FrancophonIA/ELRC3.0 huggingface dataset:
English: The PSUR records all adverse drug reactions reported worldwide during a defined time interval, together with all other emerging information relevant to safety, including proposals for safety-related action, where necessary.
Maltese: Il-PSUR jiġbor ir-reazzjonijiet mhux mixtieqa kollha għall-mediċini rapportati fid-dinja kollha matul interval ta' żmien definit, flimkien ma' kull informazzjoni oħra ġdida relevanti għassigurtà, inklużi proposti għal azzjoni relatata mas-sigurtà, meta tkun meħtieġa.
English: • Change to the composition of the Management Board, CHMP and CVMP
Maltese: • Bidla fil-kompożizzjoni tal-Bord ta' Tmexxija, tas-CHMP u tas-CVMP
English: 5 Replaced Pieter NEELS as of June 2004 meeting.
Maltese: Ħa post Pieter NEELS mil-laqgħa ta' Ġunju 2004.
English: 155 days
Maltese: 210 days 155 days
English: Plasma master files (PMF) and vaccine antigen master files (VAMF)
Maltese: Fajls prinċipali tal-plażma (PMF) u fajls prinċipali ta' l-antiġen għat-tilqim (VAMF)
English: Special contribution for orphan medicines Other income Contribution to Community programmes
Maltese: Kontribuzzjoni g?all-programmi tal-Komunità
English: In addition to the standing and temporary working parties, the CHMP has created scientific advisory groups (SAGs).
Maltese: Minbarra l-gruppi ta' ħidma permanenti u temporanji, is-CHMP ħoloq gruppi xjentifiċi konsultattivi (SAGs).
English: Companies submitted 8 new applications for veterinary medicines in 2004, of which 4 were for immunologicals and 4 were for pharmaceuticals, including 1 generic.
Maltese: Il-kumpanniji ssottomettew 8 applikazzjonijiet ġodda għal mediċini veterinarji fl-2004, li minnhom 4 kienu għal immunoloġiċi u 4 għal farmaċewtiċi, inkluża waħda ġenerika.
English: EudraVigilance is the EU s data processing network and management system for monitoring adverse drug reactions.
Maltese: EudraVigilance hija in-netwerk ta' l-ipproċessar tad-data u s-sistema ta' ġestjoni għas-sorveljanza tarreazzjonijiet mhux mixtieqa għall-mediċini ta' l-UE.
English: Chair: Pekka KURKI
Maltese: President: Pekka KURKI Kuntatt fl-EMEA:
English: 120 days
Maltese: 203 days 120 days
English: Two informal meetings were held in 2004: one in Cork, in May, under the Irish presidency, and one in Rotterdam, in November, under the Dutch presidency.
Maltese: Saru żewġ laqgħat informali fl-2004: waħda f'Cork, f'Mejju, taħt il-presidenza Irlandiża, u l-oħra f'Rotterdam, f'Novembru, taħt il-presidenza Olandiża.
English: • A CVMP audit was completed in October 2004 and four opportunities for improvement resulted; action plans addressing the concerns highlighted were finalised and submitted to the EMEA IQM team.
Maltese: • Verifika tas-CVMP tlestiet f'Ottubru 2004 li minnha rriżultaw erba' ‘opportunitajiet għal titjib'; il-pjanijiet ta' azzjoni li jindirizzaw il-problemi individwati ġew iffinalizzati u sottomessi lit-tim IQM ta' l-EMEA.
English: See Annex 8 for key internal IT projects and operational activities undertaken and delivered.
Maltese: Ara l-Anness 8 għal proġetti interni ewlenin ta' IT u attivitajiet operattivi mibdija u mwettqa.
English: EMEA/61492/2005/EN/Final
Maltese: EMEA/257575/2005/MT/Finali
English: Implementation of 3-tier architecture with appropriate security and interface to Internet services for internal and remote services
Maltese: Servizz jew proġett Deskrizzjoni tal-miżura Dettalji tal-progress Internet għal servizzi interni u remoti applikazzjoni ġdida
English: Milan MÍD (Alternate: Alfred HERA)
Maltese: Milan ŠMÍD (Sostitut:
English: • An equine vaccine for immunisation against Streptococcus equi for the condition of strangles a most debilitating disease that affects horses, characterised by high fever, coughing and difficulty in swallowing due to swelling of the mandibular lymph nodes
Maltese: • Prodott għat-tilqim taż-żwiemel għal immunizzazzjoni kontra Streptococcus equi għallkundizzjoni ta' adenite ekwina- marda li tindebolixxi u li taffetwa ż-żwiemel, ikkaraterizzata minn deni għoli, sogħla u diffikultàjiet meta jibilgħu minħabba li jintefħu n-nodi limfatiċi mandibulari
English: Oncology and immunology
Maltese: Onkologija u
English: • In 2004, the CHMP/EMEA initiated a revision of the European Commission Summary of Product Characteristics (SPC) Guideline, and agreement on sections 4.1 and 5.1 was reached.
Maltese: • Fl-2004, is-CHMP/EMEA taw bidu għal reviżjoni tal-Linja ta' Gwida tal-Kummissjoni Ewropea dwar il-ġabra fil-Qosor ta' Karatteristiċi tal-Prodott (SPC), u ntlaħaq ftehim dwar ittaqsimiet 4.1 u 5.1.
English: An EMEA PAT team was created in January 2004 to review the implications of PAT with a view to ensuring that the European regulatory framework and the authorities are prepared for and adequately equipped to conduct thorough and effective evaluations of PAT-based submissions.
Maltese: F'Jannar 2004 inħoloq tim PAT ta' l-EMEA biex jirrevedi l-implikazzjonijiet tal-PAT bil-għan li jiġi żgurat illi l-qafas regolatorju Ewropew u l-awtoritajiet jkunu preparati u armati b'mod adegwat biex iwettqu evalwazzjonijiet rigorużi u effettivi tas-sottomissjonijiet ibbażati fuq il-PAT.
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.
Maltese: Saret laqgħa konġunta bejn il-QWP u l-ispetturi ad hoc tal-GMP, li bniet fuq il-kooperazzjoni bejn listimaturi u l-ispetturi fuq kwistjonijiet relatati mal-kwalità.
English: • COMP Working Group with Interested Parties
Maltese: • Il-Grupp ta' Ħidma tal-COMP ma' Partijiet Interessati
English: Telzir !
Maltese: Tel.
English: NORWAY
Maltese: IN-NORVEĠJA
English: Scientific Advisory Group on Antimicrobials Chair: Liisa KAARTINEN EMEA contact: Kornelia GREIN
Maltese: President: Liisa KAARTINEN Kuntatt fl-EMEA:
English: Studies and consultants
Maltese: Studji u konsulenti
English: For half of the applications, the clock stop was over 200 days, while for others it was shorter in a number of cases, as short as 50 or 60 days.
Maltese: Għal nofs lapplikazzjonijiet, il-waqfien ta' l-arloġġ kien ta' aktar minn 200 jum, waqt li għall-oħrajn kien iqsarf'għadd ta' każijiet, kien madwar 50 jew 60 jum biss.
English: 279 days
Maltese: 206 days 279 days
English: palonosetron !
Maltese: Parir Xjentifiku
English: Topics included risk management strategies, pharmacovigilance and the implementation of the European telematics strategy.
Maltese: Is-suġġetti inkludew strateġiji għall-ġestjoni tarriskju, farmakoviġilanza u l-implimentazzjoni ta' l-istrateġija Ewropea tat-telematika.
English: To obtain a marketing authorisation for a veterinary medicinal product intended for use in food-producing species, so-called maximum residue limits (MRLs) for all pharmacologically active substances must be established in advance for the animal species concerned and for its relevant tissues or products, e.g. meat, milk, honey etc. An MRL is the safe level of residue in food that can be consumed by a person every day over a lifetime without it causing a harmful effect.
Maltese: L-objettivi tal-programm ta' teħid ta' kampjuni u ttestjar, derivati mir-rekwiżiti legali, huma li tiġi ssorveljata l-kwalità tal-prodotti mediċinali awtorizzati ċentralment imqegħda fuq is-suq u biex tiġi vverifikata l-konformità ta' dawn ma' l-ispeċifikazzjonijiet awtorizzati tagħhom.
English: Annex 13 Arbitration and Community referrals overview 2004
Maltese: Anness 13 Ħarsa ġenerali lejn l-arbitraġġi u r-referenzi Komunitarji fl-2004
English: This represents an increase of 10 % over 2003.
Maltese: Dan jirrappreżenta żjieda ta' 10 % fl-2003.
English: One application involved collaboration with the Food and Drug Administration (FDA) on a parallel protocol assistance procedure, which was also subject to a follow-up procedure.
Maltese: Applikazzjoni minnhom involviet kollaborazzjoni mal-Food and Drug Administration (FDA) dwar proċedura parallela ta' assistenza għall-protokoll, li kienet soġġetta wkoll għal proċedura ta' follow-up.
English: Ariclaim !
Maltese: Art.
English: • EMEA/CHMP Working Group with Patients Organisations
Maltese: • Il-Grupp ta' Ħidma ta' l-EMEA/CHMP ma' Organizzazzjonijiet tal-Pazjenti
English: A total of 108 applications for orphan product designation were received in 2004, which is a 24 % increase compared to the 87 received in 2003.
Maltese: Fl-2004 waslu 108 applikazzjoni għal klassifikar ta' prodotti ltiema, li juri żjieda ta' 24 % meta mqabbel mas-87 li waslu fl-2003.
English: Clinical trial phases of scientific advice requests 2004
Maltese: Maħruġa għall-konsultazzjoni fi Frar 2004
English: 208 days !
Maltese: 208 days 180 days
English: For enquiries concerning PMF certificates:
Maltese: Għal mistoqsijiet dwar ċertifikati ta‘ PMF:
English: Eight applications were received in 2004 for PMFs.
Maltese: Fl-2004 kien hemm ħames applikazzjonijiet għal parir xjentifiku.
English: • Eva JOHNSSON (Sweden) Alternate: Henrik HOLST
Maltese: • Eva JOHNSSON (Svezja)
English: Belgium
Maltese: Il-Belgju
English: This document was released for the purpose of transparency and has no legal force with respect to Directive 2001/83/EC.
Maltese: Dan id-dokument inħareġ għall-iskop ta' trasparenza u m'għandu ebda saħħa legali fir-rigward tad-Direttiva 2001/83/KE.
English: Working parties and ad hoc groups Ad hoc Meeting of GMP Inspection Services
Maltese: Gruppi ta' ħidma u gruppi ad hoc Laqgħa ad hoc tas-Servizzi ta' Spezzjoni tal-GMP
English: Prior to May 2004, the new Member States participated voluntarily in simplified mutual recognition procedures under the Collaboration Agreement between Veterinary Drug Registration Institutions (CAVDRI) of European Union Associated Countries.
Maltese: Qabel Mejju 2004, l-Istati Membri l-ġodda ipparteċipaw volontarjament fi proċeduri ssimplifikati ta' rikonoxximent reċiproku taħt il-Ftehim ta' Kollaborazzjoni bejn Istituzzjonijiet ta' Reġistrazzjoni ta' Mediċini Veterinarji (CAVDRI) tal-Pajjiżi Assoċjati ta' l-Unjoni Ewropea.
English: Working parties and ad hoc groups Efficacy Working Party Chair: Michael HOLZHAUSER-ALBERTI EMEA contact: Jill ASHLEY-SMITH
Maltese: Gruppi ta' ħidma u gruppi ad hoc Grupp ta' Ħidma dwar l-Effikaċja President: Michael HOLZHAUSER-ALBERTI
English: Orphan medicinal product procedures 2002 - 2004
Maltese: Pro?eduri ta' prodotti medi?inali ltiema 2002 - 2004
English: • User requirements for the database were drawn up in line with additional requirements resulting from the terms of Regulation (EC) No 726/2004, G10 recommendations and Council conclusions
Maltese: • Ġew stabbiliti r-rekwiżiti ta' l-utenti għad-database b'mod konformi marrekwiżiti addizzjonali li jirriżultaw mit-termini tar-Regolament (KE) Nru 726/2004, ir-rakkomandazzjonijiet tal-G10 u l-konklużjonijiet tal-Kunsill
English: The IT development team provided a new version of the Experts database in 2004
Maltese: It-tim ta' l-iżvilupp ta' l-IT pprovda verżjoni ġdida tad-database ta' l-Esperti fl-2004
English: Budget for 2005 as adopted by the Management Board on 16.12.2004.
Maltese: Budget għall-2005 kif adottat mill-Bord ta' Tmexxija fis-16.
English: These groups continue to bring additional expertise into the European regulatory system.
Maltese: Dawn il-gruppi jibqgħu jġibu ħila esperta addizzjonali fil-qafas tas-sistema regolatorja Ewropea.
English: An overarching document describing the mandate, objectives and rules of procedure for CHMP scientific advisory groups was adopted by the Committee.
Maltese: Dokument ġenerali li jiddeskrivi l-mandat, l-oġġettivi u rregoli ta' proċedura għall-gruppi konsultattivi xjentifiċi tas-CHMP ġie adottat mill-Kumitat.
English: 1 Commission Regulation (EC) No 1085/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products falling within the scope of Council Regulation (EEC) No 2309/93.
Maltese: 1 Regolament tal-Kummissjoni (KE) Nru 1085/2003 tat-3 ta' Ġunju 2003 dwar l-eżami ta' varjazzjonijiet fit-termini ta' awtorizzazzjoni għal tqegħid fis-suq għal prodotti mediċinali għall-użu tal-bniedem u prodotti mediċinali veterinarji li jaqgħu taħt ir-Regolament tal-Kunsill (KEE) Nru 2309/93.
English: One referral concerned the harmonisation of withdrawal periods, which differed significantly between the marketing authorisations in the different Member States, for Dectomax 1 % injectable solution (doramectin) an endectocide injectable product for sheep.
Maltese: Referenza waħda kienet tirrigwarda l-armonizzazzjoni ta' perjodi ta' irtirar, li kienu jvarjaw b'mod sinifikanti bejn l-awtorizzazzjonijiet għal tqegħid fis-suq fl-Istati Membri differenti, għal Dectomax 1 % soluzzjoni injettabbli (doramectin) - prodott ta' endectocide injettabbli għan-nagħaġ.
English: Assessment phase EMEA post-opinion phase Decision process Company clock stop
Maltese: EMEA/COMP Sottomissjoni Data tal-bidu Opinjoni Ħin attiv
English: In addition, regulatory and procedural guidance is provided to the CHMP, HMPC and COMP, and to their related working parties and ad hoc groups.
Maltese: Barra minn hekk, tingħata gwida regolatorja u proċedurali lisCHMP, l-HMPC u l-COMP, u lill-gruppi ta' ħidma u l-gruppi ad hoc relatati tagħhom.
English: The Veterinary Mutual Recognition Facilitation Group (VMRFG) met at the EMEA every month (except August) in 2004, under the chairmanship of the Irish and Dutch EU presidencies.
Maltese: Il-Grupp veterinarju ta' faċilitazzjoni tar-rikonoxximent reċiproku (VMRFG) iltaqa' fi ħdan l-EMEA kull xahar (ħlief f'Awissu) fl-2004, taħt il-presidenza Irlandiża u Olandiża ta' l-UE.
English: Silvia DOMINGO
Maltese: Patrick SALMON
English: Following entry into force of Title IV of Regulation (EC) No 726/2004 on 20 May 2004, a new Committee structure came into effect from June 2004 with one member per country.
Maltese: Wara d-dħul fis-seħħ tat-Titolu IV tar-Regolament (KE) Nru 726/2004 fl-20 ta' Mejju 2004, daħlet fis-seħħ struttura ta' Kumitat ġdid minn Ġunju ta' l-2004 b'membru wieħed għal kull pajjiż.
English: The Agency remained committed to and participated in the two international conferences on harmonisation of technical requirements for the registration of human and veterinary pharmaceuticals (ICH and VICH respectively) in 2004.
Maltese: L-Aġenzija baqgħet impenjata lejn u pparteċipat fiż-żewġ konferenzi internazzjonali dwar larmonizzazzjoni ta' ħtiġiet tekniċi għar-reġistrazzjoni ta' farmaċewtiċi għall-bniedem u veterinarji (ICH u VICH rispettivament) fl-2004.
English: There were no referral procedures under Articles 36 or 37.
Maltese: Ma kien hemm ebda proċeduri ta' referenza taħt l-Artikoli 36 jew 37.
English: Evaluation time for type-II variations (90-day procedure)
Maltese: Zmien tal-valutazzjoni g?al varjazzjonijiet tat-tip-II (pro?edura ta' 90 jum)
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.
Maltese: B'antiċipazzjoni ta' dan, xi detenturi ta' awtorizzazzjoni għal tqegħid fis-suq (MAHs) diġà ssottomettew pjanijiet talġestjoni tar-riskju għar-reviżjoni mis-CHMP matul l-2004, u fl-2004 saru bosta laqgħat mal-MAHs għal prodotti awtorizzati ċentralment, l-aktar biex jiġu diskussi kunċetti ta' ġestjoni ta' riskju.
English: Rent/charges
Maltese: Kera/spejjeż
English: 153 days
Maltese: 172 days 153 days
English: E-mail: uskvbl@flynet.sk Internet: http://www.uskvbl.sk
Maltese: E-mail: uskvbl@flynet.sk
English: The EMEA coordinates the verification of compliance with the principles of good manufacturing practice (GMP), good clinical practice (GCP) and good laboratory practice (GLP), and with certain aspects of the supervision of authorised medicinal products in use in the EU, through inspections requested by the CHMP or CVMP in connection with the assessment of marketing authorisation applications and/or the assessment of matters referred to these committees in accordance with Community legislation.
Maltese: L-EMEA tikkoordina l-verifika tal-konformità mal-prinċipji ta' prattika tajba ta' manifattura (GMP), prattika klinika tajba (GCP) u prattika tajba tal-laboratorju (GLP), u ċerti aspetti tas-superviżjoni ta' prodotti mediċinali awtorizzati li jintużaw fl-UE, permezz ta' spezzjonijiet mitluba mis-CHMP jew CVMP f'konnessjoni mal-valutazzjoni ta' applikazzjonijiet għal awtorizzazzjoni għal tqegħid fis-suq u/jew il-valutazzjoni ta' kwistjonijiet riferiti lil dawn il-kumitati skond il-leġislazzjoni tal-Komunità.
English: POLAND
Maltese: Il-Polonja
English: Committee on Orphan Medicinal Products (COMP)
Maltese: Kumitat dwar Prodotti Mediċinali Ltiema (COMP)
English: EU-US FDA confidentiality arrangements
Maltese: Istituzzonijiet ta' l-UE u awtoritajiet regolatorji
English: Acetylisovaleryl
Maltese: IL-BELĠJU
English: Paediatric Working Party (formerly Paediatric Expert Group)
Maltese: Grupp ta' Ħidma Pedjatriku (qabel kien il-Grupp Espert Pedjatriku)
English: In line with this new responsibility, the CVMP adopted the position paper Procedure to be followed to facilitate communication and dialogue between the CVMP and interested parties .
Maltese: Għaldaqstant, is-CVMP adotta d-dokument ta' pożizzjoni ‘Proċedura li għandha tiġi segwita sabiex jiġu ffaċilitati l-komunikazzjoni u d-djalogu bejn is-CVMP u l-partijiet interessati'.
English: Art. 30 of Directive 2001/83/EC (previously Art. 11 of Directive 75/319/EEC)
Maltese: 11 tad-Direttiva 75/319/KEE)
English: Human and veterinary medicinal products
Maltese: Prodotti mediċinali veterinarji:
English: Vittorio SILANO (Italy) Alternate: Marisa DELBÓ
Maltese: Marisa DELBÓ Panayiotis TRIANTAFYLLIS (Ċipru) Sostituta:
English: It held a public consultation exercise relating to the EMEA Road Map to 2010 discussion paper and a consultation on recommendations for better provision of information to patients.
Maltese: Wettqet eżerċizzju ta' konsultazzjoni pubblika relatat mad-dokument ta' diskussjoni tal-Mappa tat-Triq ta' lEMEA lejn l-2010 u konsultazzjoni dwar rakkomandazzjonijiet għal provvista aħjar ta' informazzjoni lill-pazjenti.
English: The control framework of the Agency changed significantly with the adoption of the new EMEA quality policy and new internal control standards.
Maltese: Il-qafas ta' kontroll ta' l-Aġenzija nbidel b'mod sinifikanti bl-adozzjoni tal-politika ta' kwalità ġdida ta' l-EMEA u l-istandards ġodda ta' kontroll intern.
English: In 2004, total compensation was 32 233 000 about one third of the Agencys total budget.
Maltese: Fl2004, il-kumpens totali kien ta' € 32 233 000 - madwar terz tal-budget totali ta' l-Aġenzija.
English: • Johannes DICHTL (Austria) Alternate: Jean-Pierre BINDER
Maltese: • Johannes DICHTL (Awstrija) Sostitut:
English: Heribert PITTNER (Austria) (vice-chairman) Alternate: Wolfgang KUBELKA
Maltese: Dace KALKE Heribert PITTNER (Awstrija) (viċi president) Sostitut:
English: The year 2004 was the Agency s tenth year of operations.
Maltese: 10 ta' Ġunju 2004
English: The smooth operation of EMEA internal information technology systems is critical to the Agency s ability to perform its tasks.
Maltese: It-tħaddim tajjeb tas-sistemi interni ta' teknoloġija ta' l-informazzjoni ta' l-EMEA huwa ta' importanza kritika għall-ħila ta' l-Aġenzija li twettaq ix-xogħol tagħha.
English: Babesios
Maltese: Kisbiet
English: 284 days
Maltese: 181 days 284 days
English: Art. 6(12) of Commission Regulation (EC) No 1084/2003 (previously Art. 7(5) of Commission Regulation (EC) No
Maltese: Art. 6(12) tar-Regolament talKummissjoni (KE) Nru 1084/2003 (li qabel kien l-Art. 7(5) tar-Regolament tal-Kummissjoni (KE) Nru 542/95)
English: insulin glulisine !
Maltese: Apidra insulin glulisine Part A
English: Zonegran !
Maltese: Laqgħat
English: Further details on both procedures can be found in section 2.6.
Maltese: Aktar dettalji dwar iż-żewġ proċeduri jinsabu fit-taqsima 2.6.
English: CVMP Immunologicals Working Party
Maltese: A?enti anti-neoplastici u immunomodulatorji
English: The Agency communicates the finalisation of a USR procedure and the new safety recommendations to healthcare professionals and patients by issuing an EMEA public statement.
Maltese: L-Aġenzija tikkomunika liffinalizzar ta' proċedura USR u r-rakkomandazzjonijiet ta' sigurtà ġodda lill-professjonisti tal-kura tas-saħħa u lill-pazjenti billi toħroġ stqarrija pubblika ta' l-EMEA.
English: In total, 61 518 ICSRs were reported electronically to EudraVigilance in 2004, referring both to reports for centrally authorised medicinal products as well as those authorised through the mutual recognition and national procedures.
Maltese: B'kollox, 61 518 ICSR ġew irrapportati elettronikament lil EudraVigilance fl-2004, li jirreferu kemm għal rapporti għal prodotti mediċinali awtorizzati ċentralment kif ukoll għal dawk awtorizzati permezz tal-proċeduri ta' rikonoxximent reċiproku u nazzjonali.
English: The operational and technical work of the EMEA is reported in Chapter 2 on medicines for human use, Chapter 3 on veterinary medicines and Chapter 4 on inspection activities.
Maltese: Il-ħidma operazzjonali u teknika ta' l-EMEA hija rrapportata fil-Kapitolu 2 dwar mediċini għall-użu tal-bniedem, il-Kapitolu 3 dwar mediċini veterinarji u l-Kapitolu 4 dwar attivitajiet ta' spezzjoni. Limplimentazzjoni ta' l-istrateġija telematika ta' l-UE, l-amministrazzjoni u attivitajiet ta' sostenn oħrajn huma deskritti fil-Kapitoli 5 u 6.
English: Information technology
Maltese: Teknoloġija ta' l-Informatika
English: CVMP rapporteurs, co-rapporteurs and EMEA project managers reported (in the joint EMEA/IFAHEurope survey on the centralised procedure) a much greater level of satisfaction with the quality of dossiers submitted than was reported in the previous survey, in which the outcome had already been regarded as very positive.
Maltese: Ir-relaturi u l-korelaturi tas-CVMP u l-maniġers tal-proġetti ta' l-EMEA rrapportaw (fl-istħarriġ konġunt ta' l-EMEA/IFAH-Ewropa dwar il-proċedura ċentralizzata) livell ta' sodisfazzjon ferm ogħla bil-kwalità tad-dossiers sottomessi milli kien ġie rrapportat fl-istħarriġ preċedenti, li l-eżitu tiegħu kien diġà tqies bħala pożittiv ħafna.
English: A further new transparency initiative started in September 2004: COMP press releases and CHMP monthly reports now list all designated orphan medicinal products that have been the subject of a marketing authorisation application submitted since July 2003.
Maltese: Inizjattiva oħra ġdida ta' trasparenza bdiet f'Settembru 2004: l-istqarrijiet għall-istampa tal-COMP u rrapporti ta' kull xahar tas-CHMP issa jelenkaw il-prodotti mediċinali ltiema kollha klassifikati li kienu s-suġġett ta' applikazzjoni għal awtorizzazzjoni għal tqegħid fis-suq sa minn Ġunju 2003.
English: The Committee now has one member from each of the 25 EU Member States and one member each from Iceland and Norway.
Maltese: Il-Kumitat issa għandu membru wieħed minn kull wieħed mill-25 Stati Membri ta' l-UE u membru kull wieħed mill-Islanda u n-Norveġja.
English: The EU s revised pharmaceutical legislation and the expansion of the total number of Member States to 25 brought about changes to the composition of the Management Board.
Maltese: Il-leġislazzjoni farmaċewtika riveduta ta' l-UE u ż-żjieda ta' l-għadd totali ta' Stati Membri għal 25 ġabu bidla fil-kompożizzjoni tal-Bord ta' Tmexxija.
English: Initial evaluation opinions and withdrawals
Maltese: Opinjonijiet ta' valutazzjoni inizzjali u rtirar
English: EMEA post-opinion phase
Maltese: Data ta' l-opinjoni tas
English: Adopted by CVMP in May 2004
Maltese: Adottata mis-CVMP f'Mejju 2004
English: A further 40 % increase in the number of travel and hotel bookings for reimbursed delegates occurred, as well as a 20 % increase in hotel booking requirements for non-reimbursed delegates.
Maltese: Kien hemm ukoll żjieda ulterjuri ta' 40 % fl-għadd ta' prenotazzjonijiet ta' l-ivjaġġar u ta' lukandi għad-delegati li ngħataw rimbors, kif ukoll żjieda ta' 20 % fir-rekwiżiti ta' prenotazzjoni ta' lukandi għad-delegati li ma ngħatawx rimbors.
English: Joint CHMP/CVMP Quality Working Party
Maltese: Grupp ta' Ħidma Konġunt tas-CHMP/CVMP dwar il-Kwalità