FrancophonIA/ELRC3.0 huggingface dataset:
English: The clinical trials, which have now been stopped, involved patients with CLL and indolent non-Hodgkin lymphoma.
Maltese: Il-provi kliniċi, li issa twaqqfu, involvew pazjenti b'CLL u b'limfoma nonHodgkin indolenti.
English: EMA's Pharmacovigilance Risk Assessment Committee (PRAC) is issuing provisional advice for doctors and patients using the cancer medicine Zydelig (idelalisib) to ensure that it continues to be used as safely as possible.
Maltese: Dawn huma rakkomandazzjonijiet provviżorji li l-PRAC ħareġ, bħala prekawzjoni, sabiex jipproteġi lillpazjenti waqt li l-mediċina tkun qiegħda tiġi rieżaminata.
English: • Zydelig can continue to be used in combination, only with rituximab, in CLL patients who have received at least one prior therapy, and as monotherapy in patients with follicular lymphoma that is refractory to two lines of treatment.
Maltese: • Zydelig jista' jibqa' jintuża f'kombinazzjoni, ma' rituximab biss, f'pazjenti b'CLL li jkunu rċevew għallinqas terapija preċedenti waħda, u bħala monoterapija f'pazjenti b'limfoma follikulari li hija refrattarja għal żewġ linji ta' kura.
English: The review of Zydelig has been initiated at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.
Maltese: Ir-rieżami ta' Zydelig inbeda fuq talba tal-Kummissjoni Ewropea fil-11 ta' Marzu 2016, skont lArtikolu 20 tar-Regolament (KE) Nru 726/2004.
English: • Patients should be informed about the risk of serious infections with Zydelig.
Maltese: • Il-pazjenti għandhom jiġu infurmati dwar ir-riskju ta' infezzjonijiet serji b'Zydelig.
English: The review started after a higher rate of serious adverse events was seen in three clinical trials among patients receiving Zydelig compared with placebo (a dummy treatment).1 The adverse events included deaths related to infections such as pneumonia.
Maltese: Ir-rieżami beda wara li dehret rata ogħla ta' avvenimenti avversi serji fi tliet provi kliniċi fost pazjenti li rċevew Zydelig meta mqabbel ma' plaċebo (kura finta).1
English: 3 Final accounts 2004.
Maltese: 3 Kontijiet finali 2004.
English: 301 Evaluations 302 Translation 303 Studies and consultants 304 Publications 305 Community programmes
Maltese: 301 Valutazzjonijiet 302 Traduzzjoni 303 Studji u konsulenti 304 Pubblikazzjonijiet 305 Programmi tal-Komunità
English: NATIONAL COMPETENT AUTHORITIES NATIONAL COMPETENT AUTHORITIES 3,500 EUROPEAN EXPERTS 3,500 EUROPEAN EXPERTS
Maltese: KOMPETENTI NATIONAL COMPETENT AUTHORITIES 3,500 ESPERT EWROPEW 3,500 EUROPEAN EXPERTS
English: MANAGEMENT BOARD MANAGEMENT BOARD Chairman: Hannes Wahlroos Chairman: Hannes Wahlroos
Maltese: BOARD Chairman: Hannes Wahlroos Chairman:
English: 18 Staff insurances
Maltese: 18 Assigurazzjonijiet tal-personal
English: EXECUTIVE DIRECTOR EXECUTIVE DIRECTOR Thomas Lönngren Thomas Lönngren
Maltese: DIRETTUR EZEKUTTIV EXECUTIVE DIRECTOR Thomas Lönngren Thomas Lönngren
English: Chairman: Josep Torrent - Farnell
Maltese: Josep Torrent - Farnell
English: POST-AUTHORISATION EVALUATION OF MEDICINES FOR HUMAN USE Head: Noël Wathion
Maltese: POST-AUTHORISATION EVALUATION OF MEDICINES FOR HUMAN USE Kap: Noël Wathion Head: Noël Wathion
English: Chairman: Daniel Brasseur
Maltese: Daniel Brasseur
English: Appropriation/Budget 2005 as of 31 December 2005.
Maltese: Allokazzjoni/Baġit 2005 fil-31 ta' Diċembru 2005.
English: Chairman: Konstantin Keller
Maltese: Konstantin Keller
English: Number of reimbursed delegates
Maltese: Numru ta' delegati rimborsati
English: Chairman: Gérard Moulin
Maltese: Gérard Moulin
English: AD 16 AD 15 AD 14 AD 13 AD 12 AD 11 AD 10 AD 9 AD 8 AD 7 AD 6 AD 5 Total grade AD AST 11 AST 10 AST 9 AST 8 AST 7 AST 6 AST 5 AST 4 AST 3 AST 2 AST 1 Total grade AST Total Staff
Maltese: AD 16 AD 15 AD 14 AD 13 AD 12 AD 11 AD 10 AD 9 AD 8 AD 7 AD 6 AD 5
English: Pharmacovigilance and product defect reporting
Maltese: Farmakoviġilanza u rapportaġġ ta' prodotti difettużi
English: Arbitrations and referrals
Maltese: Arbitraġġ u riferenzi
English: Evaluating risk-management plans (RMPs).
Maltese: Valutazzjoni ta' pjanijiet ta' ġestjoni tar-riskju (RMPs - Risk Management Plans).
English: 8-10 November
Maltese: 8-10 ta' Novembru
English: TEMPORARY POSTS
Maltese: KARIGI TEMPORANJI
English: POST-AUTHORISATION EVALUATION OF MEDICINES FOR
Maltese: PRE -AUTHORISATION EVALUATION OF MEDICINES FOR HUMAN USE
English: 13-16 November
Maltese: 13-16 ta' Novembru
English: 4-6 April
Maltese: 4-6 ta' April
English: Total Title 1
Maltese: Total Titolu 1
English: A significant increase (64%) in validated parallel-distribution notifications was observed in 2005, due to the implementation of Community legislation on parallel distribution (mandatory EMEA notification procedure).
Maltese: Żjieda sinifikanti (64%) f'notifiki validati ta' distribuzzjoni parallela ġiet osservata fl-2005, minħabba l-implimentazzjoni tal-leġiżlazzjoni tal-Komunità dwar id-distribuzzjoni parallela (proċedura ta' notifika obbligatorja lill-EMEA).
English: (until 30 April 2006) Category & Grade
Maltese: (sat-30 ta' April 2006)
English: Direct telephone: (44-20) 74 18 85 81 E-mail: fia.westerholm@emea.eu.int
Maltese: (44-20) 74 18 85 81 E-mail: fia.westerholm@emea.eu.int
English: Total grade A B*11
Maltese: Total grad A
English: 24-27 April
Maltese: 24-27 ta' April
English: Arbitration and Community referrals to EMEA (Veterinary medicines)
Maltese: Arbitragg u riferenzi Komunitarji lillEMEA (Medicini veterinarji)
English: Number of videoconferences and reimbursed meetings
Maltese: Numru ta' vidjokonferenzi u ta' laqghat rimborsati
English: Community programmes
Maltese: Programmi tal-Komunità
English: 7-9 March
Maltese: 7-9 ta' Marzu
English: A pilot project for the introduction of Internet telephony (voice over IP) will be started.
Maltese: Ser jinbeda proġett pilota għall-introduzzjoni tat-telefonija bl-Internet (voice over IP).
English: 19-20 April
Maltese: 19-20 ta' April
English: Parallel-distribution notifications validated (Input)
Maltese: Notifiki validati ta' distribuzzjoni parallela (Dehlin)
English: Total Title 3
Maltese: Total Titolu 3
English: Good clinical practice (including pharmacovigilance) GMP (including PMF)
Maltese: GMP (inkluż PMF)
English: Total Title 2
Maltese: Total Titolu 2
English: At the same time, five of the EU telematics systems - EudraNet, EudraVigilance, EudraCT, the database of authorised medicinal products in the EU, and the product-informationmanagement application, PIM, - will have to be operated, supported, maintained and further developed.
Maltese: Fl-istess ħin, ħamsa mis-sistemi telematiċi ta' l-UE - EudraNet, EudraVigilance, EudraCT, il-bażi tad-data ta' prodotti mediċinali awtorizzati fl-UE, u lapplikazzjoni għall-ġestjoni ta' informazzjoni dwar il-prodott, PIM, - ser ikollhom jiġu mħaddma, sostnuti, mantnuti u żviluppati aktar.
English: CHAPTER 4 EU TELEMATICS STRATEGY CHAPTER 5 SUPPORT ACTIVITIES
Maltese: KAPITOLU 4 L-ISTRATEĠIJA TELEMATIKA TA' L-UE KAPITOLU 5
English: The Agency will provide secretarial support to the CMDs and their working parties, whose responsibilities will include: preparation and distribution of documents; provision of lists of positions taken on similar issues; follow-up to meetings; facilitation of liaison with other scientific working groups and with interested parties; assistance on preparation of annual reports; specific activities assigned to the CMDs under their work programmes; assistance in providing regulatory and legal support to CMD activities; coordination of the 60-days procedure for discussion in case of disagreement between Member States in mutual-recognition or decentralised procedures; and preparation of the list of medicinal products for which a harmonised SPC should be drawn up.
Maltese: L-Aġenzija ser tipprovdi appoġġ segretarjali lis-CMDs u l-gruppi ta' ħidma tagħhom, li r-responsabilitajiet tagħhom jinkludu: it-tħejjija u d-distribuzzjoni ta' dokumenti; ilprovvediment ta' listi ta' pożizzjonijiet meħuda fi kwistjonijiet simili; xogħol li sar wara l-laqgħat; l-iffaċilitar tal-koordinazzjoni ma' gruppi ta' ħidma xjentifiċi oħra u ma' partijiet interessati; għajnuna fit-tħejjija ta' rapporti annwali; attivitajiet speċifiċi assenjati lis-CMDs taħt ilprogrammi ta' ħidma tagħhom; assistenza biex tingħata għajnuna regolatorja u legali lillattivitajiet tas-CMD, koordinazzjoni tal-proċedura ta' 60 jum għal diskussjoni f'każ ta' nuqqas ta' qbil bejn l-Istati Membri fi proċeduri ta' rikonoxximent reċiproku jew deċentralizzati; t-tħejjija tal-lista ta' prodotti mediċinali li għalihom għandha titħejja SPC armonizzata.
English: 29 May-1 June
Maltese: 29 ta' Mejju-1 ta' Ġunju
English: 11-13 July
Maltese: 11-13 ta' Lulju
English: CHMP Committee for Medicinal Products for Human Use
Maltese: CHMP Committee for Medicinal Products for Human Use Chairman:
English: Applications received/forecast (veterinary medicines)
Maltese: Applikazzjonijiet ircevuti/mbassra (medicini veterinarji)
English: A wide range of documents are published by the EMEA, including press releases, general information documents, annual reports and work programmes.
Maltese: L-EMEA tippubblika firxa wiesgħa ta' dokumenti, inklużi stqarrijiet għall-istampa, dokumenti ta' tagħrif ġenerali, rapporti annwali u programmi ta' ħidma.
English: Annex 2 EMEA establishment plan 2004-2006
Maltese: Anness 2 Pjan ta' stabbiliment ta' l-EMEA 2004-2006
English: In addition to 33 core data elements, product information (SPC, PIL, labels) will be included in the database for a subset of centrally authorised products.
Maltese: Minbarra t-33 element ċentrali ta' data, l-informazzjoni dwar il-prodott (SPC, PIL, tikketti) ser tkun inkluża fil-bażi tad-data għal sottokategorija ta' prodotti awtorizzati ċentralment.
English: The EMEA will contribute to international harmonisation discussions on quality systems and implementation of quality risk-management and pharmaceutical development.
Maltese: L-EMEA ser tikkontribwixxi għad-diskussjonijiet ta' armonizzazzjoni internazzjonali dwar sistemi ta' kwalità u l-implimentazzjoni ta' ġestjoni tar-riskju filkwalità u l-iżvilupp farmaċewtiku.
English: EMEA establishment plan 2004-2006
Maltese: Pjan ta' stabbiliment ta' l-EMEA 2004-2006
English: The EMEA PMF/VAMF certification process is an assessment of the PMF/VAMF application dossier.
Maltese: Il-proċess ta' l-EMEA għaċ-ċertifikazzjoni tal-PMF/VAMF huwa valutazzjoni tad-dossier ta' applikazzjoni tal-PMF/VAMF.
English: Staff
Maltese: Personal
English: Certificates of medicinal products
Maltese: Ċertifikati ta' prodotti mediċinali
English: 5 Appropriation/Budget 2006 as adopted by the Management Board on 15 December 2005.
Maltese: 5 Allokazzjoni/Baġit 2006 kif adottat mill-Bord ta' Tmexxija fil-15 ta' Diċembru 2005.
English: Chapter 4 EU telematics strategy
Maltese: Kapitolu 4 L-istrateġija telematika ta' l-UE
English: 8-9 March
Maltese: 8-9 ta' Marzu
English: 18-20 July
Maltese: 18-20 ta' Lulju
English: Secure and reliable communication within the EU regulatory network is assured through EudraNet and the infrastructure supporting the systems.
Maltese: Il-komunikazzjoni sigura u affidabbli fi ħdan in-netwerk regolatorja ta' l-UE hija żgurata permezz ta' l-EudraNet u l-infrastruttura li tappoġġa s-sistemi.
English: Total grade B C*7
Maltese: Total grad B
English: CHAPTER 3 INSPECTIONS
Maltese: KAPITOLU 3 SPEZZJONIJIET
English: The EMEA issues plasma master file (PMF) and vaccine antigen master file (VAMF) certificates of a medicinal product in conformity with the arrangements laid down by Community legislation.
Maltese: Ċertifikati ta' l-EMEA għal PMF (Plasma Master File)/VAMF (Vaccine Antigen Master File)
English: Applications received/forecast (Input)
Maltese: Applikazzjonijiet ircevuti/mbassra (Dehlin)
English: • by fax to (44-20) 7418 8670
Maltese: • billi tibgħat faks lil (44-20) 7418 8670
English: The Agency is continuing the development of the scientific-memory database for centrally authorised veterinary medicines.
Maltese: L-Aġenzija qed tkompli tiżviluppa bażi tad-data ta' memorja xjentifika għal mediċini veterinarji awtorizzati ċentralment.
English: Information technology Infrastructure
Maltese: Teknoloġija ta' l-informatika Infrastruttura
English: Special EU contribution for IT telematics strategy Special EU contribution for orphan medicinal products Contribution from EEA
Maltese: Kontribuzzjoni speċjali ta' l-UE għal prodotti mediċinali ltiema
English: The EU telematics programme is delivering improved communication and better access to data.
Maltese: Il-programm ta' telematika ta' l-UE qed jagħti komunikazzjoni mtejba u aċċess aħjar għad-data.
English: The main priorities for 2006 are: continued development and modification of systems to implement the new legislation; reliable operation of the EU telematics systems and related services; and continued analysis and development of the EU telematics IT projects.
Maltese: Il-prijoritajiet ewlenin għall-2006 huma: l-iżvilupp u l-modifika kontinwi ta' sistemi sabiex tiġi implimentata l-leġiżlazzjoni l-ġdida; it-tħaddim affidabbli ta' sistemi telematiċi ta' l-UE u servizzi relatati; u l-analiżi u l-iżvilupp kontinwi tal-proġetti telematiċi ta' l-IT ta' l-UE.
English: The EMEA is deeply committed to being a transparent, open and accessible organisation.
Maltese: L-EMEA hija impenjata bis-sħiħ biex tkun organizzazzjoni trasparenti, miftuħa u aċċessibbli.
English: (as from 1 May 2006) Category & Grade
Maltese: (mill-1 ta' Mejju 2006)
English: The regulatory and scientific consistency of scientific committees (CHMP and CVMP) opinions and assessment reports, and their quality, will be further improved.
Maltese: Ilkonsistenza regolatorja u xjentifika ta' l-opinjonijiet u r-rapporti ta' valutazzjoni tal-kumitati xjentifiċi (CHMP u CVMP), u l-kwalità tagħhom, ser tkompli tiġi mtejba.
English: A need for this type of meeting may emerge, for example, in the event of a pandemic-influenza outbreak.
Maltese: Jista' jinqala' l-bżonn għal laqgħat ta' dan it-tip, per eżempju f'każ illi tfaqqa' xi influwenza pandemika.
English: 14-16 March
Maltese: 14-16 ta' Marzu
English: Transparency, communication and provision of information to patients, healthcare professionals and users of medicines
Maltese: Trasparenza, komunikazzjoni u l-għoti ta' informazzjoni lill-pazjenti, lill-professjonisti tal-kura tas-saħħa u lill-utenti tal-mediċini
English: 12-13 July
Maltese: 12-13 ta' Lulju
English: 20 Investment in immovable property, renting of building and associated costs 21 Expenditure on data processing 22 Movable property and associated costs 23/25 Other administrative expenditure 24 Postage and communications
Maltese: 21 Infiq fuq l-ipproċessar tad-data 22 Proprjetà mobbli u spejjeż assoċjati 23/25
English: Both EudraCT (the clinical-trials database) and EudraGMP (the database of GMP certificates and manufacturing authorisations) will provide EU regulators a single source of information for these domains for the whole of the European Union; two new versions of EudraCT will be released during 2006 (3.0.0 in April 2006, 4.0.0 in June 2006).
Maltese: Kemm l-EudraCT (il-bażi tad-data ta' provi kliniċi) kif ukoll l-EudraGMP (il-bażi tad-data ta' ċertifikati tal-GMP u awtorizzazzjonijiet għall-manifattura) ser jipprovdu lir-regolaturi ta' lUE b'sors wieħed ta' informazzjoni f'dawn l-osqma għall-Unjoni Ewropea kollha; żewġ verżjoniiet ġodda ta' l-EudraCT ser jinħarġu matul l-2006 (3.0.0 f' April 2006, 4.0.0 f'Ġunju 2006).
English: The Agency expects to receive a total of 59 initial applications (including ones for generic, biologically similar and compassionate-use products, and products intended for non-EU markets), which is a 44% increase on the previous year;
Maltese: L-Aġenzija qed tistenna li tirċievi total ta' 59 applikazzjoni inizzjali (inklużi dawk għal prodotti ġeneriċi, bijoloġikament simili u għal użu kompassjonali, u prodotti intenzjonati għal swieq barra lUE), li hija żjieda ta' 44% mis-sena ta' qabel;
English: Inspections
Maltese: Kontabilità
English: The Agency is committed to full implementation of the EMEA integrated quality-management system and internal control standards.
Maltese: L-Aġenzija hija impenjata lejn l-implimentazzjoni sħiħa tas-sistema ta' ġestjoni integrata talkwalità ta' l-EMEA u l-istandard ta' kontroll intern.
English: The suite of business intelligence and statistical tools within EudraVigilance will enable safety data relating to products on the market and under development in Europe to be monitored, analysed and acted upon in an increasingly sophisticated manner; an interim data warehouse and business intelligence solution for medicinal products for human use will be made available to all EU/EEA regulators in March 2006.
Maltese: Is-sett ta' għodda statistiċi u ta' l-intelliġenza tan-negozju fi ħdan l-EudraVigilance ser jippermetti li d-data dwar is-sigurtà relatata ma' prodotti fuq is-suq u li qed jiġu żviluppati flEwropa tiġi ssorveljata, analizzata u tittieħed azzjoni dwarha b'mod aktar sofistikat; maħżen provvisorju ta' data u soluzjoni għall-intelliġenza dwar in-negozju għall-prodotti mediċinali għall-użu tal-bniedem ser ikunu disponibbli għar-regolaturi kollha ta' l-UE/ŻEE f'Marzu 2006.
English: 14 Socio-medical infrastructure 15 Exchange of civil servants and experts 16/17 Social welfare, entertainment and representation expenses
Maltese: 11 Personal b'impjieg attiv 13 Spejjeż fuq missjonijiet 14 Infrastruttura soċjo-medika 15 Skambju ta' uffiċjali taċ-ċivil u esperti 16/17 Spejjeż fuq l-assistenza soċjali, id-divertiment u r rappreżentazzjoni
English: The priorities for the Agency's IT activity relate to the continued provision of quality services in corporate IT, meetings-management and conferences, and electronic document-management and publishing.
Maltese: Il-prijoritajiet għall-attività ta' l-IT ta' l-Aġenzija huma relatati mat-tkomplija ta' l-għoti ta' servizzi ta' kwalità fl-IT korporattiva, il-ġestjoni tal-laqgħat u konferenzi, u l-ġestjoni elettronika tad-dokumenti u l-pubblikazzjoni.
English: The constant monitoring of the safety of medicines after authorisation (‘pharmacovigilance') is an important part of the work of the national competent authorities and EMEA.
Maltese: Is-sorveljanza kostanti tas-sigurtà tal-mediċini wara l-awtorizzazzjoni (‘farmakoviġilanza') hija parti importanti mill-ħidma ta' l-awtoritajiet kompetenti nazzjonali u l-EMEA.
English: • on the Internet at www.emea.eu.int
Maltese: • permezz ta' l-Internet minn fuq www.emea.eu.int
English: Total grade D Total Staff
Maltese: Numru totali tal-personal
English: Development and implementation of the EMEA transparency and communication strategy, as well as active contribution to the development and implementation of a transparency and communication strategy for the European medicines network;
Maltese: L-iżvilupp u l-implimentazzjoni ta' l-istrateġija ta' trasparenza u komunikazzjoni ta' l-EMEA, kif ukoll il-kontribuzzjoni attiva lejn l-iżvilupp u l-implimentazzjoni ta' strateġija ta' trasparenza u komunikazzjoni għan-netwerk Ewropew tal-mediċini;
English: Total grade C D*5
Maltese: Total grad D
English: 11-12 May
Maltese: 11-12 ta' Mejju
English: 24-27 July
Maltese: 24-27 ta' Lulju
English: Chapter 5 Support activities
Maltese: Kapitolu 5
English: 26-29 June
Maltese: 26-29 ta' Ġunju
English: The Agency will also continue its work with the World Health Organization, Codex Alimentarius and OIE.
Maltese: L-Aġenzija ser tkompli bil-ħidma tagħha ma' l-Għaqda Dinjija tas-Saħħa, il-Codex Alimentarius u l-OIE.
English: The number of meetings is forecast to increase by 5% and the number of reimbursed delegates by 33%.
Maltese: L-għadd ta' laqgħat huwa mbassar li ser jiżdied b'5% u l-għadd ta' delegati rimborsati bi
English: 13-15 June
Maltese: 13-15 ta' Ġunju
English: Annex 1 EMEA structure
Maltese: Anness 1 Organigramma ta' l-EMEA
English: Chapter 1 EMEA in the European system
Maltese: KAPITOLU 1 L-EMEA FIS-SISTEMA EWROPEA
English: CHAPTER 1 EMEA IN THE EUROPEAN SYSTEM
Maltese: Kapitolu 1 L-EMEA fis-sistema Ewropea
English: Work to develop EMEA interaction with top-quality experts from national authorities, academia, learned societies and industry on challenges relating to new technologies;
Maltese: Ħidma biex tiġi żviluppata l-interazzjoni ta' l-EMEA ma' esperti ta' l-ogħla kwalità millawtoritajiet nazzjonali, akkademiċi, is-soċjetajiet ta' studjużi u l-industrija dwar sfidi relatati ma' teknoloġiji ġodda;
English: The Agency will implement a number of adopted guidelines relating to similar biological (biosimilar) medicinal products, and will consolidate procedures for generic medicines.
Maltese: L-Aġenzija ser timplimenta għadd ta' linji gwida adottati relatati ma' prodotti bijoloġiċi simili (bijosimili), u ser tikkonsolida l-proċeduri għal mediċini ġeneriċi.
English: PRE - AUTHORISATION EVALUATION OF MEDICINES FOR HUMAN USE Head: Patrick Le Courtois
Maltese: Head: Patrick Le Courtois
English: 16-18 May
Maltese: 16-18 ta' Mejju
English: Type-IA variations
Maltese: Valutazzjoni inizzjali
English: Integrated quality management and audit
Maltese: Ġestjoni integrata tal-kwalità
English: 2 As authorised by the Budgetary Authority and adjusted by the Management Board on 15 December 2005.
Maltese: 2 Kif awtorizzati mill-Awtorità tal-Baġit u aġġustati mill-Bord Amministrattiv fil-15 ta' Diċembru 2005.
English: PMF/VAMF EMEA certificates
Maltese: Talbiet ghal certifikati
English: Type-I variation applications Type-II variation applications Line-extension applications
Maltese: Applikazzjonijiet ta' l-MRL estizi/modifikati Applikazzjonijiet godda ghal MRL
English: Scientific opinions for non-EU markets Similar biological products Generic and essentially similar products Compassionate-use products
Maltese: Prodotti ghal użu kompassjonali Prodotti generici u essenzjalment simili Prodotti bijologici simili Opinjonijiet xjentifici ghal swieq barra l-UE Prodotti medicinali ltiema Prodotti medicinali godda (mhux ltiema)
English: Contents Introduction by the Executive Director
Maltese: Introduzzjoni mid-Direttur Eżekuttiv
English: 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.eu.int http://www.emea.eu.int©EMEA 2006 Reproduction and/or distribution of this document is authorised for non-commercial purposes only provided the EMEA is acknowledged
Maltese: Bħala element importanti ta' l-istrateġija armonizzata għall-valutazzjoni xjentifika fl-UE ta' prodotti mediċinali magħmula mill-ħxejjex, il-Kumitat għall-Prodotti Mediċinali mill-Ħxejjex (HMPC) ser jagħti attenzjoni partikolari fl-2006 biex jistabbilixxi monografi Komunitarji dwar il-ħxejjex, kif ukoll biex iħejji l-iskrizzjonijiet għallabbozz ta' elenku ta' sustanzi u tħejjijiet mill-ħxejjex u taħlit tagħhom għall-użu fi prodotti mediċinali tradizzjonali magħmula mill-ħxejjex.
English: Finally, the policies concerning public access to the data included in EudraVigilance will be defined, taking into account the protection of individual and commercially confidential data.
Maltese: Fl-aħħar, għandha tiġi definita l-politika dwar l-aċċess pubbliku għad-data f'l-EudraVigilance, waqt li jiġi kkunsidrat il-ħarsien ta' data kunfidenzjali individwali u kummerċjali.
English: Establishment of maximum residue limits for veterinary medicines
Maltese: L-ifissar ta' limiti massimi ta' residwi għal mediċini veterinarji
English: The continuing emphasis on the safety of veterinary medicines in the post-authorisation phase and the need to adopt a continuing risk-management approach to this important issue will feature highly on the list of priority activities in 2006.
Maltese: L-emfażi kontinwa fuq is-sigurtà tal-mediċini veterinarji fil-fażi ta' wara l-awtorizzazzjoni u lħtieġa li tiġi adottata strateġija kontinwa ta' ġestjoni tar-riskju għal din il-kwistjoni importanti ser tkun minn ta' fuq nett fuq il-lista ta' attivitajiet prijoritarji fl-2006.
English: The related processes undergo continuous evaluation and improvement, with the close cooperation of the national competent authorities.
Maltese: Il-proċessi relatati issirilhom valutazzjoni u titjib kontinwu, b'kooperazzjoni millqrib ma' l-awtoritajiet kompetenti nazzjonali.
English: 20-23 March
Maltese: 20-23 ta' Marzu