FrancophonIA/ELRC3.0 huggingface dataset:
English: The sampling and testing programme for centrally authorised products will continue in 2006, using the expertise of the EEA's network of official medicines-control laboratories, enabling the quality of medicinal products on the market in the EEA to be controlled.
Slovenian: Program vzorčenja in preizkušanja za zdravila, odobrena po centraliziranem postopku, se bo nadaljeval v letu 2006 z uporabo strokovnega znanja mreže EGP uradnih laboratorijev za nadzor zdravil, ki omogočajo nadzor kakovosti zdravil na trgu EGP.
English: The regulatory and scientific consistency of scientific committees (CHMP and CVMP) opinions and assessment reports, and their quality, will be further improved.
Slovenian: Dodatno se bosta izboljšali regulativna in znanstvena skladnost ter kakovost mnenj in poročil o oceni odborov (CHMP in CVMP).
English: Revenue and expenditure overview 2004-2006
Slovenian: Pregled prihodkov in odhodkov za obdobje 2004-2006
English: Total grade D Total Staff
Slovenian: Stopnja D skupaj Osebje skupaj
English: Meetings at the EMEA
Slovenian: Sestanki v EMEA
English: As an important element of the harmonised approach to the scientific assessment of herbal medicinal products in the EU, the Committee on Herbal Medicinal Products (HMPC) will pay particular attention in 2006 to establishing Community herbal monographs, as well as to preparing entries to the draft list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products.
Slovenian: Odbor za zdravila rastlinskega izvora (HMPC) bo leta 2006 v okviru usklajenega pristopa k znanstvenemu ocenjevanju zdravil rastlinskega izvora v EU posvetil posebno pozornost pripravi monografij rastlin Skupnosti ter pripravi vnosov v osnutek seznama snovi rastlinskega izvora, pripravkov in njihovih kombinacij za uporabo v tradicionalnih zdravilih rastlinskega izvora.
English: The Agency is continuing the development of the scientific-memory database for centrally authorised veterinary medicines.
Slovenian: Agencija še naprej razvija svojo zbirko podatkov znanstvenega pomnilnika za veterinarska zdravila, odobrena po centraliziranem postopku.
English: The priorities for the Agency's IT activity relate to the continued provision of quality services in corporate IT, meetings-management and conferences, and electronic document-management and publishing.
Slovenian: Prednostna področja na področju informacijske tehnologije Agencije so povezana s stalnim zagotavljanjem kakovostnih storitev na področju podjetniške informacijske tehnologije, vodenjem sestankov in konferenc ter vodenjem in objavljanjem elektronske dokumentacije.
English: Subject to the outcome of the analysis of business processes, the EMEA will accept electroniconly submissions of applications for marketing authorisations in the eCTD format towards the end of the year.
Slovenian: EMEA bo enkrat konec leta glede na analizo poslovnih procesov sprejela samo elektronsko pošiljanje vlog za dovoljenje za promet v formatu eCTD.
English: Given this significant growth in activity, the Agency will develop its meetings-management system to make online booking facilities available to delegates, thereby increasing the efficiency and effectiveness of this process.
Slovenian: Ker se je število dejavnosti precej povečalo, bo Agencija razvila svoj sistem vodenja sestankov, po katerem bodo delegati lahko opravili rezervacije prek spleta, s čimer se bo povečala učinkovitost in uspešnost njenih postopkov.
English: In addition, the Agency will encourage marketing-authorisation holders to request pre-submission meetings to streamline the submission and review of line-extension and variation applications, thus facilitating the availability of new indications and pharmaceutical forms.
Slovenian: Poleg tega bo Agencija spodbujala imetnike dovoljenj za promet, naj zahtevajo sestanke pred oddajo vloge, na katerih bi poenostavili oddajo vloge ter pregledali vloge za razširitev terapevtskih indikacij in spremembe, s čimer bi poenostavili razpoložljivost novih indikacij in farmacevtskih oblik.
English: Work to develop EMEA interaction with top-quality experts from national authorities, academia, learned societies and industry on challenges relating to new technologies;
Slovenian: prizadevanje za razvoj vzajemnega delovanja EMEA in vrhunskih znanstvenikov nacionalnih organov, akademskih krogov, znanstvenih združenj in industrije glede izzivov, povezanih z novimi tehnologijami;
English: Development of corporate applications will concentrate on the completion of phase III of the Meetings Management System (end of March), the continuing update of the corporate product database and tracking system SIAMED to include provisions of the new medicines legislation, and its migration to a different technical platform, and further work on a number of smaller systems such as the contracts database.
Slovenian: Razvoj podjetniških uporabniških programov se bo osredotočal na dokončanje tretje faze sistema vodenja sestankov (konec marca), stalno posodabljanje zbirke podatkov o podjetniških izdelkih in sistem iskanja SIAMED, tako da bo vključil določbe nove zakonodaje o zdravilih in prehod na novo tehnološko platformo ter nadaljnje delo na vrsti podobnih sistemov, kot je zbirka podatkov o pogodbah.
English: The Agency will advance the work on the new database for GMP certificates and manufacturing authorisations, and will complete the construction of an EU telematics data centre with high availability, high scalability and good performance.
Slovenian: Agencija bo izboljšala delo na novi zbirki podatkov za potrdila o dobri proizvodni praksi in dovoljenjih za izdelavo ter dokončno zgradila telematski podatkovni center z visoko stopnjo razpoložljivosti, obvladljivosti in učinkovitosti.
English: Meetings at the EMEA Document management and publishing
Slovenian: Sestanki v EMEA Upravljanje dokumentov in objave
English: Managing the Agency
Slovenian: Upravljanje Agencije
English: Number of reimbursed delegates
Slovenian: Število delegatov s povrnjenimi stroški
English: For enquiries concerning PMF certificates
Slovenian: Za vprašanja o potrdilih PMF
English: Chapter 1 EMEA in the European system
Slovenian: Poglavje 1 EMEA v evropskem sistemu
English: It will also roll out the first production version of the EU-wide database on manufacturing authorisations and GMP certificates.
Slovenian: Objavila bo tudi prvo delovno različico zbirke podatkov za vso EU o dovoljenjih za izdelavo in potrdilih o dobri proizvodni praksi.
English: Annex 4 Management Board and scientific committee meeting dates in 2006
Slovenian: Priloga 4 Datumi sestankov upravnega odbora in znanstvenega odbora v letu 2006
English: Strengthen cooperation on pharmacovigilance, scientific advice, support to SMEs and the provision of information;
Slovenian: Evropska mreža zdravil krepitev sodelovanja na področju farmakovigilance, znanstvenega sodelovanja, podpore malim in srednje velikim podjetjem in zagotavljanja informacij;
English: These include acceleratedassessment, conditional-marketing-authorisation and compassionate-use procedures, and the provision of scientific opinions on medicinal products intended for non-EU markets (in cooperation with the WHO).
Slovenian: Sem se prištevajo postopki za pospešeno oceno, pogojno izdajo dovoljenja za promet in sočutno uporabo ter zagotavljanje znanstvenih mnenj o zdravilih, ki niso namenjena na trge EU (v sodelovanju z WHO).
English: Certificate requests
Slovenian: Zahtevki za potrdila
English: Coordination groups for mutual-recognition and decentralised procedures (human and veterinary products)
Slovenian: Skupine za usklajevanje za postopke vzajemnega priznavanja in decentralizirane postopke (zdravila za uporabo v humani medicini in veterinarska zdravila)
English: Thursday 28 September
Slovenian: Četrtek, 28. septembra
English: Post-authorisation activities
Slovenian: Dejavnosti po izdaji dovoljenja
English: • on the Internet at www.emea.eu.int
Slovenian: • na internetu na www.emea.eu.int
English: Operation of new regulatory procedures, including accelerated-assessment, conditionalmarketing-authorisation and compassionate-use procedures;
Slovenian: delovanje novih regulativnih postopkov, vključno s postopki za pospešeno oceno, pogojno izdajo dovoljenja za promet in sočutno uporabo;
English: The RMP identifies known and potential risks with the medicinal product so that risk-minimisation measures and other pharmacovigilance activities can be implemented proactively to protect public health.
Slovenian: Načrt za obvladovanje tveganja opredeljuje znana in potencialna tveganja zdravila, tako da je mogoče v skrbi za varovanje javnega zdravja izvesti ukrepe za zmanjšanje tveganja in druge dejavnosti na področju farmakovigilance.
English: MRL ext./mod.
Slovenian: Vloge za razš./spre.
English: The suite of business intelligence and statistical tools within EudraVigilance will enable safety data relating to products on the market and under development in Europe to be monitored, analysed and acted upon in an increasingly sophisticated manner; an interim data warehouse and business intelligence solution for medicinal products for human use will be made available to all EU/EEA regulators in March 2006.
Slovenian: Nabor orodij za poslovno inteligenco in statističnih orodij v okviru sistema EudraVigilance bo omogočil vedno bolj dodelano spremljanje varnostnih podatkov o izdelkih, ki so v Evropi že na trgu in ki se šele razvijajo, njihovo analizo in odzivanje nanje; pilotsko podatkovno skladišče in rešitev poslovne inteligence za zdravila za uporabo v humani medicini bodo na voljo vsem zakonodajalcem EU/EGS marca 2006.
English: Management Board and scientific committee meeting dates in 2006 EMEA contact points
Slovenian: Datumi sestankov upravnega odbora in znanstvenega odbora v letu 2006 Kontaktne osebe EMEA
English: Provide high-quality information to provide for adequately informed patients and improve the availability of useful information to healthcare professionals;
Slovenian: Odprtost, obveščanje in zagotavljanje informacij zagotavljanje visoko kakovostnih informacij za ustrezno obveščenost bolnikov in izboljšanje dostopnosti do koristnih informacij za zdravstvene strokovnjake;
English: The European medicines network
Slovenian: Evropska mreža zdravil
English: The existing business-continuity arrangements will be improved to support a range of disasterrecovery scenarios.
Slovenian: Obstoječe ureditve za zveznost poslovanja bodo izboljšane, tako da bodo podpirale vrsto scenarijev za obnovitve programske opreme po njeni odpovedi.
English: Total grade C D*5
Slovenian: Stopnja C skupaj D*5
English: Development of the database containing information about authorised medicinal products in the EU will also continue.
Slovenian: Nadaljeval se bo tudi razvoj zbirke podatkov EudraPharm, ki vsebuje informacije o zdravilih z dovoljenjem za promet v EU.
English: Annex 3 Revenue and expenditure overview 2004-2006
Slovenian: Priloga 3 Pregled prihodkov in odhodkov za obdobje 2004-2006
English: Total grade B C*7
Slovenian: Stopnja B skupaj C*7
English: This is a result of initiatives taken by the CVMP to facilitate the authorisation of products for minor uses and minor species.
Slovenian: To je posledica pobud Odbora za zdravila za uporabo v veterinarski medicini, s katerimi je ta želel poenostaviti izdajanje dovoljenj za zdravila za manj pomembne uporabe in vrste.
English: Modifications to the existing tasks, and the introduction of new ones, have put the EU regulatory system in a better position to ensure that safe and effective medicines, as well as adequate information about them, are available to European patients.
Slovenian: Regulativni sistem EU je tako zaradi spremembe obstoječih nalog in uvedbe novih bolj sposoben zagotavljati bolnikom v Evropi varna in učinkovita zdravila ter ustrezne informacije o njih.
English: The database of authorised medicinal products in the EU will make authoritative, up-to-date information on all these products available to regulators, health professionals and the general public; while the current version of the application is already available to EU regulators, public access will be provided by September 2006.
Slovenian: EudraPharm, zbirka podatkov o zdravilih z dovoljenjem za promet v EU, bo zakonodajalcem, zdravstvenim strokovnjakom in širši javnosti ponujala verodostojne najnovejše informacije o vseh teh izdelkih; medtem ko je zakonodajalcem EU sedanja različica uporabniških programov že na voljo, bo javni dostop zagotovljen do septembra 2006.
English: Cooperation will also continue with the European Pharmacopoeia and with the European Directorate for the Quality of Medicines, in the context of the sampling and testing programme being operated to supervise the quality of centrally authorised medicinal products placed on the market.
Slovenian: Nadaljevalo se bo tudi sodelovanje z Evropsko farmakopejo in Evropskim direktoratom za kakovost zdravil v okviru programa vzorčenja in preizkušanja, ki se izvaja za nadzor kakovosti zdravil, za katera je bilo izdano dovoljenje po centraliziranem postopku in ki so v prometu.
English: At the same time, five of the EU telematics systems - EudraNet, EudraVigilance, EudraCT, the database of authorised medicinal products in the EU, and the product-informationmanagement application, PIM, - will have to be operated, supported, maintained and further developed.
Slovenian: Hkrati bo treba upravljati, podpirati, vzdrževati in dodatno razvijati pet telematskih sistemov EU - EudraNet, EudraVigilance, EudraCT, EudraPharm - zbirko podatkov o zdravilih z dovoljenjem za promet v EU ter uporabniški program za upravljanje informacij o izdelkih.
English: Committee for Medicinal Products for Veterinary Use meetings 17-19 January
Slovenian: Sestanki Odbora za zdravila za uporabo v veterinarski medicini 17.-19. januarja
English: Information technology Infrastructure
Slovenian: Informacijska tehnologija Infrastruktura
English: Parallel-distribution notifications validated (Input)
Slovenian: Potrjena obvestila o vzporedni distribuciji (Vhodni podatek)
English: 29 May-1 June
Slovenian: 29. maja-1.
English: 18-21 September
Slovenian: 18.-21. septembra
English: E-mail: antoon.gijsens@emea.eu.int
Slovenian: E-naslov: antoon.gijsens@emea.eu.int
English: Develop scientific-advice procedures to give as much support as possible to companies at the different stages of development of medicinal products;
Slovenian: Dostop do zdravil ter spodbujanje inovacij in raziskav razvoj postopkov znanstvenega svetovanja, da bi čim bolj podprli podjetja na različnih stopnjah razvoja zdravil;
English: CHAPTER 3 INSPECTIONS
Slovenian: Poglavje 3 Inšpekcijski nadzor
English: Chapter 3 Inspections
Slovenian: POGLAVJE 3 INŠPEKCIJSKI NADZOR
English: 26-29 June
Slovenian: 26.-29. junija
English: Monitoring the safety of medicines for human and veterinary use is a priority area for the EMEA.
Slovenian: Prednostno področje EMEA je spremljanje varnosti zdravil za uporabo v humani medicini in veterinarskih zdravil.
English: New regulatory procedures aimed at increasing access to medicines, including acceleratedassessment, conditional-marketing-authorisation and compassionate-use procedures, will also be applied.
Slovenian: Uporabljali se bodo tudi novi regulativni postopki, ki naj bi izboljšali dostop do zdravil, vključno s postopki za pospešeno oceno, izdajo pogojnih dovoljenj za promet z zdravili in sočutno uporabo.
English: Scientific-advice and protocol-assistance requests (human medicines)
Slovenian: Zahtevki za znanstveno svetovanje in pomoč pri protokolu (Zdravila za uporabo v humani medicini)
English: Thursday 9 March
Slovenian: Četrtek, 9. marca
English: 5 Appropriation/Budget 2006 as adopted by the Management Board on 15 December 2005.
Slovenian: 5 Proračunska sredstva/proračun 2006, ko ga je upravni odbor sprejel 15. decembra 2005.
English: Safety of medicines
Slovenian: Varnost zdravil
English: Arbitration and Community referrals to EMEA (Veterinary medicines)
Slovenian: Arbitraža in zadeve, ki jih Skupnosti predloži EMEA (Veterinarska zdravila)
English: 8-10 November
Slovenian: 8.-10. novembra
English: Annex 2 EMEA establishment plan 2004-2006
Slovenian: Priloga 2 Načrt delovnih mest EMEA za obdobje 2004-2006
English: Committee for Medicinal Products for Human Use meetings 23-26 January
Slovenian: Sestanki Odbora za zdravila za uporabo v humani medicini 23.-26. januarja
English: Pharmacovigilance and post authorisation safety and efficacy of medicines
Slovenian: Farmakovigilanca ter varnost in učinkovitost zdravil po izdaji dovoljenja za promet
English: 11-12 May
Slovenian: 11.-12. maja
English: With the need to meet the Agency's obligations to provide more transparent veterinary pharmacovigilance reporting and communication to the outside world, as explicitly stated in the new Regulation, a considerable increase in data analysis with EudraVigilance and subsequent reporting is expected.
Slovenian: V novi uredbi so izrecno navedene obveznosti Agencije, da mora zagotoviti preglednejše poročanje in sporočanje o veterinarski farmakovigilanci širši javnosti, in če jih hoče izpolniti, mora precej povečati analizo podatkov v okviru sistema EudraVigilance in poročanje o tem.
English: Administrative and procedural assistance will be provided to SMEs by the dedicated SME Office within the Agency, which will become fully functional in 2006.
Slovenian: Posebni Urad za mala in srednje velika podjetja znotraj Agencije, ki bo začel popolnoma delovati leta 2006, bo malim in srednje velikim podjetjem zagotavljal upravno in postopkovno pomoč.
English: Veterinary marketing authorisation procedures Safety of veterinary medicines
Slovenian: Postopki za izdajo dovoljenja za promet z veterinarskimi zdravili Varnost veterinarskih zdravil
English: Total Title 1
Slovenian: Naslov 1 skupaj
English: The continuing emphasis on the safety of veterinary medicines in the post-authorisation phase and the need to adopt a continuing risk-management approach to this important issue will feature highly on the list of priority activities in 2006.
Slovenian: Leta 2006 bosta na seznamu prednostnih nalog pomembno mesto zavzemala stalen poudarek na varnosti veterinarskih zdravil po izdaji dovoljenja in potreba po sprejetju pristopa stalnega obvladovanja tveganja pri tem pomembnem vprašanju.
English: Direct telephone: (44-20) 74 18 85 81 E-mail: fia.westerholm@emea.eu.int
Slovenian: Direktni telefon: (44-20) 74 18 85 81 E-naslov: fia.westerholm@emea.eu.int
English: Direct telephone: (44-20) 75 23 71 08 E-mail: panos.tsintis@emea.eu.int
Slovenian: Direktni telefon: (44-20) 75 23 71 08 E-naslov: panos.tsintis@emea.eu.int
English: 19-20 April
Slovenian: 19.-20. aprila
English: Annex 1 EMEA structure
Slovenian: Priloga 1 Organizacijska shema EMEA
English: HUMAN USE Head: Noël Wathion
Slovenian: Vodja: Noël Wathion
English: Actual and estimated numbers of ICSR concerning centrally authorised products (Human medicines)
Slovenian: Dejansko in ocenjeno število ICSR v zvezi z zdravili, odobrenimi po centraliziranem postopku (Zdravila za uporabo v humani medicini)
English: Actual and estimated numbers of ICSR concerning non-centrally authorised products (Human medicines)
Slovenian: Dejansko in ocenjeno število ICSF v zvezi z zdravili, ki niso bila odobrena po centraliziranem postopku (Zdravila za uporabo v humani medicini)
English: Establishment of maximum residue limits for veterinary medicines
Slovenian: Določitev mejne vrednosti ostankov za veterinarska zdravila
English: 13-15 June
Slovenian: 13.-15. junija
English: • by fax to (44-20) 7418 8670
Slovenian: • po faksu na št. (44-20) 7418 8670
English: 4-6 April
Slovenian: 4.-6. aprila
English: Certificates of medicinal products Sampling and testing
Slovenian: Inšpekcijski pregledi Potrdila za zdravilo Vzorčenje in preizkušanje
English: Periodic safety update reports (Human medicines)
Slovenian: Periodično dopolnjena poročila o varnosti (Zdravila za uporabo v humani medicini)
English: Applications for initial evaluation (veterinary medicines)
Slovenian: Vloge za začetno oceno (Veterinarska zdravila)
English: In 2006, the Agency will continue to extrapolate MRLs to minor species upon request by companies, in accordance with the CVMP policy on availability.
Slovenian: Agencija bo leta 2006 v skladu s politiko Odbora za zdravila za uporabo v veterinarski medicini o razpoložljivosti na zahtevo podjetij še naprej ekstrapolirala mejne vrednosti ostankov za manj pomembne vrste.
English: In order to rationalise dossier requirements, the Joint CHMP/CVMP Quality Working Party will review assessment experiences and existing guidelines.
Slovenian: Skupna delovna skupina CHMP/CVMP za kakovost bo pregledala izkušnje iz ocenjevanj in obstoječe smernice, da bi racionalizirala zahteve po dokumentaciji.
English: Quality of medicines Safety and efficacy of medicines
Slovenian: Varnost in učinkovitost zdravil
English: The complexity of the Agency's operations will also increase, due to the growing number of submissions associated with emerging therapies and technologies, and of requests for scientific advice relating to them.
Slovenian: Prav tako bo zaradi naraščajočega števila vlog, povezanih z novimi terapijami in tehnologijami, in zaradi zahtevkov za znanstveno svetovanje, ki se nanje nanašajo, delovanje Agencije bolj zapleteno.
English: Opinions on designation (Output)
Slovenian: Mnenja o določitvah (Izhodni podatek)
English: Type-I variation applications Type-II variation applications Line-extension applications
Slovenian: Vloge za spremembo tipa I Vloge za spremembo tipa II Vloge za razširitev indikacij
English: PMF/VAMF EMEA certificates
Slovenian: Potrdila EMEA za PMF/VAMF
English: In the area of arbitrations and Community referrals relating to medicines for human use, the Agency will concentrate on two goals in 2006.
Slovenian: Agencija se bo na področju arbitraže in predložitev Skupnosti v zvezi z zdravili za uporabo v humani medicini leta 2006 posvetila dvema ciljema.
English: In addition, the Agency will continue to evaluate applications for medicinal products intended for non-EU markets, as part of its cooperation with the World Health Organization.
Slovenian: Poleg tega bo Agencija v okviru sodelovanja s Svetovno zdravstveno organizacijo še naprej ocenjevala vloge za zdravila, ki niso namenjena na trge EU.
English: Direct telephone: (44-20) 75 23 7114 Fax: (44-20) 74 18 85 45
Slovenian: Direktni telefon: (44-20) 75 23 7114 Faks: (44-20) 74 18 85 45
English: Total grade A B*11
Slovenian: Stopnja A skupaj B*11
English: Committee on Herbal Medicinal Products meetings 11-12 January
Slovenian: Sestanki Odbora za zdravila rastlinskega izvora 11.-12. januarja
English: Fully apply tools provided by the new legislation, including risk-management plans and specialised studies on safety profiles of medicinal products post authorisation; Work to establish a network for intensive monitoring of targeted medicines; Full integration of the pharmacovigilance network between EU regulatory bodies.
Slovenian: Varnost zdravil za uporabo v humani medicini in veterinarsko uporabo izvajanje in krepitev evropske strategije obvladovanja tveganja v tesnem sodelovanju z državami članicami; popolna uporaba orodij, ki jih predvideva nova zakonodaja, vključno z načrti za obvladovanje tveganja in posebnimi študijami o varnostnih lastnostih zdravil po izdaji dovoljenja; delo za vzpostavitev mreže za intenzivno spremljanje ciljno usmerjenih zdravil; polna integracija mreže za farmakovigilanco med regulativnimi organi EU.
English: Meeting management and conferences Project management
Slovenian: Upravljanje srečanj in konferenc
English: New versions of the PIM light authoring and review tools will be released at the end of April.
Slovenian: Do konca aprila bosta objavljeni novi različici orodij za izdajanje dovoljenj in pregledovanje uporabniškega programa za upravljanje informacij o izdelkih.
English: Applications for designation (Input)
Slovenian: Zahtevki za določitev (Vhodni podatek)