FrancophonIA/ELRC3.0 huggingface dataset:
English: • Markku TOIVONEN (Finland) Alternate: Riita TOKOLA8
Slovenian: • Markku TOIVONEN (Finska) Namestnik: Riita TOKOLA8
English: Piotr BLASZCZYK (Alternate: Jacek SPLAWINSKI)
Slovenian: Piotr BLASZCZYK (namestnik: Jacek SPLAWINSKI)
English: Electronic submission
Slovenian: Elektronsko pošiljanje
English: The EMEA, through its Committee for Medicinal Products for Human Use (CHMP), conducts a thorough scientific evaluation of all new applications for marketing authorisation concerning medicinal products for human use submitted through the Community or centralised procedure.
Slovenian: EMEA prek Odbora za zdravila za uporabo v humani medicini (CHMP) opravi temeljito znanstveno vrednotenje vseh novih vlog za izdajo dovoljenja za promet za zdravila za uporabo v humani medicini, ki so vložene prek Skupnosti ali po "centraliziranem" postopku.
English: Sponsors of designated orphan medicinal products are entitled to reductions on fees levied by the EMEA for protocol assistance, marketing authorisation applications and other regulatory procedures.
Slovenian: Sponzorji zdravil, določenih za zdravila sirote, so upravičeni do znižanj pristojbin, ki jih EMEA zaračunava za pomoč pri protokolu, vloge za dovoljenje za promet z zdravili in druge regulativne postopke.
English: In 2004, a total of 51 new applications for marketing authorisation were received under the centralised procedure.
Slovenian: V letu 2004 je bilo prejetih skupaj 51 novih vlog za izdajo dovoljenja po centraliziranem postopku.
English: • A first iteration forming the basis of the first production system restricted to data on products that have been approved using the centralised procedure was completed and demonstrated at the end of 2004
Slovenian: • ob koncu leta 2004 je bila končana in predstavljena prva ponovitev, ki je podlaga za prvi proizvodni sistem, omejen na podatke o izdelkih, za katere je bilo izdano dovoljenje po centraliziranem postopku.
English: Documentation services
Slovenian: Dokumentacijske službe
English: • Ioannis MALEMIS (Greece) Alternate: Orestis PAPADOPOULOS
Slovenian: • Ioannis MALEMIS (Grčija) Namestnik: Orestis PAPADOPOULOS
English: The Agency finalised the procedures well within the defined time limits.
Slovenian: Agencija je dokončno oblikovala postopke v za to določenih rokih.
English: • A CVMP audit was completed in October 2004 and four opportunities for improvement resulted; action plans addressing the concerns highlighted were finalised and submitted to the EMEA IQM team.
Slovenian: • oktobra 2004 je bila opravljena revizija CVMP, ki je pokazala "štiri priložnosti za izboljšanje"; akcijski načrti glede glavnih vprašanj so bili zaključeni in predloženi skupini EMEA za integrirano upravljanje kakovosti.
English: The Internal Audit Function of the Agency was formalised in 2004.
Slovenian: V letu 2004 je bila uradno oblikovana funkcija notranje revizije.
English: Ingolf J PETERSEN (Alternate: Rannveig GUNNARSDÓTTIR)
Slovenian: Ingolf J PETERSEN (namestnik: Rannveig GUNNARSDÓTTIR)
English: A new Procedure for coordinating pre-approval inspections in the context of plasma master file certification (SOP/INSP/2009) was developed, agreed and published on the EMEA website.
Slovenian: Razvit in dogovorjen je bil nov "Postopek za usklajevanje inšpekcijskih pregledov pred odobritvijo v okviru certificiranja glavnega dosjeja plazme" (SOP/INSP/2009), ki je bil objavljen na spletnih straneh EMEA.
English: • Pekka KURKI1 (Finland) (co-opted)
Slovenian: • Pekka KURKI1 (Finland) (sporazumno izbran)
English: Robert SCHLÖGEL (Alternate: Christian KALCHER)
Slovenian: Robert SCHLÖGEL (namestnik: Christian KALCHER)
English: The Committee on Herbal Medicinal Products (HMPC) held its inaugural meeting on 23 September 2004.
Slovenian: Ustanovitveno zasedanje Odbora za zeliščna zdravila (HMPC) je bilo 23. septembra 2004.
English: EMEA and WHO representatives participated in each other s meetings to discuss matters of global significance, such as tropical diseases, influenza pandemics, pharmacovigilance and consultations on international non-proprietary names (INNs).
Slovenian: Predstavniki EMEA in WHO so sodelovali na sestankih obeh strani, na katerih so razpravljali o vprašanjih svetovnega pomena, kot so tropske bolezni, pandemija influence, farmakovigilanca in posvetovanja o mednarodnih nelastniških imenih (INN).
English: Treatment of peripheral neuropathic pain in adults; and treatment of epilepsy as adjunctive therapy in adults with partial seizures
Slovenian: N03A (pending) Treatment of peripheral neuropathic pain in adults; and treatment of epilepsy as adjunctive therapy in adults with partial seizures
English: Neurology/CNS
Slovenian: Nevrologija/CŽS
English: • Gabriel BEECHINOR (Ireland)
Slovenian: • Gabriel BEECHINOR (Irska)
English: Data centre
Slovenian: Podatkovni center
English: In total, 61 518 ICSRs were reported electronically to EudraVigilance in 2004, referring both to reports for centrally authorised medicinal products as well as those authorised through the mutual recognition and national procedures.
Slovenian: V letu 2004 je bilo v EudraVigilance prijavljenih skupaj 61.518 ICSR-jev, ki so se nanašali na poročila za zdravila, za katera je bilo izdano dovoljenje po centraliziranem postopku, kot tudi na zdravila, za katera je bilo izdano dovoljenje po medsebojnem priznanju in nacionalnih postopkih.
English: • Provision for the CHMP to give scientific opinions in the context of cooperation with the WHO for the use of medicines outside the EU
Slovenian: • določitev, da CHMP daje znanstvena mnenja v okviru sodelovanja z WHO za uporabo zdravil zunaj EU.
English: Per CLAESON (Sweden) Alternate: Ubonwan CLAESON
Slovenian: ￭ Per CLAESON (Švedska) Namestnik: Ubonwan CLAESON
English: Other medicinal products were approved for use in combination with other chemotherapy to treat metastatic breast cancer, non-Hodgkins lymphoma and metastatic prostate cancer.
Slovenian: Druga zdravila so bila odobrena za uporabo v kombinaciji z drugo kemoterapijo za zdravljenje metastatičnega raka dojk, nehodgkinovega limfona in metastatičnega raka prostate.
English: • Giuseppe NISTICÒ (Italy) Alternate: Pasqualino ROSSI
Slovenian: • Giuseppe NISTICÒ (Italija) Namestnik: Pasqualino ROSSI
English: The EMEA s ten years of operations have proven that both EU citizens and the pharmaceutical industry benefit from centralised medicines control and supervision.
Slovenian: EMEA je v desetih letih delovanja dokazala, da centraliziran nadzor in spremljanje zdravil koristita državljanom EU in tudi farmacevtski industriji.
English: Use of EU special contribution for orphan medicines 2004
Slovenian: Poraba posebnega prispevka EU za zdravila sirote v letu 2004
English: In the anti-HIV area, several variations were implemented in 2004 to add important safety information to relevant SPCs.
Slovenian: Na področju boja proti HIV je bilo v letu 2004 uvedenih več sprememb, s katerimi so se dodale pomembne informacije o varnosti v ustrezne povzetke glavnih značilnosti zdravil (SPC).
English: • Kerstin WESTERMARK (Sweden)
Slovenian: • Kerstin WESTERMARK (Švedska)
English: • All requests for GMP, GCP (including pharmacovigilance) and GLP inspections relating to applications for products through the centralised procedure were successfully coordinated and managed within the timeframes laid down in Community law and to the standards required in the Agency s quality management system.
Slovenian: • Vse zahteve za inšpekcijski nadzor za dobro proizvodno prakso, dobro klinično prakso (vključno s farmakovigilanco) in dobro laboratorijsko prakso glede vlog za zdravila po centraliziranem postopku so bile uspešno usklajene in obravnavane v časovnih okvirih, ki jih določa zakonodaja Skupnosti, in v skladu s standardi, ki jih zahteva sistem Agencije za upravljanje kakovosti.
English: Státní ústav pro kontrolu léčiv robárová 48
Slovenian: Státní ústav pro kontrolu léčiv Šrobárová 48
English: • A new non-steroidal anti-inflammatory medicinal product (NSAID) belonging to the coxib group, which acts by selective inhibition of cyclooxygenase-2 (COX-2) medicated protaglandin synthesis, for relief of pain and inflammation associated with osteoarthritis in dogs
Slovenian: • novo nesteroidno protivnetno zdravilo (non-steroidal anti-inflammatory medicinal product, NSAID) iz skupine koksibov, ki deluje na podlagi selektivne inhibicije ciklooksigenaze-2 (COX-2) zdravilne sinteze prostaglandina, za lajšanje bolečine in vnetja pri osteoartritisu psov;
English: This includes: ensuring best practice in document and records management; verifying the quality of all published documents; and verifying the accuracy of translations.
Slovenian: dokumentov in poročil, preverjanje kakovosti vseh objavljenih dokumentov ter preverjanje točnosti prevodov.
English: Pre-submission meetings are offered to companies before they submit requests for SA/PA, during which the EMEA can provide regulatory information and scientific support on how to submit their requests, the required information and the most suitable format.
Slovenian: Pred vložitvijo zahtevka za znanstveno svetovanje ali pomoč pri protokolu so podjetjem na voljo sestanki pred oddajo vloge, na katerih lahko EMEA zagotovi regulativne informacije in znanstveno podporo glede vložitve zahtevka ter zagotovi zahtevane informacije in najprimernejšo obliko.
English: 4.2 Mutual recognition agreements
Slovenian: 4.2 Sporazumi o medsebojnem priznavanju
English: • Neuropsychiatric disorders, such as epilepsy, depression, Parkinsons disease or severe pain (7 products)
Slovenian: • nevropsihiatrične motnje, kot so epilepsija, depresija, parkinsonova bolezen ali huda bolečina
English: A further new transparency initiative started in September 2004: COMP press releases and CHMP monthly reports now list all designated orphan medicinal products that have been the subject of a marketing authorisation application submitted since July 2003.
Slovenian: Septembra 2004 se je začela izvajati nova pobuda za večjo preglednost: v sporočilih za javnost COMP in mesečnih poročilih CHMP je zdaj objavljen seznam vseh zdravil, določenih za zdravila sirote, za katere je bila vložena vloga za dovoljenje za promet z zdravili od julija 2003.
English: The objective of introducing greater consistency in the triggering of investigations following receipt of pharmacovigilance reporting has been progressed by the release for consultation of a guideline by the CVMP on this topic in June 2004.
Slovenian: Dosežen je bil napredek glede cilja uvedbe večje skladnosti pri uvedbi preiskav po prejemu poročil o farmakovigilanci, ko je CVMP junija 2004 predstavil smernice o tej temi za posvetovanje.
English: The number of requests for EMEA certificates continued to increase in 2004 due to the high number of new applications for centralised marketing authorisation received in 2003.
Slovenian: Število zahtevkov za izdajo potrdil EMEA je v letu 2004 še naprej naraščalo zaradi veliko novih zahtevkov za izdajo dovoljenja po centraliziranem postopku, prejetih v letu 2003.
English: • The CHMP recommended approval of an anti-cancer drug that targets folate-dependent reactions that are essential for cell proliferation.
Slovenian: • CHMP je priporočil odobritev zdravila proti raku, usmerjenega na reakcije, odvisne od folata, ki so nujno potrebne za proliferacijo celic.
English: • Applications for medicinal products under development for the treatment of rare diseases to be designated as orphans increased again in number.
Slovenian: • Ponovno se je povečalo število zahtevkov za zdravila, ki se razvijajo za zdravljenje redkih bolezni in ki naj bi bila določena kot sirote.
English: The procedure describes the coordination of GLP inspections of the nonclinical safety, toxicological and pharmacological studies proposed in human and veterinary applications for marketing authorisations under the centralised system.
Slovenian: Postopek določa usklajevanje inšpekcijskih pregledov za dobro laboratorijsko prakso pri nekliničnih študijah o varnosti, toksičnosti in farmakologiji, ki so predlagane pri uporabi v humani in veterinarski medicini, za dovoljenja za promet, ki se izdajo po centraliziranem postopku.
English: • (Pre-)Clinical Working Party on Comparability of Biotechnology Products
Slovenian: • (Pred)klinična delovna skupina za primerljivost biotehnoloških zdravil
English: Ústav tátnej kontroly veterinárnych biopreparátov a liečiv Biovetská 4
Slovenian: Ústav štátnej kontroly veterinárnych biopreparátov a liečiv Biovetská 4
English: • Conception, elaboration and early construction phases of a scientific advice database were completed in 2004
Slovenian: • V letu 2004 so bile končane zasnova, priprava in začetne faze izgradnje za zbirko podatkov o znanstvenem svetovanju.
English: Also delivered was the implementation of web, application and database servers in the data centre for key EU telematics and corporate applications (see 3-tier architecture)
Slovenian: Uveden je bil tudi spletni, programski in podatkovni strežnik v podatkovnem centru za bistvene telematske in podjetniške uporabe (glej triplastno strukturo).
English: These certify the marketing authorisation and good manufacturing status of medicinal products in the EU and are intended for use in support of marketing authorisation applications in and export to non-EU countries.
Slovenian: Ta potrjujejo, da je bilo za zdravila izdano dovoljenje za promet in dober proizvodni status zdravil v EU, uporabljajo pa se kot spremni dokumenti k vlogam za izdajo dovoljenja za promet v državah, ki niso članice EU, in za izvoz v te države.
English: 3.8 Regulatory guidance
Slovenian: 3.8 Regulativne smernice
English: Five applications for extension to the original marketing authorisation were received in 2004, exceeding the initial forecast of 3 applications.
Slovenian: V letu 2004 je bilo prejetih pet vlog za razširitev prvotnega dovoljenja za promet, kar je več od prvotno predvidenih 3 vlog.
English: • Anja HOLM (Denmark) Alternate: Lotte Winther
Slovenian: • Anja HOLM (Danska) Namestnik: Lotte Winther
English: Marketing authorisation holders may want to change the manufacturing process, alter or improve the medicinal product, or introduce additional warnings and contraindications.
Slovenian: Imetniki dovoljenja za promet morda želijo spremeniti proizvodni postopek, spremeniti ali izboljšati zdravilo ali pa dodati opozorila ali kontraindikacije.
English: • Kateřina KUBÁČKOVÁ (Czech Republic)
Slovenian: • Kateřina KUBÁČKOVÁ (Češka)
English: • Pieter NEELS4 (Belgium) Alternate: Bruno FLAMION5
Slovenian: • Pieter NEELS4 (Belgija) Namestnik: Bruno FLAMION5
English: • Tomas SALMONSON (Sweden) Alternate: Per NILSSON
Slovenian: • Tomas SALMONSON (Švedska) Namestnik: Per NILSSON
English: Tenth annual report of the European Medicines Agency
Slovenian: Deseto letno poročilo Evropske agencije za zdravila za leto 2004
English: Statistical information on applications under the mutual recognition procedure is provided by the EMEA and presented in the monthly MRFG press releases.
Slovenian: EMEA pripravlja statistične podatke o vlogah za postopek medsebojnega priznavanja, ki so predstavljeni v mesečnih sporočilih MRFG za javnost.
English: Despite initial delays, the preparatory work for effective operation of the Japan-EU MRA was successfully concluded through a series of visits and inspections allowing the operational phase of the agreement to come into force on 29 May 2004.
Slovenian: Kljub začetnim zamudam so bile priprave za učinkovito izvajanje sporazuma o medsebojnem priznavanju med Japonsko in EU po vrsti obiskov in inšpekcijskih pregledov uspešno zaključene, kar je omogočilo, da je operativna faza sporazuma začela veljati 29. maja 2004.
English: • Osteoporosis
Slovenian: • osteoporoza
English: Average time for orphan medicines procedures (days)
Slovenian: Povprečno trajanje postopkov za zdravila sirote (v dnevih)
English: The Management Board adopted new rules on access to EMEA documents at its March 2004 meeting.
Slovenian: Upravni odbor je na sestanku marca 2004 sprejel nove predpise o dostopu do dokumentov EMEA.
English: • Ioannis KKOLOS (Cyprus)
Slovenian: • Ioannis KKOLOS (Ciper)
English: Anna-Liisa ENKOVAARA (Finland) Alternate: Sari KOSKI
Slovenian: ￭ Anna-Liisa ENKOVAARA (Finska) Namestnik: Sari KOSKI
English: • Ingemar PERSSON1 (Sweden) (co-opted)
Slovenian: • Ingemar PERSSON1 (Švedska) (sporazumno izbran)
English: Safety and efficacy of medicines
Slovenian: Varnost in učinkovitost zdravil
English: Marketing authorisation holders may want to add new treatment options or introduce additional warnings or contraindications, or they may wish to change the manufacturing process.
Slovenian: Imetniki dovoljenja za promet morda želijo dodati nove možnosti zdravljenja ali dodatna opozorila oziroma kontraindikacije ali zamenjati proizvodni postopek.
English: Annex 14 EMEA contact points
Slovenian: Priloga 14 Kontaktne osebe EMEA
English: Centralised applications - Negative opinions
Slovenian: Vloge po centraliziranem postopku - negativna mnenja
English: Annex 7 EMEA budget summaries 2003-2005
Slovenian: Priloga 7 Povzetki proračunov EMEA za obdobje 2003−2005
English: Centralised applications - Positive opinions
Slovenian: Vloge po centraliziranem postopku - pozitivna mnenja
English: This has been the overall experience since
Slovenian: To kažejo izkušnje že od leta 1998.
English: Having completed the implementation of the data centre, the EMEA 3-tier architecture was implemented in 2004 with fully integrated security as the foundation platform for all new applications
Slovenian: Po uvedbi podatkovnega centra je bila v letu 2004 uvedena triplastna struktura s popolnoma integrirano varnostjo kot temeljna platforma za vse nove aplikacije.
English: Philippe DUNETON (Alternate: Jean MARIMBERT)
Slovenian: Philippe DUNETON (namestnik: Jean MARIMBERT)
English: 4.1 Inspections
Slovenian: 4.1 Inšpekcijski pregledi
English: The Agency completed 2 urgent safety restriction (USR) procedures for centrally authorised products during 2004, introducing warnings into the marketing authorisation of the two medicinal products.
Slovenian: Agencija je v letu 2004 zaključila 2 postopka nujnih varnostnih omejitev (urgent safety restriction, USR) za zdravila, za katera je bilo izdano dovoljenje za promet, vključno z opozorili glede dovoljenj za promet z dvema zdraviloma.
English: Five of the applications were for companion animals and 3 for food-producing animals, namely horses.
Slovenian: Pet vlog je bilo za hišne živali, tri pa za živali, namenjene proizvodnji hrane.
English: Three of those 5 concerned vaccines and 2 concerned pharmaceuticals.
Slovenian: Od teh petih vlog so bile tri za cepiva in 2 za farmacevtske izdelke.
English: • Judit EGGENHOFER (Hungary)
Slovenian: • Judit EGGENHOFER (Madžarska)
English: Results requiring further investigation were found for 3 of the 31 products.
Slovenian: Pri 3 od 31 izdelkov so rezultati pokazali, da so potrebne dodatne preiskave.
English: Milan MÍD (Alternate: Alfred HERA)
Slovenian: Milan ŠMÍD (namestnik: Alfred HERA)
English: • Eva SKOVLUND (Norway) Alternate: Liv MATHIESEN
Slovenian: • Eva SKOVLUND (Norveška) Namestnik: Liv MATHIESEN
English: 6.1 Administration.....................................................................................................................70
Slovenian: 6.1 Administracija......................................................................................................................69
English: The EMEA PMF/VAMF certification process is an assessment of the PMF/VAMF application dossier.
Slovenian: Certifikacijski postopek EMEA za PMF/VAMF je ocenitev dokumentacije za vlogo za PMF/VAMF.
English: • Ian HUDSON (United Kingdom) Alternate: Julia DUNNE
Slovenian: • Ian HUDSON (Združeno kraljestvo) Namestnik: Julia DUNNE
English: Number of payments processed
Slovenian: Število obdelanih plačil
English: The objective of the guide is to inform veterinarians and other animal-health professionals about the pharmacovigilance system for veterinary medicinal products in the EU and to stimulate their cooperation on the reporting of adverse drug reactions (ADRs).
Slovenian: Njihov cilj je seznaniti veterinarje in druge strokovnjake za zdravje živali s sistemom farmakovigilance za veterinarska zdravila v EU in jih spodbuditi k sodelovanju pri poročanju o neželenih učinkih zdravil.
English: Work relating to the improvement of various aspects of the management of referral procedures, which started in 2003, continued throughout 2004.
Slovenian: V letu 2004 so se nadaljevala prizadevanja za izboljšanje različnih vidikov upravljanja postopkov predložitev, začeta v letu 2003.
English: GCP ensures that ethical and scientific standards for designing, conducting, recording and reporting clinical trials are adhered to.
Slovenian: Dobra klinična praksa zagotavlja upoštevanje etičnih in znanstvenih standardov za načrtovanje, izvajanje in evidentiranje kliničnih preizkušanj ter poročanje o njih.
English: Plasma master files, vaccine antigen master files and medical devices containing biotechnology and blood-derived medicinal products
Slovenian: Glavni dosjeji plazme, glavni dosjeji virusnih antigenov in medicinski pripomočki, ki vsebujejo biotehnološka zdravila in zdravila iz krvi
English: EMEA contact: Isabelle MOULON
Slovenian: Kontaktna oseba EMEA: Isabelle MOULON
English: Inspections of blood establishments to support certification of PMFs were initiated in the second half of 2004 and a total of 15 inspections were carried out in this context, involving 27 blood establishment sites.
Slovenian: V drugi polovici leta 2004 so se začeli izvajati inšpekcijski pregledi zavodov za kri v okviru certificiranja glavnih dosjejev plazme (PMF), pri čemer je bilo opravljenih skupaj 15 inšpekcijskih pregledov, ki so zajemali 27 lokacij zavodov za kri.
English: These nominations for co-opted members were confirmed in all but one discipline, intensive production, by the end of
Slovenian: Ti sporazumno izbrani člani so bili do konca leta 2004 potrjeni za vsa področja razen intenzivne proizvodnje.
English: There were no negative opinions given in 2004.
Slovenian: V letu 2004 ni bilo izdanih negativnih mnenj.
English: EGFRexpressing metastatic colorectal cancer in combination with irinotecan after failure of irinotecancontaining therapy
Slovenian: Treatment of patients with EGFRexpressing metastatic colorectal cancer in combination with irinotecan after failure of irinotecancontaining therapy
English: Collection of human plasma for further manufacturing, as well as storage, testing and transportation, is subject to periodic inspections in order to ensure the expected product quality.
Slovenian: S periodičnimi inšpekcijskimi pregledi zbiranja človeške plazme za nadaljnjo proizvodnjo kakor tudi shranjevanja, testiranja in prevoza se zagotovi pričakovana kakovost izdelkov.
English: Members
Slovenian: Člani
English: Linda ANDERSON (United Kingdom) Alternate: Sue HARRIS
Slovenian: ￭ Linda ANDERSON (Združeno kraljestvo) Namestnik: Sue HARRIS
English: Head of Sector
Slovenian: Vodja Sektorja
English: 6.3 Meeting management and conferences
Slovenian: 6.3 Upravljanje srečanj in konferenc
English: • Stane SRCIC (Slovenia) Alternate: Blanka EMERSIC
Slovenian: • Stane SRCIC (Slovenija) Namestnik: Blanka EMERSIC
English: Eudra Common Directory (ECD)
Slovenian: Skupini imenik Eudra (ECD)
English: • Approved a proposal to publish the name of active substances, orphan condition and name of sponsor for all designated orphan drugs submitted for marketing authorisation
Slovenian: • odobritev predloga, da se objavijo nazivi zdravilnih učinkovin, stanje sirote in ime sponzorja za vsa zdravila, določena za zdravila sirote, za katera je oddana vloga za izdajo dovoljenja za promet.
English: These reports provide updates on the development of designated orphan products prior to submission of an application for a marketing authorisation.
Slovenian: Ta poročila vsebujejo posodobljene podatke o razvoju zdravil, določenih za zdravila sirote, pred oddajo vloge za dovoljenje za promet.