FrancophonIA/ELRC3.0 huggingface dataset:
English: After considering the grounds for this request, the CHMP re-examined the opinion, and confirmed the refusal of the marketing authorisation on 20 September 2018.
Maltese: Wara li kkunsidra r-raġunijiet għal din it-talba, is-CHMP eżamina l-opinjoni mill-ġdid u kkonferma rrifjut tal-awtorizzazzjoni għat-tqegħid fis-suq fl-20 ta' Settembru 2018.
English: Outcome of re-examination
Maltese: (eteplirsen)
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Exondys.
Maltese: Il-kumpanija infurmat lil CHMP li ma hemm ebda konsegwenza għal pazjenti li fil-preżent huma inklużi fil-provi kliniċi b'Exondys.
English: The main measure of effectiveness was the change in the distance walked during a 6-minute walking test after 24 weeks.
Maltese: Il-kejl ewlieni tal-effikaċja kien il-bidla fid-distanza li l-pazjenti rnexxielhom jimxu f'test talmixi ta' 6 minuti wara 24 ġimgħa ta' kura.
English: Therefore, the CHMP was of the opinion that the balance of benefits and risks of Exondys in the treatment of DMD could not be established and recommended that the marketing authorisation be refused.
Maltese: Għalhekk, is-CHMP kien tal-opinjoni li l-bilanċ bejn il-benefiċċji u r-riskji ta' Exondys fil-kura tad-DMD ma setax jiġi stabbilit u rrakkomanda li l-awtorizzazzjoni għat-tqegħid fis-suq tiġi rifjutata.
English: This means that the patients' DMD gene can make a working form of the dystrophin protein when a part of the gene called exon 51 is not used.
Maltese: Dan ifisser li l-ġene DMD tal-pazjenti jista' jagħmel forma ta' xogħol tal-proteina distrofin meta parti mill-ġene msejħa exon 51 ma tintużax.
English: In the first study, Exondys was compared with placebo (a dummy treatment) for the first 24 weeks, after which all patients were treated with Exondys.
Maltese: Fl-ewwel studju, Exondys tqabbel ma' plaċebo (kura finta) għall-ewwel 24 ġimgħa, u wara dan, il-pazjenti kollha ġew ikkurati b'Exondys.
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is treating you in the trial.
Maltese: Jekk inti qed tieħu sehem fi prova klinika u teħtieġ aktar informazzjoni dwar il-kura tiegħek, ikkuntattja lit-tabib li jkun qed jagħtik il-kura fil-prova.
English: • Revision of the clinical trials directive.
Maltese: • Reviżjoni tad-direttiva dwar il-provi kliniċi.
English: • The adoption of the draft Strategy Paper II 2011-2015 for public consultation.
Maltese: • L-adozzjoni tal-abbozz tat-tieni Dokument ta' Strateġija 2011-2015 għal konsultazzjoni pubblika.
English: The financial impact of the scheme was in excess of € 140,000.
Maltese: L-impatt finanzjarju tal-iskema kien f'eċċess ta' € 140,000.
English: Sara Mendosa Isabelle Moulon Frances Nuttal Agnès Saint Raymond Arielle North Nerimantas Steikūnas Zuzana O'Callaghan
Maltese: Sara Mendosa Isabelle Moulon Frances Nuttal Agnès Saint Raymond Arielle North Nerimantas Steikūnas Zuzana
English: Sponsoring of patients' organisations by pharmaceutical industry - proposed actions
Maltese: Sponsorjar tal-organizzazzjonijiet tal-pazjenti mill-industrija farmaċewtika - azzjonijiet proposti
English: Product suspension
Maltese: Punti prinċipali Sospensjoni tal-prodotti
English: The workshop was successful with 170 delegates from around 50 countries attending.
Maltese: Il-workshop kien suċċess, tant li għalih attendew 170 delegat minn madwar 50 pajjiż.
English: Representative of veterinarians' organisations
Maltese: Rappreżentant ta' organizzazzjonijiet ta' veterinarji
English: Minor Use Minor Species policy: Annual report 2010
Maltese: Il-politika ta' Użu Minuri u Speċi Minuri: Rapport annwali 2010
English: Nomination to the CVMP
Maltese: Nominazzjoni għas-CVMP
English: The establishment of a Joint CVMP/CHMP ad-hoc Expert Group on the application of the 3Rs (Replacement, Reduction and Refinement) in the development of medicinal products
Maltese: It-twaqqif ta' Grupp ta' Esperti ad-hoc tas-CVMP/CHMP konġunti dwar l-applikazzjoni tat-3Rs (Sostituzzjoni, Tnaqqis u Rfinar - Replacement, Reduction and Refinement) fliżvilupp ta' prodotti mediċinali
English: 2009 EudraVigilance Human Status Report 2009
Maltese: Rapport ta' Status tal-EudraViġilanza għall-Użu mill-Bniedem 2009
English: [EMA/MB/528780/2010; EMA/MB/216485/2009; EMA/MB/281870/2010] The Management Board adopted the revised EMA Financial Regulation and implementing rules.
Maltese: [EMA/MB/528780/2010; EMA/MB/216485/2009; EMA/MB/281870/2010] Il-Bord ta' Tmexxija adotta rRegolament Finanzjarju rivedut tal-EMA u r-regoli implimentattivi tiegħu.
English: • Nomination form and CV for the nomination to the CVMP
Maltese: • Formola tan-nominazzjoni u CV għan-nominazzjoni għas-CVMP
English: [EMA/MB/603657/2010] The Management Board adopted the transfer of € 4.4 million of ‘provisional appropriation' (€ 5.4 million) that was set aside for possible variations in fee income.
Maltese: [EMA/MB/603657/2010] Il-Bord ta' Tmexxija adotta t-trasferiment ta' € 4.4 miljun ta' ‘approprjazzjoni provviżorja' (€ 5.4 miljun) li kienet imwarrba għall-varjazzjonijiet possibbli fid-dħul mill-ħlasijiet.
English: Alternates (and other participants)
Maltese: Membri supplenti (u parteċipanti oħrajn)
English: The new EMA Financial Regulation follows the revision of the Framework Financial Regulation (EC, EURATOM) No 2343/2002 in 2008 and takes into account comments made by the European Commission.
Maltese: Ir-Regolament Finanzjarju lġdid tal-EMA jsegwi r-reviżjoni tar-Regolament Finanzjarju ta' Qafas (KE, EURATOM) Nru 2343/2002 fl2008 u jieħu f'kunsiderazzjoni l-kummenti magħmula mill-Kummissjoni Ewropea.
English: [EMA/MB/578660/2010] The Board noted the nomination to the CVMP.
Maltese: [EMA/MB/578660/2010] Il-Bord ħa nota tan-nominazzjoni għas-CVMP.
English: • The progress on the "pharmaceutical package"; pharmacovigilance legislation which is due to become applicable in mid-2012), legislative proposals on preventing entry into legal supply chain of falsified medicines and information to patients).
Maltese: • Il-progress dwar il-"pakkett farmaċewtiku"; leġiżlazzjoni dwar il-farmakoviġilanza li mistennija ssir applikabbli f'nofs l-2012), proposti leġiżlattivi dwar il-prevenzjoni tad-dħul fil-katina tal-provvista legali ta' mediċini ffalsifikati u l-informazzjoni lill-pazjenti).
English: An international workshop in the area of GCP and ethical requirements for clinical trials
Maltese: Workshop internazzjonali fil-qasam tal-GCP u r-rekwiżiti etiċi għall-provi kliniċi
English: • [EMA/496888/2010] Update report on the Agency's implementation of the EU telematics strategy
Maltese: • [EMA/496888/2010] Rapport ta' aġġornament dwar l-implimentazzjoni tal-istrateġija tat telematika tal-UE mill-Aġenzija
English: The policy will be published in November 2010.
Maltese: Il-politika sejra tiġi ppubblikata f'Novembru 2010.
English: List of participants at the 68th meeting of the Management Board, held in London, 7 October 2010
Maltese: Lista ta' parteċipanti fit-68 laqgħa tal-Bord ta' Tmexxija, li saret f'Londra fis-7 ta' Ottubru 2010
English: Held in London on 7 October 2010
Maltese: Li saret f'Londra fis-7 ta' Ottubru 2010
English: Amendment to the Agency's internal control standard on sensitive functions
Maltese: Emenda fl-istandard tal-kontroll intern tal-Aġenzija fuq funzjonijiet sensittivi
English: 4 October 2010.
Maltese: sal-4 ta' Ottubru 2010.
English: EMA Mid-year report 2010
Maltese: Rapport ta' nofs is-sena tal-EMA 2010
English: [EMA/MB/559867/2010] The Management Board endorsed the proposal to establish a joint CVMP/CHMP ad-hoc expert group on the application of the 3Rs in the development of medicinal products.
Maltese: [EMA/MB/559867/2010] Il-Bord ta' Tmexxija approva l-proposta biex jitwaqqaf grupp ta' esperti adhoc tas-CVMP/CHMP konġunti dwar l-applikazzjoni tat-3Rs fl-iżvilupp ta' prodotti mediċinali.
English: Brigitte Batliner (Liechtenstein) Gro Ramsten Wesenberg (Norway) Apology received from Iceland
Maltese: Gro Ramsten Wesenberg (in-Norveġja)
English: • [EMA/MB/539466/2010] MBTC's Telematics Implementation Group: Chair's appointment procedure and role
Maltese: • [EMA/MB/539466/2010] Grupp ta' Implimentazzjoni tat-Telematika tal-MBTC:
English: [EMA/MB/568706/2010] The Management Board adopted the proposed revision to the Agency's internal control standard on sensitive functions.
Maltese: [EMA/MB/568706/2010] Il-Bord ta' Tmexxija adotta r-reviżjoni proposta għall-istandard tal-kontroll intern tal-Aġenzija fuq funzjonijiet sensittivi.
English: A further discussion will take place at the December meeting.
Maltese: Waqt il-laqgħa ta' Diċembru sejra ssir diskussjoni oħra.
English: The European Parliament hearing on H1N1 pandemic
Maltese: Is-smigħ tal-Parlament Ewropew dwar il-pandemija H1N1
English: The Board nominated the vice-chair, Lisette Tiddens-Engwirda, as the Board representative to the Committee.
Maltese: Il-Bord innomina lill-viċi president, Lisette Tiddens-Engwirda, bħala rrappreżentanta tal-Bord għall-Kumitat.
English: [EMA/MB/579729/2010] The Management Board noted the report.
Maltese: [EMA/MB/579729/2010] Il-Bord ta' Tmexxija ħa nota tar-rapport.
English: [EMA/MB/599720/2010] The Management Board endorsed the EudraVigilance status report for Human medicinal products for 2009.
Maltese: [EMA/MB/599720/2010] Il-Bord ta' Tmexxija approva r-rapport ta' status tal-EudraViġilanza għal prodotti mediċinali għall-użu mill-bniedem għall-2009.
English: [EMA/MB/404038/2010] The Management Board noted the final minutes, adopted by written procedure on 4 August 2010.
Maltese: [EMA/MB/404038/2010] Il-Bord ta' Tmexxija ħa nota tal-minuti finali, adottati permezz ta' proċedura bil-miktub fl-4 ta' Awwissu 2010.
English: It was suggested that, in future, an agreement with the industry on the format of marketing authorisation applications in a way that would facilitate access without the need for redacting of commercial confidential and information containing personal data throughout the document should be explored.
Maltese: Ġie ssuġġerit li, fil-ġejjieni, għandu jiġi esplorat ftehim mal-industrija dwar il-format talapplikazzjonijiet għall-awtorizzazzjoni għat-tqegħid fis-suq b'tali mod li jkun iffaċilitat l-aċċess mingħajr il-ħtieġa ta' reviżjoni ta' informazzjoni kummerċjali kunfidenzjali u informazzjoni li jkun fiha data personali matul id-dokument kollu.
English: [EMA/MB/581808/2010; EMA/MB/581875/2010] The Management Board endorsed the EMA Policy on access to documents (related to medicinal products for human and veterinary use) and noted the document outlining outputs of the policy.
Maltese: [EMA/MB/581808/2010; EMA/MB/581875/2010] Il-Bord ta' Tmexxija approva l-Politika tal-EMA dwar laċċess għad-dokumenti (relatati ma' prodotti mediċinali għal użu mill-bniedem u għal użu veterinarju) u ħa nota tad-dokument li jiddeskrivi r-riżultati tal-politika.
English: A number of Board members felt that, while the final decision on appointment of a member lies with the Member State in accordance with Art. 61 of Regulation (EC) No 726/2004, only appropriately scientifically qualified members should be accepted.
Maltese: Għadd ta' membri tal-Bord ħassew li, filwaqt li d-deċiżjoni finali dwar il-ħatra ta' membru hija f'idejn l-Istat Membru skont l-Art. 61 tar-Regolament (KE) Nru 726/2004, għandhom jiġu aċċettati biss dawk il-membri li jkunu xjentifikament ikkwalifikati b'mod adegwat.
English: • [EMA/MB/528844/2010] Summary of transfers of appropriations in the budget 2010.
Maltese: • [EMA/MB/528844/2010] Sommarju tat-trasferimenti tal-approprjazzjonijiet fil-baġit għall-2010.
English: The new policy is built with three principles in mind: robustness, efficiency and transparency.
Maltese: Il-politika l-ġdida hija mibnija fuq kunsiderazzjoni ta' tliet prinċipji: ir-robustezza, l-effikaċja u ttrasparenza.
English: [EMA/MB/511582/2010] The Management Board noted the mid-year report 2010.
Maltese: [EMA/MB/511582/2010] Il-Bord ta' Tmexxija ħa nota tar-rapport ta' nofs is-sena tal-2010.
English: The endorsed document follows the public consultation launched in December 2008 and takes into account recommendations from the European Ombudsman.
Maltese: Iddokument approvat isegwi l-konsultazzjoni pubblika mnedija f'Diċembru 2008 u jieħu f'kunsiderazzjoni r-rakkomandazzjonijiet mill-Ombudsman Ewropew.
English: [EMA/MB/588579/2010; EMA/MB/589332/2010] The Management Board endorsed the Agency's updated policy on the handling of conflicts of interests of Scientific Committee members and experts, and noted the document providing an overview of the allowable interests for the EMA scientific activities.
Maltese: [EMA/MB/588579/2010; EMA/MB/589332/2010] Il-Bord ta' Tmexxija approva l-politika aġġornata talAġenzija dwar it-trattament tal-kunflitti ta' interessi tal-membri u l-esperti tal-Kumitat Xjentifiku, u ħa nota tad-dokument li jipprovdi ħarsa ġenerali lejn l-interessi permessibbli għall-attivitajiet xjentifiċi talEMA.
English: The Board discussed that in future information about signal management activities will need to be provided.
Maltese: Il-Bord iddiskuta li jeħtieġ li fil-ġejjieni tiġi pprovduta informazzjoni dwar il-ġestjoni tas-sinjali.
English: [EMA/MB/531926/2010] The Management Board discussed the issue raised in the report by the Health Action International which suggested that not all patient and consumer organisations fulfil the Agency's financial transparency criteria.
Maltese: [EMA/MB/531926/2010] Il-Bord ta' Tmexxija ddiskuta l-kwistjoni mqajma fir-rapport mill-Health Action International, li ssuġġeriet li mhux l-organizzazzjonijiet kollha tal-pazjenti u tal-konsumaturi jissodisfaw il-kriterji tat-trasparenza finanzjarja tal-Aġenzija.
English: [EMA/MB/575243/2010] The Executive Director had established the Audit Advisory Committee to oversee and advice him on internal controls, financial and risk management, and audits in order to help secure good governance and effective accountability and transparency.
Maltese: [EMA/MB/575243/2010] Id-Direttur Eżekuttiv waqqaf il-Kumitat Konsultattiv ta' Verifika biex jissorvelja u jagħtih pariri dwar il-kontrolli interni, il-ġestjoni finanzjarja u l-ġestjoni tar-riskji, u lverifiki sabiex jgħin ħalli jiżgura tmexxija tajba u kontabilità u trasparenza effettivi.
English: [EMA/MB/398075/2010] The agenda was adopted with the following item added: Draft Council conclusions on innovation and solidarity in the pharmaceutical sector.
Maltese: [EMA/MB/398075/2010] L-aġenda ġiet adottata bil-punt li ġej miżjud: Abbozz tal-konklużjonijiet talKunsill dwar l-innovazzjoni u s-solidarjetà fis-settur farmaċewtiku.
English: The EMA's involvement in this process relates to the fact that a part of substances of human origin are processed to advanced therapies, which are then covered by specific legislation.
Maltese: L-involviment tal-EMA f'dan il-proċess huwa relatat mal-fatt li parti mis-sustanzi ta' oriġini millbniedem jiġu pproċessati għal terapiji avvanzati, li mbagħad ikunu koperti minn leġiżlazzjoni speċifika.
English: The transfer follows the evaluation of its budgetary situations as at 31 August 2010 which showed favourable budget trend.
Maltese: Ittrasferiment isegwi l-evalwazzjoni tas-sitwazzjonijiet baġitarji tiegħu sal-31 ta' Awwissu 2010, li wrew xejra baġitarja favorevoli.
English: • [EMA/MB/535239/2010] Outcome of written procedures during the period from 7 June 2010 to
Maltese: • [EMA/MB/535239/2010] Riżultat tal-proċeduri bil-miktub matul il-perjodu mis-7 ta' Ġunju 2010
English: • Wider application of teleconferencing tools involving larger number of participants.
Maltese: • Applikazzjoni usa' tal-għodod ta' telekonferenzi li jinvolvu numru akbar ta' parteċipanti.
English: Preparation for written procedure on adoption of the Agency's policy on protecting the dignity of the person and preventing any form of psychological or sexual harassment
Maltese: Tħejjija għal proċedura bil-miktub dwar l-adozzjoni tal-politika tal-Aġenzija dwar ilprotezzjoni tad-dinjità tal-persuna u l-prevenzjoni ta' kwalunkwe forma ta' fastidju psikoloġiku jew sesswali
English: 16 December 2010 EMA/MB/628133/2010
Maltese: EMA/440446/2011
English: [EMA/MB/818152/2009] The Management Board adopted the amendments to the implementing rules on the Agency's fees.
Maltese: [EMA/MB/818152/2009] Il-Bord ta' Tmexxija adotta l-emendi għar-regoli implimentattivi dwar ilħlasijiet tal-Aġenzija.
English: [EMA/MB/577848/2010; EMA/577855/2010] The Management Board endorsed the annual report on the operation of the Minor Use Minor Species (MUMS) policy and the proposal to continue with the scheme for an additional year.
Maltese: [EMA/MB/577848/2010; EMA/577855/2010] Il-Bord ta' Tmexxija approva r-rapport annwali dwar ittħaddim tal-politika ta' Użu Minuri u Speċi Minuri (MUMS) u l-proposta li l-iskema titkompla għal sena oħra.
English: Revised policy on the handing of conflicts of interests
Maltese: Politika riveduta dwar it-trattament tal-kunflitti ta' interessi
English: The last meeting of the group discussed the ongoing inter-institutional review of the EU agencies with the participation of the chair of the EU executive directors group.
Maltese: Aġġornament mill-grupp ta' presidenti tal-aġenziji tal-UE L-aħħar laqgħa tal-grupp iddiskutiet ir-reviżjoni inter-istituzzjonali li għaddejja tal-aġenziji tal-UE bilparteċipazzjoni tal-president tal-grupp tad-diretturi eżekuttivi tal-UE.
English: Appology reveived
Maltese: Apoloġija rċevuta
English: The members noted the update report from the Heads of Medicines Agencies (HMA) on a number of topics, including:
Maltese: Rapport mill-Kapijiet tal-Aġenziji tal-Mediċini Il-membri ħadu nota tar-rapport ta' aġġornament mill-Kapijiet tal-Aġenziji tal-Mediċini (Heads of Medicines Agencies - HMA) dwar numru ta' suġġetti, inkluż:
English: Lisette Tiddens-Engwirda and Jean Marimbert will act as topic coordinators for the revision of the rules applied to members of the Management Board and will take into account experience gained with the above policy.
Maltese: Lisette Tiddens-Engwirda u Jean Marimbert sejrin jaġixxu bħala koordinaturi tas-suġġett għar-reviżjoni tar-regoli applikati għall-membri tal-Bord ta' Tmexxija u sejrin jieħdu f'kunsiderazzjoni l-esperjenza miksuba bil-politika msemmija hawn fuq.
English: A report proposing an operational level solution will be prepared following these discussions and will be presented to the Management Boards of the ECDC and EMA in November and December 2010 respectively.
Maltese: Wara li jsiru dawn id-diskussjonijiet, mistenni jitħejja rapport li jipproponi soluzzjoni fuq livell operattiv, sabiex imbagħad jiġi ppreżentat lill-Bordijiet ta' Tmexxija tal-ECDC u l-EMA f'Novembru u Diċembru 2010 rispettivament.
English: Minutes from the 67th meeting, held on 10 June 2010
Maltese: 3. Minuti mis-67 laqgħa, li saret fl-10 ta' Ġunju 2010
English: 9bis Transfer of appropriations in the budget 2010 in accordance with Article 23 (2) of the Financial Regulation
Maltese: 9bis Trasferiment tal-approprjazzjonijiet fil-baġit tal-2010 skont l-Artikolu 23 (2) tarRegolament Finanzjarju
English: • The HMA's endorsement of the draft Memorandum of Understanding on the monitoring of the scientific level and independence of the evaluation carried out by the NCAs for the Agency.
Maltese: • L-approvazzjoni mill-HMA tal-abbozz tal-Memorandum ta' Fehim dwar il-monitoraġġ tal-livell xjentifiku u l-indipendenza tal-evalwazzjoni mwettqa mill-NCAs għall-Aġenzija.
English: The meeting also considered future interactions between the two groups and a concept of performance indicators applicable to members of a management board.
Maltese: Il-laqgħa kkunsidrat ukoll linterazzjonijiet futuri bejn iż-żewġ gruppi u kunċett ta' indikaturi tar-rendiment applikabbli għallmembri ta' bord ta' tmexxija.
English: Minutes of the 68th meeting of the Management Board
Maltese: Minuti tat-68 laqgħa tal-Bord ta' Tmexxija
English: The amendments concerns extensions of marketing authorisation, Type II variations, annual fees, variations to plasma master files and vaccine antigen master files.
Maltese: L-emendi jikkonċernaw l-estensjonijiet tal-awtorizzazzjoni għat-tqegħid fis-suq, il-varjazzjonijiet tat-Tip II, il-ħlasijiet annwali, il-varjazzjonijiet fil-fajls prinċipali tal-plażma u l-fajls prinċipali tal-vaċċini antiġen.
English: The Board endorsed the AAC approach to its remit in March 2005.
Maltese: Il-Bord approva lapproċċ tal-AAC għall-mandat tiegħu f'Marzu 2005.
English: By introducing the new policy, the Agency aims to ensure the widest possible access to its documents whilst respecting a number of principles set out in the policy, including the protection of commercial confidential information and personal data.
Maltese: Billi tintroduċi l-politika ġdida, l-Aġenzija għandha l-għan li tiżgura l-usa' aċċess possibbli għad-dokumenti tagħha, filwaqt li tirrispetta numru ta' prinċipji stabbiliti fil-politika, inkluż il-protezzjoni ta' informazzjoni kummerċjali kunfidenzjali u data personali.
English: The Management Board provided comments with regards to the reasons for the decline in the number of applications for human medicinal products, the increase in applications for paediatric investigation plans and the previous discussions of the Board on the payment system to national competent authorities.
Maltese: Kien suġġerit ukoll li jista' jiġi previst arranġament li jkun mifrux madwar id-dinja, pereżempju fil-kuntest tal-ICH.
English: The amendment concerns the replacement of mandatory mobility with ex-post controls and/or focused audits every two years for sensitive functions.
Maltese: L-emenda tikkonċerna t-tibdil tal-mobbiltà mandatorja b'kontrolli ex-post u/jew verifiki ffokati kull sentejn għal funzjonijiet sensittivi.
English: [EMA/MB/400828/2009] The Board noted that the vacancy notice for the selection of the Executive Director of the EMA will be published on 27 October 2010 with a closing date for applications on 24 November 2010.
Maltese: Proċedura tal-Bord ta' Tmexxija għall-għażla tad-Direttur Eżekuttiv [EMA/MB/400828/2009] Il-Bord innota li l-avviż ta' post battal għall-għażla tad-Direttur Eżekuttiv talEMA sejjer jiġi ppubblikat fis-27 ta' Ottubru 2010 b'data tal-għeluq għall-applikazzjonijiet fl-24 ta' Novembru 2010.
English: The existing and new responsibilities, notably the new responsibilities in the field of pharmacovigilance, will increase pressure on financial resources.
Maltese: Ir-responsabbiltajiet eżistenti u ġodda, notevolment irresponsabbiltajiet ġodda fil-qasam tal-farmakoviġilanza, sejrin iżidu l-pressjoni fuq ir-riżorsi finanzjarji.
English: Amongst further activities, the Agency plans to revise the “Framework of Interaction” between the EMA and PCOs and to explore how patients and consumers can be involved in the benefit/risk assessment of medicinal products.
Maltese: Fost attivitajiet oħrajn, l-Aġenzija qiegħda tippjana li tirrevedi l-“Qafas ta' Interazzjoni” bejn l-EMA u l-PCOs u li tesplora kif ilpazjenti u l-konsumaturi jistgħu jkunu involuti fil-valutazzjoni tal-benefiċċji/riskji tal-prodotti mediċinali.
English: The political process to examine the fee system will be lengthy and therefore it is important to proceed as soon as possible and envisage interim solutions.
Maltese: Il-proċess politiku biex tiġi eżaminata s-sistema tal-ħlasijiet sejjer jieħu fit-tul u għalhekk huwa importanti li dan jipproċedi mill-aktar fis possibbli u li jiġu previsti soluzzjonijiet interim.
English: The current Executive Director will make the appointment.
Maltese: Rappreżentanti ta' organizzazzjonijiet ta' pazjenti
English: The European Commission anticipates that an extraordinary meeting can be convened for the last week of February 2011.
Maltese: Il-Kummissjoni Ewropea qiegħda tantiċipa li tista' tinbeda laqgħa straordinarja għallaħħar ġimgħa ta' Frar 2011.
English: Highlights
Maltese: Ċipru
English: The traceability is a complex issue, particularly for medicinal products due to their wide distribution.
Maltese: It-traċċabilità hija kwistjoni kumplessa, b'mod partikolari għall-prodotti mediċinali, minħabba d-distribuzzjoni wiesgħa tagħhom.
English: Veterinary Medicines Division
Maltese: Diviżjoni tal'Mediċini Veterinarji