FrancophonIA/ELRC3.0 huggingface dataset:
English: The suspension of a medicinal product used to treat patients suffering from Parkinson s disease was lifted in 2004, based on new data evaluated by the CHMP.
Slovenian: V letu 2004 je bila na podlagi novih podatkov, ki jih je ocenil CHMP, odpravljena začasna izključitev zdravila za zdravljenje bolnikov s Parkinsonovo boleznijo.
English: Article 35
Slovenian: Člen 35
English: • Joint CHMP/CVMP Quality Working Party
Slovenian: • Skupna delovna skupina CHMP/CVMP za kakovost
English: Director-General Valsts zāļu aģentūra Jersikas iela 15
Slovenian: Jãnis OZOLINŠ Director-General Valsts zāļu aģentūra Jersikas iela 15
English: Stanislav PRIMO IČ (Alternate: Vesna KOBLAR)
Slovenian: Stanislav PRIMOŽIČ (namestnik: Vesna KOBLAR)
English: One referral concerned the harmonisation of withdrawal periods, which differed significantly between the marketing authorisations in the different Member States, for Dectomax 1 % injectable solution (doramectin) an endectocide injectable product for sheep.
Slovenian: Pri eni predložitvi je šlo za uskladitev karenc za 1-odstotno raztopino Dectomax za injiciranje (doramektin) - cepivo endektocid za ovce - ki so se v dovoljenjih za promet v različnih državah članicah precej razlikovale.
English: The implementation of CVMP recommendations on more effective and adequate reporting of ADRs for veterinary medicines in the EU continued, following on from progress achieved in 2003.
Slovenian: Na podlagi napredka, doseženega v letu 2003, se je nadaljevalo izvajanje priporočil CVMP o učinkovitejšem in ustreznejšem poročanju o neželenih učinkih za veterinarska zdravila v EU.
English: Blood Products Working Party (formerly Blood Products Working Group) Chair: Manfred HAASE EMEA contact: John PURVES
Slovenian: Delovna skupina za izdelke iz krvi (prej Blood Products Working Group) Predsednik: Manfred HAASE Kontaktna oseba EMEA: John PURVES
English: Scientific advice and protocol assistance requests (finalised)
Slovenian: Zahtevki za znanstveno svetovanje in pomoč pri protokolu (zaključeni)
English: The sampling and testing programme underwent a comprehensive review following the outcome of a seminar held in September 2003.
Slovenian: Na podlagi rezultatov seminarja, ki je potekal septembra 2003, je bila opravljena celovita revizija programa vzorčenja in preizkušanja.
English: 6.2 Information technology at the EMEA..................................................................................74
Slovenian: 6.2 Informacijska tehnologija v EMEA.....................................................................................73
English: Communication and action by Member States in response to suspected quality defects relating to centrally authorised medicines are also coordinated by the EMEA.
Slovenian: EMEA usklajuje tudi obveščanje in ukrepanje držav članic kot odgovor na domnevne kakovostne pomanjkljivosti zdravil, za katera je bilo izdano dovoljenje po centraliziranem postopku.
English: • Vaccine Working Party
Slovenian: • Delovna skupina za cepiva
English: Scientific Advisory Group on Oncology (formerly Therapeutic Advisory Group on Oncology)
Slovenian: Znanstveno svetovalna skupina za onkologijo (prej Terapevtska svetovalna skupina za onkologijo)
English: Referrals started in 2004
Slovenian: Začete predložitve v letu 2004
English: The Committee also finalised its proposals to the Commission for a list of essential products for equidae that can be authorised without MRLs providing six-month statutory withdrawal periods are applied.
Slovenian: Komisiji glede seznama bistvenih zdravil za konje, za katera se lahko izda dovoljenje za promet brez MRL-jev, če se uporablja šestmesečna zakonsko določena karenca.
English: • Scientific Advice Working Party Temporary working party
Slovenian: • Delovna skupina za znanstveno svetovanje Začasna delovna skupina
English: EMEA contact: Spiros VAMVAKAS
Slovenian: Kontaktna oseba EMEA: Spiros VAMVAKAS
English: Scientific advice and follow-up requests Protocol assistance and follow-up requests
Slovenian: Zahtevki za znanstveno svetovanje in nadaljnje dejavnosti Zahtevki za pomoč pri protokolu in nadaljnje dejavnosti
English: Chair: Klaus CICHUTEK EMEA contact: Marisa PAPALUCA AMATI
Slovenian: Predsednik: Klaus CICHUTEK Kontaktna oseba EMEA: Marisa PAPALUCA AMATI
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: EMEA izdaja za zdravila potrdila o glavnem dosjeju plazme (PMF) in glavnem dosjeju virusnih antigenov (VAMF) v skladu z ureditvijo iz zakonodaje Skupnosti.
English: Annex 10
Slovenian: Priloga 10
English: Marie HEROUTOVÁ (Czech Republic) Thorbjörg KJARTANDSDÓTTIR (Iceland) Alternate: Kristín INGÓLFSDÓTTIR
Slovenian: ￭ Thorbjörg KJARTANDSDÓTTIR (Islandija) Namestnik: Kristín INGÓLFSDÓTTIR
English: Members of the Committee for Medicinal Products for Human Use (CHMP) Members of the Committee for Medicinal Products for Veterinary Use (CVMP) Members of the Committee on Orphan Medicinal Products (COMP) Members of the Committee on Herbal Medicinal Products (HMPC) National competent authority partners
Slovenian: Člani Odbora za zdravila za uporabo v humani medicini (CHMP) Člani Odbora za zdravila za uporabo v veterinarski medicini (CVMP) Člani Odbora za zdravila sirote (COMP) Člani Odbora za zeliščna zdravila (HMPC) Pristojni nacionalni organi kot partnerji Povzetki proračunov EMEA za obdobje 2003−2005
English: 2.6 Arbitration and Community referrals
Slovenian: 2.6 Arbitraža in predložitve Skupnosti
English: Re-release for consultation expected in 4th quarter 2004 or 1st quarter 2005
Slovenian: Ponovna predstavitev za posvetovanje se pričakuje v zadnjem četrtletju leta 2004 ali prvem četrtletju leta 2005
English: In order to accommodate delegates from the 10 new Member States following enlargement, the EMEA reorganised and refurbished the delegates offices.
Slovenian: EMEA je reorganizirala in prenovila pisarne delegatov, da bi po širitvi sprejela delegate iz novih 10 držav članic.
English: Scientific Advisory Group on Diagnostics (formerly Therapeutic Advisory Group on Diagnostics)
Slovenian: Znanstveno svetovalna skupina za diagnostiko (prej Terapevtska svetovalna skupina za diagnostiko)
English: • There was 100 % adherence to regulatory timelines for all activities relating to applications for centralised procedures and MRL applications.
Slovenian: • Pri vseh dejavnostih v zvezi z vlogami za centralizirane postopke ali postopke medsebojnega priznavanja so bili zakonski roki 100-odstotno izpolnjeni.
English: Total title 3
Slovenian: Naslov 3 skupaj
English: • An antibody that targets vascular endothelial growth factor received a positive opinion.
Slovenian: • Pozitivno mnenje je bilo izdano za protitelo, usmerjeno na dejavnik vaskularne endotelijske rasti.
English: PSURs, specific obligations and follow-up measures
Slovenian: PSUR Nadaljnji ukrepi - posebne obveznosti
English: Isabelle MOULON (until midOctober 2004)
Slovenian: Isabelle MOULON (do sredine oktobra 2004)
English: Article 30
Slovenian: Člen 30
English: The new legislation gives the CHMP the possibility of appointing up to five additional members to gain additional expertise in particular scientific areas.
Slovenian: V skladu z novo zakonodajo lahko CHMP pridobi dodatno strokovno znanje na določenih znanstvenih področjih tako, da imenuje do pet dodatnih članov.
English: • The first production version of EudraVigilance Veterinary was released at the end of 2004
Slovenian: • uveden je bil sistem podatkovnega skladiščenja in poslovne inteligence • prva proizvodna različica EudraVigilance za veterino je bila predstavljena ob koncu leta
English: Art. 6(12) of Commission Regulation (EC) No 1084/2003 (previously Art. 7(5) of Commission Regulation (EC) No
Slovenian: Člen 6(12) Uredbe Komisije (ES) št. 1084/2003 (prej člen 7(5) Uredbe Komisije (ES) št. 542/95)
English: Community harmonisation and pharmacovigilance referrals Type of referral
Slovenian: Predložitve Skupnosti za uskladitev in farmakovigilanco Vrsta predložitve
English: Published in February 2004
Slovenian: Objavljeno februarja 2004
English: Isabelle MOULON See Annexes 2, 4 and 5 for members of committees, working parties and ad hoc groups.
Slovenian: Člani odborov, delovnih in ad hoc skupin so navedeni v Prilogah 2, 4 in 5.
English: • Martin MO INA (Slovenia) • José Félix OLALLA MARAÑÓN (Spain)
Slovenian: • José Félix Olalla Marañón (Španija)
English: Structure of the EMEA
Slovenian: Organizacija EMEA
English: 4 Replaced Daniel BRASSEUR as of June 2004 meeting.
Slovenian: 4 Od sestanka v juniju 2004 namesto Daniela BRASSEURA.
English: 5 Replaced Pieter NEELS as of June 2004 meeting.
Slovenian: 5 Od sestanka v juniju 2004 namesto Pietera NEELSA.
English: All changes that are made to the terms of authorisation of a centrally authorised medicinal product throughout its life have to be approved by the Community.
Slovenian: Skupnost mora v celotnem življenjskem ciklusu zdravila, za katerega je izdano dovoljenje po centraliziranem postopku, odobriti vse spremembe glede pogojev dovoljenja za promet.
English: Jãnis OZOLIN (Alternate: Inguna ADOVICA)
Slovenian: Jãnis OZOLINŠ (namestnik: Inguna ADOVICA)
English: Working Group with Patients' Organisations Chair: Frits LEKKERKERKER/Noël WATHION
Slovenian: Predsednik: Frits LEKKERKERKER/Noël WATHION
English: Type-I variations Type-II variations Extensions
Slovenian: Spremembe tipa II Razširitve
English: Progress with the implementation of the electronic transmission of individual case safety reports (ICSRs) was delayed at the level of the national competent authorities and pharmaceutical companies.
Slovenian: Na ravni pristojnih nacionalnih organov in farmacevtskih podjetij je bil napredek pri izvajanju elektronskega prenosa varnostnih poročil o posameznih primerih (individual case safety reports, ICSR) počasnejši.
English: Arbitration and Community referrals received/forecast (Input)
Slovenian: Prejete in predvidene arbitraže in predložitve Skupnosti (vhodni podatek)
English: The MRFG met 11 times in 2004.
Slovenian: V letu 2004 je MRFG imel 11 zasedanj.
English: Quality of medicines
Slovenian: Kakovost zdravil
English: Working parties and ad hoc groups Efficacy Working Party Chair: Michael HOLZHAUSER-ALBERTI EMEA contact: Jill ASHLEY-SMITH
Slovenian: Delovne in ad hoc skupine Delovna skupina za učinkovitost Predsednik: Michael HOLZHAUSER-ALBERTI Kontaktna oseba EMEA: Jill ASHLEY-SMITH
English: Gadoteric acid
Slovenian: Gadoterska kislina
English: Introduction by the Executive Director
Slovenian: Uvod izvršnega direktorja
English: Foreword by the Chairman of the Management Board
Slovenian: Uvodna beseda predsednika upravnega odbora
English: Post-authorisation opinions 2002-2004
Slovenian: Mnenja po izdaji dovoljenja za promet 2002-2004
English: Establishment of maximum residue limits for new substances
Slovenian: Določitev mejnih vrednosti ostankov za nove učinkovine
English: • Vallo TILLMANN (Estonia) • José Manuel TOSCANO RICO (Portugal)
Slovenian: • José Manuel Toscano Rico (Portugalska)
English: Hormones
Slovenian: Hormoni
English: Vaccine Working Party (formerly Vaccine Expert Group) Chair: Roland DOBBELAER EMEA contact: John PURVES
Slovenian: Delovna skupina za cepiva (prej Strokovna skupina za cepiva) Predsednik: Roland DOBBELAER Kontaktna oseba EMEA: John PURVES
English: COMP opinions in 2004 on designation of orphan medicinal products 12.
Slovenian: Mnenja COMP v letu 2004 o določitvi zdravil sirot 12.
English: 1 Replaced Carlos LENS CABRERA as of June 2004 meeting.
Slovenian: 1 Od sestanka v juniju 2004 namesto Carlosa LENSA CABRERE .
English: Immunotherapy and oncology
Slovenian: Imunoterapija in onkologija
English: Pharmacogenetics Working Party (formerly Ad hoc Expert Group on Pharmacogenetics)
Slovenian: Delovna skupina za farmakogenetiko (prej Ad hoc strokovna skupina za farmakogenetiko)
English: Notifications Validated Finalised
Slovenian: Obvestila Odobrena Končana
English: Head of Sector for medical information
Slovenian: Vodja Sektorja za informacije o zdravilih
English: See Annex 3 for members of the committee, working parties and ad hoc groups.
Slovenian: Člani odbora, delovne in ad hoc skupine so navedeni v Prilogi 3.
English: E-mail: ragini.shivji@emea.eu.int
Slovenian: E-naslov: ragini.shivji@EMEA.eu.int
English: Article 31
Slovenian: Člen 31
English: Chair: Hans HOOGLAND EMEA contact: Kornelia GREIN
Slovenian: Predsednik: Hans HOOGLAND Kontaktna oseba EMEA: Kornelia GREIN
English: For matters relating to pharmacovigilance for medicinal products for human use:
Slovenian: Za zadeve v zvezi s farmakovigilanco za zdravila za uporabo v humani medicini:
English: EU programmes
Slovenian: Prispevki za programe Skupnosti
English: Scientific advice and protocol assistance requests (received)
Slovenian: Zahtevki za znanstveno svetovanje in pomoč pri protokolu (prejeti)
English: Diagnostic/Miscellaneous
Slovenian: Diagnostika/Razno
English: Annex 5 Members of the Committee on Herbal Medicinal Products
Slovenian: Priloga 5 Člani Odbora za zeliščna zdravila
English: Ľudevít MARTINEC Director tátny ústav pre kontrolu liečiv Kvetná 11
Slovenian: Štátny ústav pre kontrolu liečiv Kvetná 11
English: To deploy a scientific advice database
Slovenian: Uvesti zbirko podatkov o znanstvenem svetovanju
English: EMEA annual report for 2004 EMEA/61492/2005/EN/Final
Slovenian: Letno poročilo EMEA 2004 EMEA/61492/2005/SL/konč.
English: Evaluations
Slovenian: Ocenjevanje
English: 1 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.
Slovenian: 1 Uredba (ES) št. 726/2004 Evropskega parlamenta in Sveta z dne 31. marca 2004 o postopkih Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za humano in veterinarsko uporabo ter o ustanovitvi Evropske agencije za zdravila.
English: Joint CHMP/CVMP Quality Working Party
Slovenian: Skupna delovna skupina CHMP/CVMP za kakovost
English: The new Regulation gives the Committee the possibility of nominating up to five co-opted members, when necessary, to gain additional expertise in a particular scientific area.
Slovenian: V skladu z novo uredbo lahko Odbor pridobi dodatno strokovno znanje na določenem znanstvenem področju tako, da imenuje do pet sporazumno izbranih članov.
English: Revision adopted in June 2004
Slovenian: Revizija sprejeta junija 2004
English: A10AE (pending) !
Slovenian: Novo Nordisk A/S A10AE (pending)
English: ICELAND
Slovenian: ISLANDIJA
English: The EMEA chaired and organised 4 meetings each for the Ad hoc GMP and GCP Inspectors Groups in 2004.
Slovenian: EMEA je v letu 2004 vodila in organizirala po 4 srečanja za ad hoc inšpekcijski skupini za dobro proizvodno prakso in dobro klinično prakso.
English: Summaries of opinion for initial centralised applications are published at the time of adoption by the CVMP.
Slovenian: CVMP ob sprejetju mnenja za začetne vloge za centraliziran postopek objavi povzetek mnenja.
English: CVMP opinions in 2004 on medicinal products for veterinary use 11.
Slovenian: Mnenja CVMP v letu 2004 o zdravilih za uporabo v veterinarski medicini 11.
English: • Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use.
Slovenian: • Direktivo Sveta 2004/24/ES Evropskega parlamenta in Sveta z dne 31. marca 2004 o spremembi, kar zadeva tradicionalna zeliščna zdravila, Direktive 2001/82/ES o zakoniku Skupnosti o zdravilih za uporabo v humani medicini.
English: In a year which saw the adoption of four important new pieces of EU pharmaceutical legislation as well as the single biggest expansion of the European Union in its history, the year 2004 was one characterised by change.
Slovenian: Leto 2004 je bilo leto sprememb, saj je bilo zaznamovano s sprejetjem štirih pomembnih novih delov farmacevtske zakonodaje EU in največjo širitvijo Evropske unije v njeni zgodovini.
English: E-mail: silvia.domingo@emea.eu.int
Slovenian: E-naslov: silvia.domingo@EMEA.eu.int
English: Direct telephone: (44-20) 75 23 71 47 Fax: (44-20) 74 18 85 45
Slovenian: Direktni telefon: (44-20) 75 23 71 47 Faks: (44-20) 74 18 85 45
English: Scientific Advisory Group on Antimicrobials Chair: Liisa KAARTINEN EMEA contact: Kornelia GREIN
Slovenian: Znanstveno svetovalna skupina za protimikrobna sredstva Predsednik: Liisa KAARTINEN Kontaktna oseba EMEA: Kornelia GREIN
English: A selection of centrally authorised products is included in each annual programme.
Slovenian: Vsak letni program vključuje izbor zdravil, za katera je bilo izdano dovoljenje po centraliziranem postopku.
English: Good laboratory practice (GLP) activities
Slovenian: Dejavnosti dobre laboratorijske prakse
English: Plasma master files (PMF) and vaccine antigen master files (VAMF)
Slovenian: Glavni dosjeji plazme (PMF) in glavni dosjeji virusnih antigenov (VAMF)
English: Referrals made to the CVMP
Slovenian: Predložitve, posredovane CVMP
English: Work on the elaboration and construction phases will continue in
Slovenian: Dela v zvezi s pripravo in izvedbo se bodo nadaljevala v letu 2005.
English: Official Journal
Slovenian: Uradni list
English: Accounting
Slovenian: Računovodstvo
English: E-mail: qualitydefects@emea.eu.int Fax: (44-20) 74 18 85 90
Slovenian: E-naslov: qualitydefects@EMEA.eu.int Faks: (44-20) 74 18 85 90
English: CHMP Invented Name Review Group
Slovenian: Skupina CHMP za presojo izmišljenih imen
English: The development of a CVMP simple guide to veterinary pharmacovigilance in the EU was started in 2004, following consultation on a concept paper.
Slovenian: Po posvetovanju o idejnem dokumentu so se v letu 2004 začele razvijati enostavne smernice CVMP za veterinarsko farmakovigilanco v EU.
English: Adopted by CVMP/CHMP in May/July 2004
Slovenian: Sprejela CVMP/CHMP maja/julija
English: Veterinary medicinal products: 1 June 2001
Slovenian: Zdravila za uporabo v veterinarski medicini: 1. junij 2001
English: The Committee met 11 times in 2004.
Slovenian: Odbor je v letu 2004 imel 11 sestankov.
English: Scientific Advice Working Party (formerly Scientific Advice Working Group) Chair: Markku TOIVONEN EMEA contact: Agnès SAINT-RAYMOND
Slovenian: Delovna skupina za znanstveno svetovanje (prej Scientific Advice Working Group) Predsednik: Markku TOIVONEN Kontaktna oseba EMEA: Agnès SAINTRAYMOND
English: • Jean-Louis ROBERT1 (Luxembourg) (co-opted)
Slovenian: • Jean-Louis ROBERT1 (Luksemburg)
English: Forty-one products were included within the scope of the programme of sampling and testing of centrally authorised products performed by the Network of Official Medicines Control Laboratories.
Slovenian: Področje programa vzorčenja in preizkušanja zdravil, za katera je bilo izdano dovoljenje po centraliziranem postopku, ki ga izvaja mreža uradnih laboratorijev za nadzor zdravil, je zajemalo 41 izdelkov.
English: Safety Working Party Chair: Christian FRIIS EMEA contact: Kornelia GREIN
Slovenian: Delovna skupina za varnost Predsednik: Christian FRIIS Kontaktna oseba EMEA: Kornelia GREIN
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: Direct telephone: (44-20) 74 18 85 52 Fax: (44-20) 74 18 85 45
Slovenian: Direktni telefon: (44-20) 74 18 85 52 Faks: (44-20) 74 18 85 45
English: CVMP opinions in 2004 on medicinal products for veterinary use
Slovenian: Mnenja CVMP v letu 2004 o zdravilih za uporabo v veterinarski medicini
English: Guidance documents focusing on the key steps of the centralised procedure are continuously developed and updated by the EMEA.
Slovenian: EMEA stalno razvija in posodablja usmeritvene dokumente, usmerjene h ključnim fazam centraliziranega postopka.
English: Scientific Advice Working Party Chair: Reinhard KROKER EMEA contact: Jill ASHLEY-SMITH
Slovenian: Delovna skupina za znanstveno svetovanje Predsednik: Reinhard KROKER Kontaktna oseba EMEA: Jill ASHLEY-SMITH
English: Efficacy Working Party Chair: Barbara VAN ZWIETEN-BOOT EMEA contact: Agnès SAINT-RAYMOND
Slovenian: Delovna skupina za učinkovitost Predsednik: Barbara VAN ZWIETEN-BOOT Kontaktna oseba EMEA: Agnès SAINTRAYMOND
English: For enquiries concerning certificates for centrally authorised medicines for human or veterinary use:
Slovenian: Za vprašanja v zvezi s potrdili za centralno odobrena zdravila za uporabo v humani ali veterinarski medicini:
English: Head of Sector for safety of veterinary medicines
Slovenian: Vodja Sektorja za varnost veterinarskih zdravil
English: E-mail: certificate@emea.eu.int Fax: (44-20) 74 18 85 95
Slovenian: E-naslov: certificate@EMEA.eu.int Faks: (44-20) 74 18 85 95
English: CHMP Biotechnology Working Party
Slovenian: Delovna skupina CHMP za biotehnologijo
English: Chair: Josep TORRENT-FARNELL EMEA contact: Agnès SAINT-RAYMOND
Slovenian: Predsednik: Josep TORRENT-FARNELL Kontaktna oseba EMEA: Agnès SAINT-RAYMOND
English: • Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.
Slovenian: • Uredbo (ES) št. 726/2004 Evropskega parlamenta in Sveta z dne 31. marca 2004 o postopkih Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za humano in veterinarsko uporabo ter o ustanovitvi Evropske agencije za zdravila,
English: Martin HARVEY ALLCHURCH Direct telephone: (44-20) 74 18 84 27 E-mail: press@emea.eu.int
Slovenian: Martin HARVEY ALLCHURCH Direktni telefon: (44-20) 74 18 84 27 E-naslov: press@EMEA.eu.int
English: Evaluation time for type-II variations (30-day procedure)
Slovenian: Čas ovrednotenja za spremembe tipa II (30-dnevni postopek)
English: For matters relating to pharmacovigilance for medicinal products for veterinary use:
Slovenian: Za zadeve v zvezi s farmakovigilanco za zdravila za uporabo v veterinarski medicini:
English: Post-authorisation activities relate to variations, line extensions, renewals and transfers of marketing authorisation.
Slovenian: Dejavnosti po izdaji dovoljenja za promet se nanašajo na spremembe, razširitev terapevtskih indikacij, podaljšanje dovoljenja in prenose dovoljenj za promet z zdravilom.
English: Arbitration and Community referrals overview 2004
Slovenian: Pregled arbitraž in predložitev Skupnosti v letu 2004
English: Head of Sector for scientific advice and orphan drugs
Slovenian: Vodja Sektorja za zdravila sirote in znanstveno svetovanje
English: Working parties of the CHMP
Slovenian: Delovne skupine CHMP
English: Paediatric Working Party (formerly Paediatric Expert Group)
Slovenian: Pediatrična delovna skupina (prej Pediatrična strokovna skupina)
English: MRL summary opinions are published following their adoption by the CVMP.
Slovenian: Ko CVMP sprejme mnenje o MRL, se objavi njegov povzetek.
English: • Magdaléna KU ELOVÁ (Slovakia)
Slovenian: • Magdaléna Kuželová (Slovaška)
English: European Community United States
Slovenian: Evropska skupnostZdružene države
English: Article 34
Slovenian: Člen 34
English: Part A or B
Slovenian: Mednarodno nelastniško ime Del A ali B
English: The EMEA/MRFG secretariat can be contacted by e-mail to: mrp@emea.eu.int
Slovenian: Elektronski naslov sekretariata EMEA/MRFG: mrp@EMEA.eu.int
English: NORWAY
Slovenian: NORVEŠKA
English: Gianmartino BENZI, José-Luis VALVERDE LÓPEZ European Commission Horst REICHENBACH, Fernand SAUER (Alternates: Paul WEISSENBERG, Patricia BRUNKO)
Slovenian: Horst REICHENBACH, Fernand SAUER (namestnika: Paul WEISSENBERG, Patricia BRUNKO)
English: Stanislav PRIMO IC
Slovenian: Stanislav PRIMOŽIC
English: See Annex 3 for details of working parties and scientific advisory groups.
Slovenian: Podrobni podatki o delovnih skupinah in znanstveno-svetovalnih skupinah so predstavljeni v Prilogi 3.
English: Ended positively in 2004*
Slovenian: Skupaj vloženih v letu 2004*
English: Evaluation time for type-II variations (60-day procedure)
Slovenian: Čas vrednotenja za spremembe tipa II (60-dnevni postopek)