FrancophonIA/ELRC3.0 huggingface dataset:
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a signifcant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċju u r-riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: In the 12-month study, the improvements were 87 ml at 5 minutes and 143 ml at 15 minutes (both p<0.001).
Maltese: Flistudju li dam 12-il xahar, it-titjib kien ta' 87 ml fi żmien 5 minuti u ta' 143 ml fi żmien 15-il minuta
English: The mean terminal elimination half-life was much longer after inhalation (33 to 57 hours) than after intravenous (6.2 hours) and oral (2.8 hours) administration.
Maltese: Il-half life medja taleliminazzjoni terminali kienet itwal wara t-teħid tal-mediċina man-nifs (33 sa 57 siegħa) milli wara tteħid mill-vina (6.2 sigħat) u mill-ħalq (2.8 sigħat).
English: In patients with severe renal impairment (eGFR <30 ml/min/1.73 m2), including those with end-stage renal disease requiring dialysis, Tovanor Breezhaler should only be used if the expected benefit outweighs the potential risk (see section 4.4).
Maltese: F'pazjenti b'indeboliment tal-kliewi gravi (eGFR <30 ml/min/1.73 m2), inkluż dawk li jinsabu fl-aħħar stadju tal-marda tagħhom tal-kliewi u li jeħtieġu dijaliżi, Tovanor Breezhaler għandu jintuża biss jekk il-benefiċċji mistennija jegħlbu r-riskju li jista' jkun hemm (ara sezzjoni 4.4).
English: Adverse reactions reported during the first six months of two pooled pivotal Phase III trials of 6 and 12 months duration are listed by MedDRA system organ class (Table 1).
Maltese: Ir-reazzjonijiet avversi rrappurtati matul l-ewwel sitt xhur taż-żewġ provi pivitali f'Fażi III miġburin flimkien li damu għaddejjin 6 u 12-il xahar qed jitniżżlu skont is-sistema ta' klassifika tal-organi fiddatabażi MedDRA (Tabella 1).
English: Tovanor Breezhaler also reduced dyspnoea at rest measured using the Transitional Dyspnoea Index.
Maltese: Tovanor Breezhaler jista' jintuża skont id-doża rrakkomandata f'pazjenti b'indeboliment tal-kliewi bejn ħafif u moderat.
English: Inhale deeply
Maltese: F'dan il-fuljett
English: - Do not push the capsule through the foil.
Maltese: - Timbuttax il-kapsula minn ġol-fojl.
English: Concomitant administration of glycopyrronium and orally inhaled indacaterol, a beta2-adrenergic agonist, under steady-state conditions of both active substances did not affect the pharmacokinetics of either medicinal product.
Maltese: L-għoti konkomitanti ta' glycopyrronium u ta' indacaterol li jittieħed man-nifs billi jinġibed mill-ħalq, agonist beta2-adrenerġiku, waqt kundizzjonijiet ta' stat fiss għaż-żewġ sustanzi attivi ma affettwax ilfarmokokinetika tal-ebda wieħed mill-prodotti mediċinali.
English: At 12 weeks (primary endpoint), Tovanor Breezhaler increased trough FEV1 by 108 ml in the 6-month study and by 97 ml in the 12-month study compared to placebo (both p<0.001).
Maltese: Fit-12-il ġimgħa (l-endpoint primarju), Tovanor Breezhaler żied l-FEV1 b'108 ml fl-istudju li dam 6 xhur u b'97 ml fl-istudju li dam 12-il xahar imqabbel mal-plaċebo (it-tnejn p<0.001).
English: During treatment with Tovanor Breezhaler, stop taking this medicine and tell your doctor immediately: - if you experience tightness of the chest, coughing, wheezing or breathlessness immediately after using Tovanor Breezhaler (signs of bronchospasm).
Maltese: Tovanor Breezhaler hu trattament ta' manutenzjoni fit-tul, biex jintuża darba kuljum u mhux indikat biex jintuża bħala trattament inizjali ta' episodji akuti ta' spażmi tal-bronki, jiġifieri bħala terapija ta' salvataġġ.
English: 3H]-labelled glycopyrronium bromide to humans, the mean urinary excretion of radioactivity in 48 hours amounted to 85% of the dose.
Maltese: 3H] lill-bnedmin, l-eskrezzjoni medja tar-radjuattività mal-awrina fi żmien 48 siegħa kien ta' 85% tad-doża. 5% oħra tad-doża nstab malbili.
English: • Diarrhoea or stomach ache
Maltese: • Diffikulta biex torqod
English: On the first day of treatment inspiratory capacity under exercise was improved by 230 ml and exercise endurance time was improved by 43 seconds (an increase of 10%) compared to placebo.
Maltese: Fl-ewwel ġurnata tat-trattament tal-kapaċità ispiratorja waqt l-eżerċizzju dan tjieb b'230 ml u kien hemm titjib ta' 43 sekonda (żieda ta' 10%) flammont ta' ħin ta' kemm wieħed jiflaħ għall-eżerċizzju mqabbel mal-plaċebo.
English: Other medicines and Tovanor Breezhaler
Maltese: Mediċini oħra u Tovanor Breezhaler
English: Therefore the frequency was calculated from clinical trial experience.
Maltese: Għaldaqstant il-frekwenza kienet ikkalkulata minn esperjenza li tweqqtet waqt provi kliniċi.
English: Renal and urinary disorders Urinary tract infection
Maltese: Disturbi fil-kliewi u fis-sistema urinarja Infezzjoni fl-apparat tal-awrina
English: The European Medicines Agency has waived the obligation to submit the results of studies with Tovanor Breezhaler in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini rrinunzjat għall-obbligu li jiġu ppreżentati r-riżultati tal-istudji b'Tovanor Breezhaler f'kull sett tal-popolazzjoni pedjatrika fil-COPD (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: About 90% of systemic exposure following inhalation is due to lung absorption and 10% is due to gastrointestinal absorption.
Maltese: Madwar 90% tal-espożizzjoni sistemika wara li ttieħdet il-mediċina man-nifs hu riżultat tal-assorbiment mill-pulmun u 10% hu riżultat tal-assorbiment gastrointestinali.
English: Store the capsules in the original blister in order to protect from moisture.
Maltese: Aħżen il-kapsuli fil-folja oriġinali sabiex tilqa' mill-umdità.
English: Your Seebri Breezhaler Inhaler pack contains: • One Seebri Breezhaler inhaler
Maltese: 10 kapsuli Tovanor Breezhaler biex jintużaw mal-inhaler
English: Acute intoxication by inadvertent oral ingestion of Tovanor Breezhaler capsules is unlikely due to the low oral bioavailability (about 5%).
Maltese: Mhux mistenni li jkun hemm effett tossiku gravi meta l-kapsuli Tovanor Breezhaler jinbelgħu bi żball mill-ħalq minħabba l-bijodisponibbiltà orali baxxa (madwar 5%).
English: How to store Tovanor Breezhaler
Maltese: • Inhaler wieħed Tovanor Breezhaler
English: Check
Maltese: Għatu
English: Multipack comprising 3 packs (30 capsules + 1 inhaler)
Maltese: Pakkett b'ħafna li jinkludi 3 pakketti (30 kapsula + inhaler wieħed)
English: The pooled analysis also showed fewer patients treated with Tovanor Breezhaler than with placebo experienced an exacerbation requiring hospitalisation (1.7% versus 4.2%, p=0.003).
Maltese: L-analiżi miġbura wriet ukoll li kien hemm anqas pazjenti kkurati b'Tovanor Breezhaler milli dawk bi plaċebo li kellhom taħrix u li kienu jeħtieġu kura l-isptar (1.7% kontra 4.2%, p=0.003).
English: Glycopyrronium is cleared predominantly from the systemic circulation by renal excretion.
Maltese: Glycopyrronium jitneħħa primarjament miċ-ċirkulazzjoni sistemika permezz tal-eskrezzjoni renali.
English: The co-administration of Tovanor Breezhaler with other anticholinergic-containing medicinal products has not been studied and is therefore not recommended.
Maltese: L-għoti flimkien ta' Tovanor Breezhaler ma' prodotti mediċinali oħrajn antikolinerġiċi ma ġiex studjat u għaldaqstant mhuwiex irrakkomandat.
English: Do not use Tovanor Breezhaler - if you are allergic to glycopyrronium bromide or any of the other ingredients of this medicine
Maltese: Tużax Tovanor Breezhaler - jekk inti allerġiku għal glycopyrronium bromide jew għal xi sustanza oħra ta' din il-mediċina
English: Empty remaining
Maltese: Bijotrasformazzjoni
English: Tovanor Breezhaler contains lactose
Maltese: Tovanor Breezhaler fih il-lactose
English: After three weeks of treatment the improvement in inspiratory capacity with Tovanor Breezhaler was similar to the first day (200 ml), exercise endurance time however had increased by 89 seconds (an increase of 21%) compared to placebo.
Maltese: Wara tliet ġimgħat ta' trattament it-titjib fil-kapaċità ispiratorja b'Tovanor Breezhaler kien jixbah lil dak fl-ewwel ġurnata (200 ml), madanakollu kien hemm żieda ta' 89 sekonda (żieda ta' 21%) fl-ammont ta' ħin li wieħed jiflaħ għall-eżerċizzju mqabbel mal-plaċebo.
English: Infections and infestations Nasopharyngitis
Maltese: Infezzjonijiet u infestazzjonijiet Nażofarinġite
English: MA (EU) Number
Maltese: Numru tal-MA Isem (ivvintat)
English: Head: David Mackay
Maltese: Kap: David Mackay
English: Total grade AD AST 11
Maltese: Total grad AD AST 11
English: Parallel distribution
Maltese: Distribuzzjoni parallela
English: Head: Hans-Georg Wagner
Maltese: Kap: Hans-Georg Wagner
English: Head: Andreas Pott
Maltese: Kap: Andreas Pott
English: Arbitrations, Community referrals and opinions on scientific matters made to the EMEA (Input)
Maltese: Arbitration, Community referrals and opinions on scientific matters made to EMEA (Input)
English: MRL ext./mod.
Maltese: MRL ext.
English: Participate in international standardisation activities.
Maltese: Tipparteċipa f'attivitajiet internazzjonali ta' standardizzazzjoni.
English: COMMUNICATIONS AND NETWORKING
Maltese: KOMUNIKAZZJONIJIET U NETWORKING
English: EXECUTIVE DIRECTOR Thomas Lönngren
Maltese: DIRETTUR EŻEKUTTIV Thomas Lönngren
English: PMF/VAMF EMEA certificates
Maltese: Ċertifikati PMF/VAMF ta' l-EMEA
English: Permanent posts
Maltese: Karigi permanenti
English: Excluding the six additional posts for paediatrics legislation as per decision of the Management Board (EMEA/MB/244582/2007).
Maltese: 1 Esklużi s-sitt karigi addizzjonali għal-leġiżlazzjoni pedjatrika skond id-deċiżjoni tal-Bord Maniġerjali (EMEA/MB/244582/2007).
English: Applications for designation (input) Opinions on designation (output)
Maltese: Opinions on designation (output)
English: Medical information
Maltese: Informazzjoni medika
English: Annex 1 EMEA structure
Maltese: Anness 1 Struttura ta' l-EMEA
English: Annex 2 EMEA establishment plan 2006-2008
Maltese: Anness 2 Tabella ta' l-impjegati ta' l-EMEA 2006-2008
English: Total grade AST Grand Total
Maltese: Total grad AST Total kumplessiv
English: applications
Maltese: Generic applications
English: Type-I variation applications Type-II variation applications Line-extension applications
Maltese: Type-I-variation applications
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 tal-plasma-master-file (PMF) u tal-vaccine-antigen-master-file (VAMF) ta' prodott mediċinali f'konformità ma' l-arranġamenti stabbiliti fil-leġiżlazzjoni Komunitarja.
English: Applications for new medicinal products Generic applications
Maltese: Applications for new medicinal products
English: Function group & Grade Permanent posts
Maltese: Grupp ta' funzjoni u Grad Karigi permanenti
English: Martin HARVEY ALLCHURCH Direct telephone (44-20) 74 18 84 27 E-mail: press@emea.europa.eu
Maltese: Martin HARVEY ALLCHURCH Linja telefonika diretta (44-20) 74 18 84 27 E-mail: press@emea.europa.eu
English: Arbitration and Community referrals
Maltese: 2.8 Arbitraġġ u riferenzi Komunitarji
English: New applications for veterinary medicines (Input)
Maltese: New applications for veterinary medicines received/forecast (Input)
English: PDCO Paediatric Committee
Maltese: PDCO Kumitat Pedjatriku
English: The Agency anticipates that the number of delegates coming to the Agency in 2008 will increase by 8% (to 8,400) and the number of meetings by 12% compared to 2007.
Maltese: L-Aġenzija tantiċipa li n-numru ta' delegati li ġejjin fl-Aġenzija fl-2008 se jiżdied bi 8% (sa 8,400) u n-numru ta' laqgħat bi 12% meta mqabbla mas-sena 2007.
English: The Agency's full work programme for 2008, which was adopted by the Management Board on 13 December 2007, can be found on the Agency's website: www.emea.europa.eu
Maltese: Il-programm sħiħ ta' ħidma ta' l-Aġenzija għall-2008, li kien adottat mill-Bord Maniġerjali fit13 ta' Diċembru 2007, huwa disponibbli fuq is-sit ta' l-internet ta' l-Aġenzija: www.emea.europa.eu
English: Initial evaluation
Maltese: Total initial notifications
English: Advanced therapies and other emerging therapies and new technologies
Maltese: 3.3 Terapiji avvanzati u terapiji emerġenti oħrajn u teknoloġiji ġodda
English: The HMPC plans to establish 20 monographs and 10 list entries this year.
Maltese: L-HMPC jippjana li jistabbilixxi 20 monografija u 10 inklużjonijiet fil-lista din is-sena.
English: Arbitrations and Community referrals (Input)
Maltese: Arbitration and Community referrals received.forecast (Input)
English: 1.6. International cooperation
Maltese: 1.6 Kooperazzjoni internazjonali
English: The number of initial notifications received in 2008 is expected to be comparable to that for 2007.
Maltese: Fl-2008, in-numru ta' notifiki inizjali rċevuti huwa mistenni li jkun komparabbli ma' dak ta' l-2007.
English: SME Office contact point:
Maltese: Linja telefonika diretta:
English: GCP and pharmacovigilance GLP
Maltese: GCP and pharmacovigilance
English: Direct telephone: (44-20) 75 23 71 07 Fax: (44-20) 74 18 85 95
Maltese: (44-20) 75 23 71 07 Fax: (44-20) 74 18 85 95
English: Type-I variations Type-II variations (incl.
Maltese: Type-II variations (incl. line extensions)
English: A wide range of documents are published by the EMEA, including press releases, general information documents, annual reports and work programmes.
Maltese: Firxa wiesgħa ta' dokumenti huma ppubblikati mill-EMEA, inklużi stqarrijiet għall-istampa, dokumenti ta' informazzjoni ġenerali, rapporti annwali u programmi ta' ħidma.
English: Temporary posts
Maltese: Karigi temporanji
English: Cooperation with the US FDA also covers paediatric medicinal products.
Maltese: Il-kooperazzjoni ma' l-FDA ta' l-Istati Uniti tkopri wkoll prodotti mediċinali pedjatriċi.
English: Staff 11 Staff in active employment 13 Mission expenses 14 Socio-medical infrastructure 15 Exchange of civil servants and experts 16 Social welfare 17 Entertainment and representation expenses 18 Staff insurances Total Title 1 Building/equipment 20 Investment in immovable property, renting of building and associated costs 21 Expenditure on data processing 22 Movable property and associated costs 23 Other administrative expenditure 24 Postage and communications 25 Expenditure on formal and other meetings Total Title 2 Operational expenditure 300 Meetings 301 Evaluations 302 Translation 303 Studies and consultants 304 Publications 305 Community programmes Total Title 3
Maltese: Infiq għal laqgħat formali u laqgħat oħra Total Titolu 2 Infiq operattiv 300 Laqgħat 301 Valutazzjonijiet 302 Traduzzjonijiet 303 Studji u konsulenza 304 Pubblikazzjonijiet 305 Programmi Komunitarji Total Titolu 3
English: The EMEA will continue to be involved in the work of the ICH, VICH and Codex Alimentarius, will participate in international standardisation activities, and will further collaborate with the WHO, the World Organisation for Animal Health and other international organisations.
Maltese: L-EMEA se tkompli tkun involuta fix-xogħol ta' l-ICH, VICH, il-Codex Alimentarius, se tipparteċipa f'attivitajiet internazzjonali ta' standardizzazzjoni u se tikkollabora iżjed mal-WHO, lOrganizzazzjoni Dinjija tas-Saħħa ta' l-Annimali u organizzazzjonijiet internazzjonali oħra.
English: CAP non-EEA reports non-CAP EEA reports non-CAP non-EEA reports
Maltese: CAP non-EEA reports
English: on the Internet at www.emea.europa.eu by e-mail request to info@emea.europa.eu by fax to (44-20) 74 18 86 70 by writing to:
Maltese: mill-internet fuq www.emea.europa.eu fuq talba permezz tal-posta elettronika info@emea.europa.eu bil-fax fuq (44-20) 7418 8670 bil-miktub lil:
English: The Agency will develop the next phase of the EudraPharm database (EU telematics projects), introducing multilingual navigation and content, advanced search capability and better-structured product information.
Maltese: L-Aġenzija se tiżviluppa l-fażi li jmiss tad-database ta' l-EudraPharm (proġetti tat-telematika ta' lUE), tintroduċi navigazzjoni u kontenut multilingwi, kapaċità ta' riċerka avvanzata u informazzjoni strutturata aħjar tal-prodott.
English: The Agency's Road Map contains a number of strategic objectives in the field of transparency and provision of information.
Maltese: Ir-Road Map ta' l-Aġenzija għandha numru ta' objettivi strateġiċi fil-qasam tat-trasparenza u lforniment ta' informazzjoni.
English: Foster transparency, communication and provision of information
Maltese: Tadotta t-trasparenza, komunikazzjoni u l-forniment ta' informazzjoni
English: PRE-AUTHORISATION EVALUATION OF MEDICINES FOR HUMAN USE Head: Patrick Le Courtois
Maltese: Kap: Patrick Le Courtois
English: Melanie CARR
Maltese: Melanie CARR Linja telefonika diretta:
English: Scientific advice and follow-up requests Protocol assistance and follow-up requests
Maltese: Protocol assistance and follow-up requests
English: Silvia DOMINGO ROIGÉ Direct telephone: (44-20) 74 18 85 52 Fax: (44-20) 74 18 85 45
Maltese: DOMINGO ROIGÉ Linja telefonika diretta: (44-20) 74 18 85 52 Fax:
English: This trend is mirrored by the increased number of delegates from Member States attending meetings at the Agency.
Maltese: Din it-tendenza hija riflessa fin-numru li żdied ta' delegati minn Stati Membri li jattendu laqgħat fl-Aġenzija.
English: Regulatory affairs and organisational support
Maltese: Affarijiet regolatorji u sostenn ta' lorganizzazzjoni
English: GMP, GCP, GLP and pharmacovigilance inspections
Maltese: 2.12 GMP, GCP, GLP u spezzjonijiet ta' farmakoviġilanza
English: The Agency will also progress the validation of the EudraVigilance data-analysis system (EU telematics project).
Maltese: L-Aġenzija sejra ttejjeb ukoll il-validazzjoni tas-sistema ta' l-analiżi tad-data tal-EudraVigilance (il-proġett tat-telematika ta' l-UE).
English: EEA and non-EEA ADR reports transmitted to the EMEA for centralised authorisation procedure (CAP) and non-CAP products
Maltese: Actual and estimated numbers of EEA and non-EEA, ADR reports transmitted to the EMEA
English: The EMEA PMF/VAMF-certification process is an assessment of the PMF/VAMF-application dossier.
Maltese: Il-proċess ta' ċertifikazzjoni tal-PMF/VAMF ta' l-EMEA huwa valutazzjoni tad-dossier ta' applikazzjoni talPMF/VAMF.
English: The EMEA will continue to work on a new transitional programme IPA (instrument for pre-accession) for supporting the participation of Croatia, Turkey and the Former Yugoslav Republic of Macedonia as observers in meetings, training courses, and workshops planned by the EMEA.
Maltese: L-EMEA se tkompli taħdem fuq programm ġdid ta' tranżizzjoni IPA (strument għal qabel l-adeżjoni) biex tappoġġa l-parteċipazzjoni tal-Kroazja, tat-Turkija u ta' l-ex Repubblika Jugoslava tal-Maċedonja, bħala osservaturi fil-laqgħat, korsijiet ta' taħriġ, u workshops ippjanati mill-EMEA.
English: Another area of activity will relate to the continued improvement of the EudraVigilance database.
Maltese: Qasam ieħor ta' attività sejjer ikollu x'jaqsam mat-titjib kontinwu tad-database ta' l-EudraVigilance.
English: Fees
Maltese: Annessi
English: Payable initial notifications Total initial notifications Notifications of a change
Maltese: Payable initial notifications
English: Transparency, provision of information and interaction with patients and healthcare professionals
Maltese: 1.2 Trasparenza, informazzjoni u interazzjoni ma' pazjenti u professjonisti fil-kura tas-saħħa
English: Review and further strengthen collaboration with the FDA in the context of the EU/US FDA confidentiality arrangements; implement the EU/Japanese Health Authorities and EU/Health Canada confidentiality arrangements.
Maltese: Tirrevedi u tkompli ssaħħaħ il-kollaborazzjoni ma' l-FDA fil-kuntest ta' arranġamenti ta' kunfidenzjalità ta' l-UE/FDA ta' l-Istati Uniti; timplimenta l-arranġamenti ta' kunfidenzjalità bejn l-UE u l-Aworitajiet tas-Saħħa Ġappuniżi u bejn l-UE u Health Canada;
English: For product quality defects and recalls see www.emea.europa.eu/inspections/defectinstruction.html for instructions and contact points
Maltese: E-mail: vet-phv@emea.europa.eu Għal difetti fil-kwalità tal-prodott u għall-irtirar tal-prodott www.emea.europa.eu/inspections/defectinstruction.html għall-istruzzjonijiet u għall-punti ta' kuntatt
English: A number of guidance documents on advanced-therapy medicinal products and new technologies will be developed in consultation with interested parties.
Maltese: Numru ta' dokumenti ta' gwida fuq il-prodotti mediċinali b'terapija avvanzata u teknoloġiji ġodda sejrin jiġu żviluppati b'konsultazzjoni mal-partjiiet interessati.
English: ref.: EMEA/MB/556125/2007
Maltese: EMEA/172898/2008
English: TOTAL REVENUE
Maltese: INFIQ TOTALI
English: Scientific-advice requests (Input)
Maltese: Scientific advice requests received/forecast (input)
English: The EMEA/CHMP working group with healthcare professionals' organisations will finalise recommendations that will improve these interactions.
Maltese: Ilgrupp ta' ħidma ta' l-EMEA/CHMP bil-parteċipazzjoni ta' organizzazzjonijiet ta' professjonisti fil-kura tas-saħħa se jiffinalizzaw rakkomandazzjonijiet li se jtejbu dawn l-interazzjonijiet.
English: This situation is expected to continue for 2008.
Maltese: Din issitwazzjoni hija mistennija li tkompli fl-2008.
English: Safety of veterinary medicines
Maltese: Sigurtà ta' mediċini veterinarji
English: This will be the sixth year of implementation by the Agency, with national competent authorities, of the EU telematics programme.
Maltese: Din se tkun is-sitt sena ta' implimentazzjoni mill-Aġenzija, ma' awtoritajiet nazzjonali kompetenti, talprogramm ta' proġetti tat-telematika ta' l-UE.
English: Reinforce the Agency's interaction with patients and healthcare professionals, building on the initiatives undertaken in 2006 and 2007 and taking due account of satisfaction surveys.
Maltese: Issaħħaħ l-interazzjoni ta' l-Aġenzija mal-pazjenti u mal-professjonisti fil-kura tas-saħħa, tibni fuq inizjattivi mwettqa fl-2006 u 2007 filwaqt li tqis l-istħarriġ tas-sodisfazzjon.
English: In order to complete the development of EudraVigilance Veterinary, the Agency's Management Board adopted the EudraVigilance Veterinary Action Plan.
Maltese: Sabiex iwettaq l-iżvilupp ta' l-EudraVigilance Veterinajra, il-Bord Maniġerjali ta' l-Aġenzija adotta lPjan ta' Azzjoni Veterinjarja ta' l-EudraVigilance.
English: The constant monitoring of the safety of medicines after authorisation (‘pharmacovigilance') is an important part of the work of the national competent authorities and the EMEA.
Maltese: Il-monitoraġġ kostanti tas-sigurtà tal-mediċini wara l-awtorizzazzjoniet ('farmakoviġilanza') huwa parti importanti tax-xogħol ta' l-awtoritajiet nazzjonali kompetenti u l-EMEA.
English: Information technology
Maltese: Teknoloġija ta' linformatika
English: IQM adviser
Maltese: Ġestjoni integrata tal-kwalità - Verifika interna Konsulent IQM
English: The development of the electronic Application Form (eAF) for human medicinal products will be completed in 2008 (EU telematics project); A system to support the use of the eAF standard will also be developed and maintained by the Agency in connection with the centralised procedure.
Maltese: L-iżvilupp tal-Formola ta' l-Applikazzjoni elettronika (eAF) għall-prodotti mediċinali għall-użu tal-bniedem se tkun lesta fl-2008 (proġett tattelematika ta' l-UE); Sistema li tappoġġa l-użu ta' eAF standard se tkun ukoll żviluppata u miżmuma mill-Aġenzija b'konnessjoni mal-proċedura ċentralizzata.
English: HMPC Committee on Herbal Medicinal Products
Maltese: HMPC Kumitat dwar ilProdotti Mediċinali Erbali