qanastek/EMEA-V3 huggingface dataset:
Insurance against accidents and occupational disease
Assigurazzjoni kontra inċidenti u mard fuq ix- xogħol
Staff Regulations of officials of the European Communities, and in particular Article 73 thereof and Article 15 of Annex VIII thereto.
15 ta 'l - Anness VIII magħhom.
This appropriation is intended to cover the Agency's contribution towards insurance against accidents and occupational diseases and the supplementary expenditure arising from the application of the statutory provisions in this area.
Din l- approprjazzjoni hija maħsuba sabiex tkopri l - kontribuzzjoni ta 'l- Aġenzija għal- assigurazzjoni kontra inċidenti u mard fuq ix- xogħol u l- infiq supplimentari li jirriżulta mill - applikazzjoni tad- dispożizzjonijiet statutorji f' dan il- qasam.
Unemployment insurance for staff
Assigurazzjoni għall- personal li jsib ruħhu bla xogħol
Conditions of employment of other servants of the European Union, and in particular Art.
Kundizzjonijiet ta ’ impjieg ta ’ ħaddiema oħra ta ’ l- Unjoni Ewropea, u b’ mod partikolari l- Art.
28a and 96 thereof.
28 a u 96 tagħhom.
This appropriation covers the cost of unemployment insurance for relevant staff.
Din l- approprjazzjoni tkopri l- ispiża ta ’ l- assigurazzjoni kontra l - qgħad għall- personal relevanti.
Accumulation or maintenance of pension rights for staff
L- Akkumulazzjoni jew iż- żamma ta 'drittijiet ta' pensjoni
Conditions of employment of other servants of the European Communities and in particular Article 42 thereof.
0. — Il- Kondizzjonijiet ta 'l- impieg ta' impjegati o ħra tal- Komunitajiet Ewropej u b' mod partikolari l- Artikolu 42 tagħhom.
This appropriation covers payments by the Agency to accumulate or maintain pension rights for relevant staff in their country of origin.
Din l- approprjazzjoni tkopri ħlasijiet mill- A ġenzija sabiex jiġu akkumulati jew jinżammu d- drittijiet ta 'pensjoni għal personal rilevanti fil- pajjiż ta' l- ori ġini tagħhom.
Article 1 8 3 — Total
Artikolu 1 8 3 — Total
CHAPTER 1 8 — TOTAL
KAPITOLU 1 8 — Total
2
59, 840, 000
BUILDINGS, EQUIPMENT AND MISCELLANEOUS OPERATING EXPENDITURE
49, 871, 051. 61
Title 1 — Total
Titolu
64,360,000
L- INFIQ
59,840,000
Intestatura
49,871,051.61
Krediti 2009
20
Krediti 2008
INVESTMENTS IN IMMOVABLE
Riżultat 2007
PROPERTY, RENTING OF BUILDINGS AND ASSOCIATED COSTS 200
2 BINI, TAGĦMIR U NFIQ MIXXELLANJU GĦAT- TĦADDIM 20 INVESTIMENTI FI PROPRJETÀ IMMOBBLI, IL- KIRI TA 'BINI U SPEJJEŻ ASSOĊJATI 200
Rent
Kera
This appropriation is intended to cover the payment of rents relating to occupied buildings or part of buildings and the renting of storerooms, garages, off-site storage and parking facilities.
Din l- approprjazzjoni hija maħsuba sabiex tkopri l- ħlas ta 'kera għal bini jew parti minn bini okkupat u l- kiri ta' kmamar għall - ħażna, garaxxijiet u faċilitajiet ta 'parkeġġ.
Insurance
Assigurazzjoni
This appropriation is intended to cover the payment of insurance premiums on the buildings or parts of buildings occupied by the Agency, as well as for contents, civil liability and professional liability.
Din l- approprjazzjoni hija maħsuba sabiex tkopri l- ħlas ta 'premiums ta' assigurazzjoni fuq il- bini jew partijiet mill- bini okkupati mill- Aġenzija kif ukoll għall- kontenut, ir- responsabbiltà ċivili u responsabbiltà professjonali.
Water, gas, electricity and heating
Ilma, gass, elettriku u sħana
This appropriation is intended to cover water, gas, electricity and heating costs.
Din l- approprjazzjoni hija maħsuba sabiex tkopri spejjeż ta 'ilma, gass, elettriku u sħana.
Maintenance and cleaning
Manutenzjoni u tindif
This appropriation is intended to cover maintenance costs for premises, lifts, central heating, air-conditioning equipment, etc.; the expenditure occasioned by regular cleaning operations, the purchase of maintenance, washing, laundry and dry-cleaning products, etc. and by repainting, repairs and supplies.
Din l- approprjazzjoni hija maħsuba sabiex tkopri spejjeż ta 'manutenzjoni tal- post, liftijiet, sħana ċentralizzata, tagħmir għall- arja kondizzjonata, eċċ.; l- infiq dovut għal tindif regolari, ix- xiri ta' prodotti ta 'manutenzjoni, tindif, ħasil u dry cleaning eċċ. u żebgħa mill- ġdid, tiswijiet u fornituri.
It also covers purchase, rental and maintenance of plants.
Tkopri wkoll ix- xiri, il- kiri u l- manutenzjoni ta 'pjanti.
Fitting-out of premises
L- Armar tal- post
This appropriation is intended to cover the fitting-out of buildings, e. g. alterations to partitioning, alterations to technical installations and other specialist work on locks, electrical equipment, plumbing, painting, floor coverings, etc.
Din l- approprjazzjoni hija maħsuba sabiex tkopri l- armar ta 'bini, eż. tibdil fil- paravendi, tibdil fl- installazzjonijiet tekni ċi u xogħol speċjalizzat ieħor fuq serraturi, tagħmir ta' elettriku, plumbing, żebgħa, kisi ta 'artijiet, eċċ.
It also covers the necessary equipment.
Tkopri wkoll it- tagħmir neċessarju.
Security and surveillance of buildings
Sigurtà u sorveljanza ta 'bini
This appropriation is intended to cover various expenses concerned with the security of persons and buildings, especially contracts for the guarding of buildings, the purchase, the hire and the maintenance of security and fire-fighting equipment, the replacement of equipment for fire pickets and statutory inspection costs, including recurrent expenditure on, for instance, badges, access cards etc.
Din l- approprjazzjoni hija maħsuba sabiex tkopri l- ispejjeż varji fir- rigward tas- sigurtà ta 'persuni u bini, speċjalment kuntratti għas- sorveljanza ta' bini, ix- xiri, il- kiri u l- manutenzjoni ta 'tagħmir tas- sigurtà u għat- tifi tan- nar, is- sostituzzjoni ta' tagħmir għall- persuni responsabbli f' każ ta 'nar u spejjeż ta' ispezzjonijiet statutorji, inkluż infiq rikorrenti għal, per eżempju, badges, karti ta 'aċċess, eċċ.
It also covers technical assistance.
Tkopri wkoll assistenza teknika.
Other expenditure preliminary to construction or fitting-out of a building
Nfiq ieħor ta 'qabel il- kostruzzjoni jew l- armar ta' bini
This article is intended to cover the cost of the financial and technical consultancy fees prior to the acquisition and construction of buildings.
Dan l- artikolu huwa maħsub sabiex ikopri l- ispiża għal konsulenza finanzjarja u teknika qabel l- akkwist u l- kostruzzjoni ta 'bini.
It also covers technical assistance fees relating to major fitting-out operations for premises.
Ikopri wkoll miżati għal assistenza teknika relatati ma operazzjonijiet kbar għall- armar tal- post.
Other expenditure on buildings
Nfiq ieħor fuq bini
This appropriation covers expenditure on buildings not specifically provided for in the other articles of this chapter, in particular management fees for multiple-tenanted buildings, costs of surveys of premises and business premises rates.
Din l- approprijazzjoni hija ntiża sabiex tkopri spejjeż fuq bini li m’ hemmx previżjonijiet speċifiċi għalihom f’ artikoli oħra ta ’ dan il- kapitolu, b’ mod partikolari spejjeż ta ’ ġestjoni għal bini b’ diversi inkwilini, spejjeż għal kontrolli li jsiru fuq il- post u spejjeż relatati mas- servizzi pubbliċi ta ’ bini għal użu kummerċjali.
It also covers the cost of technical assistance.
Din tkopri wkoll spejjeż għal assistenza teknika.
CHAPTER 2 0 — TOTAL
KAPITOLU 2 0 — Total
21 EXPENDITURE ON DATA PROCESSING 211 Maintenance of computer networks and equipment 2110
21 NFIQ FUQ L- IPPROĊESSAR TAD- DATA 211 Il- Manutenzjoni ta 'networks u tagħmir tal- Kompjuters 2110
Purchases of new hardware for the operation of the Agency
Ix- Xiri ta 'hardware ġdid għall- operazzjoni ta' l- Aġenzija
This appropriation is intended to cover the procurement of computing and other similar electronic office equipment and hardware, including initial equipment with the Agency's standard software, necessary for normal operation.
Din l- approprjazzjoni hija maħsuba sabiex tkopri ix- xiri ta 'tagħmir u hardware tal- kompjuters u tagħmir simili eltettroniku ieħor ta' l- uffiċċju, inkluż tagħmir inizjali b' software standard ta 'l- EMEA, li huwa meħtieġ għall- operazzjoni normali ta' l - Aġenzija.
Purchase of new software for the operation of the Agency
Ix- Xiri ta 'software ġdid għall- operazzjoni ta' l- Aġenzija
This appropriation is intended to cover the procurement of program packages and software necessary for the normal operation of the Agency.
Din l- approprjazzjoni hija maħsuba sabiex tkopri x- xiri ta 'pakketti ta' programmazzjoni u software, li huma meħtieġa għall- operazzjoni normali ta 'l- Aġenzija.
Replacement of hardware and software for the operation of the Agency
Bdil ta 'hardware u ta' software għall - operazzjoni ta 'l- Aġenzija
0.— This appropriation is intended to cover the replacement of existing hardware, program packages and software necessary for the normal operation of the Agency.
0. — Din l- approprjazzjoni hija maħsuba sabiex tkopri l- bdil ta 'hardware, pakketti ta' programmazzjoni u software eżistenti, li huma meħtieġa għall- operazzjoni normali ta 'l- Aġenzija.
Hire of hardware and software for the operation of the Agency
Il- Kiri ta 'hardware u ta' software għall - operazzjoni ta 'l- Aġenzija
0.— This appropriation is intended to cover the hire or leasing of hardware and software necessary for the normal operation of the Agency, where purchase is either uneconomical or difficult because of budgetary restrictions.
0. — Din l- approprjazzjoni hija maħsuba sabiex tkopri l- kiri ta 'hardware u software, li huma meħtieġa għall- operazzjoni normali ta' l- Aġenzija, fejn ix- xiri jew mhuwiex ekonomiku jew huwa diffiċli minħabba restrizzjonijiet tal- budget.
Maintenance and repair of hardware and software for the operation of the Agency
Il- Manutenzjoni u t- tiswija ta 'hardware u
This appropriation covers expenditure on the maintenance and repair of hardware and software referred to in items 2 1 1 0 to 2 1 1 3.
ta 'software għall- operazzjoni ta' l - Aġenzija
It also includes helpdesk services for the operation of the Agency.
Tinkludi wkoll servizzi ta ’ helpdesk għat- tħaddim ta ’ l- Aġenzija.
Analysis, programming and technical assistance for the operation of the Agency
L- Analiżi, il- programmazzjoni u l - assistenza teknika għall- operazzjoni ta 'l - Aġenzija
This appropriation is intended to cover expenditure on outside staff and services, for analysis, programming and technical assistance necessary for the operation of the Agency.
Din l- approprjazzjoni hija maħsuba sabiex tkopri nfiq fuq personal u servizzi minn barra, għal analiżi, assistenza teknika u ta 'programmazzjoni, meħtieġa għall- operazzjoni ta' l - Aġenzija.
212
212 Networks u tagħmir tal- Kompjuters għal proġetti speċifikati
Purchases of new hardware for specified projects
Xiri ta 'hardware ġdid għal proġetti speċifikati
This appropriation is intended to cover the procurement of computing and other similar electronic office equipment and hardware, including initial equipment with the Agency's standard software for specified projects.
Din l- approprjazzjoni hija maħsuba sabiex tkopri ix- xiri ta 'tagħmir u hardware tal- kompjuters u tagħmir simili elettroniku ta' l- uffiċċju, inkluż tagħmir inizjali b' software standard ta 'l - EMEA għal proġetti speċifikati.
Purchase of new software for specified projects
Xiri ta 'software ġdid għall- operazzjoni ta' l- Aġenzija
This appropriation is intended to cover the procurement of programme packages and software for specified projects.
Din l- approprjazzjoni hija maħsuba sabiex tkopri x- xiri ta 'pakketti u software ta' programmazzjoni għal proġetti speċifikati.
Replacement of hardware and software for specified projects
Bdil ta 'hardware u ta' software għal proġetti speċifikati
This item is intended to cover the replacement of existing hardware, programme packages and software for specified projects.
Din l- approprjazzjoni hija maħsuba sabiex tkopri l- bdil ta 'hardware, pakketti ta' programmazzjoni u software eżistenti għal proġetti speċifikati.
Hire of hardware and software for specified projects
Il- Kiri ta 'hardware u ta' software għal proġetti speċifikati
0.— This item is intended to cover the hire or leasing of hardware of software for specified projects, where purchase is either uneconomical or difficult because of budgetary restrictions.
0. — Din l- approprjazzjoni hija maħsuba sabiex tkopri l- kiri ta 'hardware u software għal proġetti speċifikati, meta x- xiri jew mhuwiex ekonomiku jew huwa diffiċli minħabba restrizzjonijiet fuq il- budget.
Maintenance and repair of hardware and software for specified projects
Il- Manutenzjoni u t- tiswija ta 'hardware u ta' software għal proġetti speċifikati
This appropriation covers expenditure on the maintenance and repair of hardware and software referred to in items 2 1 2 0 to 2 1 2 3.
Din l- approprjazzjoni tkopri l- ispiża fuq il- manutenzjoni u t - tiswija ta ’ hardwer u softwer li hemm referenza għalihom fil - partiti 2 1 2 0 sa 2 1 2 3.
It also includes helpdesk services for specified projects.
Tinkludi wkoll servizzi ta ’ helpdesk għal proġetti speċifiċi.
Analysis, programming and technical assistance for specified projects
L- Analiżi, il- programmazzjoni u l - assistenza teknika għal proġetti speċifikati
This appropriation is intended to cover expenditure on outside staff and services, for analysis, programming and technical assistance for specified projects.
Din l- approprjazzjoni hija maħsuba sabiex tkopri nfiq fuq personal u servizzi minn barra, għal analiżi, programmazzjoni u assistenza teknika għal proġetti speċifikati.
Article 2 1 2 — Total
KAPITOLU 2 1 — Total
22
22 PROPRJETÀ MOBBLI U SPEJJEŻ ASSOĊJATI 220 Tagħmir tekniku u installazzjonijiet
New purchases of technical equipment and installations
Xiri ta 'tagħmir u installazzjonijiet tekniċi
This appropriation is intended to cover expenditure on audiovisual, reproduction, archive, library and interpreting equipment.
Din l- approprjazzjoni hija maħsuba sabiex tkopri nfiq fuq tagħmir awdjoviżiv, ta 'riproduzzjoni, ta' l- arkivju, tal- bibljoteka u ta 'interpretazzjoni.
It also covers installations and equipment for handicapped officials.
Ikopri wkoll installazzjonijiet u tagħmir għal persuni b' diżabilità.
Replacement of technical equipment and installations
Bdil ta 'tagħmir u installazzjonijiet tekniċi
This appropriation is intended to cover the replacement, in particular of audiovisual, reproduction, archive, library and interpreting equipment, namely booths, handsets and switching units for simultaneous interpreting facilities.
Din l- approprjazzjoni hija maħsuba sabiex tkopri l- bdil, b' mod partikolari ta 'tagħmir awdjovisiv, ta' riproduzzjoni, ta 'l- arkivju, tal- bibljoteka u ta' interpretazzjoni, bħal kabini, handsets u unitajiet ta 'kommutazzjoni għal faċilitajiet ta' interpretazzjoni simultanja.
It also covers the replacement of installations and equipment for handicapped persons.
Ikopri wkoll it- tibdil ta 'installazzjonijiet u ta' tag ħmir għal persuni b' diżabilità.
Hire of technical equipment and installations
Il- Kiri ta 'tagħmir u installazzjonijiet tekniċi
0.— This appropriation is intended to cover the hire of equipment whose purchase is either uneconomical or difficult because of budgetary restrictions.
0. — Din l- approprjazzjoni hija maħsuba sabiex tkopri l- kiri ta 'tagħmir li x- xiri tiegħu jew mhux eknomiku jew huwa diffiċli minħabba restrizzjonijiet fuq il- budget.
It also covers installations and equipment for handicapped persons.
Ikopri wkoll il- kiri ta 'installazzjonijiet u tag ħmir għal persuni b' diżabilità.
Lease, maintenance and repair of technical equipment and installations
Il- Kiri, il- manutenzjoni u t- tiswija ta 'tagħmir u installazzjonijiet tekniċi
This appropriation covers expenditure relating to the maintenance and repair of the equipment referred to in Items 2200 to 2201 and also, for instance, lease agreements for photocopying and other technical equipment as well as the costs for technical assistance and contracted service provision.
Din l- approprijazzjoni hija ntiża sabiex tkopri spejjeż relatati mal- manutenzjoni u t- tiswija ta ’ tagħmir msemmi fil- partiti 2200 sa 2201 kif ukoll, per eżempju, ftehim ta ’ twellija għall - fotokupjaġġ u tagħmir ieħor tekniku kif ukoll spejjeż għal assistenza teknika u provvista ta ’ servizzi b’ kuntratt.
It also covers the maintenance and repair of installations and equipment for handicapped persons.
Din tkopri wkoll il- manutenzjoni u t- tiswija ta ’ installazzjonijiet u tagħmir għal persuni b’ diżabilità.
1,315,000
Għamara
New purchases of furniture
Xiri ta 'għamara
This appropriation is intended to cover the purchase of office furniture and specialised furniture, including ergonomic furniture, shelving for archives etc.
Din l- approprjazzjoni hija maħsuba sabiex tkopri x- xiri ta 'għamara għall- uffiċċju u għamara speċjalizzata, inkluża għamara ergonomika, xkafef għall- arkivji, eċċ.
Replacement of furniture
Bdil ta 'għamara
This appropriation is intended to cover the replacement of worn-out and obsolete furniture.
Din l- approprjazzjoni hija maħsuba sabiex tkopri il- bdil ta 'għamara użata u antika.
Hire of furniture Maintenance, use and repair of furniture
Il- Kiri ta 'għamara
0.— This item is intended to cover the hiring of furniture.
0. — Din l- approprjazzjoni hija maħsuba sabiex tkopri l- kiri ta 'għamara.
0.— This appropriation is intended to cover furniture maintenance and repair costs.
0. — Din l- approprjazzjoni hija maħsuba sabiex tkopri l- ispejjeż ta 'manutenzjoni u ta' tiswija ta 'għamara.
220,000
Vetturi
New purchases of vehicles Replacement of vehicles
Xiri ta 'vetturi
deleted deleted
imħassar
This item is intended to cover new purchases of vehicles.
Din l- approprjazzjoni hija maħsuba sabiex tkopri xiri ta 'vetturi.
This item is intended to cover the replacement of vehicles which, during the year, reach a total mileage such as to justify replacement.
Din l- approprjazzjoni hija maħsuba sabiex tkopri l- bdil ta 'vetturi, li, tul is- sena jilħqu total f' mili li ji ġġustifika dan il- bdil.
Hire of vehicles
Kiri ta 'vetturi
This appropriation is intended to cover the costs of hiring cars for short or long periods.
Din l- approprjazzjoni hija maħsuba sabiex tkopri l- ispejjeż ta 'kiri ta' vetturi għal perjodi qosra jew twal.
Maintenance, use and repair of vehicles
l- użu u t- tiswija ta 'vetturi
This item is intended to cover the cost of maintaining, repairing and insuring official vehicles (fuel, lubricants, tyres, inner tubes, miscellaneous supplies, spare parts, tools, etc.).
Din l- approprjazzjoni hija maħsuba sabiex tkopri l- ispiża ta 'manutenzjoni, tiswija u assigurazzjoni ta' vetturi uffiċjali (karburant, lubrikanti, tyres, tubi interni, fornituri mixxellanji, spare parts, għodod, eċċ.).
225
225 Nfiq fuq dokumentazzjoni u bibljoteka
Library funds, purchase of books
Fondi għall- bibljoteka, xiri ta 'kotba
This appropriation is intended to cover the purchase of books, documents and other non-periodic publications and the updating of existing volumes required by Agency departments.
Din l- approprjazzjoni hija maħsuba sabiex tkopri x- xiri ta 'kotba, dokumenti u pubblikazzjonijiet oħra mhux perjodiċi u l - aġġornament ta' volumi ezistenti meħtieġa mid- dipartimenti ta 'l - Aġenzija.
Special library, documentation and reproduction equipment
Tagħmir speċjali tal- bibljoteka, ta 'dokumentazzjoni u ta' riproduzzjoni
0.— This item is intended to cover special library equipment (card indexes, shelving, catalogue units).
0. — Din l- approprjazzjoni hija maħsuba sabiex tkopri tagħmir speċjali tal- bibljoteka (indiċi bil- karti, xkafef, unitajiet ta 'katalogar).
Subscriptions to newspapers and periodicals
Abbonamenti għal gazzetti u perjodiċi
This appropriation is intended to cover the cost of subscriptions to newspapers, specialist periodicals, official journals, parliamentary papers, foreign trade statistics, various bulletins, on-line databases, other specialised publications and library services.
Din l- approprjazzjoni hija maħsuba sabiex tkopri l- ispiża ta 'abbonamenti għal gazzetti, perjodiċi speċjalizzati, ġurnali uffiċjali, dokumenti parlamentari, statistiċi ta' kummerċ barrani, bulettini varji, bażijiet tad- data online, pubblikazzjonijiet speċjalizzati oħra u servizzi tal- bibljoteka.
Article 2 2 5 — Total
Artikolu 2 2 5 — Total
Stationery and office supplies
Stationery u fornituri ta 'l- uffiċċju
This appropriation is intended to cover the cost of purchasing paper, envelopes, office supplies as well as supplies for reprographics and external printing.
Din l- approprjazzjoni hija maħsuba sabiex tkopri l- ispiża għax - xiri tal- karti, enveloppsijiet, fornituri ta 'l- uffi ċċju kif ukoll fornituri għar- riprografija u stampar estern.
Article 2 3 0 — Total Financial charges
Ħlasijiet finanzjarji
Bank charges
Ħlasijiet lill- bank
This appropriation is intended to cover bank charges (commission, agios, miscellaneous expenditure).
Din l- approprjazzjoni hija maħsuba sabiex tkopri ħlasijiet lill - bank (kummissjoni, aġġji, infiq mixxellanju).
Other financial charges Article 2 3 2 — Total Legal expenses
Ħlasijiet finanzjarji oħra Artikolu 2 3 2 — Total
Legal expenses
Spejjeż legali
This appropriation is intended to cover preliminary legal costs and the services of lawyers or other experts called in to advise the Agency.
Din l- approprjazzjoni hija maħsuba sabiex tkopri spejjeż legali tal- bidu u s- servizzi ta 'avukati jew esperti oħra msejħa sabiex jagħtu parir lill- Aġenzija.
It also covers costs awarded against the Agency by the Court of Justice, or other courts.
Tkopri wkoll spejjeż li l- A ġenzija jkollha tħallas fuq verdett tal - Qorti tal- Ġustizzja, jew ta 'Qrati oħra.
90,000
Danni
Damages Article 2 3 4 — Total Other operating expenditure
Artikolu 2 3 4 — Total
This appropriation is intended to cover expenses for damages.
Nfiq operazzjonali ieħor
Miscellaneous insurance
Assigurazzjoni mixxellanja
This appropriation covers various types of insurance (mission insurance, insurance for accountant, etc.).
Din l- approprijazzjoni hija ntiża sabiex tkopri diversi tipi ta ’ assigurazzjoni (assigurazzjoni għal missjonijiet, assigurazzjoni għal persuna inkarigata mill- kontabilità, eċċ.).
Departmental removals and associated handling
Ġarr dipartimentali u mmaniġġjar assoċjat
This appropriation is intended to cover departmental removals and regrouping and handling costs (reception, storage, placing) in respect of equipment, furniture and office supplies.
Din l- approprjazzjoni hija maħsuba sabiex tkopri spejjeż għal ġarr dipartimentali u ġbir mill- ġdid u spejjeż ta 'l- immaniġġjar (reċezzjoni, ħażna, tqegħid) fir- rigward ta' tagħmir, għamara u fornituri ta 'l- uffiċċju.
Archiving of documents
L- Arkivjar ta 'dokumenti
This appropriation is intended to cover the cost of charges relating to the handling and retrieval of documents in off-site storage areas and storage costs.
Din l- approprjazzjoni hija maħsuba sabiex tkopri l- ispiża ta 'ħlasijiet li jirrelataw ma l- immani ġġjar u t- tfittxija għal dokumenti f' imħażen li mhumiex fuq il- post u spejjeż tal- ħażna.
Business Continuity
Il- Kontinwità Kummerċjali
This appropriation covers all expenses relating to business continuity, such as costs for a recovery centre contract, business continuity planning and consultancy, testing and updating of the business continuity plan.
Din l- approprjazzjoni tkopri spejjeż li jirrelataw mal- kontinwit à kummerċjali, bħal spejjeż għal kuntratt għal ċentru ta 'rkupru, l - ippjanar u l- konsulenza għall- kontinwità kummerċjali, testing u aġġornament tal- pjan ta' kontinwità kummerċjali.
Other operating expenditure
Nfiq operazzjonali ieħor
This appropriation is intended to cover other administrative expenditure not separately provided for in other items.
Din l- approprjazzjoni hija maħsuba sabiex tkopri nfiq amministrattiv ieħor mhux previst separatament f' partiti oħra.
Article 2 3 5 — Total Publications
Pubblikazzjonijiet
Publications
Pubblikazzjonijiet
This appropriation covers publishing expenses not covered in Title 3, in particular expenses for the publication of the Agency's budget and amending budgets in the Official Journal of the European Union in compliance with Article 26 of the Agency's Financial Regulation.
Din l- approprjazzjoni tkopri spejjeż ta 'pubblikazzjoni mhux koperti fit- Titolu 3, b' mod partikolari spejjeż għall - pubblikazzjoni tal- budget ta' l- Aġenzija u budgets ta 'emenda fil - Ġurnal Uffiċjali ta' l- Unjoni Ewropea in konformità ma 'l- Artikolu 26 tar- Regolament Finanzjarju ta' l- Aġenzija.
24
24 ĦLASIJIET GĦALL- POSTA U TELEKOMUNIKAZZJONI 240 Ħlasijiet għall- posta u kunsinna 2400
Article 2 3 9 — Total CHAPTER 2 3 — TOTAL POSTAL CHARGES AND TELECOMMUNICATIONS
Ħlasijiet għall- posta u kunsinna
15,000 946,000
250, 000
15,000 896,000
250, 000
15,000.00 682,157.67
206, 106. 36
240
Din l- approprjazzjoni hija maħsuba sabiex tkopri nfiq fuq ħlasijiet għall- posta u ta 'kunsinna għal posta ordinarja, għar - rapporti u pubblikazzjonijiet, fuq pakketti postali u oħrajn mibgħuta bl- ajru, bil- baħar jew bil- ferrovija, u fuq il- posta interna ta' l- Aġenzija.
Postal and delivery charges
Artikolu 2 4 0 — Total
206,106.36
Telekomunikazzjoni
Telecommunication charges
Ħlasijiet għat- telekomunikazzjoni
This appropriation covers fixed rental costs, the cost of calls and messages, maintenance fees, repairs and maintenance of equipment, subscription charges, the cost of communications (telephone, telex, telegraph, television, audio- and videoconferencing, including data transmission) technical assistance and contracted service provision associated with telecommunications, switchboard and reception facilities.
Din l- approprjazzjoni hija ntiża sabiex tkopri spejjeż fissi tal - kera, spejjeż ta 'sejħiet u messaġġi, miżati ta ’ manutenzjoni, tiswijiet u manutenzjoni ta' tagħmir, piżijiet ta 'abbonamenti, spejjeż għall- komunikazzjoni (telefon, telex, telegrafija, televiżjoni, awdjo u vidjo konferenzi, inkluża t- trażmissjoni tad - data) assistenza teknika u provvista ta ’ servizzi b’ kuntratt assoċjati mat- telekomunikazzjonijiet, swiċċbords u faċilitajiet ta ’ riċevimenti.
It also covers the purchase of directories.
Din tkopri wkoll ix- xiri ta 'direttorji.
Telecommunications equipment
Tagħmir tat- telekomunikazzjoni
This appropriation is intended to cover expenditure on equipping buildings with telecommunications, notably purchase, hire, installation and maintenance of cabling.
Din l- approprjazzjoni hija maħsuba sabiex tkopri nfiq biex il- bini jintrama bil- mezzi ta 'telekomunikazzjoni, l- iktar ix- xiri, il- kiri, l - installazzjoni u l- manutenzjoni ta' cabling.
It also covers the purchase of mobile telephones and ancillary equipment as well as the cost of technical assistance.
Tkopri wkoll ix- xiri ta 'telefons ċellulari u tagħmir ieħor kif ukoll l - ispiża għall- assistenza teknika.
CHAPTER 2 4 — TOTAL
Artikolu 2 4 1 — Total
Meetings in general
Laqgħat in ġenerali
This appropriation is intended to cover travel, subsistence, and incidental expenses of external experts invited for meetings not directly connected with the implementation of the Agency's work programme.
Din l- approprjazzjoni hija maħsuba sabiex tkopri spejjeż ta 'l - ivvjaġġar, ta' l- għixien u dawk inċidentali ta 'esperti esterni mistiedna għall- laqgħat mhux direttament marbuta ma' l - implimentazzjoni tal- programm ta 'xogħol ta' l- Aġenzija.
It also covers the corresponding expenditure resulting from organising these meetings where they are not covered by the infrastructure.
Tkopri wkoll l- infiq relatat li jirriżulta mill- organizzazzjoni ta 'dawn il- laqgħat meta dawn ma jkunux koperti mill - infrastruttura.
Memberships to for a
Sħubijiet għal for a
This appropriation covers membership fees to fora for the exchange of experience.
Din l- approprjazzjoni tkopri l- miżati ta ’ sħubijiet għal fora għall - iskambju ta ’ l- esperjenza.
Article 2 5 0 — Total
Artikolu 2 5 0 — Total
CHAPTER 2 5 — TOTAL
KAPITOLU 2 5 — Total
OPERATING EXPENDITURE OPERATING EXPENDITURE Meetings
NFIQ OPERAZZJONALI NFIQ OPERAZZJONALI Laqgħat
Title 2 — Total
Titolu 2 — Total
Reimbursement of persons attending meetings
Ir- Rimbors ta 'persuni li jattendu laqgħat
This appropriation is intended to cover travel, subsistence, and incidental expenses of Members of the Management Board and Scientific Committees and their working parties and of experts invited to those Committees and working parties.
Din l- approprjazzjoni hija maħsuba sabiex tkopri l- ispejjeż ta 'l - ivvjaġġar, ta' l- għixien, u dawk inċidentali ta 'Membri tal- Bord ta' Tmexxija u Kumitati Xjentifiċi u l- gruppi tax- xogħol tagħhom u ta 'esperti mistiedna f' dawk il- Kumitati u gruppi tax- xogħol.
It also covers the corresponding expenditures resulting from organising these meetings where they are not covered by the existing infrastructure.
Tkopri wkoll l- infiq relatat ma l- organizzazzjoni ta 'dawn il - laqgħat meta dawn ma jkunux koperti mill- infrastruttura eżistenti.
Interpretation
Interpretazzjoni
This appropriation is intended to cover the fees and travel expenses of freelance interpreters and conference operators including the reimbursement of services provided by Commission interpreters, for all meetings connected with the implementation of the work programme.
Din l- approprjazzjoni hija maħsuba sabiex tkopri il- miżati u l - ispejjeż ta 'l- ivvjaġġar ta' interpreti freelance u operaturi ta 'konferenzi kif ukoll ir- rimbors ta' servizzi pprovduti minn interpreti tal- Kummissjoni, għal- laqħat kollha marbuta ma 'l - implimentazzjoni tal- programm ta' xogħol.
This appropriation is intended to cover the cost of catering services in respect of meetings.
Din l- approprjazzjoni hija maħsuba sabiex tkopri l- ispiża ta 'servizzi ta' catering fir- rigward ta 'laqgħat.
Other expenditure
Nfiq ieħor
0.— This appropriation covers other expenditure in relations to meetings including reprographic services, stationary and mail services.
0. — Din l- approprjazzjoni tkopri l- ispiża fir- rigward ta ’ laqgħat inkluż servizzi reprografiċi, kartolerija u servizzi postali.
Article 3 0 0 — Total
Artikolu 3 0 0 — Total
301 Evaluation of medicinal products 3010
301 Valutazzjoni ta 'prodotti mediċinali
Evaluation of medicinal products
Valutazzjoni ta 'prodotti mediċinali
This appropriation covers: - expenditure to Rapporteurs and Co-rapporteurs on specialised studies and consultations contracted out to highly qualified experts (individuals or firms), as provided for in Article 62(3) of Regulation (EC) No 726/2004; purchase of consultancy services if the Agency does not have suitable staff available to be involved with the scientific evaluation of applications; - studies already carried out or subscriptions from to specialist research institutions - payments for testing and sampling by the official medicines control laboratory under the European Department for Quality of Medicines of the European Pharmacopoeia
Din l- approprjazzjoni tkopri: - infiq fuq Rapporteurs u Ko- rapporteurs għal studji speċjalizzati u konsultazzjonijiet li jingħataw b’ kuntratt lil esperti ikkwalifikati ħafna (individwi jew ditti), kif hemm provdut fl- Artikolu 62( 3) tar- Regolament (KE) Nru 726/ 2004; xiri ta ’ servizzi ta ’ konsultazzjoni jekk l- Aġenzija ma jkollhiex biżżejjed persunal adatt sabiex ikun involut fl- evalwazzjoni xjentifika ta ’ l- applikazzjonijiet; - studji diġà mwettqa jew sottoskrizzjonijiet għal istituzzjonijiet ta ’ riċerka speċjalista - pagamenti għall- ittestjar u teħid ta ’ kampjuni mil- laboratorju uffiċjali ta ’ kontroll tal- mediċini taħt id- Dipartiment Ewropew għall- Kwalità tal- Mediċini tal- Farmakopea Ewropea
Evaluation of designated orphan medicinal products
Valutazzjoni ta 'mediċinali ltiema desinjati
This appropriation is intended to cover expenditure on the evaluation of designated orphan medicinal products on specialised studies and consultations contracted out to highly qualified experts (individuals or firms) if the Agency does not have suitable staff available to carry out such studies, as provided for in Article 53(3) of Council Regulation (EEC) No 2309/93 or Article 62(3) of European Parliament and Council Regulation (EC) No 726/2004 as appropriate.
Din l- approprjazzjoni hija maħsuba sabiex tkopri nfiq għall - valutazzjoni ta 'prodotti mediċinali ltiema desinjati fuq studji u konsultazzjonijiet speċjalizzati mogħtija b' kuntratt lil esperti b' kwalifiċi għolja (individwi jew intrapriżi) fil- każ li l- Aġenzija m' għandhiex il- personal adattat sabiex iwettaq dawn l- istudji, kif previst fl- Artikolu 53( 3) tar- Regolament tal- Kunsill (KEE) Nru 2309/ 93 jew l- Artikolu 62( 3) tar- Regolament tal- Parlament Ewropew u tal- Kunsill (KE) Nru 726/ 2004 kif applikabbli.
With regard to orphan medicinal products it also covers the purchase of studies already carried out or subscriptions from specialist research institutions and payments for testing and sampling by the official medicines control laboratory under the European Department for Quality of Medicines of the European Pharmacopoeia.
Fil- każ ta 'prodotti mediċinali ltiema tkopri wkoll ix- xiri ta' studji diġà mwettqa jew abbonamenti ma istituzzjonijiet speċjalisti ta 'ricerka u ħlas għall- ittestjar u t- teħid ta' kampjuni mill - laboratorju uffiċjali għall- kontroll tal- mediċini tad- Dipartiment Ewropew għall- Kwalità tal- Mediċini tal- Farmakopea Ewropea.
Special activities
Attivitajiet speċjali
deleted deleted
imħassar imħassar
0.— This appropriation is intended to cover expenditure for the special activities in accordance with the applicable decision of the Management Board.
0. — Din l- approprjazzjoni hija maħsuba sabiex tkopri l- infiq għall - attivitajiet speċjali skond id- deċiżjoni applikabbli tal- Bord ta 'Tmexxija.
302
302 Spejjeż ta 'Traduzzjoni 3020
Translation expenses
Iċ- Ċentru ta 'Traduzzjoni, il- Lussemburgu
This appropriation is intended to cover the costs of translations sent to the Translation Centre in Luxembourg for all texts directly connected with the implementation of the Agency's work programme.
Din l- approprjazzjoni hija maħsuba sabiex tkopri l- ispejjeż ta 'traduzzjonijiet mibgħuta liċ- Ċentru ta' Traduzzjoni fil - Lussemburgu, għat- testi kollha direttament marbuta ma 'l - implimentazzjoni tal- programm ta' xogħol ta 'l- Aġenzija.
Other translations
Traduzzjonijiet oħra
This appropriation covers the cost of checking of translations of product information by the member states.
Din l- approprijazzjoni hija ntiża sabiex tkopri spejjeż ta ’ verifika għat- traduzzjonijiet li jsiru mill- Istati Membri fir- rigward ta ’ l - informazzjoni dwar il- prodotti.
3,182,247.00
Studji u konsulenti
Studies and consultants
Studji u konsulenti
This appropriation is intended to cover costs of concluding professional service contracts and evaluation studies in relation to the Agency's activities.
Din l- approprjazzjoni hija maħsuba sabiex tkopri l- ispejjeż ta 'kuntratti għas- servizzi professjonali u studji ta' valutazzjoni fir - rigward ta 'l- attivitajiet ta' l- A ġenzija.
Article 3 0 3 — Total Information and publications
Informazzjoni u pubblikazzjonijiet
Information and publications
Informazzjoni u pubblikazzjonijiet
This appropriation covers the cost of preparing, editing and publishing, in whichever form, the Activities Report and other publications of the Agency, including, for example, costs of paper, typing, copying or printing, reproduction of slides, photos, posters, distribution and other freelance activities and costs incurred in raising awareness of the agency and its activities as well as publications related to procurement procedures
Din l- approprjazzjoni tkopri n- nefqa għall- preparazzjoni, l - editjar u l- pubblikazzjoni ta ’ Rapporti ta ’ Attivitajiet u ta ’ pubblikazzjonijiet oħra ta ’ l- Aġenzija fi kwalunkwe forma, inkluża per eżempju n- nefqa dovuta għall- karti, l- ittajpjar, l - ikkupjar jew l- istampar, ir- riproduzzjoni ta ’ slajds, ritratti, posters, distribuzzjoni u attivitajiet u nfiq ieħor freelance li sar matul il- ħidma konnessa mal- qawmien ta ’ kuxjenza dwar l - Aġenzija u l- attivitajiet tagħa, kif ukoll pubblikazzjonijiet relatati ma ’ proċeduri ta ’ xiri
305
305 Programmi Komunitarji 3050
Community programmes
Programmi Komunitarji
This appropriation is intended to cover expenditure required to execute Community programmes such as the Pan-European Regulatory Forum or other programmes undertaken by the Agency at the request of the European Commission, or other institutions of the European Union and authorised by the Agency's Management Board.
Din l- approprjazzjoni hija maħsuba sabiex tkopri l- infiq meħtieġ sabiex jiġu esegwiti programmi Komunitarji bħall- Pan European Regulatory Forum jew programmi oħra li tidħol għalihom l- EMEA fuq talba tal- Kummissjoni Ewropea, jew istituzzjonijiet oħra ta 'l- Unjoni Ewropea u awtorizzati mill- Bord ta' Tmexxija ta 'l- Aġenzija.
The appropriation covers travel, subsistence of members of the Management Board, Scientific Committee and their working parties and of CEEC delegates and of experts.
L- Appropjazzjoni tkopri l- ispejjeż ta 'l- ivvjaġġar, u ta' l- għixien ta 'membri tal- Bord ta' Tmexxija, tal - Kumitat Xjentifiku u l- gruppi tax- xogħol tagħhom u ta 'delegati mill- pajjiżi ta' l- Ewropa ċentrali u tal- lvant u ta 'esperti.
It also covers the costs of organising meetings, fees and travel expenses of interpreters or conference operators, translation costs where relevant, the costs of Agency staff attending such meetings, interim and other staff to assist in the execution of the programme, IT- related expenditure and other costs in relation to these activities.
L- Appropjazzjoni tkopri wkoll l- ispejjeż għall- organizzazzjoni ta 'laqgħat, miżati u spejjeż ta' l- ivvjaġġar ta 'interpreti jew operaturi ta' konferenzi, spejjeż ta 'traduzzjoni meta rilevanti, l - ispejjeż ta' personal ta 'l- EMEA li jattendi dawn il- laqgħat, personal interim u ieħor sabiex jassisti fl- esekuzzjoni tal - programm, infiq relatat ma' l- IT u spejjeż oħra fir- rigward ta 'dawn l- attivitajiet.
Article 3 0 5 — Total
Artikolu 3 0 5 — Total
OTHER EXPENDITURE
NFIQ IEĦOR
— TOTAL Title 3 — Total
KAPITOLU 3 0 — Total Titolu 3 — Total
90 PROVISIONAL APPROPRIATIONS 900
90 APPROPRJAZZJONIJIET 900
Provisional appropriations CHAPTER 9 0
KAPITOLU 9 0 — Total p. m.
Title 9 — Total
Titolu 9 — Total p. m.
9 of 10 ESTABLISHMENT PLAN
11 of 12 Pjan ta ’ twaqqif
Function group and grade
Postijiet tax- xogħol temporanji Kategorija u grad
1 3 4 5 34 33 33 20 41 43 22 9 248 - 6 2 11 14 33 34 56 26 19 26 227 475
11 14 33 34 56 26 19 26
1 3 4 6 36 34 34 35 40 38 34 17 282 - 6 5 12 15 38 39 46 30 25 32 248 530
12 15 38 39 46 30 25 32
CONTRACT AGENTS Function Group
Total Kategorija AST
Actual as per 31.12.2007
AĠENTI B' KUNTRATT
Planned FTE DB 2009
2009
SECONDED EXPERTS
ESPERTI NAZZJONALI
LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S) MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES
LISTA TA` L- ISMIJIET, GĦAMLA FARMAĊEWTIKA (GĦAMLIET FARMAĊEWTIĊI), QAWWA (QAWWIET) TAL- PRODOTT( I) MEDIĊINALI, MNEJN JINGĦATA, L - APPLIKANT( I), ID- DETENTUR( I) TA` L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ FL- ISTATI MEMBRI Stat Membru
Marketing Authorisation
Id- Detentur ta ’ l - Awtorizzazzjoni għat- tqegħid fis- suq
Invented name Name
Isem Ivvintat Isem
administration
Mnjen jingħata
AT - Austria
AT - Awstrija
Bayer HealthCare AG 51368 Leverkusen Germany
Bayer HealthCare AG 51368 Leverkusen Ġermanja
BE - Belgium
BE - Belġju
Bayer AG 51368 Leverkusen Germany
Bayer AG 51368 Leverkusen Ġermanja
DE - Germany
DE - Ġermanja
DK - Denmark
DK - Danimarka
EL - Greece
EL - Greċja
Bayer plc Bayer Schering Pharma Bayer House Strawberry Hill Newbury Berkshire RG14 1JA UK
Bayer plc Bayer Schering Pharma Bayer House Strawberry Hill Newbury Berkshire RG14 1JA Renju Unit
ES - Spain
ES - Spanja
Baix Llobregat, 3 y 5 08970 Sant Joan Despi - Barcelona Spain
Baix Llobregat, 3 y 5 08970 Sant Joan Despi - Barcelona Spanja
FI - Finland
FI - Finlandja
2 IT - Italy
IT - Italja
Viale Shakespeare, 47 00144 Roma Italy
Viale Shakespeare, 47 00144 Roma Italja
LU - Luxembourg
LU - Lussemburgu
Bayer Healthcare AG 51368 Leverkusen Germany
Bayer Healthcare AG 51368 Leverkusen Ġermanja
PT - Portugal
PT - Portugall
SE - Sweden
SE - Svezja
Bayer HealthCare AG 51368 Leverkusen Germany
Bayer HealthCare AG 51368 Leverkusen Ġermanja ANNESS II
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET PRESENTED BY THE EMEA
KONKLUŻJONIJIET XJENTIFIĊI U RAĠUNIJIET GĦALL- EMENDI TAS- SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT U L- FULJETT TA ’ TAGĦRIF IPPREŻENTATI MILL- EMEA KONKLUŻJONIJIET XJENTIFIĊI
Actira film-coated tablets contain 400 mg moxifloxacin as hydrochloride.
Il- pilloli miksijin b’ rita ta ’ Actira fihom 400 mg moxifloxacin bħala idroklorur.
It is approved for the treatment of the following bacterial infections if they are caused by bacteria susceptible to moxifloxacin:
Dan il- prodott huwa approvat għat- trattament ta ’ l- infezzjonijiet batteriċi li ġejjin jekk ikunu kkawżati minn batterji suxxettibbli għal moxifloxacin:
- Acute exacerbation of chronic bronchitis
- Tqanqil akut tal- bronkite kronika
- Community acquired pneumonia, except severe cases
- Infezzjonijiet tal- pulmun miksuba mill- komunità, ħlief każijiet severi
- Acute bacterial sinusitis (adequately diagnosed).
- Sinusite batterika akuta (b’ dijanjosi xierqa).
The tablets have to be taken orally once daily for up to 10 days, depending on the indication.
Il- pilloli jridu jittieħdu mill- ħalq kuljum għal massimu ta ’ għaxart ijiem, skond l- indikazzjoni.
In clinical trials the tablets have been studied for up to 14 days treatment.
Fl - istudji kliniċi il- pilloli ġew studjati sa massimu ta ’ 14- il jum trattament.
Actira was initially approved in June 1999.
Actira kien approvat inizjalment f’ Ġunju ta ’ l- 1999.
This procedure is a referral following a Mutual Recognition Procedure concerning the above variation application which was submitted for Actira film-coated tablets to Germany as Reference Member State (RMS) and the Concerned Member States (CMS) AT, BE, DK, EL, ES, FI, IT, LU, PT and SE on 5 December 2006.
Din il- proċedura hija riferiment wara Proċedura ta ’ Għarfien Reċiproku dwar l- applikazzjoni tal - varjazzjoni msemmija fuq li ġiet sottomessa għall- pilloli miksijin b’ rita ta ’ Actira lill- Ġermanja bħala Stat Membru ta ’ Referenza (RMS) u lill- Istati Membri Konċernati (CMS) AT, BE, DK, EL, ES, FI, IT, LU, PT u SE fil- 5 ta ’ Diċembru ta ’ l- 2006.
This Mutual Recognition variation procedure was started on 7 December 2006.
Din il- proċedura ta ’ varjazzjoni tal- Għarfien Reċiproku nbdiet fis- 7 ta ’ Diċembru ta ’ l- 2006.
The MRP variation application DE/ H/ 158/ 01/ II/ 32 concerned an extension of the indication to include the treatment of mild to moderate pelvic inflammatory disease (PID), i. e. infections of upper genital tract, including salpingitis and endometritis.
L- applikazzjoni tal- varjazzjoni ta ’ l- MRP DE/ H/ 158/ 01/ II/ 32 kienet dwar estensjoni ta ’ l- indikazzjoni biex ikun inkluż it- trattament tal- marda infjammatorja tal- pelvis (PID) moderata jew severa, jiġifieri infezzjonijiet tal- parti ta ’ fuq tal- passaġġ ġenitali, inklużi s- salpinġite u l- endometrite.
Objections and concerns over the efficacy and safety of Actira in the proposed indication were raised during the Mutual Recognition variation procedure.
Waqt il- proċedura tal- varjazzjoni tal- Għarfien Reċiproku tqajmu objezzjonijiet u tħassib dwar l - effikaċja u s- sigurtà ta ’ Actira fl- indikazzjoni proposta.
In view of these concerns, during the Mutual Recognition Procedure, Belgium considered that a positive benefit / risk balance had not been demonstrated and more robust evidence should be submitted in order to grant the indication applied for.
Fid- dawl ta ’ dan it- tħassib, waqt il- Proċedura ta ’ Għarfien Reċiproku, il- Belġju kkunsidra li ma kienx intwera bilanċ pożittiv bejn il- benefiċċju u r - riskju u li kellha tiġi ppreżentata evidenza iktar robusta biex tiġi approvata l- indikazzjoni li għaliha kienet qed issir l- applikazzjoni.
As these concerns were not resolved during the course of the variation procedure, a notification of an official referral for Arbitration, under Article 6(12) of Commission Regulation EC No 1084/ 2003, to the CHMP was made by Belgium on 19 October 2007.
Billi dan it- tħassib ma ġiex riżolt waqt il- proċedura ta ’ varjazzjoni, fid- 19 ta ’ Ottubru ta ’ l- 2007 il - Belġju għamel notifika ta ’ riferiment uffiċjali għall- Arbitraġġ lill- EMEA, skond l- Artiklu 6( 12) tar - Regolament tal- Kummissjoni KE Nru 1084/ 2003.
The main unresolved areas of concern identified by Belgium were in terms of efficacy the emergence of moxifloxacin-resistant strains of N. gonorrhoeae and the feasibility of the treatment in the proposed indication in clinical practice.
L- oqsma ewlenin ta ’ tħassib mhux riżolti li identifika l- Belġju kellhom x’ jaqsmu ma ’ l- effikaċja ta ’ l - emerġenza ta ’ razez ta ’ N. gonorrhoeae reżistenti għal moxifloxacin u ta ’ kemm kien fattibbli t - trattament fl- indikazzjoni proposta f’ termini kliniċi.
In terms of safety the longer treatment duration, the risk of effects on cartilage in young patients and the risk of QT-prolongation were of concern.
F’ termini ta ’ sigurtà, il- fatt li t- trattament kien se jkun itwal, ir- riskju ta ’ effetti fuq il- qarquċa f’ pazjenti żgħażagħ u r- riskju li titwal it- taqsima QT ta ’ l - ECG kienu ta ’ tħassib.
The Referral procedure was initiated on 15 November 2007 with the adoption of a CHMP List of Questions to be addressed by the MAHs.
Il- proċedura ta ’ Riferiment inbdiet fil- 15 ta ’ Novembru ta ’ l- 2007 bl- adozzjoni ta ’ Lista ta ’ Mistoqsijiet tas- CHMP li kellhom jiġu indirizzati mill- MAHs.
Efficacy
L- Effikaċja
It became evident during the course of the variation preceding this referral that an empirical therapy of PID with moxifloxacin should be avoided due to the high portion of N. gonorrhoeae being resistant to moxifloxacin and other quinolones.
Matul il- proċedura tal- varjazzjoni ta ’ qabel dan ir- riferiment kien sar evidenti li kellha tiġi evitata terapija empirika b’ moxifloxacin għall- PID minħabba l- proporzjon għoli ta ’ N. gonorrhoeae reżistenti għall- moxifloxacin u quinilones oħra.
However it was questioned that this might not be compatible with clinical practice.
Madankollu kien hemm mistoqsijiet dwar jekk dan kienx kompatibbli mal- prattika klinika.
The review of available guidelines and clinical efficacy data showed that moxifloxacin can be used for treatment of PID in the sense of a monotherapy only after results of microbiological testing are available.
L- analiżi tal- linji gwida disponibbli u tad- dejta ta ’ l- effikaċja klinika wrew li moxifloxavin jista ’ jintuża għat- trattament tal- PID bħala monoterapija biss wara li jkunu nkisbu r- riżultati tal- provi mikrobijoloġiċi.
In clinical practice these cases are usually restricted to cases when a combination with an approved agent active against fluoroquinolone resistant N. gonorrhoeae is not possible or in cases of therapeutic failure with a different therapy.
Fil- prattika klinika dawn il- każijiet ġeneralment kienu ristretti għal każijiet fejn ma jkunx possibbli li ssir kombinazzjoni ma ’ aġent approvat attiv kontra N. gonorrhoeae reżistenti għal fluoroquinolone jew f’ każijiet ta ’ falliment terapewtiku b’ terapija differenti.
5 The CHMP considered that due to the emergence of fluoroquinolone-resistant N. gonorrhoeae strains moxifloxacin should not be used in empirical monotherapy of mild to moderate PID, unless a resistance against moxifloxacin can be ruled out.
Is- CHMP ikkunsidra li minħabba t- tkattir ta ’ razez ta ’ N. gonorrhoeae reżistenti għal fluoroquinolone, moxifloxacin ma għandux jintuża fil- monoterapija empirika tal- PID ħafifa jew moderata, sakemm ma tkunx tista ’ tiġi eskluża reżistenza għal kontra moxifloxacin.
In clinical practice, this would mean that moxifloxacin should be used in combination with an approved agent active against fluoroquinolone resistant N. gonorrhoeae (e. g. a cephalosporin) for empirical treatment of PID unless moxifloxacin- resistant N. gonorrhoeae can be excluded.
Fil- prattika klinika, dan kien ifisser li moxifloxacin għandu jintuża flimkien ma ’ l- aġent approvat attiv kontra N. gonorrhoeae (per eżempju cephalosporin) għat- trattament tal- PID sakemm ma tkunx tista ’ tiġi eskluża N. gonorrhoeae reżistenti għal moxifloxacin.