FrancophonIA/ELRC3.0 huggingface dataset:
English: The number of SUSARs received electronically was 7 984, of which 3 746 were from EU sources and 4 238 from outside the EU.
Slovenian: V elektronski obliki je bilo prejetih 7.984 SUSAR-jev, od katerih jih je bilo 3.746 iz virov EU in 4.238 iz virov zunaj EU.
English: The Agency finalised 340 notifications of change.
Slovenian: Zaključila je tudi 340 obvestil o spremembi.
English: These experts and the EMEA secretariat will continue work in these and other new areas, such as cell therapy and tissue engineering, in 2005.
Slovenian: Ti strokovnjaki in sekretariat EMEA bodo v letu 2005 nadaljevali delo na teh in drugih novih področjih, kot sta celično zdravljenje in inženiring tkiv.
English: There were no referral procedures under Articles 36 or 37.
Slovenian: V skladu s členoma 36 in 37 ni bilo nobenih postopkov predložitve.
English: In 2004, total compensation was 32 233 000 about one third of the Agencys total budget.
Slovenian: V letu 2004 so plačila skupaj znašala 32.233.000 EUR, kar je približno tretjina celotnega proračuna Agencije.
English: In 2004, the EMEA validated 402 initial parallel distribution notifications and finalised 373 initial notifications.
Slovenian: V letu 2004 je EMEA potrdila 402 začetni obvestili o vzporedni distribuciji in zaključila 373 začetnih obvestil.
English: The authorities make scientific resources available in the form of a network of more than 3 500 European experts who assist the Agency in the performance of its scientific tasks.
Slovenian: Organi omogočajo dostop do znanstvenih virov v obliki mreže več kot 3500 evropskih strokovnjakov, ki Agenciji pomagajo pri opravljanju njenih znanstvenih nalog.
English: The enlargement of the European Union made it necessary to implement the Specific Mechanism in the existing notification procedure.
Slovenian: Prvič, zaradi širitve Evropske unije je bilo treba uvesti poseben mehanizem v obstoječi postopek obveščanja.
English: The ICDRA promotes worldwide collaboration between regulatory authorities for medicinal products.
Slovenian: ICDRA spodbuja sodelovanje med regulativnimi organi za zdravila po vsem svetu.
English: Annex 12 Guidelines and working documents in 2004
Slovenian: Priloga 12 Smernice in delovni dokumenti v letu 2004
English: It manages efficiently the cash resources of the Agency, maintains the Agency s relationship with its banks, and provides accurate and timely financial information to management.
Slovenian: Učinkovito upravlja z gotovinskimi viri Agencije, vzdržuje odnose Agencije z njenimi bankami in zagotavlja točne in pravočasne finančne informacije vodstvu.
English: Every Member State now has one member on the Board.
Slovenian: Zdaj ima vsaka država članica v odboru enega člana.
English: No scientific advice (n=171)
Slovenian: Brez znanstvenega svetovanja (n=171)
English: Implementation of 3-tier architecture with appropriate security and interface to Internet services for internal and remote services
Slovenian: Uvedba triplastne strukture z ustrezno varnostjo in vmesnikom za internet za interne in oddaljene storitve
English: The Executive Support Sector addresses, in particular, the need for improved relations with external partners and the provision of support for the Agency s management activities.
Slovenian: Sektor za izvršno podporo se ukvarja zlasti s potrebo po izboljšanih odnosih z zunanjimi partnerji in zagotavljanjem podpore pri dejavnostih upravljanja Agencije.
English: Legislative provisions implementing special measures for innovative medicines, technologies and therapies will help to provide more rapid access to medicines without compromising the safety of patients.
Slovenian: Zakonodajni predpisi za izvajanje posebnih ukrepov za inovativna zdravila, tehnologije in terapije bodo omogočili hitrejši dostop do zdravil, ne da bi to ogrozilo varnost bolnikov.
English: In 2004, the EMEA also published guidance for parallel distributors.
Slovenian: V letu 2004 je EMEA objavila tudi smernice za vzporedne distributerje.
English: The new Member State authorities were connected to the EudraVigilance Gateway and are actively involved in the joint implementation activities at Community level.
Slovenian: Organi novih držav članic so se povezali v EudraVigilance Gateway in dejavno sodelujejo v skupnih izvedbenih dejavnostih na ravni Skupnosti.
English: Where the original national authorisation cannot be recognised, the points in dispute are submitted to the EMEA for arbitration.
Slovenian: Kadar se izvorno nacionalno dovoljenje za promet ne more priznati, se sporne točke predložijo EMEA v arbitražo.
English: Annual reports for 32 products were prepared in 2004, each of which is prepared in cooperation with a rapporteur and co-rapporteur, and adopted by the CVMP.
Slovenian: V letu 2004 so bila pripravljena letna poročila za 32 izdelkov; vsako poročilo se pripravi v sodelovanju s poročevalcem in soporočevalcem, sprejme pa ga CVMP.
English: In 2004, the Agency began to implement a series of transparency policy measures adopted by the Management Board in October 2003.
Slovenian: V letu 2004 je Agencija začela izvajati vrsto ukrepov politike preglednosti, ki jih je upravni odbor sprejel oktobra 2003.
English: • User requirements for the database were drawn up in line with additional requirements resulting from the terms of Regulation (EC) No 726/2004, G10 recommendations and Council conclusions
Slovenian: • zahteve uporabnikov zbirke podatkov so bile sestavljene v skladu z dodatnimi zahtevami, ki izhajajo iz določb Uredbe (ES) št. 726/2004, priporočili G10 in sklepi Sveta
English: The workload relating to medicinal products for veterinary use fell somewhat in comparison to 2003 but was, nonetheless, also substantial.
Slovenian: Delovna obremenitev pri zdravilih za veterinarsko uporabo je nekoliko upadla v primerjavi z letom 2003, vendar je bila kljub temu precejšnja.
English: In addition to the members appointed by the European Commission and the European Parliament, the new Board will also have representatives from doctors and patients organisations.
Slovenian: Poleg članov, ki jih imenujeta Evropska komisija in Evropski parlament, bodo v novem odboru tudi predstavniki iz organizacij zdravnikov in bolnikov.
English: A commitment was made in 2003 to implement a large number of projects in 2004.
Slovenian: V letu 2003 je bila sprejeta zaveza o izvedbi veliko projektov v letu 2004.
English: A comprehensive upgrade to the MMS was delivered both on time and within budget.
Slovenian: Celovita nadgradnja MMS je bila opravljena pravočasno in v okviru proračuna.
English: One product was not renewed and, therefore, its marketing authorisation expired in 2004.
Slovenian: En izdelek ni bil podaljšan in zato je njegovo dovoljenje za promet v letu 2004 poteklo.
English: The procedure will be revised based on experience gained from the pilot phase in time for the introduction of the new Community legislation in November 2005.
Slovenian: Postopek bo pregledan na podlagi izkušenj, pridobljenih v pilotni fazi, v primernem času pred uvedbo nove zakonodaje Skupnosti novembra 2005.
English: • Major work was undertaken in 2004 in relation to the further development and implementation of the EudraVigilance project.
Slovenian: • V letu 2004 so se začela izvajati pomembna dela v zvezi z nadaljnjim razvojem in izvajanjem projekta EudraVigilance.
English: At the beginning of 2004 there were 3 old substances remaining for which MRLs had not been entirely completed: altrenogest, flugestone acetate and norgestomet.
Slovenian: V začetku leta 2004 so ostale še 3 "stare" učinkovine, za katere MRL-ji še niso bili popolnoma dokončani: altrenogest, flugeston acetat in norgestomet.
English: To implement one common and standard directory of all parties involved in the EU pharmaceutical regulatory process
Slovenian: Uvesti skupni in standardni imenik vseh strank, ki sodelujejo v farmacevtskem regulativnem procesu EU
English: To take over the final stages of the EDMS pre-production application, prepare it for the move into operation and operate the application when in production
Slovenian: Prevzeti zadnje faze uporabe EDMS pred proizvodnjo, jo pripraviti za prehod v delovanje in izvajati aplikacijo, ko bo v proizvodnji
English: • Integration of delegates from the new Member States
Slovenian: • vključevanje delegatov iz novih držav članic
English: The paper was released for external consultation in September 2004 and aims at putting in place a transparent process for the development, consultation, finalisation and implementation of pharmaceutical guidelines.
Slovenian: Ta dokument je bil predstavljen za zunanje posvetovanje septembra 2004, njegov namen pa je uvesti pregleden postopek za razvoj, posvetovanje, dokončno oblikovanje in izvedbo farmacevtskih smernic.
English: Greater level of satisfaction with the quality of dossiers
Slovenian: Večje zadovoljstvo s kakovostjo dokumentacije
English: 1 EMEA in the European system
Slovenian: 1 EMEA v evropskem sistemu
English: Altrenogest received a positive opinion to establish final MRLs in June 2004.
Slovenian: Za altrenogest je bilo sprejeto pozitivno mnenje za določitev končnih MRL-jev junija 2004.
English: Recommendations and advice provided include general public-health issues relating to veterinary medicinal products.
Slovenian: Priporočila in svetovanje zajemajo splošna vprašanja javnega zdravja, povezana z veterinarskimi zdravili.
English: • Implementation of new and modified accounting practices in line with the reform of the Commission
Slovenian: • izvajanje novega in spremenjenega računovodskega sistema v skladu z reformo Komisije
English: • The new EU Member States were successfully integrated in the scientific committees dealing with medicines for human use and in the activities of the Agency.
Slovenian: • Nove države članice EU so se uspešno vključile v znanstvene odbore, ki se ukvarjajo z zdravili za uporabo v humani medicini, in v dejavnosti Agencije.
English: The other sections of the guideline were reviewed in 2004 and it is expected that the European Commission will publish an amended version in the first quarter of 2005.
Slovenian: Drugi oddelki smernic so bili revidirani v letu 2004 in Evropska komisija naj bi objavila spremenjeno različico v prvem četrtletju leta 2005.
English: Transparent and public rules of conduct reinforce the Agency s reliability in the eyes of the general public.
Slovenian: Pregledna in javna pravila ravnanja krepijo ugled Agencije v očeh javnosti.
English: A key part of the plan is a pilot programme under which companies can request parallel scientific advice from the two agencies.
Slovenian: Ključni del načrta je pilotni program, v skladu s katerim lahko podjetja zaprosijo za vzporedno znanstveno svetovanje obeh agencij.
English: First contacts were established during 2004 with the new European Centre for Disease Prevention and Control (ECDC).
Slovenian: V letu 2004 je navezala prve stike z novim Evropskim centrom za preprečevanje in nadzor bolezni (ECDC).
English: • EudraNet II in operation by May 2004
Slovenian: • EudraNet II je delovala do maja 2004
English: Overall performance for the year was very good, with regulatory timelines being met in almost all areas of activity.
Slovenian: Splošna uspešnost v letu 2003 je bila zelo dobra, predpisani roki pa so bili doseženi na skoraj vseh področjih dejavnosti.
English: Such substances are evolving partly through the development of new products, while others are old molecules for which no MRLs had previously been established or which had previously not been used as veterinary medicines.
Slovenian: Take učinkovine se razvijajo delno z razvojem novih izdelkov, pri nekaterih pa gre za stare učinkovine, za katere pred tem ni bilo določenih MRL-jev ali ki se prej niso uporabljale kot veterinarska zdravila.
English: The parallel distribution activity was marked by two major changes in 2004:
Slovenian: V letu 2004 sta dejavnost vzporedne distribucije zaznamovali dve pomembni spremembi:
English: For half of the applications, the clock stop was over 200 days, while for others it was shorter in a number of cases, as short as 50 or 60 days.
Slovenian: Pri polovici vlog je bila zaustavitev časa daljša od 200 dni, pri drugih pa je bila krajša - večkrat le 50 ali 60 dni.
English: The volume of the third parties database grew significantly in 2004, with over 1 000 parties added.
Slovenian: Obseg zbirke podatkov tretjih strani se je v letu 2004 znatno povečal, saj je bilo dodanih več kot 1000 tretjih strani.
English: 18 174 reports were received from EU sources and 46 012 were from outside the EU.
Slovenian: Iz virov v EU je bilo prejetih 18.174, iz virov zunaj EU pa 46.012 poročil.
English: • Two standards for electronic information exchange (the EU Module 1 Specification and the Application Form Specification) were adopted
Slovenian: • sprejeta sta bila dva standarda za elektronsko izmenjavo informacij (specifikacija EU Modul 1 in specifikacija obrazca za vlogo)
English: Good relations were maintained with Industry, academia and other stakeholders, while cooperation with and support from the European Commission and Parliament were also extremely good.
Slovenian: Nadaljevali so se dobri odnosi z industrijo, akademskim svetom in drugimi interesnimi skupinami, izredno uspešna pa sta bila tudi sodelovanje in podpora Evropske komisije in Parlamenta.
English: Two working parties and one ad hoc group assist the Committee:
Slovenian: Odboru pomagajo dve delovni skupini in ena ad hoc skupina:
English: The Committee adopted its key position paper in June 2004 setting out to further define the problem and offering solutions to try and resolve matters from a regulatory perspective.
Slovenian: Odbor je junija 2004 sprejel ključni dokument o stališču, v katerem je izrazil svoj namen nadaljnje opredelitve problema in ponudil rešitve, s katerimi bi se lahko vprašanja rešila z regulativnega vidika.
English: • Cancer (5 new products)
Slovenian: • rak (5 novih izdelkov)
English: The control framework of the Agency changed significantly with the adoption of the new EMEA quality policy and new internal control standards.
Slovenian: Kontrolni okvir Agencije se je precej spremenil s sprejetjem nove politike kakovosti EMEA in novih standardov notranje kontrole.
English: As a result of the enlargement and the increased number of documents being posted on the EMEA website, the number of external requests for information increased by 50 % over the previous year.
Slovenian: Zaradi širitve in večjega števila dokumentov, objavljenih na spletni strani EMEA, se je število zunanjih zahtevkov za informacije povečalo za 50 % v primerjavi z letom poprej.
English: The Board heard regular progress reports on the EU telematics strategy.
Slovenian: Odbor je obravnaval redna poročila o napredku glede telematske strategije EU.
English: All working documents adopted by the HMPWP are listed in Annex 12.
Slovenian: Vsi delovni dokumenti, ki jih je sprejela HMPWP, so navedeni v Prilogi 12.
English: • In 2004, the CHMP/EMEA initiated a revision of the European Commission Summary of Product Characteristics (SPC) Guideline, and agreement on sections 4.1 and 5.1 was reached.
Slovenian: • V letu 2004 sta CHMP/EMEA začela revizijo Smernic Evropske komisije o povzetku glavnih značilnosti zdravila (Summary of Product Characteristics, SPC) in doseženo je bilo soglasje glede oddelkov 4.1 in 5.1.
English: Sterile medicinal products and some biological medicinal products are excluded from the scope.
Slovenian: Iz področja uporabe so izključena sterilna zdravila in nekatera biološka zdravila.
English: The new sector is responsible for the provision of information that is easily understandable and accessible for patients and healthcare professionals.
Slovenian: Ta sektor je odgovoren za zagotavljanje informacij, ki so lahko razumljive in dostopne bolnikom in zdravstvenim strokovnjakom.
English: A 99.5 % availability of IT services was achieved and key projects were delivered on time and within budget.
Slovenian: Dosežena je bila 99,5-odstotna razpoložljivost storitev IT, najpomembnejši projekti pa so bili izvedeni pravočasno in v okviru proračuna.
English: The constant monitoring of the safety of medicines after authorisation ( pharmacovigilance ) is an important part of the work of the national competent authorities and the EMEA.
Slovenian: Stalno spremljanje varnosti zdravil po izdaji dovoljenja za promet ("farmakovigilanca") je pomemben element dela pristojnih nacionalnih organov in EMEA.
English: The engaged involvement and intensive cooperation of so many partners, stakeholders and other interested parties contributed greatly to the success of the Agency s operations in 2004.
Slovenian: Prizadevno vključevanje in intenzivno sodelovanje številnih partnerjev, interesnih skupin in drugih zainteresiranih strani sta veliko prispevala k uspešnosti poslovanja Agencije v letu 2004.
English: Preparations started for the full application of all provisions by 20 November 2005.
Slovenian: Začele so se priprave, da bi se vse določbe do 20. novembra 2005 začele v celoti uporabljati.
English: As the Agency prepares to receive applications in relation to emerging therapies and new technologies, a new regulatory framework needs to be developed.
Slovenian: Ker se Agencija pripravlja na sprejem vlog v zvezi z novimi terapijami in tehnologijami, je treba razviti nov regulativni okvir.
English: A system of activity-based budgeting was developed, with details included in the budget reports to the Management Board and to the budgetary authority.
Slovenian: Razvit je bil sistem upravljanja proračuna po dejavnostih, katerega podrobnosti so vključene v proračunska poročila za upravni odbor in proračunski organ.
English: A major step towards improving the quality of the EU regulatory network as a whole was the agreement between the heads of regulatory agencies to introduce an EU benchmarking system.
Slovenian: Pomemben korak k izboljšanju kakovosti celotne regulativne mreže EU je bil sporazum med vodji regulativnih agencij o uvedbi sistema EU za primerjalne analize.
English: The Committee re-elected Dr Daniel Brasseur as chairman and Dr Eric Abadie as vicechairman.
Slovenian: Odbor je ponovno izvolil dr. Daniela Brasseura kot predsednika in dr. Erica Abadiea kot podpredsednika.
English: 1.5 Transparency and communication
Slovenian: 1.5 Preglednost in obveščanje
English: And while the growth of the European network to 28 EEA-EFTA countries, 42 national competent authorities and a pool of over 3 500 national experts certainly placed increased pressure on the EMEA in its role as coordinator, the Agency was able to cope without any major difficulty.
Slovenian: Čeprav je širitev evropske mreže na 28 držav EGP-EFTA, 42 pristojnih nacionalnih organov in več kot 3500 nacionalnih strokovnjakov zagotovo povečala pritisk na EMEA kot koordinatorja, je Agencija nove razmere obvladovala brez večjih težav.
English: The main achievements are described briefly in the table below.
Slovenian: Glavni dosežki so na kratko opisani v naslednji tabeli:
English: Following a comprehensive review of the EU's pharmaceutical legislative framework, which started in July 2001, the new European pharmaceutical legislation was published in the Official Journal of the European Union on 30 April 2004.
Slovenian: Po temeljiti reviziji farmacevtskega zakonodajnega okvira EU, ki se je začela julija 2001, je bila nova evropska farmacevtska zakonodaja objavljena v Uradnem listu Evropske unije 30. aprila 2004.
English: Overall, substantial progress was made on implementing the telematics strategy during the year, with projects being delivered in line with expectations.
Slovenian: Na splošno je bil v letu 2004 dosežen precejšen napredek pri izvajanju telematske strategije, pri čemer so se projekti izvajali v skladu s pričakovanji.
English: Much effort was devoted in 2004 to the establishment of a long-term vision and implementation strategy for the Agency.
Slovenian: V letu 2004 je bilo veliko truda vloženega v določitev dolgoročne vizije in izvedbene strategije za Agencijo.
English: This initiative started in 2002, and the Agency is now preparing summaries for medicinal products designated in previous years.
Slovenian: Ta pobuda se je začela izvajati leta 2002, Agencija pa zdaj pripravlja povzetke za zdravila, določena za zdravila sirote v prejšnjih letih.
English: The Agency assists delegates with logistics and practical arrangements.
Slovenian: Agencija pomaga delegatom pri logistiki in praktičnih rešitvah.
English: • Implementation of the new EMEA Financial Regulation, with revision of procedures
Slovenian: • izvajanje nove finančne uredbe EMEA z revizijo postopkov
English: New Member States took part in the testing part of the programme from May 2004 onwards, as samples of certain products had already been taken from the market prior to accession.
Slovenian: Nove države članice so od maja 2004 sodelovale v programu na področju preizkušanja, ker so bili vzorci nekaterih izdelkov že vzeti na trgu pred pristopom.
English: After the EU enlargement on 1 May 2004, the CVMP met for the first time with members from the new Member States.
Slovenian: Po širitvi EU 1. maja 2004 se je CVMP prvič sestal s člani iz novih držav članic.
English: Previous annual reports and other reference documents are available from the EMEA website:
Slovenian: Prejšnja letna poročila in drugi referenčni dokumenti so na voljo na spletnem naslovu EMEA:
English: Adopted by the Management Board on 10 March 2005
Slovenian: Sprejel upravni odbor dne 10. marca 2005
English: These two groups contribute to the harmonisation of inspection-related procedures across the EU and develop guidance documents.
Slovenian: Ti skupini prispevata k usklajevanju z inšpekcijskimi pregledi povezanih postopkov po vsej EU in razvijanju usmeritvenih dokumentov.
English: The ultimate objective of the Road Map exercise is to ensure that, building on the achievements of its first 10 years, the EMEA adequately prepares the ground for further success in the future.
Slovenian: Končni cilj izvajanja usmeritvenega načrta je zagotoviti, da EMEA na podlagi dosežkov v svojih prvih 10 letih pripravi ustrezno podlago za naslednje uspehe v prihodnosti.
English: The IT development team provided a new version of the Experts database in 2004
Slovenian: Razvojna skupina IT je v letu 2004 zagotovila novo različico zbirke podatkov o strokovnjakih
English: 5 EU telematics strategy
Slovenian: 5 Telematska strategija EU
English: The Agency ensures full compliance with all regulatory and quality requirements in the areas of document and records management.
Slovenian: Agencija zagotavlja popolno upoštevanje vseh regulativnih in kakovostnih zahtev na področju upravljanja dokumentov in poročil.
English: Not in operation.
Slovenian: Se ne izvaja.
English: Positive Withdrawn prior to opinion Negative
Slovenian: Pozitivna Umaknitev pred mnenjem Negativna
English: In light of this, the EMEA created a new Sector for Medical Information.
Slovenian: Glede na to je EMEA oblikovala nov sektor za informacije o zdravilih.
English: This was the first time that such dialogue had occurred for a veterinary scientific advice procedure.
Slovenian: To je bilo prvo tako sodelovanje v postopku veterinarskega znanstvenega svetovanja.
English: These vaccines contain no adjuvant and should result in less injection-site reactions in vaccinated cats
Slovenian: Ta cepiva ne vsebujejo adjuvansov in bi morala imeti manj reakcij na mestu cepljenja pri mačkah.
English: All procedures were completed within the legal timelines, with summaries of opinion published at the same time as the opinions.
Slovenian: Vsi postopki so bili dokončani v zakonskih rokih, povzetki mnenj pa objavljeni skupaj z mnenji.
English: With the additional national competent authorities of the new Member States and a larger number of European experts, the EMEA is now required to operate in and manage an increasingly complex system.
Slovenian: Glede na dodatne pristojne nacionalne organe novih držav članic in večje število evropskih strokovnjakov se od EMEA zdaj zahteva, da deluje v vse bolj zapletenem sistemu in ga obvladuje.