natgillin/translations-raw huggingface dataset:
Publication of summaries of opinion and EPARs, together with the product information, in all official EU languages after the European Commission decision granting marketing authorisation 
Objavljanje povzetkov mnenj in EPAR-ov, skupaj z informacijami o izdelkih, v vseh uradnih jezikih EU po sprejetju odločitve Evropske komisije o izdaji dovoljenja za promet z zdravilom.
The target for 2005 is to have a majority of Member State competent authorities and a significant number of pharmaceutical companies reporting through the system 
Cilj za leto 2005 je, da bi po tem sistemu poročala večina pristojnih organov držav članic in precejšnje število farmacevtskih podjetij.
The Agency ensures full compliance with all regulatory and quality requirements in the areas of document and records management. 
Agencija zagotavlja popolno upoštevanje vseh regulativnih in kakovostnih zahtev na področju vodenja dokumentacije in poročil.
The COMP ad hoc biotechnology group will support the designation process for emerging therapies, and the COMP group with interested parties will continue its activities on a regular basis 
Ad hoc biotehnološka skupina COMP bo podpirala postopek določitve za nove terapije, skupina COMP za zainteresirane strani pa bo nadaljevala redno izvajanje svojih dejavnosti.
Similarly, the entry into force of the remaining provisions on 20 November 2005 will be the focus of our attention this year. 
Podobno bo letos naša pozornost usmerjena k 20. novembru 2005, začetku veljavnosti preostalih določb.
The Agency's mandate for openness and provision of information is expanded. 
Naloge in pooblastila Agencije glede odprtosti in zagotavljanja informacij so večja.
After serving as a pharmacist (Captain) in a pharmaceutical control laboratory of the German Army, he joined the former German Federal Health Office in 1983. 
Potem ko je delal kot farmacevt (vodja) v farmacevtskem nadzornem laboratoriju nemške vojske, se je leta 1983 pridružil bivšemu nemškemu Zveznemu uradu za zdravje.
The EMEA is preparing for its new responsibility of providing secretarial support to the new coordination group, which will include: 
EMEA se pripravlja na svojo novo pristojnost za opravljanje tajniških del za novo skupino za usklajevanje, ki bo vključevala:
The new legislation introduces changes to the administrative structure of the Agency, extends the scope of the Agency's activities, reinforces its activities in the area of providing scientific advice to companies, and enables the Agency to provide administrative and scientific support to small and medium-sized enterprises. 
Nova zakonodaja uvaja spremembe v upravni organiziranosti Agencije, razširja obseg njenih dejavnosti, krepi njeno dejavnost na področju znanstvenega svetovanja podjetjem ter ji omogoča zagotavljanje administrativne in znanstvene podpore majhnim in srednje velikim podjetjem.
After a year in merchant banking, he was finance director of a private company from 1988 to 1995. 
Po enem letu v komercialnem bančništvu je bil od 1988 do 1995 finančni direktor zasebnega podjetja.
Reach agreement on a final list and a timetable for the list of medicinal products for SPC harmonisation with the Commission, following recommendations from the coordination group 
Doseči soglasje glede dokončnega seznama in časovnega razporeda za seznam zdravil za uskladitev SPC s Komisijo po priporočilih skupine za usklajevanje.
Further strengthening of the Agency's coordinating role in the field of pharmacovigilance, as a result of the implementation of new Community legislation 
Nadaljnja krepitev usklajevalne vloge Agencije na področju farmakovigilance kot rezultat izvajanja nove zakonodaje Skupnosti.
Revision of current procedures, including incorporation of reduced timelines for communication of opinions to the Commission from 30 to 15 days 
Revizija sedanjih postopkov, med katere spada tudi vključitev skrajšanih rokov za sporočanje mnenj Komisiji s 30 na 15 dni.
More biosimilar products are anticipated in 2005 compared to 2004 
leta 2005 se v primerjavi z letom 2004 pričakuje več biološko podobnih izdelkov;
In 2005, the Integrated Quality Management/Audit group will also have a training and coordination role in the EU benchmarking system, involving the national competent authorities of the European medicines network. 
V letu 2005 bo imela vlogo usposabljanja in usklajevanja v sistemu EU za primerjalne analize tudi Integrirana skupina za upravljanje kakovosti/revizije, v kateri bodo sodelovali pristojni nacionalni organi Evropske mreže zdravil.
Clarification of the requirements related to the content of a dossier for a registration application. 
Pojasnitev zahtev, ki se nanašajo na vsebino dokumentacije v vlogi za registracijo.
Pharmacovigilance remains a high priority of the Agency for 2005 to ensure that effective risk management is continually applied to post-authorisation monitoring of veterinary medicines throughout the EU. 
Farmakovigilanca ostaja pomembna prednostna naloga Agencije v letu 2005, ki zagotavlja, da se pri spremljanju po izdaji dovoljenja za promet z veterinarskimi zdravili v vsej EU stalno uporablja učinkovito obvladovanje tveganja.
Establishment of the necessary measures to provide assistance to companies producing veterinary products which have limited markets or are intended for diseases with a regional distribution (Article 79 of Regulation 726/2004) 
Uvedba potrebnih ukrepov, da se zagotovi pomoč podjetjem proizvajalcem veterinarskih izdelkov, ki imajo omejene trge ali so namenjeni regionalno porazdeljenim boleznim (člen 79
In addition, the EMEA will organise training of national assessors on topics agreed with the Agency's scientific committees and EU national competent authorities 
EMEA bo organizirala tudi usposabljanje nacionalnih ocenjevalcev o temah, ki jih skupno določijo znanstveni odbori Agencije in pristojni nacionalni organi EU.
Annex 3 Guidelines and working documents in 2005 
Priloga 3 Smernice in delovni dokumenti za leto 2005
It is expected that further extrapolation of existing MRLs to additional species will continue as agreed within the CVMP's policy on minor uses and minor species as a direct response to specific applications from marketing authorisation holders 
Po pričakovanjih naj bi se nadaljnja ekstrapolacija sedanjih MRL na dodatne vrste nadaljevala, kot je bilo dogovorjeno v okviru politike CVMP za manjše uporabe in manj pomembne vrste, kot neposredni odgovor na posebne vloge imetnikov dovoljenj za promet z zdravilom.
In November 2000, he became director-general of the Advanced Centre of Services and Training for Health and Life Sciences, Dr Rober Foundation (UAB). 
Novembra 2000 je postal generalni direktor Sodobnega centra za storitve in usposabljanje za zdravje in znanosti o življenju, Fundacije dr. Roberja (UAB).
Address procedural, regulatory and scientific issues arising from the mutual recognition procedure, including best practice guide for standard operating procedures for all such referrals 
Obravnava postopkovnih, regulativnih in znanstvenih vprašanj, ki izhajajo iz postopka medsebojnega priznavanja, vključno z navodili najboljše prakse za običajne operativne postopke za vse takšne predložitve.
The growing number of meetings managed by the Agency and increasing number of delegate days will require the development of meeting technologies such as IP telephony, videoconferencing and web streaming. 
Naraščajoče število sestankov, ki jih vodi Agencija, in vse večje število delegatskih dni bo zahtevalo razvoj tehnologij za sestanke, kot je telefonija IP, prenašanje preko videokonference in neprekinjen pretok po spletu (web streaming).
Ms Nuttall then served with the Food and Agriculture Organisation of the United Nations from 1990 to 1995. 
Nuttallova od 1990 do 1995 delala v Organizaciji ZN za prehrano in kmetijstvo.
To monitor and facilitate the implementation of the new legislation affecting the Agency, increase the transparency of its activities, and provide timely reports and opinions to EU institutions 
Spremljati in omogočiti izvajanje nove zakonodaje, ki zadeva Agencijo, povečati preglednost njenih dejavnosti ter institucijam EU pravočasno zagotavljati poročila in mnenja.
The scope of medicines for which the centralised procedure is mandatory extends to include new therapeutic categories. 
Obseg zdravil, za katera je centralizirani postopek obvezen, se razširi z vključitvijo novih terapevtskih kategorij.
To improve the scientific advice procedure and stimulate its use throughout the lifecycle of medicinal products, including the post-authorisation phase. 
Izboljšati postopek znanstvenega svetovanja in spodbujati njegovo uporabo v celotnem življenjskem ciklu zdravil, vključno s fazo po izdaji dovoljenja za promet.
Despite this rather negative environment, there appears to be a small but steady flow of new products in the pipeline, with 11 full centralised applications forecast for 2005 
Kljub temu dokaj neugodnemu okolju se zdi, da je se pripravlja manjši, a stalen dotok novih izdelkov, saj je za leto 2005 predvidenih enajst vlog, ki naj bi se v celoti obravnavale po centraliziranem postopku.
Periodic safety update reports, follow-up measures and specific obligations (Input) 
Periodično dopolnjena poročila o varnosti, nadaljnji ukrepi in posebne obveznosti (Vhodni podatek)
Coordination of the necessary workload for the initiation of such referrals that can be handled by the secretariat and CVMP in 2005 
Uskladitev potrebne delovne obremenitve za uvedbo takšnih predložitev, ki jo zmoreta sekretariat in CVMP v letu 2005.
The principal objectives are the development and timely and accurate management of the EMEA's human and financial resources, including personnel administration, recruitment procedures and professional training, as well as the provision of information to staff and other concerned persons on these matters 
Glavna cilja sta razvoj ter pravočasno in natančno upravljanje človeških in finančnih virov EMEA, vključno z upravljanjem osebja, zaposlitvenimi postopki in strokovnim usposabljanjem, ter zagotavljanje informacij osebju in drugim zadevnim osebam o teh zadevah.
The Agency's activities in the field of herbal medicinal products will help to harmonise procedures and provisions concerning herbal medicines laid down in the Member States and to integrate further herbal medicinal products in the European regulatory framework. 
Dejavnosti Agencije na področju zeliščnih zdravil bodo pripomogle k uskladitvi postopkov in predpisov o zeliščnih zdravilih, določenih v državah članicah, in vključitvi dodatnih zeliščnih zdravil v evropski regulativni okvir.
The first ten VAMF applications should be received in 2005. 
Prvih deset vlog za VAMF naj bi prispelo v letu 2005.
Annex 2 Revenue and expenditure overview 2003-2005 
Priloga 2 Pregled prihodkov in odhodkov za obdobje 2003-2005
There will be a continuous need for adaptation, maintenance and upgrading of the EudraVigilance database and data processing network, in collaboration with IT and project management teams at the Agency 
Stalno bo treba prilagajati, vzdrževati in nadgrajevati zbirko podatkov EudraVigilance in mrežo za obdelavo podatkov v sodelovanju s skupinami za IT in vodenje projektov v Agenciji.
Implementation of the 2005 budget 
Izvajanje proračuna za leto 2005.
The table below gives an overview of the likely workload in accounts in 2005. 
V priloženi tabeli je naveden pregled verjetne delovne obremenitve računovodstva v letu 2005.
Referrals are initiated either in order to obtain harmonisation within the Community of the conditions of authorisation for products already authorised by the Member States (Article 34 of Directive 2001/82/EC), or in case of Community interest and for safety-related issues (Articles 35 and 40 of Directive 2001/82/EC). 
Predložitve se izvedejo, zato da se v Skupnosti zagotovi uskladitev pogojev za izdajo dovoljenja za izdelke, za katere so države članice že izdale dovoljenje (člen 34 Direktive 2001/82/ES), ali če gre za interes Skupnosti ali za varnostna vprašanja (člena 35 in
Continued implementation and maintenance of the electronic transmission of ICSRs and support of the day-to-day operation and maintenance of the electronic ICSR transmission process for the pre- and post-authorisation phase via EudraVigilance 
Nadaljnje izvajanje in vzdrževanje elektronskega prenosa ICSR ter podpora vsakodnevnemu delovanju in vzdrževanju postopka elektronskih prenosov ICSR za fazo pred izdajo dovoljenja in po njej prek EudraVigilance.
In 1997, he was appointed head of the pharmaceuticals assessment unit of the French veterinary agency (AFSSA-ANMV). 
Leta 1997 je bil imenovan za vodjo ocenjevalne enote za farmacevtske izdelke pri francoski veterinarski agenciji (AFSSA-ANMV).
The EMEA/CHMP Working Party with Patients' Organisations will meet regularly and provide a forum allowing patients to provide their input into the regulatory system 
Delovna skupina EMEA/CHMP za sodelovanje z organizacijami bolnikov se bo redno sestajala in zagotavljala pristojno mesto, kjer bodo bolniki lahko oddali svoj prispevek k regulativnemu sistemu.
Increased transparency on arbitration/referral procedures and consistent presentation of available information regarding arbitration/referral procedures irrespective of the legal basis of such procedures 
Povečanje preglednosti arbitražnih postopkov/postopkov za predložitev ter dosledno zagotavljanje razpoložljivih informacij o arbitražnih postopkih/postopkih za predložitev, ne glede na njihovo pravno podlago.
Objective for 2005: 
Cilj za leto 2005:
Undertake the initial phase of the implementation plan for the EMEA Road Map to 2010 in relation to veterinary medicines, with particular emphasis on risk management of antimicrobial resistance, which may result from use of antimicrobials in animals, and on ensuring the adequacy of the environmental risk assessment in accordance with new EU legislation 
Uvedba začetne faze plana za izvajanje usmeritvenega načrta EMEA do leta 2010 za veterinarska zdravila, s posebnim poudarkom na obvladovanju tveganja protimikrobne odpornosti, ki je lahko posledica uporabe protimikrobnih sredstev pri živalih, in zagotavljanju ustreznosti ocene tveganja za okolje v skladu z novo zakonodajo EU.
She worked for the pharmaceutical industry from 1992 to 1995 before joining the EMEA in July 1995. 
Od 1992 do 1995 je delala za farmacevtsko industrijo, preden se je julija 1995 pridružila EMEA.
The working parties and scientific advisory groups will support the CVMP with its provision of scientific input to the Commission and other Community institutions on request, with regard to animal health issues of concern to the Community. 
Delovne in znanstveno svetovalne skupine bodo na zahtevo podprle CVMP pri njegovem zagotavljanju znanstvenih prispevkov Komisiji in drugim institucijam Skupnosti v zvezi z vprašanji zdravja živali, ki se nanašajo na Skupnost.
Implementation of the projects in 2005 will advance the Agency towards the goal of collecting all information about adverse drug reactions electronically and conducting automatic signal detection. 
Izvajanje projektov v letu 2005 bo Agencijo približalo cilju, ki je elektronsko zbiranje vseh informacij o neželenih učinkih zdravil in izvajanje samodejnega odkrivanja signalov.
Postgraduate studies include a PhD in socio-economic planning. 
Podiplomski študij vključuje doktorat iz socialno-ekonomskega načrtovanja.
In 1987, she joined the German Environmental Agency as scientific administrator involved in risk assessment of industrial chemicals. 
Leta 1987 se je pridružila nemški Agenciji za okolje kot znanstvena administratorka za oceno tveganja industrijskih kemikalij.
9 Particular attention will be given to the implementation of provisions reinforcing the safety of medicines, accelerating the availability of medicines to EU patients and creating the right environment to stimulate research. 
Posebna pozornost bo namenjena izvajanju določb, ki krepijo varnost zdravil, pospešujejo njihovo dostopnost bolnikom v EU in ustvarjajo ustrezno okolje za spodbujanje raziskovalnega dela.
He was appointed head of sector on 1 May 2002. 
1. maja 2002 je bil imenovan za vodjo Sektorja.
2.10 Provision of information to healthcare professionals and patients 
2.10 Zagotavljanje informacij zdravstvenim strokovnjakom in bolnikom
The Agency will capitalise on its previously successful initiatives to maintain contacts and exchanges with interested parties, and aims to fulfil its obligations in accordance with new legislation to facilitate greater communication and dialogue on matters of common interest. 
Agencija bo izkoristila svoje prvotne uspešne pobude za ohranitev stikov in izmenjav z zainteresiranimi stranmi ter namerava izpolniti svoje obveznosti v skladu z novo zakonodajo, da se omogoči boljše obveščanje in dialog o zadevah skupnega interesa.
In 1986 he joined the University of Bordeaux and was involved in various research areas in public health, including epidemiology, clinical research, pharmacovigilance, tropical and infectious diseases, health economy and health education. 
Leta 1986 se je pridružil Univerzi v Bordeauxu in se začel ukvarjati z raziskovanjem javnega zdravja, vključno z epidemiologijo, kliničnimi raziskavami, farmakovigilanco, tropskimi in nalezljivimi boleznimi, zdravstveno ekonomijo in zdravstvenim izobraževanjem.
Monitor the assessment procedures for PMFs and VAMFs, and review the procedures on the basis of experience gained 
Spremljati postopke presoje za PMF in VAMF ter preverjati postopke na podlagi pridobljenih izkušenj.
This includes making multilingual navigation possible and improving presentation, user friendliness and search tools 
To vključuje možnost večjezične navigacije ter izboljšanje predstavitve, da bo bolj prijazna do uporabnikov, in iskalnih orodij.
The Agency will continue to work closely with the relevant European institutions in the field of veterinary medicinal products, particularly the European Commission, and will work to increase the level of collaboration already established with the European Food Safety Authority during the previous year. 
Institucije EU in regulativne zadeve Agencija bo še naprej tesno sodelovala s pristojnimi evropskimi institucijami na področju veterinarskih zdravil, zlasti z Evropsko komisijo, in si prizadevala za zvišanje ravni sodelovanja, ki je bilo vzpostavljeno z Evropsko agencijo za varno hrano v preteklem letu.
Increase in number of requests for protocol assistance in line with an increase in the number of designated orphan medicinal products and on the basis of the recommendation to seek protocol assistance made by the COMP at the time of designation 
Povečevanje števila zahtevkov za pomoč pri protokolu v skladu z večjim številom zdravil, določenih za zdravila sirote, in na podlagi priporočila, da naj se med postopkom določitve poišče pomoč pri protokolu, ki ga je dal COMP.
Once completed, the EuroPharm database will help healthcare professionals, patients and the general public to access up-to-date and reliable information about medicinal products available on the EU market. 
Zbirka podatkov EuroPharm bo, ko bo dokončno oblikovana, omogočila zdravstvenim strokovnjakom, bolnikom in javnosti dostop do posodobljenih in zanesljivih podatkov o zdravilih, ki so na voljo na trgu EU.
Continued development of the EuroPharm database to increase access to information on medicines available in the European Union 
Stalno razvijanje zbirke podatkov EuroPharm, da se poveča dostop do informacij o zdravilih, ki so na voljo v Evropski uniji.
New legislation requires that Member States agree within the coordination group on a list of medicinal products for which harmonised summaries of product characteristics shall be prepared to promote harmonisation of veterinary medicines authorised in the EU. 
Nova zakonodaja zahteva, da se države članice strinjajo s skupino za usklajevanje glede seznama zdravil, za katera se pripravijo usklajeni povzetki glavnih značilnosti izdelka, da se spodbuja usklajevanje veterinarskih zdravil, ki imajo dovoljenje za promet v EU.
To this end, the CHMP has already established a Scientific Advice Working Party (SAWP) that has the sole remit of providing scientific advice to undertakings. 
V ta namen je Odbor za zdravila za uporabo v humani medicini (Committe for Medicinal Products for Human Use, CHMP) že ustanovil Delovno skupino za znanstveno svetovanje (SAWP), katere izključna naloga je znanstveno svetovanje podjetjem.
Strengthen the concept of lifecycle management and scientific consistency 
Krepitev koncepta upravljanja življenjskega cikla in znanstvene doslednosti.
To contribute to the promotion of harmonisation of authorisation of veterinary medicines in the EU 
Prispevati k spodbujanju uskladitve izdajanja dovoljenj za veterinarska zdravila v EU.
Preparatory work in the area of procedures to be established in relation to the provision to Member States and European institutions of the best scientific opinion on questions related to herbal medicinal products, as well as to the adoption of opinions at the request of the Committee for Medicinal Products for Human Use 
Pripravljalno delo na področju postopkov, ki jih je treba vzpostaviti, da se državam članicam in evropskim institucijam zagotovi najboljše znanstveno mnenje v zvezi z vprašanji o zeliščnih zdravilih in za sprejetje mnenj na zahtevo Odbora za zdravila za uporabo v humani medicini.
Management and reinforcement of the procedure, introduced in 2004, for the handling of safety concerns, both pre- and post-authorisation, for centrally processed applications 
Upravljanje in krepitev postopka, uvedenega leta 2004, za obravnavanje varnostnih vprašanj, tako pred izdajo dovoljenja kot po njej, za centralno obravnavane vloge.
Further actions necessary to meet the Agency's long-term objectives will be included in future work programmes, with a view to full implementation of the Road Map by 2010. 
Dodatni ukrepi, potrebni za izpolnitev dolgoročnih ciljev Agencije, bodo vključeni v prihodnje delovne programe, zato da se usmeritveni načrt ("Road Map")
The Agency will cooperate more actively with the WHO and will provide opinions on medicinal products intended exclusively for markets outside the EU. 
Agencija bo dejavneje sodelovala s Svetovno zdravstveno organizacijo in dajala mnenja o zdravilih, namenjenih izključno trgom zunaj EU.
In 1984 Dr Korteweg created the regulatory compliance/quality assurance audit department for the European pharmaceutical R&D division of BristolMyers Squibb, later becoming director of worldwide regulatory compliance (auditing). 
Leta 1984 je dr. Kortewegova ustanovila oddelek za revizijo regulativne skladnosti/zagotavljanja kakovosti za Divizijo R&R evropskih farmacevtskih izdelkov pri Bristol-Myers Squibb in kasneje postala direktorica svetovne regulativne skladnosti (za revizijo).
Standing and temporary working parties 
Stalne in začasne delovne skupine
The time for communication of opinion to the European Commission has been decreased considerably, which requires substantial review of the processes following the opinion of the scientific committee. 
Evropski komisiji je bil občutno skrajšan, kar zahteva poglobljen pregled postopkov ob upoštevanju mnenja znanstvenega odbora.
The EMEA will continue to support the European Commission in the updating and further development of the Notice to Applicants, providing advice on the centralised procedure and regulatory guidance for issues affecting the CHMP and its standing and temporary working parties 
EMEA bo še naprej podpirala Evropsko komisijo pri posodabljanju in nadaljnjem razvijanju obvestila vlagateljem, pri svetovanju glede centraliziranega postopka in regulativnih smernic za vprašanja, ki vplivajo na CHMP ter na njegove stalne in začasne delovne skupine.
Dr Lyngvig has 12 years' private-sector experience in the transport and consultancy industries and was appointed chief executive officer of the Danish Medicines Agency in 2000. 
Dr. Lyngvigova ima 12-letne izkušnje iz zasebnega sektorja, kjer je delala na področju transporta in svetovanja, leta 2000 pa je bila imenovana za glavno izvršno direktorico danske Agencije za zdravila.