FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, the centralised procedure is open to any other product that constitutes a significant innovation or for which there is a Community interest.
Slovenian: Poleg tega je centralizirani postopek dostopen za vse druge izdelke, ki so pomembna inovacija ali za katere obstaja interes Skupnosti.
English: The impact of new approaches to manufacturing and control methods (PAT) will be addressed in the framework of the EU PAT team.
Slovenian: Vpliv novih pristopov na postopke izdelave in nadzora (PAT) se bo obravnaval v okviru skupine EU PAT.
English: Review and possible revision of the guideline.
Slovenian: Pregled in možna revizija smernice.
English: The key objectives and priorities for 2005 can be summarised as follows: 1.
Slovenian: Ključni cilji in prednostne naloge za leto 2005 se lahko povzamejo, kot sledi:
English: Annual reports to be carried out for 37 products, prepared in cooperation with rapporteur and corapporteur
Slovenian: Letna poročila za 37 izdelkov, pripravljena v sodelovanju s poročevalcem in soporočevalcem.
English: In addition, the new legislation aims to help small and medium-sized enterprises to access the centralised procedure.
Slovenian: Cilj nove zakonodaje je tudi pomagati majhnim in srednje velikim podjetjem, da jim bo dostopen centralizirani postopek.
English: This advice is provided in the form of protocol assistance that can also include advice on the significant benefit of a product.
Slovenian: To svetovanje poteka v obliki pomoči pri protokolu, ki lahko vključuje tudi svetovanje o pomembni koristi izdelka.
English: Some deadlines were shortened in the existing approval process.
Slovenian: Nekateri roki iz obstoječega postopka odobritve so bili skrajšani.
English: That collaboration has already resulted in significant achievements over the past 10 years, and ongoing commitment from all partners will secure our position as one of the foremost regulatory systems in the world.
Slovenian: Takšno sodelovanje je že imelo svoje rezultate v pomembnih dosežkih zadnjih desetih let, stalna predanost vseh partnerjev pa bo utrdila naš položaj enega najboljših regulativnih sistemov na svetu.
English: An extensive consultation exercise with all interested parties in 2004 on the implementation of the new tools provided more details on the specific activities to be undertaken.
Slovenian: Obsežno posvetovanje z vsemi zainteresiranimi stranmi leta 2004 o izvajanju novih orodij je zagotovilo več podrobnosti o posebnih dejavnostih, ki se jih je treba lotiti.
English: Anticipated enlargement of the European Union in 2007
Slovenian: Predvidena širitev Evropske unije leta 2007.
English: The committees are to be kept informed on scientific and technological development in this scientific area
Slovenian: Odbore je treba redno obveščati o znanstvenem in tehnološkem razvoju na tem znanstvenem področju.
English: The partners of the European medicines network have set themselves an important goal to enhance overall quality of the EU regulatory system.
Slovenian: Partnerji Evropske mreže zdravil so si zastavili pomemben cilj izboljšati celotno kakovost regulativnega sistema EU.
English: 1.5 Transparency and communication in the European network
Slovenian: 1.5 Preglednost in obveščanje v Evropski mreži
English: Contribution, if requested (see BWP)
Slovenian: Prispevek, če se zahteva (glej BWP)
English: Approximately 3,500 European experts are used by the EMEA in its scientific evaluation work.
Slovenian: Pri svojem znanstveno ocenjevalnem delu EMEA uporablja približno 3500 evropskih strokovnjakov.
English: Particular challenges in the year 2005 will be:
Slovenian: Posebni izzivi v letu 2005 bodo:
English: This includes continuous improvement to its processes and interfaces with partners in the European network.
Slovenian: Ta vključuje stalno izboljševanje njenih postopkov in navezavo stikov s partnerji iz Evropske mreže.
English: To manage efficiently the cash resources of the Agency and maintain relationships with the Agency's banks
Slovenian: Učinkovito upravljanje gotovinskih virov Agencije in vzdrževanje odnosov z bankami Agencije.
English: Variations to certificates of compliance are also expected.
Slovenian: Pričakujejo se tudi spremembe potrdil o skladnosti.
English: The COMP will meet 11 times in 2005, with each meeting lasting two days, with the possibility to extend to three days, depending on the number and complexity of applications to be reviewed.
Slovenian: COMP se bo leta 2005 sestal enajstkrat, vsako zasedanje bo trajalo dva dneva, z možnostjo podaljšanja na tri dni, odvisno od števila in zahtevnosti vlog, ki jih bo treba pregledati.
English: The anniversary will be a good opportunity to reflect on what has been achieved so far, assess the needs of the present time, and consider what further contribution we can make to the protection and promotion of public and animal health in Europe.
Slovenian: Obletnica bo dobra priložnost, da se razmisli o dosedanjih dosežkih, oceni trenutne potrebe in preuči možnosti za naše nadaljnje prispevke k varovanju in spodbujanju zdravja ljudi in živali v Evropi.
English: This includes advice and recommendations on general public health issues related to medicinal products.
Slovenian: To vključuje nasvete in priporočila glede splošnih vprašanj javnega zdravstva, povezanih z zdravili.
English: Censor Jurado de Cuentas and Member of the Registro Oficial de Auditores de Cuentas in Spain.
Slovenian: Cenzor Jurado de Cuentas in član Registro Oficial de Auditores de Cuentas v Španiji.
English: The Agency plans to undertake further implementation and expansion of these projects in response to legislative requirements in 2005.
Slovenian: Agencija načrtuje prevzem nadaljnjega izvajanja in razširitev teh projektov kot odziv na zakonodajne zahteve v letu 2005.
English: Visitors to the Agency
Slovenian: Obiskovalci Agencije
English: Continuation of work with the World Health Organization and the World Organisation for Animal Health (OIE), and participation in other international forums.
Slovenian: Nadaljevanje sodelovanja s Svetovno zdravstveno organizacijo in Svetovno organizacijo za zdravje živali (OIE) ter sodelovanje v drugih mednarodnih forumih.
English: Article 31 and 36 referral procedures are mainly initiated in case of Community interest and for safety-related issues.
Slovenian: Postopki predložitve iz členov 31 in 36 se uvedejo predvsem v primeru interesa Skupnosti in za varnostna vprašanja.
English: The target is to perform as well or better compared to the previous year
Slovenian: Cilj je biti tako uspešen ali pa še bolj kot v prejšnjem letu.
English: Typically this is done to benefit from price differentials.
Slovenian: Praviloma se to izvaja zato, da se lahko izkoristijo ugodnosti zaradi razlik v ceni.
English: This will help the Agency to monitor the safety pattern of authorised medicines more effectively and to make more timely decisions.
Slovenian: To bo Agenciji pomagalo učinkoviteje spremljati varnostni vzorec odobrenih zdravil in sprejemati več pravočasnih odločitev.
English: His main activities since then have been related to the review of old substances and the assessment of complementary/alternative medicines.
Slovenian: Od takrat dalje se v glavnem ukvarja s pregledovanjem starih snovi in ocenjevanjem komplementarnih/alternativnih zdravil.
English: Revision of the 1997 ‘Statement of principles' document that sets out the basic principles of the partnership between the national competent authorities and the EMEA (including the standard contract for the performance of scientific and inspection services)
Slovenian: Revizija dokumenta "Izjava o načelih" iz leta 1997, v katerem so navedena temeljna načela partnerstva med pristojnimi nacionalnimi organi in EMEA (vključno s standardno pogodbo za izvajanje znanstvenih in inšpekcijskih storitev).
English: EMEA in the European system
Slovenian: EMEA v evropskem sistemu
English: Some aspects of the new pharmaceutical legislation came into force in 2004, while fundamental changes to the European regulatory system will have their first effects in 2005.
Slovenian: Nekateri vidiki nove farmacevtske zakonodaje so začeli veljati leta 2004, medtem ko bodo imele temeljne spremembe evropskega regulativnega sistema svoje prve učinke leta 2005.
English: As the first director-general of the NAM he was responsible for establishing the Agency's strategies and working operations.
Slovenian: Kot prvi generalni direktor te nacionalne agencije je bil pristojen za vzpostavitev strategij in delovnih postopkov Agencije.
English: Number of financial transactions
Slovenian: Število finančnih transakcij
English: The post-designation workload is expected to increase by 35 % (the number of designated orphan medicinal products was 246 at the end of 2004)
Slovenian: Delovna obremenitev po določitvi naj bi se predvidoma povečala za 35 % (na koncu leta 2004 je bilo kot zdravila sirote določenih 246 zdravil).
English: Collaboration with the national competent authorities to evolve the European Surveillance Strategy
Slovenian: Sodelovanje s pristojnimi nacionalnimi organi pri razvoju evropske strategije nadzorovanja.
English: 1.7 Corporate governance - Integrated management system
Slovenian: 1.7 Podjetniško upravljanje - Integrirani sistem upravljanja
English: There will be continued cooperation with the Commission on reinforcing contributions to international activities where the Commission is involved, and provision of technical support in such forums as appropriate.
Slovenian: Še naprej bo sodelovala s Komisijo pri krepitvi prispevkov k mednarodnim dejavnostim, v katere je vključena Komisija, ter zagotavljanju tehnične podpore na takšnih forumih, kot je ustrezno.
English: This will be the first full year of activity for the Management Board with its new composition introduced by the revised pharmaceutical legislation.
Slovenian: To bo prvo polno leto delovanja upravnega odbora v novi sestavi, ki jo je uvedla revidirana farmacevtska zakonodaja.
English: She was responsible for scientific advice until December 2000.
Slovenian: Do decembra 2000 je bila odgovorna za znanstveno svetovanje.
English: Services attached to the Executive Director
Slovenian: Službe, dodeljene izvršnemu direktorju
English: Whilst the work to establish MRLs for the ‘old' substances has all but finished, the secretariat continues to respond to a considerable number of enquiries for clarification and interpretation of the lists of MRLs in the Annexes to Council Regulation (EC) No 2377/90 from interested parties within and outside the Community.
Slovenian: Medtem ko je delo za določitev MRL za "stare" učinkovine že skoraj končano, sekretariat še naprej odgovarja na precejšnje število zahtevkov za pojasnitev in razlago seznamov MRL iz prilog k Uredbi Sveta (ES) št. 2377/90, ki so jih poslale zainteresirane strani iz Skupnosti in zunaj nje.
English: This information will not only be more easily accessible to patients, healthcare professionals and the public, but will also be written in a manner that is understandable to the public.
Slovenian: Te informacije ne bodo samo lažje dostopne bolnikom, zdravstvenim strokovnjakom in javnosti, temveč bodo tudi napisane tako, da bodo razumljive za javnost.
English: This increase is a result of the 2004 enlargement, entry into force of new legislation which introduces a new committee, new scientific groups and the setting of new priorities, and a result of the established role of the Agency not only in the EU but also in the international regulatory forum.
Slovenian: Povečanje je posledica širitve leta 2004, začetka veljavnosti nove zakonodaje, ki uvaja nov odbor, nove znanstvene skupine in določitev novih prednostnih nalog, ter posledica uveljavljene vloge Agencije ne samo v EU, temveč tudi v mednarodnem regulativnem forumu.
English: Consider and endorse provisions aimed at greater openness of the Management Board
Slovenian: Preučil in odobril določbe, katerih cilj je večja odprtost upravnega odbora.
English: She was also involved in international harmonisation activities on this subject.
Slovenian: V zvezi s tem je sodelovala tudi pri dejavnostih mednarodnega usklajevanja.
English: An open public procedure for the appointment of members of the Audit Advisory Committee will be launched in 2005.
Slovenian: Odprt javni postopek za imenovanje članov Posvetovalnega odbora za revizije bo sprožen leta 2005.
English: To assure the continuing effectiveness of the European medicines system, it is essential that the solid partnership between the EMEA and the national regulatory authorities of the Member States be maintained.
Slovenian: Za zagotovitev stalne učinkovitosti evropskega sistema zdravil je pomembno, da se ohranja trdno partnerstvo med EMEA in nacionalnimi regulativnimi organi držav članic.
English: The Committee was provisionally established in 2004 and will be fully functional in 2005.
Slovenian: Odbor je bil začasno ustanovljen leta 2004, v celoti pa bo začel delovati leta 2005.
English: Orphan medicinal products are intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions affecting not more than five in 10,000 persons in the European Community, or where for economic reasons such medicines would not be developed without incentives.
Slovenian: Zdravila sirote so namenjena za ugotavljanje, preprečevanje ali zdravljenje življenjsko nevarnih ali kronično izčrpavajočih razmer, ki v Evropski skupnosti ne prizadenejo več kot pet od 10.000 ljudi, ali kjer se takšna zdravila zaradi ekonomske neupravičenosti brez spodbud ne bi razvila.
English: It is to be expected that further referrals shall be received, mainly concerning safety of medicines where Community interest is of primary concern (Article 35)
Slovenian: Treba je pričakovati prejem nadaljnjih predložitev, predvsem v zvezi z varnostjo zdravil, kjer je interes Skupnosti prva skrb (člen 35).
English: It will not only streamline and automate a number of related procedures but will also explore alternatives to physical meetings.
Slovenian: Poleg tega, da bo poenostavila in avtomatizirala številne s tem povezane postopke, bo tudi preučila alternativne možnosti za fizične sestanke.
English: The total in 2005 is expected to reach € 33,498,000
Slovenian: Skupna vsota naj bi v letu 2005 predvidoma dosegla 33,498.000 EUR.
English: The Agency will consult with the European Commission on responses to IFAH-Europe concerning their representation to the Commission expressing fears about the excessive development of guidelines in the veterinary sector.
Slovenian: Agencija se bo z Evropsko komisijo posvetovala o odzivih na IFAH-Evropa v zvezi z njihovo predstavitvijo Komisiji, v katerih je bila izražena bojazen pred čezmernim razvojem smernic na veterinarskem področju.
English: To this end, the EMEA will establish two new services in 2005: a sector for medical information and a dedicated structure for the provision of assistance to small and medium-sized enterprises.
Slovenian: V ta namen bo EMEA v letu 2005 ustanovila dve novi službi: sektor za obveščanje o zdravilih ter namensko organizacijo za zagotavljanje pomoči majhnim in srednje velikim podjetjem.
English: Entry into force of the new legislation, requiring considerable effort to set up structures, processes and tools for the changed regulatory environment
Slovenian: Začetek veljavnosti nove zakonodaje, ki zahteva precejšnja prizadevanja pri vzpostavitvi struktur, postopkov in orodij za spremenjeno regulativno okolje.
English: Improvement of general transparency and communication between all stakeholders
Slovenian: Izboljšanje splošne preglednosti in komuniciranja med vsemi zainteresiranimi stranmi.
English: The system of integrated audits is complemented by the work of the Agency's Audit Advisory Committee.
Slovenian: Sistem povezanih revizij dopolnjuje delo Posvetovalnega odbora Agencije za revizije.
English: During the 1980s, he developed a computer system to support the complex task of editing and managing the assignment of European Commission interpreters to meetings.
Slovenian: V 80-ih je razvil računalniški sistem za podporo zahtevni nalogi urejanja in vodenja dodeljevanja tolmačev Evropske komisije sestankom.
English: 2005 will be the first full year of operation of the rules on access to EMEA documents adopted by the Management Board in May 2004.
Slovenian: Leto 2005 bo prvo polno leto uporabe pravilnika o dostopu do dokumentov EMEA, ki ga je sprejel upravni odbor maja 2004.
English: Following a very useful exchange of views in 2004 with IFAH-Europe, the procedure and guidance for prospective applicants to request scientific advice have been considerably amended.
Slovenian: Po zelo koristni izmenjavi stališč z IFAH-Evropa leta 2004 so bili postopek in navodila za možne vlagatelje zahtevkov za znanstveno svetovanje precej spremenjeni.
English: Focus on health & safety in the workplace
Slovenian: Usmeritev k zdravju in varnosti na delovnem mestu.
English: ICH quality system approach initiative EU Comments in preparation of ICH Guideline
Slovenian: ICH quality system approach initiative Pripombe EU k pripravi smernice ICH
English: The extended scope of the centralised procedure will be implemented in the fourth quarter of 2005 resulting in a minimal increase in the number of applications
Slovenian: razširjen obseg uporabe centraliziranega postopka se bo začel izvajati v zadnjem četrtletju leta 2005, kar bo imelo za posledico majhno povečanje števila vlog;
English: The Agency will publish and communicate more information about its processes and activities.
Slovenian: Agencija bo objavila in sporočila več informacij o svojih postopkih in dejavnostih.
English: The work in the area of infrastructure is directly linked to the increase in staff, meetings, telecommunications activities and visitors to the Agency.
Slovenian: Delo na področju infrastrukture je neposredno povezano s povečanjem števila osebja, sestankov, telekomunikacijskih dejavnosti in obiskovalcev Agencije.
English: Implementation of the new pharmaceutical legislation and the EMEA long-term plan
Slovenian: Izvajanje nove farmacevtske zakonodaje in dolgoročnega načrta EMEA
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: He later taught as a lecturer and senior lecturer at the same university until he joined the European Commission in Luxembourg in January 1986.
Slovenian: Nato je bil predavatelj in višji predavatelj na isti univerzi, dokler se ni januarja 1986 pridružil Evropski komisiji v Luksemburgu.
English: The new pharmaceutical legislation requires the introduction of a number of new processes in the inspection field.
Slovenian: Nova farmacevtska zakonodaja zahteva uvedbo mnogih novih postopkov na področju inšpekcijskega nadzora.
English: This will allow more time for discussion with companies requesting advice, for preparation of conclusions ahead of CHMP meetings, and for the provision of faster advice and assistance to sponsors.
Slovenian: To bo omogočilo več časa za razprave s podjetji, ki želijo nasvet, za pripravo sklepov pred zasedanji CHMP ter za zagotavljanje hitrejšega svetovanja in pomoči sponzorjem.
English: Development of a new document with PEG (Paediatrics Working Party)
Slovenian: Pripravi se nov dokument skupaj s PEG (Pediatrično delovno skupino)
English: Communication of programmes and results to stakeholders will increase due to the agreed greater transparency.
Slovenian: Obveščanje zainteresiranih strani o programih in rezultatih se bo zaradi dogovorjene večje preglednosti povečalo.
English: The EMEA ensures efficient support for meetings organised by the Agency, provides facilities and services, and constantly improves the resources available.
Slovenian: EMEA zagotavlja učinkovito podporo sestankom, ki jih organizira Agencija, zagotavlja zmogljivosti in storitve ter stalno izboljšuje razpoložljive vire.
English: This work programme for 2005 incorporates many of the actions detailed in our Road Map implementation plan.
Slovenian: Ta delovni program za leto 2005 vključuje številne ukrepe, ki so podrobno opisani v našem načrtu za izvedbo usmeritvenega načrta ("Road Map").
English: The consequences of the new legislation:
Slovenian: Posledice nove zakonodaje:
English: Work on implementation of mutual recognition agreements is expected to move towards consolidation as all agreements, with the exception of that with the US, become fully operational.
Slovenian: Delo pri izvajanju sporazumov o medsebojnem priznavanju naj bi se po pričakovanjih premaknilo h konsolidaciji, saj so vsi sporazumi, razen sporazuma z ZDA, v celoti pripravljeni za izvajanje.
English: Continue reflection on the long-term financing of the Agency and the European medicines network
Slovenian: Nadaljeval preučevanje dolgoročnega financiranja Agencije in Evropske mreže zdravil.
English: CHMP standing and temporary working parties will continue to streamline their processes, improving their transparency and effectiveness.
Slovenian: Stalne in začasne delovne skupine CHMP bodo nadaljevale poenostavljanje svojih postopkov, s čimer bodo izboljšale njihovo preglednost in učinkovitost.
English: The activities entail close cooperation with the European Parliament and the Council (Budgetary Authority), as well as with the Commission and the Court of Auditors, on matters relating to administration, the budget, personnel, and rules and regulations on finances, audit and accounting.
Slovenian: Te dejavnosti imajo za posledico tesno sodelovanje z Evropskim parlamentom in Svetom (s proračunskim organom) ter Komisijo in Računskim sodiščem pri zadevah, ki se nanašajo na upravljanje, proračun, osebje, ter pri pravilih in predpisih za finance, revizijo in računovodstvo.
English: Regulatory and procedural guidance
Slovenian: Regulativne in postopkovne smernice
English: The Council Directive on the conduct of clinical trials on medicinal products for human use came into force on 1 May 2004
Slovenian: Direktiva Sveta o izvajanju kliničnega preizkušanja zdravil za uporabo v humani medicini je začela veljati 1. maja 2004.
English: The document on frequently asked questions published on the EMEA website has facilitated this task and further steps will be undertaken to maximise the information available.
Slovenian: Dokument o pogosto zastavljenih vprašanjih, objavljen na spletni strani EMEA, je to nalogo olajšal, sprejeti pa bodo nadaljnji ukrepi, da se čim bolj poveča število razpoložljivih informacij.
English: The new pharmaceutical legislation has given the EMEA and the European network as a whole a wider mandate to increase the transparency of its activities.
Slovenian: Nova farmacevtska zakonodaja je EMEA in Evropski mreži kot celoti podelila širše naloge in pooblastila za povečanje preglednosti njenih dejavnosti.
English: Support the Commission with the preparation of its five-year report on experience following the implementation of the orphan medicinal products regulation
Slovenian: Podpora Komisiji pri pripravi njenega petletnega poročila o izkušnjah, pridobljenih pri izvajanju uredbe o zdravilih sirotah.
English: Revision, where necessary, of the Agency's management of minor variations, taking into account the first year's experience of the implementation of new Community legislation
Slovenian: Po potrebi sprememba upravljanja Agencije za manjše spremembe, ob upoštevanju izkušenj, pridobljenih v prvem letu izvajanja nove zakonodaje Skupnosti.
English: There he was responsible for a number of groups in the technical support division of the Euratom Safeguards Directorate.
Slovenian: Tam je bil odgovoren za številne skupine na oddelku za tehnično podporo Direktorata Euratoma za varnostne ukrepe.
English: The Committee on Orphan Medicinal Products (COMP) is responsible for making recommendations to the European Commission for the designation of orphan medicinal products for rare diseases.
Slovenian: Odbor za zdravila sirote (COMP) je pristojen za pripravo priporočil Evropski komisiji za določitev zdravil sirot za redke bolezni.