FrancophonIA/ELRC3.0 huggingface dataset:
English: Norvir is used in combination with other HIV medicines to treat patients over two years of age who are infected with human immunodeficiency virus type 1 (HIV 1), a virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Norvir jintuża ma' mediċini oħra kontra l-HIV fit-trattament ta' pazjenti 'l fuq minn sentejn li jkunu infettati mill-virus tal-immunodefiċjenza umana tat-tip 1 (HIV 1), virus li jikkawża s-sindromu minn immunodefiċjenza akkwiżita (AIDS).
English: In the first study of Norvir as an antiviral medicine, 16% of the Norvir-treated patients (86 out of 543) experienced a worsening of disease or died, compared with 33% of the patients taking placebo (181 out of 547).
Maltese: Fl-ewwel studji ta' Norvir bħala mediċina antivirali, 16% tal-pazjenti ttrattati b'Norvir (86 minn 543) qalbu għall-agħar jew mietu, meta mqabbel ma' 33% tal-pazjenti li kienu qegħdin jieħdu plaċebo (181 minn 547).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Norvir on 26 August 1996.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Norvir valida fl-Unjoni Ewropea kollha fis-26 ta' Awwissu 1996.
English: The first compared Norvir with placebo (a dummy treatment) in 1,090 adults, as an add-on to the antiviral medicines the patients were already taking.
Maltese: L-ewwel studju qabbel Norvir ma' plaċebo (trattament finta) f'1,090 adult, bħala żieda mal-mediċini antivirali li l-pazjenti jkunu qed jieħdu diġà.
English: A risk management plan has been developed to ensure that Norvir is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jassigura li Norvir jintuża bl-aktar mod sigur possibbli.
English: What is Norvir?
Maltese: X'inhu Norvir?
English: This means that it blocks a viral enzyme called protease, which is involved in the reproduction of HIV.
Maltese: Dan ifisser li jimblokka enzima virali msejħa proteażi, li għandha sehem fir-riproduzzjoni tal-HIV.
English: The second study compared Norvir taken alone, zidovudine (another antiviral medicine) taken alone and the combination of Norvir and zidovudine in 356 adults who had not taken treatment for HIV infection before.
Maltese: It-tieni studju qabbel Norvir meħud waħdu, zidovudine (mediċina antiviral oħra) meħud waħdu u l-kombinazzjoni ta' Norvir u zidovudine fi 356 adult li ma kinux ħadu trattament għall-infezzjoni tal-HIV qabel.
English: At higher doses, ritonavir acts as a ‘protease inhibitor'.
Maltese: B'dożi aktar għolja, ir-ritonavir jaġixxi bħala aġent "inibitur tal-proteażi".
English: Why has Norvir been approved?
Maltese: Għaliex ġie approvat Norvir?
English: CD4 T cells are white blood cells that are important in helping to fight infections, but which are killed by HIV.
Maltese: Iċċelloli CD4 T huma ċelloli tad-demm bojod li huma importanti fil-ġlieda kontra l-infezzjonijiet, imma li jinqatlu bl-HIV.
English: Norvir can also be used as an HIV medicine, where it acts directly against the virus.
Maltese: Norvir jista' jintuża wkoll bħala mediċina kontra l-HIV, fejn jaġixxi direttament kontra l-virus.
English: When the active substance, ritonavir, acts as a ‘booster' it does so by slowing down the rate at which certain antiviral medicines given in combination with ritonavir are broken down in the body.
Maltese: Meta s-sustanza attiva, ir-ritonavir, taġixxi bħala "buwster", dan isir billi titnaqqas ir-rata li biha ċerti mediċini antivirali li jingħataw flimkien mar-ritonavir jitkissru fil-ġisem.
English: Norvir, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Maltese: Norvir, meħud flimkien ma' mediċini antivirali oħra, inaqqas l-ammont ta' HIV fid-demm u jżommu f'livell baxx.
English: Norvir, in combination with other antiviral medicines, also reduced viral loads in children.
Maltese: Norvir, meħud flimkien ma' mediċini antivirali oħra, naqqas ukoll il-tagħbija virali fit-tfal.
English: Norvir has been studied as a booster in clinical studies that were designed to assess the effects of the antiviral medicines that it is used to boost.
Maltese: Norvir ġie studjat bħala buwster fi studji kliniċi li tfasslu biex jivvalutaw l-effetti tal-mediċini antivirali li s-soltu jibbuwstja.
English: The recommended dose for adults (aged 18 years or over) is 600 mg twice a day.
Maltese: Għalladulti (minn 18-il sena 'l fuq), id-doża rakkomandata hija ta' 600 mg darbtejn kuljum.
English: What measures are being taken to ensure the safe and effective use of Norvir?
Maltese: X'miżuri qed jitteħdu biex jassiguraw l-użu sigur u effikaċi ta' Norvir?
English: How has Norvir been studied?
Maltese: Kif ġie studjat Norvir?
English: When the enzyme is blocked, the virus does not reproduce normally, slowing down its rate of multiplication.
Maltese: Meta l-enzima tiġi mblokkata, il-virus ma jirriproduċix ruħu b'mod normali, u jittardja r-rata ta' multiplikazzjoni.
English: What is the risk associated with Norvir?
Maltese: Għal xiex jintuża Norvir?
English: Norvir does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Maltese: Norvir ma jfejjaqx infezzjoni tal-HIV jew l-AIDS, iżda jista' jtawwal iż-żmien qabel ma ssir ħsara lis-sistema immunitarja u l-iżvilupp ta' infezzjonijiet u mard marbut mal-AIDS.
English: Treatment with Norvir should be given by a doctor who has experience in the treatment of HIV infection.
Maltese: Il-kura b'Norvir għandha tinbeda minn tabib li jkollu esperjenza fit-trattament tal-infezzjoni tal-HIV.
English: The main measure of effectiveness was the change in the levels of HIV in the blood (viral load) and CD4 T cell levels in the blood (CD4 cell count).
Maltese: Il-kejl ewlieni tal-effikaċja kien it-tibdil fil-livelli tal-HIV fid-demm (tagħbija virali) u l-livelli taċ-ċelloli CD4 T fid-demm (l-għadd taċ-ċelloli CD4 ).
English: For the full list of all restrictions and side effects reported with Norvir, see the package leaflet.
Maltese: Għal-lista sħiħa taleffetti sekondarji kollha rrappurtati b'Norvir, ara l-fuljett ta' tagħrif.
English: The CHMP decided that Norvir's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Norvir huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: 1.850 GBq/ml Radiopharmaceutical precursor
Maltese: 1.850 GBq/ml
English: Invented name Strength Pharmaceutical form
Maltese: Għamla farmaċewtika
English: EU/1/18/1301/001
Maltese: UE/1/18/1301/001
English: 2 mg/ml
Maltese: 2 mg/mL Konċentrat għassoluzzjoni għallinfużjoni
English: MA (EU) number (Invented)
Maltese: Numru tal-EU (MA)
English: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
Maltese: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
English: • Report from BNP Paribas Real Estate.
Maltese: • Rapport minn BNP Paribas Real Estate.
English: Annual report 2010
Maltese: Rapport annwali 2010
English: Mary G. Baker (morning session) Mike O'Donovan
Maltese: Baker (sessjoni ta' filgħodu) Mike O'Donovan
English: Held in London on 16-17 March 2011
Maltese: Li saret f'Londra fis-16-17 ta' Marzu 2011
English: Brigitte Batliner (Liechtenstein) Gro Ramsten Wesenberg (Norway)
Maltese: Brigitte Batliner (Il-Liechtenstein) Gro Ramsten Wesenberg (In-Norveġja)
English: • Zuzana O'Callaghan.
Maltese: O'Callaghan.
English: • A meeting with the medical device authorities.
Maltese: • Laqgħa mal-awtoritajiet tal-apparat mediku.
English: • [EMA/MB/62985/2011] Information technology.
Maltese: • [EMA/MB/62985/2011] Teknoloġija tal-Informatika.
English: [EMA/MB/19969/2011] The agenda was adopted.
Maltese: [EMA/MB/19969/2011] L-aġenda ġiet adottata.
English: (Ernst & Young report), presented by Nerimantas Steikūnas, of the EMA;
Maltese: (rapport ta' Ernst & Young), ippreżentat minn Nerimantas Steikūnas, tal-EMA;
English: 22 March 2011
Maltese: It-22 ta' Marzu 2011
English: Rannveig Gunnarsdóttir (Iceland)
Maltese: Rannveig Gunnarsdóttir (LIslanda)
English: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX XXXXXXXXXXXXXXXXXXXXXXXXXXX
Maltese: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX XXXXXXXXXXXXXXXXXXXXXXXXXXX
English: Guiseppe Nisticó Björn Lemmer
Maltese: Il-Parlament Ewropew Guiseppe Nisticó Björn Lemmer
English: • [EMA/MB/805742/2011] Preliminary work programme.
Maltese: • [EMA/MB/805742/2011] Programm ta' ħidma preliminari.
English: Therefore we cannot give our approval for current activities of Thomas Lönngren."
Maltese: Għalhekk, aħna ma nistgħux nagħtu l-approvazzjoni tagħna għallattivitajiet attwali ta' Thomas Lönngren."
English: • Presentation: The EMA in 2010 - highlights.
Maltese: L-EMA fl-2010 - punti prinċipali.
English: There has been a significant increase in the numbers of paediatric procedures (around 20% higher than in 2009) and inspections (a 30% increase), and a very high increase in veterinary scientific advice applications (21 applications received, which is a 90% increase).
Maltese: Kien hemm żieda sinjifikanti fin-numri ta' proċeduri pedjatriċi (madwar 20% ogħla mill-2009) u spezzjonijiet (żieda ta' 30%), u żieda għolja ħafna fl-applikazzjonijiet veterinarji għal pariri xjentifiċi (ġew riċevuti 21 applikazzjoni, jiġifieri żieda ta' 90%).
English: The provisional draft budget (PDB) 2012 amounts to EUR 238.4 million, representing an increase of EUR 29.5 million over the 2011 budget.
Maltese: L-abbozz provviżorju tal-baġit (PDB) 2012 jammonta għal EUR 238.4 miljun, li jirrappreżentaw żieda ta' EUR 29.5 miljun fuq il-baġit tal-2011.
English: Management Board consultation procedure for CHMP and CVMP nominations: follow-up from December 2010 discussion
Maltese: Proċedura ta' konsultazzjoni tal-Bord ta' Tmexxija għannominazzjonijiet fis-CHMP u s-CVMP: segwitu middiskussjoni ta' Diċembru 2010
English: • Road map to 2015.
Maltese: • Pjan direzzjonali għall-2015.
English: [EMA/MB/105478/2011] The Board adopted the revised consultation procedure and the revised CV template.
Maltese: [EMA/MB/105478/2011] Il-Bord adotta l-proċedura ta' konsultazzjoni riveduta u t-template tas-CV riveduta.
English: The Board adopted the decision with two votes against.
Maltese: Il-Bord adotta d-deċiżjoni b'żewġ voti kontra.
English: Following the appointment of Marcus Müllner as Heads of Medicines Agencies (HMA) representative to the Management Board Telematics Committee (MBTC), the Chair invited members to express their interest to represent the Management Board at the MBTC.
Maltese: Wara l-ħatra ta' Marcus Müllner bħala rappreżentant tal-Kapijiet tal-Aġenziji tal-Mediċini (HMA) filKumitat tat-Telematika tal-Bord ta' Tmexxija (MBTC), il-President stieden lill-membri biex jesprimu linteress tagħhom li jirrappreżentaw lill-Bord ta' Tmexxija fl-MBTC.
English: [EMA/MB/218686/2011] The Management Board adopted a decision giving its approval for the currently declared activities of Thomas Lönngren, who stepped down as Executive Director of the Agency on 31 December 2010.
Maltese: [EMA/MB/218686/2011] Il-Bord ta' Tmexxija adotta deċiżjoni li tagħti l-approvazzjoni għall-attivitajiet iddikjarati attwalment ta' Thomas Lönngren, li rriżenja mill-kariga ta' Direttur Eżekuttiv tal-Aġenzija fil31 ta' Diċembru 2010.
English: Minutes from the 69th meeting, held on 7 October 2010
Maltese: 3. Minuti mid-69 laqgħa, li saret fis-7 ta' Ottubru 2010
English: • [EMA/807799/2010] Annual report 2010 of the Agency's Internal Audit.
Maltese: • [EMA/807799/2010] Rapport annwali 2010 tal-Verifika Interna tal-Aġenzija.
English: Request of the former Executive Director for authorisation of external activities after leaving the service
Maltese: Talba tad-Direttur Eżekuttiv preċedenti għallawtorizzazzjoni tal-attivitajiet esterni wara li jħalli s-servizz
English: • The public consultation on the Transparency Directive (a proposal for the review of the Directive may be made by the end of 2011).
Maltese: • Il-konsultazzjoni pubblika dwar id-Direttiva tat-Trasparenza (tista' ssir proposta għar-reviżjoni tadDirettiva sal-aħħar tal-2011).
English: These comprised six consultations on new membership in the CHMP and CVMP, the adoption of the non-automatic carryover of appropriations from 2010 to 2011, and the adoption of the minutes of the 69th meeting of the Management Board from 16 December, as indicated below:
Maltese: Dawn kienu jikkonsistu minn sitt konsultazzjonijiet dwar is-sħubija ġdida fis-CHMP u s-CVMP, ladozzjoni tat-trasferiment mhux awtomatiku tal-approprjazzjonijiet mill-2010 għall-2011, u l-adozzjoni tal-minuti tad-69 laqgħa tal-Bord ta' Tmexxija mis-16 ta' Diċembru, kif indikat hawn taħt:
English: A smaller number of generic medicines in the centralised procedure comes as a result of the European Commission's policy on multiple applications for centrally authorised products.
Maltese: Numru iżgħar ta' mediċini ġeneriċi fil-proċedura ċentralizzata jiġi bħala riżultat tal-politika tal-Kummissjoni Ewropea dwar applikazzjonijiet multipli għal prodotti awtorizzati ċentralment.
English: • implementation of the new pharmacovigilance legislation, presented by Noël Wathion, of the EMA;
Maltese: • l-implimentazzjoni tal-leġiżlazzjoni l-ġdida dwar il-farmakoviġilanza, ippreżentat minn Noël Wathion,
English: Kingdom, finalised on 11 January 2011.
Maltese: iffinalizzata fil-11 ta' Jannar 2011.
English: • [EMA/MB/111120/2011] Summary of transfers of appropriations in the budget 2010.
Maltese: • [EMA/MB/111120/2011] Sommarju tat-trasferimenti tal-approprjazzjonijiet fil-baġit tal-2010.
English: • No 01/2011 - the appointment of Helen JUKES as CVMP member, proposed by the United
Maltese: • Nru 01/2011 - il-ħatra ta' Helen JUKES bħala membru tas-CVMP, proposta mir-Renju Unit,
English: During the period from 25 November 2010 to 15 March 2011, the Board finalised eight written procedures.
Maltese: Matul il-perjodu mill-25 ta' Novembru 2010 sal-15 ta' Marzu 2011, il-Bord iffinalizza tmien proċeduri bil-miktub.
English: At the last meeting, the EMA Chair handed over the chairmanship for the group to the Chair of EFSA.
Maltese: Fl-aħħar laqgħa, il-President tal-EMA għadda l-presidenza għall-grupp lill-President tal-EFSA.
English: The Chair invited the Board members to volunteer as topic coordinators for the analysis and assessment of the Acting Executive Director's Annual Activity Report 2010.
Maltese: Il-President stieden lill-membri tal-Bord biex jivvolontarjaw bħala koordinaturi tas-suġġetti għall-analiżi u l-valutazzjoni tar-Rapport tal-Attivitajiet Annwali tal-2010 tal-Aġent Direttur Eżekuttiv.
English: The Acting Executive Director met with Commissioner Dalli on 11 March 2011.
Maltese: L-Aġent Direttur Eżekuttiv iltaqa' mal-Kummissarju Dalli fil-11 ta' Marzu 2011.
English: • No 32/2010 - the appointment of Dana Gabriela MARIN as CHMP alternate, proposed by Romania,
Maltese: • Nru 32/2010 - il-ħatra ta' Dana Gabriela MARIN bħala membru supplenti tas-CHMP, proposta mir
English: • [EMA/786515/2010] Annual report 2010 of the Agency's Audit Advisory Committee.
Maltese: • [EMA/786515/2010] Rapport annwali 2010 tal-Kumitat Konsultattiv tal-Verifika tal-Aġenzija.
English: "We believe that Thomas Lönngren's advisory role regarding strategic development of the companies, as well as business plans and investment opportunities are strictly connected with privileged information and confidential data that he gained during his mandate as EMA Executive Director.
Maltese: "Aħna nemmnu li r-rrwol konsultattiv ta' Thomas Lönngren fir-rigward tal-iżvilupp strateġiku talkumpaniji, kif ukoll il-pjanijiet kummerċjali u l-opportunitajiet ta' investiment huma strettament marbuta mal-informazzjoni privileġġata u d-dejta kunfidenzjali li huwa kiseb matul il-mandat tiegħu bħala Direttur Eżekuttiv tal-EMA.
English: 4 February 2011.
Maltese: Jannar 2011.
English: • 69th Management Board minutes from 16 December 2010, finalised on 11 February 2011.
Maltese: • Il-minuti tad-69 laqgħa tal-Bord ta' Tmexxija mis-16 ta' Diċembru 2010, iffinalizzati fil-11 ta' Frar
English: The Board stressed its role in protecting the public interest and the reputation of the Agency.
Maltese: Il-Bord enfasizza ir-rwol tiegħu fil-protezzjoni tal-interess pubbliku u tar-reputazzjoni tal-Aġenzija.
English: 1 Committee for Medicinal Products for Human Use (CHMP) or Committee for Medicinal Products for Veterinary Use (CVMP).
Maltese: 1 Il-Kumitat għall-Prodotti Mediċinali għal Użu mill-Bniedem (CHMP) jew il-Kumitat għall-Prodotti Mediċinali għal Użu Veterinarju (CVMP).
English: • The progress on the five calls within the process on corporate responsibility in the field of pharmaceuticals: coordinated access to orphan medicinal products, capacity building on contractual agreements for innovative medicines, market access for biosimilars, facilitating supply in small markets and promoting a good governance for non-prescription medicines.
Maltese: • Il-progress dwar il-ħames sejħiet fi ħdan il-proċess dwar ir-responsabbiltà korporattiva fil-qasam tal-prodotti farmaċewtiċi: l-aċċess ikkoordinat għal prodotti mediċinali orfni, il-bini tal-kapaċità dwar ftehimiet kuntrattwali għal mediċini innovattivi, l-aċċess tas-suq għal mediċini bijosimili, liffaċilitar tal-provvista fi swieq żgħar u l-promozzjoni ta' governanza tajba għal mediċini mingħajr riċetta ta' tabib.
English: • [EMA/MB/784841/2011] Preliminary draft budget.
Maltese: • [EMA/MB/784841/2011] Abbozz preliminari tal-baġit.
English: • Plans for limited and targeted amendement to the Penalties Regulation (focusing on the scope of the Regulation; a public consultation will be launched in spring 2011).
Maltese: • Pjanijiet għal emenda limitata u mmirata għar-Regolament dwar il-Pieni (li jiffokaw fuq l-ambitu tar-Regolament; fir-rebbiegħa tal-2011 ser titneda konsultazzjoni pubblika).
English: • No 03/2011 - the appointment of Zanda AUCE as CVMP member, proposed by Latvia, finalised on
Maltese: • Nru 03/2011 - il-ħatra ta' Zanda AUCE bħala membru tas-CVMP, proposta mil-Latvja, iffinalizzata fl-4 ta' Frar 2011.
English: It was also agreed that chairs may ask for the possibility to sit as observers in the meetings of the boards of other agencies.
Maltese: Intlaħaq qbil ukoll li l-presidenti jistgħu jitolbu għall-possibbiltà li jipparteċipaw bħala osservaturi fil-laqgħat tal-bordijiet ta' aġenziji oħrajn.
English: • No 04/2011 - the appointment of Lyubina TODOROVA as CHMP alternate, proposed by Bulgaria,
Maltese: • Nru 04/2011 - il-ħatra ta' Lyubina TODOROVA bħala membru supplenti tas-CHMP, proposta mill
English: The KPIs enable the performance of the newly established cooperation agreements with national competent authorities to be monitored.
Maltese: Il-KPIs jippermettu li tiġi mmonitorjata il-prestazzjoni tal-ftehimiet ta' kooperazzjoni stabbiliti ġodda mal-awtoritajiet nazzjonali kompetenti.
English: Following such a uniform position at the EU level, a proposal can be made at the level of te International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), with a view to changing the format of the dossier to enable automatic publication of application information without releasing information that is commercially confidential or contains personal data.
Maltese: Wara tali pożizzjoni uniformi fil-livell tal-UE, tista' ssir proposta fillivell tal-Konferenza Internazzjonali dwar l-Armonizzazzjoni tar-Rekwiżiti Tekniċi għar-Reġistrazzjoni tal-Prodotti Farmaċewtiċi għall-Użu mill-Bniedem (ICH), bil-għan li jinbidel il-format tad-dossier sabiex tkun tista' ssir il-pubblikazzjoni awtomatika tal-informazzjoni tal-applikazzjoni mingħajr ma tinħareġ informazzjoni li tkun kummerċjalment kunfidenzjali jew li jkun fiha dejta personali.
English: [EMA/MB/80540/2011] The Management Board adopted the revised charter of the accounting officer, which clarifies the accounting officer's obligations and responsibilities in line with the Financial Regulation.
Maltese: [EMA/MB/80540/2011] Il-Bord ta' Tmexxija adotta l-karta riveduta tal-uffiċjal tal-kontabilità, li tikkjarifika l-obbligi u r-responsabbiltajiet tal-uffiċjal tal-kontabilità skont ir-Regolament Finanzjarju.
English: The Acting Executive Director updated the Board on the issue of products containing benfluorex, saying that the Agency had provided a platform for discussion but had not had a mandate to deal with national products.
Maltese: L-Aġent Direttur Eżekuttiv aġġorna lill-Bord dwar il-kwistjoni tal-prodotti li fihom il-benfluorex, fejn qal li l-Aġenzija pprovdiet pjattaforma għad-diskussjoni, iżda ma kellhiex mandat biex tittratta prodotti nazzjonali.
English: • [EMA/MB/78578/2011] Update report on the Agency's implementation of the EU telematics strategy.
Maltese: • [EMA/MB/78578/2011] Rapport ta' aġġornament dwar l-implimentazzjoni mill-Aġenzija tal istrateġija tat-telematika tal-UE.
English: • The enquiry by MEPs into off-label use of medicines in the EU (the MEPs' letters will be included on the April HMA agenda).
Maltese: • L-investigazzjoni mill-MPE dwar l-użu ‘off-label' tal-mediċini fl-UE (l-ittri tal-MPE sejrin jiġu inklużi fuq l-aġenda tal-HMA ta' April).
English: • [EMA/634206/2010] Minutes from the latest Management Board Telematics Committee meeting
Maltese: • [EMA/634206/2010] Minuti mill-aħħar laqgħa tal-Kumitat tat-Telematika tal-Bord ta' Tmexxija tal
English: • No 33/2010 - the appointment of Dalibor VALÍK as CHMP member, proposed by the Czech
Maltese: • Nru 33/2010 - il-ħatra ta' Dalibor VALÍK bħala membru tas-CHMP, proposta mir-Repubblika Ċeka,
English: • Non-automatic carryover of appropriations from 2010 to 2011, finalised on 13 January 2011.
Maltese: • It-trasferiment mhux awtomatiku tal-approprjazzjonijiet mill-2010 għall-2011, iffinalizzat fit-13 ta'
English: The Board adopted the establishment plan of 612 posts, which represents an increase of 45 posts required for the preparation and implementation of the pharmacovigilance legislation.
Maltese: Il-Bord adotta l-pjan ta' stabbiliment ta' 612-il kariga, li jirrappreżenta żieda ta' 45 kariga meħtieġa għat-tħejjija u l-implimentazzjoni tal-leġiżlazzjoni dwar il-farmakoviġilanza.
English: The Management Board also suggested considering how the training needs of regulators can be reflected in the projects undertaken under the Innovative Medicines Initiative (IMI).
Maltese: Il-Bord ta' Tmexxija ssuġġerixxa wkoll li jiġi kkunsidrat kif il-ħtiġijiet tat-taħriġ tar-regolaturi jistgħu jiġu riflessi fil-proġetti mwettqa taħt lInizjattiva dwar il-Mediċini Innovattivi (IMI).
English: The Board supported the proposed transitional measures for the pharmaceutical industry to comply with the 2 July 2011 deadline for the electronic submission of information on medicinal products for human use.
Maltese: Il-Bord appoġġa l-miżuri tranżitorji proposti għall-industrija farmaċewtika sabiex tkun tista' tikkonforma maliskadenza tat-2 ta' Lulju 2011 għas-sottomissjoni elettronika ta' informazzjoni dwar prodotti mediċinali għal użu mill-bniedem.