FrancophonIA/ELRC3.0 huggingface dataset:
English: • a dose-calculation tool that enables prescribers to input a patient's height and weight in order to calculate the body surface area (BSA) and thereby to determine the appropriate VELCADE dose.
Slovenian: Navodila za odmerjanje zdravila morajo vsebovati naslednje ključne elemente: odel izračuna, s katerim bo lahko predpisovalec izračunal odmerek zdravila in telesno površino na podlagi bolnikove višine in telesne mase, in tako določil pravi odmerek zdravila VELCADE.
English: • that Velcade is to be given only by IV or SC injections; no other route of administration is allowed
Slovenian: ali s.c., nobena druga uporaba ni dovoljena.
English: It is a pleasure for me, at this point, to congratulate him and wish him every success in his further term of office.
Slovenian: V veliko zadovoljstvo mi je, da mu ob tej priložnosti čestitam in zaželim veliko uspeha v novem mandatu.
English: On behalf of the Management Board, I would like to emphasise a couple of events that took place last year.
Slovenian: V imenu upravnega odbora bi rad izpostavil nekaj dogodkov, ki so se zgodili v lanskem letu.
English: This close-knit network has been strengthened in recent years.
Slovenian: Ta tesno prepletena mreža se je v zadnjih letih okrepila.
English: 1 IMPLEMENTATION OF THE REVISED LEGISLATION
Slovenian: 1 IZVAJANJE REVIDIRANE ZAKONODAJE
English: 7 SUPPORT TO SMALL AND MEDIUM-SIZED ENTERPRISES
Slovenian: 7 PODPORA MALIM IN SREDNJE VELIKIM PODJETJEM
English: In addition to these notifications, the Agency received over 1,000 notifications of changes.
Slovenian: Agencija je poleg teh obvestil prejela tudi več kot 1000 obvestil o spremembah.
English: There were no negative opinions.
Slovenian: Negativnih mnenj ni bilo.
English: This number includes reports originating in the EU and in countries outside the EU, such as the United States.
Slovenian: Ta številka vključuje poročila, ki izvirajo iz EU in držav zunaj EU, kot na primer Združenih držav Amerike.
English: The evaluation period for the pandemic variation is then expected to be very short, typically less than one week.
Slovenian: Obdobje vrednotenja variacije pandemije naj bi bilo tako zelo kratko, navadno manj kot en teden.
English: This has been achieved by rationalisation of human resources and further process automation.
Slovenian: To je bilo doseženo z racionalizacijo človeških virov in nadaljnjo avtomatizacijo procesa.
English: An initial prototype was demonstrated to the responsible implementation group in December.
Slovenian: Začetni prototip je bil decembra predstavljen odgovorni izvedbeni skupini.
English: This initiative runs in parallel to a similar one initiated by Member States through the Mutual Recognition Facilitation Group.
Slovenian: Ta pobuda poteka vzporedno s podobno pobudo, ki so jo sprožile države članice prek skupine za poenostavitev medsebojnega priznavanja (Mutual Recognition Facilitation Group).
English: 12 COORDINATION GROUPS FOR THE MUTUAL RECOGNITION PROCEDURE AND THE DECENTRALISED PROCEDURE
Slovenian: 12 USKLAJEVALNI SKUPINI ZA POSTOPEK MEDSEBOJNEGA PRIZNAVANJA IN DECENTRALIZIRANI POSTOPEK
English: Ultimate responsibility for the Agency's operational work rests with the Executive Director.
Slovenian: Končno odgovornost za operativno delo Agencije ima izvršni direktor.
English: Working with national competent authorities
Slovenian: Sodelovanje z nacionalnimi pristojnimi organi
English: The full annual report 2005 in English can be found on the Agency's website: www.emea.eu.int
Slovenian: Celotno letno poročilo za leto 2005 v angleškem jeziku lahko najdete na spletni strani Agencije: www.emea.eu.int
English: OJ L 136, 30.04.2004, p. 1.
Slovenian: UL L 136, 30. 4. 2004, str. 1.
English: Competitiveness of the European pharmaceutical industry in the context of the ‘Lisbon Agenda' remains high on the political agenda.
Slovenian: Konkurenčnost evropske farmacevtske industrije v okviru "programa lizbonske strategije" ostaja še naprej ena od prednostnih nalog politične agende.
English: Despite the increasing number of requests, the average issuing time has remained within procedural limits.
Slovenian: Kljub naraščajočemu številu zahtevkov je povprečni čas izdaje ostal v postopkovnih mejah.
English: This document provides a summary of the Agency's annual report for 2005, adopted by the Management Board on 9 March 2006.
Slovenian: Ta dokument je povzetek letnega poročila Agencije za leto 2005, ki ga je upravni odbor sprejel 9. marca 2006.
English: The EMEA provided full secretariat and administrative support to the work of the two coordination groups.
Slovenian: EMEA je zagotovila polno podporo sekretariata in administrativno podporo za delo teh dveh usklajevalnih skupin.
English: 10 CONTRIBUTION TO EU PUBLIC HEALTH STRATEGIES
Slovenian: 10 PRISPEVEK K STRATEGIJAM JAVNEGA ZDRAVJA EU
English: The scheme will only become fully operational once the guidelines on adaptation of data requirements become available.
Slovenian: Program bo začel v celoti delovati, šele ko bodo na razpolago smernice o prilagoditvi podatkovnih zahtev.
English: Only 32 reports related to food-producing animals.
Slovenian: Samo 32 poročil se je nanašalo na živali, namenjene proizvodnji hrane.
English: Integrated quality management system
Slovenian: Integrirani sistem upravljanja kakovosti
English: I would also like to thank the secretariat of the Management Board for their constructive and outstanding collaboration throughout the year.
Slovenian: Rad bi se zahvalil tudi članom sekretariata upravnega odbora za njihovo konstruktivno in izjemno sodelovanje skozi vso leto.
English: I am confident that, as a result, the broadened outlook of the Management Board will have a favourable impact on our work.
Slovenian: Prepričan sem, da bodo tako povečane možnosti upravnega odbora pozitivno vplivale na naše delo.
English: On 20 November 2005, the Agency welcomed the full entry into force of Regulation (EC) No 726/20042, which heralds a more robust, modern and effective regulatory framework for pharmaceuticals in Europe.
Slovenian: 20. novembra 2005 je Agencija pozdravila začetek veljavnosti Uredbe (ES) št. 726/20041, ki uvaja bolj robusten, sodoben in učinkovit regulativni okvir za farmacevtske izdelke v Evropi.
English: 11 PREPARATION FOR NEW TYPES OF APPLICATIONS
Slovenian: 11 PRIPRAVE ZA NOVE VRSTE VLOG
English: Achievements of particular note include:
Slovenian: Med še zlasti pomembnimi dosežki naj omenimo:
English: These stakeholders reported electronically a total of 144,786 individual case safety reports (ICSRs) originating from within and outside the EU.
Slovenian: Te zainteresirane strani so elektronsko sporočile skupno 144.786 varnostnih poročil o posameznih primerih (individual case safety reports - ICSR), ki so izvirali iz EU in zunaj nje.
English: Administrative and procedural assistance from the SME Office at the Agency
Slovenian: administrativno in postopkovno pomoč, ki jo zagotavlja Urad za MSP pri Agenciji;
English: Commission Regulation (EC) No 2049/2005, OJ L329, 16.12.2005, p. 4.
Slovenian: Uredba Komisije (ES) št. 2049/2005, UL L329, 16. 12. 2005, str. 4.
English: The Agency looked again at the safety of Micotil, following a request by the European Commission to take into account new information.
Slovenian: Agencija je spet preučila varnost Micotila, potem ko je Evropska komisija zahtevala, naj se upoštevajo nove informacije.
English: Fee exemptions for certain administrative services of the EMEA
Slovenian: oprostitve pristojbin za določene administrativne storitve EMEA;
English: It provided support to the European Commission with the technical requirements for such products, and will continue to do so as necessary during the Council and European Parliament consultation process.
Slovenian: Evropski komisiji je zagotovila podporo s tehničnimi zahtevami za takšne izdelke in bo po potrebi še naprej zagotavljala podporo med postopkom posvetovanja med Svetom in Evropskim parlamentom.
English: Thanks to the excellent planning and preparations put in place during the run-up to that date, the Agency was able to successfully implement all relevant provisions and guidelines stemming from the new legislation.
Slovenian: Zahvaljujoč izvrstnemu načrtovanju in pripravam v obdobju pred tem datumom, je Agenciji uspelo uspešno izvesti vse zadevne določbe in smernice, ki izhajajo iz nove zakonodaje.
English: A total of 1,213 applications were received, which represents a 10% increase compared to 2004.
Slovenian: Prejetih je bilo skupno 1213 vlog, kar pomeni 10-odstotno povečanje v primerjavi z letom 2004.
English: On behalf of the Management Board, therefore, I would like to thank the personnel of the EMEA for their important input in promoting European regulation in the field of pharmaceuticals.
Slovenian: V imenu upravnega odbora bi se zato rad zahvalil osebju EMEA za njihov pomemben prispevek k spodbujanju evropske regulacije na farmacevtskem področju.
English: Lastly, I extend my wholehearted thanks to all EMEA staff, whose tireless efforts throughout this challenging year resulted in such a positive outcome for the Agency.
Slovenian: Na koncu pa se iz vsega srca zahvaljujem tudi celotnemu osebju EMEA, katerega neutrudni napori skozi vse to leto, polno izzivov, so doprinesli k tako pozitivnim rezultatom Agencije.
English: The Committee concluded in November 2005 that, based on the available evidence, no action to protect consumer safety or animal safety was necessary.
Slovenian: Novembra 2005 je Odbor sklenil, da na podlagi razpoložljivih dokazov niso potrebni nobeni ukrepi za zaščito varnosti potrošnikov ali živali.
English: The recommendations were the outcome of an extensive external consultation exercise with the Agency's partners and stakeholders.
Slovenian: Priporočila so bila rezultat obsežnih zunanjih posvetovanj s partnerji Agencije in zainteresiranimi stranmi.
English: The SME Office has the sole remit of offering assistance to SMEs.
Slovenian: Urad za MSP je pristojen samo za zagotavljanje pomoči malim in srednje velikim podjetjem.
English: The Committee focused on work to establish the necessary procedures for conducting its business.
Slovenian: Odbor je namenil glavno pozornost pripravam za določitev potrebnih postopkov za opravljanje svoje dejavnosti.
English: 3.2.3 Maximum residue limits
Slovenian: 3.2.3 Najvišje mejne vrednosti ostankov
English: Those ten years of continuous growth and consolidation gave the Agency the experience and confidence it needed to meet the greatest challenge it has had to face so far: the full entry into force of the revised EU pharmaceutical legislation, in November 2005.
Slovenian: Teh deset let nenehne rasti in utrjevanja je dalo Agenciji izkušnje in zaupanje , ki ju potrebuje, da se bo lahko spopadla s svojim največjim izzivom doslej: novembra 2005 bo namreč v celoti stopila v veljavo revidirana farmacevtska zakonodaja EU.
English: 9 INFORMATION AND COMMUNICATION
Slovenian: 9 OBVEŠČANJE IN KOMUNICIRANJE
English: I know I can rely on your continuing commitment as we bring the EMEA forward into its second decade.
Slovenian: Vem, da se lahko na vašo nadaljnjo zavezanost zanesem tudi zdaj, ko EMEA stopa v svoje drugo desetletje.
English: A special group (ERMS facilitation group) was set up to oversee the delivery of these key objectives through the development of a rolling work plan for 2005-2007.
Slovenian: Ustanovljena je bila posebna skupina (skupina za poenostavitev ERMS) za nadzor izpolnjevanja teh ključnih ciljev s pomočjo razvoja tekočega načrta dela za obdobje 2005-2007.
English: The Year 2005 was a very promising beginning for the second decade of the EMEA.
Slovenian: Leto 2005 je bil zelo obetaven začetek drugega desetletja delovanja EMEA.
English: Altogether, 238 deaths in animals were reported.
Slovenian: Prijavljenih je bilo skupaj 238 smrtnih primerov pri živalih.
English: 5.3 Sampling and testing
Slovenian: 5.3 Vzorčenje in preizkušanje
English: Finally, in view of the next phase of EU enlargement, the EMEA completed preparations for pre-accession linguistic check activities for Bulgaria and Romania, to be launched in January 2006.
Slovenian: Končno, v luči nove faze širitve EU je EMEA zaključila priprave za predpristopne dejavnosti jezikovnega preverjanja za Bolgarijo in Romunijo, ki se bodo začele januarja 2006.
English: In years to come, the EMEA will need further top-quality expertise and will be increasingly reliant on the Member States and their authorities to offer this.
Slovenian: V prihodnjih letih bo EMEA potrebovala dodatno vrhunsko strokovno znanje in izkušnje ter se bo za zagotovitev tega vse bolj zanašala na države članice in njihove organe.
English: 2 IMPLEMENTATION OF THE ROAD MAP
Slovenian: 2 IZVAJANJE USMERITVENEGA NAČRTA ("ROAD MAP")
English: 13 EU TELEMATICS STRATEGY AND INFORMATION TECHNOLOGY
Slovenian: 13 TELEMATSKA STRATEGIJA EU IN INFORMACIJSKA TEHNOLOGIJA
English: The results presented in this Annual Report prove that the EMEA ably faced up to its many challenges in 2005.
Slovenian: Rezultati, predstavljeni v tem letnem poročilu, dokazujejo, da se je EMEA primerno spoprijela s številnimi izzivi v letu 2005.
English: The 11th year of operation of the European Medicines Agency (EMEA) was eventful.
Slovenian: Enajsto leto delovanja Evropske agencije za zdravila (EMEA) je bilo polno dogodkov.
English: A number of meetings were held with companies ahead of possible future applications.
Slovenian: Pred možnimi prihodnjimi uporabami so bili organizirani številni sestanki s podjetji.
English: Electronic reporting of adverse reactions is now mandatory.
Slovenian: Elektronsko poročanje o neželenih učinkih je sedaj obvezno.
English: The list was submitted to the Commission in May 2005 to serve as basis for a list of essential substances, which is provided for by the new legislation .
Slovenian: Seznam je bil predložen Komisiji maja 2005 in bo podlaga za seznam bistvenih snovi, ki ga določa nova zakonodaja.
English: The Agency contributed to the development of a proposed regulation on advanced therapies.
Slovenian: Agencija je prispevala k razvoju predlagane uredbe o naprednih zdravljenjih.
English: A further 15 applications were withdrawn prior to opinion.
Slovenian: Nadaljnjih 15 vlog je bilo umaknjenih, preden je bilo mnenje sprejeto.
English: The extrapolations are carried out without specific applications or payment of fees, provided the criteria detailed in the relevant CVMP guideline are met, thus ensuring consumer safety.
Slovenian: Ekstrapolacije se izvajajo brez posebnih vlog ali plačila pristojbin, če so izpolnjena merila iz ustreznih smernic CVMP in je tako zagotovljena varnost potrošnika.
English: Strengthening interaction with patients' and consumers' organisations
Slovenian: krepitvijo sodelovanja z organizacijami bolnikov in potrošnikov;
English: 14 MANAGING THE AGENCY
Slovenian: 14 UPRAVLJANJE AGENCIJE
English: It began with celebrations to mark an important milestone in the history of the EMEA: its tenth anniversary.
Slovenian: Začelo se je s praznovanjem v čast pomembnemu mejniku v zgodovini Agencije: njeni deseti obletnici.
English: While the majority of these concerned new pharmaceutical forms, 2 concerned new target species.
Slovenian: Medtem ko se jih je večina nanašala na nove farmacevtske oblike, sta 2 zadevali nove ciljne vrste.
English: This development will greatly enhance the ability of the EMEA to evaluate the safety of medicines.
Slovenian: Ta razvoj bo bistveno okrepil sposobnost EMEA za vrednotenje varnosti zdravil.
English: The year 2005 was the first full year of operation of the Committee on Herbal Medicinal Products (HMPC), following its inaugural meeting in September 2004.
Slovenian: Leto 2005 je bilo prvo polno leto delovanja Odbora za zdravila rastlinskega izvora (HMPC) po njegovem ustanovitvenem zasedanju septembra 2004.
English: In 2005, the Agency discussed implementation plans for electronic reporting with major partners in the veterinary pharmaceutical industry.
Slovenian: V letu 2005 je Agencija razpravljala o izvedbenih načrtih za elektronsko poročanje s pomembnejšimi partnerji v veterinarski farmacevtski industriji.
English: A total of 34,352 ICSRs relating to SUSARs were received.
Slovenian: Prejetih je bilo skupaj 34.352 ICSR-jev, ki so se nanašali na SUSAR-je.
English: The strategy includes earlier and more frequent involvement of experts particularly on rare diseases and new therapies.
Slovenian: Strategija vključuje zgodnejše in pogostejše vključevanje strokovnjakov, zlasti v zvezi z redkimi boleznimi in novimi zdravljenji.
English: Thomas Lönngren was unanimously appointed by the Management Board to serve in this demanding post for another five-year period, from 2006 to 2010.
Slovenian: Upravni odbor je soglasno imenoval Thomasa Lönngrena na to zahtevno delovno mesto za nadaljnje petletno obdobje, od leta 2006 do leta 2010.
English: 5 INSPECTIONS
Slovenian: 5 INŠPEKCIJSKI NADZOR
English: Strengthening the EU pharmacovigilance system to make the best use of the scientific resources and expertise available at EU level.
Slovenian: krepitvijo sistema farmakovigilance EU za čim boljšo uporabo znanstvenih virov in strokovnega znanja ter izkušenj, ki so na razpolago na ravni EU.
English: This policy put in place a framework for the checking of translations of product information by the national competent authorities, and set up a financial compensation scheme.
Slovenian: Ta politika je vzpostavila okvir za preverjanje prevodov informacij o izdelkih s strani pristojnih nacionalnih organov in oblikovala program finančnih nadomestil.
English: A reflection paper to highlight patients' benefits in this new area was issued.
Slovenian: Objavljen je bil preučitveni dokument za izpostavitev koristi za bolnike na tem novem področju.
English: New medicinal products (non-orphan) Orphan medicinal products Similar biological products
Slovenian: Nova zdravila (ki niso zdravila sirote) Zdravila sirote Biološko podobni izdelki
English: The Agency was given responsibility for implementing the EU telematics strategy agreed by the European Commission, Member States and the EMEA.
Slovenian: Agenciji je bila zaupana odgovornost za izvajanje telematske strategije EU, o kateri so se dogovorile Evropska komisija, države članice in EMEA.
English: At the same time, it provides new tools for strengthened protection of public health.
Slovenian: Uredba hkrati zagotavlja nova orodja za okrepljeno varstvo javnega zdravja.
English: Electronic reporting into the EudraVigilance database became mandatory in November 2005.
Slovenian: Elektronsko poročanje v zbirko podatkov EudraVigilance je postalo obvezno novembra 2005.
English: The information updates published on the EMEA website relating to these issues have been acclaimed as extremely useful.
Slovenian: Posodobljene informacije o teh vprašanjih, ki se objavljajo na spletni strani EMEA, so bile ocenjene kot zelo uporabne.
English: In addition, I would like to thank the Member States' competent authorities, which, together with the EMEA, form the core regulatory network for medicinal products.
Slovenian: Poleg tega se želim zahvaliti pristojnim organom držav članic, ki skupaj z EMEA sestavljajo temeljni regulativni okvir za zdravila.
English: The EMEA will be involved in the issues of relative effectiveness and provision of information to patients.
Slovenian: EMEA bo sodelovala pri vprašanjih relativne učinkovitosti in zagotavljanja informacij bolnikom.
English: To further improve the management of translations, the Management Board adopted a revised EMEA translation policy in September 2005.
Slovenian: Za nadaljnje izboljšanje upravljanja prevodov je upravni odbor septembra 2005 sprejel revidirano prevajalsko politiko EMEA.
English: Pandemic influenza preparedness
Slovenian: Pripravljenost na pandemijo influence
English: Following the entry into force of new ‘Regulations and Rules applicable to officials and other servants of the European Communities', the EMEA prepared a series of implementing rules for adoption by the Management Board.
Slovenian: Po začetku veljavnosti novih "predpisov in pravil za uradnike in druge uslužbence Evropskih skupnosti" je EMEA pripravila vrsto izvedbenih pravil, ki jih sprejme upravni odbor.
English: This led to a doubling of parallel distribution notifications submitted to the EMEA in 2005.
Slovenian: To je pripeljalo do podvojitve števila obvestil o vzporedni distribuciji, predloženih EMEA v letu 2005.
English: The overall volume of pre- and post-authorisation applications received was high, but the Agency was able to handle its tasks successfully.
Slovenian: Skupno število prejetih vlog pred in po izdaji dovoljenja za promet je bilo visoko, vendar je Agencija zmogla uspešno opraviti svoje naloge.
English: The group will provide progress reports to the EMEA Management Board and to the group of heads of national medicines agencies.
Slovenian: Skupina bo poslala poročila o napredku upravnemu odboru EMEA in skupini vodij nacionalnih agencij za zdravila.
English: The Agency also developed guidelines and concept papers designed to improve the consistency of safety data assessments.
Slovenian: Agencija je razvila tudi smernice in konceptualne dokumente za izboljšanje skladnosti presoj podatkov o varnosti.
English: Together with this key document, a further 6 draft guidelines on specific types of products were released for consultation in the first half of the year.
Slovenian: Skupaj s tem ključnim dokumentom je bilo v prvi polovici leta za namene posvetovanja objavljenih 6 osnutkov smernic o posebnih vrstah izdelkov.
English: The Management Board has been closely following the progress of the European innovation and technology platform, especially in the area of veterinary medicines.
Slovenian: Upravni odbor budno spremlja napredek evropske platforme za inovacije in tehnologijo, zlasti na področju veterinarskih zdravil.
English: The number of issued certificates continued to increase, and certificate number 100,000 was issued (for an AIDS product) in August 2005.
Slovenian: Število izdanih potrdil še naprej narašča, avgusta 2005 pa je bilo izdano potrdilo številka 100.000 (za izdelek za AIDS).
English: In 2005 this included the annual management review, which aims to ensure that management tools are effective and suitable in relation to the Agency's needs, and a self-assessment carried out in the context of the EU benchmarking system in order to improve the EMEA management system.
Slovenian: V letu 2005 je to vključevalo letni pregled upravljanja, katerega cilj je zagotoviti, da so orodja upravljanja učinkovita in primerna za potrebe Agencije, ter samoocenjevanje, ki je bilo opravljeno v okviru sistema primerjalnih analiz EU za izboljšanje sistema upravljanja EMEA.
English: Strengthening the Agency's interaction with European industry associations representing the innovative, generic and self-medication industries
Slovenian: krepitvijo sodelovanja Agencije z evropskimi panožnimi združenji, ki zastopajo inovativno in generično industrijo in industrijo samozdravil;
English: 5.2 Product defects and deviations
Slovenian: 5.2 Pomanjkljivosti in odstopanja pri proizvodih
English: I am particularly grateful for the excellent participation of our partners from the new Member States, in what was the first full year of operation in a European Union of 25 nations.
Slovenian: Posebno zahvalo sem dolžan našim partnerjem iz novih držav članic za njihovo izjemno sodelovanje pri dejavnostih Agencije v prvem celem letu, ko Evropsko unijo sestavlja 25 narodov.
English: The first submission of a core dossier was made in December 2005, and discussions on a number of other submissions were under way at the year's end.
Slovenian: Prva predložitev temeljne dokumentacije je bila opravljena decembra 2005, na koncu leta pa so potekale razprave o številnih drugih predložitvah.
English: In addition, 67 sponsors conducting clinical trials within the European Economic Area (EEA) were reporting suspected unexpected serious adverse reactions (SUSARs) to the EudraVigilance Clinical Trial Module (EVCTM).
Slovenian: Poleg tega je 67 sponzorjev, ki so izvajali klinična preizkušanja znotraj evropskega gospodarskega prostora (EGP), poročalo o sumih na resne nepričakovane neželene učinke (suspected unexpected serious adverse reactions - SUSAR) v modul kliničnih preizkušanj EudraVigilance (EudraVigilance Clinical Trial Module - EVCTM).