FrancophonIA/ELRC3.0 huggingface dataset:
English: 0.3264 mg Tablet
Maltese: 0.3264 mg Pillola
English: United Kingdom NORTON HEALTHCARE Limited, Albert Basin, Royal Docks, London E16 2QJ, UK Pergolide 50mcg tablet
Maltese: NORTON HEALTHCARE Limited, Albert Basin, Royal Docks, London E16 2QJ, UK Pergolide 50mcg tablet
English: United Kingdom NORTON HEALTHCARE Limited, Albert Basin, Royal Docks, London E16 2QJ, UK Pergolide 250mcg tablet 0.25 mg
Maltese: NORTON HEALTHCARE Limited, Albert Basin, Royal Docks, London E16 2QJ, UK Pergolide 250mcg tablet 0.25 mg
English: 0.0655 mg Tablet
Maltese: 0.0655 mg Pillola
English: RATIOPHARM Nederland BV Ronde Tocht 11 1507 CC Zaandam, Netherlands Pergolide Ratiopharm 1 1.0 mg
Maltese: Zaandam, Netherlands Pergolide Ratiopharm 1 1.0 mg
English: COPYFARM A/S, Energivej 15, DK-5260 Odense S, Denmark
Maltese: A/S, Energivej 15, DK-5260
English: 0.0653 mg Tablet
Maltese: 0.0653 mg Pillola
English: Empreendimento Lagoas ParkEdifício 1 - 3º 2740-264 Porto Salvo, Portugal
Maltese: Empreendimento Lagoas ParkEdifício 1 - 3º 2740-264
English: Empreendimento Lagoas Park - Edifício 1 - 3º 2740-264 Porto Salvo, Portugal
Maltese: Empreendimento Lagoas Park - Edifício 1 - 3º 2740-264
English: MERCK GENERICS B.V.; Dieselweg 26; 3752 LB Bunschoten/NL, Netherlands
Maltese: 3752 LB Bunschoten/NL, Netherlands
English: STADAPHARM GmbH Stadastr.
Maltese: MERCK Dura GmbH Alsfelder Str.
English: United Kingdom BETAPHARM Arzneimittel GmbH; Kobelweg 95; D-86156 Augsburg, Germany Pergolide 50mcg tablet
Maltese: D-86156 Augsburg, Germany Pergolide 50mcg tablet
English: MERCK Dura GmbH Alsfelder Str. 19, D-64289 Darmstadt, Germany
Maltese: 19, D-64289 Darmstadt, Germany
English: United Kingdom BETAPHARM Arzneimittel GmbH; Kobelweg 95; D-86156 Augsburg, Germany Pergolide 250mcg tablet 0.25 mg
Maltese: D-86156 Augsburg, Germany Pergolide 250mcg tablet 0.25 mg
English: TEVA Pharma B.V., P.O.
Maltese: PFIZER B.V, Rivium
English: BETAPHARM Arzneimittel GmbH; Kobelweg 95; D-86156 Augsburg, Germany
Maltese: D-86156 Augsburg, Germany
English: The CHMP noted:
Maltese: Is-CHMP innota:
English: Moxifloxacin is a fluoroquinolone antibiotic with a broad spectrum of activity and bactericidal action.
Maltese: Moxifloxacin huwa antibijotiku tal-kategorija tal-fluworokinoloni (fluoroquinolones) bi spettru wiesa' u b'azzjoni batteriċida.
English: In the European Union (EU), Moxifloxacin film coated tablet are indicated for the treatment of acute bacterial sinusitis (ABS), acute exacerbation of chronic bronchitis (AECB) and community acquired pneumonia (CAP) except severe cases, at the dose of 400 mg daily for 7 days for ABS, 5-10 days for AECB and for 10 days for CAP.
Maltese: Fl-Unjoni Ewropea (UE), il-pilloli ta' moxifloxacin miksijin b'rita huma indikati għat-trattament tas-sinużite akuta ta' oriġini batterika (acute bacterial sinusitis, ABS), tattaħrix akut tal-bronkite kronika (AECB) u pulmonite akkwiżita f'komunità (CAP) għajr għal każijiet gravi, f'doża ta' 400 mg kuljum għal 7 ijiem għal ABS, 5-10 ijiem għal AECB u għal 10 ijiem għal CAP.
English: ABS is generally a non-severe infection associated with high spontaneous cure rates (90%).
Maltese: Normalment, ABS hija infezzjoni mhux severa assoċjata ma' rati għoljin ta' kura spontanja (90%).
English: Of a total of 48 identified cases of possibly moxifloxacin-related liver disorders with a fatal outcome of any cause, 8 were suspected cases of moxifloxacin-induced fatal hepatotoxicity.
Maltese: Minn total ta' 48 każ identifikat ta' disturbi epatiċi possibbilment relatati ma' moxifloxacin b'eżitu fatali ta' kwalunkwe kawża, 8 kienu każijiet suspettati ta' epatotossiċità fatali indotta minn moxifloxacin.
English: Severe hepatotoxicity, cardiac toxicity including QTc interval prolongation, severe skin reactions, Clostridium difficile associated colitis, tendon and muscular toxicity (including rhabdomyolysis) are important identified risks of the treatment with moxifloxacin which are already described in the product information (PI) and under close monitoring.
Maltese: Epatotossiċità serja, tossiċità kardijaka inkluż prolungament tal-intervall QTc, reazzjonijiet gravi talġilda, kolite assoċjata ma' Clostridium difficile, tossiċità fit-tendini u muskolari (inkluż rabdomjoliżi) jikkostitwixxu riskji identifikati importanti tat-trattament b'moxifloxacin li huma diġà deskritti fittagħrif dwar il-prodott (PI) u taħt monitoraġġ mill-qrib.
English: The Committee considered the procedure under Article 107 of Directive 2001/83/EC, as amended, for medicinal products containing moxifloxacin in oral formulations.
Maltese: Il-Kumitat ikkunsidra l-proċedura skont l-Artikolu 107 tad-Direttiva 2001/83/KE, kif emendata, għal prodotti mediċinali li fihom moxifloxacin f'formulazzjonijiet orali.
English: Moxifloxacin has shown efficacy in all of the approved indications.
Maltese: Moxifloxacin wera effikaċja fl-indikazzjonijiet approvati kollha.
English: ANNEX II THE SCIENTIFIC CONCLUSIONS AND THE GROUNDS FOR AMENDMENTS OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
Maltese: ANNESS II KONKLUŻJONIJIET XJENTIFIĊI
English: A cumulative review up to 30 September 2007 of all hepatic reactions (serious and non-serious) and an overall assessment of the benefit/risk ratio of moxifloxacin treatment was performed.
Maltese: Sar eżami kumulattiv mill-ġdid tar-reazzjonijiet epatiċi kollha (gravi u mhux gravi) sad-data tat-30 ta' Settembru 2007 u valutazzjoni ġenerali tar-relazzjoni benefiċċju/riskju tat-trattament b'moxifloxacin.
English: In October 2007, the assessment of the 15th and 16th PSUR for moxifloxacin identified major safety concerns including life threatening hepatotoxicity cases.
Maltese: F'Ottubru 2007, il-valutazzjoni tal-15 u s-16-il PSUR għal moxifloxacin identifikat tħassib maġġuri għas-sigurtà, fosthom każijiet ta' epatotossiċità potenzjalment fatali.
English: The benefit of antibiotic treatment of AECB was supported by several publications including a metaanalysis and by a recent systematic review from Cochrane Centre suggesting a mortality benefit with the use of antibiotics in this indication in comparison with placebo and a beneficial effect on lung function.
Maltese: Il-benefiċċju tat-trattament antibijotiku tal-AECB ġie appoġġjat minn bosta pubblikazzjonijiet inkluż minn metanaliżi u minn reviżjoni sistematika reċenti mwettqa minn Cochrane Centre li tissuġġerixxi benefiċċju meta mqabbla ma' plaċebo, f'termini ta' mortalità, bl-użu ta' antibijotiċi f'din l-indikazzjoni u effett pożittiv fuq il-funzjoni tal-pulmun.
English: nd line treatment in the indications for moxifloxacin containing medicinal products (oral formulation) and further amendments to the PI, to include fatal hepatotoxicity cases, risk factors for QTc interval prolongation, and strengthen the warnings on Clostridium difficille-associated colitis and bullous skin reactions.
Maltese: Minħabba dan li għandu kif intqal hawn fuq, is-CHMP irrakkomanda r-restrizzjoni għat-trattament tat-tieni linja fl-indikazzjonijiet għal prodotti mediċinali li fihom moxifloxacin (formulazzjoni orali) u emendi oħra għall-PI, sabiex jinkludi każijiet ta' epatotossiċità fatali u fatturi ta' riskju għallprolungament tal-intervall QTc, u li jsiru iktar inċiżivi t-twissijiet dwar kolite assoċjata ma' Clostridium difficile u reazzjonijiet tal-ġilda bl-infafet (bullous).
English: Based on the above, on 2 June 2008, the UK issued a Rapid Alert informing Members States, the European Medicines Agency (EMEA) and the European Commission (EC) in accordance with Article 107 of Directive 2001/83/EC, as amended of its intention to vary the marketing authorisation of all oral formulations of moxifloxacin containing medicinal products to remove the indications in ABS and AECB and to restrict the indication in CAP.
Maltese: Abbażi ta' dan ta' hawn fuq, fit-2 ta' Ġunju 2008, ir-Renju Unit ħareġ Twissija Rapida li fiha informa lill-Istati Membri, lill-Aġenzija Ewropea għall-Mediċini (EMEA) u lill-Kummissjoni Ewropea (KE) skont l-Artikolu 107 tad-Direttiva 2001/83/KE, kif emendata, bl-intenzjoni tiegħu li jbiddel lawtorizzazzjoni għat-tqegħid fis-suq għall-formulazzjonijiet orali kollha ta' prodotti mediċinali li fihom moxifloxacin sabiex jitneħħew l-indikazzjonijiet fl-ABS u AECB u sabiex tiġi ristretta lindikazzjoni għall-CAP.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF ORAL FORMULATIONS OF MOXIFLOXACIN CONTAINING MEDICINAL PRODUCTS (see Annex I)
Maltese: TA' PRODOTTI MEDIĊINALI LI FIHOM MOXIFLOXACIN (ara l-Anness I)
English: In line with the safety profile, and considering that AECB can be a less severe infection, with high spontaneous resolution rate for which bacteria can be found in only 50% of all exacerbations, the benefit risk can only be considered favourable if moxifloxacin is not used as the first line treatment option.
Maltese: B'konformità mal-profil tas-sigurtà, u filwaqt li jiġi kkunsidrat li AECB tista' tikkostitwixxi infezzjoni inqas severa, b'rata ta' riżoluzzjoni spontanja għolja bi preżenza batterika tal-50% biss tat-taħrixiet kollha, ir-relazzjoni bejn ir-riskju u l-benefiċċju jista' jitqies favorevoli biss jekk moxifloxacin ma jintużax bħala l-għażla ta' trattament tal-ewwel linja.
English: Clinical trial and published data indicate that moxifloxacin generally has benefits in the indication CAP.
Maltese: Prova klinika u tagħrif ippubblikat jindikaw li b'mod ġenerali, moxifloxacin għandu benefiċċji flindikazzjoni CAP.
English: 23 November 2011
Maltese: 23 ta' Novembru 2011
English: Olympics 2012
Maltese: Logħob Olimpiku 2012
English: Operational excellence programme - OpEx
Maltese: Programm ta' eċċellenza operattiva - OpEx
English: Apologies from Mary Baker Mike O'Donovan
Maltese: Apoloġiji minn Mary Baker Mike O'Donovan
English: • part-time working scheme;
Maltese: • skema ta' xogħol part-time;
English: Andreas Pott Patrick Le Courtois David Mackay Hans-Georg Wagner Noël Wathion Sylvie Bénéfice Riccardo Ettore Martin Harvey Allchurch Isabelle Moulon Frances Nuttall Vincenzo Salvatore Emer Cooke Karen Quigley Zuzana O'Callaghan Nerimantas Steikūnas
Maltese: Andreas Pott Patrick Le Courtois David Mackay Hans-Georg Wagner Noël Wathion Sylvie Bénéfice Riccardo Ettore Martin Harvey Allchurch Isabelle Moulon Frances Nuttall Vincenzo Salvatore Emer Cooke Karen Quigley Zuzana
English: Representative of veterinarians' organisations
Maltese: Rappreżentant ta' organizzazzjonijiet veterinarji
English: Paola Testori Coggi
Maltese: Il-Kummissjoni Ewropea Paola Testori Coggi
English: The policy for experts was implemented on 29 September 2011, with declarations of experts published on 30 September.
Maltese: Il-politika għall-esperti ġiet implimentata fid-29 ta' Settembru 2011, filwaqt li d-dikjarazzjonijiet tal-esperti ġew ippubblikati fit-30 ta' Settembru.
English: Members of the group are: Björn Lemmer, Jytte Lyngvig, Guido De Clercq and Vincenzo Salvatore.
Maltese: Björn Lemmer, Jytte Lyngvig, Guido De Clercq u Vincenzo Salvatore.
English: [EMA/MB/650168/2011] The agenda was adopted.
Maltese: [EMA/MB/650168/2011] L-aġenda ġiet adottata.
English: • leave;
Maltese: • liv;
English: The Board also noted the proposed meeting dates in 2013.
Maltese: Il-Bord innota wkoll id-dati ta' laqgħat proposti fl-2013.
English: At the time of the report, 2,600 of 5,000 experts who are included in the database had signed their declarations of interest.
Maltese: Fi żmien ir-rapport, 2,600 minn 5,000 espert li huma inklużi fid-database ffirmaw id-dikjarazzjonijiet ta' interess tagħhom.
English: Minor use minor species (MUMS) policy: Annual report
Maltese: Politika għall-Użu Minuri Speċji Minuri (MUMS): Rapport annwali 2011
English: [EMA/MB/742275/2011; EMA/MB/751326/2011; EMA/MB/742295/2011; EMA/MB/752482/2011] The Management Board adopted the following implementing rules:
Maltese: [EMA/MB/742275/2011; EMA/MB/751326/2011; EMA/MB/742295/2011; EMA/MB/752482/2011] IlBord ta' Tmexxija adotta r-regoli ta' implimentazzjoni li ġejjin:
English: • Wednesday, 21 March & Thursday, 22 March;
Maltese: • L-Erbgħa, 21 ta' Marzu u l-Ħamis, 22 ta' Marzu;
English: • HMA paper published in the context of the review of the veterinary legislation.
Maltese: • Dokument HMA ppubblikat fl-ambitu tar-reviżjoni tal-leġiżlazzjoni veterinarja.
English: 3bis Appointment of Guido Rasi as Executive Director
Maltese: 3bis Ħatra ta' Guido Rasi bħala Direttur Eżekuttiv
English: Held in London on 6 October 2011
Maltese: Li saret f'Londra fis-6 ta' Ottubru 2011
English: Guido Rasi will take office on 16 November 2011.
Maltese: Guido Rasi sejjer jieħu l-kariga fis-16 ta' Novembru 2011.
English: EudraVigilance status report for veterinary medicinal products
Maltese: Rapport dwar l-istatus tal-EudraVigilance għall-prodotti mediċinali veterinarji
English: The Board thanked the topic coordinators (Christina Åkerman, Aginus Kalis, Jytte Lyngvig, Marcus Müllner, Giuseppe Nisticó and Lisette Tiddens) for their role in preparing this document.
Maltese: Il-Bord irringrazzja lkoordinaturi tas-suġġetti (Christina Åkerman, Aginus Kalis, Jytte Lyngvig, Marcus Müllner, Giuseppe Nisticó u Lisette Tiddens) għar-rwol tagħhom fil-preparazzjoni ta' dan id-dokument.
English: • [EMA/MB/793451/2011] EU telematics Operations Report.
Maltese: • [EMA/MB/793451/2011] Rapport tal-Operazzjonijiet għat-telematika tal-UE.
English: • [EMA/MB/711444/2011; EMA/MB/711456/2011; EMA/MB/711459/2011] Minutes from the
Maltese: • [EMA/MB/711444/2011; EMA/MB/711456/2011; EMA/MB/711459/2011] Minuti mill-Kumitat għatTelematika tal-Bord ta' Tmexxija (MBTC) mil-laqgħat tiegħu ta' Marzu, Mejju u Ġunju.
English: [EMA/MB/743894/2011; EMA680110/2011] The Management Board noted the report on the implementation of the MUMS policy.
Maltese: [EMA/MB/743894/2011; EMA680110/2011] Il-Bord ta' Tmexxija nnota r-rapport dwar limplimentazzjoni tal-politika tal-MUMS.
English: • No 09/2011 - the appointment of Michel Tougouz Nevessignsky as CHMP alternate, proposed by Belgium, finalised on 9 September 2011.
Maltese: • Nru 09/2011 - il-ħatra ta' Michel Tougouz Nevessignsky bħala supplenti tas-CHMP, proposta millBelġju, finalizzata fid-9 ta' Settembru 2011.
English: • Falsified medicines directive (the date of implementation is January 2013; the three areas of activity for implementing measures are the implementation of the safety feature, control of import of active pharmaceutical ingredients and preparing a logo for online pharmacies).
Maltese: • Direttiva dwar il-mediċini ffalsifikati (id-data ta' implimentazzjoni hija Jannar 2013; it-tliet oqsma ta' attività għall-miżuri ta' implimentazzjoni huma l-implimentazzjoni tal-karatteristika ta' sigurtà, il-kontroll tal-importazzjoni ta' ingredjenti farmaċewtiċi attivi u l-preparazzjoni ta' logo għallispiżeriji online).
English: • No 07/2011 - the appointment of Helder Mota-Filipe as CHMP alternate, proposed by Portugal, finalised on 5 July 2011.
Maltese: • Nru 07/2011 - il-ħatra ta' Helder Mota-Filipe bħala supplenti tas-CHMP, proposta mill-Portugal, finalizzata fil-5 ta' Lulju 2011.
English: The Management Board topic coordinators Xavier De Cuyper (Belgium), Walter Schwerdtfeger (Germany) and Lisette Tiddens (Vice-chair) are revising the conflicts of interests policy applicable to the Board.
Maltese: Il-koordinaturi tas-suġġett tal-Bord ta' Tmexxija Xavier De Cuyper (Belġju), Walter Schwerdtfeger (Ġermanja) u Lisette Tiddens (Viċi-president) qegħdin jirrevedu l-politika dwar il-kunflitti ta' interess applikabbli għall-Bord.
English: Giuseppe Nisticó Björn Lemmer
Maltese: Björn Lemmer
English: EMA/MB/828587/2011 Adopted Management Board
Maltese: EMA/511028/2012 Adottata Bord ta' Tmexxija
English: More specifically, in five Member States responsibility for SoHO is given to NCAs responsible for medicinal products, in a further ten some of the responsibility in the field is given to NCAs responsible for medicinal products, while in twelve Member States responsibility for SoHO is given to NCAs that are not responsible for medicinal products.
Maltese: Stati Membri, ir-responsabbiltà għall-SoHO hija mogħtija lill-NCAs responsabbli għall-prodotti mediċinali, f'10 pajjiżi oħra, parti mir-responsabbiltà fil-qasam hija mogħtija lill-NCAs responsabbli għall-prodotti mediċinali, filwaqt li fi 12-il Stat Membru r-responsabbiltà għall-SoHO hija mogħtija lillNCAs li mhumiex responsabbli għall-prodotti mediċinali.
English: [EMA/MB/376489/2011] The Management Board adopted the following meeting dates in 2012:
Maltese: [EMA/MB/376489/2011] Fl-2012, il-Bord ta' Tmexxija adotta d-dati ta' laqgħat li ġejjin:
English: • No 08/2011 - the appointment of Janne Komi as CHMP member, proposed by Finland, finalised on 14 July 2011.
Maltese: • Nru 08/2011 - il-ħatra ta' Janne Komi bħala supplenti tas-CHMP, proposta mill-Finlandja, finalizzata fl-14 ta' Lulju 2011.
English: [EMA/MB/550544/2011] The Management Board endorsed the implementation plan for the 'Road map to 2015'.
Maltese: [EMA/MB/550544/2011] Il-Bord ta' Tmexxija approva l-pjan ta' implimentazzjoni għall-'Pjan direzzjonali għall-2015'.
English: Tabled documents
Maltese: Dokumenti ppreżentati
English: [EMA/MB/744342/2011; EMA/MB/24913/2005/rev.1] The Management Board adopted the revised criteria that have to be fulfilled by patients' and consumers' organisations involved in EMA activities.
Maltese: [EMA/MB/744342/2011; EMA/MB/24913/2005/rev.1] Il-Bord ta' Tmexxija adotta l-kriterji riveduti li għandhom jiġu sodisfatti mill-organizzazzjonijiet tal-konsumaturi u l-pazjenti involuti fl-attivitajiet talEMA.
English: • [EMA/MB/730141/2011] Summary of transfers of appropriations in the budget 2011.
Maltese: • [EMA/MB/730141/2011] Sommarju tat-trasferimenti ta' approprjazzjonijiet fil-baġit tal-2011.
English: Rannveig Gunnarsdóttir (Iceland) Brigitte Batliner (Liechtenstein) Apologies from Norway
Maltese: Rannveig Gunnarsdóttir (Islanda)
English: 7bis EU telematics projects report
Maltese: 7bis Rapport dwar il-proġetti telematiċi tal-UE
English: Members discussed that the governance of the EU telematics programme needs further strengthening.
Maltese: Ilmembri ddiskutew li t-tmexxija tal-programm għat-telematika tal-UE jeħtieġ li jissaħħaħ ulterjorment.
English: • Revised draft Agenda version 4.0.
Maltese: • Verżjoni 4.0 tal-abbozz tal-Aġenda rivedut.
English: [EMA/MB/744682/2011] The Management Board noted the regular update report on the status of implementation of the European database for the collection of adverse events related to veterinary medicines.
Maltese: [EMA/MB/744682/2011] Il-Bord ta' Tmexxija nnota r-rapport regolari ta' aġġornament dwar l-istatus tal-implimentazzjoni tad-database Ewropew għall-ġabra ta' avvenimenti negattivi relatati mal-mediċini veterinarji.
English: [EMA/MB/465305/2011] The Management Board noted the final minutes, adopted by written procedure on 11 August 2011.
Maltese: [EMA/MB/465305/2011] Il-Bord ta' Tmexxija nnota l-minuti finali, li ġew adottati permezz ta' proċedura bil-miktub fil-11 ta' Awwissu 2011.
English: [EMA/MB/751210/2011] The Management Board appointed Sir Kent Woods as a member of the Management Board Telematics Committee following the departure of Pat O'Mahony from the committee earlier this year.
Maltese: [EMA/MB/751210/2011] Il-Bord ta' Tmexxija ħatar lil Sir Kent Woods bħala membru tal-Kumitat għatTelematika tal-Bord ta' Tmexxija wara t-tluq ta' Pat O'Mahony mill-kumitat iktar kmieni din is-sena.
English: The meeting noted that the budgetary situation has evolved since the March 2011 Management Board meeting when the preliminary draft budget 2012 was adopted.
Maltese: Il-laqgħa nnotat li s-sitwazzjoni baġitarja evolviet mil-laqgħa tal-Bord ta' Tmexxija f'Marzu 2011 meta ġie adottat l-abbozz preliminari tal-baġit għall2012.
English: The meetings which cannot be cancelled or postponed during the peak Olympic period in the months of July and August 2012 will be hosted at other locations.
Maltese: Il-laqgħat li ma jistgħux jitħassru jew jiġu postposti matul l-eqqel perjodu tal-Logħob Olimpiku fixxhur ta' Lulju u Awwissu 2012 sejrin jiġu organizzati f'postijiet oħra.
English: • Thursday, 7 June;
Maltese: • Il-Ħamis, 7 ta' Ġunju;
English: The Chair informed the Board that he had reviewed declarations of interests of Board members and alternates and will send a number of letters to clarify certain issues.
Maltese: Il-President informa lill-Bord li huwa rreveda d-dikjarazzjonijiet ta' interessi tal-membri tal-Bord u tassostituti u sejjer jibgħat numru ta' ittri sabiex jiċċara l-kwistjonijiet.
English: [EMA/MB/729369/2011] The Management Board reinstated Gerard O'Malley as the Agency's accounting officer, effective 6 October 2011, following his return from long-term absence.
Maltese: [EMA/MB/729369/2011] Il-Bord ta' Tmexxija re-ingaġġat Gerard O'Malley bħala l-uffiċjal talkontabbiltà tal-Aġenzija, mis-6 ta' Ottubru 2011, wara r-ritorn tiegħu minn assenza twila.
English: Those experts who work with the EMA but have not yet updated their declaration of interests in line with the new policy were reminded that they will not receive documents and/or invitations to the October meetings of scientific committees unless a signed declaration of interests is received.
Maltese: Dawk l-esperti li jaħdmu mal-EMA, iżda li għadhom ma aġġornawx id-dikjarazzjoni ta' interessi tagħhom f'konformità mal-politika l-ġdida, ġew imfakkra li mhumiex sejrin jirċievu dokumenti u/jew stediniet għal-laqgħat ta' Ottubru tal-kumitati xjentifiċi sakemm ma tiġix riċevuta dikjarazzjoni ta' interessi ffirmata.
English: [EMA/MB/744981/2011; EMA/632696/2011] The Management Board noted the report on the interactions with patients' and consumers' organisations within the framework agreed in 2005.
Maltese: [EMA/MB/744981/2011; EMA/632696/2011] Il-Bord ta' Tmexxija nnota r-rapport dwar l-interazzjonijiet mal-organizzazzjonijiet tal-konsumaturi u l-pazjenti fi ħdan il-qafas miftiehem fl-2005.
English: Members were asked to declare any specific interests that could be considered to be prejudicial to their independence with respect to the items on the agenda.
Maltese: Il-Membri ntalbu li jiddikjaraw kull interess speċifiku li jista' jitqies bħala preġudikanti għallindipendenza tagħhom fir-rigward tal-punti fuq l-aġenda.
English: Now a new human resource module of the system has been launched, which replaced a further three databases.
Maltese: Issa tnieda modulu tar-riżorsi umani ġdid tassistema, li ħa post tliet databases oħra.
English: Following the appointment, Guido Rasi joined the meeting of the Management Board.
Maltese: Wara l-ħatra, Guido Rasi attenda għall-laqgħa tal-Bord ta' Tmexxija.
English: • parental and family leave.
Maltese: • liv tal-ġenituri u tal-familja.
English: Revised criteria to be fulfilled by patients' and consumers' organisations involved in EMA activities
Maltese: Kriterji riveduti li għandhom jiġu sodisfatti millorganizzazzjonijiet tal-pazjenti u tal-konsumaturi involuti flattivitajiet tal-EMA
English: [EMA/MB/746083/2011] The Management Board discussed whether to review the decision-making process in cases where there is evidence of a lack of consensus.
Maltese: [EMA/MB/746083/2011] ll-Bord ta' Tmexxija ddiskuta jekk għandux jirrevedi l-proċess ta' teħid ta' deċiżjoni f'każijiet fejn hemm evidenza ta' nuqqas ta' kunsens.
English: The objectives of the meeting were to address strategic issues requiring HMA orientation, with particular focus on challenging aspects impacting on the NCAs; and to raise awareness on specific areas.
Maltese: L-objettivi tal-laqgħa kienu li jindirizzaw il-kwistjonijiet strateġiċi li jeħtieġu orjentazzjoni tal-HMA, b'fokus partikolari fuq l-aspetti ta' sfida li għandhom impatt fuq l-NCAs; u li jqajmu kuxjenza fuq oqsma speċifiċi.
English: • A proposal on health security to better protect citizens against serious cross-border threats to public health (the European Commission expects the adoption of the proposal in July 2012).
Maltese: • Proposta dwar is-sigurtà tas-saħħa biex iċ-ċittadini jiġu protetti aħjar kontra t-theddid transkonfinali għas-saħħa pubblika (il-Kummissjoni Ewropea tistenna l-adozzjoni tal-proposta f'Lulju 2012).
English: rd meeting of the Management Board, held in London on 6 October 2011
Maltese: Lista ta' parteċipanti fit-73 laqgħa tal-Bord ta' Tmexxija, li saret f'Londra fis-6 ta' Ottubru 2011