FrancophonIA/ELRC3.0 huggingface dataset:
English: The EMEA received 38 quality defect reports concerning human medicinal products and 2 defect reports for veterinary medicinal products.
Maltese: L-EMEA rċeviet 38 rapport ta' difetti fil-kwalità dwar prodotti mediċinali għall-bniedem u 2 rapporti ta' difetti għal prodotti mediċinali veterinarji.
English: • Nikolaos DRAKOULIS (Greece) Alternate: Michalis AVGERINOS
Maltese: • Nikolaos DRAKOULIS (Greċja) Sostitut: Michalis
English: • A pilot data-warehousing and business intelligence system was put in place
Maltese: • Ġiet stabbiltà sistema pilota ta' ħżin ta' data u ta' busines intelligence
English: This brings the total to 5 national competent authorities and 39 pharmaceutical companies in production with EudraVigilance at the end of 2004.
Maltese: Dan iġib it-total għal 5 awtoritajiet nazzjonali kompetenti u 39 kumpannija farmaċewtika fi produzzjoni ma' l-EudraVigilance sat-tmiem ta' l-2004.
English: • Jean-Louis ROBERT1 (Luxembourg) (co-opted)
Maltese: • Jean-Louis ROBERT1 (Lussemburgu)
English: Audronis LUKOSIUS (Lithuania) Steinar MADSEN (Norway) Alternate: Gro FOSSUM
Maltese: Ľudmila Štrbová Audronis LUKOSIUS (Litwanja) Steinar MADSEN (Norveġja)
English: An observer for the veterinary authority of one EEA-EFTA state participated in plenary sessions.
Maltese: Osservatur għall-awtorità veterinarja ta' stat wieħed taż-ŻEE-EFTA ħa sehem fis-sessjonijiet plenarji.
English: Ad hoc Biotechnology Working Group Chair: Harrie SEEVERENS/Jean-Hugues TROUVIN
Maltese: Harrie SEEVERENS/Jean-Hugues TROUVIN
English: • Adopted 2005 work programme and budget totalling 110 160 000, together with an establishment plan requesting 379 temporary-agent posts for 2005
Maltese: • Adotta l-programm tax-xogħol ta' l-2005 u budget li jammonta għal € 110 160 000, flimkien ma' pjan ta' stabbiliment li jitlob 379 impieg għal pożizzjonijiet ta' uffiċjali temporanji għall
English: 6.3 Meeting management and conferences................................................................................75
Maltese: 6.3 Ġestjoni ta' laqgħat u konferenzi.........................................................................................74
English: Predictions for 2005-2006 indicate a relatively stable level of applications.
Maltese: It-tbassir għall-2005-2006 indika livell relattivament stabbli ta' applikazzjonijiet.
English: Marie HEROUTOVÁ (Czech Republic) Thorbjörg KJARTANDSDÓTTIR (Iceland) Alternate: Kristín INGÓLFSDÓTTIR
Maltese: Thorbjörg KJARTANDSDÓTTIR (Islanda) Sostituta: Kristín INGÓLFSDÓTTIR
English: Ľudevít MARTINEC Director tátny ústav pre kontrolu liečiv Kvetná 11
Maltese: Štátny ústav pre kontrolu liečiv Kvetná 11
English: • There was 100 % adherence to regulatory timelines for all activities relating to applications for centralised procedures and MRL applications.
Maltese: • Kien hemm konformità ta' 100 % mat-termini ta' skadenza regolatorji għall-attivitajiet kollha relatati ma' applikazzjonijiet għal proċeduri ċentralizzati u applikazzjonijiet ta' l-MRL.
English: Type of referral
Maltese: Tip ta' referenza
English: Musculo-skeletal
Maltese: Muskoluskeletriku
English: Alimentary tract and metabolism
Maltese: Apparat alimentari u metaboliżmu
English: A10AE (pending) !
Maltese: Novo Nordisk A/S A10AE (pending)
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.
Maltese: Il-Grupp ta' Spetturi ad hoc tal-GMP inħatar mill-Grupp ta' Implimentazzjoni tat-Telematika (TIG) għad-database Komunitarja tal-GMP f'Mejju 2004, u ġie mfassal pjan ta' implimentazzjoni preliminari.
English: In addition, an extraordinary meeting was held in December in order to discuss safety concerns relating to SSRIs and SNRIs (see section 2.5).
Maltese: Barra minn hekk, saret laqgħa straordinarja f'Diċembru sabiex jiġu diskussi kwistjonijet ta' sigurtà relatati ma' SSRIs u SNRIs (ara t-taqsima 2.5).
English: VMRFG members met with interested parties from the animal health industry 5 times during 2004, in February, April, June, September and December.
Maltese: Il-membri tal-VMRFG iltaqgħu 5 darbiet mal-partijiet interessati mill-industrija tas-saħħa ta' lannimali matul l-2004, fi Frar, April, Ġunju, Settembru u Diċembru.
English: The evaluation of variations was carried out within the legally defined time limits.
Maltese: Il-valutazzjoni tal-varjazzjonijiet twettqet fil-limiti ta' termini definiti legalment.
English: • Vallo TILLMANN (Estonia) • José Manuel TOSCANO RICO (Portugal)
Maltese: • José Manuel Toscano Rico (Portugall)
English: March 2004
Maltese: Marzu 2004
English: Quintanrix !
Maltese: Quintanrix comb.
English: Heads of Medicines Agencies Veterinary http://www.hevra.org
Maltese: Kapijiet ta' l-Aġenziji tal-Mediċini-Veterinarji http://www.hevra.org
English: Chair: Gérard MOULIN EMEA contact: Peter JONES Members
Maltese: Kuntatt fl-EMEA: Peter JONES Membri
English: 6.3 Meeting management and conferences
Maltese: 6.3 Ġestjoni ta' laqgħat u konferenzi
English: CVMP opinions in 2004 on medicinal products for veterinary use 11.
Maltese: Opinjonijiet tas-CVMP fl-2004 dwar prodotti mediċinali għal użu veterinarju 11.
English: Not in operation.
Maltese: Nefqa ta' l-operat
English: Document title
Maltese: Titolu tad-dokument
English: Electronic submission
Maltese: Sottomissjoni elettronika
English: • Refurbishment of parts of the EMEA offices to accommodate new staff, telematics projects, and delegates and experts from the new Member States
Maltese: • Xogħol ta' arranġamenti f'partijiet mill-uffiċċji ta' l-EMEA biex jiġu akkomodati personal ġdid, proġetti ta' telematika, u delegati u esperti mill-Istati Membri l-ġodda
English: Treatment of hyperphenylalanine mia
Maltese: Treatment of hyperphenylalani nemia
English: EMEA contact: Spiros VAMVAKAS
Maltese: Kuntatt fl-EMEA: Spiros VAMVAKAS
English: 6 Replaced Jens ERSBØLL as of November 2004 meeting.
Maltese: Ħa post Jens ERSBØLL mil-laqgħa ta' Novembru 2004.
English: Part B
Maltese: anagrelide Part B
English: The establishment of SAGs for HIV/viral diseases, endocrinology/diabetes, CNS/psychiatry and cardiology is planned for 2005.
Maltese: It-twaqqif ta' SAGs għall-HIV/mard virali, endokrinoloġija/dijabete, CNS/psikjatrija u kardjoloġija huwa ppjanat għall-2005.
English: The EMEA participated in all meetings of the Heads of Medicines Agencies organised during the Irish and Dutch EU presidencies in 2004.
Maltese: L-EMEA pparteċipat fil-laqgħat kollha tal-Kapijiet ta' Aġenziji tal-Mediċini organizzati tul ilpresidenzi Irlandiżi u Olandiżi ta' l-UE fl-2004.
English: Art. 29(2) of Directive 2001/83/EC (previously Art. 10(2) of Directive 75/319/EEC)
Maltese: Art. 29(2) tad-Direttiva 2001/83/KE (li qabel kien l-Art. 10(2) tad-Direttiva 75/319/KEE)
English: Isabelle MOULON See Annexes 2, 4 and 5 for members of committees, working parties and ad hoc groups.
Maltese: Isabelle MOULON Ara l-Annessi 2, 4 u 5 għall-membri tal-kumitati, gruppi ta' ħidma u gruppi ad hoc.
English: Gianmartino BENZI, José-Luis VALVERDE LÓPEZ European Commission Horst REICHENBACH, Fernand SAUER (Alternates: Paul WEISSENBERG, Patricia BRUNKO)
Maltese: Il-Parlament Ewropew Gianmartino BENZI, José-Luis VALVERDE LÓPEZ Il-Kummissjoni Ewropea Horst REICHENBACH, Fernand SAUER
English: • Ioannis KKOLOS (Cyprus)
Maltese: • Ioannis KKOLOS (Ċipru)
English: Dimitrios VAGIONAS (Alternate: Vassilis KONTOZAMANIS)
Maltese: Dimitrios VAGIONAS (Sostitut:
English: • Greg MARKEY1 (United Kingdom)
Maltese: • Greg MARKEY1 (Renju Unit)
English: 1.79 % Portugal
Maltese: Spanja 9.69 % Ir-Repubblika Slovakka 1.79 % Il-Portugall
English: This cooperation follows a new legal provision of Article 59 of Regulation (EC) No 726/2004, which lays down provisions to avoid conflicts between scientific opinions of different Community bodies.
Maltese: Din il-kooperazzjoni ssegwi dispożizzjoni legali ġdida ta' l-Artikolu 59 tar-Regolament (KE) Nru 726/2004, li tistabbilixxi dispożizzjonijiet sabiex jiġu evitati kunflitti bejn l-opinjonijiet xjentifiċi ta' korpi Komunitarji differenti.
English: • Bernd JILMA (Austria)
Maltese: • Bernd JILMA (Awstrija)
English: Management and internal control systems are part of EMEA corporate governance and are consolidated in an integrated management system at the EMEA.
Maltese: Is-sistemi ta' ġestjoni u ta' kontroll intern huma parti mill-governanza korporattiva ta' l-EMEA u huma kkonsolidati f'sistema ta' ġestjoni integrata fi ħdan l-EMEA.
English: Andrea KUPKOVÁ (Slovakia) Alternate: Ľudmila TRBOVÁ
Maltese: Andrea KUPKOVÁ (Slovakkja) Sostituta:
English: 2.7 Regulatory guidance
Maltese: 2.7 Gwida regolatorja
English: Members • Eric ABADIE (EMEA representative)
Maltese: • Eric ABADIE (rappreżentant ta' l-EMEA)
English: In addition, the notification of the parallel distribution of centrally authorised medicinal products to the EMEA became mandatory on 20 May 2004, in accordance with Title IV of Regulation (EC) No 726/2004.
Maltese: Barra minn hekk, in-notifika lill-EMEA tad-distribuzzjoni parallela ta' prodotti mediċinali awtorizzati ċentralment saret obbligatorja fl-20 ta' Mejju 2004, skond it-Titolu IV tar-Regolament (KE) Nru 726/2004.
English: 143-147, boulevard Anatole France F 93285 Saint-Denis Cedex Tel. (33-1) 55 87 30 14
Maltese: 143-147, boulevard Anatole Franza F - 93285
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.
Maltese: Ġiet żviluppata wkoll sistema interna ta' reviżjoni talpari sistematika biex tgħin tiżgura livell għoli ta' kontinwità, konsistenza u kwalità ta' ittri ffinalizzati ta' SA/PA adottati mis-CHMP.
English: Musculoskeletal and nervous systems
Maltese: Sistemi muskoluskeletrika u nervuża
English: EMEA PMF/VAMF certificates
Maltese: Ċertifikati PMF/VAMF ta' l-EMEA
English: Article 34
Maltese: Artikolu 34
English: • Revision 4 of the Guideline on the acceptability of invented names for human medicinal products processed through the centralised procedure (CPMP/328/98, Rev 4) was released for external consultation in September 2004.
Maltese: • Ir-reviżjoni 4 tal-‘Linja ta' gwida dwar l-aċċettabilità ta' ismijiet ivvintati għal prodotti mediċinali għall-użu tal-bniedem ipproċessati bil-proċedura ċentralizzata' (CPMP/328/98, Rev 4) inħareġ għal konsultazzjoni esterna f'Settembru 2004.
English: • Heribert PITTNER (Austria)
Maltese: • Heribert PITTNER (Awstrija)
English: Stanislav PRIMO IC
Maltese: Stanislav PRIMOŽIC
English: • Magdaléna KU ELOVÁ (Slovakia)
Maltese: • Magdaléna Kuželová (Slovakkja)
English: The Board heard regular progress reports on the EU telematics strategy.
Maltese: Il-Bord irċieva rapporti regolari dwar progress fl-istrateġija telematika ta' l-UE.
English: Other
Maltese: Diversi
English: • Milan MÍD (Czech Republic)
Maltese: • Milan ŠMÍD (Repubblika Ċeka)
English: Two informal meetings were held in 2004, in Dublin and Scheveningen.
Maltese: Fl-2004 saru żewġ laqgħat informali, f'Dublin u Scheveningen.
English: Veterinary immunologicals and vaccines excluded
Maltese: Immunoloġiċi veterinarji u prodotti għat-tilqim esklużi
English: The network within which the EMEA operates increased from 27 to 42 national competent authorities.
Maltese: In-netwerk li fih topera l- EMEA żdied minn 27 għal 42 awtorità nazzjonali kompetenti.
English: Kristin RAUDSEPP (Alternate: Alar IRS)
Maltese: Kristin RAUDSEPP (Sostitut:
English: Direct telephone: (44-20) 75 23 71 08 E-mail: panos.tsintis@emea.eu.int
Maltese: (44-20) 75 23 71 08 E-mail: panos.tsintis@EMEA.eu.int
English: • 85 % of all national competent aurthorities were connected to EudraNet II at the end of 2004
Maltese: • 85 % ta' l-awtoritajiet nazzjonali kompetenti kollha kienu mqabbda ma' l
English: Romano MARABELLI Direttore Generale
Maltese: Romano MARABELLI
English: Reinhard KURTH Kommissarischer Leiter Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) Kurt-Georg-Kiesinger-Allee 3 D 53175 Bonn
Maltese: Kurt-Georg-Kiesinger-Allee 3 D - 53175 Bonn
English: The EMEA set up a pre-accession linguistic review process for 199 human and 41 veterinary centrally authorised products in the 9 new EU languages.
Maltese: L-EMEA waqqfet ‘proċess ta' reviżjoni lingwistika ta' qabel l-adeżjoni' għal 199 prodott għall-użu tal-bniedem u 41 prodott veterinarju awtorizzati ċentralment bid-9 lingwi ġodda ta' l-UE.
English: Article 31
Maltese: Artikolu 31
English: See Annex 12 for full list of guidelines.
Maltese: Ara l-Anness 12 għal lista sħiħa ta' linji ta' gwida.
English: Documentation services
Maltese: Servizzi ta' dokumentazzjoni
English: Substance INN
Maltese: INN tas-Sustanza
English: EMEA and WHO representatives participated in each other s meetings to discuss matters of global significance, such as tropical diseases, influenza pandemics, pharmacovigilance and consultations on international non-proprietary names (INNs).
Maltese: Rappreżentanti ta' l-EMEA u tal-WHO ipparteċipaw fil-laqgħat ta' xulxin sabiex jiddiskutu kwistjonjiet ta' sinifikat globali, bħall-mard tropiku, il-pandemiji ta' influwenza, il-farmakoviġilanza u l-konsultazzjonijiet dwar ismijiet komuni internazzjonali (INNs).
English: 11 March 2004
Maltese: 11 ta' Marzu 2004
English: The CHMP gave 2 opinions on referrals under Article 29 and 2 opinions on referrals under Article 30.
Maltese: Is-CHMP ta 2 opinjonijiet dwar referenzi taħt l-Artikolu 29 u 2 opinjonijiet dwar referenzi taħt lArtikolu 30.
English: Val DIEZ1 (Alternate: José MARTINEZ OLMOS)
Maltese: José MARTINEZ OLMOS)
English: Non-EU ADRs EU ADRs
Maltese: ADRs mhux fl-UE ADRs fl-UE
English: Chair: Josep TORRENT-FARNELL EMEA contact: Agnès SAINT-RAYMOND
Maltese: President: Josep TORRENT-FARNELL Kuntatt fl-EMEA: Agnès SAINT-RAYMOND
English: The three-month consultation period that followed generated feedback from some 65 contributors, including EU institutions, national health authorities, patients groups, professional healthcare organisations, pharmaceutical companies, trade associations, academics and other interested parties.
Maltese: Fil-perjodu ta' konsultazzjoni ta' tlett xhur li segwa twasslu kummenti minn madwar 65 kontributur, inklużi l-istituzzjonijiet ta' l-UE, l-awtoritajiet nazzjonali tas-saħħa, gruppi ta' pazjenti, organizzazzjonjiet professjonisti fil-kura tas-saħħa, kumpanniji farmaċewtiċi, assoċjazzjonijiet kummerċjali, akkademiċi u partijiet oħra interessati.
English: SPAIN
Maltese: SPANJA
English: Tamás L PAÁL (Alternate: Beatrix HORVÁTH)
Maltese: Tamás L PAÁL (Sostituta:
English: The EMEA chaired and organised 4 meetings each for the Ad hoc GMP and GCP Inspectors Groups in 2004.
Maltese: L-EMEA ppresediet 4 laqgħat għal kull wieħed mill-Gruppi ta' Spetturi ad hoc tal-GMP u GCP fl2004.
English: Valstybinė maisto ir veterinarijos tarnyba J. Naujalio g. 21B
Maltese: Naujalio g. 21B
English: 2 Replaced Manfred HAASE as of September 2004 meeting.
Maltese: 2 Ħa post Manfred HAASE mil-laqgħa ta' Settembru 2004.
English: • The EMEA/CHMP Working Group with Patients Organisations finalised its Recommendations and proposals for action after extensive consultation.
Maltese: • Il-Grupp ta' Ħidma EMEA/CHMP ma' Organizzazzjonijiet tal-Pazjenti ffinalizza r‘Rakkomandazzjonijiet u proposti għal azzjoni' tiegħu wara konsultazzjoni estensiva.
English: Cardiovascular and respiratory systems
Maltese: Sistemi kardjovaskulari u respiratorja
English: Haematology
Maltese: Ematologija
English: At the beginning of 2004 there were 3 old substances remaining for which MRLs had not been entirely completed: altrenogest, flugestone acetate and norgestomet.
Maltese: Fil-bidu ta' l-2004 kien hemm 3 sustanzi ‘qodma' li għalihom kien għadhom ma nħolqux għal kollox MRLs: altrenogest, flugestone acetate u norgestomet.
English: Genito-urinary system and sex hormones
Maltese: Sistema ?enito-urinarja u ormoni sesswali
English: The EMEA/CHMP Working Party with Patients Organisations reviewed the comments and contributions received following the release for consultation of the paper Recommendations and proposals for action (CPMP/5819/04) in April 2004.
Maltese: Il-Grupp ta' Ħidma ta' l-EMEA/CHMP ma' l-Organizzazzjonijiet tal-Pazjenti rreveda lkummenti u l-kontribuzzjonijiet li saru wara li nħareġ id-dokument ‘Rakkomandazzjonijiet u proposti għal azzjoni' (CPMP/5819/04) għall-konsultazzjoni f'April 2004.
English: Chair: Daniel BRASSEUR EMEA contact: Anthony HUMPHREYS
Maltese: Daniel BRASSEUR Kuntatt fl-EMEA: Anthony HUMPHREYS
English: The MMS includes an Experts database and enables the automation of many administrative documents, such as invitations, participation lists and reimbursement forms, and the setting up of a tracking system for hotel and travel details.
Maltese: L-MMS tinkludi database ta' l-Esperti u tippermetti l-awtomazzjoni ta' ħafna dokumenti amministrattivi, bħal stediniet, listi ta' parteċipazzjoni u formoli ta' rimbors, u t-twaqqif ta' sistema ta' ntraċċar għad-dettalji ta' lukandi u ta' l-ivjaġġar.
English: 1.3 A long-term strategy for the EMEA
Maltese: 1.3 Strateġija fit-tul għall-EMEA
English: • Michał PIROŻYŃSKI (Poland) Alternate: Piotr SIEDLECKI
Maltese: • Michał PIROŻYŃSKI (Polonja) Sostitut:
English: SK 825 08 Bratislava 26 Tel. (421-2) 55 56 50 81 Fax (421-2) 55 56 41 27 E-mail: martinec@sukl.sk Internet: http://www.sukl.sk
Maltese: SK - 825 08 Bratislava 26 Tel. (421-2) 55 56 50 81 Fax (421-2) 55 56
English: Including validation time, the overall procedure took 102 days on average.
Maltese: Inkluż iż-żmien ta' validazzjoni, il-proċedura kollha ħadet medja ta' 102 ijiem.
English: A total of 5 925 delegate visits were reimbursed, leading to a 47 % increase in expenditure in 2004.
Maltese: Ġew rimborsati total ta' 5 925 żjara ta' delegati, li wassal għal żjieda ta' 47 % fin-nefqa fl-2004.
English: Purevax RCPCh
Maltese: Purevax RCPCh FeLV
English: See Annex 10 for a detailed list of opinions adopted.
Maltese: Ara l-Anness 10 għal lista ddettaljata ta' l-opinjonijiet adottati.
English: 1 Replaced Rashmi SHAH as of December 2004 meeting.
Maltese: 1 Ħa post Rashmi SHAH mil-laqgħa ta' Diċembru 2004.
English: EMEA contact points and reference documents
Maltese: Punti ta' kuntatt fl-EMEA u dokumenti ta' referenza
English: The standard operating procedure (SOP) and web guidance document were revised considerably, taking into account comments received from interested parties.
Maltese: Il-proċedura ta' operazzjoni standard (SOP) u ddokument ta' gwida għall-web ġew riveduti b'mod konsiderevoli, waqt li ġew meqjusa l-kummenti li għamlu l-partijiet interessati.
English: Treatment of HIV-1 infected adults in combination with other antiretroviral products
Maltese: Treatment of HIV-1 infected adults in combination with other antiretroviral pruducts
English: Chair: Bjarne ORSKOV LINDHARDT EMEA contact: Agnès SAINT-RAYMOND
Maltese: Bjarne ORSKOV LINDHARDT Kuntatt fl-EMEA: Agnès SAINT-RAYMOND
English: Panayiota KOKKINOU (Alternate: Louis PANAYI)
Maltese: Panayiota KOKKINOU (Sostitut:
English: Important areas of the remaining provisions include: the implementation of conditional marketing authorisation and accelerated review procedures for the authorisation of medicinal products; expanded scope of the centralised procedure to include mandatory application to the EMEA for evaluation of medicinal products for HIV/AIDS, cancer, neurodegenerative diseases and diabetes; new pharmacovigilance and surveillance tools to increase the safety of medicines; greater emphasis on transparency, communication and the provision of information.
Maltese: Oqsma importanti tad-dispożizzjonjiet li jibqa' jinkludu: l-implimentazzjoni ta' awtorizzazzjoni kondizzjonali għal tqegħid fis-suq u proċeduri mgħaġġla ta' reviżjoni għall-awtorizzazzjoni ta' prodotti mediċinali; qasam ta' applikazzjoni estiż tal-proċedura ċentralizzata sabiex tiġi inkluża lapplikazzjoni obbligatorja lill-EMEA għall-valutazzjoni ta' prodotti mediċinali għall-HIV/AIDS, ilkanċer, il-mard newrodeġenerattiv u d-dijabete; għajnuniet ġodda ta' farmakoviġilanza u sorveljanza sabiex tiżdied is-sigurtà ta' mediċini; emfasi akbar fuq it-trasparenza, il-komunikazzjoni u l-provvista ta' informazzjoni.
English: To achieve 99.5 % availability for all IT services supporting the corporate activities of the EMEA
Maltese: Li tinkiseb disponibbiltà ta' 99.5 % għas-servizzi kollha ta' l-IT li jappoġġaw lattivitajiet korporattivi ta' lEMEA
English: 271 days
Maltese: 181 days 271 days
English: The IT sector provides reliable and robust IT services to EMEA staff, delegates and all users of panEuropean systems.
Maltese: Is-settur ta' l-IT jipprovdi servizzi ta' IT affidabbli u robusti lill-personal u d-delegati ta' l-EMEA kif ukoll lill-utenti kollha ta' sistemi pan-Ewropej.
English: Chair: Konstantin KELLER EMEA contact: Anthony HUMPHREYS
Maltese: Konstantin KELLER Kuntatt fl-EMEA: Anthony HUMPHREYS
English: Per CLAESON (Sweden) Alternate: Ubonwan CLAESON
Maltese: Ubonwan CLAESON
English: By the end of 2004, almost 10 % of the total of 335 EMEA staff members were nationals of one of the 10 new Member States.
Maltese: Sat-tmiem ta' l2004, kważi 10 % tat-total ta' 335 membru tal-personal ta' l-EMEA kienu ċittadini ta' xi wieħed mill10 Stati Membri ġodda.
English: • Peter EKSTRÖM (Sweden) (co-opted)
Maltese: • Peter EKSTRÖM (Svezja)
English: Structure of the EMEA
Maltese: Struttura ta' l-EMEA
English: Date of CHMP opinion International non-proprietary name (INN)
Maltese: Isem intenazzjonali mhux proprjetarju (International non-proprietary name - INN)
English: The remaining provisions will come into force 18 months later, on 20 November 2005.
Maltese: Id-Disposizzjonijiet li jifdal jidħlu fis-seħħ 18-il xahar iktar tard, fl-20 ta' Novembru 2005.
English: Chair: Michel MARTY EMEA contact: Agnès SAINT-RAYMOND
Maltese: President: Michel MARTY Kuntatt fl-EMEA: Agnès SAINT-RAYMOND
English: Scientific advice and protocol assistance requests (received)
Maltese: Talbiet g?al parir xjentifiku u assistenza g?all-protokoll (ir?evuti)
English: • Frances ROTBLAT1 (United Kingdom) (co-opted)
Maltese: • Frances ROTBLAT1 (Renju Unit)
English: Evaluation in < 60 days Evaluation in 60-120 days Evaluation in > 120 days
Maltese: Valutazzjoni f' < 60 jum Valutazzjoni f'60-120 jum Valutazzjoni f'> 120 jum
English: The outcome of the consultation exercise was discussed during a workshop held at the EMEA in December 2004.
Maltese: L-eżitu ta' l-eżerċizzju ta' konsultazzjoni ġie diskuss matul workshop li sar l-EMEA f'Diċembru 2004.
English: A wide range of documents has now been published by the EMEA, including press releases, general information documents, annual reports and work programmes.
Maltese: L-EMEA ppubblikat firxa wiesgħa ta' dokumenti, li jinkludu stqarrijiet għall-istampa, dokumenti ta' informazzjoni ġenerali, rapporti annwali u programmi tax-xogħol.
English: Clinical trials databases
Maltese: Databases ta' provi kliniċi
English: Useful websites: International Conference on Harmonisation http://www.ich.org
Maltese: Il-Konferenza Internazzjonali dwar l-Armonizzazzjoni http://www.ich.org
English: The majority of recalls were initiated by the marketing authorisation holder and were in response to problems such as the presence of particulate matter, raised impurity levels, sterility failures, dissolution test failures and unsatisfactory inspection reports.
Maltese: Il-maġġoranza ta' ġabriet lura inbdew mid-detentur ta' l-awtorizzazzjoni għal tqegħid fis-suq u ġraw b'reazzjoni għal problemi bħall-preżenza ta' materja partikolata, livelli miżjuda ta' impurità, fallimenti ta' sterilità, fallimenti ta' testijiet ta' dissoluzzjoni u rapporti ta' spezzjoni mhux sodisfaċenti.
English: EU programmes
Maltese: Programmi ta' l-UE
English: Annex 10
Maltese: Anness 10
English: Representatives attended from the VMRFG, IFAHEurope and the European Group for Generic Veterinary Products (EGGVP).
Maltese: Attendew rappreżentanti millVMRFG, IFAH-Ewropa u l-Grupp Ewropew għal Prodotti Veterinarji Ġeneriċi (EGGVP).
English: In 2004, the VMRFG provided answers to a wide range of questions from both Member States and Industry on a number of different regulatory issues.
Maltese: Fl-2004, il-VMRFG ta risposti għal firxa wiesgħa ta' mistoqsijiet kemm mill-Istati Membri kif ukoll mill-Industrija dwar għadd ta' kwistjonijiet regolatorji differenti.