FrancophonIA/ELRC3.0 huggingface dataset:
English: 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
Slovenian: Dodatne informacije o pristojnih nacionalnih organih so na voljo tudi na spletnih straneh nacionalnih organov: http://heads.medagencies.org and http://www.hevra.org
English: Wojciech DYMOWSKI (Poland) Alternate: Elżbieta WOJTASIK
Slovenian: ￭ Wojciech DYMOWSKI (Poljska) Namestnik: Elżbieta WOJTASIK
English: Information on USRs can be found on the EMEA website at: http://www.emea.eu.int/htms/human/drugalert/drugalert.htm
Slovenian: Informacije o postopkih USR so na voljo na spletni strani EMEA: http://www.EMEA.eu.int/htms/human/drugalert/drugalert.htm
English: 3.6 Pharmacovigilance and maintenance activities
Slovenian: 3.6 Farmakovigilanca in vzdrževalne dejavnosti
English: • Approved the European Medicines Agency Road Map to 2010 consultation paper for release for public consultation
Slovenian: • odobritev predstavitve posvetovalnega dokumenta o "Usmeritvenem načrtu Evropske agencije za zdravila do leta 2010" za javno obravnavo
English: The certificates also confirm the Good Manufacturing Practice (GMP) compliance status of the manufacturing site(s) producing the medicinal product bulk pharmaceutical form.
Slovenian: S potrdili se potrdi tudi skladnost proizvodne lokacije (proizvodnih lokacij), ki proizvaja(jo) zdravilo v razsuti farmacevtski obliki, z dobro proizvodno prakso.
English: • Bernd JILMA (Austria)
Slovenian: • Bernd JILMA (Avstrija)
English: Annex 1 Members of the Management Board
Slovenian: Priloga 1 Člani upravnega odbora
English: 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).
Slovenian: EMEA je razvila tudi obsežen program usposabljanja za poslovne partnerje Agencije (pristojni nacionalni organi in farmacevtska podjetja), ki ga je začela izvajati maja 2004.
English: 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.
Slovenian: 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.
English: • David LYONS (Ireland) Alternate: Patrick SALMON
Slovenian: • David LYONS (Irska) Namestnik: Patrick SALMON
English: 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.
Slovenian: 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.
English: • Bruno URBAIN (Belgium) Alternate: Lionel LAURIER
Slovenian: • Bruno URBAIN (Belgija) Namestnik: Lionel LAURIER
English: • Raul KIIVET (Estonia) Alternate: Alar IRS
Slovenian: • Raul KIIVET (Estonija) Namestnik: Alar IRS
English: For the first time, the total number, including type-I and II variations and line extensions, was over one thousand
Slovenian: Skupno število, vključno s spremembami tipa I in II in razširitvami terapevtskih indikacij, je preseglo tisoč vlog (1101).
English: 2.5 Pharmacovigilance and maintenance activities
Slovenian: 2.5 Farmakovigilanca in vzdrževalne dejavnosti
English: Catherine HARVALA (Greece) Alternate: Foteini TZAVELLA
Slovenian: ￭ Catherine HARVALA (Grčija) Namestnik: Foteini TZAVELLA
English: • Judita HEDEROVÁ (Slovakia)
Slovenian: • Judita HEDEROVÁ (Slovaška)
English: • Heribert PITTNER (Austria)
Slovenian: • Heribert PITTNER (Avstrija)
English: Mariette BACKES-LIES (Luxembourg) Alternate: Jacqueline GENOUX-HAMES
Slovenian: ￭ Mariette BACKES-LIES (Luksemburg) Namestnik: Jacqueline GENOUX-HAMES
English: Details of these can be found in Annex 13.
Slovenian: Podrobnosti o tem so navedene v Prilogi 13.
English: Applications for orphan medicinal product designation are reviewed by the EMEA, through its Committee on Orphan Medicinal Products (COMP).
Slovenian: Vloge za določitev zdravil sirot obravnava EMEA prek svojega Odbora za zdravila sirote (COMP).
English: • Beatriz SILVA LIMA (Portugal) Alternate: Cristina SAMPAIO
Slovenian: • Beatriz SILVA LIMA (Portugalska) Namestnik: Cristina SAMPAIO
English: Evaluation in <7 days Evaluation in 7-14 days Evaluation in >14 days
Slovenian: Ovrednotenje v <7 dneh Ovrednotenje v 7-14 dneh Ovrednotenje v >14 dneh
English: CVMP General
Slovenian: CVMP splošno
English: Christian CUSCHIERI (Malta) Alternate: Caroline ATTARD
Slovenian: ￭ Christian Cuschieri (Malta) Namestnik: Caroline ATTARD
English: 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).
Slovenian: 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.
English: 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.
Slovenian: 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.
English: • Liisa KAARTINEN (Finland) Alternate: Kristina LEHMANN
Slovenian: • Liisa KAARTINEN (Finska) Namestnik: Kristina LEHMANN
English: Wilson s disease
Slovenian: Treatment of Wilson's disease
English: 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
Slovenian: 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
English: • Christian FRIIS (Denmark) (co-opted)
Slovenian: • Christian FRIIS (Danska) (sporazumno izbran)
English: 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.
Slovenian: 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.
English: A standard operating procedure for coordination of PMF inspections and a guideline on PMF/VAMF 2nd step were developed and published in 2004.
Slovenian: V letu 2004 sta bila razvita in objavljena standardni operativni postopek za uskladitev inšpekcijskih pregledov PMF in smernice za "drugi korak" PMF/VAMF.
English: • Patricia VELLA BONANNO9 (Malta) Alternate: John Joseph BORG10
Slovenian: • Patricia VELLA BONANNO9 (Malta) Namestnik: John Joseph BORG10
English: • Laimi JODKONIS (Lithuania) Alternate: Juozas JOKIMAS
Slovenian: • Laimi JODKONIS (Litva) Namestnik: Juozas JOKIMAS
English: Inspections - Highlights in 2004
Slovenian: Inšpekcijski nadzor - glavni poudarki v letu 2004
English: Dairíne DEMPSEY (Ireland) Alternate: Elaine BRESLIN
Slovenian: ￭ Dairíne DEMPSEY (Irska) Namestnik: Elaine BRESLIN
English: • Maria TOLLIS (Italy) Alternate: Virgilio DONINI
Slovenian: • Maria TOLLIS (Italija) Namestnik: Virgilio DONINI
English: It provides efficient support and helpdesk services to the Agency s corporate users.
Slovenian: Zagotavlja učinkovito podporo in pomoč podjetjem, ki so uporabniki storitev Agencije.
English: • Johannes DICHTL (Austria) Alternate: Jean-Pierre BINDER
Slovenian: • Johannes DICHTL (Avstrija) Namestnik: Jean-Pierre BINDER
English: Ľudevít MARTINEC (Alternate: Stanislava GAJDO OVÁ)
Slovenian: Ľudevít MARTINEC (namestnik: Stanislava GAJDOŠOVÁ)
English: Cardiovascular system
Slovenian: Kardiovaskularni sistem
English: The duration of the procedure was maintained well within the official timeframe.
Slovenian: Pri trajanju postopka so bili ustrezno upoštevani uradni časovni okviri.
English: 6.4 Document management and publishing
Slovenian: 6.4 Upravljanje dokumentov in objave
English: Arbitration and Community referrals 1995-2004
Slovenian: Arbitraža in predložitve Skupnosti 1995-2004
English: UNITED KINGDOM
Slovenian: Združeno kraljestvo
English: 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.
Slovenian: 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.
English: The three therapeutic areas where the number of applications was highest are oncology, HIV and diabetes.
Slovenian: Število vlog je bilo najvišje na področju onkologije, HIV in sladkorne bolezni.
English: Kristin RAUDSEPP (Alternate: Alar IRS)
Slovenian: Kristin RAUDSEPP (namestnik: Alar IRS)
English: • EDMS, the Agencys electronic document management system, was successfully launched in September 2004
Slovenian: • Septembra 2004 se je začel uspešno izvajati sistem elektronskega vodenja dokumentacije Agencije (electronic document management system, EDMS).
English: • Jacqueline GENOUX-HAMES (Luxembourg) • Manfred HAASE1 (Germany) (co-opted)
Slovenian: • Jacqueline GENOUX-HAMES (Luksemburg) • Manfred HAASE1 (Nemčija) (sporazumno izbran)
English: • Katia STEPHANIDOU (Cyprus) Alternate: Phedias LOUCAIDES
Slovenian: • Katia STEPHANIDOU (Ciper) Namestnik: Phedias LOUCAIDES
English: Decision process
Slovenian: Proces odločanja
English: Human and veterinary medicinal products and recognition of official batch control of biologicals
Slovenian: Zdravila za uporabo v humani in veterinarski medicini in priznanje uradnega nadzora serij bioloških zdravil
English: One joint meeting of the QWP and ad hoc GMP inspectors took place, building on cooperation between assessors and inspectors on quality-related matters.
Slovenian: 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.
English: Discussions to harmonise the certificate of GMP compliance of a manufacturer and maintenance programmes were initiated in 2004.
Slovenian: V letu 2004 so se začele razprave za uskladitev potrdila proizvajalca o skladnosti z dobro proizvodno prakso in programov vzdrževanja.
English: • Jolanta WIECKOWSKA (Poland)
Slovenian: • Jolanta WIECKOWSKA (Poljska)
English: Details of all referrals are given in Annex 13.
Slovenian: Podrobnosti o vseh predložitvah so predstavljene v Prilogi 13.
English: Specifications: Test procedures and acceptance criteria for new biotechnological/biological veterinary medicinal products
Slovenian: VICH Topic GL40Specifications: Test procedures and acceptance criteria for new biotechnological/biological veterinary medicinal products
English: 2.3 Initial evaluation
Slovenian: 2.3 Začetno vrednotenje
English: Specifications: Test procedures and acceptance criteria for new veterinary drug substances and new medicinal products: Chemical substances
Slovenian: VICH Topic GL39Specifications: Test procedures and acceptance criteria for new veterinary drug substances and new medicinal products: Chemical substances
English: Dimitrios VAGIONAS (Alternate: Vassilis KONTOZAMANIS)
Slovenian: Dimitrios VAGIONAS (namestnik: Vassilis KONTOZAMANIS)
English: 1 Applications to the EMEA which request that its refusal of an initial application for access to documents be reconsidered.
Slovenian: 1 Vloge, predložene EMEA, s katerimi se le-to zaprosi za ponovno obravnavo prvotne vloge za dostop do dokumentov, ki jo je EMEA zavrnila.
English: European Commission
Slovenian: Evropska komisija
English: • Kristina PAVLOVSKA (Latvia)
Slovenian: • Kristina PAVLOVSKA (Latvija)
English: Head of Sector for inspections
Slovenian: Vodja Sektorja za inšpekcijske preglede
English: • Safety Working Party
Slovenian: • Delovna skupina za varnost
English: 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.
Slovenian: V letu 2004 je bil po uveljavitvi naslova IV Uredbe (ES) št. 726/2004 in Direktive o zeliščnih zdravilih ustanovljen nov znanstveni odbor EMEA.
English: Unit for veterinary medicines and inspections Head of Unit
Slovenian: Enota za veterinarska zdravila in inšpekcijske preglede Vodja enote
English: 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.
Slovenian: 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.
English: Total title 1
Slovenian: Naslov 1 skupaj
English: Members of the Management Board
Slovenian: Člani upravnega odbora
English: Out of hours telephone: (44-7880) 55 06 97
Slovenian: Telefon izven uradnih ur: (44-7880) 55 06 97
English: Walter SCHWERDTFEGER (Alternate: Ilse-Dore SCHÜTT)
Slovenian: Walter SCHWERDTFEGER (namestnik: Ilse-Dore SCHÜTT)
English: Scientific guidance
Slovenian: Znanstvene smernice
English: Progress continued in extrapolating major species MRLs to minor uses.
Slovenian: Nadaljevala se je ekstrapolacija MRL-jev za pomembnejše živalske vrste na manj pogoste živalske vrste.
English: • Katarzyna KRZYŻAŃSKA (Poland) Alternate: Roman LECHOWKSI
Slovenian: • Katarzyna KRZYŻAŃSKA (Poljska) Namestnik: Roman LECHOWKSI
English: Kent WOODS
Slovenian: ZDRUŽENO KRALJESTVO Kent WOODS
English: • Eric ABADIE (France) (vice-chairman) Alternate: Jean-Hugues TROUVIN
Slovenian: • Eric ABADIE (Francija) (podpredsednik) Namestnik: Jean-Hugues TROUVIN
English: The Committee on Orphan Medicinal Products is responsible for reviewing applications for orphan medicinal product designation.
Slovenian: Odbor za zdravila sirote je odgovoren za revizijo vlog za določitev zdravila za "zdravilo siroto".
English: Implementation status
Slovenian: Stanje na področju izvajanja
English: The COMP adopted 75 positive opinions on orphan medicinal product designation in 2004.
Slovenian: COMP je v letu 2004 sprejel 75 pozitivnih mnenj za določitev zdravil kot zdravil sirot.
English: Amlodipine maleate
Slovenian: Amlodipin maleat
English: 2 Medicines for human use
Slovenian: 2 Zdravila za uporabo v humani medicini
English: Variations to marketing authorisations can be either minor (type-IA or IB) or major (type-II) changes.
Slovenian: Spremembe dovoljenj za promet z zdravilom so lahko manjše (tipa IA ali IB) ali večje (tipa II).
English: • Sigurður ÖRN HANSSON (Iceland) Alternate: Halldór RUNÓLFSSON
Slovenian: • Sigurður ÖRN HANSSON (Islandija) Namestnik: Halldór RUNÓLFSSON
English: The EMEA promotes public and animal health by reviewing new applications for authorisation of medicinal products in a timely and efficient manner, thus contributing to the provision of new and safe treatment options.
Slovenian: EMEA s pravočasnim in učinkovitim pregledovanjem novih vlog za izdajo dovoljenja za promet z zdravilom podpira zdravje ljudi in živali in tako prispeva k zagotavljanju novih in varnih možnosti zdravljenja.
English: • The CHMP recommended a marketing authorisation for a monoclonal antibody that binds to the epidermal growth factor receptor associated with the growth of many cancers
Slovenian: • CHMP je priporočil izdajo dovoljenja za promet za monoklonsko protitelo, ki se veže z receptorjem dejavnika epidermalne rasti, povezanim z razvojem številnih oblik raka;
English: • The Scientific Advisory Group on Antimicrobials was created as planned, and its mandate and work objectives agreed and formalised by the CVMP.
Slovenian: • Po načrtih je bila ustanovljena Znanstveno-svetovalna skupina za protimikrobna zdravila, CVMP pa se je dogovoril o njenih nalogah in ciljih in jih formalno oblikoval.
English: Experts
Slovenian: Strokovnjaki
English: The first meeting took place in September 2004.
Slovenian: Delovna skupina se je prvič sestala septembra 2004.
English: • Birgit AASMÄE (Estonia) Alternate: Helen MAHLA
Slovenian: • Birgit AASMÄE (Estonija) Namestnik: Helen MAHLA
English: Brigitte BATLINER (Alternate: Peter MALIN)
Slovenian: Brigitte BATLINER (namestnik: Peter MALIN)
English: The work of the CVMP is supported by a number of working parties, composed of European experts selected from a list maintained by the EMEA.
Slovenian: CVMP pri delu podpira več delovnih skupin, ki sestojijo iz evropskih strokovnjakov, izbranih s seznama, ki ga vodi EMEA.
English: The evaluation of variations was carried out within the legally defined time limits.
Slovenian: Vrednotenje sprememb je bilo opravljeno v zakonsko določenih rokih.
English: • Tonje HØY (Norway) Alternate: Hanne BERGENDAHL
Slovenian: • Tonje Høy (Norveška) Namestnik: Hanne Bergendahl
English: To promote internal awareness of IT and training on EMEA-specific systems amongst EMEA staff and delegates
Slovenian: Okrepiti interno ozaveščenost osebja EMEA in delegatov o IT in usposabljanju o posebnih sistemih EMEA
English: • Jean-Claude ROUBY (France) Alternate: Michael HOLZHAUSERALBERTI
Slovenian: • Jean-Claude ROUBY (Francija) Namestnik: Michael HOLZHAUSERALBERTI
English: Evaluation in <90 days Evaluation in 90-180 days Evaluation in >180 days
Slovenian: Ovrednotenje v <90 dneh Ovrednotenje v 90-180 dneh Ovrednotenje v >180 dneh
English: Vytautas BASYS (Alternate: Juozas JOKIMAS)
Slovenian: Vytautas BASYS (namestnik: Juozas JOKIMAS)
English: • Algirdas UTKUS (Lithuania)
Slovenian: • Algirdas UTKUS (Litva)
English: • Michał PIROŻYŃSKI (Poland) Alternate: Piotr SIEDLECKI
Slovenian: • Michał PIROŻYŃSKI (Poljska) Namestnik: Piotr SIEDLECKI
English: Evaluation time for type-IB variations 2004
Slovenian: Čas ovrednotenja za spremembe tipa IB v letu 2004
English: Gro Ramsten WESENBERG (Alternate: Hans HALSE)
Slovenian: Gro Ramsten WESENBERG (namestnik: Hans HALSE)
English: A systematic in-house peer-review system was also developed to help ensure a high level of continuity, consistency and quality of finalised SA/PA letters adopted by the CHMP.
Slovenian: Razvit je bil tudi sistematičen interni sistem strokovnega pregleda, ki naj bi pomagal zagotoviti visoko raven skladnosti, doslednosti in kakovosti dokončno oblikovanih obvestil o znanstvenem svetovanju ali pomoči pri protokolu, ki jih je izdal CHMP.
English: GMP is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use.
Slovenian: V okviru zagotavljanja kakovosti dobra proizvodna praksa zagotavlja, da se izdelki dosledno proizvajajo in nadzorujejo v skladu s standardi kakovosti, ki ustrezajo njihovi predvideni uporabi.
English: CVMP Environmental Risk Assessment (Temporary Working Party)
Slovenian: Ocena tveganja za okolje CVMP (začasna delovna skupina)
English: General guidelines
Slovenian: Splošne smernice
English: • Eduardo MARQUES-FONTES (Portugal) Alternate: Leonor Maria MEISEL
Slovenian: • Eduardo MARQUES-FONTES (Portugalska) Namestnik: Leonor Maria MEISEL
English: • Eva JOHNSSON (Sweden) Alternate: Henrik HOLST
Slovenian: • Eva JOHNSSON (Švedska) Namestnik: Henrik HOLST
English: 2.9 Improvement of the Agency's structures and procedures for human medicines
Slovenian: 2.9 Izboljšanje struktur in postopkov Agencije za zdravila za uporabo v humani medicini
English: Clinical trial phases of scientific advice requests 2004
Slovenian: Faze kliničnega preizkušanja pri prošnjah za znanstveno svetovanje v letu 2004
English: By providing scientific advice to companies developing new medicinal products, the EMEA helps to increase the likelihood of those products being granted a marketing authorisation, and thus helps to bring the products to market more quickly.
Slovenian: EMEA z zagotavljanjem znanstvenega svetovanja podjetjem, ki razvijajo nova zdravila, pomaga povečati verjetnost, da bo za ta zdravila izdano dovoljenje za promet, in tako pomaga dati zdravila hitreje na trg.
English: • Reinhard KROKER (Germany) Alternate: Manfred MOOS
Slovenian: • Reinhard KROKER (Nemčija) Namestnik: Manfred MOOS
English: Patricia VELLA BONANNO (Alternate: Kenneth MIFSUD)
Slovenian: Patricia VELLA BONANNO (namestnik: Kenneth MIFSUD)
English: Seven applications for renewal of marketing authorisations were received in 2004.
Slovenian: V letu 2004 je bilo prejetih sedem vlog za podaljšanje dovoljenja za promet.
English: Specific training on all aspects of Eudranet was given to Eudranet NCA delegates at the EMEA
Slovenian: Za delegate pristojnih nacionalnih organov Eudranet je bilo na EMEA organizirano posebno usposabljanje o vseh vidikih Eudranet.
English: 1 The EMEA Herbal Medicinal Products Working Party (HMPWP) was succeeded by the Committee on Herbal Medicinal Products (HMPC).
Slovenian: 1 Delovno skupino EMEA za zeliščna zdravila (HMPWP) je nasledil Odbor za zeliščna zdravila (HMPC).
English: The Agency continued to work on a business continuity plan, which sets out the overall business continuity and disaster recovery planning and arrangements to be implemented over a number of years.
Slovenian: Agencija je nadaljevala dela v zvezi z načrtom zveznosti poslovanja, ki določa večletno izvajanje načrtov in ureditev za splošno zveznost poslovanja in obnovitev programske opreme po njeni odpovedi.
English: The work of the CHMP is supported by a number of working parties, composed of European experts selected from a list maintained by the EMEA.
Slovenian: CHMP pri delu podpira več delovnih skupin, ki sestojijo iz evropskih strokovnjakov, izbranih s seznama, ki ga vodi EMEA.
English: • Gonzalo CALVO ROJAS (Spain) Alternate: Fernando DE ANDRES-TRELLES
Slovenian: • Gonzalo CALVO ROJAS (Španija) Namestnik: Fernando DE ANDRÉSTRELLES
English: Members • Eric ABADIE (EMEA representative)
Slovenian: • Eric ABADIE (predstavnik EMEA)
English: • New procedures for plasma master files (PMFs) and vaccine antigen master files (VAMFs) were implemented in 2004 and paved the way for the submission of the first PMFs.
Slovenian: • V letu 2004 so bili uvedeni novi postopki za glavne dosjeje plazme (PMF) in glavne dosjeje virusnih antigenov (VAMF), ki so utrli pot za predložitev prvih PMF-jev.
English: Infrastructure
Slovenian: Infrastruktura
English: In order to support initiatives promoting pharmacovigilance in the EU, with particular focus on providing support to the new Member States, a common reporting form for reporting suspected adverse reactions to veterinary medicinal products by veterinarians and other veterinary health professionals was developed by the CVMP Pharmacovigilance Working Party for use in all EU Member States, and was released for consultation by the CVMP in October 2004.
Slovenian: Delovna skupina CVMP za farmakovigilanco je, da bi podprla pobude za spodbuditev farmakovigilance v EU in zlasti za zagotavljanje podpore novim državam članicam, razvila enoten obrazec za poročanje sumov na neželene učinke veterinarskih zdravil za veterinarje in druge veterinarske zdravstvene strokovnjake, ki naj bi se uporabljal v vseh država članicah EU, in ga predstavila za posvetovanje oktobra 2004.