natgillin/translations-raw huggingface dataset:
The objective of introducing greater consistency in the triggering of investigations following receipt of pharmacovigilance reporting has been progressed by the release for consultation of a guideline by the CVMP on this topic in June 2004. 
Dosežen je bil napredek glede cilja uvedbe večje skladnosti pri uvedbi preiskav po prejemu poročil o farmakovigilanci, ko je CVMP junija 2004 predstavil smernice o tej temi za posvetovanje.
The number of requests for EMEA certificates continued to increase in 2004 due to the high number of new applications for centralised marketing authorisation received in 2003. 
Število zahtevkov za izdajo potrdil EMEA je v letu 2004 še naprej naraščalo zaradi veliko novih zahtevkov za izdajo dovoljenja po centraliziranem postopku, prejetih v letu 2003.
• The CHMP recommended approval of an anti-cancer drug that targets folate-dependent reactions that are essential for cell proliferation. 
• CHMP je priporočil odobritev zdravila proti raku, usmerjenega na reakcije, odvisne od folata, ki so nujno potrebne za proliferacijo celic.
• Applications for medicinal products under development for the treatment of rare diseases to be designated as orphans increased again in number. 
• Ponovno se je povečalo število zahtevkov za zdravila, ki se razvijajo za zdravljenje redkih bolezni in ki naj bi bila določena kot sirote.
The procedure describes the coordination of GLP inspections of the nonclinical safety, toxicological and pharmacological studies proposed in human and veterinary applications for marketing authorisations under the centralised system. 
Postopek določa usklajevanje inšpekcijskih pregledov za dobro laboratorijsko prakso pri nekliničnih študijah o varnosti, toksičnosti in farmakologiji, ki so predlagane pri uporabi v humani in veterinarski medicini, za dovoljenja za promet, ki se izdajo po centraliziranem postopku.
• (Pre-)Clinical Working Party on Comparability of Biotechnology Products 
• (Pred)klinična delovna skupina za primerljivost biotehnoloških zdravil
• Conception, elaboration and early construction phases of a scientific advice database were completed in 2004 
• V letu 2004 so bile končane zasnova, priprava in začetne faze izgradnje za zbirko podatkov o znanstvenem svetovanju.
Also delivered was the implementation of web, application and database servers in the data centre for key EU telematics and corporate applications (see 3-tier architecture) 
Uveden je bil tudi spletni, programski in podatkovni strežnik v podatkovnem centru za bistvene telematske in podjetniške uporabe (glej triplastno strukturo).
These certify the marketing authorisation and good manufacturing status of medicinal products in the EU and are intended for use in support of marketing authorisation applications in and export to non-EU countries. 
Ta potrjujejo, da je bilo za zdravila izdano dovoljenje za promet in dober proizvodni status zdravil v EU, uporabljajo pa se kot spremni dokumenti k vlogam za izdajo dovoljenja za promet v državah, ki niso članice EU, in za izvoz v te države.
3.8 Regulatory guidance 
3.8 Regulativne smernice
Five applications for extension to the original marketing authorisation were received in 2004, exceeding the initial forecast of 3 applications. 
V letu 2004 je bilo prejetih pet vlog za razširitev prvotnega dovoljenja za promet, kar je več od prvotno predvidenih 3 vlog.
• Anja HOLM (Denmark) Alternate: Lotte Winther 
• Anja HOLM (Danska) Namestnik: Lotte Winther
Marketing authorisation holders may want to change the manufacturing process, alter or improve the medicinal product, or introduce additional warnings and contraindications. 
Imetniki dovoljenja za promet morda želijo spremeniti proizvodni postopek, spremeniti ali izboljšati zdravilo ali pa dodati opozorila ali kontraindikacije.
• Kateřina KUBÁČKOVÁ (Czech Republic) 
• Kateřina KUBÁČKOVÁ (Češka)
• Pieter NEELS4 (Belgium) Alternate: Bruno FLAMION5 
• Pieter NEELS4 (Belgija) Namestnik: Bruno FLAMION5
• Tomas SALMONSON (Sweden) Alternate: Per NILSSON 
• Tomas SALMONSON (Švedska) Namestnik: Per NILSSON
Tenth annual report of the European Medicines Agency 
Deseto letno poročilo Evropske agencije za zdravila za leto 2004
Statistical information on applications under the mutual recognition procedure is provided by the EMEA and presented in the monthly MRFG press releases. 
EMEA pripravlja statistične podatke o vlogah za postopek medsebojnega priznavanja, ki so predstavljeni v mesečnih sporočilih MRFG za javnost.
Despite initial delays, the preparatory work for effective operation of the Japan-EU MRA was successfully concluded through a series of visits and inspections allowing the operational phase of the agreement to come into force on 29 May 2004. 
Kljub začetnim zamudam so bile priprave za učinkovito izvajanje sporazuma o medsebojnem priznavanju med Japonsko in EU po vrsti obiskov in inšpekcijskih pregledov uspešno zaključene, kar je omogočilo, da je operativna faza sporazuma začela veljati 29. maja 2004.
• Osteoporosis 
• osteoporoza
Average time for orphan medicines procedures (days) 
Povprečno trajanje postopkov za zdravila sirote (v dnevih)
The Management Board adopted new rules on access to EMEA documents at its March 2004 meeting. 
Upravni odbor je na sestanku marca 2004 sprejel nove predpise o dostopu do dokumentov EMEA.
• Ioannis KKOLOS (Cyprus) 
• Ioannis KKOLOS (Ciper)
Anna-Liisa ENKOVAARA (Finland) Alternate: Sari KOSKI 
￭ Anna-Liisa ENKOVAARA (Finska) Namestnik: Sari KOSKI
• Ingemar PERSSON1 (Sweden) (co-opted) 
• Ingemar PERSSON1 (Švedska) (sporazumno izbran)
Safety and efficacy of medicines 
Varnost in učinkovitost zdravil
Marketing authorisation holders may want to add new treatment options or introduce additional warnings or contraindications, or they may wish to change the manufacturing process. 
Imetniki dovoljenja za promet morda želijo dodati nove možnosti zdravljenja ali dodatna opozorila oziroma kontraindikacije ali zamenjati proizvodni postopek.
Annex 14 EMEA contact points 
Priloga 14 Kontaktne osebe EMEA
Centralised applications - Negative opinions 
Vloge po centraliziranem postopku - negativna mnenja
Annex 7 EMEA budget summaries 2003-2005 
Priloga 7 Povzetki proračunov EMEA za obdobje 2003−2005
Centralised applications - Positive opinions 
Vloge po centraliziranem postopku - pozitivna mnenja
This has been the overall experience since 
To kažejo izkušnje že od leta 1998.
Having completed the implementation of the data centre, the EMEA 3-tier architecture was implemented in 2004 with fully integrated security as the foundation platform for all new applications 
Po uvedbi podatkovnega centra je bila v letu 2004 uvedena triplastna struktura s popolnoma integrirano varnostjo kot temeljna platforma za vse nove aplikacije.
Philippe DUNETON (Alternate: Jean MARIMBERT) 
Philippe DUNETON (namestnik: Jean MARIMBERT)
4.1 Inspections 
4.1 Inšpekcijski pregledi
The Agency completed 2 urgent safety restriction (USR) procedures for centrally authorised products during 2004, introducing warnings into the marketing authorisation of the two medicinal products. 
Agencija je v letu 2004 zaključila 2 postopka nujnih varnostnih omejitev (urgent safety restriction, USR) za zdravila, za katera je bilo izdano dovoljenje za promet, vključno z opozorili glede dovoljenj za promet z dvema zdraviloma.
Five of the applications were for companion animals and 3 for food-producing animals, namely horses. 
Pet vlog je bilo za hišne živali, tri pa za živali, namenjene proizvodnji hrane.
Three of those 5 concerned vaccines and 2 concerned pharmaceuticals. 
Od teh petih vlog so bile tri za cepiva in 2 za farmacevtske izdelke.
• Judit EGGENHOFER (Hungary) 
• Judit EGGENHOFER (Madžarska)
Results requiring further investigation were found for 3 of the 31 products. 
Pri 3 od 31 izdelkov so rezultati pokazali, da so potrebne dodatne preiskave.
Milan MÍD (Alternate: Alfred HERA) 
Milan ŠMÍD (namestnik: Alfred HERA)
• Eva SKOVLUND (Norway) Alternate: Liv MATHIESEN 
• Eva SKOVLUND (Norveška) Namestnik: Liv MATHIESEN
6.1 Administration.....................................................................................................................70 
6.1 Administracija......................................................................................................................69
The EMEA PMF/VAMF certification process is an assessment of the PMF/VAMF application dossier. 
Certifikacijski postopek EMEA za PMF/VAMF je ocenitev dokumentacije za vlogo za PMF/VAMF.
• Ian HUDSON (United Kingdom) Alternate: Julia DUNNE 
• Ian HUDSON (Združeno kraljestvo) Namestnik: Julia DUNNE
Number of payments processed 
Število obdelanih plačil
The objective of the guide is to inform veterinarians and other animal-health professionals about the pharmacovigilance system for veterinary medicinal products in the EU and to stimulate their cooperation on the reporting of adverse drug reactions (ADRs). 
Njihov cilj je seznaniti veterinarje in druge strokovnjake za zdravje živali s sistemom farmakovigilance za veterinarska zdravila v EU in jih spodbuditi k sodelovanju pri poročanju o neželenih učinkih zdravil.
Work relating to the improvement of various aspects of the management of referral procedures, which started in 2003, continued throughout 2004. 
V letu 2004 so se nadaljevala prizadevanja za izboljšanje različnih vidikov upravljanja postopkov predložitev, začeta v letu 2003.
GCP ensures that ethical and scientific standards for designing, conducting, recording and reporting clinical trials are adhered to. 
Dobra klinična praksa zagotavlja upoštevanje etičnih in znanstvenih standardov za načrtovanje, izvajanje in evidentiranje kliničnih preizkušanj ter poročanje o njih.
Plasma master files, vaccine antigen master files and medical devices containing biotechnology and blood-derived medicinal products 
Glavni dosjeji plazme, glavni dosjeji virusnih antigenov in medicinski pripomočki, ki vsebujejo biotehnološka zdravila in zdravila iz krvi
EMEA contact: Isabelle MOULON 
Kontaktna oseba EMEA: Isabelle MOULON
Inspections of blood establishments to support certification of PMFs were initiated in the second half of 2004 and a total of 15 inspections were carried out in this context, involving 27 blood establishment sites. 
V drugi polovici leta 2004 so se začeli izvajati inšpekcijski pregledi zavodov za kri v okviru certificiranja glavnih dosjejev plazme (PMF), pri čemer je bilo opravljenih skupaj 15 inšpekcijskih pregledov, ki so zajemali 27 lokacij zavodov za kri.
These nominations for co-opted members were confirmed in all but one discipline, intensive production, by the end of 
Ti sporazumno izbrani člani so bili do konca leta 2004 potrjeni za vsa področja razen intenzivne proizvodnje.
There were no negative opinions given in 2004. 
V letu 2004 ni bilo izdanih negativnih mnenj.
Collection of human plasma for further manufacturing, as well as storage, testing and transportation, is subject to periodic inspections in order to ensure the expected product quality. 
S periodičnimi inšpekcijskimi pregledi zbiranja človeške plazme za nadaljnjo proizvodnjo kakor tudi shranjevanja, testiranja in prevoza se zagotovi pričakovana kakovost izdelkov.
Members 
Člani
Linda ANDERSON (United Kingdom) Alternate: Sue HARRIS 
￭ Linda ANDERSON (Združeno kraljestvo) Namestnik: Sue HARRIS
Head of Sector 
Vodja Sektorja
6.3 Meeting management and conferences 
6.3 Upravljanje srečanj in konferenc
• Stane SRCIC (Slovenia) Alternate: Blanka EMERSIC 
• Stane SRCIC (Slovenija) Namestnik: Blanka EMERSIC
Eudra Common Directory (ECD) 
Skupini imenik Eudra (ECD)
• Approved a proposal to publish the name of active substances, orphan condition and name of sponsor for all designated orphan drugs submitted for marketing authorisation 
• odobritev predloga, da se objavijo nazivi zdravilnih učinkovin, stanje sirote in ime sponzorja za vsa zdravila, določena za zdravila sirote, za katera je oddana vloga za izdajo dovoljenja za promet.
These reports provide updates on the development of designated orphan products prior to submission of an application for a marketing authorisation. 
Ta poročila vsebujejo posodobljene podatke o razvoju zdravil, določenih za zdravila sirote, pred oddajo vloge za dovoljenje za promet.
Further information on the national competent authorities is also available on the national authorities Internet sites: http://heads.medagencies.org and http://www.hevra.org 
Dodatne informacije o pristojnih nacionalnih organih so na voljo tudi na spletnih straneh nacionalnih organov: http://heads.medagencies.org and http://www.hevra.org
Wojciech DYMOWSKI (Poland) Alternate: Elżbieta WOJTASIK 
￭ Wojciech DYMOWSKI (Poljska) Namestnik: Elżbieta WOJTASIK
Information on USRs can be found on the EMEA website at: http://www.emea.eu.int/htms/human/drugalert/drugalert.htm 
Informacije o postopkih USR so na voljo na spletni strani EMEA: http://www.EMEA.eu.int/htms/human/drugalert/drugalert.htm
3.6 Pharmacovigilance and maintenance activities 
3.6 Farmakovigilanca in vzdrževalne dejavnosti
• Approved the European Medicines Agency Road Map to 2010 consultation paper for release for public consultation 
• odobritev predstavitve posvetovalnega dokumenta o "Usmeritvenem načrtu Evropske agencije za zdravila do leta 2010" za javno obravnavo
The certificates also confirm the Good Manufacturing Practice (GMP) compliance status of the manufacturing site(s) producing the medicinal product bulk pharmaceutical form. 
S potrdili se potrdi tudi skladnost proizvodne lokacije (proizvodnih lokacij), ki proizvaja(jo) zdravilo v razsuti farmacevtski obliki, z dobro proizvodno prakso.
• Bernd JILMA (Austria) 
• Bernd JILMA (Avstrija)
Annex 1 Members of the Management Board 
Priloga 1 Člani upravnega odbora
Furthermore, a large-scale training programme was developed by the EMEA and launched in May 2004 to provide training to the Agency s business partners (national competent authorities and pharmaceutical companies). 
EMEA je razvila tudi obsežen program usposabljanja za poslovne partnerje Agencije (pristojni nacionalni organi in farmacevtska podjetja), ki ga je začela izvajati maja 2004.
Under this procedure, there is a case-by-case decision on whether the handling of safety concerns for a medicine, both pre- and post-authorisation, requires additional scientific input. 
Pri tem postopku se za vsak primer odloča, ali so pri obravnavi varnostnih vprašanj glede zdravila pred izdajo dovoljenja za promet in po njej potrebni dodatni znanstveni prispevki.
• David LYONS (Ireland) Alternate: Patrick SALMON 
• David LYONS (Irska) Namestnik: Patrick SALMON
In anticipation, some marketing authorisation holders (MAHs) already submitted risk management plans for review by the CHMP during 2004, and several meetings with MAHs for centrally authorised products were held in 2004, mainly to discuss risk management concepts. 
Pred tem so nekateri imetniki dovoljenj za promet z zdravili že predložili načrte za obvladovanje tveganja, ki jih je CHMP pregledal v letu 2004, v istem letu pa je bilo opravljenih tudi več sestankov z imetniki dovoljenj za zdravila, za katera je bilo izdano dovoljenje po centraliziranem postopku, na katerih so razpravljali predvsem o konceptih obvladovanja tveganja.
• Bruno URBAIN (Belgium) Alternate: Lionel LAURIER 
• Bruno URBAIN (Belgija) Namestnik: Lionel LAURIER
• Raul KIIVET (Estonia) Alternate: Alar IRS 
• Raul KIIVET (Estonija) Namestnik: Alar IRS
For the first time, the total number, including type-I and II variations and line extensions, was over one thousand 
Skupno število, vključno s spremembami tipa I in II in razširitvami terapevtskih indikacij, je preseglo tisoč vlog (1101).
2.5 Pharmacovigilance and maintenance activities 
2.5 Farmakovigilanca in vzdrževalne dejavnosti
Catherine HARVALA (Greece) Alternate: Foteini TZAVELLA 
￭ Catherine HARVALA (Grčija) Namestnik: Foteini TZAVELLA
• Judita HEDEROVÁ (Slovakia) 
• Judita HEDEROVÁ (Slovaška)
• Heribert PITTNER (Austria) 
• Heribert PITTNER (Avstrija)
Mariette BACKES-LIES (Luxembourg) Alternate: Jacqueline GENOUX-HAMES 
￭ Mariette BACKES-LIES (Luksemburg) Namestnik: Jacqueline GENOUX-HAMES
Details of these can be found in Annex 13. 
Podrobnosti o tem so navedene v Prilogi 13.
Applications for orphan medicinal product designation are reviewed by the EMEA, through its Committee on Orphan Medicinal Products (COMP). 
Vloge za določitev zdravil sirot obravnava EMEA prek svojega Odbora za zdravila sirote (COMP).
• Beatriz SILVA LIMA (Portugal) Alternate: Cristina SAMPAIO 
• Beatriz SILVA LIMA (Portugalska) Namestnik: Cristina SAMPAIO
Evaluation in <7 days Evaluation in 7-14 days Evaluation in >14 days 
Ovrednotenje v <7 dneh Ovrednotenje v 7-14 dneh Ovrednotenje v >14 dneh
CVMP General 
CVMP splošno
Christian CUSCHIERI (Malta) Alternate: Caroline ATTARD 
￭ Christian Cuschieri (Malta) Namestnik: Caroline ATTARD
In line with its new responsibilities, the Board was consulted on the nominations for the Agency s Committee for Medicinal Products for Human Use (CHMP) and the Committee for Medicinal Products for Veterinary Use (CVMP). 
Z upravnim odborom so bila v skladu z njegovimi novimi odgovornostmi opravljena posvetovanja o imenovanjih v Odbor za zdravila za uporabo v humani medicini (CHMP) in Odbor za zdravila za uporabo v veterinarski medicini (CVMP) Agencije.
In 2004, the number of presubmission meetings held for scientific advice procedures was 40, with a further 20 pre-submission meetings held for protocol assistance procedures. 
V letu 2004 je bilo za postopke znanstvenega svetovanja opravljenih 40 sestankov pred oddajo vloge, za postopke pomoči pri protokolu pa 20 sestankov pred oddajo vloge.
• Liisa KAARTINEN (Finland) Alternate: Kristina LEHMANN 
• Liisa KAARTINEN (Finska) Namestnik: Kristina LEHMANN
Annex 8 IT projects and operational activities Annex 9 CHMP opinions in 2004 on medicinal products for human use Annex 10 CVMP opinions in 2004 on medicinal products for veterinary use Annex 11 COMP opinions in 2004 on designation of orphan medicinal products Annex 12 Guidelines and working documents in 2004 
Priloga 9 Mnenja CHMP v letu 2004 o zdravilih za uporabo v humani medicini Priloga 10 Mnenja CVMP v letu 2004 o zdravilih za uporabo v veterinarski medicini Priloga 11 Mnenja COMP v letu 2004 o določitvi zdravil sirot Priloga 12 Smernice in delovni dokumenti v letu 2004
• Christian FRIIS (Denmark) (co-opted) 
• Christian FRIIS (Danska) (sporazumno izbran)
As a consequence of the increasing number of centrally authorised products, the number of applications for variations to marketing authorisations increased once more in 2004. 
Zaradi vse več zdravil, za katera se dovoljenja izdajo po centraliziranem postopku, se je v letu 2004 zopet povečalo število vlog za spremembe dovoljenj za promet.
A standard operating procedure for coordination of PMF inspections and a guideline on PMF/VAMF 2nd step were developed and published in 2004. 
V letu 2004 sta bila razvita in objavljena standardni operativni postopek za uskladitev inšpekcijskih pregledov PMF in smernice za "drugi korak" PMF/VAMF.
• Patricia VELLA BONANNO9 (Malta) Alternate: John Joseph BORG10 
• Patricia VELLA BONANNO9 (Malta) Namestnik: John Joseph BORG10
• Laimi JODKONIS (Lithuania) Alternate: Juozas JOKIMAS 
• Laimi JODKONIS (Litva) Namestnik: Juozas JOKIMAS
Inspections - Highlights in 2004 
Inšpekcijski nadzor - glavni poudarki v letu 2004
Dairíne DEMPSEY (Ireland) Alternate: Elaine BRESLIN 
￭ Dairíne DEMPSEY (Irska) Namestnik: Elaine BRESLIN
• Maria TOLLIS (Italy) Alternate: Virgilio DONINI 
• Maria TOLLIS (Italija) Namestnik: Virgilio DONINI
It provides efficient support and helpdesk services to the Agency s corporate users. 
Zagotavlja učinkovito podporo in pomoč podjetjem, ki so uporabniki storitev Agencije.
• Johannes DICHTL (Austria) Alternate: Jean-Pierre BINDER 
• Johannes DICHTL (Avstrija) Namestnik: Jean-Pierre BINDER
Ľudevít MARTINEC (Alternate: Stanislava GAJDO OVÁ) 
Ľudevít MARTINEC (namestnik: Stanislava GAJDOŠOVÁ)
Cardiovascular system 
Kardiovaskularni sistem
The duration of the procedure was maintained well within the official timeframe. 
Pri trajanju postopka so bili ustrezno upoštevani uradni časovni okviri.
6.4 Document management and publishing 
6.4 Upravljanje dokumentov in objave
Arbitration and Community referrals 1995-2004 
Arbitraža in predložitve Skupnosti 1995-2004
UNITED KINGDOM 
Združeno kraljestvo
The authorisation holder is required to notify the EMEA of any defect or abnormal restriction of a centrally authorised medicinal product that could result in a recall. 
Imetnik dovoljenja za promet mora EMEA obvestiti o kakršni koli pomanjkljivosti ali neobičajni omejitvi zdravila, za katero je bilo izdano dovoljenje po centraliziranem postopku, ki bi lahko imela za posledico umik zdravila.
The three therapeutic areas where the number of applications was highest are oncology, HIV and diabetes. 
Število vlog je bilo najvišje na področju onkologije, HIV in sladkorne bolezni.
Kristin RAUDSEPP (Alternate: Alar IRS) 
Kristin RAUDSEPP (namestnik: Alar IRS)
• EDMS, the Agencys electronic document management system, was successfully launched in September 2004 
• Septembra 2004 se je začel uspešno izvajati sistem elektronskega vodenja dokumentacije Agencije (electronic document management system, EDMS).
• Jacqueline GENOUX-HAMES (Luxembourg) • Manfred HAASE1 (Germany) (co-opted) 
• Jacqueline GENOUX-HAMES (Luksemburg) • Manfred HAASE1 (Nemčija) (sporazumno izbran)
• Katia STEPHANIDOU (Cyprus) Alternate: Phedias LOUCAIDES 
• Katia STEPHANIDOU (Ciper) Namestnik: Phedias LOUCAIDES
Decision process 
Proces odločanja
Human and veterinary medicinal products and recognition of official batch control of biologicals 
Zdravila za uporabo v humani in veterinarski medicini in priznanje uradnega nadzora serij bioloških zdravil
One joint meeting of the QWP and ad hoc GMP inspectors took place, building on cooperation between assessors and inspectors on quality-related matters. 
Opravljen je bil skupni sestanek delovne skupine za kakovost in ad hoc inšpektorjev za dobro proizvodno prakso, ki je temeljil na sodelovanju med ocenjevalci in inšpektorji glede vprašanj, povezanih s kakovostjo.
Discussions to harmonise the certificate of GMP compliance of a manufacturer and maintenance programmes were initiated in 2004. 
V letu 2004 so se začele razprave za uskladitev potrdila proizvajalca o skladnosti z dobro proizvodno prakso in programov vzdrževanja.
• Jolanta WIECKOWSKA (Poland) 
• Jolanta WIECKOWSKA (Poljska)
Details of all referrals are given in Annex 13. 
Podrobnosti o vseh predložitvah so predstavljene v Prilogi 13.
2.3 Initial evaluation 
2.3 Začetno vrednotenje
Dimitrios VAGIONAS (Alternate: Vassilis KONTOZAMANIS) 
Dimitrios VAGIONAS (namestnik: Vassilis KONTOZAMANIS)
1 Applications to the EMEA which request that its refusal of an initial application for access to documents be reconsidered. 
1 Vloge, predložene EMEA, s katerimi se le-to zaprosi za ponovno obravnavo prvotne vloge za dostop do dokumentov, ki jo je EMEA zavrnila.
• Kristina PAVLOVSKA (Latvia) 
• Kristina PAVLOVSKA (Latvija)
Head of Sector for inspections 
Vodja Sektorja za inšpekcijske preglede
• Safety Working Party 
• Delovna skupina za varnost
The year 2004 saw the establishment of a new scientific committee at the EMEA, following the entry into force of Title IV of Regulation (EC) No 726/2004 and the Directive on Herbal Medicinal Products. 
V letu 2004 je bil po uveljavitvi naslova IV Uredbe (ES) št. 726/2004 in Direktive o zeliščnih zdravilih ustanovljen nov znanstveni odbor EMEA.
Unit for veterinary medicines and inspections Head of Unit 
Enota za veterinarska zdravila in inšpekcijske preglede Vodja enote
The Ad hoc GMP Inspectors Group was appointed as the Telematics Implementation Group (TIG) for the Community GMP database in May 2004, and a preliminary implementation plan was drawn up. 
Maja 2004 je bila imenovana ad hoc skupina inšpektorjev za dobro proizvodno prakso kot skupina za izvedbo telematike (Telematics Implementation Group, TIG) za zbirko podatkov dobre proizvodne prakse Skupnosti in sestavljen je bil predhodni izvedbeni načrt.
Total title 1 
Naslov 1 skupaj
Members of the Management Board 
Člani upravnega odbora
Out of hours telephone: (44-7880) 55 06 97 
Telefon izven uradnih ur: (44-7880) 55 06 97
Walter SCHWERDTFEGER (Alternate: Ilse-Dore SCHÜTT) 
Walter SCHWERDTFEGER (namestnik: Ilse-Dore SCHÜTT)