FrancophonIA/ELRC3.0 huggingface dataset:
English: Due to immature renal function in neonates up to 4 weeks of age and infants up to 1 year of age, {Invented name} should only be used in these patients after careful consideration at a dose not exceeding {x} mmol/kg body weight.
Maltese: Minħabba funzjoni tal-kliewi immatura fi trabi għadhom jitwieldu sa 4 ġimgħat u trabi sa età ta' sena, {Isem inventat} għandu jintuża biss f'dawn il-pazjenti wara konsiderazzjoni bir-reqqa b'doża li ma taqbiżx {x} mmol/kg piż tal-ġisem.
English: Bracco Imaging Deutschland GmbH Max-Stromeyer-Strasse 116 D-78467 Konstanz
Maltese: Bracco Imaging Deutschland GmbH Max-Stromeyer-Strasse 116
English: The GdCAs are available for different types of MR scan varying from product to product, including liver, brain and whole body scan.
Maltese: Il-GdCAs huma disponibbli għal tipi differenti ta' skansjoni MR li jvarjaw minn prodott għall-ieħor, fosthom skansjoni tal-fwied, talmoħħ jew tal-ġisem sħiħ.
English: Insight Agents GmbH Ringstrasse 19 B 69115 Heidelberg Germany
Maltese: Insight Agents GmbH Ringstrasse 19 B 69115
English: Due to immature renal function in infants up to 1 year of age, {Invented name} should only be used in patients 6 to 12 months of age after careful consideration.
Maltese: Minħabba funzjoni tal-kliewi immatura fi tfal b'età sa sena, f'pazjenti b'età minn 6 xhur sa 12-il xahar, {Isem ivvintat} għandu jintuża biss wara kunsiderazzjoni b'attenzjoni.
English: Lactation [Amend currently approved text for data in lactating women and animal studies in line with the CHMP Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: From Data to Labelling (24 July 2008)]
Maltese: [Uża t-test attwalment approvat biż-żieda ta' informazzjoni dwar indeboliment fil-funzjoni tal-kliewi, l-użu fi trabi u tfal żgħar u l-użu fl-anzjani]
English: Neonates up to 4 weeks of age and infants up to 1 year of age
Maltese: {Isem ivvintat} m'għandux jingħata lil trabi tat-twelid b'età sa 4 ġimgħat.
English: Use of {Invented name} should be avoided in patients with severe renal impairment (GFR < 30 ml/min/1.73m2) and in patients in the perioperative liver transplantation period unless the diagnostic information is essential and not available with non-contrast enhanced MRI (see section 4.4).
Maltese: L-użu ta' {Isem inventat} għandu jiġi evitat f'pazjenti li għandhom indeboliment renali sever (GFR < 30 ml/min/1.73m2) u f'pazjenti li qegħdin fil-perijodu perioperattiv ta' trapjant tal-fwied kemm-il darba l-informazzjoni dijanjostika hi essenzjali u mhix disponibbli b'MRI mhux imtejjeb b'kuntrast (ara sezzjoni 4.4).
English: 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 13 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Maltese: (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
English: International Non-Proprietary Name (INN): piroxicam
Maltese: Mhux Patentat (INN): piroxicam
English: London, 20 September 2007 EMEA/380917/2007
Maltese: Londra, 20 ta' Settembru 2007 EMEA/470092/2007
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 31(2) REFERRAL
Maltese: (CHMP) WARA REFERENZA SKOND L-ARTIKOLU 31(2)
English: Piroxicam is a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic and antipyretic properties.
Maltese: Piroxicam huwa mediċina anti-infjammatorja mhux sterojdali (SNAID) bi kwalitajiet antiinfjammatorji, analġeżiċi u antipiretiċi.
English: The MAHs presented oral explanations to the CHMP on 22 and 23 May 2007.
Maltese: Il-MAHs ippreżentaw spjegazzjonijiet verbali lill-CHMP fit-22 u fit-23 ta' Mejju 2007.
English: PIROXICAM CONTAINING MEDICINAL PRODUCTS
Maltese: PRODOTTI MEDIĊINALI LI FIHOM PIROXICAM
English: On 2 August 2006, the European Commission referred the matter to the EMEA under Article 31 of Directive 2001/83/EC, as amended, for piroxicam containing medicinal products.
Maltese: Fit-2 ta' Awwissu 2006, il-Kummissjoni Ewropea rreferiet il-kwistjoni lill-EMEA skond l-Artikolu 31 tad-Direttiva 2001/83/KE, kif emendata, għal prodotti mediċinali li fihom piroxicam.
English: ∗ Notes: the information given in this document and annexes reflects only the CHMP Opinion dated 21 June 2007.
Maltese: ∗ Noti: l-informazzjoni mogħtija f'dan id-dokument u fl-annessi tirrifletti biss l-Opinjoni tal-CHMP datata 21 ta' Ġunju 2007.
English: Written explanations were provided by the Marketing Authorisation Holders (MAH) on 18 December 2006 and 13 April 2007.
Maltese: Id-Detenturi ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) ipprovdew spjegazzjonijiet bilmiktub fit-18 ta' Diċembru 2006 u fit-13 ta' April 2007.
English: The Rapporteur and Co-Rapporteur appointed were Dr Rossi and Dr Calvo-Rojas respectively.
Maltese: Rossi u d-Dott. Calvo-Rojas rispettivament.
English: The review found that limited epidemiological data and spontaneous adverse drug reaction data provided a signal of increased risk of gastrointestinal and skin reactions (including life-threatening bullous reactions) for piroxicam relative to other non-selective NSAIDs.
Maltese: Din l-evalwazzjoni sabet li dejta epidemjoloġika limitata u dejta spontanja dwar ir-reazzjonijiet avversi tal-mediċina pprovdiet sinjal ta' riskju akbar ta' reazzjonijiet gastro-intestinali u tal-ġilda (fosthom reazzjonijiet bullużi ta' theddida għall-ħajja) għal piroxicam meta mqabbel ma' NSAIDs oħra mhux selettivi.
English: Based on the available data the CHMP considered that the benefit/risk balance for systemic formulations of piroxicam is positive in the treatment of symptomatic relief of osteoarthritis, rheumatoid arthritis or ankylosing spondylitis; however the CHMP considered that the benefit/risk balance of piroxicam in the treatment of acute conditions is negative and that these indications should be revoked.
Maltese: Fuq il-bażi tad-dejta disponibbli, il-CHMP ikkunsidra li l-bilanċ bejn il-benefiċċju u r-riskju għallformulazzjonijiet sistemiċi ta' piroxicam huwa pożittiv fit-trattament tas-serħan mis-sintomi ta' losteoartrite, l-artrite rewmatika jew l-ispondilite li twassal għall-ankilosi; madankollu l-CHMP ikkunsidra li l-bilanċ bejn il-benefiċċju u r-riskju ta' piroxicam fit-trattament ta' kundizzjonijiet akuti huwa negattivi u li dawn l-indikazzjonijiet għandhom jiġu revokati.
English: The Member states competent Authorities will continue to keep the product under regular review.
Maltese: L-Awtoritajiet kompetenti ta' l-Istati Membri ser ikomplu jżommu l-prodott taħt osservazzjoni regolari.
English: This review was finalised in June 2006.
Maltese: Din l-evalwazzjoni ntemmet f'Ġunju 2006.
English: BACKGROUND INFORMATION *
Maltese: TAGĦRIF ĠENERALI *
English: The reasons for referral concerned the risk of gastrointestinal and skin reactions.
Maltese: Ir-raġunijiet għar-riferiment kienu jikkonċernaw ir-riskju ta' reazzjonijiet gastro-intestinali u tal-ġilda.
English: Other information about Vectra 3D
Maltese: Informazzjoni oħra dwar Vectra 3D
English: Further information on Vectra 3D can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/vectra-3d.
Maltese: ema.europa.eu/medicines/veterinary/EPAR/vectra-3d.
English: Vectra 3D (dinotefuran / pyriproxyfen / permethrin)
Maltese: Vectra 3D (dinotefuran / piriproksifen / permetrina)
English: Vectra 3D received a marketing authorisation valid throughout the EU on 4 December 2013.
Maltese: Vectra 3D ngħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fl-4 ta' Diċembru 2013.
English: Other side effects with Vectra 3D (which may affect up to 1 in 1000 dogs) are behavioural disorders such as increased activity, barking or signs of anxiety, lethargy (lack of energy), or anorexia (loss of appetite), and nervous system signs such as muscle tremor (shaking).
Maltese: Effetti sekondarji oħra b'Vectra 3D (li jistgħu jaffettwaw mhux aktar minn kelb 1 minn kull 1000) huma disturbi fl-imġiba bħal żieda flattività, inbiħ jew sinjali ta' ansjetà, letarġija (nuqqas ta' enerġija), jew anoressija (telf ta' aptit), u sinjali tas-sistema nervuża bħal tregħid ta' muskoli (rogħda).
English: The effectiveness of Vectra 3D against fleas, ticks, mosquitoes and flies was investigated in 24 laboratory studies and in two field studies.
Maltese: L-effettività ta' Vectra 3D kontra l-briegħed, il-qurdien, in-nemus u d-dubbien ġiet investigata f'24 studju tal-laboratorju u f'żewġ studji fuq il-post.
English: What are the risks associated with Vectra 3D?
Maltese: X'inhuma r-riskji assoċjati ma' Vectra 3D?
English: It showed that Vectra 3D-treated dogs had an average flea count reduction of 95% compared with 97% for the dogs treated with fipronil and (s)-methoprene.
Maltese: Dan wera li klieb ikkurati b'Vectra 3D kellhom medja ta' tnaqqis fl-għadd ta' briegħed ta' 95 % meta mqabbla ma' 97 % għall-klieb ikkurati bil-fipronil u l-(s)-metopren.
English: The active substances in Vectra 3D act as ‘ectoparasiticides'.
Maltese: Is-sustanzi attivi f'Vectra 3D jaġixxu bħala “ektoparassitiċidi”.
English: Dinotefuran acts on nerve receptors called nicotinic acetylcholine receptors and permethrin interferes with sodium channels on nerves that play a role in transmitting signals; when given together, they reinforce each other's action.
Maltese: Iddinotefuran taġixxi fuq ir-riċetturi tan-nervituri li jissejħu riċetturi tal-aċetilkolina nikotinika u lpermetrina tinterferixxi mal-kanali tas-sodju fuq in-nervituri li jkollhom rwol fit-trażmissjoni tas-sinjali; meta jitqiesu flimkien, isaħħu l-azzjoni ta' xulxin.
English: Vectra 3D contains three active substances: dinotefuran, pyriproxyfen and permethrin.
Maltese: Vectra 3D fih tliet sustanzi attivi: id-dinotefuran, il-piriproksifen u l-permetrina.
English: Vectra 3D is a veterinary medicine used on dogs to treat and prevent flea and tick infestations and to repel sand flies, mosquitoes and stable flies.
Maltese: Vectra 3D huwa mediċina veterinarja li tintuża fuq il-klieb għall-kura u l-prevenzjoni ta' infestazzjonijiet tal-briegħed u l-qurdien u biex tiġi miġġielda s-sand fly, in-nemus u d-dubbien talirziezet.
English: The second field study involved 278 dogs with flea infestations which were treated three times at monthly intervals either with Vectra 3D or another spot-on product containing fipronil and (s)methoprene.
Maltese: It-tieni studju fuq il-post involva 278 kelb b'infestazzjonijiet tal-briegħed li ġew ikkurati tliet darbiet f'intervalli ta' kull xahar jew b'Vectra 3D jew inkella prodott ieħor ta' użu lokalizzat li fih il-fipronil u l(s)-metopren.
English: For a full list of all side-effects reported with Vectra 3D, see the package leaflet.
Maltese: Għal-lista sħiħa ta' effetti sekondarji rrappurtati b'Vectra 3D, ara l-fuljett ta' tagħrif.
English: Dinotefuran and permethrin are insecticides which kill insects by acting on their nervous system by different mechanisms; permethrin also acts similarly on ticks.
Maltese: Id-dinotefuran u l-permetrina huma insettiċidi li joqtlu l-insetti billi jaġixxu fuq is-sistema nervuża tagħhom minn mekkaniżmi differenti; il-permetrina taġixxi wkoll bl-istess mod fuq il-qurdien.
English: The dogs treated with Vectra 3D had an average tick reduction of 94% over 4 weeks compared with 97% with the other product.
Maltese: Il-klieb ikkurati b'Vectra 3D kellhom tnaqqis medju ta' qurdien ta' 94 % matul 4 ġimgħat meta mqabbla ma' 97 % mal-prodott l-ieħor.
English: Vectra 3D can be obtained without a prescription and is available as a spot-on solution in applicators of five different strengths for use on dogs of different weights.
Maltese: Vectra 3D jista' jinkiseb mingħajr riċetta ta' tabib u jiġi bħala soluzzjoni għall-użu lokalizzat f'applikaturi ta' ħames qawwiet differenti għall-użu fuq klieb ta' piżijiet differenti.
English: The first field study involved 485 dogs with flea and/or tick infestations.
Maltese: L-ewwel studju fuq il-post involva 485 kelb b'infestazzjonijiet tal-briegħed u/jew tal-qurdien.
English: The most common side effects with Vectra 3D (which may affect up to 1 in 1000 dogs) are short-lived redness, itching or other signs of discomfort at the application site.
Maltese: L-effetti sekondarji l-aktar komuni b'Vectra 3D (li jistgħu jaffettwaw mhux aktar minn kelb 1 minn kull 1000) huma ħmura b'ħajja qasira, ħakk jew sinjali oħrajn ta' skumdità fis-sit tal-applikazzjoni.
English: Pyriproxyfen is an insect growth regulator which stops the flea life cycle by causing production of infertile eggs as well as blocking development of juvenile flea stages into adults.
Maltese: Il-piriproksifen hija regolatur tat-tkabbir tal-insetti li jwaqqaf iċ-ċiklu tal-ħajja tal-briegħed billi jikkawża l-produzzjoni ta' bajd infertili kif ukoll jimblokka liżvilupp ta' stadji tal-briegħed iż-żgħar milli jsiru adulti.
English: What is Vectra 3D and what is it used for?
Maltese: X'inhu Vectra 3D u għal xiex jintuża?
English: The European Medicines Agency decided that Vectra 3D's benefits are greater than its risks and it can be authorised for use in the EU.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li l-benefiċċji ta' Vectra 3D huma akbar mir-riskji tiegħu u li jista' jiġi awtorizzat għall-użu fl-UE.
English: The requested Community contribution of €46m will be reduced to €37m.
Maltese: Il-kontribuzzjoni ta' €46m mitluba lill-Komunità sejra titnaqqas għal €37m.
English: Telematics master plan 2009-2013
Maltese: Il-pjan prinċipali tat-Telematika 2009-2013
English: European Commission Heinz Zourek Isabel de la Mata
Maltese: Il-Kummissjoni Ewropea Heinz Zourek Isabel de la Mata
English: − Mike O'Donovan (representative of the patients' organisations).
Maltese: Mike O'Donovan (rappreżentant tal-organizzazzjonijiet tal-pazjenti).
English: Pandemic vaccines
Maltese: Vaċċini tal-pandemija
English: EMEA/MB/642672/2009/EN/Adopted 13 November 2009
Maltese: EMA/MB/151663/2010/MT/Adottat 13 ta' Novembru 2009
English: Giuseppe Nisticó Björn Lemmer
Maltese: Il-Parlament Ewropew Giuseppe Nisticó Björn Lemmer
English: Fergus Sweeney Mario Benetti Claus Christiansen Hans-Georg Eichler Anne-Sophie Henry-Eude Xavier Luria Arielle North Nerimantas Steikūnas Spiros Vamvakas
Maltese: Fergus Sweeney Mario Benetti Claus Christiansen Hans-Georg Eichler Anne-Sophie Henry-Eude Xavier Luria
English: Consultation on appointment of a CVMP member
Maltese: Konsultazzjoni dwar il-ħatra ta' membru tas-CVMP
English: The letter informed the Board, inter alia, that these persons were members of an editorial team for a book, which was sponsored by a pharmaceutical company.
Maltese: L-ittra informat lill-Bord, inter alia, li dawn il-persuni kienu membri ta' tim editorjali għal ktieb, li kien sponsorjat minn kumpanija farmaċewtika.
English: The Board noted the proposed dates for 2011 as follows: 16 and 17 March, 16 June, 6 October and 15 December.
Maltese: Il-Bord ħa nota tad-dati proposti għall-2011 kif ġej: 16 u 17 ta' Marzu, 16 ta' Ġunju, 6 ta' Ottubru u 15 ta' Diċembru.
English: Participants at the sixty-fourth meeting of the Management Board London, 1 October 2009
Maltese: Parteċipanti fl-erbgħa u sittin laqgħa tal-Bord ta' Tmexxija Londra, 1 ta' Ottubru 2009
English: [EMEA/MB/170391/2009/Rev.3] The Management Board adopted the revisions to the fee implementing rules.
Maltese: [EMEA/MB/170391/2009/Rev.3] Il-Bord ta' Tmexxija adotta r-reviżjonijiet tar-regoli talimplimentazzjoni tal-miżati.
English: Lisette Tiddens-Engwirda was nominated as chair of the committee.
Maltese: Lisette Tiddens-Engwirda ġiet innominata bħala l-president tal-kumitat.
English: [EMEA/MB/472819/2009*;
Maltese: [EMEA/MB/472819/2009*; EMEA/MB/569756/2009] Rapporti dwar l-implimentazzjoni tal
English: The topic coordinators, Jean Marimbert and Marcus Müllner, have reviewed the proposal and gave positive feedback.
Maltese: Il-koordinaturi tas-suġġett, Jean Marimbert u Marcus Müllner, irrivedew il-proposta u taw rispons pożittiv.
English: [EMEA/MB/320040/2009] Summary of transfers of appropriations in the budget 2009.
Maltese: [EMEA/MB/320040/2009] Sommarju tat-trasferiment tal-approprijazzjonijiet fil-baġit 2009.
English: The Board generally supported the introduction of quantitative indicators.
Maltese: Il-Bord appoġġa b'mod ġenerali l-introduzzjoni ta' indikaturi kwantitattivi.
English: [EMEA/69619/2009] The Management Board adopted the 2009 part of the telematics master plan.
Maltese: [EMEA/69619/2009] Il-Bord ta' Tmexxija adotta l-parti tal-2009 tal-pjan prinċipali tat-telematika.
English: The Board will send a summary of this discussion to the Director General of DG Enterprise and Industry.
Maltese: Il-Bord sejjer jibgħat sommarju ta' din id-diskussjoni lid-Direttur Ġenerali tad-DĠ għall-Intrapriża u lIndustrija.
English: Good progress was made in the field of international collaboration on inspections.
Maltese: Sar progress tajjeb fil-qasam ta' kollaborazzjoni internazzjonali dwar lispezzjonijiet.
English: [EMEA/433259/2009] The Board noted the outcome of the written procedure on consultation on the nomination to the CVMP and considered the nomination as insufficient.
Maltese: [EMEA/433259/2009] Il-Bord ħa nota tal-eżitu tal-proċedura bil-miktub dwar il-konsultazzjoni dwar in-nomina għas-CVMP u qies in-nomina bħala insuffiċjenti.
English: The EU (European Commission/EMEA) - FDA meeting The meeting took place on the 27-29 September.
Maltese: Il-laqgħa tal-UE (Kummissjoni Ewropea/EMEA) - FDA Il-laqgħa saret fis-27-29 ta' Settembru.
English: EMEA mid-year report 2009
Maltese: Ir-rapport ta' nofs is-sena 2009 tal-EMEA
English: There is a significant increase in applications for authorisation of generic medicinal products, with 31 applications received.
Maltese: Hemm żieda sinifikanti fl-applikazzjonijiet għall-awtorizzazzjoni ta' prodotti mediċinali ġeneriċi, bilwasla ta' 31 applikazzjoni.
English: [EXT/548688/2009] Further to the decision of the Telematics steering committee and the proposal of the European Commission, the Management Board adopted the decision to create the EMEA Management Board Telematics Committee (MBTC) as a subgroup of the Management Board.
Maltese: [EXT/548688/2009] Wara d-deċiżjoni tal-kumitat ta' tmexxija tat-Telematika u l-proposta talKummissjoni Ewropea, il-Bord ta' Tmexxija adotta d-deċiżjoni li joħloq il-Kumitat tat-Telematika talBord ta' Tmexxija tal-EMEA (MBTC) bħala sottogrupp tal-Bord ta' Tmexxija.
English: Report from the Task force on scientific qualifications of CHMP and CVMP members
Maltese: Rapport mit-Task force dwar il-kwalifiki xjentifiċi tal-membri tas-CHMP u tas-CVMP
English: Simplification of the contractual arrangements between the EMEA and the national competent authorities of the Member States: development of a cooperation agreement
Maltese: Simplifikazzjoni tal-arranġament kuntrattwali bejn l-EMEA u l-awtoritajiet kompetenti nazzjonali tal-Istati Membri: żvilupp ta' ftehim ta' kooperazzjoni
English: [EMEA/MB/589426/2009] The Management Board noted the report on interaction with patients' and consumers' organisations.
Maltese: [EMEA/MB/589426/2009] Il-Bord ta' Tmexxija ħa nota tar-rapport dwar l-interazzjoni malorganizzazzjonijiet tal-pazjenti u tal-konsumaturi.
English: The members noted the update report from the Heads of Medicines Agencies (HMA) on a number of topics, including: the development of the new HMA strategy paper, expected to be completed by the end of 2010; the ongoing discussion on transparency issues, with focus on commercially confidential information; and the reflection on the future of the veterinary medicines legislation.
Maltese: Il-membri ħadu nota tar-rapport ta' aġġornament mill-Kapijiet tal-Aġenziji tal-Mediċini (HMA) fuq għadd ta' suġġetti, inkluż: l-iżvilupp tad-dokument tal-istrateġija l-ġdida tal-HMA, li mistenni li jkun lest sal-aħħar tal-2010; id-diskussjoni li għaddejja dwar kwistjonijiet ta' trasparenza, b'attenzjoni speċjali lejn l-informazzjoni li hija kummerċjalment kunfidenzjali; u r-riflessjoni dwar il-futur talleġiżlazzjoni tal-mediċini veterinarji.
English: Minutes from the 63rd meeting, held on 11 June 2009
Maltese: Minuti mit-63 laqgħa, li saret fil-11 ta' Ġunju 2009
English: A significant amount of resources was allocated to work relating to the H1N1 pandemic.
Maltese: Ammont sinifikanti ta' riżorsi ġie allokat għal xogħol relatat malpandemija tal-H1N1.
English: It was reiterated that the overall objective of the exercise is to bring the system better in line with the requirements of good governance and ensure that the remuneration system is justified, manageable and transparent.
Maltese: Ġie mtenni li l-objettiv globali tal-eżerċizzju huwa li ssistema tinġieb aktar konformi mar-rekwiżiti ta' governanza tajba u li jkun żgurat li s-sistema ta' remunerazzjoni tkun iġġustifikata, maniġevoli u trasparenti.
English: [EMEA/MB/565964/2009] The Board also noted the proposed future amendment of the fee implementing rules in relation to the new legislation on variations.
Maltese: [EMEA/MB/565964/2009] Il-Bord ħa nota wkoll tal-emenda futura proposta tar-regoli talimplimentazzjoni tal-miżati relatati mal-leġiżlazzjoni l-ġdida dwar il-varjazzjonijiet.
English: [EMEA/MB/366757/2009] The Management Board noted the adoption of the minutes by written procedure on 28 July 2009.
Maltese: [EMEA/MB/366757/2009] Il-Bord ta' Tmexxija ħa nota tal-adozzjoni tal-minuti permezz ta' proċedura bil-miktub fit-28 ta' Lulju 2009.
English: A proposed framework on the interaction with HCPs' organisations will be discussed at the October meeting of the working group.
Maltese: Qafas propost dwar l interazzjoni mal-organizzazzjonijiet tal-HCPs sejjer jiġi diskuss fil-laqgħa ta' Ottubru tal-grupp ta' ħidma.
English: Amendments to the fee implementing rules
Maltese: Emendi għar-regoli tal-implimentazzjoni tal-miżati
English: [EMEA/MB/589426/2009] The Board further considered the proposal on contractual arrangements following the discussion in June and a subsequent round of consultation.
Maltese: [EMEA/MB/589426/2009] Il-Bord kompla jikkunsidra l-proposta dwar l-arranġamenti kuntrattwali wara d-diskussjoni f'Ġunju u rawnd sussegwenti ta' konsultazzjonijiet.
English: [EMEA/MB/503751/2009] The Management Board reviewed the progress of the implementation of the Agency's work programme 2009.
Maltese: [EMEA/MB/503751/2009] Il-Bord ta' Tmexxija irreveda l-progress tal-implimentazzjoni talprogramm ta' ħidma 2009 tal-Aġenzija.
English: The text should read: “The Board discussed the EMEA rules on attachment of staff.
Maltese: It-test għandu jaqra: “Il-Bord iddiskuta r-regoli tal-EMEA dwar lassenjazzjoni ta' persunal.
English: [EMEA/MB/518171/2009] The Board adopted the following meeting dates for 2010: 17 and 18 March, 10 June, 7 October and 16 December.
Maltese: Dati tal-laqgħat għall-2010 u dati provviżorji tal-laqgħat għall-2011 [EMEA/MB/518171/2009] Il-Bord adotta dawn id-dati li ġejjin għal-laqgħat tal-2010: 17 u 18 ta' Marzu, 10 ta' Ġunju, 7 ta' Ottubru u 16 ta' Diċembru.
English: [EMEA/MB/517929/2009] The Board adopted the proposals aiming to improve the consultation process on nomination of scientific committee members.
Maltese: [EMEA/MB/517929/2009] Il-Bord adotta l-proposti li għandhom l-għan li jtejbu l-proċess ta' konsultazzjoni dwar in-nomina ta' membri tal-kumitati xjentifiċi.
English: The Agency's long-term strategy will be coordinated with the strategy paper of the Heads of Medicines Agencies (HMA).
Maltese: L-istrateġija fit-tul tal-Aġenzja sejra tkun ikkoordinata mad-dokument ta' strateġija tal-Kapijiet talAġenziji tal-Mediċini (HMA).
English: A reflection paper, which will be presented at the December meeting, will provide proposals on further involvement of patients' and consumers' organisations in the Agency's activities, including in the scientific review process.
Maltese: Dokument ta' riflessjoni, li sejjer jiġi ippreżentat fillaqgħa ta' Diċembru, sejjer jipprovdi proposti dwar involviment akbar min-naħa talorganizzazzjonijiet tal-pazjenti u tal-konsumaturi fl-attivitajiet tal-Aġenzija, inkluż fil-proċess ta' reviżjoni xjentifika.