije, povezane z inšpekcijskim nadzorom, bodo: usklajevale inšpekcijske postopke in procese, zlasti tiste, ki se nanašajo na inšpekcijske preglede aktivnih snovi in farmakovigilanco; razvijale smernice v duhu zahtev zakonodaje Skupnosti o kliničnih preizkusih in krvi ter nadaljevale delo na smernicah dobre proizvodne prakse pri izdelkih, ki se uporabljajo za gensko in celično zdravljenje.
Cooperation between the EMEA and the US Food and Drug Administration will continue in the context of the EU-USA confidentiality arrangements, with primary focus on the parallel scientificadvice process and the exchange of safety-related information. 
Sodelovanje med EMEA in FDA ZDA se bo nadaljevalo v okviru dogovorov o zaupnosti med EU in ZDA, pri čemer se bo največ pozornosti posvetilo vzporednemu znanstvenemu svetovanju in izmenjavi informacij, povezanih z varnostjo.
As part of this approach, the EMEA and national competent authorities have implemented the EU Benchmarking System, with its regular cycle of self-assessment activities and peer-review visits. 
EMEA in nacionalni pristojni organi so v okviru tega pristopa začeli izvajati sistem EU za primerjalne analize z rednim ciklusom dejavnosti samoocenjevanja in medsebojnih pregledov.
Protocol-assistance and follow-up requests Scientific-advice and follow-up requests 
Zahtevki za pomoč pri protokolu in spremljanje Zahtevki za znanstveno svetovanje in spremljanje
The sampling and testing programme for centrally authorised products will continue in 2006, using the expertise of the EEA's network of official medicines-control laboratories, enabling the quality of medicinal products on the market in the EEA to be controlled. 
Program vzorčenja in preizkušanja za zdravila, odobrena po centraliziranem postopku, se bo nadaljeval v letu 2006 z uporabo strokovnega znanja mreže EGP uradnih laboratorijev za nadzor zdravil, ki omogočajo nadzor kakovosti zdravil na trgu EGP.
The regulatory and scientific consistency of scientific committees (CHMP and CVMP) opinions and assessment reports, and their quality, will be further improved. 
Dodatno se bosta izboljšali regulativna in znanstvena skladnost ter kakovost mnenj in poročil o oceni odborov (CHMP in CVMP).
Revenue and expenditure overview 2004-2006 
Pregled prihodkov in odhodkov za obdobje 2004-2006
Total grade D Total Staff 
Stopnja D skupaj Osebje skupaj
Meetings at the EMEA 
Sestanki v EMEA
As an important element of the harmonised approach to the scientific assessment of herbal medicinal products in the EU, the Committee on Herbal Medicinal Products (HMPC) will pay particular attention in 2006 to establishing Community herbal monographs, as well as to preparing entries to the draft list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products. 
Odbor za zdravila rastlinskega izvora (HMPC) bo leta 2006 v okviru usklajenega pristopa k znanstvenemu ocenjevanju zdravil rastlinskega izvora v EU posvetil posebno pozornost pripravi monografij rastlin Skupnosti ter pripravi vnosov v osnutek seznama snovi rastlinskega izvora, pripravkov in njihovih kombinacij za uporabo v tradicionalnih zdravilih rastlinskega izvora.
The Agency is continuing the development of the scientific-memory database for centrally authorised veterinary medicines. 
Agencija še naprej razvija svojo zbirko podatkov znanstvenega pomnilnika za veterinarska zdravila, odobrena po centraliziranem postopku.
The priorities for the Agency's IT activity relate to the continued provision of quality services in corporate IT, meetings-management and conferences, and electronic document-management and publishing. 
Prednostna področja na področju informacijske tehnologije Agencije so povezana s stalnim zagotavljanjem kakovostnih storitev na področju podjetniške informacijske tehnologije, vodenjem sestankov in konferenc ter vodenjem in objavljanjem elektronske dokumentacije.
Subject to the outcome of the analysis of business processes, the EMEA will accept electroniconly submissions of applications for marketing authorisations in the eCTD format towards the end of the year. 
EMEA bo enkrat konec leta glede na analizo poslovnih procesov sprejela samo elektronsko pošiljanje vlog za dovoljenje za promet v formatu eCTD.
Given this significant growth in activity, the Agency will develop its meetings-management system to make online booking facilities available to delegates, thereby increasing the efficiency and effectiveness of this process. 
Ker se je število dejavnosti precej povečalo, bo Agencija razvila svoj sistem vodenja sestankov, po katerem bodo delegati lahko opravili rezervacije prek spleta, s čimer se bo povečala učinkovitost in uspešnost njenih postopkov.
In addition, the Agency will encourage marketing-authorisation holders to request pre-submission meetings to streamline the submission and review of line-extension and variation applications, thus facilitating the availability of new indications and pharmaceutical forms. 
Poleg tega bo Agencija spodbujala imetnike dovoljenj za promet, naj zahtevajo sestanke pred oddajo vloge, na katerih bi poenostavili oddajo vloge ter pregledali vloge za razširitev terapevtskih indikacij in spremembe, s čimer bi poenostavili razpoložljivost novih indikacij in farmacevtskih oblik.
Work to develop EMEA interaction with top-quality experts from national authorities, academia, learned societies and industry on challenges relating to new technologies; 
prizadevanje za razvoj vzajemnega delovanja EMEA in vrhunskih znanstvenikov nacionalnih organov, akademskih krogov, znanstvenih združenj in industrije glede izzivov, povezanih z novimi tehnologijami;
Development of corporate applications will concentrate on the completion of phase III of the Meetings Management System (end of March), the continuing update of the corporate product database and tracking system SIAMED to include provisions of the new medicines legislation, and its migration to a different technical platform, and further work on a number of smaller systems such as the contracts database. 
Razvoj podjetniških uporabniških programov se bo osredotočal na dokončanje tretje faze sistema vodenja sestankov (konec marca), stalno posodabljanje zbirke podatkov o podjetniških izdelkih in sistem iskanja SIAMED, tako da bo vključil določbe nove zakonodaje o zdravilih in prehod na novo tehnološko platformo ter nadaljnje delo na vrsti podobnih sistemov, kot je zbirka podatkov o pogodbah.
The Agency will advance the work on the new database for GMP certificates and manufacturing authorisations, and will complete the construction of an EU telematics data centre with high availability, high scalability and good performance. 
Agencija bo izboljšala delo na novi zbirki podatkov za potrdila o dobri proizvodni praksi in dovoljenjih za izdelavo ter dokončno zgradila telematski podatkovni center z visoko stopnjo razpoložljivosti, obvladljivosti in učinkovitosti.
Meetings at the EMEA Document management and publishing 
Sestanki v EMEA Upravljanje dokumentov in objave
Managing the Agency 
Upravljanje Agencije
Number of reimbursed delegates 
Število delegatov s povrnjenimi stroški
For enquiries concerning PMF certificates 
Za vprašanja o potrdilih PMF
Chapter 1 EMEA in the European system 
Poglavje 1 EMEA v evropskem sistemu
It will also roll out the first production version of the EU-wide database on manufacturing authorisations and GMP certificates. 
Objavila bo tudi prvo delovno različico zbirke podatkov za vso EU o dovoljenjih za izdelavo in potrdilih o dobri proizvodni praksi.
Annex 4 Management Board and scientific committee meeting dates in 2006 
Priloga 4 Datumi sestankov upravnega odbora in znanstvenega odbora v letu 2006
Strengthen cooperation on pharmacovigilance, scientific advice, support to SMEs and the provision of information; 
Evropska mreža zdravil krepitev sodelovanja na področju farmakovigilance, znanstvenega sodelovanja, podpore malim in srednje velikim podjetjem in zagotavljanja informacij;
These include acceleratedassessment, conditional-marketing-authorisation and compassionate-use procedures, and the provision of scientific opinions on medicinal products intended for non-EU markets (in cooperation with the WHO). 
Sem se prištevajo postopki za pospešeno oceno, pogojno izdajo dovoljenja za promet in sočutno uporabo ter zagotavljanje znanstvenih mnenj o zdravilih, ki niso namenjena na trge EU (v sodelovanju z WHO).
Certificate requests 
Zahtevki za potrdila
Coordination groups for mutual-recognition and decentralised procedures (human and veterinary products) 
Skupine za usklajevanje za postopke vzajemnega priznavanja in decentralizirane postopke (zdravila za uporabo v humani medicini in veterinarska zdravila)
Thursday 28 September 
Četrtek, 28. septembra
Post-authorisation activities 
Dejavnosti po izdaji dovoljenja
• on the Internet at www.emea.eu.int 
• na internetu na www.emea.eu.int
Operation of new regulatory procedures, including accelerated-assessment, conditionalmarketing-authorisation and compassionate-use procedures; 
delovanje novih regulativnih postopkov, vključno s postopki za pospešeno oceno, pogojno izdajo dovoljenja za promet in sočutno uporabo;
The RMP identifies known and potential risks with the medicinal product so that risk-minimisation measures and other pharmacovigilance activities can be implemented proactively to protect public health. 
Načrt za obvladovanje tveganja opredeljuje znana in potencialna tveganja zdravila, tako da je mogoče v skrbi za varovanje javnega zdravja izvesti ukrepe za zmanjšanje tveganja in druge dejavnosti na področju farmakovigilance.
MRL ext./mod. 
Vloge za razš./spre.
The suite of business intelligence and statistical tools within EudraVigilance will enable safety data relating to products on the market and under development in Europe to be monitored, analysed and acted upon in an increasingly sophisticated manner; an interim data warehouse and business intelligence solution for medicinal products for human use will be made available to all EU/EEA regulators in March 2006. 
Nabor orodij za poslovno inteligenco in statističnih orodij v okviru sistema EudraVigilance bo omogočil vedno bolj dodelano spremljanje varnostnih podatkov o izdelkih, ki so v Evropi že na trgu in ki se šele razvijajo, njihovo analizo in odzivanje nanje; pilotsko podatkovno skladišče in rešitev poslovne inteligence za zdravila za uporabo v humani medicini bodo na voljo vsem zakonodajalcem EU/EGS marca 2006.
Management Board and scientific committee meeting dates in 2006 EMEA contact points 
Datumi sestankov upravnega odbora in znanstvenega odbora v letu 2006 Kontaktne osebe EMEA
Provide high-quality information to provide for adequately informed patients and improve the availability of useful information to healthcare professionals; 
Odprtost, obveščanje in zagotavljanje informacij zagotavljanje visoko kakovostnih informacij za ustrezno obveščenost bolnikov in izboljšanje dostopnosti do koristnih informacij za zdravstvene strokovnjake;
The European medicines network 
Evropska mreža zdravil
The existing business-continuity arrangements will be improved to support a range of disasterrecovery scenarios. 
Obstoječe ureditve za zveznost poslovanja bodo izboljšane, tako da bodo podpirale vrsto scenarijev za obnovitve programske opreme po njeni odpovedi.
Total grade C D*5 
Stopnja C skupaj D*5
Development of the database containing information about authorised medicinal products in the EU will also continue. 
Nadaljeval se bo tudi razvoj zbirke podatkov EudraPharm, ki vsebuje informacije o zdravilih z dovoljenjem za promet v EU.
Annex 3 Revenue and expenditure overview 2004-2006 
Priloga 3 Pregled prihodkov in odhodkov za obdobje 2004-2006
Total grade B C*7 
Stopnja B skupaj C*7
This is a result of initiatives taken by the CVMP to facilitate the authorisation of products for minor uses and minor species. 
To je posledica pobud Odbora za zdravila za uporabo v veterinarski medicini, s katerimi je ta želel poenostaviti izdajanje dovoljenj za zdravila za manj pomembne uporabe in vrste.
Modifications to the existing tasks, and the introduction of new ones, have put the EU regulatory system in a better position to ensure that safe and effective medicines, as well as adequate information about them, are available to European patients. 
Regulativni sistem EU je tako zaradi spremembe obstoječih nalog in uvedbe novih bolj sposoben zagotavljati bolnikom v Evropi varna in učinkovita zdravila ter ustrezne informacije o njih.
The database of authorised medicinal products in the EU will make authoritative, up-to-date information on all these products available to regulators, health professionals and the general public; while the current version of the application is already available to EU regulators, public access will be provided by September 2006. 
EudraPharm, zbirka podatkov o zdravilih z dovoljenjem za promet v EU, bo zakonodajalcem, zdravstvenim strokovnjakom in širši javnosti ponujala verodostojne najnovejše informacije o vseh teh izdelkih; medtem ko je zakonodajalcem EU sedanja različica uporabniških programov že na voljo, bo javni dostop zagotovljen do septembra 2006.
Cooperation will also continue with the European Pharmacopoeia and with the European Directorate for the Quality of Medicines, in the context of the sampling and testing programme being operated to supervise the quality of centrally authorised medicinal products placed on the market. 
Nadaljevalo se bo tudi sodelovanje z Evropsko farmakopejo in Evropskim direktoratom za kakovost zdravil v okviru programa vzorčenja in preizkušanja, ki se izvaja za nadzor kakovosti zdravil, za katera je bilo izdano dovoljenje po centraliziranem postopku in ki so v prometu.
At the same time, five of the EU telematics systems - EudraNet, EudraVigilance, EudraCT, the database of authorised medicinal products in the EU, and the product-informationmanagement application, PIM, - will have to be operated, supported, maintained and further developed. 
Hkrati bo treba upravljati, podpirati, vzdrževati in dodatno razvijati pet telematskih sistemov EU - EudraNet, EudraVigilance, EudraCT, EudraPharm - zbirko podatkov o zdravilih z dovoljenjem za promet v EU ter uporabniški program za upravljanje informacij o izdelkih.
Committee for Medicinal Products for Veterinary Use meetings 17-19 January 
Sestanki Odbora za zdravila za uporabo v veterinarski medicini 17.-19. januarja
Information technology Infrastructure 
Informacijska tehnologija Infrastruktura
Parallel-distribution notifications validated (Input) 
Potrjena obvestila o vzporedni distribuciji (Vhodni podatek)
29 May-1 June 
29. maja-1.
18-21 September 
18.-21. septembra
E-mail: antoon.gijsens@emea.eu.int 
E-naslov: antoon.gijsens@emea.eu.int
Develop scientific-advice procedures to give as much support as possible to companies at the different stages of development of medicinal products; 
Dostop do zdravil ter spodbujanje inovacij in raziskav razvoj postopkov znanstvenega svetovanja, da bi čim bolj podprli podjetja na različnih stopnjah razvoja zdravil;
CHAPTER 3 INSPECTIONS 
Poglavje 3 Inšpekcijski nadzor
Chapter 3 Inspections 
POGLAVJE 3 INŠPEKCIJSKI NADZOR
26-29 June 
26.-29. junija
Monitoring the safety of medicines for human and veterinary use is a priority area for the EMEA. 
Prednostno področje EMEA je spremljanje varnosti zdravil za uporabo v humani medicini in veterinarskih zdravil.
New regulatory procedures aimed at increasing access to medicines, including acceleratedassessment, conditional-marketing-authorisation and compassionate-use procedures, will also be applied. 
Uporabljali se bodo tudi novi regulativni postopki, ki naj bi izboljšali dostop do zdravil, vključno s postopki za pospešeno oceno, izdajo pogojnih dovoljenj za promet z zdravili in sočutno uporabo.
Scientific-advice and protocol-assistance requests (human medicines) 
Zahtevki za znanstveno svetovanje in pomoč pri protokolu (Zdravila za uporabo v humani medicini)
Thursday 9 March 
Četrtek, 9. marca
5 Appropriation/Budget 2006 as adopted by the Management Board on 15 December 2005. 
5 Proračunska sredstva/proračun 2006, ko ga je upravni odbor sprejel 15. decembra 2005.
Safety of medicines 
Varnost zdravil