FrancophonIA/ELRC3.0 huggingface dataset:
English: See Annex 2 for information on working parties and scientific advisory groups.
Slovenian: Podatki o delovnih skupinah in znanstveno-svetovalnih skupinah so predstavljeni v Prilogi 2.
English: CHMP opinions in 2004 on medicinal products for human use 10.
Slovenian: Mnenja CHMP v letu 2004 o zdravilih za uporabo v humani medicini 10.
English: • Pharmacovigilance Working Party
Slovenian: • Delovna skupina za farmakovigilanco
English: CHMP Blood Products Working Party
Slovenian: Delovna skupina CHMP za izdelke iz krvi
English: • Scientific Advice Working Party
Slovenian: • Delovna skupina za znanstveno svetovanje
English: 6 Replaced Jens ERSBØLL as of November 2004 meeting.
Slovenian: 6 Od sestanka v novembru 2004 namesto Jensa
English: Rules of procedure for individual SAGs will follow, based on this document.
Slovenian: Na podlagi tega dokumenta bodo kasneje sprejeta postopkovna pravila za posamezne znanstveno- svetovalne skupine.
English: Czech Republic
Slovenian: Češka republika
English: Establishment of the Committee on Herbal Medicinal Products (HMPC)
Slovenian: Ustanovitev Odbora za zeliščna zdravila (HMPC)
English: Musculo-skeletal system
Slovenian: Mišično-kostni sistem
English: EMEA post-opinion phase
Slovenian: Faza pri EMEA po izdaji mnenja
English: 2 Replaced Manfred HAASE as of September 2004 meeting.
Slovenian: 2 Od sestanka v septembru 2004 namesto Manfreda HAASE 3 Od sestanka v juliju 2004 namesto Pavela ŠVECA.
English: Prevalence Ad hoc Working Group Chair: Kalle HOPPU EMEA contact: Spiros VAMVAKAS
Slovenian: Ad hoc delovna skupina za prevalenco Predsednik: Kalle HOPPU Kontaktna oseba EMEA: Spiros VAMVAKAS
English: Applications for orphan medicinal product designation Withdrawals
Slovenian: Vloge za določitev zdravila kot zdravila sirote Umiki
English: The Agency received a total of 64 1861 adverse drug reaction reports (ADRs) during 2004 for centrally authorised products from EU national competent authorities and marketing authorisation holders.
Slovenian: Agencija je v letu 2004 od pristojnih nacionalnih organov EU in imetnikov dovoljenj za promet z zdravili skupaj prejela 64.1861 poročil o neželenih učinkih zdravil za zdravila, za katera je bilo izdano dovoljenje po centraliziranem postopku.
English: CVMP Safety Working Party
Slovenian: Delovna skupina CVMP za varnost
English: The year s most notable evaluations concerned:
Slovenian: Najpomembnejša vrednotenja v letu 2004 so bila opravljena za:
English: Good clinical practice (GCP) activities
Slovenian: Dejavnosti dobre klinične prakse
English: European Community Switzerland
Slovenian: Evropska skupnostŠvica
English: Scientific advice requests by therapeutic area 2004
Slovenian: Prošnje za znanstveno svetovanje po terapevtskih področjih v letu 2004
English: Barbara FREISCHEM Direct telephone: (44-20) 74 18 85 81 E-mail: barbara.freischem@emea.eu.int
Slovenian: Barbara FREISCHEM Direktni telefon: (44-20) 74 18 85 81 E-naslov: barbara.freischem@EMEA.eu.int
English: Head of Sector for quality of medicines
Slovenian: Vodja Sektorja za kakovost zdravil
English: EMEA-US FDA parallel scientific advice
Slovenian: Vzporedno znanstveno svetovanje EMEA in FDA ZDA
English: Evaluation time for type-II variations (90-day procedure)
Slovenian: Čas vrednotenja za spremembe tipa II (90-dnevni postopek)
English: COMP opinions by therapeutic area 2004
Slovenian: Mnenja COMP po terapevtskih področjih v letu 2004
English: Working parties and ad hoc groups Biotechnology Working Party Chair: Jean-Hugues TROUVIN EMEA contact: John PURVES
Slovenian: Delovne in ad hoc skupine Delovna skupina za biotehnologijo Predsednik: Jean-Hugues TROUVIN Kontaktna oseba EMEA: John PURVES
English: Post-authorisation activities relate to variations, line extensions and transfers of marketing authorisation.
Slovenian: Dejavnosti po izdaji dovoljenja se nanašajo na spremembe, razširitev terapevtskih indikacij in prenose dovoljenj za promet z zdravilom.
English: ESTONIA
Slovenian: ESTONIJA
English: The safety of medicines is always a primary concern of the Agency, and work was begun in 2004 on developing a risk management strategy with the heads of
Slovenian: Varnost zdravil je vedno glavna skrb Agencije, zato je v letu 2004 z vodji agencij za zdravila začela razvijati strategijo obvladovanja tveganja, ki naj bi skupaj z novimi zakonodajnimi orodji za okrepitev nadzora varnosti prinesla izboljšave na tem življenjsko pomembnem področju.
English: 10 Replaced Patricia VELLA BONANNO as of November 2004 meeting.
Slovenian: 10 Od sestanka v novembru 2004 namesto Patricie VELLA
English: Veterinary medicinal products: 1 June 2002
Slovenian: Zdravila za uporabo v veterinarski medicini: 1. junij 2002
English: Pharmacovigilance Working Party Chair: Cornelia IBRAHIM EMEA contact: Kornelia GREIN
Slovenian: Delovna skupina za farmakovigilanco Predsednik: Cornelia IBRAHIM Kontaktna oseba EMEA: Kornelia GREIN
English: Heads of Medicines Agencies Veterinary http://www.hevra.org
Slovenian: Vodje agencij za zdravila - uporaba v veterinarski medicini http://www.hevra.org
English: EMEA mission statement
Slovenian: Poslanstvo EMEA
English: Human and veterinary medicinal products
Slovenian: Zdravila za uporabo v humani in veterinarski medicini
English: Safety Working Party Chair: Beatriz SILVA LIMA EMEA contact: Agnès SAINT-RAYMOND
Slovenian: Delovna skupina za varnost Predsednik: Beatriz SILVA LIMA Kontaktna oseba EMEA: Agnès SAINTRAYMOND
English: Immunologicals Working Party Chair: Jean-Claude ROUBY EMEA contact: Jill ASHLEY-SMITH
Slovenian: Delovna skupina za imunološke izdelke Predsednik: Jean-Claude ROUBY Kontaktna oseba EMEA: Jill ASHLEY-SMITH
English: Purevax RCPCh
Slovenian: Purevax RCPCh FeLV
English: Chair: Bjarne ORSKOV LINDHARDT EMEA contact: Agnès SAINT-RAYMOND
Slovenian: Predsednik: Bjarne ORSKOV LINDHARDT Kontaktna oseba EMEA: Agnès SAINTRAYMOND
English: IT provided support and helpdesk services to the EMEA s corporate users to a high and professional level.
Slovenian: IT je zagotovila visoko strokovno raven podpore in pomoči podjetjem, ki so uporabniki EMEA.
English: Pharmacovigilance and postauthorisation safety and efficacy of medicines
Slovenian: Farmakovigilanca ter varnost in učinkovitost zdravil po izdaji dovoljenja za promet
English: Heparin-Sodium Prof. Dr W Seeger
Slovenian: Heparin-Sodium Prof.
English: January 2004
Slovenian: Januar 2004
English: Marijke KORTEWEG Direct telephone: (44-20) 74 18 85 56 E-mail: iqmanagement@emea.eu.int
Slovenian: Marijke KORTEWEG Direktni telefon: (44-20) 74 18 85 56 E-naslov: iqmanagement@EMEA.eu.int
English: • Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products.
Slovenian: • Direktivo Sveta 2004/28/ES Evropskega parlamenta in Sveta z dne 31. marca 2004 o spremembi Direktive 2001/82/ES o zakoniku Skupnosti o zdravilih za uporabo v veterinarski medicini,
English: In 2004, a total of 34 marketing authorisation applications received a positive opinion from the EMEA.
Slovenian: V letu 2004 je EMEA izdala pozitivno mnenje za 34 vlog za izdajo dovoljenja za promet z zdravili.
English: Meetings management system (MMS)
Slovenian: Sistem vodenja sestankov (MMS)
English: Replaced Steffen THIRSTRUP as of November 2004 meeting.
Slovenian: Od sestanka v novembru 2004 namesto Steffena
English: Luxembourg
Slovenian: LUKSEMBURG
English: Adopted by CVMP in July 2004
Slovenian: Sprejel CVMP julija 2004
English: Chair: Daniel BRASSEUR EMEA contact: Anthony HUMPHREYS
Slovenian: Predsednik: Daniel BRASSEUR Kontaktna oseba EMEA: Anthony HUMPHREYS
English: Adopted by CVMP in March 2004
Slovenian: Sprejel CVMP marca 2004
English: See Annex 10 for details of guidance documents.
Slovenian: Podrobni podatki o usmeritvenih dokumentih so navedeni v Prilogi 10.
English: General anti-infectives for systemic use Anti-neoplastic and immunomodulating agents Nervous system Various
Slovenian: Antimikotiki za sistemsko zdravljenje Zdravila z delovanjem na novotvorbe in imunomodulatorji Živčni sistem
English: CHMP opinions in 2004 on medicinal products for human use
Slovenian: Mnenja CHMP v letu 2004 o zdravilih za uporabo v humani medicini
English: EMEA Herbal Medicinal Products Working Party1
Slovenian: Delovna skupina EMEA za zeliščna zdravila1
English: 271 days
Slovenian: 181 days 271 days
English: Committee on Herbal Medicinal Products (HMPC)
Slovenian: Odbor za zeliščna zdravila (HMPC)
English: • Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use.
Slovenian: • Direktivo Sveta 2004/27/ES Evropskega parlamenta in Sveta z dne 31. marca 2004 o spremembi Direktive 2001/82/ES o zakoniku Skupnosti o zdravilih za uporabo v humani medicini,
English: Adopted in December 2003
Slovenian: Sprejeto decembra 2003
English: EMEA/61492/2005/EN/Final
Slovenian: EMEA/226014/2005/SL/konč.
English: Marketing authorisation holder
Slovenian: Imetnik dovoljenja za promet
English: Unit for the post-authorisation evaluation of medicines for human use Head of Unit
Slovenian: Enota za vrednotenje zdravil za uporabo v humani medicini po izdaji dovoljenja za promet Vodja enote
English: The guide also advises on how to report ADRs.
Slovenian: Smernice svetujejo tudi glede načina poročanja o neželenih učinkih zdravil.
English: Purevax RCP
Slovenian: Purevax RCP FeLV
English: Adopted by CVMP in May 2004
Slovenian: Sprejel CVMP maja 2004
English: CVMP Immunologicals Working Party
Slovenian: Delovna skupina CVMP za imunološke izdelke
English: See Annex 10 for a detailed list of opinions adopted.
Slovenian: Podroben seznam sprejetih mnenj je naveden v Prilogi 10.
English: The number of applications for orphan medicinal product designation withdrawn by sponsors in 2004 was 22.
Slovenian: V letu 2004 so sponzorji umaknili 22 vlog za določitev zdravila kot zdravila sirote.
English: EU and non-EU adverse drug reaction reports
Slovenian: Poročila, ki niso iz EU Poročila iz EU
English: Number of certificates
Slovenian: Število potrdil
English: Unit for the pre-authorisation evaluation of medicines for human use Head of Unit
Slovenian: Enota za vrednotenje zdravil za uporabo v humani medicini pred izdajo dovoljenja za promet Vodja enote
English: Re-release for consultation expected in 1st quarter 2005
Slovenian: Ponovna predstavitev za posvetovanje se pričakuje v prvem četrtletju leta 2005
English: Herbal Medicinal Products Working Party Chair: Konstantin KELLER EMEA contact: Anthony HUMPHREYS
Slovenian: Delovna skupina za zeliščna zdravila Predsednik: Konstantin KELLER Kontaktna oseba EMEA: Anthony HUMPHREYS
English: CHMP Vaccine Working Party
Slovenian: Delovna skupina CHMP za cepiva
English: 6.3 Meeting management and conferences................................................................................75
Slovenian: 6.3 Upravljanje srečanj in konferenc.........................................................................................74
English: Medical information
Slovenian: Informacije o zdravilih
English: Initial marketing authorisation applications per therapeutic area in 2004
Slovenian: Začetne vloge za izdajo dovoljenja za trženje po terapevtskih področjih v letu 2004 8.9%
English: Deputy Head of Sector for pharmacovigilance and post-authorisation safety and efficacy of medicines
Slovenian: Namestnica vodje Sektorja za farmakovigilanco ter varnost in učinkovitost zdravil po izdaji dovoljenja za promet
English: CVMP Efficacy Working Party
Slovenian: Delovna skupina CVMP za učinkovitost
English: 346 days
Slovenian: 196 days 346 days
English: CVMP Pharmacovigilance Working Party
Slovenian: Delovna skupina CVMP za farmakovigilanco
English: Latvia
Slovenian: LATVIJA
English: Useful websites: Heads of Medicines Agencies Human http://heads.medagencies.org
Slovenian: Koristni spletni naslovi: Vodje agencij za zdravila - uporaba v humani medicini http://heads.medagencies.org
English: Websites: Heads of Medicines Agencies Human http://heads.medagencies.org
Slovenian: Vodje agencij za zdravila - uporaba v humani medicini http://heads.medagencies.org
English: Ireland
Slovenian: IRSKA
English: IRELAND
Slovenian: Irska
English: Chair: Konstantin KELLER EMEA contact: Anthony HUMPHREYS
Slovenian: Predsednik: Konstantin KELLER Kontaktna oseba EMEA: Anthony HUMPHREYS
English: Consultation ended in September
Slovenian: Posvetovanje zaključeno septembra
English: Netherlands
Slovenian: NIZOZEMSKA
English: NETHERLANDS
Slovenian: Nizozemska
English: Scientific Advice Working Party
Slovenian: Delovna skupina za znanstveno svetovanje
English: Useful website: Heads of Medicines Agencies Veterinary http://www.hevra.org
Slovenian: Koristen spletni naslov: Vodje agencij za zdravila - uporaba v veterinarski medicini http://www.hevra.org
English: GREECE
Slovenian: GRČIJA
English: 4.4 Certificates of a medicinal product
Slovenian: 4.4 Potrdila za zdravilo
English: bevacizumab !
Slovenian: ERSBØLLA.
English: Adopted by CPMP/CVMP in June
Slovenian: Sprejela CPMP/CVMP junija 2004
English: 801 days
Slovenian: 177 days 801 days
English: Belgium
Slovenian: BELGIJA
English: Firocoxib !
Slovenian: Previcox Firocoxib Part B
English: • COMP Biotechnology Working Group • Ad hoc Working Group on Prevalence
Slovenian: • Ad hoc delovna skupina za prevalenco
English: 141 days
Slovenian: 210 days 141 days
English: • Immunological Working Party
Slovenian: • Delovna skupina za imunološke izdelke
English: Part B
Slovenian: Zonegran zonisamide Part B
English: EMEA contact: John PURVES
Slovenian: Predsednik: Pekka KURKI Kontaktna oseba EMEA: John PURVES
English: VETERINARY MEDICINES AND INSPECTIONS
Slovenian: ZDRAVILA ZA UPORABO V VETERINI IN INŠPEKCIJSKI PREGLEDI
English: Paroxetine
Slovenian: Paroksetin
English: Musculoskeletal and nervous systems
Slovenian: Kardiovaskularni in respiratorni sistem Mišično-kostni in živčni sistem Drugo
English: Scientific advice requests by topic
Slovenian: Prošnje za znanstveno svetovanje po temah v letu 2004
English: There were no negative CVMP opinions in 2004.
Slovenian: V letu 2004 CVMP ni izdal negativnih mnenj.
English: 124 days
Slovenian: 120 days 124 days
English: Deputy Head of Sector for safety and efficacy of medicines
Slovenian: Namestnik vodje Sektorja za varnost in učinkovitost zdravil
English: Chair: Michel MARTY EMEA contact: Agnès SAINT-RAYMOND
Slovenian: Predsednik: Michel MARTY Kontaktna oseba EMEA: Agnès SAINTRAYMOND
English: Start date !
Slovenian: Datum začetka
English: 467 days
Slovenian: 118 days 467 days
English: POST-AUTHORISATION EVALUATION OF MEDICINES FOR HUMAN USE
Slovenian: VREDNOTENJE ZDRAVIL ZA UPORABO V HUMANI MEDICINI PO IZDAJI DOVOLJENJA ZA PROMET
English: SPAIN
Slovenian: ŠPANIJA
English: Significant variations/new treatment options for patients suffering from neurodegenerative diseases
Slovenian: Pomembne spremembe/nove možnosti zdravljenja za bolnike z nevrodegenerativnimi boleznimi
English: Building/equipment
Slovenian: Poslopje/oprema Najemnina/stroški Stroški obdelave podatkov
English: EMEA annual report for 2004 EMEA/61492/2005
Slovenian: Letno poročilo EMEA 2004 EMEA/226014/2005 ©EMEA 2005
English: In addition, the EMEA released advice to healthcare professionals and patients in the form of question and answer documents accompanying the EMEA public statements, in line with the Agency s policy for increased transparency towards the public.
Slovenian: V skladu s politiko Agencije za večjo preglednost za javnost je EMEA skupaj z izjavami za javnost objavila tudi nasvete zdravstvenim strokovnjakom in bolnikom v obliki vprašanj in odgovorov.
English: SWEDEN
Slovenian: Švedska
English: Sweden
Slovenian: ŠVEDSKA
English: Adopted in February 2004
Slovenian: Sprejeto februarja 2004
English: Significant variations/new treatment options for patients suffering from HIV/AIDS
Slovenian: Pomembne spremembe/nove možnosti zdravljenja za bolnike s HIV/AIDS
English: 6.4 Document management and publishing...............................................................................76 Annexes
Slovenian: 6.4 Upravljanje dokumentov in objave......................................................................................74 Priloge
English: European Community New Zealand
Slovenian: Evropska skupnostNova Zelandija
English: Mutual recognition agreement (MRA) implementation status and coverage
Slovenian: Status izvajanja in področje sporazumov o medsebojnem priznavanju
English: Art. 29(2) of Directive 2001/83/EC (previously Art. 10(2) of Directive 75/319/EEC)
Slovenian: Člen 29(2) Direktive št. 2001/83/ES (prej člen 10(2) Direktive 74/319/EGS)
English: 243 days
Slovenian: 210 days 243 days
English: CZECH REPUBLIC
Slovenian: ČEŠKA
English: CVMP Scientific Advice Working Party
Slovenian: Delovna skupina CVMP za znanstveno svetovanje
English: Opinion !
Slovenian: Mnenje
English: COMP designation opinions EC designation decisions
Slovenian: Mnenja COMP o določitvi Odločbe Evropske komisije o določitvi
English: France
Slovenian: FRANCIJA
English: FRANCE
Slovenian: Francija
English: Special contribution for orphan medicines Other income Contribution to Community programmes
Slovenian: Poseben prispevek za zdravila sirote
English: Adopted in July 2004
Slovenian: Sprejeto julija 2004
English: Joint CHMP/CVMP Quality Working Party Chair: Jean-Louis ROBERT EMEA contact: Emer COOKE
Slovenian: Predsednik: Jean-Louis ROBERT Kontaktna oseba EMEA: Emer COOKE
English: FINLAND
Slovenian: FINSKA
English: AUSTRIA
Slovenian: Avstrija
English: Lithuania
Slovenian: LITVA
English: Inspections
Slovenian: Pregled
English: Scientific Advisory Group on Anti-infectives (formerly Therapeutic Advisory Group on Antiinfectives)
Slovenian: Znanstveno svetovalna skupina za antimikotike (prej Terapevtska svetovalna skupina za antimikotike)
English: o Feline viral rhinotracheitis o Calcivirus infection o Chlamydophilia felis infection o Feline panleucopenia o Feline leukaemia
Slovenian: o mačji virusni rhinotracheitis o infekcija s calicivirusom o infekcija s Chlamydophilia felis o mačja panleukopenija o mačja levkemija
English: PRE-AUTHORISATION EVALUATION OF MEDICINES FOR HUMAN USE
Slovenian: VREDNOTENJE ZDRAVIL ZA UPORABO V HUMANI MEDICINI PRED IZDAJO DOVOLJENJA ZA PROMET
English: Annexes
Slovenian: Priloge
English: Finalisation expected in 2nd quarter
Slovenian: Dokončno oblikovanje se pričakuje v drugem četrtletju leta 2005
English: New applications Type-IA variations
Slovenian: Nove vloge Spremembe tipa IA
English: Working Group with Interested Parties Chair: Yann LE CAM/Agnès SAINT-RAYMOND EMEA contact: Spiros VAMVAKAS
Slovenian: Delovna skupina za sodelovanje z zainteresiranimi stranmi Predsednik: Yann LE CAM/Agnès SAINTRAYMOND
English: Released for consultation in September 2004
Slovenian: Predstavljeno za posvetovanje septembra 2004
English: Immunotherapy and oncology Musculo-skeletal
Slovenian: Infekcije Imunoterapija in onkologijaMišično-kostni sistem Nevrologija/CŽS
English: Adopted in November 2004
Slovenian: Sprejeto novembra 2004
English: Fee income
Slovenian: Prihodki iz pristojbin
English: Herbal Medicinal Products Working Party
Slovenian: Delovna skupina za zeliščna zdravila
English: One GLP inspection was requested in 2004.
Slovenian: V letu 2004 je bila oddana ena prošnja za inšpekcijski pregled za dobro laboratorijsko prakso.
English: • Frances ROTBLAT1 (United Kingdom) (co-opted)
Slovenian: (sporazumno izbran) • Frances ROTBLAT1 (Združeno kraljestvo)
English: Therapeutic area EMEA/CVMP European Commission
Slovenian: EMEA/CVMP Odobritev Mnenje
English: Veterinary marketing authorisation procedures
Slovenian: Vodja Sektorja za postopke za izdajo dovoljenja za promet z veterinarskimi zdravili
English: POLAND
Slovenian: Poljska
English: CHMP Safety Working Party
Slovenian: Delovna skupina CHMP za varnost
English: Wilzin !
Slovenian: BONANNO.
English: Head of Sector for safety and efficacy of medicines
Slovenian: Vodja Sektorja za varnost in učinkovitost zdravil
English: • Barbara VAN ZWIETEN-BOOT (Netherlands) Alternate: Frits LEKKERKERKER
Slovenian: • Barbara VAN ZWIETEN-BOOT (Nizozemska)
English: Product !
Slovenian: izdelkov)
English: The new rules clarify procedures relating to the release of documents originating from a third party and
Slovenian: predpisi jasno določajo postopke glede posredovanja javnosti dokumentov tretjih strank in izvršnemu direktorju posebej nalagajo odgovornost za obravnavo zahtevkov za odobritev1.
English: Adopted in January 2004
Slovenian: Sprejeto januarja 2004
English: March 2004
Slovenian: Marec 2004
English: Active time
Slovenian: Porabljeni čas
English: 207 days
Slovenian: 177 days 207 days
English: Referrals made to the CHMP
Slovenian: Predložitve, posredovane CHMP
English: 113 days
Slovenian: 210 days 113 days
English: See Annex 12 for full list of guidelines.
Slovenian: Celoten seznam smernic je naveden v Prilogi 12.
English: Released for consultation in February 2004
Slovenian: Predstavljeno za posvetovanje februarja 2004
English: The Oncology SAG, SAG on Diagnostics and SAG on Anti-infectives were the first SAGs created by the Committee.
Slovenian: Prve znanstveno-svetovalne skupine, ki jih je ustanovil Odbor, so bile za onkologijo, za diagnostiko in za antimikotike.
English: Adopted in June 2004
Slovenian: Sprejeto junija 2004
English: Members of the Committee for Medicinal Products for Veterinary Use
Slovenian: Priloga 3 Člani Odbora za zdravila za uporabo v veterinarski medicini
English: Company clock stop
Slovenian: Čas obravnave Zaustavitev časa
English: Date of decision
Slovenian: Postopek odločanja
English: CHMP Efficacy Working Party
Slovenian: Delovna skupina CHMP za učinkovitost
English: 162 days
Slovenian: 184 days 162 days
English: 577 days
Slovenian: 217 days 577 days
English: Released for consultation in October 2004
Slovenian: Predstavljeno za posvetovanje oktobra 2004
English: Art. 30 of Directive 2001/83/EC (previously Art. 11 of Directive 75/319/EEC)
Slovenian: Člen 30 Direktive št. 2001/83/ES (prej člen 11 Direktive 75/319/EGS
English: Released for consultation in January 2004
Slovenian: Predstavljeno za posvetovanje januarja 2004
English: 221 days
Slovenian: 181 days 221 days
English: CHMP Scientific Advice Working Party
Slovenian: Delovna skupina CHMP za znanstveno svetovanje
English: Genito-urinary system and sex hormones
Slovenian: Sečila in spolovila ter spolni hormoni
English: Denmark
Slovenian: DANSKA
English: DENMARK
Slovenian: Danska
English: Adopted in April 2004
Slovenian: Sprejeto aprila 2004
English: 3-tier architecture
Slovenian: Triplastna struktura
English: Adopted in December 2004
Slovenian: Sprejeto decembra 2004
English: Chair: To be appointed EMEA contact: Agnès SAINT-RAYMOND
Slovenian: Predsednik: bo imenovan Kontaktna oseba EMEA: Agnès SAINTRAYMOND
English: Fourteen GCP inspections were requested in 2004.
Slovenian: V letu 2004 je bilo oddanih 14 prošenj za inšpekcijske preglede za dobro klinično prakso.
English: Good manufacturing practice (GMP) activities
Slovenian: Dejavnosti dobre proizvodne prakse
English: 118 days
Slovenian: 118 days 0 days
English: CHMP Pharmacovigilance Working Party
Slovenian: Delovna skupina CHMP za farmakovigilanco
English: • Romaldas MACIULAITIS (Lithuania) Alternate: Mykolas MAURICAS
Slovenian: • Romaldas MACIULAITIS (Litva)
English: The Agency will publish the required analysis and assessment on its website once it has been adopted by the Management Board.
Slovenian: Potem ko ju bo sprejel upravni odbor, ju bo objavila na svoji spletni strani.
English: 631 days
Slovenian: 244 days 631 days
English: Annex 2 Members of the Committee for Medicinal Products for Human Use Annex 3 Members of the Committee for Medicinal Products for Veterinary Use Annex 4 Members of the Committee on Orphan Medicinal Products Annex 5 Members of the Committee on Herbal Medicinal Products Annex 6 National competent authority partners Annex 7 EMEA budget summaries 2003-2005
Slovenian: Priloga 2 Člani Odbora za zdravila za uporabo v humani medicini Priloga 3 Člani Odbora za zdravila za uporabo v veterinarski medicini Priloga 4 Člani Odbora za zdravila sirote
English: • Steffen THIRSTRUP6 (Denmark) Alternate: Jens ERSBØLL7
Slovenian: • Steffen THIRSTRUP6 (Denmark)