qanastek/EMEA-V3 huggingface dataset:
The regulatory and scientific consistency of scientific committees (CHMP and CVMP) opinions and assessment reports, and their quality, will be further improved.
Il - konsistenza 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.
In addition, the Agency will encourage marketing-authorisation holders to request pre-submission meetings to streamline the submission and review of line-extension and variation applications, thus facilitating the availability of new indications and pharmaceutical forms.
Barra minn hekk, l - Aġenzija ser tħeġġeġ lid- detenturi ta 'l- awtorizzazzjoni għal tqegħid fis- suq biex jitolbu laqgħat ta' qabel is- sottomissjoni sabiex iħaffu l- proċess ta 'sottomissjoni u reviżjoni ta' applikazzjonijiet għal estensjoni tal- linja u varjazzjoni, biex b' hekk tiġi ffaċilitata d- disponibbiltà ta 'indikazzjonijiet u forom farmaċewtiċi ġodda.
Applications received/ forecast Applications received/ forecast (veterinary medicines) (human medicines)
Applikazzjonijiet ircevuti/ mbassra Applikazzjonijiet ircevuti/ mbassra (medicini veterinarji) (medicini ghall- bniedem) 12 325 2006
258
252 258
235
235 265 325
325
5
Type-II (quality) variations Line extensions
Varjazzjonijiet tat- tip IA Varjazzjonijiet tat- tip II (kwalità) Estensjoni tal- linji
Type-II (clinical) variations
Varjazzjonijiet tat- tip IB Varjazzjonijiet tat- tip II (klinici)
Type-I variation applications Line-extension applications
Applikazzjonijiet ghal estensjoni tal- linji Applikazzjonijiet ghal varjazzjoni tat- tip II Applikazzjonijiet ghal varjazzjoni tat- tip I
Parallel distribution
Distribuzzjoni parallela
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).
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).
The number of parallel-distribution notifications is forecast to increase by a further 14% in 2006, reaching 750.
L- għadd ta 'notifiki ta' distribuzzjoni paralleli huwa mbassar li ser ikompli jiżdied b' 14% fl- 2006, biex b' hekk jilħaq 750.
However, despite the mandatory nature of the notification procedure, compliance is still considered to be an issue, and the forecast will be closely monitored.
Madanakollu, minkejja n- natura obbligatorja tal- proċedura ta 'notifika, il- konformità xorta waħda titqies li hija kwistjoni importanti, u t- tbassir ser jiġi sorveljat mill- qrib.
Summary of the EMEA work programme 2006 EMEA/ 62913/ 2006 Parallel-distribution notifications validated (Input)
Ġabra fil- qosor tal- programm ta 'ħidma ta' l- EMEA 2006
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Safety of medicines
Sigurtà tal- mediċini
Monitoring the safety of medicines for human and veterinary use is a priority area for the EMEA.
Is- sorveljanza tas- sigurtà tal- mediċini għall- użu tal- bniedem u veterinarju hija qasam ta 'prijorità għall- EMEA.
The related processes undergo continuous evaluation and improvement, with the close cooperation of the national competent authorities.
Il- proċessi relatati issirilhom valutazzjoni u titjib kontinwu, b' kooperazzjoni mill - qrib ma 'l- awtoritajiet kompetenti nazzjonali.
In the area of medicines for human use, the Agency will focus on fully integrating the new legislative requirements relating to pharmacovigilance into its processes, alongside further development and implementation of the European risk-management strategy.
Fil- qasam tal- mediċini għall- użu tal- bniedem, l- Aġenzija ser tiffoka fuq l- integrazzjoni sħiħa tar - rekwiżiti leġiżlattivi l- ġodda relatati mal- farmakoviġilanza fil- proċessi tagħha, flimkien ma 'l - iżvilupp u l- implimentazzjoni ulterjuri ta' l- istrateġija Ewropea ta 'ġestjoni tar- riskju.
The novel concept of risk-management plans (RMPs) introduced by the new legislation will require adequate evaluation, both in the pre- and post-authorisation phases.
Il- kunċett ġdid ta 'pjanijiet ta' ġestjoni tar- riskju (RMPs) li ddaħħal mill- leġiżlazzjoni l- ġdida ser jeħtieġlu valutazzjoni adegwata, fil- fażijiet kemm ta 'qabel kif ukoll ta' wara l- awtorizzazzjoni.
The workload on RMPs will be considerable in the post-authorisation phase, taking into account the need for updates of RMPs agreed at the time of authorisation.
L - ammont ta 'xogħol marbut mar- RMPs ser ikun konsiderevoli fil- fażi ta' wara l- awtorizzazzjoni, meta titqies il- ħtieġa għal aġġornamenti ta 'RMPs miftiehma fiż- żmien li tingħata l - awtorizzazzjoni.
In addition, reviews of RMPs (including risk-minimisation measures and other pharmacovigilance activities) to identify known and potential risks with the medicinal product will be required for some variations and line extensions which result in a significant change in a marketing authorisation.
Barra minn hekk, ser ikunu meħtieġa reviżjonijiet ta 'l- RMPs (inklużi miżuri għall- imminimizzar tar- riskju u attivitajiet oħra ta' farmakoviġilanza) sabiex jiġu identifikati r - riskji magħrufa u potenzjali marbuta mal- prodott mediċinali għal xi varjazzjonijiet u estensjonijiet tal- linja li jwasslu għal bidla sinifikanti f' awtorizzazzjoni għal tqegħid fis- suq.
Existing procedures (such as the CHMP handling of safety concerns for centrally processed applications) will be revised to effectively incorporate the concept of RMPs in the evaluation process.
Il - proċeduri eżistenti (bħat- trattament mill- CHMP ta 'tħassib dwar is- sigurtà għal applikazzjonijiet ipproċessati ċentralment) ser jiġu riveduti sabiex jiġi inkorporat b' mod effettiv il- kunċett ta' l - RMPs fil- proċess ta 'valutazzjoni.
The most appropriate involvement of specialised expertise in the various processes will have to be carefully considered during such revision.
L- involviment l- aktar xieraq tal- ħila esperta speċjalizzata għandu jiġi kkunsidrat bir- reqqa matul din ir- reviżjoni.
Further development of the European risk-management strategy will target the implementation of the new legislation, complementary implementation initiatives (in the fields of risk detection, risk assessment, risk minimisation and risk communication, and in insufficiently developed fields of pharmacovigilance such as paediatrics and vaccines) and further strengthening of the EU pharmacovigilance system.
L- iżvilupp ulterjuri ta 'l- istrateġija Ewropea ta' ġestjoni tar- riskju ser jimmira lejn l - implimentazzjoni tal- leġiżlazzjoni l- ġdida, inizzjattivi kumplimentari ta 'implimentazzjoni (fl - oqsma tas- sejba tar- riskju, valutazzjoni tar- riskju u komunikazzjoni tar- riskju, u f' oqsma li m' humiex żviluppati biżżejjed tal- farmakoviġilanza bħall- pedjatrija u t- tilqim) u t- tisħiħ ulterjuri tas- sistema ta' farmakoviġilanza ta 'l- UE.
This should result in a more intensive drug-monitoring system.
Dan għandu jwassal għal sistema ta 'sorveljanza tal - mediċini aktar intensiva.
A two- year rolling work plan on the detailed initiatives to be undertaken up to mid 2007 has been established.
Ġie stabbilit pjan ta 'ħidma kontinwu fuq medda ta' sentejn dwar l - inizzjattivi dettaljati li għandhom jittieħdu sa nofs l- 2007.
Further development of the EudraVigilance system (comprising an electronic database and data- processing network for adverse drug reactions) is paramount to the successful implementation of the strategy and will, therefore, remain at the top of the Agency’ s agenda in the field of safety of medicines.
L- iżvilupp ulterjuri tas- sistema EudraVigilance (li tinkludi bażi tad- data elettroniku u netwerk ta 'l- ipproċessar tad- data għar- reazzjonijiet mhux mixtieqa għall- mediċini) huwa essenzjali għall - implimentazzjoni ta' l- istrateġija b' suċċess. u għaldaqstant ser jibqa 'minn ta' fuq nett fuq l- aġenda ta 'l- Aġenzja fil- qasam tas- sigurtà tal- mediċini.
The Agency expects that all national competent authorities will be reporting electronically to the EudraVigilance system by the end of 2006, which is reflected in the forecast increase of electronic reports in the chart below.
L- Aġenzija tistenna li l- awtoritajiet kompetenti nazzjonali kollha ser jibdew jirrapportaw elettronikament lis- sistema EudraVigilance sat- tmiem ta 'l- 2006, li hija riflessa fiż- żjieda ta' rapporti elettroniċi mbassra fil- grafika li tinsab hawn taħt.
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.
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.
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Actual and estimated numbers of ICSR
Numru attwali u stmat ta 'l- ICSR (Individual
concerning centrally authorised products (Human medicines) 50,000 50,500
Case Safety Reports) dwar prodotti awtorizzati centralment (Medicini ghall- bniedem)
concerning non-centrally authorised products (Human medicines) 72,000
72, 000
144,000
144, 000
41,000 20,500
20, 500 20, 074
5,000
9, 887
35,000
5, 000
65,000
35, 000
95,000 5,000 35,000 65,000
65, 000
95,000 125,000 155,000
95, 000
EU reports
5, 000
Non-EU reports EU reports
35, 000
Non-EU reports
65, 000
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.
L- emfażi kontinwa fuq is- sigurtà tal- mediċini veterinarji fil- fażi ta 'wara l- awtorizzazzjoni u l - ħtieġa 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.
Following the full switch to electronic reporting of adverse drug reactions (ADRs) to veterinary medicines for all Member States in 2005, a number of activities relating to further training and the provision of assistance to Member States and industry will be required.
Wara l- qalba għal rapportaġġ elettroniku ta 'reazzjonijiet mhux mixtieqa (ADRs – Adverse Drug Reactions) għal mediċini veterinarji fl- Istati Membri kollha fl- 2005, għadd ta' attivitajiet relatati mat- taħriġ ulterjuri u l- għoti ta 'għajnuna lill- Istati Membri u l- industrija ser ikunu meħtieġa.
Furthermore, in order to identify safety signals, the EMEA will have to provide assistance to Member States on the import of product-related data and analysis of pharmacovigilance data.
Barra minn hekk, sabiex jiġu identifikati s- sinjali tas- sigurtà, l- EMEA ikollha tagħti għajnuna lill - Istati Membri dwar l- importazzjoni ta 'data relatata mal- prodott u l- analiżi ta' data tal - farmakoviġilanza.
In addition, the Agency will collaborate fully and work with the Member States ’ veterinary regulatory authorities in the European Surveillance System to foster a joint approach to optimising efficiency in EU veterinary pharmacovigilance for all medicinal products authorised in the Community.
Barra minn hekk, l- Aġenzija ser tikkollabora bis- sħiħ u taħdem ma 'l- awtoritajiet regolatorji veterinarji ta' l- Istati Membri fi ħdan is- Sistema ta 'Sorveljanza Ewropea sabiex trawwem strateġija konġunta għat- titjib ta' l- effiċjenza fil- farmakoviġilanza veterinarja ta 'l- UE għall - prodotti mediċinali kollha awtorizzati fil- Komunità.
With the need to meet the Agency’ s obligations to provide more transparent veterinary pharmacovigilance reporting and communication to the outside world, as explicitly stated in the new Regulation, a considerable increase in data analysis with EudraVigilance and subsequent reporting is expected.
Minħabba l- ħtieġa li jiġu sodisfatti l- obbligi ta 'l- Aġenzija li tipprovdi rapportaġġ u kommunikazzjoni tal- farmakoviġilanza veterinarja aktar trasparenti lid- dinja barranija, kif huwa ddikjarat espliċitament fir- Regolament il- ġdid, hija mistennija żjieda konsiderevoli fl- analiżi tad - data bl- EudraVigilance u r- rapportaġġ sussegwenti.
The Agency will continue to improve on its communication to the public and encourage a reporting culture through its collaborative efforts with interested parties and the Member States.
L- Aġenzija ser tkompli ttejjeb il - komunikazzjoni tagħha mal- pubbliku u tħeġġeġ kultura ta 'rapportaġġ permezz ta' l- isforzi kollaborattivi tagħha mal- partijiet interessati u ma 'l- Istati Membri.
Periodic safety update reports (Human medicines)
Rapporti perjodici ta 'aggornament dwar is- sigurtà (Medicini ghall- bniedem)
Periodic safety update reports (Veterinary medicines)
Rapporti perjodici ta 'aggornament dwar is- sigurtà (Medicini veterinarji)
Arbitrations and referrals
Arbitraġġ u riferenzi
In the area of arbitrations and Community referrals relating to medicines for human use, the Agency will concentrate on two goals in 2006.
Fil- qasam ta 'l- arbitraġġi u riferenzi Komunitarji relatati mal- mediċini għall- użu tal- bniedem, l - Aġenzija ser tikkonċentra fuq żewġ għanijiet fl- 2006.
Summary of the EMEA work programme 2006 EMEA/ 62913/ 2006
L- ewwel għan ser jinkludi l- introduzzjoni Ġabra fil- qosor tal- programm ta 'ħidma ta' l- EMEA 2006
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initiation of the referral procedure and adoption of the Committee’ s opinion.
ta 'aktar titjib fill- proċeduri ta' riferenzi li għandhom x' jaqsmu mas- sigurtà tal- mediċini, sabiex jitqassar iż- żmien bejn il- bidu tal- proċedura ta ’ riferenza u l- adozzjoni ta 'l- opinjoni tal- Kumitat.
This is in line with the Agency’ s priorities in the area of safety of medicinal products.
Dan huwa konformi mal- prijoritajiet ta 'l- Aġenzija fil- qasam tas- sigurtà tal- prodotti mediċinali.
The second goal is to effectively manage arbitrations and referrals.
It- tieni għan huwa li jitmexxew b' mod effettiv l- arbitraġġi u r- riferenzi.
The Agency will also establish a framework and tools for evaluation of referral and arbitration procedures relating to traditional herbal medicinal products.
L- Aġenzija ser tistabbilixxi wkoll qafas u għodda għall- valutazzjoni ta 'proċeduri ta' riferenza u ta 'arbitraġġ relatati ma' prodotti mediċinali tradizzjonali magħmula mill- ħxejjex.
Taking into account the change in the legislation regarding automatic referrals and the development of lists of medicinal products for which a harmonised summary of product characteristics (SPC) should be drawn up, an increase in arbitrations/ referrals for both human and veterinary medicines is expected.
Meta wieħed iqis il- bidliet fil- leġiżlazzjoni fir- rigward tar- riferenzi awtomatiċi u l- iżvilupp ta 'listi ta' prodotti mediċinali li għalihom għandhom jinkitbu ġabriet fil- qosor tal- karatteristiċi tal - prodott (SPC – Summary of Product Characteristics) b' mod armonizzat, hija mistennija żjieda fl - arbitraġġi/ riferenzi għall- mediċini kemm għall- bniedem kif ukoll dawk veterinarji.
Arbitration and Community referrals to EMEA (Veterinary medicines)
Arbitragg u riferenzi Komunitarji lill - Arbitragg u riferenzi Komunitarji lill - EMEA (Medicini veterinarji) EMEA (Medicini ghall- bniedem)
30 0 2
30
Herbal medicinal products for human use
Prodotti mediċinali magħmula mill- ħxejjex għall- użu tal- bniedem
The Agency will continue its work to fully implement recent Community legislation on herbal medicinal products and to provide Member States and EU institutions with the best-possible scientific opinion on questions relating to herbal medicinal products.
L- Aġenzija ser tkompli l- ħidma tagħha biex timplimenta b' mod sħiħ il- leġiżlazzjoni riċenti tal - Komunità dwar prodotti mediċinali magħmula mill- ħxejjex u biex tipprovdi lill- Istati Membri u lill- istituzzjonijiet ta 'l- UE bl- aħjar opinjonijiet xjentifiċi possibbli dwar kwistjonijiet relatati ma' prodotti mediċinali magħmula mill- ħxejjex.
As an important element of the harmonised approach to the scientific assessment of herbal medicinal products in the EU, the Committee on Herbal Medicinal Products (HMPC) will pay particular attention in 2006 to establishing Community herbal monographs, as well as to preparing entries to the draft list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products.
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 għall - abbozz ta' elenku ta 'sustanzi u tħejjijiet mill- ħxejjex u taħlit tagħhom għall- użu fi prodotti mediċinali tradizzjonali magħmula mill- ħxejjex.
In addition, the HMPC will continue its work on updating the guidance for the content of applications to register the traditional medicinal use of herbal medicinal products.
Barra minn hekk, l- HMPC ser ikompli l- ħidma tiegħu biex jaġġorna l- gwida dwar il- kontenut ta 'l- applikazzjonijiet biex jiġi rreġistrat l- użu mediċinali tradizzjonali ta' prodotti mediċinali magħmula mill- ħxejjex.
Coordination groups for mutual-recognition and decentralised procedures (human and veterinary products)
Gruppi ta 'koordinazzjoni għar- rikonoxximent reċiproku u proċeduri deċentralizzati (prodotti għall- bniedem u veterinarji)
The year 2006 is the first full year of operation of the Coordination Groups for Mutual-Recognition and Decentralised Procedures (CMDs) established by the new Community legislation.
Is- sena 2006 hija l- ewwel sena sħiħa ta 'ħidma tal- Gruppi ta' Koordinazzjoni għar- Rikonoxximent Reċiproku u l- Proċeduri Deċentralizzati (CMDs) mwaqqfa taħt il- leġiżlazzjoni l- ġdida tal - Komunità.
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.
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; il - provvediment 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 il - programmi ta 'ħidma tagħhom; assistenza biex tingħata għajnuna regolatorja u legali lill - attivitajiet 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.
Summary of the EMEA work EMEA/ 62913/ 2006 Chapter 3
Ġabra fil- qosor tal- programm ta 'ħidma ta' l- EMEA 2006 EMEA/ 145694/ 2006 Kapitolu 3
©EMEA 2006
Spezzjonijiet
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Inspections
Spezzjonijiet
The Agency expects the number of inspections to remain stable in 2006.
L- Aġenzija qed tistenna li l- għadd ta 'spezzjonijiet jibqa' stabbli fl- 2006.
During the year, the Agency will complete its implementation of legislative and procedural requirements in the area of good manufacturing practice (GMP) for active substances and certain excipients.
Matul is- sena, l - Aġenzija ser tlesti l- implimentazzjoni tagħha ta 'rekwiżiti leġiżlattivi u proċedurali fil- qasam ta' prattika tajba ta 'manifattura (GMP – Good Manufacturing Practice) għal sustanzi attivi u ċerti eċċipjenti.
It will also roll out the first production version of the EU-wide database on manufacturing authorisations and GMP certificates.
Hija ser toħroġ ukoll l- ewwel verżjoni għall- produzzjoni tal- bażi tad- data dwar awtorizzazzjonijiet għall- manifattura u ċertifikati tal- GMP li jkopri l- UE kollha.
The EMEA will contribute to international harmonisation discussions on quality systems and implementation of quality risk-management and pharmaceutical development.
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.
The EMEA will liaise with EU medicines-enforcement officers on their work to investigate the incidence of counterfeit medicines.
L- EMEA ser taħdem fil- qrib ma 'l- uffiċjali ta' l- infurzar tal- mediċini ta 'l- UE fil- ħidma tagħhom biex jinvestigaw l- inċidenza ta' mediċini foloz.
Number of inspections
Numru ta 'spezzjonijiet
Good laboratory practice Good clinical practice (including pharmacovigilance) GMP (including PMF)
Prattika tajba tal- laboratorju Prattika klinika tajba (inkluż farmakovigilanza) GMP (inkluż PMF)
The Agency will also continue to support implementation of the clinical trials directive and will further develop relevant procedures and guidelines, and support the operation and further development of the clinical trials database.
L- Aġenzija ser tkompli tappoġġa l- implimentazzjoni tad- direttiva dwar il- provi kliniċi u ser tkompli tiżviluppa l- proċeduri u l- linji gwida relevanti, u tappoġġa t- tħaddim u l- iżvilupp ulterjuri tal- bażi tad- data dwar il- provi kliniċi.
The Agency ’ s inspection-related working parties will: harmonise inspection procedures and processes, in particular those relating to inspections of active substances and to pharmacovigilance; develop guidelines in light of the requirements of Community legislation on clinical trials and blood; and continue to work on GMP guidelines on products used as gene and cell therapies.
Il- gruppi ta 'ħidma ta' l- Aġenzija relatati ma 'l- ispezzjonijiet ser: jarmonizzaw il- proċeduri u l - proċessi ta' l- ispezzjonijiet, b' mod partikolari dawk relatati ma 'spezzjonijiet ta' sustanzi attivi u mal- farmakoviġilanza; jiżviluppaw linji ta 'gwida fid- dawl tar- rekwiżiti tal- leġiżlazzjoni tal - Komunità dwar provi kliniċi u d- demm; u jkomplu jaħdmu fuq linji ta' gwida tal- GMP dwar prodotti użati għal terapija ġenetika u dik ċellulari.
In order to rationalise dossier requirements, the Joint CHMP/ CVMP Quality Working Party will review assessment experiences and existing guidelines.
Sabiex jiġu razzjonalizzati r- rekwiżiti tad- dossier, il- Grupp ta 'Ħidma Konġunt tal- CHMP/ CVMP dwar il- Kwalità ser jirrevedi l- esperjenzi tal- valutazzjoni u l- linji gwida eżistenti.
Innovation and continual improvement in the context of manufacturing and control methods will be facilitated through the work of the Process Analytical Technology (PAT) team.
L- innovazzjoni u t- titjib kontinwu fil- kuntest tal- metodi ta 'manifattura u kontroll ser jiġu ffaċilitati permezz tal- ħidma tat- tîm tat- Teknoloġija Analitika tal- Proċess (Process Analytical Technology - PAT).
National competent authorities are expected to complete the remaining internal evaluation work and follow-up with new Member States in the context of the EC-Canada mutual-recognition agreement.
L- awtoritajiet kompetenti nazzjonali huma mistennija li jlestu x- xogħol li fadal ta 'valutazzjoni interna u x- xogħol li jiġi wara ma' l- Istati Membri fil- kuntest tal- ftehim ta 'rikonoxximent reċiproku bejn il- KE u l- Kanada.
The Agency also expects good progress on external evaluations carried out by Canada by the end of the year.
L- Aġenzija qed tistenna wkoll li jsir progress tajjeb fir- rigward tal- valutazzjonijiet esterni mwettqa mill- Kanada sa tmiem is- sena.
Summary of the EMEA work programme 2006 EMEA/ 62913/ 2006 of charge to small and medium-sized enterprises will
Ġabra fil- qosor tal- programm ta 'ħidma ta' l- EMEA 2006 EMEA/ 145694/ 2006 Ċertifikati ta 'prodotti mediċinali
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to work on rationalisation of the process and will follow up on the removal of the legalisation step formerly performed by the European Commission.
B' mod
Certificate requests
Talbiet ghal certifikati
Sampling and testing
Teħid ta 'kampjuni u ttestjar
The sampling and testing programme for centrally authorised products will continue in 2006, using the expertise of the EEA’ s network of official medicines-control laboratories, enabling the quality of medicinal products on the market in the EEA to be controlled.
Il- programm ta 'teħid ta' kampjuni u ttestjar għal prodotti awtorizzati ċentralment ser ikompli fl - 2006, u ser juża l- ħila esperta tan- netwerk taż- ŻEE ta 'laboratorji uffiċjali għall- kontroll tal - mediċini, sabiex b' hekk tkun tista' tiġi kkontrollata l- kwalità tal- prodotti mediċinali fuq is- suq fiż - ŻEE.
Close collaboration between the EMEA, the European Directorate for the Quality of Medicines and the national authorities in this programme continues to prove invaluable in assuring effective and continued post-marketing surveillance of the quality of medicines.
Il- kollaborazzjoni mill- qrib bejn l- EMEA, id- Direttorat Ewropew għall- Kwalità tal - Mediċini u l- awtoritajiet nazzjonali f' dan il- programm tibqa 'tkun imprezzabbli sabiex tiġi żgurata sorveljanza effettiva u kontinwa tal- kwalità tal- mediċini wara li jitpoġġew fuq is- suq.
In 2006, the Agency will work with its partners to implement a new strategy for the testing of medicinal products, to accommodate a more risk-based approach to the selection of products for inclusion in annual testing programmes.
Fl- 2006, l - Aġenzija ser taħdem ma 'l- imsieħba tagħha biex timplimenta strateġija ġdida għall- ittestjar ta' prodotti mediċinali, sabiex jiġi sostnut approċċ li jkun iktar ibbażat fuq ir- riskju fl- għażla ta 'prodotti li jiddaħħlu fi programmi ta' testijiet annwali.
Summary of the EMEA work EMEA/ 62913/ 2006 Chapter 4
Ġabra fil- qosor tal- programm ta 'ħidma ta' l- EMEA 2006 EMEA/ 145694/ 2006 Kapitolu 4
programme 2006 EU telematics strategy
L- istrateġija telematika ta 'l- UE
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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.
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.
In 2006, development work on a number of EU telematics projects and sub-projects needs to be continued.
Fl- 2006, jeħtieġ li jitkompla x- xogħol ta 'żvilupp fuq għadd ta' proġetti u sottoproġetti ta 'telematika ta' l- UE.
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-information- management application, PIM, — will have to be operated, supported, maintained and further developed.
Fl- istess ħin, ħamsa mis- sistemi telematiċi ta 'l- UE — EudraNet, EudraVigilance, EudraCT, il- bażi tad- data ta' prodotti mediċinali awtorizzati fl- UE, u l - applikazzjoni għall- ġestjoni ta 'informazzjoni dwar il- prodott, PIM, — ser ikollhom jiġu mħaddma, sostnuti, mantnuti u żviluppati aktar.
The Agency will advance the work on the new database for GMP certificates and manufacturing authorisations, and will complete the construction of an EU telematics data centre with high availability, high scalability and good performance.
L- Aġenzija ser tmexxi 'l quddiem il- ħidma fuq il - bażi tad- data l- ġdid għaċ- ċertifikati tal- GMP u għall- awtorizzazzjonijiet għall- manifattura, u ser tlesti l- bini ta' ċentru ta 'data telematiku ta' l- UE b' disponibbiltà għolja, skalabilità għolja u prestazzjoni tajba.
The EU telematics programme is delivering improved communication and better access to data.
Il- programm ta 'telematika ta' l- UE qed jagħti komunikazzjoni mtejba u aċċess aħjar għad- data.
As the programme advances, the benefits, including those listed below, become more apparent
Hekk kif javvanza l- programm, il- benefiċċji, inklużi dawk elenkati hawn taħt, isiru aktar ċari
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.
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 fl - Ewropa 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.
The corresponding suite for veterinary medicines will be rolled out in September 2006.
Is- sett korrispondenti għal mediċini veterinarji ser jinħareġ f' Settembru 2006.
Two to three new upgrade versions of the main EudraVigilance application (7.1, 7.2, 7.3) will be released in the course of 2006.
Matul l- 2006 għandhom jinħarġu bejn tnejn u tlett verżjonijiet ġodda li jaġġornaw l - applikazzjoni ewlenija ta 'l- EudraVigilance (7. 1, 7. 2, 7. 3).
The database of authorised medicinal products in the EU will make authoritative, up-to-date information on all these products available to regulators, health professionals and the general public; while the current version of the application is already available to EU regulators, public access will be provided by September 2006.
Il- bażi tad- data ta 'prodotti mediċinali awtorizzati fl- UE ser ipoġġi għad- dispożizzjoni tar - regolaturi, tal- professjonisti tal- kura tas- saħħa u tal- pubbliku ġenerali informazzjoni awtorevoli u aġġornata dwar dawn il- prodotti kollha; fil- waqt li l- verżjoni preżenti hija diġà disponibbli għar- regolaturi ta' l- UE, ser jingħata aċċess pubbliku sa Settembru 2006.
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.
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.
Information on nationally authorised products may be included for those Member States who have provided their product data and signed a memorandum of understanding on data exchange and maintenance.
Informazzjoni dwar prodotti awtorizzati nazzjonalment tista 'tiġi inkluża għal dawk l- Istati Membri li pprovdew id- data dwar prodotti tagħhom u li ffirmaw memorandum ta' ftehim dwar il- bdil u l- manutenzjoni tad- data.
By the end of the year, advanced query facilities will be provided.
Sa tmiem is- sena, ser jiġu pprovduti faċilitajiet avvanzati għat- tfiċċija ta ’ informazzjoni.
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).
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 'l - UE 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).
The first production version of EudraGMP will be ready for use in the third quarter of 2006.
L- ewwel verżjoni għall- produzzjoni ta 'l- EudraGMP ser tkun lesta għall- użu fit- tielet kwart ta' l- 2006.
Subject to the outcome of the analysis of business processes, the EMEA will accept electronic- only submissions of applications for marketing authorisations in the eCTD format towards the end of the year.
B’ kundizzjoni tar- riżultati ta 'l- analiżi tal- proċessi tan- negozju, l- EMEA ser taċċetta biss sottomissjonijiet elettroniċi ta' applikazzjonijiet għall- awtorizzazzjonijiet għal tqegħid fis- suq fil- format eCTD lejn l- aħħar tas- sena.
New versions of the PIM light authoring and review tools will be released at the end of April.
Verżjonijiet ġodda ta 'l- għodda ta' kitba u ta 'reviżjoni PIM ser jinħarġu lejn it- tmiem ta' April.
Secure and reliable communication within the EU regulatory network is assured through EudraNet and the infrastructure supporting the systems.
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.
Summary of the EMEA work EMEA/ 62913/ 2006 Chapter 5
Ġabra fil- qosor tal- programm ta 'ħidma ta' l- EMEA 2006 EMEA/ 145694/ 2006 Kapitolu 5
programme 2006 Support activities
Attivitajiet ta 'sostenn
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Information technology
Teknoloġija ta 'l- informatika
In addition to the maintenance and operational support of corporate and EU telematics applications — and the development of new EU telematics projects — the Agency’ s efforts and resources in the IT area will be applied to the operation, support, maintenance and development of a number of corporate and business-continuity projects.
Minbarra l- manutenzjoni u l- appoġġ għat- tħaddim ta 'l- applikazzjonijiet telematiċi korporattivi u ta' l- UE - u l- iżvilupp ta 'proġetti telematiċi ġodda ta' l- UE - l- isforzi u r- riżorsi ta 'l- Aġenzija fil - qasam ta' l- IT ser jiġu applikati għat- tħaddim, l- apoġġ, il- manutenzjoni u l- iżvilupp ta 'għadd ta' proġetti korporattivi u ta 'kontinwità tan- negozju.
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.
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.
The Agency will progress its work on IP telephony, web-streaming, video-streaming and other audiovisual-meetings systems, to support the Agency’ s objectives in the area of meetings- management.
L- Aġenzija ser tmexxi 'l quddiem il- ħidma tagħha dwar it- telefonija IP, il- web- streaming, il - video- streaming u sistemi oħra ta' laqgħat awdjoviżivi, biex tappoġġa l- għanijiet ta 'l- Aġenzija fil - qasam tal- ġestjoni tal- laqgħat.
The Agency may also need to implement the changeover to the newly created “ europa. eu ” domain for websites and e-mail addresses to meet the requirement of the European Parliament and Council Regulation.
L- Aġenzija jista 'jkollha bżonn ukoll timplimenta bidla għad - domain “ europa. eu ” li għadu kif inħoloq dan l- aħħar għal websajts u indirizzi ta' l- email sabiex tintlaħaq il- ħtieġa tar- Regolament tal- Parlament Ewropew u tal- Kunsill.
Development of corporate applications will concentrate on the completion of phase III of the Meetings Management System (end of March), the continuing update of the corporate product database and tracking system SIAMED to include provisions of the new medicines legislation, and its migration to a different technical platform, and further work on a number of smaller systems such as the contracts database.
L- iżvilupp ta 'applikazzjonijiet korporattivi ser jikkonċentra fuq it- tlestija tal- fażi III tas- Sistema ta' Ġestjoni tal- Laqgħat (tmiem ta 'Marzu), l- aġġornament kontinwu tal- bażi tad- data tal- prodotti u sistema ta' intraċċar korporattiv SIAMED sabiex jinkludu dispożizzjonijiet tal- leġiżlazzjoni l - ġdida dwar il- mediċini, u l- migrazzjoni tagħha għal pjattaforma teknika differenti, u aktar xogħol fuq għadd ta 'sistemi iżgħar bħal- bażi tad- data tal- kuntratti.
The existing business-continuity arrangements will be improved to support a range of disaster- recovery scenarios.
L- arranġamenti eżistenti tal- kontinwità tan- negozju ser jiġu mtejba sabiex jingħata appoġġ lil firxa ta 'xenarji ta' rkupru f' każ ta 'diżastru.
The Agency’ s work in the infrastructure area is directly linked to the increased number of meetings, visitors to the Agency, telecommunications activities and staff.
Il- ħidma ta 'l- Aġenzija fil- qasam ta' l- infrastruttura hija marbuta direttament maż- żjieda fl- għadd ta 'laqgħat, viżitaturi lejn l- Aġenzija, attivitajiet ta' telekomunikazzjoni u l- personal.
The Agency plans to undertake a major refurbishment project to increase meeting facilities for the Agency’ s scientific committees and working groups, following entry into force of the new legislation.
L- Aġenzija qed tippjana li twettaq proġett kbir ta 'rranġar biex iżżid il- faċilitajiet ta' laqgħat għall- kumitati xjentifiċi u l- gruppi ta 'ħidma ta' l- Aġenzija, wara d- dħul fis- seħħ tal- leġiżlazzjoni l- ġdida.
Taking into account further changes of the Agency’ s regulatory and legal environment, the Agency will develop a strategy for any future expansion and reorganisation of its offices.
Waqt li tikkunsidra l- bidliet ulterjuri fl- ambjent regolatorju u legali tagħha, l- Aġenzija ser tiżviluppa strateġija għal kull espansjoni u reorganizzazzjoni fil- futur ta 'l- uffiċċji tagħha.
The Agency will conduct exercises and continually test its business-continuity plan, to ensure its proper functioning.
L- Aġenzija ser tmexxi eżerċizzji u tittestja b' mod kontinwu l- pjan ta 'kontinwità tan- negozju tagħha, sabiex jiġi żgurat li jaħdem sew.
Number of visits to the Agency
Numru ta 'zjarat fl- Agenzija
25,551
25, 551
20,000
20, 000
40,000
40, 000
Summary of the EMEA work programme 2006 EMEA/ 62913/ 2006 Meetings at the EMEA
Ġabra fil- qosor tal- programm ta 'ħidma ta' l- EMEA 2006 EMEA/ 145694/ 2006 Laqgħat fi ħdan l- EMEA
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Meeting forecasts for 2006 again point to a significant increase in the number of meetings and delegate-days.
It- tbassir ta 'laqgħat għall- 2006 għal darb' oħra juri żjieda sinifikanti fl- għadd ta' laqgħat u t- tul tagħhom.
The number of meetings is forecast to increase by 5% and the number of reimbursed delegates by 33%.
L- għadd ta 'laqgħat huwa mbassar li ser jiżdied b' 5% u l- għadd ta' delegati rimborsati bi 33%.
Given this significant growth in activity, the Agency will develop its meetings-management system to make online booking facilities available to delegates, thereby increasing the efficiency and effectiveness of this process.
Minħabba t- tkabbir sinifikanti fl- attività tagħha, l- Aġenzija ser tiżviluppa s- sistema tagħha ta 'ġestjoni tal- laqgħat sabiex faċilitajiet ta' prenotazzjoni online ikunu disponibbli għad- delegati, biex b' hekk jiżdiedu l- effiċjenza u l- effettività ta 'dan il- proċess.
Existing facilities and services for videoconferencing over the Internet will be extended and improved.
Il- faċilitajiet u servizzi eżistenti għall- vidjokonferenzi fuq l- Internet ser jiġu estiżi u mtejba.
A pilot project for the introduction of Internet telephony (voice over IP) will be started.
Ser jinbeda proġett pilota għall- introduzzjoni tat- telefonija bl- Internet (voice over IP).
A pilot exercise for web meetings will run during the first half of 2006 to examine the potential benefits of this approach.
Eżerċizzju pilota għal laqgħat fuq il- web ser jinbeda matul l- ewwel nofs ta 'l- 2006 sabiex jiġu eżaminati l - benefiċċji potenzjali ta' dan il- metodu.
The Agency will implement procedures for the organisation of emergency meetings.
L- Aġenzija ser timplimenta proċeduri għall- organizzazzjoni ta 'laqgħat ta' emerġenza.
The Agency will be able to organise meetings within 24 hours, on any day of the week.
L- Aġenzija ser tkun tista 'torganizza laqgħat fi żmien 24 siegħa, f' kull jum tal- ġimgħa.
A need for this type of meeting may emerge, for example, in the event of a pandemic-influenza outbreak.
Jista 'jinqala' l- bżonn għal laqgħat ta 'dan it- tip, per eżempju f' każ illi tfaqqa' xi influwenza pandemika.
Number of videoconferences and reimbursed meetings
Numru ta 'vidjokonferenzi u ta' laqghat rimborsati
Number of reimbursed delegates
Numru ta 'delegati rimborsati
5,925
5, 925
Document management and publishing
Ġestjoni u pubblikazzjoni ta 'dokumenti
The Agency will continue upgrading its electronic document management system, as this forms the bedrock for effective publishing of core business information to the Web interface, and will undertake the necessary development of records management (including retention policies) and mail registration.
L- Aġenzija ser tkompli ttejjeb is- sistema eletronnika għall- ġestjoni ta 'dokumenti tagħha, billi din hija s- sisien tal- pubblikazzjoni effettiva ta' informazzjoni importanti dwar il- ħidma tagħha fuq il - Web, u ser twettaq l- iżvilupp meħtieġ fil- ġestjoni ta 'rekords (inkluża l- politika tagħha dwar żamma) u r- reġistrazzjoni ta' posta.
The European Commission has issued new regulations on transparency and will be reviewing European copyright laws.
Il- Kummissjoni Ewropea ħarġet regolamenti ġodda dwar it- trasparenza u ser tirrevedi l- liġijiet Ewropej dwar id- drittijiet ta 'l- awtur.
This comes in response to heightened public awareness and a subsequent demand for the re-use of information.
Dan ser isir b' reazzjoni għall- kuxjenza pubblika akbar u d - domanda sussegwenti għall- użu mill- ġdid ta 'informazzjoni.
The Agency therefore needs to revisit its policy on access to documents and related copyright issues.
L- Aġenzija għalhekk teħtieġ li teżamina mill- ġdid il- politika tagħha dwar aċċess għal dokumenti u kwistjonijiet oħrajn relatati mad- drittijiet ta 'l- awtur.
As part of the Agency’ s mission to provide information to interested parties, the Agency will work to improve the quality of translations.
Bħala parti mill- missjoni ta 'l- Aġenzija li tipprovdi informazzjoni lill- partijiet interessati, l - Aġenzija ser taħdem biex ittejjeb il- kwalità tat- traduzzjonijiet.
To that effect, the EMEA will investigate translation memory, with the attendant requirement for the development of a translation-terminology database.
Għal dan il- għan, l- EMEA ser tistħarreġ dwar memorja tat- traduzzjoni, bil- ħtieġa konsegwenti li tiżviluppa bażi tad- data ta 'terminoloġija għat- traduzzjonijiet.
Summary of the EMEA work programme 2006 EMEA/ 62913/ 2006 Annexes 1.
Ġabra fil- qosor tal- programm ta 'ħidma ta' l- EMEA 2006 EMEA/ 145694/ 2006 Annessi 1.
EMEA structure
Organigramma ta 'l- EMEA
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EMEA establishment plan 2004-2006
Pjan ta 'stabbiliment ta' l- EMEA 2004- 2006
Revenue and expenditure overview 2004-2006
Ħarsa ġenerali lejn id- dħul u l- infiq 2004- 2006
Management Board and scientific committee meeting dates in 2006
Dati ta 'laqgħat tal- Bord ta ’ Tmexxija u l- kumitati xjentifiċi fl- 2006
EMEA contact points
Punti ta ’ kuntatt fl- EMEA
Summary of the EMEA work programme 2006 EMEA/ 62913/ 2006 Annex 1 EMEA structure
Ġabra fil- qosor tal- programm ta 'ħidma ta' l- EMEA 2006 EMEA/ 145694/ 2006 Anness 1 Organigramma ta 'l- EMEA
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MANAGEMENT BOARD MANAGEMENT BOARD Chairman:
BORD TA ’ TMEXXIJA MANAGEMENT BOARD Chairman:
EXECUTIVE DIRECTOR EXECUTIVE DIRECTOR Thomas Lönngren Thomas Lönngren
DIRETTUR EZEKUTTIV EXECUTIVE DIRECTOR Thomas Lönngren Thomas Lönngren
Executive support Integrated quality management and audit Legal sector
Sostenn ezekuttiv Verifika u gestjoni integrata tal- kwalità Settur legali
ADMINISTRATION
AMMINISTRAZZJONI
PRE--AUTHORISATION PREAUTHORISATION EVALUATION OF
PRE- AUTHORISATION QABEL
POST-AUTHORISATION POST-AUTHORISATION
POST- AUTHORISATION L- AWTORIZZAZZJONI TA ’
EVALUATION OF MEDICINES FOR
KOMUNIKAZZJONIJIET
MEDICINES FOR
MEDICINI GHALL- UZU
MEDICINES FOR
U SPEZZJONIJIET
HUMAN USE
U NETWERKING
MEDICINES FOR
MEDICINES FOR TAL- BNIEDEM
AndreasPott
HUMAN USE
HUMAN USE HUMAN USE
Andreas Pott
Head:
Kap:
AndreasPott
Patrick Le Courtois
PatrickLe Courtois Head:
Noëlël Wathion Head:
No Wathion
AndreasPott
Hans Wagner
Affarijiet regolatorji u
Personnel and budget
Personal u bagit
Scientific advice and orphan drugs
Parir xjentifiku u medicini ltiema
Regulatory affairs and organisational support Pharmacovigilance and post -
sostenn ta ’ l- organizzazzjoni Farmakovigilanza u -
Veterinary marketing authorisation procedures
Proceduri ta ’ awtorizzazzjoni veterinarja ghal tqeghid fis - suq
Document management and publishing
pubblikazzjoni
Infrastructure services
Servizzi ta ’ l- infrastruttura
Quality of medicines
Kwalità tal- medicini
authorisation safety and efficacy of medicines
sigurtà u effikacja wara l - Awtorizzazzjon tal - medicini
Safety of veterinary medicines
Sigurtà ta ’ medicini veterinariji
Meeting management and conferences
Gestjoni ta ’ laqghat u konferenzi
Accounting
Kontabilità
Safety and efficacy of medicines
Sigurtà u effikacja tal- medicini
Medical information
Informazzjoni medika
Project management
Gestjoni ta ’ progetti
Information technology
Teknologija ta ’ l- informatika
Committee for
ghal Prodotti
Committee for Committee for
ghal Prodotti
Committee on Herbal Committee on Herbal
Kumitat ghal Prodotti Committee for
Committee for Committee for
Committee on Herbal
Orphan Medicinal
Medicinali Ltiema
Orphan Medicinal Products
Medicinali ghall- Uzu
Medicinal Products Medicinal Products
Medicinali maghmula
Medicinal Products Medicinal Products
Medicinali ghall- Uzu Medicinal Products
Medicinal Products Medicinal Products
Veterinarju for Veterinary Use
Products Chairman:
Products Chairman:
for Veterinary Use for Veterinary Use
Torrent Farnell
Chairman:
Konstantin
TorrentFarnell
Chairman:
Konstantin Keller Konstantin Keller
Keller
NATIONAL COMPETENT AUTHORITIES NATIONAL COMPETENT AUTHORITIES 3,500 EUROPEAN EXPERTS 3,500 EUROPEAN EXPERTS
AWTORITAJIET NAZZJONALI KOMPETENTI NATIONAL COMPETENT AUTHORITIES 3, 500 ESPERT EWROPEW 3, 500 EUROPEAN EXPERTS
EUROPEAN UNION INSTITUTIONS EUROPEAN UNION INSTITUTIONS
ISTITUZZJONIJIET TA ’ L- UNJONI EWROPEA EUROPEAN UNION INSTITUTIONS
Summary of the EMEA work programme 2006 EMEA/ 62913/ 2006 Annex 2 EMEA establishment plan 2004-2006 (until 30 April 2006)
Ġabra fil- qosor tal- programm ta 'ħidma ta' l- EMEA 2006 EMEA/ 145694/ 2006 Anness 2 Pjan ta 'stabbiliment ta' l- EMEA 2004- 2006 (sat- 30 ta 'April 2006)
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Category & Grade
Kategorija u Grad
TEMPORARY POSTS
KARIGI TEMPORANJI
Occupied as per 31.12.04
Awtorizzati għall -
A*16 A*15 A*14 A*13 A*12 A*11 A*10 A*9 A*8 A*7 A*6 A*5 Total grade A B*11 B*10 B*9 B*8 B*7 B*6 B*5 B*4 B*3 Total grade B C*7 C*6 C*5 C*4 C*3 C*2 C*1 Total grade C D*5 D*4 D*3 D*2 Total grade D Total Staff
Total grad A B* 11 B* 10 B* 9 B* 8 B* 7 B* 6 B* 5 B* 4 B* 3 Total grad B C* 7 C* 6 C* 5 C* 4 C* 3 C* 2 C* 1 Total grad Ċ D* 5 D* 4 D* 3 D* 2 Total grad D
1 As authorised by the Budgetary Authority and adjusted by the Management Board on 15 December 2005.
1 Kif awtorizzati mill- Awtorità tal- Baġit u aġġustati mill- Bord ta ’ Tmexxija fil- 15 ta 'Diċembru 2005.
Summary of the EMEA work programme 2006 EMEA/ 62913/ 2006 (as from 1 May 2006)
Ġabra fil- qosor tal- programm ta 'ħidma ta' l- EMEA 2006 EMEA/ 145694/ 2006 (mill- 1 ta 'Mejju 2006)
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AD 9
Total grad AD AST 11 AST 10 AST 9 AST 8 AST 7 AST 6 AST 5 AST 4 AST 3 AST 2 AST 1 Total grad AST
11
150 - 6 - 8 11 31 33 50 11 - - 150
195 - 6 - 10 12 31 32 51 19 2 21 184 379
195 - 6 - 10 12 31 32 51 19 2 21 184
213 - 6 2 10 14 30 32 54 23 10 30 211 424
213 - 6 2 10 14 30 32 54 23 10 30 211
2 As authorised by the Budgetary Authority and adjusted by the Management Board on 15 December 2005.
2 Kif awtorizzati mill- Awtorità tal- Baġit u aġġustati mill- Bord Amministrattiv fil- 15 ta 'Diċembru 2005.