FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH shall ensure that, at launch of Velcade 3.5mg new dual route package and thereafter, all healthcare professionals involved in the prescribing, dispensing, handling or administration of Velcade 3.5mg are provided with educational material.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH għandu jiżgura li, fit-tnedija tal-pakkett ġdid għall-mod doppju mnejn jista' jingħata Velcade u wara dan, il-professjonisti kollha fil-qasam tal-kura tas-saħħa involuti fil-kitba ta' riċetti, l-għoti, il-ġestjoni jew l-għoti ta' mnejn jingħata ta' Velcade 3.5mg huma pprovduti b'materjal edukattiv.
English: • Reconstitution, dosing and administration booklet
Maltese: • Fuljett dwar ir-rikostituzzjoni, id-dożaġġ u l-għoti
English: • dosing instructions and examples: how to calculate the body surface area of a patient and the volume of reconstituted Velcade (both IV and SC use) required for different body surface areas (cross reference to Dosing Slide Rule)
Maltese: • istruzzjonijiet dwar d-dożaġġ u eżempji: kif għandek tikkalkula l-erja superfiċjali tal-ġisem ta' pazjent u l-volum ta' Velcade rikostitwit (kemm għall-użu IV u SC) meħtieġ għall-erja differenti ta' partijiet tal-ġisem (referenza inkroċjata mad-Dosing Slide Rule)
English: • need to handling the medicinal product in sterile setting
Maltese: • il-ħtieġa li l-prodott mediċinali għandu jiġi ġestit f'ambjent sterile
English: • potential risks of administration errors including overdosing, underdosing and that inadvertent intrathecal administration has resulted in death
Maltese: • riskji potenzjali tal-għoti li jinkludi dożaġġ eċċessiv, sottodożaġġ u li l-għoti bi żvista fitteka wassal għal mewt
English: • a dose-calculation tool that enables prescribers to input a patient's height and weight in order to calculate the body surface area (BSA) and thereby to determine the appropriate VELCADE dose.
Maltese: • għodda biex tikkalkula d-doża li tippermetti lit-tobba jieħdu t-tul u l-piż tal-pazjent sabiex jikkalkulaw l-erja superfiċjali tal-ġisem (BSA - Body Surface Area) u b'hekk tiġi stabbilita d-doża xierqa ta' VELCADE.
English: • dosing instructions and examples: how to calculate the body surface area of a patient and the volume of reconstituted Velcade (both IV and SC use) required for different body surface areas.
Maltese: • Istruzzjonijiet dwar id-doża u eżempji: kif għandek tikkalkula l-erja superfiċjali tal-ġisem ta' pazjent u l-volum ta' VELCADE rikostitwit (kemm IV u SC) meħtieġ għal erja superfiċjali tal-ġisem differenti.
English: OJ L 136, 30.04.2004, p. 1.
Maltese: ĠU L 136, 30.04.2004, p. 1.
English: 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 09 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: (44-20) 74 18 84 00 Fax (44-20) 74 18 84 09 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.
English: Orphan medicinal product procedures 2003 - 2005
Maltese: Proceduri ta' prodotti medicinali orfni 2003 - 2005
English: Commission Regulation (EC) No 2049/2005, OJ L329, 16.12.2005, p. 4.
Maltese: Ir-Regolament tal-Kummissjoni (KE) Nru 2049/2005, ĠU L329, 16.12.2005, p. 4.
English: 9 INFORMATION AND COMMUNICATION
Maltese: 9 INFORMAZZJONI U KOMUNIKAZZJONI
English: A total of 34,352 ICSRs relating to SUSARs were received.
Maltese: Ġew irċevuti total ta' 34,352 ICSR li għandhom x'jaqsmu mas-SUSAR.
English: Non-EU ADRs EU ADRs
Maltese: ADRs minn barra l-UE ADRs mill-UE
English: 3.2.3 Maximum residue limits
Maltese: 3.2.3 Limiti massimi ta' residwi (MRLs)
English: Conclusion of the safety review of COX-2 inhibitors
Maltese: Konklużjoni tar-reviżjoni tas-sigurtà ta' inibituri COX-2
English: New applications for veterinary medicines received/forecast (Input)
Maltese: Applikazzjonijiet godda ghal medicini veterinarji rcevuti/mbassra (Input)
English: Pandemic influenza preparedness
Maltese: Il-preparazzjoni għall-influwenza pandemika
English: Availability of veterinary medicines
Maltese: Disponibbiltà ta' mediċini veterinarji
English: Integrated quality management system
Maltese: Sistema ta' ġestjoni integrata tal-kwalità
English: Management and internal-control systems are part of EMEA corporate governance and are consolidated in an integrated management system at the EMEA.
Maltese: Sistemi amministrattivi u ta' kontroll intern huma parti mill-governanza korporattiva ta' l-EMEA u huma kkonsolidati f'sistema ta' ġestjoni integrata fl-EMEA.
English: This policy put in place a framework for the checking of translations of product information by the national competent authorities, and set up a financial compensation scheme.
Maltese: Din il-politika implimentat qafas għallkontroll tat-traduzzjonijiet ta' l-informazzjoni dwar il-prodotti mill-awtoritajiet nazzjonali kompetenti u waqqfet skema ta' kumpens finanzjarju.
English: 8 HERBAL MEDICINES
Maltese: 8 MEDIĊINI MAGĦMULIN
English: 1 GXP means 'good clinical practice' (GCP), 'good manufacturing practice' (GMP) and 'good laboratory practice' (GLP) collectively.
Maltese: 1 GXP tfisser b'mod kollettiv 'prattika klinika tajba' (GCP - good clinical practice), 'prattika tajba ta' manifattura' (GMP - good manufacturing practice) u ‘prattika tajba tal-laboratorju' (GLP - good laboratory practice).
English: Similar biological medicinal products: An overarching guideline on similar biological medicines was finalised in November 2005.
Maltese: Prodotti mediċinali bijoloġiċi simili: Linja gwida wiesgħa fuq mediċini bijoloġiċi simili ġiet iffinalizzata f'Novembru 2005.
English: Safety review of non-steroidal anti-inflammatory drugs (NSAIDs)
Maltese: Ir-reviżjoni tas-sigurtà tad-mediċini anti-inflammatorji li mhumiex sterojdi (NSAIDs)
English: Conclusion of the safety review of the selective serotonin reuptake inhibitor (SSRI) class of antidepressants
Maltese: Il-konkluzjoni tar-reviżjoni tas-sigurtà tal-klassi ta' antidipressivi magħrufa bħala selective serotonin reuptake inhibitors (SSRI)
English: 13 EU TELEMATICS STRATEGY AND INFORMATION TECHNOLOGY
Maltese: 13 L-ISTRATEĠIJA TAT-TELEMATIKA TA' L-UE U T-TEKNOLOĠIJA TA' L-INFORMATIKA
English: 5.1 GMP, GCP, GLP inspections
Maltese: 5.1 Spezzjonijiet tal-GMP, GCP u GLP
English: Safety reviews
Maltese: Reviżjonijiet tas-sigurtà
English: Achievements of particular note include:
Maltese: Indikazzjonijiet ġodda:
English: New therapies
Maltese: Terapiji avvanzati
English: 3.2.2 Initial evaluation
Maltese: 3.2.2 Valutazzjoni inizjali
English: The EMEA received 65 quality-defect reports concerning human medicinal products and 3 qualitydefect reports for veterinary medicinal products.
Maltese: L-EMEA rċeviet 65 rapport dwar difetti fil-kwalità li kienu relatati ma' prodotti mediċinali għall-użu tal-bniedem u 3 rapporti dwar difetti fil-kwalità għal prodotti mediċinali veterinarji.
English: A similar sub-group was created of CMD(v) representatives, an observer of the Commission and the EMEA to draw up such a list for veterinary medicinal products.
Maltese: Ġie maħluq sottogrupp simili magħmul mir-rappreżentanti tal-CMD(v), osservatur talKummissjoni u ta' l-EMEA sabiex iħejji lista tal-prodotti mediċinali veterinarji.
English: Contra-indications and warnings: A total of 5 new contra-indications were introduced for 11 medicinal products used in the fields of HIV, immunosuppression, osteoporosis and metabolic diseases.
Maltese: Ġie introdott total ta' 5 kontra-indikazzjonijiet ġodda għal 11il prodott mediċinali fil-qasam ta' l-HIV, immunosuppressjoni, osteoporożi u mard metaboliku.
English: Introduced revised fee implementing rules providing, in particular, for graduations in the fee levels payable for certain new types of applications Approved a total budget of EUR 111,935,000 for 2005 (a 12% increase compared to the previous year), together with an establishment plan bringing the Agency's total number of temporary-agent posts to 379.
Maltese: Approva baġit totali ta' EUR 111,935,000 għall-2005 (żieda ta' 12% meta mqabbel mas-sena ta' qabel), flimkien ma' pjan ta' stabbiliment li jġib in-numru totali ta' karigi bħala aġenti temporanji ta' l-Aġenzija għal 379.
English: The EMEA will assume an active role in precautionary measures against pandemic influenza.
Maltese: L-EMEA se tassumi rwol attiv f'miżuri ta' prekawzjoni kontra l-influwenza pandemika.
English: The Agency released the ‘EMEA pandemic influenza crisis management plan for the evaluation and maintenance of pandemic influenza vaccines and antivirals' for consultation in 2005.
Maltese: Fl-2005, l-Aġenzija ħarġet għall-konsultazzjoni ‘EMEA pandemic influenza crisis management plan for the evaluation and maintenance of pandemic influenza vaccines and antivirals' (Il-pjan ta' l-EMEA għall-amministrazzjoni tal-kriżi ta' l-influwenza pandemika għall-valutazzjoni u l-manutenzjoni talvaċċini ta' l- influwenza pandemika u l-antivirali).
English: 3.1.3 Initial evaluation
Maltese: 3.1.3 Valutazzjoni inizjali
English: Opinions in 2005 In 2005, the CVMP adopted a total of 5 positive opinions for initial marketing authorisation applications.
Maltese: Opinjonijiet fl-2005 Fl-2005, il-CVMP adotta total ta' 5 opinjonijiet pożittivi dwar applikazzjonijiet inizjali għal awtorizzazzjoni għat-tqegħid fis-suq.
English: A total of 41 type-I variation applications were received, relating to 14 type-IA and 27 type-IB variations.
Maltese: Waslu total ta' 41 applikazzjoni għal varjazzjoni tat-tip I, li kellhom x'jaqsmu ma' 14-il varjazzjoni tattip IA u 27 varjazzjoni tat-tip IB.
English: A total of 880 suspected signals, concerning 87 products, were detected and investigated.
Maltese: Ġew intraċċati u nvestigati total ta' 880 sinjal suspett li jikkonċernaw 87 prodott.
English: Good progress with EudraVigilance
Maltese: Progress tajjeb bil-EudraVigilance
English: Addressing antimicrobial resistance by progressing a new strategy on risk management and risk assessment for antimicrobials in veterinary medicinal products
Maltese: Indirizzar tar-reżistenza antimikrobika bl-avvanz ta' strateġija ġdida dwar il-ġestjoni tar-riskji u stima tar-riskji għall-antimikrobiċi fi prodotti mediċinali veterinarji
English: Good progress was made with the implementation of EudraVigilance in 2005, with 23 national competent authorities and 105 marketing authorisation holders reporting electronically to the EudraVigilance Post-Authorisation Module (EVPM).
Maltese: Sar progress tajjeb bl-implimentazzjoni ta' l-EudraVigilance fl-2005, bi 23 awtorità nazzjonali kompetenti u 105 detenturi ta' awtorizzazzjoni għat-tqegħid fis-suq jirrapportaw b'mod elettroniku lillEudraVigilance Post-Authorisation Module (Modulu ta' l-EudraViġilanza għall-wara lAwtorizzazzjoni) (EVPM).
English: 3.2 Medicines for veterinary use 3.2.1 Scientific advice
Maltese: 3.2 Mediċini għal użu veterinarju 3.2.1 Parir xjentifiku
English: The number of issued certificates continued to increase, and certificate number 100,000 was issued (for an AIDS product) in August 2005.
Maltese: In-numru taċ-ċertifikati maħruġa kompla jiżdied u ċ-ċertifikat numru 100,000 nħareġ (għal prodott għall-AIDS) f'Awwissu 2005.
English: Applications are submitted directly to the EMEA.
Maltese: L-applikazzjonijiet huma ppreżentati direttament lill-EMEA.
English: Building and equipment-related expenditure (including EU telematics)
Maltese: Infiq relatat mal-bini u ma' l-apparat (inkluż telematici ta' l-UE)
English: Electronic reporting into the EudraVigilance database became mandatory in November 2005.
Maltese: F'Novembru 2005, ir-rappurtaġġ elettroniku fil-bażi tad-data EudraVigilance sar mandatorju.
English: The Year 2005 was a very promising beginning for the second decade of the EMEA.
Maltese: Is-Sena 2005 kienet bidu ferm promettenti għat-tieni deċennju ta' l-EMEA.
English: Designated orphan medicinal products.
Maltese: Prodotti klassifikati bħala mediċini orfni.
English: Personnel management
Maltese: Amministrazzjoni tal-personal
English: Several class-labelling procedures were performed for HIV products.
Maltese: Ġew imwettqa bosta proċeduri ta' ttikkettjar tal-klassi għal prodotti kontra l-HIV.
English: Submitted
Maltese: Sottomessi
English: Applications received 2003-2005
Maltese: Applikazzjonijiet ircevuti 2003-2005
English: Number of inspections 2003-2005
Maltese: Numru ta' spezzjonijiet 2003-2005
English: Withdrawals
Maltese: Irtirar
English: Of these 24 products, 3 are designated orphan medicinal products.
Maltese: Minn dawn l-24 prodott, 3 huma prodotti klassifikati bħala mediċini orfni.
English: Orphan drug fund
Maltese: Fond tad-drogi orfni
English: In 2005, the EMEA received and validated 3 new applications for maximum residue limits (MRLs).
Maltese: Fl-2005, l-EMEA rċeviet u vvalidat 3 applikazzjonijiet ġodda għal-limiti massimi ta' residwi (MRLs).
English: The full annual report 2005 in English can be found on the Agency's website: www.emea.eu.int
Maltese: Ir-rapport annwali sħiħ għall-2005 bl-Ingliż jinsab fuq il-websajt ta' l-Aġenzija: www.emea.eu.int
English: A number of meetings were held with companies ahead of possible future applications.
Maltese: Saru numru ta' laqgħat mal-kumpaniji fid-dawl tal-possibilità ta' applikazzjonijiet futuri.
English: Line-extension applications Type-II variation applications Type-I variation applications
Maltese: Applikazzjonijiet ghal estensjoni tal-linja Applikazzjonijiet ghal varjazzjoni tat-Tip II Applikazzjonijiet ghal varjazzjoni tat-Tip I
English: 5.3 Sampling and testing
Maltese: 5.3 Teħid ta' kampjuni u ttestjar
English: The EMEA coordinated and managed requests for 98 good manufacturing practice (GMP) and plasma master file inspections, 14 good clinical practice (GCP) and pharmacovigilance inspections, and 2 good laboratory practice (GLP) inspections during 2005, representing a total increase of 23% relative to 2004.
Maltese: Matul l-2005, l-EMEA kkoordinat u amministrat talbiet għal 98 spezzjonijiet tal-prattika tajba ta' manifattura (GMP - Good Manufacturing Practice) u tal-master file tal-plażma, 14-il spezzjoni talprattika klinika tajba (GCP - Good Clinical Practice) u tal-farmakoviġilanza u 2 tal-prattika tajba tallaboratorju (GLP - Good Laboratory Practice)), li jirrappreżentaw żieda totali ta' 23% meta mqabbel ma' l-2004.
English: 3.1 Medicines for human use 3.1.1 Orphan designation
Maltese: 3.1 Mediċini għall-użu tal-bniedem 3.1.1 Klassifikar bħala mediċini orfni
English: These stakeholders reported electronically a total of 144,786 individual case safety reports (ICSRs) originating from within and outside the EU.
Maltese: Dawn il-parteċipanti rrappurtaw b'mod elettroniku total ta' 144,786 rapport dwar is-sigurtà ta' każijiet individwali (ICSRs - Individual Case Safety Reports) li oriġinaw kemm fi ħdan l-UE kif ukoll minn barra l-UE.
English: Meeting four times in 2005, the EMEA Management Board:
Maltese: Fl-erba' laqgħat tiegħu matul l-2005, il-Bord ta' Tmexxija ta' l-EMEA:
English: The Committee for Orphan Medicinal Products (COMP) adopted 88 positive opinions on designation of orphan medicines in 2005 - the highest number since the entry into force of EU legislation on orphan medicines (Regulation (EC) No 141/2000) in 2000.
Maltese: Il-Kumitat dwar Prodotti Mediċinali Orfni (COMP) adotta 88 opinjoni pożittiva għall-ikklassifikar ta' mediċini orfni fl-2005 - l-akbar numru mid-dħul fis-seħħ tal-leġiżlazzjoni ta' l-UE dwar mediċini orfni (Regolament (KE) Nru 141/2000) fl-2000.
English: This led to a doubling of parallel distribution notifications submitted to the EMEA in 2005.
Maltese: Dan wassal għal irduppjar tan-notifiki ta' distribuzzjoni parallela sottomessi lill-EMEA fl-2005.
English: Working through the EMEA/CHMP Working Group with Patients' and Consumers' Organisations (the Agency's platform for interaction with patients and consumers), a set of recommendations was published in March 2005 relating to: transparency and dissemination of information; product information; pharmacovigilance; and interaction between the EMEA and patients' organisations.
Maltese: Permezz ta' xogħol li sar bejn il-Grupp ta' Ħidma ta' l-EMEA/CHMP u l-Organizzazzjonijiet talPazjenti u tal-Konsumaturi (il-pjattaforma ta' l-aġenzija għall-interazzjoni mal-pazjenti u lkonsumaturi), f'Marzu 2005, ġew ippubblikati sett ta' rakkomandazzjonijiet li għandhom x'jaqsmu mat-trasparenza u t-tixrid ta' l-informazzjoni; l-informazzjoni dwar il-prodotti; il-farmakoviġilanza; u l-interazzjoni bejn l-EMEA u l-organizzazzjonijiet tal-pazjenti.
English: The CVMP launched a public consultation for a number of guidelines proposing the adaptation of data requirements for the testing of veterinary medicines for minor uses and minor species regarding quality, safety, including maximum residue limits (MRLs), and efficacy, while ensuring public health.
Maltese: Il-CVMP nieda konsultazzjoni pubblika fuq numru ta' linji gwida li jipproponu l-addattament tarrekwiżiti tad-data għall-ittestjar tal-mediċini veterinarji għal użu minuri u għal speċi minuri fuq ilkwalità, is-sigurtà, inkluż il-limitu massimu ta' residwi (MRLs), u l-effikaċja, waqt li tiġi żgurata ssaħħa pubblika.
English: Basic EU and EEA contribution
Maltese: Kontribuzzjoni bażika ta' l-UE u taż-ŻEE
English: Thereof, 73,198 ICSRs were received electronically for CAPs corresponding to 80% of the total adverse reaction reports received for CAPs in 2005.
Maltese: Minn dawn, 73,198 ICSR daħlu b'mod elettroniku għal prodotti awtorizzati b'mod ċentrali (CAPs) li jikkorrispondu għal 80% mir-rapporti totali li daħlu għal CAPs fl-2005 dwar reazzjonijiet mhux mixtieqa għall-mediċini.
English: Initiatives in the areas of risk detection, risk assessment, risk minimisation and risk communication
Maltese: Inizjattivi fl-oqsma ta' l-intraċċar tar-riskju, tal-valutazzjoni tar-riskju, tal-minimizzazzjoni tarriskju u tal-komunikazzjoni tar-riskju.
English: The new CHMP Working Party on Similar Biological Medicinal Products was established in 2005.
Maltese: Il-Grupp ta' Ħidma tal-CHMP dwar Prodotti Mediċinali Bijoloġiċi Simili (Working Party on Similar Biological Medicinal Products) ġie mwaqqaf fl-2005.
English: Working with national competent authorities
Maltese: Ħidma ma' l-awtoritajiet nazzjonali kompetenti
English: In November 2005, the MRFG was replaced by the ‘Coordination Group for Mutual Recognition and Decentralised Procedures-Human', or ‘CMD(h)' and the VMRFG was replaced by the ‘Coordination Group for Mutual Recognition and Decentralised Procedures-Veterinary', or ‘CMD(v)'.
Maltese: F'Novembru 2005, l-MRFG ġie sostitwit bil-'Grupp ta' Koordinazzjoni għall-Proċedura għarRikonoxximent Reċiproku u għall-Proċedura Deċentralizzata - tal-Bniedem, jew ‘CMD(h)' u lVMRFG ġie sostitwit bil-'Grupp ta' Koordinazzjoni għall-Proċedura għar-Rikonoxximent Reċiproku u għall-Proċedura Deċentralizzata - Veterinarju' jew ‘CMD(v)'.
English: Opinions in 2005 The CHMP adopted 24 positive opinions and 1 negative opinion in 2005 on products intended for the European market.
Maltese: Opinjonijiet fl-2005 Il-CHMP adotta 24 opinjoni pożittiva u opinjoni negattiva waħda fl-2005 dwar prodotti maħsubin għas-suq Ewropew.
English: The EMEA provided full secretariat and administrative support to the work of the two coordination groups.
Maltese: L-EMEA ipprovdiet sostenn segretarjali u amministrattiv sħiħ għax-xogħol taż-żewġ gruppi ta' koordinazzjoni.
English: Strengthening interaction with patients' and consumers' organisations
Maltese: Tisħiħ ta' l-interazzjoni ma' l-organizzazzjonijiet tal-pazjenti u tal-konsumaturi
English: Public health impact of opinions in 2005 Of the medicinal products intended for the European market for which a positive opinion was adopted: 2 are for use in cancer therapy, including the treatment of lung cancer - one of the highest causes of cancer-related deaths in the EU 7 are anti-infectives, of which 2 are for the treatment of HIV and AIDS 4 are for the treatment of metabolic disorders, of which 1 offers a new route of administration for diabetes patients by allowing insulin to be delivered via the lungs 5 are for the treatment of diseases of the central nervous system and sensory organs 6 are for the diagnosis or treatment of cardiovascular or pulmonary diseases.
Maltese: 2 huma għall-użu fil-kura tal-kanċer, inkluż il-kura tal-kanċer tal-pulmun - waħda mill-ogħla kawżi ta' mewt relatata mal-kanċer fl-UE 7 huma kontra l-infezzjonijiet, li minnhom 2 huma għall-kura ta' l-HIV u ta' l-AIDS 4 huma għall-kura ta' problemi metaboliċi; wieħed minnhom joffri rotta ġdida ta' amministrazzjoni għal pazjenti li jbagħtu mid-dijabete billi l-insulina titwassal minn ġol-pulmun 5 huma għall-kura ta' mard tas-sistema nervuża ċentrali u ta' l-organi sensorjali 6 huma għad-djanjożi jew kura ta' mard kardjovaskulari jew tal-pulmun.
English: Among the 5 positive opinions were: 1 for a third-generation cephalosporin used to treat bacterial infections in pigs 1 for a novel combination endoparasiticide to treat roundworms and tapeworms in cats 3 vaccines for horses, against equine influenza and tetanus.
Maltese: Fost il-5 opinjonijiet pożittivi kien hemm: 1 għal cephalosporin tat-tielet ġenerazzjoni wżat għall-kura ta' infezzjonijiet batteriċi fil-ħnieżer 1 għal endoparasitiċida f'kombinazzjoni ġdida għall-kura ta' dud (roundworms) u dud ċatt (tapeworms) fil-qtates 3 vaċċini għaż-żwiemel, kontra l-influwenza u t-tetnu ta' l-ekwini.
English: Contributions were made to the Innovative Medicines Initiative (IMI), the development of the European Technology Platform on Global Animal Health (ETPGAH), and the establishment of priorities for rare diseases.
Maltese: Saru kontribuzzjonijiet għall-Inizjattiva għal Mediċini Innovattivi (IMI), għall-iżvilupp talPjattaforma Teknoloġika Ewropea dwar is-Saħħa Globali ta' l-Annimali (ETPGAH), (European Technology Platform on Global Animal Health) u għall-istabbiliment ta' prijoritajiet għal mard rari.
English: Dealing with R&D bottlenecks
Maltese: It-trattament ta' dewmien fir-riċerka u l-iżvilupp
English: Following the entry into force of new ‘Regulations and Rules applicable to officials and other servants of the European Communities', the EMEA prepared a series of implementing rules for adoption by the Management Board.
Maltese: Wara d-dħul fis-seħħ ta' ‘Regulations and Rules applicable to officials and other servants of the European Communities' (Regolamenti u Regoli applikabbli għall-uffiċjali u ħaddiema oħra talKomunitajiet Ewropej) ġodda, l-EMEA ħejjiet serje ta' regoli implimentattivi sabiex jiġu adottati millBord ta' Tmexxija.
English: 3.1.2 Scientific advice and protocol assistance
Maltese: 3.1.2 Parir xjentifiku u għajnuna għall-protokoll
English: 2 IMPLEMENTATION OF THE ROAD MAP
Maltese: INTRODUZZJONI MID-DIRETTUR EŻEKUTTIV
English: Eight applications for extension of a marketing authorisation were received: 6 related to pharmaceuticals and 2 to immunologicals.
Maltese: Waslu tmien applikazzjonijiet għal estensjoni ta' awtorizzazzjoni għat-tqegħid fis-suq: 6 kellhom x'jaqsmu ma' farmaċewtiċi u 2 ma' sustanzi immunoloġiċi.
English: To further improve the management of translations, the Management Board adopted a revised EMEA translation policy in September 2005.
Maltese: Sabiex tiġi mtejba aktar l-amministrazzjoni tat-traduzzjonijiet, il-Bord tat-Tmexxija adotta politika riveduta ta' l-EMEA dwar it-traduzzjoni f'Settembru 2005.
English: In addition, 67 sponsors conducting clinical trials within the European Economic Area (EEA) were reporting suspected unexpected serious adverse reactions (SUSARs) to the EudraVigilance Clinical Trial Module (EVCTM).
Maltese: Barra minn hekk, 67 sponsor li għamlu provi kliniċi fiż-Żona Ekonomika Ewropea (ŻEE) kienu qegħdin jirrapportaw reazzjonijiet suspettati serji mhux mixtieqa u mhux mistennija (SUSARs) filEudraVigilance Clinical Trial Module (EVCTM) (Modulu tal-Provi Kliniċi ta' l-EudraViġilanza).
English: The evaluation period for the pandemic variation is then expected to be very short, typically less than one week.
Maltese: Il-perjodu ta' valutazzjoni talvarjazzjoni pandemika huwa mistenni li jkun qasir ħafna, normalment inqas minn ġimgħa.