FrancophonIA/ELRC3.0 huggingface dataset:
English: Following the paroxetine referral, the Committee conducted a review of data available for the whole class of SSRI (serotonin selective reuptake inhibitor) and SNRI (serotonin-norepinephrine reuptake inhibitor) products at the request of the European Commission.
Maltese: Wara r-referenza tal-paroxetine, il-Kumitat wettaq reviżjoni tad-data disponibbli għall-klassi talprodotti ta' l-SSRI (impeditur silettiv ta' l-assorbiment mill-ġdid tas-serotonin) u l-SNRI ( impeditur ta' l-assorbiment mill-ġdid tas-serotonin-norepinefrina) fuq talba tal-Kummissjoni Ewropea.
English: Scientific Advisory Group on Oncology (formerly Therapeutic Advisory Group on Oncology)
Maltese: Grupp Xjentifiku Konsultattiv dwar lOnkoloġija (qabel kien il-Grupp Konsultattiv Terapewtiku dwar l-Onkoloġija)
English: 1 Joined from September 2004 meeting.
Maltese: 1 Ingħaqad mil-laqgħa ta' Settembru 2004.
English: Evaluation in <7 days Evaluation in 7-14 days Evaluation in >14 days
Maltese: Valutazzjoni f' <7 ijiem Valutazzjoni f' 7-14-il jum Valutazzjoni f' >14-il jum
English: No applications were received for VAMFs.
Maltese: Ebda applikazzjonijiet ma waslu għal VAMFs.
English: • A new vaccine (the only one available) for active immunisation of dogs against Babesia canis and Babesia rossi to reduce severity of clinical signs associated with acute babesiosis and the anaemia that ensues following a heterologous challenge infection
Maltese: • Prodott għat-tilqim ġdid (l-uniku disponibbli) għal immunizzazzjoni attiva tal-klieb kontra Babesia canis u Babesia rossi li jnaqqas is-serjetà ta' sinjali kliniċi assoċjati ma' babesjosi akuta u l-anemija li tirriżulta minn dan wara infezzjoni ta' sensibilizzazzjoni eterologa
English: Scientific Advisory Group on Anti-infectives (formerly Therapeutic Advisory Group on Antiinfectives)
Maltese: Grupp Xjentifiku Konsultattiv dwar l-Antiinfettivi (qabel kien il-Grupp Konsultattiv Terapewtiku dwar l-Anti-infettivi)
English: Press officer:
Maltese: Telefon dirett:
English: • Jacqueline GENOUX-HAMES (Luxembourg) • Manfred HAASE1 (Germany) (co-opted)
Maltese: • Jacqueline GENOUX-HAMES (Lussemburgu)
English: Many of these projects were big and involved development and deployment through collaboration with the EMEA Human and Veterinary Units.
Maltese: Ħafna mill-proġetti kienu kbar u involvew żvilupp u tiftiħ permezz ta' kollaborazzjoni ma' l-Unitajiet ta' prodotti għall-Bniedem u Veterinarji ta' l- EMEA.
English: Ireland
Maltese: L-IRLANDA
English: IRELAND
Maltese: L-Irlanda
English: Biosimilar Medicinal Products Working Party (formerly Ad hoc Working Group on (Pre-) Clinical Comparability of Biotechnology Products)
Maltese: Grupp ta' Ħidma dwar Prodotti Mediċinali Bijosimili (qabel kien il-Grupp ta' Ħidma Ad hoc dwar ilParagunabbiltà (Pre-) Klinika ta' Prodotti talBijoteknoloġija)
English: COMP opinions in 2004 on designation of orphan medicinal products 12.
Maltese: Opinjonijiet tal-COMP fl-2004 dwar il-klassifikazzjoni ta' prodotti mediċinali ltiema 12.
English: In 2004, the regulatory time for proceeding through the centralised procedure remained stable, at an average of 288 days, including 187 days for assessment.
Maltese: Fl-2004, iż-żmien regolatorju għall-proċess tal-proċedura ċentralizzata baqa' stabbli, b'medja ta' 288 jum, inklużi 187 jum għall-valutazzjoni.
English: In addition, the EMEA participated in the eleventh International Conference of Drug Regulatory Authorities (ICDRA), in Madrid.
Maltese: Barra minn hekk, l-EMEA pparteċipat fil-ħdax-il Konferenza Internazzjonali ta' Awtoritajiet Regolatorji tad-Droga (ICDRAInternational Conference of Drug Regulatory Authorities), f'Madrid.
English: The EMEA issues plasma master file (PMF) and vaccine antigen master file (VAMF) certificates of a medicinal product in conformity with the arrangements laid down by Community legislation.
Maltese: L-EMEA toħroġ ċertifikati ta' prodotti mediċinali għal fajls prinċipali tal-plażma (PMF) u fajls prinċipali ta' l-antiġen għat-tilqim (VAMF) b'mod konformi ma' l-arranġamenti stabbiliti filleġislazzjoni tal-Komunità.
English: The Agency also participated in international activities of the Codex Alimentarius, the World Organisation for Animal Health (OIE) and the European Directorate for the Quality of Medicines (EDQM)/European Pharmacopoeia.
Maltese: L-Aġenzija pparteċipat ukoll f'attivitajiet internazzjonali tal-Codex Alimentarius, l- Għaqda Dinjija għas-Saħħa ta' l-Annimali (OIE) u d-Direttorat Ewropew għall-Kwalità tal-Mediċini (EDQMEuropean Directorate for the Quality of Medicines)/il-Farmakopeja Ewropea.
English: 185 days
Maltese: 202 days 185 days
English: The EMEA component of the EudraVigilance project proceeded as planned in 2004.
Maltese: Il komponent ta' l-EMEA tal-proġett ta' EudraVigilance ipproċeda kif ippjanat fl-2004.
English: The Agency also received 6 referrals under Articles 29 and 30.
Maltese: L-Aġenzija rċeviet ukoll 6 referenzi taħt l-Artikoli 29 u 30.
English: The EU special contribution in 2004 amounted to 4 million, most of which contributed towards reduced fees for marketing authorisation applications and for protocol assistance.
Maltese: Il-kontribut speċjali ta' lUE fl-2004 ammonta għal € 4 miljun, li l-biċċa l-kbira tiegħu kkontribwixxa lejn tnaqqis fil-ħlasijiet għal applikazzjonijiet ta' l-awtorizzazzjoni għal tqegħid fis-suq u għall-assistenza għall-protokoll.
English: Plasma master files, vaccine antigen master files and medical devices containing biotechnology and blood-derived medicinal products
Maltese: Fajls prinċipali tal-plażma, fajls prinċipali tal-antiġen għat- tilqim u strumenti mediċi li fihom prodotti mediċinali miksuba mill-bijoteknoloġija u mid-demm
English: Chair: Klaus CICHUTEK EMEA contact: Marisa PAPALUCA AMATI
Maltese: Klaus CICHUTEK Kuntatt fl-EMEA:
English: Community harmonisation and pharmacovigilance referrals Type of referral
Maltese: Referenzi għal armonizzazzjoni fil-Komunità u dwar farmakoviġilanza
English: • Security: security policies were proposed for adoption
Maltese: • Sigurtà: ġew proposti linji ta' sigurtà għall-adozzjoni
English: This indicates that there were fewer premature applications.
Maltese: Dan jindika illi kien hemm inqas applikazzjonijiet prematuri.
English: EMEA/CHMP/SWP/94227/2004 Guideline on investigation of dependence potential of medicinal products
Maltese: EMEA/CHMP/SWP/94227/2004
English: In 2004, a total of 51 new applications for marketing authorisation were received under the centralised procedure.
Maltese: Fl-2004, kien hemm total ta' 51 applikazzjoni ġdida għal awtorizzazzjoni għal tqegħid fis-suq taħt ilproċedura ċentralizzata.
English: 303 days
Maltese: 183 days 303 days
English: Reception - visitors to the agency
Maltese: Reception - viżitaturi fl-a?enzija
English: This was developed in direct consultation with the EMEA s Conferences Sector and radically improved their ability to arrange all EMEA meetings and conferences
Maltese: Dan ġie żviluppat b'konsultazzjoni diretta mas-Settur tal-Konferenzi ta' lEMEA u tejjeb b'mod radikali l-ħila tagħhom li jirranġaw il-laqgħat u lkonferenzi kollha ta' l-EMEA
English: In 2004, as an initial trial, there was an exchange of information with the US Food and Drug Administration regarding 4 scientific advice procedures in the context of the EU-FDA confidentiality arrangements.
Maltese: Fl-2004, bħala prova inizjali, kien hemm skambju ta' informazzjoni mal-Food and Drug Administration (FDA) ta' l-Istati Uniti fir-rigward ta' 4 proċeduri ta' konsulenza xjentifika fil-kuntest ta' l-arranġamenti ta' kunfidenzjalità ta' bejn l-UE u l-FDA.
English: The total number of requests for protocol assistance (PA) was 35, of which 32 were finalised.
Maltese: L-għadd totali ta' talbiet għal assistenza għall-protokoll (PA) kien ta' 35, li minnhom 32 ġew iffinalizzati.
English: Scientific Advice Working Party (formerly Scientific Advice Working Group) Chair: Markku TOIVONEN EMEA contact: Agnès SAINT-RAYMOND
Maltese: Grupp ta' Ħidma dwar Pariri Xjentifiċi President: Markku TOIVONEN Kuntatt fl-EMEA: Agnès SAINT-RAYMOND
English: The enlargement of the European Union to 25 Member States on 1 May 2004 and the entry into force of the new pharmaceutical legislation, which introduced a fourth scientific committee and new scientific groups, led to a considerable increase in the number of meetings organised, in the number of meeting days, and in the number of delegates to be reimbursed.
Maltese: It-tkabbir ta' l-Unjoni Ewropea għal 25 Stat Membru fl-1 ta' Mejju 2004 u d-dħul fis-seħħ talleġislazzjoni farmaċewtika ġdida, li introduċiet ir-raba' kumitat xjentifiku u gruppi xjentifiċi ġodda, wasslu għal żjieda konsiderevoli fl-għadd ta' laqgħat organizzati, fl-għadd ta' ġranet ta' laqgħat, u flgħadd ta' delegati li jridu jiġu rimborsati.
English: In light of the steady growth of the Agency, a new floor providing office space for EMEA staff was fitted out in 2004.
Maltese: Minħabba t-tkabbir kontinwu ta' l-Aġenzija, ġie armat sular ġdid li jipprovdi spazju għall-uffiċini tal-personal ta' l-EMEA fl-2004.
English: Scientific Advice Working Party Chair: Reinhard KROKER EMEA contact: Jill ASHLEY-SMITH
Maltese: Kuntatt fl-EMEA: Jill ASHLEY-SMITH
English: Adopted in April 2004, updated in September 2004
Maltese: Adottata f'April 2004, aġġornata f' Settembru 2004
English: 363 days
Maltese: 168 days 363 days
English: Fees
Maltese: Gravis
English: EMEA contact: John PURVES
Maltese: Jean-Hugues TROUVIN Kuntatt fl-EMEA: John PURVES
English: Annex 2 Members of the Committee for Medicinal Products for Human Use Annex 3 Members of the Committee for Medicinal Products for Veterinary Use Annex 4 Members of the Committee on Orphan Medicinal Products Annex 5 Members of the Committee on Herbal Medicinal Products Annex 6 National competent authority partners Annex 7 EMEA budget summaries 2003-2005
Maltese: Membri tal-Kumitat għal Prodotti Mediċinali għall-Użu tal-Bniedem (CHMP) Membri tal-Kumitat għal Prodotti Mediċinali għal Użu Veterinarju (CVMP) Membri tal-Kumitat dwar Prodotti Mediċinali Ltiema (COMP) Membri tal-Kumitat dwar Prodotti Mediċinali mill-Ħxejjex (HMPC) Imsieħba ta' l-awtoritajiet nazzjonali kompetenti Il-Budgets ta' l-EMEA fil-Qosor għall-2003-2005
English: ATC code !
Maltese: Mhux operattiv.
English: General anti-infectives for systemic use Anti-neoplastic and immunomodulating agents Nervous system Various
Maltese: Anti-infettivi ?enerali g?al użu sistemiku
English: CVMP opinions in 2004 on medicinal products for veterinary use
Maltese: Opinjonijiet tas-CVMP fl-2004 dwar prodotti mediċinali għal użu veterinarju
English: EMEA/CHMP/SWP/178958/2004 Guideline on drug-induced hepatotoxicity
Maltese: EMEA/CHMP/SWP/178958/2004
English: NETHERLANDS
Maltese: L-Olanda
English: Sampling from the market in different countries is carried out by national inspectorates and testing is performed by Official Medicines Control Laboratories coordinated through the EDQM (European Directorate for the Quality of Medicines).
Maltese: It-teħid ta' kampjuni mis-suq f'pajjiżi differenti isir mill-ispettorati nazzjonali u l-ittestjar isir mill-Laboratorji Uffiċjali ta' Kontroll tal-Mediċini u jiġi kkoordinat permezz ta' l-EDQM (Direttorat Ewropew għall-Kwalità talMediċini).
English: Scientific Advisory Group on Antimicrobials
Maltese: Grupp Xjentifiku Konsultattiv dwar l-Antimikrobiċi
English: The other safety review related to the class of COX-2 inhibitor medicines.
Maltese: Ir-reviżoni l-oħra ta' sigurtà kienet relatata mal-klassi tal-medicini li jimpedixxu l-COX-2.
English: SLOVAKIA
Maltese: IS-SLOVAKKJA
English: Slovakia
Maltese: Is-Slovakkja
English: The authorities make scientific resources available in the form of a network of more than 3 500 European experts who assist the Agency in the performance of its scientific tasks.
Maltese: L-Awtoritajiet jagħmlu disponibbli riżorsi xjentifiċi fil-forma ta' netwerk ta' iktar minn 3500 espert Ewropew li jassistu lill-Aġenzija fit-twettiq tal-kompiti xjentifiċi tagħha.
English: 6.2 Information technology at the EMEA
Maltese: .2 Teknoloġija ta' l-informatika fi ħdan l-EMEA
English: CHMP opinions in 2004 on medicinal products for human use 10.
Maltese: Opinjonijiet tas-CHMP fl-2004 dwar prodotti mediċinali għall-użu tal-bniedem 10.
English: Meeting reimbursements increased by 38 % due to EU enlargement with a corresponding increase in the recording of new third parties.
Maltese: Ir-rimborsi għal laqgħat żdiedu bi 38 % - minħabba t-tkabbir ta' l-UE - b'żjieda korrispondenti firreġistrazzjonijiet ta' partijiet terzi ġodda.
English: • Katia STEPHANIDOU (Cyprus) Alternate: Phedias LOUCAIDES
Maltese: • Katia STEPHANIDOU (Ċipru) Sostitut:
English: Antoine SAWAYA (France) Alternate: Jacqueline VIGUET POUPELLOZ
Maltese: Jacqueline VIGUET POUPELLOZ Vittorio SILANO (Italja) Sostituta:
English: • Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use.
Maltese: • Id-Direttiva 2004/27/KE tal-Parlament Ewropew u tal-Kunsill tal-31 ta' Marzu 2004 li temenda d-Direttiva 2001/83/KE dwar il-kodiċi tal-Komunità li jirrelata għal prodotti mediċinali għal użu mill-bniedem.
English: Pharmacovigilance Working Party Chair: Cornelia IBRAHIM EMEA contact: Kornelia GREIN
Maltese: Grupp ta' Ħidma dwar il-Farmakoviġilanza President: Cornelia IBRAHIM
English: Felin Interferon !
Maltese: Virbagen Omega Felin Interferon Part A
English: 18 of the 21 members are appointed by the CHMP and 3 members are appointed by the COMP.
Maltese: 18 mill-21 membru jinħatru misCHMP u 3 membri jinħatru mill-COMP.
English: Activities in the administration area relate to a number of functions, including managing and administering staff and seconded personnel, conducting recruitment procedures, and managing revenue, expenditure and accounts according to existing rules and regulations, as well as providing and running the necessary infrastructure services for effective functioning of the Agency.
Maltese: L-attivitajiet fil-qasam ta' l-amministrazzjoni huma relatati ma' għadd ta' funzjonijiet, inklużi limmaniġġjar u l-amministrazzjoni ta' impjegati u personal issekondat, inkluż it-tmexxija ta' proċeduri ta' reklutaġġ, u l-ġestjoni ta' dħul, nefqa u kontijiet skond ir-regoli u regolamenti eżistenti, kif ukoll ilprovvista u t-tmexxija tas-servizzi meħtieġa ta' infrastruttura għall-iffunzjonar effettiv ta' l-Aġenzija.
English: Draft guidance documents were developed, including external guidance that will become publicly available in 2005.
Maltese: Ġew żviluppati abbozzi ta' dokumenti ta' gwida, inkluża gwida esterna li ser isiru disponibbli pubblikament fl-2005.
English: • The EMEA took over responsibility for publication of the compilation of Community procedures for GMP inspectorates and developed a revised procedure for development of EU pharmaceutical guidelines, which takes into account new calls for transparency.
Maltese: • L-EMEA assumiet ir-responsabbiltà għall-pubblikazzjoni tal-kumpilazzjoni ta' proċeduri talKomunità għall-ispettorati tal-GMP u żviluppat proċedura riveduta għall-iżvilupp ta' linji ta' gwida farmaċewtiċi ta' l-UE, li jikkunsidraw is-sejħiet ġodda għal trasparenza.
English: Adopted by CVMP/CHMP in May/July 2004
Maltese: Adottata mis-CVMP/CHMP f'Mejju/Lulju 2004
English: 50 % fee reduction for inspections
Maltese: 50 % tnaqqis fil-ħlas għal attivitajiet ta' wara l-awtorizzazzjoni u drittijiet annwali
English: • Tibor SOÓS (Hungary) Alternate: Gábor KULCSÁR
Maltese: • Tibor SOÓS (Ungerija) Sostitut:
English: Annex 6 National competent authority partners
Maltese: Anness 6 Imsieħba ta' l-awtoritajiet nazzjonali kompetenti
English: 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)
Maltese: Twettqet ukoll l-implimentazzjoni ta' servers għall-web, ta' applikazzjonijiet u ta' databases fiċ-ċentru tad-data għal applikazzjonijiet ewlenin tat-telematika ta' lUE u korporattivi (ara l-arkitettura ta' tlett livelli)
English: • János BORVENDEG (Hungary) Alternate: Agnes GYURASICS
Maltese: • János BORVENDÉG (Ungerija) Sostituta:
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.
Maltese: Sabiex jingħata appoġġ għal inizjattivi li jippromwovu l-farmakoviġilanza fl-UE, b'emfasi partikolari fuq l-għoti ta' appoġġ lill-Istati Membri l-ġodda, ġiet żvilupata formola komuni ta' rapportaġġ għal reazzjonijiet susspettati mhux mixtieqali jiġu rrapportati għal prodotti mediċinali veterinarji minn veterinarji u professjonisti oħra tas-saħħa veterinarja mill-Grupp ta' Ħidma dwar il-Farmakoviġilanza tas-CVMP għal użu fl-Istati Membri kollha ta' l-UE, u nħareġet għal konsultazzjoni mis-CVMP f'Ottubru 2004.
English: The comments received were taken into account in the final, revised version of the Road Map, which was approved by the EMEA Management Board in December 2004.
Maltese: Il-Kummenti riċevuti ġew ikkunsidrati filverżjoni finali, riveduta tal-Mappa tat-Triq, li kienet approvata mill-Bord ta' Tmexxija ta' l-EMEA f'Diċembru 2004.
English: Evaluation time for type-II variations (60-day procedure)
Maltese: Zmien tal-valutazzjoni g?al varjazzjonijiet tat-tip-II (pro?edur ta' 60 jum)
English: The PAT team held 5 meetings in 2004 and established contacts with 3 pharmaceutical companies.
Maltese: It-tim tal-PAT għamel 5 laqgħat fl2004 u stabbilixxa kuntatti ma' 3 kumpanniji farmaċewtiċi.
English: Adopted by CVMP in March 2004
Maltese: Adottata f'Marzu 2004
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
Maltese: Aktar tagħrif dwar l-awtoritajiet nazzjonali kompetenti huwa disponibbli wkoll fuq is-siti ta' l-Internet ta' l-awtoritajiet nazzjonali: http://heads.medagencies.org u http://www.hevra.org
English: • Osteoporosis
Maltese: • Ostejoporożi
English: • Business continuity: a second data room was established and disaster recovery sites identified
Maltese: • Kontinwità ta' l-operazzjonijiet: ġiet stabbilita t-tieni kamra tad-data u ġew identifikati siti ta' rkupru f'każ ta' diżastru
English: • Joint CHMP/CVMP Quality Working Party
Maltese: • Grupp ta' Ħidma konġunt tas-CHMP/CVMP dwar il-Kwalità
English: • Good progress was achieved on improving the quality and consistency of scientific assessment reports, with a revision of the assessor guideline and the initiation of a scientific memory database for centralised procedures.
Maltese: • Inkiseb progress tajjeb fit-titjib tal-kwalità u l-konsistenza ta' rapporti ta' valutazzjoni xjentifika, b'reviżjoni tal-linja ta' gwida għall-istimatur u l-bidu ta' database ta' memorja xjentifika għal proċeduri ċentralizzati.
English: See Annex 3 for details of working parties and scientific advisory groups.
Maltese: Ara l-Anness 3 għal dettalji ta' gruppi ta' ħidma u gruppi xjentifiċi konsultattivi.
English: Corporate helpdesk To provide help and support between the hours of 08h30 and 18h00, five days a week
Maltese: Li jingħataw għajnuna u appoġġ bejn il-ħinijiet tat08.30 u s-18.00, ħamest ijiem fil-ġimgħa
English: • Juris POKROTNIEKS (Latvia) Alternate: Indulis PURVINS
Maltese: • Juris POKROTNIEKS (Latvja)
English: This includes: ensuring best practice in document and records management; verifying the quality of all published documents; and verifying the accuracy of translations.
Maltese: Dan jinkludi: li tiġi żgurata l-aħjar prattika filġestjoni ta' dokumenti u rekords; li tiġi vverifikata l-kwalità tad-dokumenti kollha ppubblikati; u li tiġi vverifikata r-reqqa tat-traduzzjonijiet.
English: The sampling and testing programme underwent a comprehensive review following the outcome of a seminar held in September 2003.
Maltese: Il-programm ta' teħid ta' kampjuni u ttestjar għadda minn reviżjoni komprensiva wara l-eżitu ta' seminar li sar f'Settembru 2003.
English: The EMEA checks compliance of such products distributed in parallel with the appropriate terms of the Community marketing authorisation.
Maltese: L-EMEA tivverifika l-konformità ta' dawn il-prodotti distribwiti b'mod parallel mat-termini xierqa ta' l-awtorizzazzjoni Komunitarja għal tqegħid fis-suq.
English: For matters relating to pharmacovigilance for medicinal products for human use:
Maltese: Position paper on control of impurities of pharmacopoeial substances:
English: E-mail: certificate@emea.eu.int Fax: (44-20) 74 18 85 95
Maltese: Telefon ta' wara l-ħin tax-xogħol: (44-7880) 55
English: 2004 saw the first cooperation with the European Food Safety Authority (EFSA), involving the establishment of maximum residue limits for Lasalocid sodium (coccidiostat) for chicken and game birds, which was also evaluated in 2004 by EFSA for approval as a feed additive.
Maltese: Il-Kodiċi ta' Kondotta ta' l-EMEA ġie rivedut fl-2004 sabiex tiġi ċċarata t-tifsira ta' xi taqsimiet.
English: 30 September 2004
Maltese: 30 ta' Settembru 2004
English: 148 days
Maltese: 183 days 148 days
English: • Rare metabolic diseases affecting the blood or the cardiovascular system in neonates (5 products)
Maltese: • Mard metaboliku rari li jolqot id-demm jew is-sistema kardjovaskulari fit-trabi tat-twelid (5 prodotti)
English: EMEA budget evolution in euro
Maltese: Evoluzzjoni tal-budget ta' l-EMEA
English: To take over the final stages of the EDMS pre-production application, prepare it for the move into operation and operate the application when in production
Maltese: Li jittieħed kontroll ta' listadji finali ta' lapplikazzjonijiet ta' qabel ilproduzzjoni ta' l-EDMS, isiru preparazzjonijiet għallbidu ta' l-operat u li tiġi operata l-applikazzjoni waqt
English: A new Procedure for coordinating pre-approval inspections in the context of plasma master file certification (SOP/INSP/2009) was developed, agreed and published on the EMEA website.
Maltese: Ġiet żviluppata, miftiehma u ppublikata ‘Proċedura għall-koordinazzjoni ta' spezzjonijiet ta' qabel l-approvazzjoni fil-kuntest taċ-ċertifikazzjoni ta' fajls prinċipali tal-plażma' ġdida (SOP/INSP/2009) fuq il-website ta' l-EMEA.
English: Altrenogest received a positive opinion to establish final MRLs in June 2004.
Maltese: Altrenogest irċieva opinjoni pożittiva biex jiġu ffissati MRLs finali f'Ġunju 2004.
English: This included class labellings for all antiretroviral medicinal products with regard to liver impairment and immune reactivation syndrome, and a statement on mitochondrial toxicity in children with postnatal or in utero exposure to nucleotide and nucleoside analogues.
Maltese: Dan kien jinkludi ‘it-tikkettjar għal klassijiet' għall-prodotti mediċinali antiretrovirali kollha fir-rigward ta' l-indeboliment tal-fwied u ssindromu li jħaddem mill-ġdid is-sistema immunitarja, u stqarrija dwar it-tossiċità mitokondrijali fi tfal esposti wara t-twelid jew in utero għal analogi ta' nukleotidi u nukleosidi.
English: Evaluation time for type-IB variations 2004
Maltese: Zmien tal-valutazzjoni g?al varjazzjonijiet tat-tip IB 2004
English: Interim and other support persons 1 845 000 2.19 % 2 087 000 2.11 % 2 695 000 2.45 % Other staff-related expenditure
Maltese: Kontribuzzjoni ġenerali ta' l- UE 12 300 000 14.61 % 17 000 000 17.16 % 17 900 000 16.25 % Kontribuzzjoni speċjali ta' l-UE għall-istrateġija telematika ta' l
English: Head of Sector for regulatory affairs and organisational support
Maltese: Kap tas-Settur għal affarijiet regolatorji u sostenn ta' l-organizzazzjoni
English: There were very few deviations from planned results, one notable exception being the slow implementation of EudraVigilance by Member States.
Maltese: Ftit kien hemm devjazzjonijiet mir-riżultati ppjanati - eċċezzjoni notevoli kienet l-implimentazzjoni bil-mod ta' EudraVigilance mill-Istati Membri.