FrancophonIA/ELRC3.0 huggingface dataset:
English: emtricitabine + tenofovir disoproxil fumarate !
Slovenian: Truvada emtricitabine + tenofovir disoproxil fumarate Part B
English: Useful websites: International Conference on Harmonisation http://www.ich.org
Slovenian: Koristni spletni naslovi: Mednarodna konferenca o usklajevanju http://www.ich.org
English: 3.2 Initial evaluation
Slovenian: 3.2 Začetno vrednotenje
English: Significant line extension applications approved in 2004 to include child populations
Slovenian: V letu 2004 odobrene vloge za znatno razširitev terapevtskih indikacij za vključitev populacij otrok
English: • Peter EKSTRÖM (Sweden) (co-opted)
Slovenian: • Peter EKSTRÖM (Švedska) (sporazumno izbran)
English: 2.1 Orphan medicinal products
Slovenian: 2.1 Zdravila sirote
English: Ad hoc Biotechnology Working Group Chair: Harrie SEEVERENS/Jean-Hugues TROUVIN
Slovenian: Ad hoc delovna skupina za biotehnologijo Predsednik: Harrie SEEVERENS/Jean-Hugues TROUVIN
English: 100 % fee reduction for protocol assistance
Slovenian: 100-odstotno znižanje pristojbin za pomoč pri protokolu 50-odstotno znižanje pristojbin za nadzor
English: In addition, a training meeting for GCP inspectors was organised in Lisbon, focusing also on cooperation, bioequivalence studies and GCP/GMP interfaces.
Slovenian: Poleg tega je bilo v Lizboni organizirano usposabljanje za inšpektorje za dobro klinično prakso, ki je bilo usmerjeno tudi na sodelovanje, študije biološke enakosti in odnose med dobro klinično prakso in dobro proizvodno prakso.
English: • Kenneth MIFSUD (Malta) Alternate: Joseph VELLA
Slovenian: • Kenneth MIFSUD (Malta) Namestnik: Joseph VELLA
English: See also Annex 13.
Slovenian: Glej tudi Prilogo 13.
English: 3.10 Improving the Agency's structures and procedures for veterinary medicines
Slovenian: 3.10 Izboljšanje struktur in postopkov Agencije za veterinarska zdravila
English: Orphan medicinal products for the treatment of children 2004
Slovenian: Zdravila sirote za zdravljenje otrok v letu 2004
English: 8 Replaced Pekka KURKI as of September 2004 meeting.
Slovenian: 8 Od sestanka v septembru 2004 namesto Pekka KURKIJA.
English: 1.79 % Portugal
Slovenian: 2.04 % Francija
English: 2.7 Regulatory guidance
Slovenian: 2.7 Regulativne smernice
English: In addition, there was an increase in the number of arbitrations of new applications compared to previous years.
Slovenian: V primerjavi s prejšnjimi leti se je povečalo tudi število arbitraž za nove vloge.
English: • Arvils JAKOVSKIS (Latvia)
Slovenian: • Arvils JAKOVSKIS (Latvija)
English: • Nikolaos DRAKOULIS (Greece) Alternate: Michalis AVGERINOS
Slovenian: • Nikolaos DRAKOULIS (Grčija) Namestnik: Michalis AVGERINOS
English: • Metoda LIPNIK-STANGELJ (Slovenia) Alternate: Barbara RAZINGER-MIHOVEC
Slovenian: • Metoda LIPNIK-STANGELJ (Slovenija) Namestnik: Barbara RAZINGER-MIHOVEC
English: Human medicinal products: 1 January 1999
Slovenian: Zdravila za uporabo v humani medicini: 1. januar 1999
English: Feline leukaemia
Slovenian: Cats Feline leukaemia
English: • Sif ORMARSDÓTTIR (Iceland) Alternate: Magnús JÓHANNSSON
Slovenian: • Sif ORMARSDÓTTIR (Islandija) Namestnik: Magnús JÓHANNSSON
English: General EU contribution Special EU contribution for IT telematics strategy Special EU contribution for orphan medicinal products Contribution from EEA Contribution from EU programmes (PERF)
Slovenian: Splošni prispevek EU Posebni prispevek EU za IT in telematsko strategojo Posebni prispevek EU za zdravila sirote
English: The batch certificate format has been adapted to include investigational medicinal products and active substances.
Slovenian: Oblika potrdila serije je bila prilagojena tako, da zajema zdravila in učinkovine za raziskave.
English: So far, 15 companies, mainly EU-based, have contacted the EMEA expressing interest in the procedure.
Slovenian: Do zdaj je pri EMEA izrazilo interes za tak postopek 15 podjetij, predvsem s sedeži v EU.
English: For enquiries concerning PMF certificates:
Slovenian: Za vprašanja o potrdilih PMF:
English: Oncology and immunology
Slovenian: Onkologija in imunologija
English: • Gottfried KREUTZ (Germany) Alternate: Karl BROICH2
Slovenian: • Gottfried KREUTZ (Nemčija) Namestnik: Karl BROICH2
English: Impact of scientific advice
Slovenian: Učinek znanstvenega svetovanja
English: EMEA budget evolution in euro
Slovenian: Razvoj proračuna EMEA
English: Translation
Slovenian: Prevodi
English: Press office
Slovenian: Tiskovno predstavništvo
English: Sampling and testing for centrally authorised products 2002-2004
Slovenian: Vzorčenje in preizkušanje za zdravila, za katera je bilo izdano dovoljenje po centraliziranem postopku, v obdobju 2002-2004
English: Initiatives to improve veterinary pharmacovigilance
Slovenian: Pobude za izboljšanje veterinarske farmakovigilance
English: Several medicinal products already authorised through the centralised procedure for cancer treatment had their indications extended to include new treatment options for patients suffering from breast cancer, ovarian cancer or (non-small cell) lung cancer.
Slovenian: Za več zdravil za zdravljenje raka, za katera je bilo izdano dovoljenje po centraliziranem postopku, so bile razširjene terapevtske indikacije tako, da vključujejo nove možnosti zdravljenja za bolnike z rakom dojk, rakom jajčnikov in pljučnim rakom (nemajhnih celic).
English: Marketing authorisation applications Protocol assistance Inspections
Slovenian: Vloge za dovoljenja za trženje Pomoč pri protokolu Nadzor
English: Initial evaluation opinions and withdrawals
Slovenian: Mnenja in umaknjene vloge za začetno vrednotenje
English: • The CVMP adopted its Position paper regarding availability of products for minor uses and minor species (EMEA/CVMP/477/03/Final) detailing the strategy to be taken in advancing the greater availability of medicines in the veterinary sector.
Slovenian: • CVMP je sprejel "Dokument o stališču glede razpoložljivosti zdravil za manjše uporabe in manj pomembne vrste" (EMEA/CVMP/477/03/konč.
English: Scientific advice and orphan drugs
Slovenian: Znanstveno svetovanje in zdravila sirote
English: 1 Replaced Rashmi SHAH as of December 2004 meeting.
Slovenian: 1 Od sestanka v decembru 2004 namesto Rashmija SHAHA.
English: There was a shortfall of 3 applications from the 11 forecast for the year.
Slovenian: Vložene so bile 3 vloge manj od predvidenih 11 vlog za leto 2004.
English: International Cooperation on Harmonisation (Veterinary)
Slovenian: Mednarodna konferenca o usklajevanju (veterina)
English: Clinical trials databases
Slovenian: Zbirke podatkov o kliničnih preizkušanjih
English: Scientific Advisory Group on Antimicrobials
Slovenian: Znanstveno-svetovalna skupina za protimikrobna sredstva
English: The Committee held 11 plenary meetings in 2004.
Slovenian: V letu 2004 je imel Odbor 11 plenarnih zasedanj.
English: Annex 13 Arbitration and Community referrals overview 2004
Slovenian: Priloga 13 Pregled arbitraž in predložitev Skupnosti v letu 2004
English: • An equine vaccine for immunisation against Streptococcus equi for the condition of strangles a most debilitating disease that affects horses, characterised by high fever, coughing and difficulty in swallowing due to swelling of the mandibular lymph nodes
Slovenian: • cepivo za konje za imunizacijo pred Streptococcus equi, ki povzroča smoliko - zelo izčrpljujočo bolezen konj, za katero so značilni visoka vročina, kašelj in težave pri požiranju zaradi otekanja mandibularnih limfnih vozličev;
English: • Tibor SOÓS (Hungary) Alternate: Gábor KULCSÁR
Slovenian: • Tibor SOÓS (Madžarska) Namestnik: Gábor KULCSÁR
English: In 2004, a wide range of user, technical and NCA training was successfully provided to EMEA staff and delegates alike.
Slovenian: V letu 2004 je bila za osebje EMEA in delegate zagotovljena vrsta uporabniških in tehničnih usposabljanj ter usposabljanj za pristojne nacionalne organe.
English: The Committee is composed of one member and one alternate per Member State, in addition to one member and one alternate each from Iceland and Norway.
Slovenian: Odbor sestavljajo po en predsednik in en namestnik iz vsake države članice ter po en član in en namestnik iz Islandije in Norveške.
English: • Rory BREATHNACH (Irland) (co-opted)
Slovenian: • Rory BREATHNACH (Irska) (sporazumno izbran)
English: The annual report for 2004 is presented to the Management Board by the Executive Director in accordance with Article 64(3) of 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: Letno poročilo za leto 2004 je upravnemu odboru predstavil izvršni direktor v skladu s členom 64(3) Uredbe (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: See Annex 8 for key internal IT projects and operational activities undertaken and delivered.
Slovenian: Glavni interni projekti IT in operativne dejavnosti, ki so se začeli izvajati in ki so izvedeni, so navedeni v Prilogi 8.
English: Mean duration of scientific advice procedures
Slovenian: Povprečno trajanje postopkov znanstvenega svetovanja
English: In the case of sponsors developing designated orphan medicinal products, the scientific advice provided by the Agency is referred to as protocol assistance and is offered free of charge.
Slovenian: Pri sponzorjih, ki razvijajo zdravila, določena za zdravila sirote, znanstveno svetovanje poteka v obliki pomoči pri protokolu in je brezplačno.
English: • Marc WIRTOR (Luxembourg) Alternate: Maurice HOLPER
Slovenian: • Marc WIRTOR (Luksemburg) Namestnik: Maurice HOLPER
English: • Blood Products Working Party
Slovenian: • Delovna skupina za izdelke iz krvi
English: 11 March 2004
Slovenian: 11. marec 2004
English: Jytte LYNGVIG (vice-chairman) (Alternate: Paul SCHÜDER)
Slovenian: Jytte LYNGVIG (podpredsednik) (namestnik: Paul SCHÜDER)
English: 3.5 Post-authorisation activities
Slovenian: 3.5 Dejavnosti po izdaji dovoljenja
English: Tamás PAÁL
Slovenian: MADŽARSKA Tamás PAÁL
English: A new procedure for requesting and reporting GLP inspections for centralised applications came into effect on 15 August 2004.
Slovenian: Za vloge po centraliziranem postopku je 15. avgusta 2004 začel veljati nov postopek za oddajo prošenj za inšpekcijske preglede za dobro laboratorijsko prakso in poročanje o njih.
English: Improving the availability of medicinal products is one of the core objectives of the EMEA.
Slovenian: Eden glavnih ciljev EMEA je izboljšati razpoložljivost zdravil.
English: Two medicinal products already authorised through the centralised procedure for the treatment of diabetes had their use extended to include new combination regimens for diabetes.
Slovenian: Za dve zdravili za zdravljenje sladkorne bolezni, za kateri je bilo izdano dovoljenje po centraliziranem postopku, je bila uporaba razširjena tako, da so zajete nove kombinacije odmerjanja za sladkorno bolezen.
English: European Community Canada
Slovenian: Evropska skupnostKanada
English: The working parties are involved, according to their specific area of responsibility, in the development and revision of scientific guidelines and in the provision of recommendations and advice on medicinal products for which applications are made for orphan drug designation, scientific advice, protocol assistance, marketing authorisation or postauthorisation activities.
Slovenian: Delovne skupine glede na posebno področje, za katerega so odgovorne, sodelujejo pri razvoju in reviziji znanstvenih smernic ter pri dajanju priporočil in svetovanju o zdravilih, za katera so oddane vloge za njihovo določitev za zdravila sirote, za znanstveno svetovanje, pomoč pri protokolu, izdajo dovoljenja za promet ali dejavnosti po izdaji dovoljenja za promet.
English: Anticoagulant in patients undergoing percutaneous coronary intervention (PCI)
Slovenian: B01A (pending) Anticoagulant in patients undergoing percutaneous coronary intervention (PCI)
English: Date of CVMP opinion International non-proprietary name (INN)
Slovenian: Datum mnenja CVMP Mednarodno nelastniško ime (INN)
English: Useful website: EudraVigilance http://eudravigilance.emea.eu.int
Slovenian: Koristen spletni naslov: EudraVigilance http://eudravigilance.EMEA.eu.int
English: Creation of scientific advisory groups
Slovenian: Oblikovanje znanstveno-svetovalnih skupin
English: • Elected Hannes Wahlroos (Finland) as chairman of the Board and re-elected Jytte Lyngvig (Denmark) as vice-chairman
Slovenian: • izvolitev predsednika odbora Hannesa Wahlroosa (Finska) in ponovna izvolitev podpredsednice Jytte Lyngvig (Danska)
English: Chair: Gérard MOULIN EMEA contact: Peter JONES Members
Slovenian: Predsednik: Gérard MOULIN Kontaktna oseba EMEA: Peter JONES Člani
English: Human Fibrinogen + Human Thrombin !
Slovenian: TachoSil Human Fibrinogen + Human Thrombin Part B
English: Medicines for veterinary use - Highlights in 2004
Slovenian: Zdravila za uporabo v veterinarski medicini - glavni poudarki v letu 2004
English: Revision 2 finalised in July 2004
Slovenian: 2. revizija zaključena julija 2004
English: In 2004, 8 (22 %) out of 37 applications for marketing authorisation that had an outcome in the centralised procedure received prior scientific advice.
Slovenian: V letu 2004 je bilo predhodno znanstveno svetovanje opravljeno pri 8 (22 %) od 37 vlog za izdajo dovoljenja za promet z zdravili, za katere je bil opravljen centraliziran postopek.
English: Staff
Slovenian: Osebje
English: In addition, a new Scientific Advice Working Party was created, and its mandate and work objectives agreed by the CVMP.
Slovenian: Oblikovana je bila tudi nova delovna skupina za znanstveno svetovanje in CVMP se je dogovoril o njenih obveznostih in ciljih.
English: Revenue
Slovenian: Prihodki
English: • Biotechnology Working Party
Slovenian: • Delovna skupina za biotehnologijo
English: Evaluation time for type-IA variations 2004
Slovenian: Čas vrednotenja za spremembe tipa IA v letu 2004
English: A special contribution ( orphan drug fund ) is allocated each year by the European Parliament and the Council for these reductions.
Slovenian: Evropski parlament in Svet vsako leto dodelita poseben prispevek ("sklad za zdravila
English: 2 Replaced George SHORTEN as of December 2004 meeting.
Slovenian: 2 Od sestanka v decembru 2004 namesto Georgea SHORTENA.
English: on the Internet at: www.emea.eu.int by e-mail request to: info@emea.eu.int by fax to: (44-20) 74 18 86 70 by writing to: EMEA Documentation service European Medicines Agency 7 Westferry Circus Canary Wharf UK London E14 4HB
Slovenian: na internetu na www.EMEA.eu.int na podlagi zahtevka, ki ga pošljete na e-naslov: info@EMEA.eu.int po faksu na št. (44-20) 74 18 86 70 pisno na: EMEA Documentation service European Medicines Agency 7 Westferry Circus Canary Wharf UK - London E14 4HB
English: A new referral procedure under Article 31 (Article 18 for centrally authorised products) was started for all COX-2 inhibitor medicines available in the EU in October 2004, due to concerns over cardiovascular safety.
Slovenian: Zaradi vprašanj v zvezi z kardiovaskularno varnostjo je bil oktobra 2004 uveden nov postopek predložitve v skladu s členom 31 (oz. členom 18 za zdravila, za katera je bilo izdano dovoljenje po centraliziranem postopku) za vse inhibitorje COX-2, ki so na voljo v EU.
English: The total number of active substances in applications submitted was 45 the highest number seen in the past five years.
Slovenian: V prejetih vlogah je bilo skupaj 45 zdravilnih učinkovin, kar je največ v zadnjih petih letih.
English: Article 29
Slovenian: Člen 29
English: Management and organisation of the Committee on Orphan Medicinal Products (COMP)
Slovenian: Upravljanje in organizacija Odbora za zdravila sirote (COMP)
English: Parallel distribution notifications 2002-2004
Slovenian: Obvestila o vzporedni distribuciji v obdobju 2002-2004
English: The number of applications for orphan medicinal products remained relatively stable in 2004, with 10 applications.
Slovenian: V letu 2004 je bilo prejetih 10 vlog za zdravila sirote, kar je relativno stabilno število.
English: 2.4 Post-authorisation activities
Slovenian: 2.4 Dejavnosti po izdaji dovoljenja
English: Steffen BAGER (Denmark) Alternate: Kristine HVOLBY
Slovenian: ￭ Steffen BAGER (Danska) Namestnik: Kristine HVOLBY
English: Document management and publishing
Slovenian: Upravljanje dokumentov in objave
English: • Efficacy Working Party
Slovenian: • Delovna skupina za učinkovitost
English: • Alfred HERA (Czech Republic) Alternate: Jiří BURE
Slovenian: • Alfred HERA (Češka) Namestnik: Jiří BUREŠ
English: Chair: Hannes WAHLROOS EMEA contact: Martin HARVEY ALLCHURCH
Slovenian: Predsednik: Hannes WAHLROOS Kontaktna oseba EMEA: Martin HARVEY ALLCHURCH
English: • 85 % of all national competent aurthorities were connected to EudraNet II at the end of 2004
Slovenian: • ob koncu leta 2004 je bilo 85 % vseh pristojnih nacionalnih organov vključenih v
English: 10 June 2004
Slovenian: 10. junij 2004
English: Consultation ends in February 2005
Slovenian: Posvetovanje se bo zaključilo februarja 2005
English: Biosimilar products
Slovenian: Biološko podobni izdelki
English: New applications for maximum residue limits 2002-2004
Slovenian: Nove vloge za mejne vrednosti ostankov v obdobju 2002-2004
English: The Agency remained committed to and participated in the two international conferences on harmonisation of technical requirements for the registration of human and veterinary pharmaceuticals (ICH and VICH respectively) in 2004.
Slovenian: Agencija je ostala zavezana uskladitvi tehničnih zahtev za registracijo farmacevtskih izdelkov za humano in veterinarsko uporabo (ICH in VICH) in je v letu 2004 sodelovala na dveh mednarodnih konferencah o tej temi.
English: Number of inspections 2002-2004
Slovenian: Število inšpekcijskih pregledov v obdobju 2002
English: The IT development team started work on the inception phase of this project with the Inspections TIG.
Slovenian: Razvojna skupina IT je začela z deli v zvezi z začetno fazo tega projekta skupaj s Skupino za izvedbo telematike pri inšpekcijskih pregledih.
English: Evaluation in < 60 days Evaluation in 60-120 days Evaluation in > 120 days
Slovenian: Ovrednotenje v < 60 dneh Ovrednotenje v 60-120 dneh Ovrednotenje v > 120 dneh
English: Scientific advice
Slovenian: Znanstveno svetovanje
English: 50 % fee reduction for new applications for a marketing authorisation in the centralised procedure 50 % fee reduction for post-authorisation activities and annual fees
Slovenian: 50-odstotno znižanje pristojbin za dejavnosti po izdaji dovoljenja za promet in letne pristojbine
English: Date of CHMP opinion International non-proprietary name (INN)
Slovenian: Datum mnenja CHMP Mednarodno nelastniško ime (INN)
English: 9 Replaced Helen VELLA as of July 2004 meeting.
Slovenian: 9 Od sestanka v juliju 2004 namesto Helen VELLA.
English: 2.11 Mutual recognition facilitation group
Slovenian: 2.11 Skupina za poenostavitev medsebojnega priznavanja
English: Working parties
Slovenian: Delovne skupine
English: Requests should be sent in writing to the EMEA or by e-mail to: europeanexperts@emea.eu.int
Slovenian: Pisni zahtevki se pošljejo EMEA ali na e-naslov: europeanexperts@EMEA.eu.int
English: This has radically improved the EMEA s ability to arrange all meetings and conferences
Slovenian: EMEA je tako korenito izboljšala svoje možnosti za vodenje sestankov in konferenc.
English: Zsuzsanna BIRÓ-SÁNDOR (Hungary) Alternate: Gyöngyi BACS
Slovenian: ￭ Zsuzsanna BIRÓ-SÁNDOR (Madžarska) Namestnik: Gyöngyi BACS
English: 3.7 Arbitration and Community referrals
Slovenian: 3.7 Arbitraža in predložitve Skupnosti
English: Type-IB variations
Slovenian: Spremembe tipa IB
English: Adopted by CPMP/CVMP in January/February 2004
Slovenian: Sprejela CPMP/CVMP januarja/februarja 2004
English: European product index http://heads.medagencies.org/mrindex/index.html
Slovenian: Evropski seznam zdravil (European product index) http://heads.medagencies.org/mrindex/index.html
English: Initial evaluation applications 2002-2004
Slovenian: Vloge za začetno vrednotenje v letih 2002-2004
English: Establishment of maximum residue limits for old substances
Slovenian: Določitev mejnih vrednosti ostankov za stare učinkovine
English: To speed up the implementation of EudraVigilance, the EMEA took additional initiatives.
Slovenian: EMEA je sprejela dodatne pobude, da bi pospešila izvajanje EudraVigilance.
English: Implement videoconferencing and webstreaming services for EMEA/NCA meetings
Slovenian: Uvesti storitve videokonference in neprekinjenega pretoka po spletu za sestanke EMEA in pristojnih nacionalnih organov
English: Annex 9
Slovenian: Priloga 9
English: Positive opinions per therapeutic area 2004
Slovenian: Pozitivna mnenja po terapevtskih področjih v letu 2004
English: Medicines for human use - Highlights in 2004
Slovenian: Zdravila za uporabo v humani medicini - glavni poudarki v letu 2004
English: In 2004, the number of pre-submission meetings held was 65.
Slovenian: V letu 2004 je bilo opravljenih 65 sestankov pred oddajo vloge.
English: To ensure the timely back-up and archiving of the EMEA data, including off-site disaster recovery scenarios
Slovenian: Zagotoviti pravočasno varnostno kopiranje in arhiviranje podatkov EMEA, vključno s scenarijem za obnovitev programske opreme na drugi lokaciji po njeni odpovedi
English: Vaccine against
Slovenian: Vaccine Part A
English: Evaluation in <30 days Evaluation in 30-60 days Evaluation in >60 days
Slovenian: Ovrednotenje v <30 dneh Ovrednotenje v 30-60 dneh Ovrednotenje v >60 dneh
English: Annex 4 Members of the Committee on Orphan Medicinal Products
Slovenian: Priloga 4 Člani Odbora za zdravila sirote
English: Meeting management and conferences
Slovenian: Upravljanje srečanj in konferenc
English: • Milan MÍD (Czech Republic)
Slovenian: • Milan ŠMÍD (Češka)
English: Committee for Medicinal Products for Human Use (CHMP)
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP)
English: Metacam 20mg/ml solution for injection !
Slovenian: Metacam 20mg/ml solution for injection Meloxicam Part BExtension
English: • János BORVENDEG (Hungary) Alternate: Agnes GYURASICS
Slovenian: • János BORVENDÉG (Madžarska) Namestnik: Agnes GYURASICS
English: 2.2 Scientific advice and protocol assistance
Slovenian: 2.2 Znanstveno svetovanje in pomoč pri protokolu
English: To deploy the inspections database
Slovenian: Inšpekcijski pregledi Uvesti zbirko podatkov o inšpekcijskih pregledih
English: Committee on Orphan Medicinal Products (COMP)
Slovenian: Odbor za zdravila sirote (COMP)
English: Milan MÍD
Slovenian: Milan ŠMÍD
English: Target species
Slovenian: Terapevtsko področje Ciljne vrste
English: European Community Japan
Slovenian: Evropska skupnostJaponska
English: Pharmacovigilance and product defect reporting
Slovenian: Farmakovigilanca in poročanje o pomanjkljivostih izdelkov
English: The enlargement of the European Union on 1 May 2004 and the preparation for the implementation of the new Community legislation were permanent items on the MRFG agenda.
Slovenian: Stalni točki dnevnega reda MRFG sta bili širitev Evropske unije 1. maja 2004 in priprava na izvajanje nove zakonodaje Skupnosti.
English: EMEA PMF/VAMF certificates
Slovenian: Potrdila EMEA za PMF/VAMF
English: They are involved, according to their specific area of responsibility, in the development and revision of guidelines and in the provision of recommendations and advice on medicinal products for which applications are made for scientific advice, marketing authorisation or post-authorisation activities.
Slovenian: Delovne skupine glede na posebno področje, za katerega so odgovorne, sodelujejo v razvoju in reviziji smernic ter v dajanju priporočil in svetovanju o zdravilih, za katera so oddane vloge za znanstveno svetovanje, izdajo dovoljenja za promet ali dejavnosti po izdaji dovoljenja za promet.
English: Executive support
Slovenian: Izvršna podpora
English: • Paediatric Working Party
Slovenian: • Pediatrična delovna skupina