FrancophonIA/ELRC3.0 huggingface dataset:
English: Often, such guidelines are developed as a result of the EU s cooperation with Japan, the US and other international partners on the harmonisation of regulatory requirements for medicinal products, particularly through the International Conference on Harmonisation (ICH), and thus reflect a harmonised approach.
Slovenian: Take smernice se pogosto razvijejo na podlagi sodelovanja EU z Japonsko, ZDA in drugimi mednarodnimi partnerji za uskladitev regulativnih zahtev za zdravila, zlasti prek Mednarodne konference o usklajevanju (ICH), in zato odsevajo usklajen pristop.
English: Under evaluation in 2004*
Slovenian: Vrednotenih v letu 2004*
English: 126 annual reports were reviewed and reported to the COMP in 2004.
Slovenian: V letu 2004 je bilo pregledanih in COMP posredovanih 126 poročil.
English: The dedicated range of services provided to EMEA staff, delegates and users of EU telematics systems from the applications themselves to the three levels of helpdesk support services ensure these systems are in line with the Agency s operating requirements
Slovenian: Vrsta storitev, ki se zagotavljajo osebju EMEA, delegatom in uporabnikom telematskih sistemov EU, od samih aplikacij do treh ravni storitev pomoči uporabnikom, zagotavlja skladnost teh sistemov z obratovalnimi zahtevami Agencije.
English: Members European Parliament
Slovenian: Člani Evropski parlament
English: Referral procedures under Article 30 of Directive 2001/83/EC are mainly initiated in order to obtain harmonisation within the Community of the conditions of authorisation for products already authorised by the Member States.
Slovenian: Postopki predložitve v skladu s členom 30 Direktive 2001/83/ES se uvedejo predvsem, da se v Skupnosti uskladijo pogoji za izdajo dovoljenj za zdravila, za katera so države članice že izdale dovoljenja.
English: Ninety-four mutual recognition procedures were completed in 2004.
Slovenian: V letu 2004 je bilo dokončanih 94 postopkov priznanja.
English: The mandate and work plan for the new group were published.
Slovenian: Objavljena so bila njena pooblastila in načrt dela.
English: The EMEA started the implementation of the newly established procedure for the handling of safety concerns in relation to centrally processed applications in April 2004, with a pilot phase based on selected medicines undergoing evaluation for marketing authorisation.
Slovenian: EMEA je aprila 2004 začela izvajati na novo uveden postopek za obvladovanje varnostnih vprašanj v zvezi z vlogami, ki se obdelujejo po centraliziranem postopku, katerega pilotna faza temelji na izbranih zdravilih, za katera se opravlja vrednotenje za namene izdaje dovoljenja za promet.
English: In April, the EMEA released for public consultation a discussion paper entitled The European Medicines Agency Road Map to 2010: Preparing the Ground for the Future .
Slovenian: EMEA je aprila za javno posvetovanje predstavila posvetovalni dokument z naslovom "Usmeritveni načrt Evropske agencije za zdravila do leta 2010: Priprava podlage za prihodnost".
English: • A new vaccine (the only one available) for active immunisation of dogs against Babesia canis and Babesia rossi to reduce severity of clinical signs associated with acute babesiosis and the anaemia that ensues following a heterologous challenge infection
Slovenian: • novo cepivo (edino, ki je na voljo) za aktivno imunizacijo psov proti Babesia canis in Babesia rossi za zmanjšanje resnosti kliničnih znakov, povezanih z babeziozo in anemijo, ki sta posledica heterologne infekcije;
English: This was developed in direct consultation with the EMEA s Conferences Sector and radically improved their ability to arrange all EMEA meetings and conferences
Slovenian: Razvita je bila v neposrednem posvetovanju s sektorjem EMEA za konference in je temeljito izboljšala njihove možnosti za vodenje vseh sestankov in konferenc EMEA.
English: The programme of internal audits continued in 2004, including audits of the Committee for Medicinal Products for Human Use, the Committee for Medicinal Products for Veterinary Use and the Committee on Orphan Medicinal Products.
Slovenian: V letu 2004 se je nadaljeval program notranjih revizij, ki je zajemal revizije Odbora za zdravila za uporabo v humani medicini, Odbora za zdravila za uporabo v veterinarski medicini in Odbora za zdravila sirote.
English: World Health Organization http://www.who.int
Slovenian: Svetovna zdravstvena organizacija http://www.who.int
English: • Initiatives to acquaint and train assessors and other regulatory staff with new environmental safety testing requirements were begun.
Slovenian: • Sprožene so bile pobude, da se ocenjevalci in drugo zakonodajno osebje seznanijo in usposobijo na področju novih zahtev za preverjanje okoljske varnosti.
English: In addition, the EMEA was pleased to support the launch of the IFAH-Europe Good Veterinary Pharmacovigilance Practice Guide, produced by Industry to encourage further advances in the consistent reporting of ADRs throughout the Community.
Slovenian: EMEA je tudi z veseljem podprla začetek izvajanja Smernic dobre prakse za veterinarsko farmakovigilanco IFAH-Evropa, ki jih je pripravila panoga, da bi spodbudila nadaljnji napredek pri skladnem poročanju o neželenih učinkih zdravil po vsej Skupnosti.
English: • The EMEA risk management strategy was further developed, in particular through the implementation of a newly established procedure for the handling of safety concerns, both pre- and post-authorisation, for centrally processed applications.
Slovenian: • Strategija EMEA za obvladovanje tveganja se je še naprej razvijala, zlasti z izvajanjem na novo uvedenega postopka za obvladovanje vprašanj glede varnosti pred izdajo dovoljenja za promet in po njej za vloge, ki se obravnavajo po centraliziranem postopku.
English: It remains challenging to accurately predict the number of applications to be received, despite forecasts supplied by Industry, as there is, unfortunately, little intelligence available in the veterinary sector regarding new products in the development pipeline.
Slovenian: Kljub napovedim, ki jih posreduje industrija, je še vedno težko natančno predvideti število vlog, ki bodo prejete, in na žalost je v veterini na voljo malo informacij o novih proizvodih, ki se razvijajo.
English: • Arthur ISSEYEGH (Cyprus) Alternate: Panayiota KOKKINOU
Slovenian: • Arthur ISSEYEGH (Ciper) Namestnik: Panayiota KOKKINOU
English: Tamás L PAÁL (Alternate: Beatrix HORVÁTH)
Slovenian: Tamás L PAÁL (namestnik: Beatrix HORVÁTH)
English: The three-month consultation period that followed generated feedback from some 65 contributors, including EU institutions, national health authorities, patients groups, professional healthcare organisations, pharmaceutical companies, trade associations, academics and other interested parties.
Slovenian: V posvetovalnem obdobju naslednjih treh mesecev se je s povratnimi informacijami odzvalo približno 65 strank, vključno z institucijami EU, nacionalnimi zdravstvenimi organi, skupinami bolnikov, poklicnimi zdravstvenimi organizacijami, farmacevtskimi podjetji, trgovskimi združenji, akademskim krogom in drugimi zainteresiranimi stranmi.
English: The EMEA component of the EudraVigilance project proceeded as planned in 2004.
Slovenian: V letu 2004 so dejavnosti EMEA v zvezi s projektom EudraVigilance potekale po načrtih.
English: No applications were received for VAMFs.
Slovenian: Za VAMF-je ni bila prejeta nobena vloga.
English: An inventory accounting system was implemented and all data, including tangible and intangible assets, were uploaded to the system.
Slovenian: Uveden je bil sistem računovodskega vodenja premoženja, v katerega so bili vpisani vsi podatki, vključno z opredmetenimi in neopredmetenimi sredstvi.
English: If so, the CHMP adopts a positive opinion that is reflected in a European Public Assessment Report and makes a recommendation to the European Commission that a marketing authorisation be granted for that product.
Slovenian: Če so te zahteve izpolnjene, CHMP sprejme pozitivno mnenje, ki je prikazano v evropskem javnem poročilu o oceni zdravila, in Evropski komisiji pošlje priporočilo, da se izda dovoljenje za promet za to zdravilo.
English: The new pharmaceutical legislation also gives the Executive Director, in liaison with the Committee for Medicinal Products for Human Use (CHMP), the responsibility of setting up the administrative structures and procedures allowing the development of scientific advice for companies and sponsors.
Slovenian: Na podlagi nove farmacevtske zakonodaje je izvršni direktor pristojen, da skupaj z Odborom za zdravila za uporabo v humani medicini (CHMP) vzpostavi upravno organiziranost in postopke, ki bodo omogočali razvoj svetovanja za podjetja in sponzorje.
English: • Rare metabolic diseases affecting the blood or the cardiovascular system in neonates (5 products)
Slovenian: • redke bolezni presnove, ki vplivajo na kri ali kardiovaskularni sistem novorojenčkov (5
English: The Board elected Hannes Wahlroos as its chairman and re-elected Jytte Lyngvig as vice-chairman.
Slovenian: Odbor je izvolil Hannesa Wahlroosa kot predsednika ter ponovno izvolil Jytte Lyngvig kot podpredsednico.
English: Seventy-eight GMP inspections were requested in 2004; 40 % of these related to requests for reinspection of sites already inspected two to three years previously.
Slovenian: V letu 2004 je bilo oddanih 78 prošenj za inšpekcijske preglede za dobro proizvodno prakso; 40 % jih je bilo za ponovni pregled lokacij, ki so bile že pregledale dve ali tri leta pred tem.
English: • Domenica TARUSCIO (Italy)
Slovenian: • Domenica TARUSCIO (Italija)
English: The EMEA checks compliance of such products distributed in parallel with the appropriate terms of the Community marketing authorisation.
Slovenian: EMEA preverja skladnost takšnih izdelkov, ki so v vzporedni distribuciji, z ustreznimi pogoji Skupnosti za izdajo dovoljenja za promet z zdravilom.
English: The programme focuses primarily on important breakthrough drugs, and includes a mechanism for the EMEA, FDA and companies to exchange views on scientific issues during the development phase of new medicinal products.
Slovenian: Program je usmerjen predvsem na pomembna zdravila, ki prodirajo na trg, in vključuje mehanizem za izmenjavo mnenj o znanstvenih vprašanjih med EMEA, FDA in podjetji med razvojem novih zdravil.
English: The EMEA continually supported the Commission and the Member States with the implementation of Directive 2001/20/EC on clinical trials through the activities of the ad hoc meetings of GCP and GMP inspection services, through participation in working groups of the Commission, and through support to the implementation of European databases for clinical trials.
Slovenian: EMEA je nenehno podpirala Komisijo in države članice pri izvajanju Direktive 2001/20/ES o kliničnem preizkušanju z dejavnostmi ad hoc sestankov inšpekcijskih služb za dobro klinično prakso in dobro proizvodno prakso, sodelovanjem v delovnih skupinah Komisije in podporo pri izvajanju evropskih zbirk podatkov o kliničnih preizkušanjih.
English: Regulatory affairs and organisational support
Slovenian: Zakonske zadeve in organizacijska podpora
English: Major tasks of the HMPC: preparatory work for the establishment of a draft list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products; the elaboration of Community herbal monographs for herbal medicinal products with a well-established use and for traditional herbal medicinal products.
Slovenian: Glavne naloge HMPC: priprave za določitev osnutka seznama zeliščnih snovi, pripravkov in njihovih kombinacij za uporabo v tradicionalnih zeliščnih zdravilih; izdelava zeliščnih monografij Skupnosti za zeliščna zdravila, katerih uporaba je dobro uveljavljena, in za tradicionalna zeliščna zdravila.
English: Systems and procedures are fully in place for the timely back-up and archiving of the EMEA data
Slovenian: V celoti so vpeljani sistemi in postopki za pravočasno varnostno kopiranje in arhiviranje podatkov EMEA.
English: It became the first product approved by the Agency that plays a role in the treatment of malignant pleural mesothelioma, a rare form of cancer
Slovenian: To je prvi izdelek z odobritvijo Agencije, ki igra vlogo v zdravljenju malignega plevralnega mezotelioma, redke oblike raka;
English: Initiatives
Slovenian: Pobude
English: Activities in relation to new and emerging therapies
Slovenian: Dejavnosti, povezane z novimi terapijami
English: • Inspections of blood establishments to support certification of plasma master files (PMF) were initiated in the second half of 2004 and a new procedure was developed and published.
Slovenian: • Inšpekcijski pregledi zavodov za kri v okviru certificiranja glavnega dosjeja plazme (PMF) so se začeli izvajati v drugi polovici leta 2004 in razvit in objavljen je bil nov postopek.
English: Eight applications were received in 2004 for PMFs.
Slovenian: Za PMF-je je bilo v letu 2004 prejetih osem vlog.
English: Each Committee member has an alternate.
Slovenian: Vsak član odbora ima namestnika.
English: • (Invented) Name Review Group
Slovenian: • Skupina za presojo (izmišljenih) imen
English: The use of a pneumococcal vaccine was extended to include the age range 2 to 5 years and a new treatment option for children under 6 suffering from haemophilia A was made available.
Slovenian: Uporaba pnevmokoknih cepiv se je razširila tako, da zajema otroke od 2 do 5 let starosti, na voljo pa je tudi nova možnost zdravljenja za otroke s hemofilijo A, mlajše od 6 let.
English: • The EMEA/CHMP Working Group with Patients Organisations finalised its Recommendations and proposals for action after extensive consultation.
Slovenian: • Delovna skupina EMEA/CHMP za sodelovanje z organizacijami bolnikov je po obsežnem posvetovanju dokončala "Priporočila in predloge za ukrepanje".
English: Environmental Risk Assessment (temporary working party)
Slovenian: Ocena tveganja za okolje (začasna delovna skupina)
English: • Margarita ARBOIX (Spain) Alternate: Ricardo de la FUENTE LÓPEZ
Slovenian: • Margarita ARBOIX (Španija) Namestnik: Ricardo de la FUENTE LÓPEZ
English: • Assessment report templates to harmonise and facilitate the assessment review by the CHMP during the evaluation of the dossier pre-/post-authorisation were updated to take into consideration the changes of the European pharmaceutical legislation, especially Annex 1 of Directive 2001/83/EC.
Slovenian: • Vzorci poročil o oceni so bili posodobljeni, da se uskladi in omogoči revizija vrednotenja, ki jo izvaja CHMP, med presojo dokumentacije pred izdajo dovoljenja za promet in po njej, glede na spremembe v evropski farmacevtski zakonodaji, zlasti Prilogo 1 k Direktivi 2001/83/ES.
English: The referral was initiated because of safety concerns relating to potential risk of emotional changes and withdrawal reactions associated with the use of paroxetine.
Slovenian: Predložitev se je uvedla zaradi varnostnih vprašanj v zvezi z možnim tveganjem, da bi uporaba paroksetina lahko povzročila čustvene spremembe in zapiranje vase.
English: To ensure that the help and support available to EMEA staff, delegates and users of EU telematics systems is in line with the Agency s operating requirements
Slovenian: Zagotoviti, da sta pomoč in podpora, ki sta na voljo osebju EMEA, delegatom in uporabnikom telematskih sistemov EU, skladni z obratovalnimi zahtevami Agencije
English: IT training was provided to all EMEA staff on a regular basis.
Slovenian: Zagotovljeno je bilo redno usposabljanje o IT za vse osebje EMEA.
English: EMEA contact points and reference documents
Slovenian: Kontaktne osebe in referenčni dokumenti EMEA
English: This included class labellings for all antiretroviral medicinal products with regard to liver impairment and immune reactivation syndrome, and a statement on mitochondrial toxicity in children with postnatal or in utero exposure to nucleotide and nucleoside analogues.
Slovenian: Te zajemajo "označevanje razreda" za vsa protiretrovirusna zdravila glede poškodbe jeter in sindroma imunske reaktivacije ter izjavo o mitohondrijski toksičnosti pri otrocih, ki so bili postnatalno ali in utero izpostavljeni nukleotidom in nukleosidnim analogom.
English: 4 Inspections
Slovenian: 4 Inšpekcijski nadzor
English: Mutual recognition procedure
Slovenian: Postopek medsebojnega priznavanja
English: The Agency also began, in July 2004, publishing the name of the active substance (international non-proprietary name, or INN), the orphan condition and the name of the sponsor for all designated orphan drugs submitted for marketing authorisation, in order to improve transparency with regard to orphan medicinal products.
Slovenian: Agencija je julija 2004 začela objavljati tudi naziv zdravilnih učinkovin (mednarodno nelastniško ime, oziroma INN), stanje sirote in ime sponzorja za vsa zdravila, določena za zdravila sirote, za katera je predložena vloga za izdajo dovoljenja za promet z zdravili, da bi izboljšala preglednost, kar zadeva zdravila sirote.
English: Integrated quality management / audit
Slovenian: Integrirano upravljanje kakovosti /pregledovanje
English: Other activities in 2004 focused on the quality and consistency of CVMP assessments for centrally authorised products.
Slovenian: Druge dejavnosti v letu 2004 so bile usmerjene na kakovost in skladnost vrednotenja CVMP za zdravila, za katera je bilo izdano dovoljenje po centraliziranem postopku.
English: In line with this new responsibility, the CVMP adopted the position paper Procedure to be followed to facilitate communication and dialogue between the CVMP and interested parties .
Slovenian: Glede na to novo nalogo je CVMP sprejel dokument o stališču z naslovom "Postopek za pospešitev obveščanja in dialoga med CVMP in zainteresiranimi stranmi".
English: Applications are submitted directly to the EMEA.
Slovenian: Vloge se vložijo neposredno na EMEA.
English: Rui SANTOS IVO Presidente
Slovenian: PORTUGALSKA Rui SANTOS IVO Presidente
English: In addition to the standing and temporary working parties, the CHMP has created scientific advisory groups (SAGs).
Slovenian: Poleg stalnih in začasnih delovnih skupin je CHMP oblikoval tudi znanstveno-svetovalne skupine.
English: All variation procedures were handled within the legal timeframes.
Slovenian: Vsi postopki v zvezi s spremembami so bili opravljeni v zakonskih časovnih okvirih.
English: Assessment phase
Slovenian: Faza vrednotenja
English: This total includes 3 applications for biosimilar products and 6 multiple applications.
Slovenian: Skupno število vlog zajema 3 vloge za biološko podobne izdelke in 6 večnamenskih vlog.
English: • Creation of a new EMEA scientific committee: the Committee on Herbal Medicinal Products (HMPC)
Slovenian: • oblikovanje novega znanstvenega odbora EMEA: Odbor za zeliščna zdravila (HMPC);
English: This reflects the upward trend in the number of applications that has been experienced since the shortfall in 2002, with the highest number of active substances in the past five years.
Slovenian: Iz tega je razvidna tendenca zviševanja števila zahtevkov, ki je prisotna od upada v letu 2002, število zdravilnih učinkovin pa je bilo najvišje v zadnjih petih letih.
English: Project management
Slovenian: Upravljanje projektov
English: Often, such guidelines are developed as a result of the EU s cooperation with Japan, the US and other international partners on the harmonisation of regulatory requirements for medicinal products, particularly through the VICH conference, and thus reflect a harmonised approach.
Slovenian: Take smernice se pogosto razvijejo na podlagi sodelovanja EU z Japonsko, ZDA in drugimi mednarodnimi partnerji za uskladitev regulativnih zahtev za zdravila, zlasti konference VICH, in zato odsevajo usklajen pristop.
English: Three of the orphan product designation applications received in 2004 were from sponsors established in the new Member States.
Slovenian: Izmed vlog za določitev zdravil sirot, prejetih v letu 2004, so bile tri prejete od sponzorjev s sedežem v novih državah članicah.
English: • John O BRIEN (United Kingdom) Alternate: Martin ILOTT
Slovenian: • John O'BRIEN (Združeno kraljestvo) Namestnik: Martin ILOTT
English: As part of this, the Board and committees agreed to the publication of the declarations of interests of the members of the Agency s scientific committees on the EMEA website.
Slovenian: V tem okviru so se upravni odbor in znanstveni odbori dogovorili o objavi izjav o interesih članov znanstvenih odborov Agencije na spletni strani EMEA.
English: ADMINISTRATION
Slovenian: ADMINISTRACIJA
English: • Emmanuel HÉRON (France)
Slovenian: • Emmanuel HÉRON (Francija)
English: Applications for extension/modification of maximum residue limits 2002-2004
Slovenian: Vloge za razširitev/spremembo mejnih vrednosti ostankov v obdobju 2002-2004
English: To implement a new data centre at the EMEA with full switched back-up capability to the existing computer room
Slovenian: Uvesti nov podatkovni center v EMEA z možnostjo popolnega varnostnega kopiranja v obstoječo računalniško sobo
English: Days
Slovenian: Dni
English: Emiel VAN GALEN (Netherlands) Alternate: Burt H KROES
Slovenian: ￭ Emiel VAN GALEN (Nizozemska) Namestnik: Burt H KROES
English: 3.11 Veterinary mutual recognition facilitation group
Slovenian: 3.11 Veterinarska skupina za poenostavitev medsebojnega priznavanja
English: • Ivo CLAASEN (Netherlands) (co-opted)
Slovenian: • Ivo CLAASEN (Nizozemska) (sporazumno izbran)
English: Patricia VELLA BONANNO
Slovenian: MALTA Patricia VELLA BONANNO
English: The EMEA coordinates the verification of compliance with the principles of good manufacturing practice (GMP), good clinical practice (GCP) and good laboratory practice (GLP), and with certain aspects of the supervision of authorised medicinal products in use in the EU, through inspections requested by the CHMP or CVMP in connection with the assessment of marketing authorisation applications and/or the assessment of matters referred to these committees in accordance with Community legislation.
Slovenian: EMEA usklajuje preverjanje skladnosti z načeli dobre proizvodne prakse, dobre klinične prakse in dobre laboratorijske prakse ter z določenimi vidiki nadzorovanja zdravil, za katera je bilo izdano dovoljenje za promet in se uporabljajo v Evropski uniji, z inšpekcijskimi pregledi, ki jih zahtevata CHMP ali CVMP v zvezi z oceno vlog za izdajo dovoljenja za promet in/ali oceno zadev, ki so bile tema odboroma predložene v skladu z zakonodajo Skupnosti.
English: • André LHOIR (Belgium)
Slovenian: • André LHOIR (Belgija)
English: After two years of decline, 2004 saw a recovery in the number of applications submitted to the EMEA for products containing new active substances.
Slovenian: Po dveh leti upadanja se je v letu 2004 število vlog, predloženih EMEA za izdelke, ki vsebujejo nove zdravilne učinkovine, povečalo.
English: EPARs were made public in all official languages within four weeks of the European Commission adopting its decision.
Slovenian: Evropska javna poročila o oceni zdravila (EPARs) so bili objavljeni v vseh uradnih jezikih v štirih tednih po tem, ko je Evropska komisija sprejela odločitev.
English: Scientific advice (SA) activity increased in 2004.
Slovenian: Dejavnost znanstvenega svetovanja se je v letu 2004 povečala.
English: One of these related to SSRI (serotonin selective reuptake inhibitor) and SNRI (serotonin-norepinephrine reuptake inhibitor) products, in particular regarding the use of these products in children and adolescents.
Slovenian: Prva presoja varnosti je obravnavala zdravila SSRI (selektivni inhibitorji ponovnega privzema serotonina) in SNRI (inhibitorji ponovnega privzema serotonin-norepinefrina), zlasti glede uporabe teh zdravil pri otrocih in mladostnikih.
English: IT projects and operational activities
Slovenian: Projekti IT in operativne dejavnosti
English: Following the paroxetine referral, the Committee conducted a review of data available for the whole class of SSRI (serotonin selective reuptake inhibitor) and SNRI (serotonin-norepinephrine reuptake inhibitor) products at the request of the European Commission.
Slovenian: Po predložitvi paroksetina je Odbor na zahtevo Evropske komisije pregledal podatke, ki so na voljo za ves razred zdravil SSRI (selektivni inhibitorji ponovnega privzema serotonina) in SNRI (inhibitorji