FrancophonIA/ELRC3.0 huggingface dataset:
English: The focus of additional activities in the area of evaluation of veterinary medicines will include further improvement of the quality-assurance system in respect of the procedures of the Committee for Medicinal Products for Veterinary Use (CVMP) and establishing systems for peer review of the quality and consistency of scientific assessments.
Slovenian: Na področju vrednotenja veterinarskih zdravil bo poudarek na dodatnih dejavnostih za nadaljnje izboljšave sistema zagotavljanja kakovosti glede na postopke Odbora za zdravila v veterinarski medicini (CVMP) in uvedbo sistema za stanovski strokovni pregled kakovosti in skladnosti znanstvenih vrednotenj.
English: In 2008, the scope of the mandatory centralised procedure will extend to products for autoimmune diseases and other immune dysfunctions and viral diseases.
Slovenian: V letu 2008 bo obvezen centralizirani postopek veljal tudi za zdravila za avtoimune bolezni in druge motnje
English: In addition, the Agency plans to upgrade the functionality of the EudraCT database as specified by the Clinical Trials Facilitation Group (EU telematics project).
Slovenian: Poleg tega namerava Agencija nadgraditi funkcionalnost podatkovne baze EudraCT, kot jo je opredelila Skupina za omogočanje kliničnih preskušanj (telematski projekt EU).
English: The effective conduct of the Agency's core responsibilities, in cooperation with all members of the European medicines network, in the areas of scientific advice, evaluation and supervision of medicinal products to the highest quality standards will continue to constitute the Agency's overall priority.
Slovenian: Splošna prednostna naloga Agencije bo še naprej ostalo učinkovito opravljanje njenih glavnih nalog, v sodelovanju z vsemi člani Evropske mreže zdravil, na področju znanstvenega svetovanja ter vrednotenja in nadzora zdravil za dosego najvišjih standardov kakovosti.
English: The certificates confirm the marketing-authorisation status of products authorised through the centralised procedure.
Slovenian: Potrdila potrjujejo, da so zdravila pridobila dovoljenje za promet po centraliziranem postopku.
English: In order to strengthen active pharmacovigilance, the Agency, together with its partners in the European medicines network, is implementing the European Risk-Management Strategy.
Slovenian: Da bi Agencija okrepila aktivno farmakovigilanco, izvaja s svojimi partnerji v Evropski mreži zdravil evropsko strategijo o obvladovanju tveganj (ERMS).
English: Medical information
Slovenian: Zdravstvene informacije
English: SPECIFIC MEDICINAL PRODUCT AREAS
Slovenian: Specifična področja zdravil
English: Work will continue on improving the website to enable easy access to information currently contained in various EMEA databases and other sources by stakeholders, in particular patients and healthcare professionals.
Slovenian: Delo bo usmerjeno v izboljšavo spletne strani, da se zainteresiranim stranem, zlasti bolnikom in zdravstvenim delavcem, omogoči preprost dostop do informacij, ki so trenutno zajete v različnih podatkovnih bazah EMEA in drugih virih.
English: Integrated quality management - Internal audit
Slovenian: Celovito obvladovanje kakovosti - notranja revizija Svetovalka za celovito obvladovanje kakovosti
English: In the field of human medicinal products, the Agency, in addition to the actions mentioned above, will focus on the implementation of the initiatives that the EMEA/CHMP Think-Tank on innovative drug development has elaborated.
Slovenian: Poleg zgoraj omenjenih dejavnosti se bo Agencija na področju zdravil za uporabo v humani medicini osredotočila na izvajanje pobud, ki jih je razvila ustvarjalna enota EMEA/CHMP za razvoj inovativnih zdravil.
English: Legal sector
Slovenian: Sektor za pravne zadve
English: The Agency will also progress the validation of the EudraVigilance data-analysis system (EU telematics project).
Slovenian: Agencija bo tudi nadaljevala validacijo sistema obdelave podatkov EudraVigilance (telematski projekt EU).
English: MANAGEMENT BOARD
Slovenian: UPRAVNI ODBOR
English: Additional functionalities will be added to the database and known defects resolved in the course of 2008 (EU telematics project).
Slovenian: V letu 2008 bodo podatkovni bazi dodane dodatne funkcionalnosti, in odpravljene bodo ugotovljene pomanjkljivosti (telematski projekt EU).
English: Taking this into account, and also considering the EU legislation aimed at improving the availability of medicinal products in children, the Agency will increase its supervision of the conduct and ethical standards of clinical trials performed outside the EU.
Slovenian: Ob upoštevanju tega dejstva ter glede na zakonodajo EU, ki želi izboljšati dostopnost zdravil za otroke, bo Agencija povečala nadzor izvajanja ter etičnih standardov pri kliničnih preskušanjih zunaj EU.
English: Continue the contribution to pan-European efforts to facilitate innovation and research, and thus to increase availability of medicines, in particular through participation in the work of the Innovative Medicines Initiative for human medicines, the European Technology Platform for Global Animal Health for veterinary medicines, and the continued implementation of recommendations of the EMEA/CHMP Think-Tank Group on innovative drug development.
Slovenian: Nadalje prispevati k vseevropskemu prizadevanju za spodbujanje inovacij in raziskav ter tako povečati dostopnost zdravil, zlasti s sodelovanjem pri delu pobude za inovativna zdravila za uporabo v humani medicini (Innovative Medicines Initiative), evropske tehnološke platforme za globalno zdravje živali (European Technology Platform for Global Animal Health) za zdravila za uporabo v veterinarski medicini ter z nadaljnjim izvajanjem priporočil ustvarjalne enote EMEA/CHMP za razvoj inovativnih zdravil;
English: The Agency provides financial incentives because such medicines might, for economic reasons, not otherwise be developed.
Slovenian: Takih zdravil iz gospodarskih razlogov morda ne bi razvijali, zato Agencija prispeva finančne spodbude.
English: For matters relating to pharmacovigilance for
Slovenian: Za zadeve v zvezi s farmakovigilanco za
English: Pharmacovigilance and post-authorisation safety and efficacy of medicines
Slovenian: Farmakovigilanca ter varnost in učinkovitost zdravil po izdaji dovoljenja za promet
English: Contribute to earlier availability of medicines for human and veterinary use
Slovenian: Prispevati k zgodnejši dostopnosti zdravil za uporabo v humani in veterinarski medicini
English: Promote the supervision of veterinary medicines once authorised, through effective and targeted pharmacovigilance, including further development and use of the EudraVigilance veterinary database for continuous surveillance, and establishment of the concept of risk-management plans as it applies to the veterinary context.
Slovenian: Spodbujanje nadzora zdravil za uporabo v veterinarski medicini po izdaji dovoljenja za promet z učinkovito in ciljno farmakovigilanco, kar vključuje nadaljnji razvoj in uporabo veterinarske baze podatkov EudraVigilance za stalni nadzor, in uvedbo koncepta načrtov za obvladovanje tveganja v okviru veterinarske medicine.
English: The Agency plans to make further progress on parallel review of the development of paediatric medicines with this international partner.
Slovenian: Agencija želi s svojim mednarodnim partnerjem doseči nadaljnji razvoj pri vzporednem ocenjevanju razvoja pediatričnih zdravil.
English: Expenditure
Slovenian: Odhodki
English: European public- and animal-health activities
Slovenian: 1.4 Evropske dejavnosti na področju javnega zdravja in zdravja živali
English: For product quality defects and recalls see www.emea.europa.eu/inspections/defectinstruction.html for instructions and contact points
Slovenian: Za pomanjkljivosti izdelkov in druge preklice pojdite na naslov www.emea.europa.eu/inspections/defectinstruction.html, ki vsebuje navodila in kontaktne osebe E-pošta: qdefect@emea.europa.eu
English: Pharmacovigilance and maintenance activities
Slovenian: 2.6 Farmakovigilanca in vzdrževalne dejavnosti
English: The Agency plans to streamline the implementation of legislative requirements regarding the review of profitability of such medicines after their authorisation, in the light of a new Commission guideline.
Slovenian: V skladu z novimi smernicami Komisije namerava Agencija racionalizirati izvajanje zakonodajnih zahtev v zvezi z ocenjevanjem dobičkonosnosti takih zdravil po pridobitvi dovoljenja za promet.
English: Parallel-distribution notifications (Input)
Slovenian: Obvestila o vzporedni distribuciji (Vhodni podatek)
English: To strengthen this trend and to facilitate the availability of medicines, the Agency will work with the Heads of Veterinary Medicines Agencies to implement new measures to provide support to companies considering applications for limited markets and/or for regional diseases.
Slovenian: Da bi te smernice okrepili in omogočili lažjo dostopnost zdravil, bo Agencija sodelovala z vodji agencij za veterinarska zdravila, da se bodo izvedli novi ukrepi za pomoč podjetjem, ki se zanimajo za dovoljenja za omejene trge in/ali lokalne bolezni.
English: The EMEA will continue to be involved in the work of the ICH, VICH and Codex Alimentarius, will participate in international standardisation activities, and will further collaborate with the WHO, the World Organisation for Animal Health and other international organisations.
Slovenian: EMEA bo še naprej vključena v delo ICH, VICH, Codexa Alimentariusa ter bo sodelovala pri mednarodnih dejavnostih na področju standardizacije.
English: Implement initiatives in cooperation with the Heads of Veterinary Medicines Agencies aimed at facilitating greater availability of veterinary medicines, particularly through measures to assist micro, small and medium-sized veterinary enterprises and companies seeking to authorise products for minor species and/or limited markets.
Slovenian: Izvajati pobude v sodelovanju z vodji agencij za zdravila za uporabo v veterinarski medicini s ciljem, da se omogoči večja dostopnost zdravil za uporabo v veterinarski medicini, zlasti z ukrepi za pomoč mikro, malim in srednje velikim veterinarskim podjetjem in družbam, ki želijo pridobiti dovoljenje za promet z zdravili za manj pomembne vrste in/ali za omejene trge.
English: Continue to improve the safety-monitoring of medicines for human and veterinary use
Slovenian: Nadalje izboljšati spremljanje varnosti zdravil za uporabo v humani in veterinarski medicini
English: Strengthen the European medicines network
Slovenian: Okrepiti Evropsko mrežo zdravil
English: Post-authorisation activities
Slovenian: 2.5 Dejavnosti po izdaji dovoljenja
English: Sampling from the market in different countries is carried out by national inspectorates and testing is performed by official medicines-control laboratories coordinated by the European Directorate for the Quality of Medicines and HealthCare (EDQM).
Slovenian: Vzorčenje s trgov v različnih državah opravljajo nacionalni inšpektorati, preskušanje pa izvajajo uradni laboratoriji za kontrolo
English: This will be the sixth year of implementation by the Agency, with national competent authorities, of the EU telematics programme.
Slovenian: Leto 2008 bo šesto leto izvajanja programa EU telematskih projektov s strani Agencije v sodelovanju z nacionalnimi odgovornimi organi.
English: The Agency's Committee on Herbal Medicinal Products (HMPC) provides scientific opinions on questions relating to herbal medicines; establishes Community herbal monographs for traditional and well-established herbal medicinal products; establishes a draft list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products; provides opinions on herbal substances as needed; and evaluates referrals and arbitrations concerning traditional herbal medicinal products.
Slovenian: Odbor za zdravila rastlinskega izvora (HMPC) pripravlja strokovna mnenja o vprašanjih v zvezi z zdravili rastlinskega izvora, oblikuje monografije rastlin Skupnosti za tradicionalna in dobro uveljavljena zdravila rastlinskega izvora ter pripravlja osnutek seznama snovi rastlinskega izvora, pripravkov in njihovih kombinacij za uporabo v tradicionalnih zdravilih rastlinskega izvora.
English: on the Internet at www.emea.europa.eu by e-mail request to info@emea.europa.eu by fax to (44-20) 74 18 86 70 by writing to:
Slovenian: na internetu na naslovu www.emea.europa.eu na podlagi zahtevka, ki ga pošljete na elektronski naslov info@emea.europa.eu po faksu na št. (44-20) 7418 8670 pisno na naslov:
English: Temporary posts
Slovenian: Začasna delovna mesta
English: For enquiries concerning PMF certificates
Slovenian: Za vprašanja v zvezi s potrdili PMF
English: Applications for designation (input) Opinions on designation (output)
Slovenian: Vloge za določitev (vhodni podatek) Mnenja o določitvah (izhodni podatek)
English: SME Office contact point:
Slovenian: Kontaktna oseba Urada za mala in srednje velika podjetja:
English: The EMEA will work with the Heads of Veterinary Medicines Agencies to implement initiatives to be adopted by the EMEA Management Board aimed at facilitating greater availability of veterinary medicines through a set of measures to assist companies seeking to authorise products for minor species and/or limited markets.
Slovenian: EMEA bo sodelovala z vodji agencij za veterinarska zdravila pri izvajanju pobud, ki jih bo sprejel upravni odbor EMEA, katerih namen bo omogočiti večjo dostopnost veterinarskih zdravil, z ukrepi, ki bodo nudili pomoč podjetjem, ki bodo želela pridobiti dovoljenje za promet z zdravili za manj pomembne vrste in/ali omejene trge.
English: Arbitration and Community referrals
Slovenian: 2.8 Arbitraža in napotitve Skupnosti
English: Scientific advice and follow-up requests Protocol assistance and follow-up requests
Slovenian: Zahtevki za znanstveno svetovanje in spremljanje Zahtevki za pomoč pri protokolu in spremljanje
English: The EMEA issues plasma-master-file (PMF) and vaccine-antigen-master-file (VAMF) certificates of a medicinal product in conformity with the arrangements laid down by Community legislation.
Slovenian: Agencija EMEA izdaja potrdila o glavnem dosjeju o plazmi (PMF) in glavnem dosjeju o antigenih cepiva (VAMF) v skladu z zakonodajo Skupnosti.
English: The Agency expects that the number of certificate requests will increase in 2008 by
Slovenian: Agencija pričakuje, da se bo število prošenj za potrdila v letu 2008 povečalo za 20 %.
English: In order to complete the development of EudraVigilance Veterinary, the Agency's Management Board adopted the EudraVigilance Veterinary Action Plan.
Slovenian: Upravni odbor Agencije je sprejel akcijski načrt veterinarskega sistema EudraVigilance (EudraVigilance Veterinary Action Plan), da bi dokončali razvoj veterinarskega sistema EudraVigilance.
English: A separate programme encompassing all information-management activities in the Agency will be launched to implement this objective.
Slovenian: Za dosego tega cilja bo Agencija začela izvajati poseben program, ki bo obsegal vse dejavnosti, ki zadevajo upravljanje informacij v Agenciji.
English: Project management
Slovenian: Projektno vodenje
English: Applications for initial evaluation (Input)
Slovenian: Vloge za začetno oceno (Vhodni podatek)
English: This will be done through the implementation of the EudraVigilance Action Plan, which helps the European medicines network to improve the quality of data submitted to the database.
Slovenian: Drugo področje dejavnosti bo zadevalo nenehne izboljšave podatkovne baze sistema EudraVigilance, kar bo Agenciji omogočilo izvajanje akcijskega načrta EudraVigilance, ki pomaga Evropski mreži zdravil izboljšati kakovost podatkov, posredovanih v podatkovno bazo.
English: ANNEXES
Slovenian: Priloge
English: In preparation for the implementation of legislation on advanced-therapy medicinal products, the Agency will develop guidance in the fields of post-authorisation follow-up on efficacy, adverse reactions and risk-management of these products.
Slovenian: Začetna obvestila skupaj izvajanje zakonodaje o zdravilih za napredne terapije razvila smernice za spremljanje učinkovitosti po izdaji dovoljenja za promet, neželenih učinkov ter obvladovanja tveganja pri teh zdravilih.
English: E-mail: certificate@emea.europa.eu authorised medicines for human or veterinary use
Slovenian: Za vprašanja v zvezi z dovoljenji za zdravila E-pošta: certificate@emea.europa.eu za uporabo v humani medicini in zdravila
English: Out-of-hours telephone: (44) 78 80 55 06 97
Slovenian: Telefon zunaj uradnih ur: (44)-7880 55 06 97
English: Martin HARVEY ALLCHURCH Direct telephone (44-20) 74 18 84 27 E-mail: press@emea.europa.eu
Slovenian: Martin HARVEY ALLCHURCH Direktni telefon (44-20) 74 18 84 27 E-pošta: press@emea.europa.eu
English: Function group & Grade Permanent posts
Slovenian: Funkcionalna skupina in stopnja
English: CVMP Committee for Medicinal Products for Veterinary Use
Slovenian: CVMP Odbor za zdravila za uporabo v veterinarski medicini
English: Initial evaluation
Slovenian: 2.3 Začetna ocena
English: Establishment of maximum residue limits for veterinary medicines
Slovenian: 2.4 Določitev mejne vrednosti ostankov za zdravila za uporabo v veterinarski medicini
English: Fees
Slovenian: COMP
English: Occupied as per
Slovenian: Zasedenost na dan
English: New applications for veterinary medicines (Input)
Slovenian: Nove vloge za zdravila za uporabo v veterinarski medicini, prejete/predvidene (vhodni podatek)
English: This trend will be further strengthened as a consequence of the implementation of the paediatric legislation.
Slovenian: Zaradi zakonodaje o pediatriji se bo te smernice še okrepile.
English: An improved tool that will help the Agency and its partners to rationalise the processing of pharmacovigilance information - the EudraVigilance Veterinary Data Warehouse (EU telematics project) - will be implemented in 2008.
Slovenian: V letu 2008 bo Agencija uvedla izboljšano orodje telematskega projekta EU - skladišče veterinarskih podatkovni zbirk Eudravigilance (EudraVigilance Veterinary Data Warehouse) - ki bo njej in njenim partnerjem pomagalo racionalizirati obdelavo podatkov o farmakovigilanci.
English: Direct telephone: (44-20) 74 18 85 81 E-mail: vet-phv@emea.europa.eu
Slovenian: Direktni telefon: (44-20) 74 18 85 81 E-pošta: vet-phv@emea.europa.eu
English: CHMP Committee for Medicinal Products for Human Use
Slovenian: CHMP Odbor za zdravila za uporabo v humani medicini
English: Scientific-advice and protocol-assistance requests (Input)
Slovenian: Zahtevki za znanstveno svetovanje in pomoč pri protokolu (Vhodni podatek)
English: As part of this initiative, the EMEA will finalise the development of its communication strategy and will consolidate the various communication tools into a communication ‘platform'.
Slovenian: Kot del te pobude bo EMEA dokončala razvoj svoje komunikacijske strategije in združila različna komunikacijska orodja v komunikacijsko „platformo“, kar ji bo pomagalo zagotoviti, da bodo bolniki in zdravstveni delavci prejemali visokokakovostne, ciljne in pravočasne informacije.
English: This includes support to the implementation of the referral procedure, development and maintenance of the memory of regulatory and scientific agreements, and activities arising from the paediatric medicines regulation.
Slovenian: Agencija bo še naprej podpirala koordinacijske skupine za postopek medsebojnega priznavanja in decentralizirani postopek (za zdravila za uporabo v humani in veterinarski medicini), kar vključuje pomoč pri izvajanju napotitvenega postopka, razvoj in vzdrževanje spomina regulativnih in znanstvenih dogovorov ter dejavnosti, ki izvirajo iz uredbe o zdravilih za uporabo v pediatriji.
English: Type-I variation applications Type-II variation applications Line-extension applications
Slovenian: Vloge za spremembe tipa II
English: MEDICINES FOR HUMAN AND VETERINARY USE
Slovenian: Zdravila za uporabo v humani in veterinarski medicini
English: A number of guidance documents on advanced-therapy medicinal products and new technologies will be developed in consultation with interested parties.
Slovenian: Po posvetovanju z zainteresiranimi stranmi bo Agencija razvila številne smernice o zdravilih za napredne terapije in nove tehnologije.
English: Nonetheless, applications for MRLs for products classified by the CVMP as indicated for limited markets may be forthcoming in response to the assistance provided by the Agency for these types of products.
Slovenian: Kot odgovor na pomoč, ki jo Agencija daje za taka zdravila, pa bodo verjetno vseeno prispele vloge za mejne vrednosti ostankov (MVO) za zdravila, ki jih CVMP opredeljuje kot namenjene za omejene trge.
English: One of the main activities in 2008 will be to prepare for the implementation of the project on the European Network of
Slovenian: Ena glavnih dejavnosti v letu 2008 bo priprava na izvajanje projekta Evropske mreže centrov za farmakovigilanco in farmakoepidemiologijo.
English: COMP Committee for Orphan Medicinal Products
Slovenian: Odbor za zdravila sirote
English: Press office
Slovenian: Tiskovni urad Tiskovni predstavnik
English: Total grade AST Grand Total
Slovenian: Stopnja AST skupaj Skupaj
English: VETERINARY MEDICINES AND INSPECTIONS
Slovenian: ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI IN INŠPEKCIJSKI PREGLEDI
English: As such, the European medicines network is fundamental to the successful work of the Agency.
Slovenian: Za izpolnitev svoje naloge javnega zdravja se Agencija opira na uporabo znanstvenih virov Evropske mreže zdravil, ki je tako osnovnega pomena za uspešno delo Agencije.
English: Silvia DOMINGO ROIGÉ Direct telephone: (44-20) 74 18 85 52 Fax: (44-20) 74 18 85 45
Slovenian: Silvia DOMINGO ROIGÉ Direktni telefon: (44-20) 74 18 85 52 Faks: (44-20) 74 18 85 45
English: For enquiries concerning certificates for centrally
Slovenian: izdanimi po centraliziranem postopku
English: HMPC Committee on Herbal Medicinal Products
Slovenian: HMPC Odbor za zdravila rastlinskega izvora
English: Health authorities rely on centralised assessments to support marketing in their own countries, thus facilitating the availability of medicines and avoiding the need for costly and double assessment work.
Slovenian: Tako se omogoči dostopnost zdravil ter izogne potrebi po dragem in dvojnem ocenjevanju.
English: Designation of orphan medicinal products
Slovenian: Določitev zdravil sirot
English: Applications for new medicinal products Generic applications
Slovenian: Vloge za nova zdravila Vloge za generična zdravila
English: Medicines for children
Slovenian: 3.1 Zdravila za otroke
English: Scientific advice and protocol assistance
Slovenian: 2.2 Znanstveno svetovanje in pomoč pri protokolu
English: Direct telephone: (44-20) 74 18 85 75/84 63 Fax: (44-20) 75 23 70 40
Slovenian: Direktni telefon: (44-20) 74 18 85 75/84 63 Faks: (44-20) 75 23 70 40
English: Safety of veterinary medicines
Slovenian: Varnost zdravil za uporabo v veterinarski medicini
English: Scientific-advice requests (Input)
Slovenian: Zahtevki za znanstveno svetovanje, prejeti/predvideni (Vhodni podatek)
English: GMP, GCP, GLP and pharmacovigilance inspections
Slovenian: 2.12 Inšpekcijski pregledi dobre proizvodne prakse, dobre klinične prakse, dobre laboratorijske prakse in farmakovigilance
English: E-mail: smeoffice@emea.europa.eu
Slovenian: E-pošta: smeoffice@emea.europa.eu
English: E-mail: VAMF@emea.europa.eu
Slovenian: E-pošta: VAMF@emea.europa.eu
English: Direct telephone: (44-20) 74 18 86 98 Fax: (44-20) 74 18 85 45
Slovenian: Direktni telefon: (44-20) 74 18 8698 Faks: (44-20) 74 18 85 45
English: E-mail: PMF@emea.europa.eu
Slovenian: E-pošta: PMF@emea.europa.eu
English: EEA and non-EEA ADR reports transmitted to the EMEA for centralised authorisation procedure (CAP) and non-CAP products
Slovenian: Dejansko in ocenjeno število poročil o neželenih učinkih zdravil iz EGP in zunaj EGP, poslanih EMEA
English: Orphan medicinal products for human use
Slovenian: 2.1 Zdravila sirote za uporabo v humani medicini
English: medicinal products for human use
Slovenian: Zdravila za uporabo v humani medicini
English: medicinal products for veterinary use
Slovenian: zdravila za uporabo v veterinarski medicini