FrancophonIA/ELRC3.0 huggingface dataset:
English: Robert SCHLÖGEL (Alternate: Christian KALCHER)
Maltese: Robert SCHLÖGEL (Sostitut:
English: EudraVigilance version 7.0 was launched in May 2004, including a Clinical Trial module (EVCTM) to support the electronic reporting of suspected unexpected serious adverse reactions (SUSARs) occurring during clinical trials.
Maltese: Il-verżoni 7.0 ta' l-EudraVigilance ġiet ippreżentata f'Mejju 2004, inkluż modulu għall-Provi Kliniċi (EudraVigilance Clinical Trial module - EVCTM) b'appoġġ għar-rapportaġġ elettroniku ta' reazzjonijiet serji ssuspettati mhux mixtieqa u mhux mistennija (SUSARs) li jseħħu matul il-provi kliniċi.
English: Annex 14 EMEA contact points
Maltese: Anness 14 Punti ta' Kuntatt fl-EMEA
English: • Maria TOLLIS (Italy) Alternate: Virgilio DONINI
Maltese: • Maria TOLLIS (Italja) Sostitut:
English: Art. 36 of Directive 2001/83/EC (previously Art. 15(a) of Directive 75/319/EEC)
Maltese: Art. 36 tad-Direttiva 2001/83/KE (li qabel kien l-Art. 15(a) tad-Direttiva 75/319/KEE)
English: Coverage
Maltese: Kopertura
English: Immunotherapy and oncology
Maltese: Immunoterapija u onkolo?ija
English: Guideline on adjuvants in vaccines Released for consultation in March
Maltese: Guideline on adjuvants in vaccines Maħruġa għall-konsultazzjoni f'Marzu 2004
English: 346 days
Maltese: 196 days 346 days
English: ADMINISTRATION
Maltese: AMMINISTRAZZJONI
English: • Liisa KAARTINEN (Finland) Alternate: Kristina LEHMANN
Maltese: • Liisa KAARTINEN (Finlandja) Sostituta:
English: Data centre
Maltese: Ċentru tad-data
English: Keratoconjunctiviti s
Maltese: Keratoconjunctivi tis
English: Annex 11
Maltese: Anness 11
English: Evaluation in <90 days Evaluation in 90-180 days Evaluation in >180 days
Maltese: Valutazzjoni f'<90 jum Valutazzjoni f'90-180 jum Valutazzjoni f' >180 jum
English: In addition, a management audit based on ISO 9004:2000 was conducted.
Maltese: Barra minn hekk, saret verifika tal-maniġment ibbażata fuq ISO 9004:2000.
English: IT maintained high service levels throughout 2004, achieving more than 99.5 % availability to corporate users
Maltese: L-IT żamm livelli ta' servizz għoljin matul l2004, b'kisba ta' disponibbiltà ta' aktar minn 99.5 % għall-utenti korporattivi
English: In 2004, a total of 34 marketing authorisation applications received a positive opinion from the EMEA.
Maltese: Fl-2004, total ta' 34 applikazzjoni għal awtorizzazzjoni għal tqegħid fis-suq irċevew opinjoni pożittiva mill-EMEA.
English: Information on USRs can be found on the EMEA website at: http://www.emea.eu.int/htms/human/drugalert/drugalert.htm
Maltese: Tagħrif dwar l-USRs jinsab fuq il-website ta' l-EMEA fuq: http://www.EMEA.eu.int/htms/human/drugalert/drugalert.htm
English: The EMEA PMF/VAMF certification process is an assessment of the PMF/VAMF application dossier.
Maltese: Il-proċess ta' l-EMEA għaċ-ċertifikazzjoni PMF/VAMF jinvolvi valutazzjoni tad-dokument ta' applikazzjoni tal-PMF/VAMF.
English: Flugestone acetate and norgestomet were placed in Annex III of Regulation (EEC) No 2377/90 in 2003, with provisional MRLs expiring in 2008.
Maltese: III tar-Regolament (KEE) Nru 2377/90 fl-2003, b'MRLs proviżorji li jiskadu fl-2008.
English: IT provided support and helpdesk services to the EMEA s corporate users to a high and professional level.
Maltese: L-IT pprovda appoġġ u servizzi ta' helpdesk lill-utenti korporattivi ta' l-EMEA b'livell għoli u professjonali.
English: • Bruno URBAIN (Belgium) Alternate: Lionel LAURIER
Maltese: • Bruno URBAIN (Belġju) Sostitut:
English: Annex 9
Maltese: Anness 9
English: 6.2 Information technology at the EMEA..................................................................................74
Maltese: .2 Teknoloġija ta' l-informatika fi ħdan l-EMEA....................................................................74
English: Barbara FREISCHEM Direct telephone: (44-20) 74 18 85 81 E-mail: barbara.freischem@emea.eu.int
Maltese: (44-20) 74 18 85 81 E-mail: barbara.freischem@EMEA.eu.int
English: Annex 3
Maltese: Anness 3
English: The dedicated range of services provided to EMEA staff, delegates and users of EU telematics systems from the applications themselves to the three levels of helpdesk support services ensure these systems are in line with the Agency s operating requirements
Maltese: Il-firxa dedikata ta' servizzi pprovduti lillpersonal ta' l-EMEA, delegati u utenti ta' sistemi telematiċi ta' l-UE millapplikazzjonijiet innifishom lit-tlett livelli tas-servizzi ta' appoġġ tal-helpdesk tiżgura li dawn is-sistemi jkunu konformi mal-ħtiġijiet tax-xogħol ta' l-Aġenzija
English: Number of inspections 2002-2004
Maltese: Numru ta' spezzjonijiet 2002-2004
English: Purevax RCP
Maltese: Purevax RCP FeLV
English: Service or project Description of measure Details of progress Corporate service availability
Maltese: Servizz jew proġett Deskrizzjoni tal-miżura Dettalji tal-progress Disponibbiltà ta' servizz korporattiv
English: Two national competent authorities and 21 pharmaceutical companies implemented the electronic transmission of ICSRs during 2004.
Maltese: Żewġ awtoritajiet nazzjonali kompetenti u 21 kumpannija farmaċewtika implimentaw it-trasmissjoni elettronika ta' ICSRs matul l-2004.
English: Implement videoconferencing and webstreaming services for EMEA/NCA meetings
Maltese: Implimentazzjoni talvidjokonferenzi u servizzi ta' web-streaming għal-laqgħat ta' l-EMEA/awtoritajiet kompetenti nazzjonali
English: Pharmacovigilance and product defect reporting
Maltese: Farmakoviġilanza u rapportaġġ dwar difetti fi prodotti
English: 801 days
Maltese: 177 days 801 days
English: • Ian HUDSON (United Kingdom) Alternate: Julia DUNNE
Maltese: • Ian HUDSON (Renju Unit) Sostituta:
English: Preparations started for the full application of all provisions by 20 November 2005.
Maltese: Bdew preparazzjonjiet għall-applikazzjoni sħiħa tad-dispożizzjonijiet kollha sa l-20 ta' Novembru 2005.
English: Blood
Maltese: Hans
English: 6.4 Document management and publishing
Maltese: 6.4 Ġestjoni u pubblikazzjoni ta' dokumenti
English: The Committee re-elected Dr Daniel Brasseur as chairman and Dr Eric Abadie as vicechairman.
Maltese: Il-Kumitat eleġġa mill-ġdid lil Dr Daniel Brasseur bħala bħala president u lil Dr Eric Abadie bħala viċi-president.
English: • Birgit AASMÄE (Estonia) Alternate: Helen MAHLA
Maltese: • Birgit AASMÄE (Estonja)
English: 141 days
Maltese: 210 days 141 days
English: • Margarita ARBOIX (Spain) Alternate: Ricardo de la FUENTE LÓPEZ
Maltese: Ricardo de la FUENTE LÓPEZ
English: Marijke KORTEWEG Direct telephone: (44-20) 74 18 85 56 E-mail: iqmanagement@emea.eu.int
Maltese: (44-20) 74 18 85 56 E-mail: iqmanagement@EMEA.eu.int
English: Integrated quality management
Maltese: Ġestjoni Integrata tal-Kwalità
English: 124 days
Maltese: 120 days 124 days
English: In April, the EMEA released for public consultation a discussion paper entitled The European Medicines Agency Road Map to 2010: Preparing the Ground for the Future .
Maltese: F'April, l-EMEA ħarġet għal konsultazzjoni pubblika dokument ta' diskussjoni bl-isem ‘The European Medicines Agency Road Map to 2010:
English: In the anti-HIV area, several variations were implemented in 2004 to add important safety information to relevant SPCs.
Maltese: Fil-qasam ta' kontra l-HIV, ġew implimentati diversi varjazzjonijiet fl-2004 sabiex tiżdied informazzjoni ta' sigurtà importanti ma' l-SPCs relevanti.
English: The Internal Audit Function of the Agency was formalised in 2004.
Maltese: Il-Funzjoni ta' Verifika Interna ta' l-Aġenzija ġiet ifformalizzata fl-2004.
English: • Marc WIRTOR (Luxembourg) Alternate: Maurice HOLPER
Maltese: • Marc WIRTOR (Lussemburgu) Sostitut:
English: The EMEA/MRFG secretariat can be contacted by e-mail to: mrp@emea.eu.int
Maltese: Is-segretarjat ta' l-EMEA/MRFG jista' jiġi kkuntattjat permezz ta' email lil: mrp@EMEA.eu.int
English: • Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products.
Maltese: • Id-Direttiva 2004/28/KE tal-Parlament Ewropew u tal-Kunsill tal-31 ta' Marzu 2004 li temenda d-Direttiva 2001/82/KE dwar il-kodiċi tal-Komunità dwar prodotti mediċinali veterinarji.
English: The batch certificate format has been adapted to include investigational medicinal products and active substances.
Maltese: Il-format ta' ċertifikat tal-lott ġie adattat biex jinkludi prodotti mediċinali investigattivi u sustanzi attivi.
English: • Pieter NEELS4 (Belgium) Alternate: Bruno FLAMION5
Maltese: • Pieter NEELS4 (Belġju) Sostitut:
English: Number of visitors
Maltese: Numru ta' viżitaturi
English: Replaced Steffen THIRSTRUP as of November 2004 meeting.
Maltese: Ħa post Steffen THIRSTRUP mil-laqgħa ta' Novembru 8 Ħadet post Pekka KURKI mil-laqgħa ta' Settembru 2004.
English: • (Pre-)Clinical Working Party on Comparability of Biotechnology Products
Maltese: • Il-Grupp ta' Ħidma (Pre-)Klinikali dwar il-Paragunabbiltà ta' Prodotti Bijoteknoloġiċi
English: Dairíne DEMPSEY (Ireland) Alternate: Elaine BRESLIN
Maltese: Dairíne DEMPSEY (Irlanda) Sostituta:
English: The volume of applications for scientific assessment of medicinal products for human use was substantially higher than in 2003, with 21 more applications for orphan medicine designation, 25 more requests for scientific advice and protocol assistance, 12 more applications for initial marketing evaluation, 8 more opinions on initial marketing evaluation, and 61 more post-authorisation opinions.
Maltese: Il-volum ta' applikazzjonijiet għal valutazzjoni xjentifika ta' prodotti mediċinali għall-użu tal-Bniedem kien sostanzjalment ogħla milli fl-2003, b'21 applikazzjoni aktar għal klassifikar ta' prodotti bħala mediċini ltiema, 25 talba aktar għal parir xjentifiku u assistenza għall-protokoll, 12-il applikazzjoni aktar għal valutazzjoni inizjali għal tqegħid fis-suq, 8 opinjonijiet aktar dwar valutazzjoni inizjali għal tqegħid fis-suq, u 61 opinjoni aktar ta' wara l-awtorizzazzjoni.
English: Veterinary medicinal products: 1 June 2002
Maltese: Prodotti mediċinali veterinarji: l-1 ta' Ġunju 2002
English: Vytautas BASYS (Alternate: Juozas JOKIMAS)
Maltese: Vytautas BASYS (Sostitut:
English: This document provides the procedures to implement Article 58 of Regulation (EC) No 726/2004 and was released for external consultation in November 2004.
Maltese: Dan iddokument jipprovdi l-proċeduri għall-implimentazzjoni ta' l-Artikolu 58 tar-Regolament (KE) Nru 726/2004 u nħareġ għal konsultazzjoni esterna f'Novembru 2004.
English: 467 days
Maltese: 118 days 467 days
English: • Anja HOLM (Denmark) Alternate: Lotte Winther
Maltese: • Anja HOLM (Danimarka) Sostituta:
English: MRAs with Australia, New Zealand, Switzerland, Canada and Japan are currently operational, but with slightly different provisions as to scope and applicability.
Maltese: L-MRAs ma' l-Awstralja, New Zealand, l-Isvizzera, il-Kanada u l-Ġappun huma operattivi bħalissa, iżda b'dispożizzjonijiet kemmxejn differenti fir-rigward ta' l-iskop u l-applikabilità.
English: A selection of corporate projects in 2004:
Maltese: Għażla ta' proġetti korporattivi fl-2004:
English: Integrated quality management / audit
Maltese: Verifika/Ġestjoni integrata tal-kwalità
English: Pat O MAHONY (Alternate: Joan GILVARRY)
Maltese: Pat O'MAHONY (Sostituta:
English: • Alfred HERA (Czech Republic) Alternate: Jiří BURE
Maltese: • Alfred HERA (Repubblika Ċeka) Sostitut:
English: The COMP adopted 75 positive opinions on orphan medicinal product designation in 2004.
Maltese: Il-COMP adotta 75 opinjoni pożittiva dwar il-klassifikar ta' prodotti mediċinali ltiema fl-2004.
English: • Raul KIIVET (Estonia) Alternate: Alar IRS
Maltese: • Raul KIIVET (Estonja)
English: • John O BRIEN (United Kingdom) Alternate: Martin ILOTT
Maltese: • John O'BRIEN (Renju Unit) Sostitut:
English: • Eric ABADIE (France) (vice-chairman) Alternate: Jean-Hugues TROUVIN
Maltese: • Eric ABADIE (Franza) (viċi president) Sostitut:
English: Dr Geoffrey Allan Treatment of Rabson-Mendenhall syndrome
Maltese: Dr Geoffrey Allan Treatment of Rabson
English: Arbitration procedures are initiated because of disagreement between Member States in the framework of the mutual recognition procedure (Article 33 of Directive 2001/82/EC).
Maltese: Il-proċeduri ta' arbitraġġ jinbdew minħabba nuqqas ta' qbil bejn l-Istati Membri fil-qafas talproċedura ta' rikonoxximent reċiproku (l-Artikolu 33 tad-Direttiva 2001/82/KE).
English: The CHMP working parties and groups have, over time, developed positions on a wide range of topics, including variant Creutzfeldt-Jakob disease (vCJD), viral safety, influenza pandemic, new technologies and therapies, etc.
Maltese: Il-gruppi ta' ħidma tas-CHMP żviluppaw, matul iż-żmien, pożizzjonijiet dwar firxa wiesgħa ta' suġġetti, inkluża l-marda varjanti Creutzfeldt-Jakob (vCJD), is-sigurtà virali, il-pandemija ta' linfluwenza, teknoloġiji u terapiji ġodda, eċċ.
English: Piotr BLASZCZYK (Alternate: Jacek SPLAWINSKI)
Maltese: Jacek SPLAWINSKI)
English: Working parties and ad hoc groups
Maltese: Gruppi ta' ħidma u gruppi ad hoc
English: • A range of vaccines for cats, containing live and inactivated components in various valency combinations, allowing veterinarians to adapt the vaccination programme to the needs of individual cats, for active immunisation of:
Maltese: • Gamma ta' prodotti għat-tilqim tal-qtates, li jkun fihom komponenti ħajjin u inattivati f'kombinazzjonijiet ta' valenzi diversi, li jippermettu l-veterinarji jadattaw il-programm ta' tilqim skond il-bżonnijiet ta' qtates individwali, għall-immunizzazzjoni attiva ta':
English: Publications
Maltese: Publikazzjonijiet
English: Nello MARTINI (Alternate: Silvia FABIANI)
Maltese: Silvia FABIANI)
English: In some cases where the applicant has been unable to address these questions and the dossier was heading for a negative opinion, this has led to the withdrawal of the application.
Maltese: Ma kien hemm ebda opinjoni negattiva u applikazzjoni waħda ġiet irtirata qabel ma ngħatat l-opinjoni.
English: The report also summarises the operation of the decentralised (mutual recognition) procedure in accordance with Article 38(1) of Council Directive 2001/83/EC on the Community code relating to medicinal products for human use as amended by Directive 2004/27/EC and Article 42(1) of Council Directive 2001/82/EC as amended by Directive 2004/28/EC.
Maltese: Ir-rapport jiġbor ukoll fil-qosor l-operat tal-proċedura deċentralizzata (ta' rikonoxximent reċiproku) skond l-Artikolu 38(1) tad-Direttiva tal-Kunsill 2001/83/KE dwar il-kodiċi Komunitarja relatata ma' prodotti mediċinali għall-użu mill-bniedem kif emendata bid-Direttiva 2004/27/KE u l-Artikolu 42(1) tad-Direttiva tal-Kunsill 2001/82/KE kif emendata bid-Direttiva 2004/28/KE.
English: • Stane SRCIC (Slovenia) Alternate: Blanka EMERSIC
Maltese: • Stane SRCIC (Slovenja) Sostituta:
English: Sterile medicinal products and some biological medicinal products are excluded from the scope.
Maltese: Il-prodotti mediċinali sterili u xi prodotti mediċinali bijoloġiċi huma esklużi mill-iskop.
English: 243 days
Maltese: 210 days 243 days
English: Arnold J VLIETINCK (Belgium) Alternate: Heidi NEEF
Maltese: Maria STAVROU Arnold J VLIETINCK (Belġju) Sostituta:
English: Catherine HARVALA (Greece) Alternate: Foteini TZAVELLA
Maltese: Catherine HARVALA (Greċja) Sostitut:
English: There were no negative CVMP opinions in 2004.
Maltese: Ma kien hemm ebda opinjoni negattiva mis-CVMP fl-2004.
English: In 2004, 8 (22 %) out of 37 applications for marketing authorisation that had an outcome in the centralised procedure received prior scientific advice.
Maltese: Fl-2004, 8 (22 %) minn 37 applikazzjoni għall-awtorizzazzjoni għal tqegħid fis-suq li kellhom eżitu fil-proċedura ċentralizzata ngħataw parir xjentifiku minn qabel.
English: 18 174 reports were received from EU sources and 46 012 were from outside the EU.
Maltese: 18 174 rapport intbagħtu minn sorsi ġewwa l-UE waqt li 46 012 ġew minn barra l-UE.
English: The EMEA operates in partnership with the national competent authorities for human and veterinary medicinal products in the Member States and the EEA-EFTA countries Iceland, Liechtenstein and Norway.
Maltese: L-EMEA topera bi sħubija ma' l-awtoritajiet kompetenti nazzjonali għal prodotti għall-bniedem u veterinarji fl-Istati Membri u fil-pajjiżi taż-ŻEE u l-EFTA bħall-Islanda, il-Liechtenstein u nNorveġja.
English: The number of SUSARs received electronically was 7 984, of which 3 746 were from EU sources and 4 238 from outside the EU.
Maltese: L-għadd ta' SUSARs li ntbagħtu elettronikament kien ta' 7 984, li minnhom 3 746 kienu minn sorsi flUE u 4 238 minn barra l-UE.
English: • David LYONS (Ireland) Alternate: Patrick SALMON
Maltese: • David LYONS (Irlanda) Sostitut:
English: The principles of GLP define a set of rules and criteria for a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, reported and archived.
Maltese: Il-prinċipji tal-GLP iddefinixxu ġabra ta' regoli u kriterji għal sistema ta' kwalità li għandha x'taqsam mal-proċess organizattiv u l-kondizzjonijiet li jistabbilixxu kif għandhom jiġu ppjantati, mwettqa, irrekordjati, irrapportati u arkivjati l-istudji ta' saħħa mhux klinika u tas-sigurtà ta' l-ambjent.
English: The Management Board adopted the EMEA quality policy in March 2004, with a revision in June 2004.
Maltese: Il-Bord ta' Tmexxija adotta l-politika ta' kwalità ta' l-EMEA f'Marzu ta' l-2004, b'reviżjoni f'Ġunju 2004.
English: • Ján MAZÁG3 (Slovakia) Alternate: Leila FARAH
Maltese: • Ján MAZÁG3 (Slovakkja)
English: Firocoxib !
Maltese: Previcox Firocoxib Part B
English: Istituto Superiore di Sanità Viale Regina Elena 299 IT 00161 Roma Tel. (39-06) 44 86 94 55 Fax (39-06) 44 86 94 40 E-mail: presidenza@iss.it Internet: http://www.iss.it
Maltese: Fax (39-06) 44 86 94 40 E-mail: presidenza@iss.it Internet: http://www.iss.it
English: COMMUNICATIONS AND NETWORKING
Maltese: KOMUNIKAZZJONIJIET U NETWERKING
English: Immunologicals Working Party Chair: Jean-Claude ROUBY EMEA contact: Jill ASHLEY-SMITH
Maltese: Grupp ta' Ħidma dwar Prodotti Immunoloġiċi President: Jean-Claude ROUBY Kuntatt fl-EMEA: Jill ASHLEY-SMITH
English: There were no negative CHMP opinions in 2004.
Maltese: Ma kien hemm ebda opinjoni negattiva tas-CHMP fl-2004.
English: • Kenneth MIFSUD (Malta) Alternate: Joseph VELLA
Maltese: • Kenneth MIFSUD (Malta) Sostitut:
English: 3-tier architecture
Maltese: Arkitettura fuq 3 livelli
English: The code ensures that a consistent standard of professional conduct applies to all parties associated with the EMEA s work and responsibilities.
Maltese: IlKodiċi jassigura li standard konsistenti ta' kodiċi professjonali japplika għall-partijiet kollha assoċjati max-xogħol u mar-responsabbiltajiet ta' l-EMEA.
English: • Tomas SALMONSON (Sweden) Alternate: Per NILSSON
Maltese: • Tomas SALMONSON (Svezja)
English: • Giuseppe NISTICÒ (Italy) Alternate: Pasqualino ROSSI
Maltese: • Giuseppe NISTICÒ (Italja) Sostitut:
English: The MRFG met 11 times in 2004.
Maltese: L-MRFG iltaqa' 11-il darba fl-2004.
English: EC subsidy/EEA contribution
Maltese: Sussidju tal-KE/kontribuzzjoni taż-ŻEE
English: 253 periodic safety update reports (PSURs) were reviewed in 2004.
Maltese: Fl-2004 ġew riveduti 253 rapport perjodiku ta' aġġornament dwar is-sigurtà (PSURs).
English: Operational since 29 May 2004
Maltese: Operattiv sa mid-29 ta' Mejju 2004
English: Discussions to harmonise the certificate of GMP compliance of a manufacturer and maintenance programmes were initiated in 2004.
Maltese: Id-diskussjonijiet biex jiġi armonizzat iċ-ċertifikat ta' konformità GMP ta' manifattur u l-programmi ta' manutenzjoni nbdew fl-2004.
English: Upon request from the EMEA, national competent authorities have nominated more than 100 specialised experts in the areas of pharmacovigilance, pharmacoepidemiology, epidemiology, emerging therapies (such as gene therapy) and risk communication.
Maltese: Fuq talba ta' l-EMEA, l-awtoritajiet nazzjonali kompetenti ħatru aktar minn 100 espert speċjalizzat fl-oqsma tal-farmakoviġilanza, ilfarmakoepidemjoloġia, l-epidemjoloġia, it-terapiji li qegħdin jitfaċċaw (bħat-terapija tal-ġeni) u lkommunikazzjoni ta' riskji.
English: Blood Products Working Party (formerly Blood Products Working Group) Chair: Manfred HAASE EMEA contact: John PURVES
Maltese: Grupp ta' Ħidma dwar Prodotti mid-Demm President: Manfred HAASE Kuntatt fl-EMEA: John PURVES
English: Prevalence Ad hoc Working Group Chair: Kalle HOPPU EMEA contact: Spiros VAMVAKAS
Maltese: Grupp ta' Ħidma Ad hoc dwar il-Prevalenza President: Kalle HOPPU Kuntatt fl-EMEA: Spiros VAMVAKAS
English: A total of 27 recruitment procedures were carried out in 2004.
Maltese: Fl-2004 twettqu total ta' 27 proċedura ta' reklutaġġ.
English: • Revised the rules on public access to EMEA documents 16 December 2004
Maltese: • Irreveda r-regoli dwar aċċess pubbliku għal dokumenti ta' l-EMEA 16 ta' Diċembru 2004
English: Number of payments processed
Maltese: Ghadd ta' pagamenti pprocessati
English: Interaction with stakeholders especially patients organisations was extensive during 2004.
Maltese: L-interazzjoni mal-partijiet interessati - speċjalment lorganizzazzjonijiet tal-pazjenti - kienet estensiva matul l-2004.
English: • Neuropsychiatric disorders, such as epilepsy, depression, Parkinsons disease or severe pain (7 products)
Maltese: • Disturbi newropsikjatriċi, bħall-epilessija, id-depressjoni, il-marda ta' Parkinson jew uġigħ qawwi (7 prodotti)
English: The paper was released for external consultation in September 2004 and aims at putting in place a transparent process for the development, consultation, finalisation and implementation of pharmaceutical guidelines.
Maltese: Iddokument inħareġ għal konsultazzjoni esterna f'Settembru 2004 u jimmira li jistabilixxi proċess trasparenti għall-iżvilupp, il-konsultazzjoni, il-finalizzazzjoni u l-implimentazzjoni ta' linji ta' gwida farmaċewtiċi.
English: In 2004, the CVMP met 11 times and held 2 informal meetings.
Maltese: Fl-2004, is-CVMP iltaqa' 11-il darba u għamel 2 laqgħat informali.
English: • COMP Biotechnology Working Group • Ad hoc Working Group on Prevalence
Maltese: • Grupp ta' Ħidma ad hoc dwar il-Prevalenza
English: Brigitte BATLINER (Alternate: Peter MALIN)
Maltese: Brigitte BATLINER (Sostitut:
English: Good clinical practice (GCP) activities
Maltese: Attivitajiet ta' prattika klinika tajba (GCP)
English: The Agency completed 2 urgent safety restriction (USR) procedures for centrally authorised products during 2004, introducing warnings into the marketing authorisation of the two medicinal products.
Maltese: L-Aġenzija wettqet 2 proċeduri ta' restrizzjoni urġenti minħabba sigurtà (USR) għal prodotti awtorizzati ċentralment matul l-2004, u daħħlet twissijiet fl-awtorizzazzjoni għal tqegħid fis-suq tażżewġ prodotti mediċinali.
English: Inspections of blood establishments to support certification of PMFs were initiated in the second half of 2004 and a total of 15 inspections were carried out in this context, involving 27 blood establishment sites.
Maltese: L-ispezzjonijiet ta' stabbilimenti tad-demm bħala sostenn għaċ-ċertifikazzjoni tal-PMFs inbdew fittieni nofs ta' l-2004 u saru total ta' 15-il spezzjoni f'dan il-kuntest, li involvew 27 sit ta' stabbilimenti tad-demm.
English: The revised EudraVigilance Veterinary test system was available from early September 2004, with the production system becoming available on 18 October 2004 well before 1 January 2005, the date for implementation of electronic reporting agreed with the Member States Heads of Veterinary Regulatory Authorities.
Maltese: Is-sistema riveduta ta' testijiet veterinarji EudraVigilance kienet disponibbli mill-bidu ta' Settembru 2004, waqt li s-sistema ta' produzzjoni kienet disponibbli mit-18 ta' Ottubru 2004 - ferm qabel l-1 ta' Jannar 2005, id-data għall-implimentazzjoni tar-rapportaġġ elettroniku miftiehem mal-Kapijiet ta' l-Awtoritajiet Regolatorji Veterinarji ta' l-Istati Membri.
English: The CHMP adopted an opinion on a referral under Article 31 regarding paroxetine-containing medicines in April 2004.
Maltese: Is-CHMP adotta opinjoni dwar referenza taħt l-Artikolu 31 fir-rigward ta' mediċini li fihom ilparoxetine f'April 2004.
English: Greece
Maltese: Il-Grecja