FrancophonIA/ELRC3.0 huggingface dataset:
English: • [EMA/888135/2011] MBTC-2012-02-002 Management Board Telematics Committee meeting held on 9 November 2011
Maltese: • [EMA/888135/2011] MBTC-2012-02-002 Laqgħa tal-Kumitat tat-Telematika tal-Bord ta' Tmexxija li saret fid-9 ta' Novembru 2011
English: There was also a strong increase (over 20%) in post-authorisation activities, and a major rise in the number of referral procedures (77 compared to 55 in 2010).
Maltese: Kien hemm anki żieda qawwija (iktar minn 20%) f'attivitajiet ta' wara l-awtorizzazzjoni, u żieda kbira fin-numru ta' proċeduri ta' riferiment (77 imqabbla ma' 55 fl-2010).
English: The number of national experts would remain unchanged, with 15 FTEs expected.
Maltese: In-numru ta' esperti nazzjonali jibqa' mhux mibdul, bi 15-il FTE mistennija.
English: European Surveillance of Veterinary Antimicrobial Consumption (ESVAC)
Maltese: Sorveljanza Ewropea tal-Konsum tal-Antimikrobiċi għal Użu Veterinarju (ESVAC)
English: • Report of performance with respect to a limited subset of quantitative KPIs 2011.
Maltese: • Rapport tal-prestazzjoni fir-rigward ta' subsett limitat ta' KPIs kwantitattivi 2011.
English: • the definitions of ownership of a patent and (principal) investigator;
Maltese: • id-definizzjonijiet ta' sjieda ta' privattiva u investigatur (prinċipali);
English: Held in London, 21-22 March 2012
Maltese: Li saret f'Londra, 21-22 ta' Marzu 2012
English: The EU contribution remains at the 2012 level of €38.8 million.
Maltese: Il-kontribuzzjoni tal-UE tibqa' fil-livell tal2012 ta' €38.8 miljun.
English: • The endorsement of the reflection paper on ethical and GCP aspects of clinical trials in third countries.
Maltese: • L-approvazzjoni tad-dokument ta' riflessjoni dwar aspetti etiċi u tal-GCP ta' provi kliniċi f'pajjiżi terzi.
English: List of participants at the 75th meeting of the Management Board, held in London, 21-22 March 2012
Maltese: Lista ta' parteċipanti fil-75 laqgħa tal-Bord ta' Tmexxija, li saret f'Londra, 21-22 ta' Marzu 2012
English: This should be analysed separately.
Maltese: Dan għandu jiġi analizzat b'mod separat.
English: COFEPRIS
Maltese: Il-COFEPRIS
English: • The split of the amended proposal into two proposals: 'information to patients' and 'pharmacovigilance'.
Maltese: • Il-qasma tal-proposta emendata f'żewġ proposti: ‘informazzjoni għall-pazjenti' u 'farmakoviġilanza'.
English: [EMA/MB/13210/2012] The Management Board adopted the amended rules, adjusting the fees payable to the Agency by 3.1%, for inflation.
Maltese: [EMA/MB/13210/2012] Il-Bord ta' Tmexxija adotta r-regoli emendati, filwaqt li aġġusta t-tariffi pagabbli lill-Aġenzija bi 3.1% għall-inflazzjoni.
English: c.) Information and communications technology
Maltese: c.) Teknoloġija tal-informazzjoni u tal-komunikazzjoni
English: • [EMA/MB/115063/2012] Summary of transfers of appropriations in the budget 2012.
Maltese: • [EMA/MB/115063/2012] Sommarju tat-trasferimenti ta' approprjazzjonijiet fil-baġit 2012.
English: The Agency also requested 21 additional posts, which will be financed from the fee revenue, and plans to reduce the number of contract agents by 7 full-time equivalents (FTEs).
Maltese: L-Aġenzija talbet ukoll 21 impjieg addizzjonali, li sejrin jiġu ffinanzjati mid-dħul mit-tariffi, u għandha l-pjan li tnaqqas in-numru ta' aġenti kuntrattwali b'7 ekwivalenti għal full-time (FTEs).
English: Its members are Klaus Cichutek, Kristin Raudsepp and Grzegorz Cessak.
Maltese: Il-membri tiegħu huma Klaus Cichutek, Kristin Raudsepp u Grzegorz Cessak.
English: Appointment of Michael Lenihan as the Agency's accounting officer
Maltese: Il-ħatra ta' Michael Lenihan bħala l-uffiċjal tal-kontabilità tal-Aġenzija
English: The document was adopted.
Maltese: Id-dokument ġie adottat.
English: [MB/EMA/155755/2012] The Management Board adopted the change to the entry grade from AST 3 to AD 6 for the post of Section Head for Financial Support services.
Maltese: [MB/EMA/155755/2012] Il-Bord ta' Tmexxija adotta l-bidla fil-grad tad-dħul minn AST 3 għal AD 6 għall-kariga ta' Kap tat-Taqsima għas-servizzi ta' Appoġġ Finanzjarju.
English: [EMA/MB/945561/2011] The Management Board adopted the Agency's preliminary draft work programme 2013.
Maltese: [EMA/MB/945561/2011] Il-Bord ta' Tmexxija adotta l-abbozz tal-programm ta' ħidma preliminari 2013.
English: [EMA/MB/124276/2012] The Management Board appointed Michael Lenihan, Head of the Finance and Budget Sector, as the Agency's accounting officer, replacing Gerard O'Malley.
Maltese: [EMA/MB/124276/2012] Il-Bord ta' Tmexxija ħatar lil Michael Lenihan, Kap tas-Settur Finanzjarju u tal-Baġit, bħala l-uffiċjal tal-kontabilità tal-Aġenzija, li ħa post Gerard O'Malley.
English: • The legislative proposals for clinical trials and medical devices planned for 2012.
Maltese: • Il-proposti leġiżlattivi għall-provi kliniċi u l-istrumenti mediċinali ppjanati għall-2012.
English: • Consultation no. 01/2012 on the appointment of Ingunn Hagen Westgaard as CHMP alternate, proposed by Norway, ended on 26 January 2012.
Maltese: • Konsultazzjoni nru. 01/2012 dwar il-ħatra ta' Ingunn Hagen Westgaard bħala supplent tas-CVMP, proposta min-Norveġja, iffinalizzata fis-26 ta' Jannar 2012.
English: • Consultation no. 02/2012 on the appointment of Outi Maki-Ikola as CHMP member, proposed by Finland, ended on 26 January 2012.
Maltese: • Konsultazzjoni nru. 02/2012 dwar il-ħatra ta' Outi Maki-Ikola bħala membru tas-CHMP, proposta mill-Finlandja, iffinalizzata fis-26 ta' Jannar 2012.
English: Topic coordinators
Maltese: Koordinaturi tas-suġġetti
English: [EMA/MB/64234/2012] The Management Board adopted the revised policy on managing conflicts of interests of its members.
Maltese: [EMA/MB/64234/2012] Il-Bord ta' Tmexxija adotta l-politika riveduta dwar il-ġestjoni ta' kunflitti ta' interess tal-membri tiegħu.
English: • Consultation no. 03/2012 on the appointment of Martti Nevalainen as CVMP member, proposed by Finland ended on 2 February 2012 with Members' observations, raised in respect of the candidate's level of conflict of interests and supported by the CVMP Chair, sent to the nominating authority on 13 February 2012.
Maltese: • Konsultazzjoni nru. 03/2012 dwar il-ħatra ta' Martti Nevalainen bħala membru tas-CVMP, propost mill-Finlandja, iffinalizzata fit-2 ta' Frar 2012 b'osservazzjonijiet tal-Membri, imqajma fir-rigward tal-livell ta' kunflitt ta' interessi tal-kandidat u appoġġjati mill-President tas-CVMP, mibgħuta lillawtorità ta' nominazzjoni fit-13 ta' Frar 2012.
English: • Consultation no. 14/2011 on the appointment of Ugne Zymantaite as CVMP alternate, proposed by Lithuania, ended on 19 December 2011.
Maltese: • Konsultazzjoni nru. 14/2011 dwar il-ħatra ta' Ugne Zymantaite bħala supplent tas-CVMP, proposta mil-Litwanja, iffinalizzata fid-19 December 2011.
English: [EMA/MB/139702/2012] The Management Board adopted the procedure for consultation on final composition of the Pharmacovigilance Risk Assessment Committee (PRAC).
Maltese: [EMA/MB/139702/2012] Il-Bord ta' Tmexxija adotta l-proċedura għal konsultazzjoni dwar l-għamla finali tal-Kumitat dwar il-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC).
English: Visit of Commissioner John Dalli
Maltese: Żjara tal-Kummissarju John Dalli
English: [EMA/112052/2012] The Management Board noted the report on a sample of key performance indicators included in contractual arrangements with national competent authorities.
Maltese: [EMA/112052/2012] Il-Bord ta' Tmexxija ħa nota tar-rapport dwar kampjun ta' indikaturi talprestazzjoni ewlenin inklużi f'arranġamenti kuntrattwali ma' awtoritajiet kompetenti nazzjonali.
English: The discussion of the Board focused on the possible divergence of opinions between the PRAC and the CHMP/CMD(h).
Maltese: Id-diskussjoni tal-Bord iffokat fuq il-possibilità ta' diverġenza fl-opinjonijiet bejn il-PRAC u sCHMP/CMD(h).
English: The EU team met with a high-level team from the FDA's leadership, and discussed, among other topics: the FDA's pathway to global product safety and quality; regulatory science; biosimilars; a global approach to clinical studies; and inspection-related matters.
Maltese: It-tim tal-UE ltaqa' ma' tim ta' livell għoli mittmexxija tal-FDA, u ddiskutew, fost l-oħrajn: It-triq tal-FDA lejn is-sikurezza u l-kwalità globali talprodotti; ix-xjenza regolatorja; il-bijosimili; approċċ globali għall-istudji kliniċi; u kwistjonijiet relatati mal-ispezzjonijiet.
English: Cooperation with EFSA
Maltese: Kooperazzjoni mal-EFSA
English: • Pharmacovigilance Risk Assessment Committee (PRAC) rapporteur appointment.
Maltese: • Il-ħatra ta' rapporteur tal-Kumitat dwar il-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC).
English: • Consultation no. 13/2011 on the appointment of Merete Blixenkrone-Moller as CVMP alternate, proposed by Denmark, ended on 8 December 2011.
Maltese: • Konsultazzjoni nru. 13/2011 dwar il-ħatra ta' Merete Blixenkrone-Moller bħala supplent tas-CVMP, proposta mid-Danimarka, iffinalizzata fit-8 ta' Diċembru 2011.
English: Pat O'Mahony participated on Thursday, 22 March 2012
Maltese: Pat O'Mahony ħa sehem il-Ħamis, 22 ta' Marzu 2012 Salvatore D'acunto ħa sehem il-Ħamis, 22 ta' Marzu 2012
English: • Written procedure for adoption of non-automatic carry-over of appropriations from 2011-2012 closed on 30 January 2012.
Maltese: • Proċedura bil-miktub għall-adozzjoni ta' riport mhux awtomatiku ta' approprjazzjonijiet mill-20112012 magħluqa fit-30 ta' Jannar 2012.
English: However, patient representatives expressed their wish to see such hearings extended to other areas where patients have high expectations (e.g. unmet medical needs), where there is public concern (controversial media coverage), divergence between regulatory and HTA assessments, etc. Public hearings should address not just safety issues but also expected benefits of medicinal products.
Maltese: smigħ estiżi għal oqsma oħrajn fejn il-pazjenti jkollhom aspettattivi għoljin (eż. ħtiġijiet mediċi mhux milħuqa), fejn ikun hemm tħassib pubbliku (rapportar medjatiku kontroversjali), diverġenza bejn valutazzjonijiet regolatorji u tal-HTA, eċċ.
English: • [EMA/MB/137391/2012] Overview of implementing rules to Staff Regulations signed by the MB Chair during the period from 7 October 2011 to 29 February 2012.
Maltese: • [EMA/MB/137391/2012] Ħarsa ġenerali lejn ir-regoli implimentattivi għar-Regolamenti tal-Persunal iffirmati mill-President tal-MB matul il-perjodu ta' bejn is-7 ta' Ottubru 2011 u d-29 ta' Frar 2012.
English: [EMA/MB/146762/2012] The Management Board noted the nominations to the PRAC provided by Member States to date.
Maltese: [EMA/MB/146762/2012] Il-Bord ta' Tmexxija ħa nota tan-nominazzjonijiet għall-PRAC ipprovduti millIstati Membri sa dakinhar.
English: European Commission Andrzej Rys Pedro Ortum Silvan
Maltese: Il-Parlament Ewropew Giuseppe Nisticó Björn Lemmer Il-Kummissjoni Ewropea Andrzej Rys Pedro Ortum Silvan
English: Amending budget 01-2012 for changes to entry grade for a post
Maltese: Baġit emendatorju 01-2012 għall-bidliet fil-grad ta' dħul għal inkarigu
English: • [EMA/177625/2012 Rev.1] Minutes from the Management Board Telematics Committee meeting held on 14 February 2012.
Maltese: • [EMA/177625/2012 Rev.1] Minuti mil-laqgħa tal-Kumitat tat-Telematika tal-Bord ta' Tmexxija li saret fl-14 ta' Frar 2012.
English: The hearings should see a 'real public participation'.
Maltese: Il-laqgħat tas-smigħ għandhom jinvolvu ‘parteċipazzjoni pubblika reali'.
English: Although recognising that it is not possible to cover all clinical areas within the committee, members considered that more clinical experts would be welcome, to ensure that PRAC recommendations take due account of the benefits of medicinal products.
Maltese: Għad li fehmu li mhuwiex possibbli li jiġu koperti l-oqsma kliniċi kollha fi ħdan il-kumitat, il-membri qiesu li iktar esperti kliniċi jkunu ta' ġid sabiex jiġi żgurat li rrakkomandazzjonijiet tal-PRAC jieħdu f'kunsiderazzjoni dovuta l-benefiċċji tal-prodotti mediċinali.
English: Circulated to the Board by e-mail on 17 January 2012; recorded in the minutes of the next meeting, as relevant.
Maltese: Iċċirkulat lill-Bord permezz tal-posta elettronika fis-17 ta' Jannar 2012; irreġisrat fil-minuti tal-laqgħa li jmiss, skont irrilevanza.
English: • [EMA/MB/2671/2012] Outcome of written procedures during the period 25 November 2010 to 29 February 2012.
Maltese: • [EMA/MB/2671/2012] Eżitu tal-proċeduri bil-miktub matul il-perjodu ta' bejn il-25 ta' Novembru 2010 u d-29 ta' Frar 2012.
English: [Post-meeting note: the Agency secretariat, when further reflecting on the amendment made, and taking into account additional feedback from CHMP members, will specify in a Q&A document (which will be published on the Agency's website, as well as being provided to all members/experts when completing their DoI) that a 'department' needs to be understood as 'the immediate organisational entity in which the member/expert operates'.]
Maltese: [Nota ta' wara l-laqgħa: is-segretarjat tal-Aġenzija, meta rrifletta ulterjorment dwar l-emenda li saret, u filwaqt li ħa f'kunsiderazzjoni r-rispons mill-membri tas-CHMP, f'dokument ta' Q&A (li sejjer jiġi ppubblikat fuq il-websajt tal-Aġenzija, minbarra li qiegħed jiġi pprovdut lill-membri/l-esperti kollha meta jtemmu dDoI tagħhom) sejjer jispeċifika li ‘dipartiment' jeħtieġ li jinftiehem bħala ‘l-entità organizzazzjonali immedjata li l-membru/espert jopera fiha'.] Fuq nota ġenerali, l-Aġenzija qablet sabiex tissorvelja b'mod kontinwu jekk ir-regoli emendati jillimitawx l-aċċess għall-kompetenza meħtieġa.
English: This included 62 applications for new medicines, an increase of 35% as compared to 2010.
Maltese: Dawn inkludew 62 applikazzjoni għal mediċini ġodda, żieda ta' 35% meta mqabbla mal-2010.
English: [EMA/MB/131620/2012] The Board discussed whether the current practice of holding one-day meetings is the most efficient arrangement.
Maltese: [EMA/MB/131620/2012] Il-Bord iddiskuta jekk il-prattika attwali li jsiru laqgħat ta' jum wieħed hijiex liktar arranġament effiċjenti.
English: [EMA/154320/2012] The Management Board endorsed the breach of trust procedure on conflicts of interests for scientific-committee members and experts.
Maltese: [EMA/154320/2012] Il-Bord ta' Tmexxija approva l-proċedura dwar il-ksur tal-fiduċja fuq kunflitti ta' interessi għal membri u esperti tal-kumitat xjentifiku.
English: [EMA/MB/33634/2012] The Management Board noted the final minutes, adopted by written procedure on 9 February 2012.
Maltese: [EMA/MB/33634/2012] Il-Bord ta' Tmexxija ħa nota tal-minuti finali, adottati permezz ta' proċedura bil-miktub fid-9 ta' Frar 2012.
English: The mandate of the nominee commenced on 27 January 2012.
Maltese: Il-mandat tal-persuna nominata beda fis-27 ta' Jannar 2012.
English: [EMA/MB/82882/2012] The Management Board noted the document outlining the preliminary budget for ICT project development and systems maintenance in 2013.
Maltese: [EMA/MB/82882/2012] Il-Bord ta' Tmexxija ħa nota tad-dokument li jispjega l-baġit preliminari għalliżvilupp tal-proġetti tal-ICT u l-manutenzjoni tas-sistemi fl-2013.
English: • The action plan and road map to tackle antimicrobial resistance.
Maltese: • Il-pjan ta' azzjoni u l-mappa direzzjonali biex tiġi indirizzata r-reżistenza antimikrobika.
English: • EMA/MB/157253/2012 Performance of the Agency's scientific procedures: Survey 2011 for medicinal products for human use.
Maltese: • EMA/MB/157253/2012 Prestazzjoni tal-proċeduri xjentifiċi tal-Aġenzija:
English: The final wording will be verified with the Legal Service of the Agency.
Maltese: Ittest finali sejjer jiġi verifikat mas-Servizz Legali tal-Aġenzija.
English: Interpretation will be discontinued, starting from the June 2012 meeting, resulting in savings of around EUR 25,000 per year.
Maltese: L-interpretazzjoni sejra titwaqqaf mil-laqgħa ta' Ġunju 2012 'il quddiem, u dan jirriżulta f'EUR 25,000 iffrankati fis-sena.
English: • clarification on the involvement in academic trials and in publicly funded research/development initiatives;
Maltese: • kjarifika dwar l-involviment fil-provi akkademiċi u f'inizjattivi ta' riċerka/żvilupp iffinanzjati b'mod pubbliku;
English: The mandate of the nominee commenced on 9 December 2011.
Maltese: Il-mandat tal-persuna nominata beda fid-9 ta' Diċembru 2011.
English: • [EMA/185199/2012] EU telematics projects report; [EMA/189200/2012] EU telematics operations report; [EMA/177625/2012] Minutes from the Management Board Telematics Committee meeting held on 14 February 2012.
Maltese: • [EMA/185199/2012] Rapport dwar il-proġetti tat-telematika tal-UE;
English: • A discussion on the concept of public hearing and transparency.
Maltese: • Diskussjoni dwar il-kunċett ta' smigħ pubbliku u trasparenza.
English: • The CMD(v)'s work to prioritise the veterinary medicinal products for which summaries of product characteristics (SmPCs) should be harmonised and to propose an approach to SmPC harmonisation.
Maltese: • Il-ħidma tas-CMD(v) biex jipprijoritizza l-prodotti mediċinali veterinarji li jridu jiġu armonizzati ssommarji tal-karatteristiċi tal-prodott (SmPCs) tagħhom u biex jipproponi approċċ għallarmonizzazzjoni tal-SmPC.
English: • Consultation no. 15/2011 on the appointment of Esther Werner as CVMP alternate, proposed by Germany, ended, with observations from Members raised in respect of the candidate's expertise, on 3 January 2012.
Maltese: • Konsultazzjoni nru. 15/2011 dwar il-ħatra ta' Esther Werner bħala supplent tas-CVMP, proposta mill-Ġermanja, iffinalizzata, b'osservazzjonijiet mill-Membri mqajma fir-rigward tal-kompetenza tal-persuna kandidata, fit-3 ta' Jannar 2012.
English: a.) Preliminary draft work programme 2013
Maltese: a.) Abbozz tal-programm ta' ħidma preliminari 2013
English: The Board was informed that, following the receipt of the Commission Decision of 23 January 2012 confirming agreement on the Agency's rules under Article 110 of the Staff Regulations, the Chair signed the 'Decision on rules relating to Articles 11a and 13 of the Staff Regulations concerning the handling of declared interests of employees of the European Medicines Agency', on 1 February 2012.
Maltese: Il-Bord ġie mgħarraf li, wara r-riċevuta tad-Deċiżjoni tal-Kummissjoni tat-23 ta' Jannar 2012 li tikkonferma l-qbil dwar ir-regoli tal-Aġenzija skont l-Artikolu 110 tar-Regolamenti dwar il-Persunal, fl-1 ta' Frar 2012 il-President iffirma d-‘Deċiżjoni dwar ir-regoli relatati mal-Artikoli 11a u 13 tarRegolamenti dwar il-Persunal li tikkonċerna l-ġestjoni tal-interessi ddikjarati tal-impjegati tal-Aġenzija Ewropea għall-Mediċini' ('Decision on rules relating to Articles 11a and 13 of the Staff Regulations concerning the handling of declared interests of employees of the European Medicines Agency').
English: The Board welcomed the presentation by Hans-Georg Eichler, the Agency's Senior Medical Officer, and provided supportive feedback about the concept and issues raised.
Maltese: Il-Bord laqa' l-preżentazzjoni minn Hans-Georg Eichler, l-Uffiċjal Mediku Superjuri tal-Aġenzija, u pprovda kummenti ta' appoġġ dwar il-kunċett u l-kwistjonijiet imqajma.
English: • Revised draft agenda version 4.0.
Maltese: • Abbozz revedut tal-verżjoni 4.0 tal-aġenda.
English: [EMA/MB/977044/2011] The Management Board adopted the Agency's annual report 2011.
Maltese: [EMA/MB/977044/2011] Il-Bord ta' Tmexxija adotta r-rapport annwali tal-Aġenzija.
English: [EMA/154547/2012] The Board noted the analysis on the implementation of the revised conflicts of interests policy for Committee members and experts.
Maltese: [EMA/154547/2012] Il-Bord ħa nota tal-analiżi dwar l-implimentazzjoni tal-kunflitti riveduti tal-politika tal-interessi għall-membri u l-esperti tal-Kumitat.
English: The meeting also noted the proposal about the timing between PRAC and CHMP/CMD(h) meetings.
Maltese: Ġie propost perjodu ta' ġimgħa bejn il-laqgħat PRAC u s-CHMP/CMD(h).
English: It was suggested that for already authorised products and ongoing procedures, the system of the rapporteur in the pre-authorisation stage being appointed as the PRAC rapporteur could be applied.
Maltese: Ġie suġġerit li għall-prodotti u proċeduri kurrenti li diġà ġew awtorizzati, tista' tiġi applikata s-sistema tar-rapporteur fl-istadju ta' qabel l-awtorizzazzjoni li jinħatar bħala r-rapporteur tal-PRAC.
English: • The EU proposal to reform ICH as regards its governance, global outreach and greater transparency.
Maltese: • Il-proposta tal-UE għal riforma tal-ICH fir-rigward tal-governanza, il-komunikazzjoni globali u ttrasparenza ikbar tagħha.
English: • EMA/135587/2012 Annual report 2011 of the Agency's Internal Audit.
Maltese: • EMA/135587/2012 Rapport annwali 2011 tal-Awditjar Intern tal-Aġenzija.
English: A number of alternative meeting formats are possible, including holding meetings over two half-days (where more complex items could be discussed on the first day, allowing for any follow-up on the second), starting meetings earlier, arranging meeting agendas differently (to ensure the quorum for items requiring adoption), using teleconferencing, or a combination of these measures.
Maltese: Hemm numru ta' formati alternattivi possibbli għal-laqgħat, inklużi l-organizzazzjoni ta' laqgħat ta' nofs ġurnata l-waħda fuq jumejn (fejn elementi iktar kumplessi jkunu jistgħu jiġu diskussi fl-ewwel jum, u dan ikun jippermetti għal xi segwitu fit-tieni), il-laqgħat jinbdew iktar kmieni, isiru arranġamenti għallaġendi tal-laqgħat b'mod differenti (biex jiġi żgurat il-kworum għall-elementi li jeħtieġu adozzjoni), lużu ta' telekonferenzi, jew taħlita ta' dawn il-miżuri.
English: The Chair informed the Board that he had examined declarations of interests of members, together with the secretariat, and concluded that there were no conflicts of interests that could interfere with the topics of the meeting.
Maltese: Il-President għarraf lill-Bord li eżamina d-dikjarazzjonijiet tal-interessi tal-membri, flimkien massegretarjat, u kkonkluda li ma kien hemm ebda kunflitti ta' interessi li setgħu jinterferixxu massuġġetti tal-laqgħa.
English: Overall, the number of applications is stable, with 112 applications for marketing authorisations for medicines for human use and 13 for veterinary use forecast.
Maltese: B'mod ġenerali, in-numru ta' applikazzjonijiet huwa stabbli, b'112-il applikazzjoni għal awtorizzazzjonijiet għat-tqegħid fis-suq għall-mediċini għall-użu mill-bniedem u 13 għal previżjoni ta' użu veterinarju.
English: The nominating authority confirmed the withdrawal of the nomination in a letter addressed to the MB Chair, received on 24 February 2012.
Maltese: L-awtorità ta' nominazzjoni kkonfermat l-irtirar tannomina f'ittra indirizzata lill-President tal-MB, li waslet fl-24 ta' Frar 2012.
English: Mexico plans to recognise unilaterally EU centralised authorisations.
Maltese: Messiku qed jippjana biex jiġu rikonoxxuti b'mod unilaterali awtorizzazzjonijiet ċentralizzati tal-UE.
English: [EMA/513078/2010] The Management Board endorsed the amendments to the revised conflicts of interests policy for Committee members and experts.
Maltese: [EMA/513078/2010] Il-Bord ta' Tmexxija approva l-emendi għall-politika riveduta dwar il-kunflitti ta' interessi għall-membri u l-esperti tal-Kumitat.
English: • The HMA's agreement to publish information on the authorisation of clinical trials in the EU as part of the impact assessment of the revision of the Clinical Trials directive.
Maltese: • Il-qbil tal-HMA biex tippubblika informazzjoni dwar l-awtorizzazzjoni ta' provi kliniċi fl-UE bħala parti mill-valutazzjoni tal-impatt tar-reviżjoni tad-direttiva dwar il-Provi Kliniċi.
English: Significant progress was made in other areas, including the launch of the EU clinical-trials register and the new online database of European experts.
Maltese: Sar progress notevoli f'oqsma oħrajn, inkluża t-tnedija tar-reġistru tal-UE dwar il-provi kliniċi u ddatabase online l-ġdida tal-esperti Ewropej.
English: The paper will be discussed by the newly created PRAC, and a final proposal will be submitted to the Board later this year.
Maltese: Id-dokument sejjer jiġi diskuss mal-PRAC imwaqqaf riċentement, u tard din is-sena sejra tiġi ppreżentata proposta finali lill-Bord.