FrancophonIA/ELRC3.0 huggingface dataset:
English: The CVMP nominated additional members as follows: one expert on quality aspects of biotechnology products; three experts on clinical medicine (one for companion animals, one for large animals and one for intensive production, with a focus on poultry); and one expert on safety and risk assessment.
Maltese: Is-CVMP innomina membri addizzjonali skond kif ġej: espert wieħed dwar aspetti ta' kwalità ta' prodotti talbijoteknoloġija; tlett esperti dwar il-mediċina klinika (wieħed għal annimali tat-tgħammir, wieħed għal annimali kbar u wieħed għall-produzzjoni intensiva, b'emfasi fuq it-tjur); u espert wieħed dwar ilvalutazzjoni tas-sigurtà u r-riskju.
English: 207 days
Maltese: 177 days 207 days
English: Annex 2
Maltese: Anness 2
English: Ľudevít MARTINEC (Alternate: Stanislava GAJDO OVÁ)
Maltese: Ľudevít MARTINEC (Sostituata:
English: Philippe DUNETON (Alternate: Jean MARIMBERT)
Maltese: Philippe DUNETON (Sostitut:
English: ICELAND
Maltese: L-ISLANDA
English: 113 days
Maltese: 210 days 113 days
English: • New procedures for plasma master files (PMFs) and vaccine antigen master files (VAMFs) were implemented in 2004 and paved the way for the submission of the first PMFs.
Maltese: • Proċeduri ġodda għal fajls prinċipali tal-plażma (PMFs) u fajls prinċipali ta' l-antiġen għattilqim (VAMFs) ġew implimentati fl-2004 u dawn wittew it-triq għas-sottomissjoni ta' lewwel PMFs.
English: • Ioannis MALEMIS (Greece) Alternate: Orestis PAPADOPOULOS
Maltese: • Ioannis MALEMIS (Greċja) Sostitut:
English: Chair: Hans HOOGLAND EMEA contact: Kornelia GREIN
Maltese: Kuntatt fl-EMEA: Kornelia GREIN
English: • Romaldas MACIULAITIS (Lithuania) Alternate: Mykolas MAURICAS
Maltese: • Romaldas MACIULAITIS (Litwanja)
English: EMEA/CVMP !
Maltese: EMEA/CVMP Validazzjoni Opinjoni
English: • David LYONS (EMEA representative) • Henri METZ (Luxembourg)
Maltese: • David LYONS (rappreżentant ta' l-EMEA)
English: Vaccine Working Party (formerly Vaccine Expert Group) Chair: Roland DOBBELAER EMEA contact: John PURVES
Maltese: Roland DOBBELAER Kuntatt fl-EMEA: John PURVES
English: • Steffen THIRSTRUP6 (Denmark) Alternate: Jens ERSBØLL7
Maltese: • Steffen THIRSTRUP6 (Danimarka)
English: Klaus REH (Germany) Alternate: Christine WERNER
Maltese: Wolfgang KUBELKA Klaus REH (Ġermanja) Sostituta: Christine WERNER Marie SAARSOO (Estonja) Sostituta:
English: Human medicinal products only Currently excludes active substances, investigational medicinal products, medicinal gases
Maltese: Prodotti mediċinali għall-bniedem biss Preżentament jeskludi sustanzi attivi, prodotti mediċinali investigattivi, gassijiet mediċinali
English: Centralised applications - Positive opinions
Maltese: Applikazzjonijiet ċentralizzati - opinjonijiet negattivi
English: Of these, phase-I clinical trials represented 15 %, compared to 18 % the year before, and 68 % related to phase-III trials.
Maltese: Minn dawn, il-provi kliniċi filfażi-I rrappreżentaw 15 %, meta mqabbla ma' 18 % tas-sena ta' qabel, u 68 % kienu relatati ma' provi fil-fażi-III.
English: 1.5 Transparency and communication
Maltese: It-Trasparenza u l-komunikazzjoni
English: 162 days
Maltese: 184 days 162 days
English: 577 days
Maltese: 217 days 577 days
English: EMEA general information service:
Maltese: Servizz ġenerali ta' informazzjoni ta' l-EMEA:
English: The CVMP created a Scientific Advisory Group on Antimicrobials in 2004.
Maltese: Is-CVMP ħoloq Grupp Xjentifiku Konsultattiv dwar l-Antimikrobiċi fl-2004.
English: 50 % fee reduction for new applications for a marketing authorisation in the centralised procedure 50 % fee reduction for post-authorisation activities and annual fees
Maltese: 50 % tnaqqis fil-ħlas għal applikazzjonijiet ġodda għal awtorizzazzjoni għal tqegħid fis-suq filproċedura ċentralizzata
English: 221 days
Maltese: 181 days 221 days
English: o Feline viral rhinotracheitis o Calcivirus infection o Chlamydophilia felis infection o Feline panleucopenia o Feline leukaemia
Maltese: o Rinotrakejite virali tal-qtates o Infezzjoni kalċivirali o Infezzjoni ta' Chlamydophilia felis o Panlewkopenija felina o Lewkemija felina
English: Efficacy Working Party Chair: Barbara VAN ZWIETEN-BOOT EMEA contact: Agnès SAINT-RAYMOND
Maltese: Grupp ta' Ħidma dwar l-Effikaċja President: Barbara VAN ZWIETEN-BOOT Kuntatt fl-EMEA: Agnès SAINT-RAYMOND
English: Ingolf J PETERSEN (Alternate: Rannveig GUNNARSDÓTTIR)
Maltese: Ingolf J PETERSEN (Sostitut:
English: The Management Board adopted new rules on access to EMEA documents at its March 2004 meeting.
Maltese: Il-Bord ta' Tmexxija adotta regoli ġodda dwar aċċess għal dokumenti ta' l-EMEA fil-laqgħa tiegħu f' Marzu 2004.
English: • Elected Hannes Wahlroos (Finland) as chairman of the Board and re-elected Jytte Lyngvig (Denmark) as vice-chairman
Maltese: • Ħatar lil Hannes Wahlroos (Finlandja) b'elezzjoni bħala president tal-Bord u ħatar mill-ġdid lil Jytte Lyngvig (Danimarka) bħala viċi president
English: • Implementation of new and modified accounting practices in line with the reform of the Commission
Maltese: • L-implimentazzjoni ta' prassi ġodda u modifikati ta' kontabilità b'mod konfirmi mar-riforma tal-Kummissjoni
English: To deploy a scientific advice database
Maltese: Li titħaddem database ta' parir xjentifiku
English: See also Annex 13.
Maltese: Ara wkoll l-Anness 13.
English: The EMEA is responsible for the implementation and the operational aspects of these MRAs.
Maltese: L-EMEA hija responsabbli għall-implimentazzjoni ta' l-aspetti operazzjonali ta' dawn l-MRAs.
English: Linda ANDERSON (United Kingdom) Alternate: Sue HARRIS
Maltese: Linda ANDERSON (Renju Unit) Sostituta:
English: • Laimi JODKONIS (Lithuania) Alternate: Juozas JOKIMAS
Maltese: • Laimi JODKONIS (Litwanja) Sostitut:
English: Accounting
Maltese: Kontabilità
English: With a view to ensuring the quality and consistency of regulatory practices, a benchmarking exercise based on ISO 9004:2000 was started in 2004, involving the EMEA and national competent authorities.
Maltese: Bil-ħsieb li jiġu assigurati il-kwalità u l-konsistenza ta' prassi regolatorji, ingħata bidu fl-2004 għal eżerċizzju ta' referenza bbażat fuq ISO 9004:2000, li jinvolvi lill-EMEA u lill-awtoritajiet kompetenti nazzjonali.
English: 3.9 Management and organisation of the CVMP
Maltese: 3.9 Tmexxija u organizzazzjoni tas-CVMP
English: Work relating to the improvement of various aspects of the management of referral procedures, which started in 2003, continued throughout 2004.
Maltese: Ix-xogħol relatat mat-titjib ta' diversi aspetti tal-ġestjoni ta' proċeduri ta' referenza, li beda fl-2003, issokta matul l-2004.
English: General EU contribution Special EU contribution for IT telematics strategy Special EU contribution for orphan medicinal products Contribution from EEA Contribution from EU programmes (PERF)
Maltese: Kontribuzzjoni mill-programmi ta' l-UE (PERF)
English: 118 days
Maltese: 118 days 0 days
English: The average duration of the procedures was 86 days in 2004.
Maltese: It-tul medju tal-proċeduri kien ta' 86 jum fl-2004.
English: The workload arising from the handling of periodic safety updates, follow-up measures and specific obligations decreased slightly compared to 2003, owing partly to a decrease in the number of marketing authorisation applications received at the EMEA in the years 2002 and 2003.
Maltese: Ix-xogħol li jinħoloq millimmaniġġjar ta' aġġornamenti perjodiċi ta' sigurtà, miżuri ta' follow-up u obbligi speċifiċi naqas xi ftit meta mqabbel ma' l-2003, parzjalment minħabba tnaqqis fin-numru ta' applikazzjonijiet għal awtorizzazzjoni għal tqegħid fis-suq li waslu għand l-EMEA fis-snin 2002 u 2003.
English: TachoSil !
Maltese: eċċ.
English: Regulatory affairs and organisational support
Maltese: Affarijiet regolatorji u sostenn ta' l-organizzazzjoni
English: 631 days
Maltese: 244 days 631 days
English: • EudraVigilance in the veterinary sector for electronic reporting of adverse reactions became fully operational on 1 January 2005.
Maltese: • Il-EudraVigilance fis-settur veterinarju għar-rapportaġġ elettroniku ta' reazzjonijet mhux mixtieqa saret operattiva għal kollox fl-1 ta' Jannar 2005.
English: To implement one common and standard directory of all parties involved in the EU pharmaceutical regulatory process
Maltese: Li jiġi implimentat direttorju wieħed komuni u standard tal-partijiet kollha involuti fil-proċess regolatorju farmaċewtiku ta' l-UE
English: The EMEA continually supported the Commission and the Member States with the implementation of Directive 2001/20/EC on clinical trials through the activities of the ad hoc meetings of GCP and GMP inspection services, through participation in working groups of the Commission, and through support to the implementation of European databases for clinical trials.
Maltese: L-EMEA kompliet tappoġġa lill-Kummissjoni u lill-Istati Membri bl-implimentazzjoni tad-Direttiva 2001/20/KE dwar provi kliniċi permezz ta' l-attivitajiet tal-laqgħat ad hoc tas-servizzi ta' spezzjoni tal-GCP u l-GMP, permezz ta' parteċipazzjoni fil-gruppi ta' ħidma tal-Kummissjoni, u permezz ta' appoġġ għall-implimentazzjoni tad-databases Ewropej għal provi kliniċi.
English: One of these related to SSRI (serotonin selective reuptake inhibitor) and SNRI (serotonin-norepinephrine reuptake inhibitor) products, in particular regarding the use of these products in children and adolescents.
Maltese: Waħda minn dawn kienet relatata ma' prodotti ta' l-SSRI (serotonin selective reuptake inhibitor - impeditur silettiv ta' l-assorbiment mill-gdid tas-serotonin) u SNRI (serotonin-norepinephrine reuptake inhibitor - impeditur ta' l-assorbiment mill-ġdid tas-serotonin-norepinefrina), b'mod partikolari fir-rigward ta' l-użu ta' dawn il-prodotti fit-tfal u l-adoloxxenti.
English: Joint CHMP/CVMP Quality Working Party Chair: Jean-Louis ROBERT EMEA contact: Emer COOKE
Maltese: Jean-Louis ROBERT Kuntatt fl-EMEA: Emer COOKE
English: Issues discussed included: enlargement of the EU and implementation of the new legislation; integration of the new members; the new Committee structure; quality and integrity of scientific assessments; and improvements called for following an audit of the Committee in October 2004.
Maltese: Il-kwistjonijiet diskussi inkludew: it-tkabbir ta' l-UE u l-implimentazzjoni tal-leġislazzjoni l-ġdida; integrazzjoni tal-membri l-ġodda; listruttura l-ġdida tal-Kumitat; il-kwalità u l-integrità tal-valutazzjonijiet xjentifiċi; u t-titjib meħtieġ wara verifika tal-Kumitat f'Ottubru 2004.
English: Annex 7 EMEA budget summaries 2003-2005
Maltese: Anness 7 Il-Budgets ta' l-EMEA fil-Qosor għall-2003-2005
English: Ana Paula MARTINS (Portugal) Alternate: Maria Helena PINTO FERREIRA
Maltese: Ana Paula MARTINS (Portugall) Sostituta:
English: 297 days
Maltese: 215 days 297 days
English: • The CVMP adopted its Position paper regarding availability of products for minor uses and minor species (EMEA/CVMP/477/03/Final) detailing the strategy to be taken in advancing the greater availability of medicines in the veterinary sector.
Maltese: • Is-CVMP adotta d-‘dokument ta' pożizzjoni dwar id-disponibbiltà ta' prodotti għal użu minuri u speċji minuri' (EMEA/CVMP/477/03/Final) li jagħti dettalji dwar l-istrateġija li għandha tittieħed sabiex tiġi avvanzata d-disponibbiltà akbar tal-mediċini fis-settur veterinarju.
English: • A new non-steroidal anti-inflammatory medicinal product (NSAID) belonging to the coxib group, which acts by selective inhibition of cyclooxygenase-2 (COX-2) medicated protaglandin synthesis, for relief of pain and inflammation associated with osteoarthritis in dogs
Maltese: • Prodott mediċinali anti-infjammatorju mhux sterojdu (NSAID) li jappartjeni fil-kategorija coxib, li jaġixxi billi jimpedixxi b'mod selettiv is-sintesi ta' prostaglandin, permezz tascyclooxygenase-2 (COX-2), għal serħan mill-uġigħ u infjammazzjoni assoċjata ma' lostejoartrite fil-klieb
English: With the enlargement of the European Union in 2004, the number of official EU languages increased from 11 to 20.
Maltese: Mat-tkabbir ta' l-Unjoni Ewropea fl-2004, in-numru ta' lingwi uffiċjali ta' l-UE żdied minn 11 għal 20.
English: 289 days
Maltese: 197 days 289 days
English: Working Group with Interested Parties Chair: Yann LE CAM/Agnès SAINT-RAYMOND EMEA contact: Spiros VAMVAKAS
Maltese: Grupp ta' Ħidma ma' Partijiet Interessati President: Yann LE CAM/Agnès SAINTRAYMOND
English: • The EMEA provided support for the implementation of the Clinical Trials Directive, ensuring the successful rollout of the European clinical trials database (EudraCT) in line with the legal deadline of 1 May 2004.
Maltese: • L-EMEA pprovdiet appoġġ għall-implimentazzjoni tad-Direttiva dwar provi kliniċi, sabiex b'hekk ġiet żgurata l-attwazzjoni b'suċċess tad-database Ewropea ta' provi kliniċi (EudraCT) b'mod konformi mat-terminu ta' skadenza legali ta' l-1 ta' Mejju 2004.
English: Martin HARVEY ALLCHURCH Direct telephone: (44-20) 74 18 84 27 E-mail: press@emea.eu.int
Maltese: (44-20) 74 18 84 27 E-mail: press@EMEA.eu.int
English: Direct telephone: (44-20) 74 18 85 52 Fax: (44-20) 74 18 85 45
Maltese: (44-20) 74 18 85 52 Fax:
English: Slovenia
Maltese: IS-SLOVENJA
English: Head of Sector for veterinary marketing authorisation procedures Jill ASHLEY-SMITH Deputy Head of Sector for veterinary marketing authorisation procedures
Maltese: Peter JONES Kap tas-Settur għal proċeduri ta' awtorizzazzjoni veterinarji għal tqegħid fis-suq Jill ASHLEY-SMITH Viċi Kap tas-Settur għal proċeduri ta' awtorizzazzjoni veterinarji għal tqegħid fis-suq Melanie LEIVERS
English: • Eduardo MARQUES-FONTES (Portugal) Alternate: Leonor Maria MEISEL
Maltese: • Eduardo MARQUES-FONTES (Portugall) Sostituta:
English: 213 days
Maltese: 182 days 213 days
English: Nycomed Austria GmbH
Maltese: Nycomed LAwstrija GmbH
English: Direct telephone: (44-20) 75 23 71 47 Fax: (44-20) 74 18 85 45
Maltese: (44-20) 75 23 71 47 Fax:
English: A new referral procedure under Article 31 (Article 18 for centrally authorised products) was started for all COX-2 inhibitor medicines available in the EU in October 2004, due to concerns over cardiovascular safety.
Maltese: Proċedura ta' referenza ġdida taħt l-Artikolu 31 (Artikolu 18 għal prodotti awtorizzati ċentralment) inbdiet għall-mediċini kollha li jimpedixxu l-COX-2 disponibbli fl-UE f'Ottubru 2004, minħabba tħassib dwar is-sigurtà kardjovaskulari.
English: Involving its partners and stakeholders in this consultation process allowed the EMEA to achieve a broad consensus on the best way forward for the Agency in an operating environment characterised by significant political, institutional, legislative and scientific developments.
Maltese: L-involviment ta' l-imsieħba u tal-partijiet interessati fil-proċess tagħha ta' konsultazzjoni ippermetta lill-EMEA tilħaq konsensus wiesa' dwar l-aħjar direzzjoni'il quddiem għall-Aġenzija f'ambjent ta' operazzjoni kkaratterizzat minn żviluppi sinifikanti politiċi, istituzzjonali, leġislattivi u xjentifiċi.
English: Positive opinions per therapeutic area 2004
Maltese: Opinjonijiet pozittivi skond il-qasam terapewtiku 2004
English: Applications are submitted directly to the EMEA.
Maltese: applikazzjoni lill- EMEA.
English: • Gottfried KREUTZ (Germany) Alternate: Karl BROICH2
Maltese: • Gottfried KREUTZ (Ġermanja) Sostitut:
English: Creation of scientific advisory groups
Maltese: Ħolqien ta' gruppi xjentifiċi konsultattivi
English: Inspections
Maltese: Osservaturi
English: Evaluation in <30 days Evaluation in 30-60 days Evaluation in >60 days
Maltese: Valutazzjoni fi <30 jum Valutazzjoni f'30-60 jum Valutazzjoni f'>60 jum
English: Adopted in November 2004
Maltese: Adottata f'Novembru 2004
English: For enquiries concerning VAMF certificates:
Maltese: Għal mistoqsijiet dwar ċertifikati ta‘ VAMF:
English: 154 days
Maltese: 184 days 154 days
English: 1 Replaced Carlos LENS CABRERA as of June 2004 meeting.
Maltese: 1 Ħa post Carlos LENS CABRERA mill-laqgħa ta' Ġunju 2004.
English: Adopted in April 2004
Maltese: Adottati f'April 2004
English: Patricia VELLA BONANNO (Alternate: Kenneth MIFSUD)
Maltese: Patricia VELLA BONANNO (Sostitut:
English: In 2004, a wide range of user, technical and NCA training was successfully provided to EMEA staff and delegates alike.
Maltese: Fl-2004, firxa wiesgħa ta' taħriġ tekniku, lill-utenti u lawtoritajiet kompetenti nazzjonali ingħata b'suċċess lill-personal u d-delegati kollha ta' l-EMEA.
English: • Markku TOIVONEN (Finland) Alternate: Riita TOKOLA8
Maltese: • Markku TOIVONEN (Finlandja) Sostituta:
English: 173 days
Maltese: 60 days 173 days
English: Good manufacturing practice (GMP) activities
Maltese: Attivitajiet ta' prattika tajba ta' manifattura (GMP)
English: • Two standards for electronic information exchange (the EU Module 1 Specification and the Application Form Specification) were adopted
Maltese: • Ġew adottati żewġ standards għall-iskambju ta' informazzjoni elettronika (lIspeċifikazzjoni ta' Modulu 1 ta' l-UE u l-Ispeċifikazzjoni tal-Formola ta' Applikazzjoni)
English: Final appropriations for the 2003 budget.
Maltese: Approprijazzjonijiet finali għall-budget ta' l-2003.
English: A new procedure for requesting and reporting GLP inspections for centralised applications came into effect on 15 August 2004.
Maltese: Proċedura ġdida għat-talba u r-rapportaġġ ta' spezzjonijiet GLP għal applikazzjonijiet ċentralizzati daħlet fis-seħħ fil-15 ta' Awissu 2004.
English: And while the growth of the European network to 28 EEA-EFTA countries, 42 national competent authorities and a pool of over 3 500 national experts certainly placed increased pressure on the EMEA in its role as coordinator, the Agency was able to cope without any major difficulty.
Maltese: U waqt li t-tkabbir tan-netwerk għal 28 pajjiż taż-ŻEE-EFTA, 42 awtorità nazzjonali kompetenti u ġabra ta' aktar minn 3 500 espert nazzjonali m'għandniex xi ngħidu żied il-pressjoni fuq l-EMEA fir-rwol tagħha bħala koordinatriċi, madanakollu l-Aġenzija rnexxielha tlaħħaq mingħajr diffikultajiet kbar.
English: Safety Working Party Chair: Beatriz SILVA LIMA EMEA contact: Agnès SAINT-RAYMOND
Maltese: Grupp ta' Ħidma dwar is-Sigurtà President: Beatriz SILVA LIMA Kuntatt fl-EMEA: Agnès SAINT-RAYMOND
English: Adopted by CPMP/CVMP in June
Maltese: Adottata mis-CPMP/CVMP f'Ġunju 2004
English: European product index http://heads.medagencies.org/mrindex/index.html
Maltese: Kapijiet ta' l-Aġenziji tal-Mediċini għall-Bniedem http://heads.medagencies.org Indiċi ta' prodotti Ewropej http://heads.medagencies.org/mrindex/index.html
English: Six (75 %) of these received a positive CHMP opinion, indicating that, while SA/PA is no guarantee of a positive outcome, it appears to have a favourable influence.
Maltese: Sitta (75 %) minn dawn irċevew opinjoni pożittiva tas-CHMP, li tindika li, waqt li l-SA/PA m'hi ebda garanzija ta' eżitu pożittiv, jidher li kellha influwenza pożittiva.
English: A provisional Audit Advisory Committee was established in September 2004 with a number of external and internal members.
Maltese: Kumitat konsultattiv proviżorju ta' Verifika ġie stabbilit f'Settembru 2004 b'għadd ta' membri esterni u interni.
English: • Assessment report templates to harmonise and facilitate the assessment review by the CHMP during the evaluation of the dossier pre-/post-authorisation were updated to take into consideration the changes of the European pharmaceutical legislation, especially Annex 1 of Directive 2001/83/EC.
Maltese: • Il-mudelli ta' rapport ta' valutazzjoni li jarmonizzaw u jiffaċilitaw ir-reviżjoni ta' valutazzjoni mis- CHMP matul il-valutazzjoni tad-dossier qabel u wara l-awtorizzazzjoni ġew aġġornati sabiex jiġu meqjusa l-bidliet fil-leġislazzjoni farmaċewtika Ewropea, speċjalment l-Anness 1 tad-Direttiva 2001/83/KE.
English: COMP opinions by therapeutic area 2004
Maltese: Opinjonijiet tal-COMP skond it-taqsima terapewtika 2004
English: Postage and communications
Maltese: Posta u komunikazzjonijiet
English: Emiel VAN GALEN (Netherlands) Alternate: Burt H KROES
Maltese: Emiel VAN GALEN (Olanda) Sostitut:
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 the EMEA.
Maltese: Il-monitoraġġ kontinwu tas-sigurtà tal-mediċini wara l-awtorizzazzjoni (‘il-farmakoviġilanza') huwa parti importanti mix-xogħol ta' l-awtoritajiet nazzjonali kompetenti u l-EMEA.
English: Steffen BAGER (Denmark) Alternate: Kristine HVOLBY
Maltese: Steffen BAGER (Danimarka) Sostituta:
English: 236 days
Maltese: 194 days 236 days
English: 129 days
Maltese: 181 days 129 days
English: 4.4 Certificates of a medicinal product
Maltese: 4.4 Ċertifikati ta' prodott mediċinali
English: The ICDRA promotes worldwide collaboration between regulatory authorities for medicinal products.
Maltese: L-ICDRA tippromwovi kollaborazzjoni dinjija bejn awtoritajiet regolatorji għal prodotti mediċinali.
English: Estonia
Maltese: L-ESTONJA
English: • The EMEA, together with the Inspections Telematics Implementation Group, began to work on the deployment of an inspections database which comprises information about all inspections activities carried out in the European system
Maltese: • L-EMEA, flimkien mal-Grupp ta' Implimentazzjoni ta' Spezzjonijiet Telematiċi, beda jaħdem fuq il-bini ta' database ta' spezzjonijiet li tinkludi informazzjoni dwar l-attivitajiet kollha ta' spezzjoni mwettqa fis-sistema Ewropea
English: Type-II variations *The numbers include multiple procedures as stated at 31 December 2004.
Maltese: *In-numri jinkludu proċeduri multipli kif iddikjarat fil-31 ta' Diċembru 2004.
English: Chair: Eric ABADIE
Maltese: President: Eric ABADIE Kuntatt fl-EMEA:
English: Annex 8 IT projects and operational activities Annex 9 CHMP opinions in 2004 on medicinal products for human use Annex 10 CVMP opinions in 2004 on medicinal products for veterinary use Annex 11 COMP opinions in 2004 on designation of orphan medicinal products Annex 12 Guidelines and working documents in 2004
Maltese: Anness 9 Opinjonijiet tas-CHMP fl-2004 dwar prodotti mediċinali għall-użu tal-bniedem 99 Anness 10 Opinjonijiet tas-CVMP fl-2004 dwar prodotti mediċinali għal użu veterinarju 105 Anness 11 Opinjonijiet tal-COMP fl-2004 dwar il-klassifikar ta' prodotti mediċinali ltiema 108 Anness 12 Linji ta' gwida u dokumenti tax-xogħol ta' l-EMEA fl-2004
English: Submission !
Maltese: Sostituta:
English: # Denotes an orphan medicinal product designated under Regulation (EC) No 121/2000.
Maltese: Juri prodott mediċinali ltim klassifikat taħt ir-Regolament (KE) Nru 121/2000.
English: 2.1 Orphan medicinal products
Maltese: 2.1 Prodotti mediċinali ltiema
English: A new policy and procedure on the handling of conflicts of interests of scientific committee members and experts was adopted in March 2004.
Maltese: Ġiet adottata politika u proċedura ġdida dwar it-trattament ta' kunflitti ta' interessi ta' membri u esperti tal-kumitati xjentifiċi f'Marzu 2004.
English: Support was provided through scientific and regulatory training for committee members, experts and assessors.
Maltese: Ingħata appoġġ permezz ta' taħriġ xjentifiku u regolatorju għall-membri tal-kumitat, esperti u stimaturi.
English: • Sif ORMARSDÓTTIR (Iceland) Alternate: Magnús JÓHANNSSON
Maltese: • Sif ORMARSDÓTTIR (Islanda) Sostitut:
English: The database now totals approximately 5 000 records.
Maltese: Id-database issa tammonta għal madwar 5 000 rekord.
English: Released for consultation in October 2004
Maltese: Il-konsultazzjoni ntemmet f'Awissu 2004
English: Since July 2004, additional details of COMP opinions have been published in the COMP press release.
Maltese: Sa minn Lulju 2004, dettalji addizzjonali ta' l-opinjonijiet tal-COMP bdew jiġu ppubblikati flistqarrijiet għall-istampa tal-COMP.
English: Post-authorisation opinions 2002-2004
Maltese: Opinjonijiet ta' wara l-awtorizzazzjoni 2002-2004
English: 356 days
Maltese: 228 days 356 days